5 July 1999

EMBARGOED UNTIL PUBLIC RELEASE BYDIRECTOR-GENERAL OF HEALTH

INQUIRY UNDER S.47

OF

THE HEALTH AND DISABILITY SERVICES ACT 1993

INTO THE PROVISION OF

CHEST PHYSIOTHERAPY TREATMENT

PROVIDED TO PRE-TERM BABIES

AT

NATIONAL WOMENS HOSPITAL

BETWEEN APRIL 1993 AND DECEMBER 1994

Inquiry Members: Helen Cull QC ChairDr Philip Weston NeonatologistJan Adams Director of Nursing

5 July 1999 2

COUNSEL AND PARTIES APPEARING

Assisting Commission - Ms Elizabeth Hird

For Parents - Mr Peter Edwards

For National Womens Hospital - Mr Murray Gilbert

For Health Professional 6 - Mr Greg Everard

and Ms Jacqueline Mulligan

For University of Auckland - Ms Antonia Fisher

Schedule of Witnesses Appearing at the Inquiry

Parents 1a & 1b – 9a & 9bHealth Professionals 1-13Experts 1-18

Published in July 1999 by theMinistry of HealthManatu HauoraPO Box 5013Wellington, New ZealandISBN 0-478-23556-9Internet ISBN 0-478-23558-5.

5 July 1999 3

CONTENTS

Letter of Appointment and Terms of Reference............................................................. 4

Terms Used in the Report ................................................................................................ 8

Chapter One - Summary.........................................................................................11

Chapter Two - The Setting – Neonatology............................................................20

Chapter Three - The Problem – “What Happened” ................................................29

Chapter Four - The Change in Treatment – 1993-1994 ......................................39

Chapter Five - Key Differences in Treatment .......................................................49

Chapter Six - The Assessment of the Treatment................................................88

Chapter Seven - Ethical Issues................................................................................119

Chapter Eight - Training and Supervision.............................................................149

Chapter Nine - Analysis of the Treatment ............................................................165

Chapter Ten - Lessons to be Learned...............................................................174

Appendices

Appendix I - Table Comparison of Physiotherapy Treatments in First 28 Days ..................................................................................180

Appendix II - Case Details of the 13 Babies ........................................................181

Appendix III - Detail of Witnesses from Other Hospitals ......................... [withdrawn]

Appendix IV - Procedure of the Inquiry..................................................................189

Appendix V - Rulings of the Inquiry dated 29.1.99................................................194

Appendix VI - Minutes of Meeting with Inquiry Members dated 29.1.99 ................196

Appendix VII - Decision of Inquiry Regarding a Public or Private Hearing .............200

5 July 1999 4

LETTER OF APPOINTMENT

5 July 1999 5

5 July 1999 6

TERMS OF REFERENCE

TERM ONE

Whether changes were introduced to the provision to chest physiotherapy treatment(the treatment) provided to pre-term babies at NWH in or about April 1993?

TERM TWO

If changes were made:

(a) What key differences were there in the way in which the treatment wasperformed prior to April 1993 and during the period April 1993 and December1994, including comparisons with other selected hospitals?

(b) Did the changes result in patients being given treatment in a manner which failedto meet the protocols which existed at that time either in New Zealand orinternationally governing the intensity and duration of this form of treatment?

(c) Why did NWH change its policy on the administration of this form of treatment?

(d) What steps were taken before and after the changes in treatment wereintroduced, including the: (i) clinical assessments (if any) which were carried out of the need or

reason for the change, or any review of the treatment; (ii) assessments (if any) of the risks associated with the change in

treatment including the steps taken to minimise any risks;

(iii) assessments carried out of the training needs of the staff who would becalled upon to provide the treatment;

(iv) assessments made of the need to seek parental consent for the changein treatment proposed.

(e) Were the steps taken by NWH, before and after introducing the change in theway in which the treatment was performed, consistent with relevant NewZealand or international clinical or ethical guide-lines for effecting changes totreatment protocols?

(f) Were the changes in treatment implemented as planned by NWH?

(g) Was there any training and ongoing supervision provided to staff carrying out thetreatment and was this training and supervision in accordance with relevant NewZealand or international standards or protocols?

(h) What steps were taken by NWH (if any):

(i) To assess the safety and efficacy of the treatment provided during April1993 to December 1994, and

5 July 1999 7

(ii) to inform and support parents with respect to the onset of brain damagein their children if such steps were necessary.

(i) What lessons which can be learned (if any) about the way in which this changein the treatment was planned and implemented for the wider health sector?

5 July 1999 8

TERMS USED IN THE REPORT

NWH - National Womens Hospital

NICU - Neonatal Intensive Care Unit

SCBU - Special Care Baby Unit

P & P - Positioning and Percussion. This term was used at NWHbetween 1993 to 1994 to describe nurses doing aparticular form or technique of nCPT. Nurses positionedand percussed the babies chests.

CLD - Chronic Lung Disease

nCPT - Neonatal Chest Physiotherapy

Endotracheal Tube - Endotracheal tube placed from the nostril to the(ET) trachea (windpipe)Intubation - A tube inserted into the trachea

Extubation - Refers to a baby being taken off a ventilator and removingthe endotracheal tube

ECPE - Encephaloclastic porencephaly being the cerebral lesionthat was seen in the 13 babies at NWH, betweenSeptember 1992 and October 1994. This is also referredto in this Inquiry as the brain lesion.

Peri-VentricularLeukomalacia (PVL) - Cysts in the white matter of the brain, adjacent to the

cerebral ventricles.IVH - Intraventricular haemorrhage – bleeding into the lining of

the fluid spaces in the brain (ventricles). Described as“one of the most serious complications of the treatment ofpre-term babies”.

B - Brief of evidence(Most witnesses presented a written brief of evidencewhich was made available to the Inquiry and to the partiesbefore the hearing which formed the basis of theevidence-in-chief of the witness.)

In footnotes, references to briefs are shown as follows:e.g. B31 p127 Expert x. This refers to page 31 of thebrief, paragraph 127.

SB - Supplementary brief of evidencee.g. SB5 p12 – refers to supplementary brief page 5,paragraph 12

T - Transcript(The transcript of evidence taken in respect of the Inquiry)References are shown as T200, which means page 200of the transcript.

ACC - Accident Compensation Corporation

MMAC - Medical Misadventure Advisory Committee

5 July 1999 9

ROP - Retinopathy of Prematurity

CP - Cerebral Palsy

RDS - Respiratory Distress Syndrome

HMD - Hyaline Membrane Disease

5 July 1999 10

INTRODUCTION

Following a preliminary meeting on 29 January 1999 to determine the procedure of theInquiry, the hearing of the Inquiry commenced on 15 February 1999 as a public hearingand evidence was heard and examined for four weeks.

The evidence of three international witnesses was heard by audiolink and videolinkrespectively, and to accommodate those witnesses, the Inquiry sat in the evening ontwo consecutive nights.

A record of the oral evidence was kept, totalling 883 pages in addition to the writtenbriefs of all the witnesses which were read by them to the Inquiry. A large number ofdocuments and exhibits were also produced including three video tapes of the type ofchest physiotherapy relevant to this Inquiry.

This report has been anonymised to protect the identity of those involved.

5 July 1999 11

CHAPTER ONE

Summary

The problem of chronic lung disease and respiratory failure was a constant impedimentto the successful treatment of sick pre-term babies at all neonatal intensive care unitsduring the 1980’s and early 1990’s. The prolonged use of ventilators to assist and treatrespiratory problems in the very premature neonatal infant contributed to tissue damagein the lungs, which in turn led to respiratory problems and lung damage resulting inchronic lung disease. Sometimes, an infant would survive the early complications ofprematurity often still dependent on a ventilator, only to die some months later fromrespiratory failure.

One of the ways to deal with and overcome chronic lung disease was neonatal chestphysiotherapy. This treatment was being used in other areas of paediatrics to shiftairway blockages as in the case of patients with cystic fibrosis. The regular tapping ofthe external chest assisted in the clearing of the internal secretions and improving lungfunction.

Neonatal chest physiotherapy was practised at National Women’s Hospital (NWH)throughout the 1980’s. In 1985, NWH introduced the technique of percussion by meansof “cupping” or “tapping” using a small plastic face mask on the chest wall of the pre-term baby to loosen thick mucus from the lungs. This method, known throughout thisreport as “percussion” was undertaken by physiotherapists only until June 1993.

During that time, physiotherapy hours had been reduced and because the benefits ofpercussion were seen to improve lung function, the staff at NWH wanted the treatmentavailable overnight as well as during the day, to prevent the deterioration of respiratorycare for the sick pre-term infant. In 1993, after discussion and planning, nurses weretrained by Health Professional 6 to undertake neonatal chest physiotherapy by the useof the technique of percussion. From June 1993, when the training of nurses began, toDecember 1994, when the treatment by percussion was stopped, a total of 76 nurseswere trained and the treatment was available for 24 hours a day, providing six potentialtreatments a day at 4 hourly intervals.

Between September 1992 and June 1993, an unusual brain lesion occurred in threebabies born during this period. A further ten babies born between September 1993 andSeptember 1994 also developed the brain lesion. By February 1994, the medical staffat NWH were concerned that the brain lesion, being an extensive cerebral destruction ofa type not previously observed, had developed in a cluster of very low birth-weightinfants in their unit.

A case control study was undertaken to identify the cause. Following a presentation ofthe study in December 1994, the link was made between chest physiotherapy and thebrain lesion in the 13 babies identified.

As soon as this link was suspected at National Womens Hospital, chest physiotherapyfor pre-term babies was stopped immediately. Until further investigation was carriedout, only two medical clinicians knew of the link and ensured that no further chestphysiotherapy was undertaken.

5 July 1999 12

An immediate re-evaluation of the cases was undertaken during December 1994 andJanuary 1995 which identified enough evidence to support the association betweenchest physiotherapy and the brain lesion. The staff of NWH and the parents of theaffected babies were informed and NWH publicised their findings widely, includingnotifying all neonatal units in Australia and New Zealand.

After contact with most of the parents, National Womens Hospital issued a pressrelease in February 1995, to inform the public and other members of the medicalcommunity of the link or association of chest physiotherapy with the brain lesion, andultimately published a research article in a Medical Journal to disclose their findings.

In informing the parents, the staff of National Womens Hospital indicated that they wouldbe eligible for ACC compensation for medical mishap, as it was considered that thebrain lesion (ECPE) was a serious and rare complication1 of medical treatment.

Applications were made to ACC for compensation, and they were successful.Following receipt of further material and evidence, the Medical Misadventure AdvisoryCommittee of ACC determined that the injury sustained by two babies after receivingchest physiotherapy at National Womens Hospital constituted medical error.2

Following its decision on 21 April 1998, ACC referred the matter to the Director Generalof Health for her consideration under s.5(10) of the Accident Rehabilitation andCompensation Insurance Act 1992.

After consideration of the issues associated with this referral, the Director Generaldirected an Inquiry be carried out into the provision of chest physiotherapy to babies inthe neonatal unit at National Womens Hospital between April 1993 and December 1994.The members of the Inquiry were formally appointed in January 1999 to undertake theInquiry on the terms of reference set out at the commencement of this report.

Findings and Conclusions

The Inquiry was established to make findings on the following terms of reference andwe set out the conclusions which have been reached in relation to each of the terms ofreference. It should be noted that the terms of reference have been premised on thebasis that the change in providing the treatment of neonatal chest physiotherapy wasthe cause of the lesion. It is clear from our findings that the occurrence of the lesionscannot be attributed solely to the change at NWH in the provision of neonatal chestphysiotherapy. Three cases occurred prior to the commencement of the change intreatment and the remainder occurred following the change.

We have found however that there were differences in undertaking the technique ofpercussion at NWH in comparison with other hospitals, in particular the vigour withwhich the percussion was undertaken and the duration of the percussion, combinedwith the variability of the application of the technique by staff at NWH. The importanceof these differences became more apparent after the change in treatment, with 10 of the13 affected babies developing the brain lesion between June 1993 and December 1994.When the treatment was discontinued in December 1994, the brain lesion did notreoccur.

1 B.52 p 247, Health Professional 32 ACC 00020 - 00022

5 July 1999 13

FINDINGS & CONCLUSIONS

ON THE TERMS OF REFERENCE

TERM ONE

Whether changes were introduced to the provision to chest physiotherapytreatment (the treatment) provided to pre-term babies at NWH in or around April1993?

Conclusion

Changes were introduced to the provision of chest physiotherapy treatment (“thetreatment”) provided to pre-term babies at NWH. These changes were:

(a) The treatment of chest physiotherapy was available 24 hours a day, namely amaximum of six times a day, compared to a maximum of four times a day forthe period 1989 to 1993 and a maximum of five times a day between 1985 to1989.

(b) Nurses were introduced to the provision of chest physiotherapy by being trainedin the technique of positioning and percussion. Those nurses (andphysiotherapists) undertook this technique, following completion of the training ofthe nurses, the first of which occurred in June 1993.

5 July 1999 14

TERM TWO

If changes were made:

(a) What key differences were there in the way in which the treatment wasperformed prior to April 1993 and during the period April 1993 andDecember 1994, including comparisons with other selected hospitals?

Conclusion

The reference to April 1993 is not particularly relevant as the change in practice beganto be phased in from June 1993.

(a) There were two changes at NWH after June 1993 as indicated under Term ofReference One: the treatment was available 24 hours per day, and nursesbegan to perform the treatment, namely chest physiotherapy by the technique ofpercussion.

(b) The percussions were given with greater vigour at NWH than at other hospitals.(c) The duration of percussion was greater at NWH than at other hospitals.(d) The stability limits of the baby during physiotherapy were allowed to vary to a

greater degree than at other hospitals.(e) The trend of decreasing need for physiotherapy during 1992-1994 at other

hospitals was not evident at NWH.

(b) Did the changes result in patients being given treatment in a mannerwhich failed to meet the protocols which existed at that time either in NewZealand or internationally governing the intensity and duration of thisform of treatment?

Conclusion

The changes did not result in patients being given treatment in a manner that failed tomeet the protocols in New Zealand or internationally at the time.

The protocols were of variable quality. Although the physiotherapy treatment at NWHwas substantially different from the treatment in other units, this difference would nothave been apparent from inspection of other protocols.

(c) Why did NWH change its policy on the administration of this form oftreatment?

Conclusion

NWH changed its policy on the administration of this form of treatment to provide 24hour care to the babies to prevent overnight deterioration of their condition. The financialconsiderations and physiotherapy resources were secondary to the clinical reasons forthe change.

5 July 1999 15

(d) What steps were taken before and after the changes in treatment wereintroduced, including the:

(i) clinical assessments (if any) which were carried out of the need orreason for the change, or any review of the treatment;

Conclusion

(a) No specific clinical assessments were made of the need, but the evidence fromthe medical, nursing and physiotherapy witnesses indicated it was clinicallymotivated.

(b) The only clinical assessment or review of the treatment after the change wasthe informal review of nurses following their training.

(ii) assessments (if any) of the risks associated with the change intreatment including the steps taken to minimise any risks;

Conclusion

(a) Before the changes were introduced there was an assessment of the risksassociated with the change. They were that nursing staff, untrained inphysiotherapy would carry out the chest physiotherapy technique of positioningand percussion, and that the treatment might not be carried out appropriately.Steps taken to minimise these risks were that only senior nurses undertook thetraining, there was a planned training programme for nurses, and detailednursing protocols were developed. In addition, detailed record keeping wasrequired, and the daytime physiotherapist would leave written instructionsregarding the overnight chest physiotherapy to be performed by the nurses.

(b) After the change there were no assessments of the risk of the chest

physiotherapy treatment until December 1994 when the association wassuspected. This is regrettable because a variety of factors arose which inhindsight can be seen to be indicators of risk. These were the Registrar’scomplaint, the IVH comment and the neck and shoulder pain of the nurses.

At the time, NWH did not perceive any risk from the treatment, as evidenced byits omission from the 50 factors identified in the first case-control study. Oncethe association with the treatment was suspected, a detailed assessment of therisk of the treatment was undertaken.

(iii) assessments carried out of the training needs of the staff whowould be called upon to provide the treatment;

Conclusion

In June 1993 there were three categories of staff providing the treatment:

5 July 1999 16

(a) Health professional 6, who had paid informal visits to overseas units but whowas not formally assessed with respect either to training or to practice.

(b) Physiotherapists, who were assessed by Health Professional 6 on an annualbasis.

(c) The nurses had their training needs assessed and set by the PhysiotherapyWorking Party prior to the change and were trained by the staff membermentioned in (a).

(iv) assessments made of the need to seek parental consent for thechange in treatment proposed.

Conclusion

There were no such assessments made.

(e) Were the steps taken by NWH, before and after introducing the change inthe way in which the treatment was performed, consistent with relevantNew Zealand or international clinical or ethical guidelines for affectingchanges to treatment protocols?

Conclusion

Treatment ProtocolsThe implementation of the changes did not require ethical review or approval, on thewording of the 1991 National Standard, which was applicable in 1993. It would havebeen outside standard practice to seek ethical review at the time of implementing thechange in treatment.

Parental Consent:

(a) For treatment or the change in treatment. Parental consent was not obtained for either the treatment of chest physiotherapy or forthe change in treatment. The consent for a change in treatment was not required, butthe issue of consent to treatments given or undertaken needs to be addressed. Apartfrom treatments which contain a degree of risk or treatments being used for researchpurposes, the present practice of NWH and other units in New Zealand is not to seekconsent for treatment. The various treatments and procedures undertaken in a neonatal intensive care unit,given the exigency of the situation and the developing technology, requires the issue ofinformed consent from parents on behalf of their babies, particularly in the neonatalintensive care unit, to be properly addressed for the future at a national level. (b) For trainingParental consent for training was not sought. The relevant guidelines require parentalconsent for training, although no distinction is drawn between training of clinical staffand training of students.

5 July 1999 17

Because of the divergence between national practice and the guidelines, furtherclarification of this issue at a national level is required.

ResearchThe case-control study being a retrospective review of medical records was researchbut also conformed to the definition of “internal clinical audit” contained in the 1991-1994Ethical Standard. It therefore did not require referral to the Ethics Committee.

Patient AdvocacyThe Patient Advocacy Service was not involved in assisting the parents in this Inquiry.Positive steps must be taken to ensure that referrals of patients, including parentsreceiving news such as in this Inquiry, to the Patient Advocacy Service is undertakenand encouraged to ensure full accessibility by patients to a service which may assistthem in obtaining information and liaising with the clinicians of the relevant section of theHospital. The positive role which the Patient Advocacy Service can play in assistingpatients should be encouraged.

Peer ReviewTo ensure safe practice at all levels within the health profession including specialistsenior experts, effective peer review must be undertaken, even if access to overseasexperts is required in some circumstances.

(f) Were the changes in treatment implemented as planned by NWH?

Conclusion

The changes in treatment were implemented as planned with two exceptions.(i) The training of the nurses appeared to take longer than had originally been

anticipated(ii) The clinical audit planned for 1994 did not take place.

(g) Was there any training and ongoing supervision provided to staff carryingout the treatment and was this training and supervision in accordancewith relevant New Zealand or international standards or protocols?

Conclusion

(a) (i) The training of nurses at NWH in the treatment was thorough.(ii) The supervision of the nurses was informal and inconsistent.(iii) The training and supervision of the staff physiotherapists was

satisfactory.(iv) Health Professional 6 learnt the treatment by observing other pioneers in

the technique and introducing it to NWH. This occurred without technical supervisionand without peer review, which was not required in any relevant New Zealand Code ofEthics or practice guideline at the relevant time. This was consistent with theinternational practice, in that international standards did not appear to require ongoingsupervision for that particular category of health professional.

(b) There are no relevant standards and protocols for training and supervision ofstaff carrying out this treatment.

5 July 1999 18

(h) What steps were taken by NWH (if any):

(i) To assess the safety and efficacy of the treatment provided duringApril 1993 to December 1994,

Conclusion

The steps taken by NWH to research and publicise the results of the link between chestphysiotherapy treatment as practised at NWH and the brain lesion were timely andappropriate. NWH deserve commendation for their openness in acknowledging thetragic occurrence within their unit, to alert others of the potential consequences.

(ii) to inform and support parents with respect to the onset of braindamage in their children if such steps were necessary.

Conclusion

(a) The initial steps taken by NWH staff to inform parents of the brain damage totheir children were appropriate, professional and timely, with the exception of theomission to involve the Patient Advocacy Service.

(b) Referral to the Patient Advocacy Service could have assisted in providing further

information and support to those parents requiring it.

(i) What lessons which can be learned (if any) about the way in which thischange in the treatment was planned and implemented for the widehealth sector?

5 July 1999 19

Lesson One: Peer Review:

All health professionals who have responsibility for patient care must have effective andregular peer review. This should include a regular review of their clinical and practicalskills under direct observation by peers of equivalent or senior competence.

Lesson Two: Adequate Information of Outcome

Particular care needs to be taken with parents of pre-term infants to ensure that theyhave been informed of the risk of adverse events, in clear and understandable language.

Lesson Three: Detailed Clinical Record Keeping:

The detailed and thorough clinical records at NWH enabled the association betweenchest physiotherapy and the brain lesion to be made. Detailed record keeping isrecommended as good practice for all health professionals.

Lesson Four: Parental Consent in neonatal intensive care units:

A committee comprising consumers of the neo-natal intensive care unit, clinicians andmembers of multi-disciplinary teams should confer to provide a standard approach toconsent, given the range of procedures and the complexity of treatments undertaken ina neo-natal intensive care unit.

Lesson Five: Consent for Training

The issue of a difference in seeking consent between staff training and student trainingneeds to be clarified in the National Ethical Guidelines.

Lesson Six: Clarification of Publication of Internal Audits and EthicsCommittee Approval

The issue of Ethics Committee approval to publicise internal clinical audits should beclarified in the National Standard for Ethics Committees.

Lesson Seven: Patient Advocacy Services

It is recommended that all health professionals be urged to refer consumers to thePatient Advocacy Service, to assist in any outstanding inquiries or needs, which theymay have. In this respect, the role of the Patient Advocacy Service should bestrengthened.

Lesson Eight: Research in Neonatology

The identification of the adverse consequences of chest physiotherapy at NWH is anexample of the importance of audit and research in this speciality. Whilst a high degreeof ethical rigour must be maintained in undertaking such research, it is imperative thatthe scientific questioning process continues. Ongoing neonatal audit and research is tobe encouraged and supported.

CHAPTER TWO

2. THE SETTING - NEONATOLOGY

5 July 1999 20

Description

Before embarking on an analysis of the terms of reference of the Inquiry, it is importantto describe the relevant area of medical science, namely neonatology which is central tothe focus of this Inquiry.

Neonatology is the branch of medicine that provides care for sick newborn infants. It is arelatively new specialty,3 with the term only defined in 1960. Prior to that newborninfants were cared for by obstetric care providers, although paediatricians were taking aprogressively more active role in the care of those infants who were unwell.

The Neonatal Services have evolved in New Zealand such that there are now six unitsproviding the most complex levels of care. These are based at National Women’sHospital, Middlemore Hospital, Waikato Hospital, Wellington Hospital, ChristchurchWomen’s Hospital, and Dunedin Hospital. The level of care provided in these centres isknown internationally as “Level 3” care and includes life-support methods such asmechanical ventilation for prolonged periods. Many other hospitals in New Zealand alsoprovide a slightly lesser level of care, known as “Level 2”. This level of care includesstabilisation of infants requiring ventilatory support, and there is a system of air and roadtransport to transfer these sick infants to a Level 3 centre.

Neonatologists are medical specialists, who are trained through a paediatric trainingprogramme. Neonatal nurses are also trained to a high level of expertise. The physicalenvironment for neonatology include the Neonatal Intensive Care Unit (NICU), andnurses make up the majority of staff in these units. Because of the need for expertise,most NICU’s have a formal system of training in place for new nursing staff and anorganised system of continuing education for existing nursing staff.

Other key staff may also contribute to the care of the babies, although this can varyfrom unit to unit. Such staff include physiotherapists, dieticians, pharmacists,educators, pharmacologists, surgeons, anaesthetists, ophthalmologists, andaudiologists.

Since the advent of neonatology in 1960, the workload has changed dramatically.Whereas the early neonatologists devoted much of their skill to the term and near-termbabies, the current work is predominantly based around care for very premature infants.The average duration of stay for a term baby admitted to a NICU would be a matter of afew days, but a premature baby will need to stay in hospital almost until their full-termdate. For an infant born at 25 weeks (15 weeks early), this would mean a stay of threemonths in hospital.

3 B.53, p. 251, Health Professional 3

5 July 1999 21

Outcomes

(a) Survival Rates

The Inquiry received evidence that indicated an increasing survival rate over a 25year period since 1974 for babies with a birthweight under 1500g.4 Thisbirthweight threshold relates to an approximate gestation of 31 weeks, althoughthere is some variation around this.5 In 1974, only 60% of babies withbirthweight 1000-1500g survived, whereas it is now greater than 95%.

In the category of less than 1000g, the survival rate has improved from 10% to80%.

Neonatal Survival of Inborn VLBW Babies, NWH

Year

1960 1965 1970 1975 1980 1985 1990 1995

Per

cent

age

Sur

viva

l to

28 d

ays

0

20

40

60

80

100

501-1000 g

1001-1500g

4 ACC 00309.5 SB3/4, p.3-5, Health Professional 3

5 July 1999 22

The success of the neonatal intervention was noted by the Obstetric Service,and changes in the threshold for premature delivery occurred, such that morepremature infants were admitted to the Neonatal Services. The staffingresource in all disciplines had to increase progressively, as did physical space inorder to deal with this workload.

(b) Illness

Whilst the evaluation of survival rates (mortality data) were encouraging, 6 theydid not give an adequate indication of the levels of illness (morbidity) that werebeing experienced.

(i) Long-Term Outcomes

The evidence before the Inquiry regarding long-term outcomes at NWH confirmsthat there is an incidence (around 20%) of serious adverse outcome in terms ofneurological functioning, in that some premature infants subsequently havecerebral palsy and/or other disabilities (which are not always apparent duringtheir neonatal admission).7 The accepted trend is that the smaller and/or sickerthe infant, the greater the chance of long-term disability.8

In order to better understand a particular infant’s prospects, it is a routineprocedure in NICU’s to perform head ultrasound scans. These scans areperformed via the soft fontanelle of the infant and allow an image of the brain tobe viewed and recorded. These scans were performed at NWH. They areperformed generally in the first week of life which is the likely time to detect Intra-Ventricular Haemorrhage (IVH) and again at 4-6 weeks, which is the likely time todetect Peri-Ventricular Leukomalacia (PVL).

If IVH is detected, it is graded according to severity, and a prognosis (taking intoaccount other factors) may be assessed.

Similarly, the recognition of PVL carries prognostic significance. It is notuncommon that a prognosis of high likelihood of severe disability would lead todiscussion with parents about withdrawal of intensive care support, althoughsuch withdrawal would only apply to those babies still requiring intensive caresupport. In the evidence before the Inquiry, there were examples in the 13 caseswhere intensive care support was withdrawn due to the severity of theprognostic assessment, based substantially on the ultrasound findings.9

6 T.157 L.17-29; T158 L.1-3;7 T446 l.23-308 T 447 l.1-119 Babies 12, 10, and 4

5 July 1999 23

(ii) Short-Term Outcomes

The short-term morbidity refers to those day-to-day issues that the neonatalteam has to deal with. These include among others, ventilator dependency,chronic lung disease, patent ductus arteriosis, feeding difficulties, electrolyteinstability, necrotising enterocolitis, pneumonia, septicaemia, poor growth,osteopenia, intravenous access and social factors. The ward rounds are a timewhen these factors are discussed by those present, and treatment plansinitiated, altered, or curtailed. The issues of chronic lung disease and osteopeniaare relevant to this Inquiry and require further description.

Chronic Lung Disease (CLD)

There was a sudden upsurge in the survival of premature infants between 1975and 1980. This was the time when assisted ventilation support becameavailable, although it was much less refined than the techniques available today.There was very little research data available at the time to attest to its efficacy,but the effect of ventilation was so beneficial that it was embraced by all Units.Whilst there continued to be marked variation around the world in the fine detailof the technique, the difference between life and death was stark.

Unfortunately, this life-saving technique had some problems. In the lungs, theforced mechanical exchange of vital gases (oxygen and carbon dioxide) actuallycontributed to tissue damage. The tissue damage led to weaknesses in thesmall airway walls, along with inflammation of those walls. Accordingly, therewas an increased amount of fluid and mucous (secretions) in the airways whichtended to block them. The air sacs of the lungs (alveoli) beyond the blockageswere unavailable for gas exchange, and the respiratory system was potentiallycompromised.

This tissue damage did not always occur, and when it did it was of varyingseverity. At the minor end, no treatment was required. Other babies would havesevere lung damage (Chronic Lung Disease) which would require continuedventilator support, with consequent further damage occurring. Sometimes aninfant would survive the early complications of prematurity often still ventilator-dependent, only to die some months later, from respiratory failure.

One of the methods used to deal with Chronic Lung Disease was chestphysiotherapy, (“nCPT as it will be referred to throughout this report). Thistreatment was being used in other areas of paediatrics to shift airway blockages(eg cystic fibrosis). The regular tapping of the external chest was thought toassist in the clearing of the internal secretions, and therefore improve the lungfunction.

Since 1970, Chronic Lung Disease has vexed the care of pre-term infants. In the1980’s an arbitrary definition was arrived at, namely, oxygen dependency at 28days of life, and it was then possible to observe a significant variation in the ratesof Chronic Lung Disease in different Units. It became a unit of measurement forthose (units) that were prepared to collect their data, and allowed comparisonsof treatments at different units. Subsequently, a second and more favoureddefinition has been advocated (oxygen dependency at 36 weeks, eg an infantborn at 28 weeks gestation would be assessed for this at 8 weeks of age).

5 July 1999 24

In1986, Expert 3 carried out an audit of all babies born in New Zealand with abirthweight less than 1500g, who were admitted to a neonatal unit for intensivecare10. For that year, NWH cared for the largest number of babies, had one ofthe highest survival rates, and had the lowest rate of chronic lung disease. The28 day Oxygen dependency at NWH was 31%, whereas the other units rangedfrom 33% to 52%. This was at a time when neonatal chest physiotherapy wasbeing used.

The same expert also carried out a further study between 1994-199711 in eachof the units in New Zealand, comparing Chronic Lung Disease rates in thevarious centres. Again NWH had the largest number of babies, the lowestmortality, and one of the lowest rates for Chronic Lung Disease. It should benoted that nCPT was not largely used during this time at NWH.

Osteopenia

Osteopenia was a frequent complication of premature infants and arises whenthe mineral stores of the body, particularly phosphate, are depleted, such thatthe bone development is compromised. This leads to weak bones and fractures.Whether these fractures occur spontaneously, or as a result of gentle handlingof the baby is unknown. Rib fractures in this situation are quite common.Physiotherapy was known to be a risk factor for rib fractures. In recent years, thephosphate problem has been better appreciated and nutritional improvementshave led to a decrease in fractures, such that it is now quite unusual to seebabies with fractures.

In this Inquiry, two of the infants affected had rib fractures. The first was Baby1,12 who had evidence of early bone weakness. This may have been a factor inthe case of that particular baby, who has, however, evidently not gone on to havea problem of weak bones. The second was Baby 7.13 Health Professional 3gave evidence that there were only two cases of rib fracture in 1994, anincidence of less than 2%14. This incidence is similar to that suggested byExpert 12,15 who had knowledge of the only other unit of a similar size to NWH.

10 B6, P.13, Expert 311 B6, P.14, Expert 312 Refer Appendix II Case 313 Refer Appendix II Case 1114 B39 p159 Health Professional 315 T783 l.23-26

5 July 1999 25

Parental and Public Expectations of the Neonatal Service

Health Professional 3 gave evidence of the successful outcomes from NeonatalIntensive Care.16 Whilst it is apparent that death and disability are possible outcomes,the most likely outcome is a normal child. Expert 3 indicated that it might be ethicallydifficult to withhold treatment from premature babies where (hypothetically) the parentsmight object to the treatment; this was with reference to babies for whom a goodoutcome could be expected. Health Professional 7 spoke of concern about treatingbabies of 24 and 25 weeks, as being of questionable viability.17

During the Inquiry, each of the parents were asked of their expectations for their infantwhilst in the neonatal unit. The responses indicated that 3 of the parents were not awareof the possibility of death as an outcome, and 11 said that they did not appreciate thatthere was a chance of disability.18 Many gave accounts of the developmental issuesthat were relevant for their child, and Parent 2a spoke bluntly of the impact on a parentof having a child with disabilities.19

Health Professional 3 expressed surprise at these answers20. Health Professionals 321

and 722 described how they talk with parents and identify future outcomes; although thestressful time at which such discussion takes place may mean the information is notunderstood or absorbed.

The latter further stated…

“Society should not be asking us to look after these smaller and smaller babiesif the community is not able to acknowledge that there is always a risk that whatwe do today will be found with hindsight to be harmful… Parents of a very tinybaby want us to help at all costs and they can on occasion expect us to performmiracles. We try to tell them that there are risks associated but we know onlytoo well that at that stage people will focus only on the positive aspects…I do notsee this dilemma changing unless we stop the progression of medicine rightnow”.23

Problems in Neonatology

There are many surviving premature infants in the world today who are healthy and wellas a result of their neonatal care, but who would have been dead or damaged withoutthat care. Some would be in their forties, although most would be below 20 years ofage. There are others who have survived with damage and others that have died.Infants with similar conditions today would be expected to survive well. The history ofthis rapidly maturing specialty has been marked by success and marred by unexpectedproblems. Not all problems were recognised quickly, and some were part ofestablished practice for many years. Health Professional 3 listed them for the Inquiry.24

16 SB 3-4 p 3-5 Health Professional 317 T 441, L.15-1718 T 10 l.3-6; T23 l.10-18; T29 l.11-13; T32 l.5-9; T36 l.20-21; l.26-28; T51 l.1-9; T54 l.3-9; T58 l.1-2; T61 l.26-27; T 75

l.10-11; T78 l.3-619 T.31, L.10-1620 T.212 L.23-2421 B51, P.237-243 Health Professional 322 B7 p.21 Health Professional 723 B10, p.32 Health Professional 724 B53 p251 Health Professional 3. There were a number of other adverse outcomes from the use of medicalinterventions. They include:

- Kernicterus from sulfonamide use in the 1950’s (1000’s affected)

5 July 1999 26

Retinopathy and Cerebral Palsy

“Retinopathy of Prematurity (ROP) is a condition of the eye. It occurs in prematureinfants, and was first recognised in 1942. At that time, the high death rate of prematureinfants was recognised, mostly due to respiratory disease. Oxygen supplementationwas used widely in order to help these babies. ROP became increasingly common,blinding 10,000 babies around the world. It was not until 1954 that the use ofsupplemental oxygen was clearly found to be related to the development of ROP.Accordingly, there was a severe curtailment in the use of oxygen supplementation.

The severe oxygen restriction which followed acceptance of the role of oxygen in ROPwas associated with increased deaths among premature infants. Cerebral Palsy (CP)is a condition of the brain affecting muscle function in the body. It occurs from injury tothe developing brain, sometimes due to lack of oxygen to the brain cells. CP was foundto be much more likely in those babies which received restricted oxygensupplementation. These adverse effects were first noted in 1955, and continued until anew ventilation strategy became available in the early 1960’s.

This related pair of examples was given to the Inquiry as an example of how Neonatalmedicine has had to develop rules and guidelines through which to benefit its patients,often following the recognition of the adverse effects of a treatment. The correction ofone problem as demonstrated by these examples, has led to the development ofanother.

Health Professional 5 in giving evidence foreshadowed that there would be more:

“… these phenomena [have been described] as being frequent and disastrous,but given that a large proportion of medicine is not based on sound research butis based on practices which are widely accepted and thought to be clinicallybeneficial, I fear that we will continue to see these disasters.”25

This statement was made with reference to a recent paper in which Dr Jane Hardinghad stated:

“Nevertheless, we continue to get it right and no doubt we continue to get itwrong. A list of the changes recalled by staff in the newborn unit at NationalWomen’s over the last five to ten years … is a very long list. Only some of thechanges are based on solid research evidence such as randomised controlledtrials. Some we changed because we found out we had it wrong. No doubt the listfor the next few years will show that some of these we have wrong as well." 26

- Grey Syndrome (cardiovascular collapse and death) from chloramphenicol in the 1950’s

(1000’s affected)- Hypoglycaemia, convulsions and developmental delay from starvation policies in

premature infants in the 1950’s and early 1960’s (1000’s affected)- Rapid infusion of volume and sodium bicarbonate in very preterm babies leading to intra-

ventricular haemorrhage in the 1970’s and 1980’s (?100’s affected)- Chronic Lung Disease from ventilation policies in the 1980’s (1000’s affected)- Death and brain damage from stabilisers in drugs in the 1980’s (scores affected)- Encephaloclastic Porencephaly linked to chest physiotherapy in the 1990’s (28

affected)- Acetazolamide and frusemide for post-haemorrhagic ventricular dilatation, resulting in

increased mortality and hydrocephalus, discovered in 1998 (100’s affected)25 T.314 L.3-726 Harding JE (1998) Neonatology: Will the infant learn to speak” New Zealand Medical Journal 1998 iii:434-7

5 July 1999 27

Neonatology in the 1990’s

In the 1990’s, a number of new therapies have become available to treat and/or preventdiseases of prematurity. The most significant of these was the introduction ofsurfactant, but there have been other factors also.

(a) Surfactant

The major cause of death from prematurity was a condition known variously asRespiratory Distress Syndrome (RDS) and Hyaline Membrane Disease (HMD).The two terms are used interchangeably. The condition is due to a lack ofsurfactant in the lungs of the preterm infant. As maturity progresses in utero, sothe likelihood of RDS reduces, such that it is very rare at 36 weeks. However aninfant born at 26 weeks is in grave danger from this condition. Typically, thepremature infants lungs are able to produce surfactant in sufficient quantitiesafter 3 days of life, if the baby can survive. Pioneering research at NWH in theearly 1970’s showed the world that this condition could be reduced if steroidmedications were given to the mother prior to the delivery. Twenty years later(1991), surfactant was available to give directly into the lungs of the infants.Research showed that mortality would reduce by 40%, and it was anticipatedthat there would be much less ventilator dependency.

(b) Other Factors

At the same time, other factors also contributed towards improvements,including new humidifiers for the ventilator circuits, new approaches to thetreatment and prevention of patent ductus arteriosis, new patient triggeredventilators, and new preferences for Continuous Positive Airways Pressure(CPAP). These all combined to reduce the problem of Chronic Lung Disease.

Expert 12 reported that:

“..our physio practices were evolving. I think they have been evolvingsince the late 1970’s. The greatest changes in the practice ofphysiotherapy probably occurred in 1991 after the introduction ofsurfactant. It was around this time that we had a new generation ofventilators, the Fisher and Paykel company had improved humidificationvia their humidifiers, so undoubtedly the requirement for active chestphysiotherapy was declining through that period of time. We saw muchless in the way of severe collapse/consolidation, chronic neonatal lungdisease was improving and overall the requirement for active chestphysiotherapy was declining.”27

Similar views were echoed by Experts 1428, Expert 929 and 730 (from Hospitals1 and 2). Expert 17 (then at Overseas Hospital 4) did not agree that the needhad declined, although his/her evidence also indicated that the use of percussivephysiotherapy was much more restrained than at NWH31.

27 T.777 l.10-2028 T.836, l.11-1729 B4 p2 Expert 930 T.661, l.27-2831 T.874, l.6-20

5 July 1999 28

In general, the need for active chest physiotherapy in many Units was reducingin the early 1990’s, but that same trend did not seem to be apparent at NWH,despite the use of surfactant at NWH.32

Summary

Staff in neonatal units have had to adapt to ever changing standards of care, along withnew therapies and equipment. The likelihood of survival for a very pre-term infant hasvastly improved in the 1990’s compared with previous decades, and the likelihood ofdisability, whilst real, has not increased. A baby with a birth weight of 800g with the bestavailable care in 1970 was much more likely to die than a baby in 1990. Whilst thestandard of care in 1970 would be considered deficient in 1990, the death of that infantcould not be attributable to deficiencies in care.

Neonatology has had remarkable successes, but mixed with that there have also beenfailures. Some of the failures took many years to become apparent, but the recognitionof adverse effects by researchers has led to a better understanding of the infantcondition, and to further improvements.

One of the conditions requiring special attention in the 1980’s was chronic lung disease,a consequence of the life-saving ventilation treatment. With improvements in this andother conditions has come the reduction in the need for some of the therapiespreviously required commonly. Physiotherapy was one such therapy that many unitswere finding less need for in 1993-1994.

32 T28 l.2

5 July 1999 29

CHAPTER THREE

THE PROBLEM – “WHAT HAPPENED”

The Sequence of Events

In 1985, Health Professional 6 was granted one week’s leave to visit Overseas Hospital2 to look at the role of the physiotherapist in the neonatal unit.33 While there, HealthProfessional 6 first observed the technique of “cupping”.34 This technique, which iscalled “percussion” at National Women’s Hospital, consisted of postural drainage and“cupping” or “tapping” using a Bennetts mask (later being replaced by the Laerdal mask)on the chest wall of the preterm baby, followed by suctioning.

During this week, Health Professional 6 observed the percussion technique and inhis/her evidence to the inquiry, stated “my lasting impressions at that time were theintensity of the cupping (percussion) and the frequency of treatment”.35

Health Professional 6 noted that one hourly treatment was given when there was severecollapse and consolidation or excessive secretions present in the preterm infant’s lungswhich could not be removed by suction alone. Each lung segment was drained forthree to five minutes with treatment time no longer than ten to fifteen minutes and theirpost-extubation treatment (ie after the tube was removed) was hourly for six hourstreating only one position each treatment, and two hourly treatment for the next two tothree days.36

Following his/her return, Health Professional 6 discussed with consultant neonatalpaediatricians the use of the technique of percussion along with the development of achest physiotherapy treatment protocol for ventilated and non-ventilated babies.37 Thiswas to include both before and after extubation (ie before and after the tube into thetrachea was removed.)

In November 1985 percussion was introduced to NWH. Prior to the introduction ofpercussion, the respiratory physiotherapy techniques were:-

(a) vibration being a fine oscillatory movement of the chest wall on expiration usingthe pads of one’s fingers (used for small preterm babies);

(b) clapping the chest using the whole hand cupped (for larger post-term babies);(c) battery operated toothbrush for small unstable babies (the bristles from the

toothbrush were removed and the “head” of the toothbrush was used like aminiature vibrator) – the “head” was placed on gauze sponges on the preterminfant’s chest;

(d) electric vibrator (for larger unstable babies).

After discussion with the neonatal paediatricians at NWH, Health Professional 6recommended that the technique of percussion be carried out four hourly for intubatedbabies (ie for babies with tubes inserted into the lung) and two hourly for a period ofeight hours post-extubation then four hourly for the following 48 hours. (It should be

33 B6, p4, Health Professional 634 Ibid35 B7, p4, Health Professional 636 Ibid37 B7 p5, Health Professional 6

5 July 1999 30

noted that the frequency was less than that observed overseas, which he/she believedwas excessive.)

Health Professional 6 wrote the first NWH protocol based on the current literatureavailable at the time, protocols from Overseas Hospitals 2 and 5 – (the latter being onein which Health Professional 3 had previously worked) and such other material whichwas available to the NWH physiotherapy department.38 A post-extubation protocol waswritten by the clinical nurse specialist in consultation with Health Professional 6, basedon two research articles and the Overseas Hospital 2 protocol.39

The evidence from Health Professional 6 is pertinent:

“As was the practice at that time these protocols were reviewed by all those staffphysiotherapists who provided neonatal chest physiotherapy (nCPT) but theywere not reviewed by the senior medical staff. At that time, as in 1999,physiotherapists were responsible for their own protocols without the detailedscrutiny of medical personnel.” 40

From November 1985 to April 1989, the physiotherapy service at National Womensprovided an evening shift 7 days per week up to 12 midnight (then 8pm) a day for thewhole hospital, but with a significant input into the Neonatal Unit.41

Referral for neonatal chest physiotherapy (“nCPT”) was made in writing by the medicalstaff following discussion on all referrals through attendance of physiotherapy staff atthe daily chest x-ray round and the relevant parts of the daily ward round, “so thatmedical, nursing and physiotherapy staff could have an input”.42

In April 1989, difficulties were experienced in recruiting physiotherapy staff and therostered hours of physiotherapists were reduced. Instead of nCPT by cupping beingavailable up to five times a day, it was reduced to four times a day in 1989. BecausenCPT was seen to be an important part of the medical management of ventilated babiesand babies with severe chronic lung disease, the loss of the extra treatment wasconsidered to be detrimental, and in June 1989 a teaching programme was introducedto teach nurses to undertake nCPT. Although nurses completed the lectures and satthe exam, the programme of introducing nurses to undertake chest physiotherapy didnot eventuate.

During this time, Health Professional 6 conducted courses for physiotherapiststhroughout New Zealand, lectured, and set the examination for the neonatal nurses,both in their neonatal nursing courses and in the programme commenced and laterabandoned in 1989.

On the 6th November 1991, a Physiotherapy Working Party was established to explorethe possibility of nurses doing nCPT. There had been concern that the physiotherapyservice was only able to meet the demands of the neonatal unit by rostering morephysiotherapists in the peak times to cover the workload. The Inquiry was told that at

38 B7 p5 Health Professional 639 Finer, N N., Moriarty, R R., Boyd, J., Phillips, H J., Stewart, A R., and Ulan, O. (1979) “Post-Extubation at Atelectasis:A Retrospective Review and a Prospective Controlled Study”, Journal of Paediatrics, 94,110-113Wyman & Kuhns (1977) “Lobar Opacification of the Lung after Tracheal Extubation in Neonates” Journal ofPaediatrics, 91,109-112 and the Overseas Hospital 2 chest physiotherapy documents.40 B7, p5, Health Professional 641 B9 p9, Health Professional 642 Ibid p.8,p7;

5 July 1999 31

times staff exhaustion was high from working long hours with frequent call-backs atnight.43

From 1991 to March 1993, despite earlier consensus decisions “that physiotherapistsare the best people to provide respiratory physiotherapy to the neonate”44, discussionwas undertaken on specific criteria and competency levels required for nursing staff toundertake nCPT. Planning for this change was undertaken both in relation to theteaching of senior experienced nursing staff and from a comparison with informationreceived from three other Neonatal Intensive Care Units (“NICU’s”) in New Zealand.

The teaching of nursing staff was to be undertaken by Health Professional 6, whoundertook most if not all lectures, practical demonstrations, practical assessments andreviews. Although assisted by another physiotherapist from time to time, HealthProfessional 6 carried out the training both in theory and in practice.

In June 1993, the training of nurses to undertake chest physiotherapy began, with theresult that treatment was available for 24 hours a day, with the availability of up to sixtreatments a day at four hourly intervals. By December 1994, a total of 76 nurses weretrained and did undertake neonatal chest physiotherapy by the technique of cuppingduring the period June 1993 to December 1994. It was referred to as positioning andpercussion, by nursing staff.

The Occurrence of the Brain Lesion - ECPE

Three of the affected children were born in the same week of early 1994. Thegestational age of all three babies was 26 weeks, ie 14 weeks early.

Baby 10 (when 11 days old) was noted to have an extensive brain lesion, and intensivecare treatment was stopped after this lesion was noted to be extensive almost a weeklater. The baby died two days afterwards, and a brain post-mortem examination wascarried out.

Baby 3, at the age of one month, was found to have an extensive lesion of the brain.This was not of the same severity as that of Baby 10, and Baby 3 continued to makeprogress, albeit with some complications along the way.

Baby 4 (at age five days) had evidence of an intra-ventricular haemorrhage at the timeof a first scan. By age three weeks, it became evident that the brain damage wasextensive, and intensive care treatment was withdrawn. Baby 4 died three days afterthat.

These three cases created a significant level of concern for the medical staff at NWH.The pathology report on Baby 10 referred to a similar lesion seen in a baby who haddied on 30 June 1993 whose brain lesion was described as being due to “MiddleCerebral Artery Infarction”. It was recognised even then that this was an unusual lesion.Whilst specific brain abnormalities are a problem with some preterm infants, it wasapparent to the doctors that the lesions seen in this cluster of babies were different fromwhat they normally recognised.

Further cases occurred in 1994, such that Health Professional 3 said:

43 p.11, p7 Health Professional 6;44 B.12, p8, Health Professional 6

5 July 1999 32

“It made me very worried, to the extent that I was dreading the next case thatoccurred. We had babies who were sick, but we thought would survive, who, at amonth of age, their scans showed this dreadful lesion. We had no idea what thecause was. So it filled me with dread.”45

After this cluster, Health Professional 5 and a registrar reviewed the three casestogether with the June 1993 case. The topic of “Cerebral Artery Infarction” was reviewedat a clinical meeting early in 199446, and a suggestion was made that the timing of thelesions might have corresponded with a change in the use of a drug, namelyindomethacin, to mothers prior to delivery47. Indomethacin had been thought by some tohelp suppress preterm labour. An inspection of the four sets of case notes showed thatmaternal indomethacin was not the reason for the brain lesion48.

As 1994 progressed, there were more cases of serious brain injury, thought to be of asimilar type to the four cases which were reviewed. Accordingly, Health Professional 5converted the study to a more formal “case-control” design. In this case control study,the important initial characteristics of each case were noted such as date of birth,birthweight and gestation; and a similar baby who had not developed the brain lesionwas selected from the other admissions.49 The factors that were considered potentiallycontributory to the lesion were then tabulated for each case and each control, andstatistical tests were applied to evaluate any differences. Because the cases wereinitially few, the likelihood of detecting a difference was compromised. One method toimprove the chances of finding a difference is to increase the number of controls.Therefore, two controls were selected for each case. As the year unfolded, there weremore cases that occurred (without any planned treatment change) and accordinglyeach was added to the list once their brain lesion was recognised, along with twomatched controls50.

This study was finalised towards the end of 1994. There were 11 babies recognised ashaving the severe brain injury, along with the 22 controls who did not have the injury.Fifty different factors were evaluated, but chest physiotherapy was not one of them. Thestudy showed that there was a recognisable difference between the two groups. Thecases were more likely to have suffered from low blood pressure, also known ashypotension (91% of the cases compared with 36% of the controls). This explanationwas only partially plausible, given that the incidence of hypotension was not new, but thebrain lesion was new as far as they were aware51.

This study was presented at a professional meeting in New Zealand of otherpractitioners interested in the care of the foetus and newborn52. The audience wasasked by Health Professional 5 if anyone present had any alternative explanation for thelesions, and if the lesion as presented had been seen in any other unit. The answer atthe time to both questions was “no”. One paediatrician who was present contacted theNWH doctors shortly thereafter, and drew their attention to an article that had beenpublished in 1992, which also referred to a dramatic and new brain lesion53.

45 T215 l.24-2846 T214 Health Professional 347 T297 Health Professional 548 ibid49 T298 Health Professional 550 ibid51 ACC volume, pg 31752 B3 p 6 Health Professional 553 B3 p7 Health Professional 5

5 July 1999 33

The 1992 Article

The article was called “Postnatal encephaloclastic porencephaly – A new lesion?” andwas published in the “Archives of Diseases in Childhood”, in 1992. There were sevenauthors, the senior author being Dr J H Cross. The article described a specific braininjury in 15 preterm infants which had occurred between September 1988 and April1990 in a maternity Hospital.

The injury was described as a “relatively late development of extensive echodense andcystic lesions involving the periphery of the cerebrum. The pattern seen … has notbeen previously reported in liveborn infants.”54 More detailed radiological andpathological descriptions are given in the article, which describes how 14 of the 15babies died. The surviving baby was described as having a severe neurological deficit.The average birthweight of the affected babies was 940g, and seven had treatment forlow blood pressure. All were profoundly abnormal before they died and eight requiredtreatment for frank convulsions. The pathological condition was termed“encephaloclastic porencephaly” (ECPE), a condition which had only been previouslyreported in stillborn infants. The sole reference to possible causation was “it seemsprobable that they represent the effects of an as yet unidentified postnatal event”

A communication ensued between NWH and the hospital. Health Professional 5 spokeby telephone with Expert 15:55

“We immediately contacted the authors … by telephone. They told us that theyhad thought that chest physiotherapy was the likely cause of the damage. Theyhad not undertaken any study to confirm this suspicion and had not publishedtheir suspicions. They speculated that the occurrence of the lesions in theirhospital was associated with a change in the brand of incubator used, and thatthe new incubator had soft mattresses on which the babies’ heads moved rathermore than previously. They had changed their approach to doing physiotherapysuch that the head was steadied, and they had not had further problems with thebrain damage.”

At the request of the Inquiry, Expert 15 was available to give evidence by audio telelink,and had a different recollection of that conversation,56 believing that the reference tothe bedding was that they had used bedding (rolls of towels) to stabilise the head.Expert 15 said that at his/her hospital (Overseas Hospital 3), they had always steadiedthe head during physiotherapy, but following these brain lesions they had increased theirattention to this requirement, using bedrolls to assist them. In addition, Expert 15 wassure of having said that there were factors of greater importance, being the condition ofthe baby at birth and the hypotension, and was able to give considerable detail of thatconversation.57 Expert 15’s evidence was that Overseas Hospital 3 clinicians did notbelieve it was the chest physiotherapy alone which was causative of the brain lesionsand this is explored in Chapter 5 of this report.

There was, in addition, a separate conversation between the pathologists involved,Expert 19 in New Zealand and Expert 20 (Overseas Hospital 3). A letter from the latter

54 Cross JH et al: ‘Postnatal encephaloclastic porencephaly – A New lesion?’55 B3 p7, Health Professional 556 T859 Expert 1557 Reference was made by counsel for NWH to a written note made by Health Professional 5 at the time of thetelephone conversation, during the audio telelink of Expert 15’s evidence. This note was read to that expert at thetime of being questioned about the telephone call with Health Professional 5 and subsequently, the note wasforwarded to Expert 15, who made no further comment. The note was never produced to the Inquiry.

5 July 1999 34

was available to the Inquiry,58 and confirmed that the overseas group had not publishedthe association between the brain lesion (ECPE) and physiotherapy. It indicated someregret that this had not happened, and intimated that a second paper had been preparedbut not submitted for publication due to some reluctance on the part of the clinicians toaccept that the cause was traumatic. Expert 20 intended to proceed with publication,although it is apparent that this did not happen.

Expert 15 confirmed that the doctors at NWH could not reasonably have known of a linkbetween brain injury and physiotherapy, because it was not identified in the 1992 paper.

Health Professional 5 then informed Health Professional 3, who told us:

“It was a Sunday morning and I was on-call. I received two telephone calls, onefrom [Health Professional 5], and one from [Expert 19]. One of them mentionedthat they had called [the overseas hospital and]: “…was told they suspectedchest physiotherapy. My response was ‘Oh, my God’. And it was a very mixedemotion I had, because if this turned out to be true, firstly we had damagedbabies, but secondly we could do something about it. ..I was on call, I went intothe nursery and quietly stopped physiotherapy on all babies.”59

Physiotherapy did not stop on all babies, but it did for those who were small, and at anearly stage of care.60

Health Professionals 3 and 5 agreed that they would not share their concerns at thatstage with the other clinical staff. This was relatively easy to do, given that they were thedominant clinicians on duty at that time61.

With the new and clear knowledge of the ultrasound features of ECPE, the 11 cases ofthe previous study were re-evaluated62. This occurred during December 1994 andJanuary 1995. Each of the ultrasound images of the cases were reviewed, and 5 ofthem were thought not to be consistent with ECPE. Then an assessment of all theultrasound reports of all babies admitted from the beginning of 1992 was made, whichallowed an 18 month extension from the first case of which they were aware (mid-1993)63. A decision was made not to evaluate cases prior to 1992. Those thatcontained reference to any significant abnormalities were noted. The ultrasound imagesof these babies were then inspected by the radiologist along with Health Professionals 3and 5. Health Professional 5:

“I remember the sinking feeling each morning when [Health Professional 3] and Iwould come in and meet with the radiologist and go through another pile of filmsand find another case.”64

By 26 January 1995, they had identified nine cases (ie six of the previous eleven plusthree new cases), and had enough evidence to support the association between chestphysiotherapy and ECPE to tell other clinical staff. A further four cases were identifiedover the next week, prior to the external release of information, to bring the total to 13cases65. 58 NWH Docs Vol 2, p65659 T235 l18-24 Health Professional 360 B20 p35 Health Professional 661 T303 Health Professional 562 T299 Health Professional 563 T299 Health Professional 564 T299 l.30 / 300 l1-265 T299 Health Professional 5

5 July 1999 35

The 13 babies who were found to have this particular lesion ranged in gestational agefrom 24 to 27 weeks, and the range of birthweight was 680 to 1090g.

5 July 1999 36

The characteristics of the 13 babies are listed in the following table.

Case n Name DateofBirth

Gestation Birth-weight(grammes)

Age (days)when physiostarted

Age (days)when ECPEevident

Outcome

Case 1 Baby 11 26 900 4 18 DiedCase 2 Baby 12 24 680 16 26 DiedCase 3 Baby 1 27 695 12 41 CPCase 4 Baby 2 27 885 8 35 CPCase 5 Baby 8 27 750 8 23 CPCase 6 Baby 3 26 990 4 31 HypotomiaCase 7 Baby 10 26 880 4 11 DiedCase 8 Baby 4 26 1090 11 24 DiedCase 9 Baby 13 25 735 9 28 DiedCase 10 Baby 5 27 1040 12 31 DelayCase 11 Baby 7 24 730 7 24 DelayCase 12 Baby 6 26 870 12 26 Speech

difficultyCase 13 Baby 9 26 725 13 31 Global CP

The following timeline sets out in a pictorial way, the clustering of the 13 affected babies.

Timeline: When the cases occurred

1992 1993 1994

(3)

5 July 1999 37

Each of the records of the 39 babies were examined for specific details that might havebeen causative of the lesion. There were 51 different factors for each baby that wererecorded and analysed. As examples, these factors included mode of delivery, maternaltemperature in labour, Apgar scores, use of antenatal steroids, presence of foetaldistress, various complications after birth, and various treatments after birth.

Health Professional 5’s assessment of physiotherapy was specifically the number oftreatments received in the first four weeks. This was clearly documented in the chartsof the babies.66 The differences in the number of treatments in each of the first fourweeks were also assessed. These and other findings are given in the following table,adapted from the 1998 paper, discussed below.

Cases Controls Significant?PhysiotherapyMedian Age physio started (days) 12 12 NoWeek 1 (median number of treatments) 0 0 NoWeek 2 (median number of treatments) 16 0 YesWeek 3 (median number of treatments) 31 5 YesWeek 4 (median number of treatments) 28 0 YesTotal: weeks 1-4 (median number of treatments) 79 19 YesIndices of HypotensionIncidence 92% 58% YesDuration (days) 4 0.5 YesLowest Mean Arterial Pressure (median) 24 27 YesPresentation at BirthCephalic (Head first) 31% 81% Yes

The News Release

Health Professionals 5 and 3 undertook a series of steps at that point in late Januaryand early February 1995. They informed the other specialists and Health Professional 6.They attempted to locate the parents of the affected cases in order to inform them of thediscovery, and they were successful in locating all but one family. They notified all ofthe other Level 3 Units in New Zealand and Australia by telephone, and fax. Theyprepared a press statement for public release, and the item was covered prominentlyon the news on 8 February 1995.

Chest physiotherapy ceased immediately on very low birthweight babies under a monthof age.67 Guidelines were written by Health Professional 3 in 1995 which allowed forsome chest physiotherapy in specific circumstances, with strict controls, and byphysiotherapists only.68 Health Professional 6 said that he/she subsequently did notperform the treatment very often.69

66 Expert 12 highly complimented the quality of this documentation. T782 l.9-1167 B53, p255 Health Professional 368 NWH Vol 1, 10669 T334

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The 1998 Paper

In the March 1998 edition of the Journal of Paediatrics70, an article entitled “ChestPhysiotherapy may be associated with brain damage in extremely premature infants”was published. The principal author was Professor Jane Harding.71

The article72 described how a new brain lesion (“an extensive cerebral destruction of atype we had not previously observed”) developed in a cluster of babies. This lesion wasfound to be the same as one described by the authors of the 1992 article.

The statistical analysis showed that there were three factors that were associated withthe brain lesion. These were

- the number of physiotherapy treatments (average of 79 in the cases comparedwith 19 in the controls),

- the duration of low blood pressure (average of 4 days in the cases comparedwith 0.5 days in the controls),

- abnormal presentation at delivery (69% in the cases compared with 19% inthe controls).

The paper was careful to discuss the weakness of this methodology in establishingcausation, but concluded:73

“We recognised in retrospect that our cluster of cases had occurred after achange in policy whereby chest physiotherapy treatment, previously largelyconfined to regular working hours, was made available 24 hours each day.”

The issue of whether a change or changes were introduced to the provision of chestphysiotherapy treatment is formally addressed in the next chapter. It is sufficient toobserve that in addressing the issue of the change, witnesses to the Inquiry werereferring to the fact that from June 1993 to December 1994, nurses who had receivedspecific training were able to undertake a limited form of chest physiotherapy, namelythe technique of percussion particularly during evening and night shifts.

70 The “Journal of Pediatrics” is an American monthly publication, and available internationally.71 There were four other authors listed: Dr Fiona Miles, a paediatric registrar; Dr David Becroft a paediatricpathologist; Dr Bruce Allen, a radiologist; and Dr David Knight, a neonatologist .72 It should be noted that the delay in publication was due to repeated rejection of the article, and not by any delay ofNWH.73 Harding et al (1988): Chest physiotherapy may be associated with brain damage in extremely premature infants.The Journal of Paediatrics. Volume 132, Number 3, Part 1

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CHAPTER FOUR:

4. THE CHANGE IN TREATMENT DURING THE PERIOD APRIL 1993 –DECEMBER 1994

Prior to 1985, the respiratory physiotherapy techniques which were undertaken in theneonatal unit of NWH were:74

(a) Vibration – where the fingers are applied to the chest over a particular lobe andshaken rapidly and finally to produce a vibration movement of the chest wall,using the pads of one’s fingers (used for small pre-term babies).

(b) Clapping – where the chest is clapped using the whole hand which is cupped(used for larger post term babies).

(c) Electric toothbrush (battery operated – which is a rapidly vibratory movementfrom an electric toothbrush on the chest wall of small unstable babies. Thebristles from the toothbrush were removed and the “head” of the toothbrush wasused like a miniature vibrator, where the “head” was placed on gauze spongeson the pre-term infant’s chest.

(d) Electric vibrator – applied also to the chest wall (for larger unstable babies).

In October 1985, Health Professional 6 visited an overseas hospital “to look at the roleof the physiotherapist in the neonatal unit”75 and first observed the technique of“cupping”.

As this is central to the focus of this Inquiry, a description of the technique follows.

“Cupping” or percussionThe technique of “cupping” which was called “percussion” at NWH refers to the tappingof the chest wall of an infant, in order to generate a shaking of the lung beneath. Thesecretions within the lung which are mobilised are transferred to larger airways wherethey can be retrieved by suctioning. There are a number of percussion methods, whichwill be described below, but “cupping” was the method employed at NWH. Thisinvolves tapping the chest wall of an infant with a small plastic face mask, which is heldby the fingers. Two types of masks are used namely the Bennett’s and Laerdal maskand each come in various sizes. They are devices used in artificial ventilation ofpatients, and were adopted for use as a physiotherapy tool. There is a hole in the top ofthe mask which may be plugged during physiotherapy. If plugged, this can be done witha finger, or with a stopper.

Two other forms of percussion were described to the Inquiry.

Tenting which involves the use of the index and ring fingers being held together with themiddle finger on top of them in a tent-like position. The fingers are then tapped againstthe chest wall of an infant, in a percussive manner namely tapping the chest wall toachieve the shaking of the lung beneath as described above.

Finger tapping which is also known as finger percussion and involves the index andmiddle fingers being used to tap against the chest wall to achieve the same object.

74 B6, p3 Health Professional 675 B6, p4 Health Professional 6, refer ch3 – sequence of events

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As part of the technique of percussion, the terms “positioning” and “suctioning” shouldalso be understood.

PositioningAs a nursing term, “positioning” refers to the sequential placement of the baby indifferent positions for comfort. In physiotherapy terms, it is also known as “posturaldrainage” where the caregiver lies the baby in a certain position that favours theclearance of secretions from a particular lobe or segment of the lung. Nurses areregularly involved in positioning babies, although the specific positions for particularsegment drainage of the lungs is more within the expertise of the physiotherapist.

SuctioningWhen secretions from the babies lungs are problematic, suctioning is undertaken toremove the secretions. For this reason it is usually performed after physiotherapy whensecretions are loosened from the lung, although it can be performed at any stage whensecretions are a problem. Suctioning involves the use of a narrow plastic tube attachedto a negative pressure device to suction the secretions from the baby. In an intubatedbaby, namely where an endotracheal tube has been inserted, the suctioning isperformed only through the endotracheal tube and in the mouth and nose. Otherwisethe suctioning is performed through the mouth and nose of the baby. This procedure isperformed by both nurses and physiotherapists.

Percussion by cupping since 1985

From November 1985, the technique of percussion by cupping was introduced to NWH.It should be noted that Health Professional 6 did not perform the technique duringhis/her overseas visit and did not receive any practical training in the method.76

From November 1985 to April 1989 nCPT was available to the neonatal unit up to fivetimes a day. This was achieved by the physiotherapy service at NWH providing anevening shift 7 days per week for 24 hours a day for the whole hospital, but with a“significant input” into the neonatal unit.77

Referrals for neonatal chest physiotherapy were made in writing by the medical stafffollowing discussion on all referrals through attendance of physiotherapy staff at thedaily chest x-ray round and the relevant parts of the daily ward round, “so that medical,nursing and physiotherapy staff could have an input”.78

In April 1989, difficulties were experienced in recruiting physiotherapy staff and therostered hours of physiotherapists were reduced79. Instead of nCPT by cupping beingdone up to 5 times a day, it was reduced to 4 times a day in 1989. Because nCPT wasseen to be an important part of the medical management of ventilated babies andbabies with severe chronic lung disease, the loss of the extra treatment was consideredto be detrimental, and in June 1989 a teaching programme was introduced to teachnurses to undertake nCPT. Although nurses completed the lectures and sat theexamination, the programme of introducing nurses to undertake chest physiotherapywas abandoned80.

76 T351, line 4-677 B9, p.9 Health Professional 678 B9, p.9 Health Professional 679 B34 p.129-31 Health Professional 380 B34, p.129 Health Professional 3

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What were the Changes?

The plan to train nurses to undertake nCPT, although mooted as early as 198481 andundertaken and abandoned in 1989, was rekindled in November 1991, when thedemands of the neonatal unit on the physiotherapy service was such that aPhysiotherapy Working Party was established to explore the possibility of nurses doingnCPT. The working party’s first meeting took place on 6th November 1991 andcomprised Health Professional 6 together with one other physiotherapist, HealthProfessional 10, and a number of neonatal nurses and nurse managers. There were anumber of issues which were identified at its first meeting82 and they included:

(a) The impact of undertaking nCPT on the nurses role(b) The benefits for the babies, and in particular babies with significant lung disease

were deteriorating overnight with nCPT being given only four times a day with a12 hour break overnight.

(c) Industrial issues involving a consideration of nurses depriving physiotherapists oftheir positions.

(d) The definition of physiotherapists if nurses were to share nCPT with them(e) Training of nursing staff and the issue of how much intensive care experience

did they need before being orientated to nCPT.

At the second meeting of the working party on the 13th November 1991, the groupreached agreement that “physiotherapists are the best people to provide respiratoryphysiotherapy to the neonates”.83

Following that decision, discussions continued through 1992 amongst the managers ofthe clinical support, physiotherapy services, neonatal nursing service and the NationalWomen’s Hospital Project Group, for NICU and SCBU and the PSA culminating finallyin an agreement that nurses would be trained in the neonatal chest physiotherapytechniques of positioning and percussion (P + P).84

As a result of the agreement reached (which also involved the PSA and the NZ NursesAssociation) a further meeting of the respiratory Physiotherapy Working Party wasreconvened in March 1993, at which point the specific criteria and competency levelsrequired for nursing staff to undertake nCPT were undertaken.85 This groupimplemented the changes which were introduced to the provision of nCPT.

The changes in the provision of nCPT commenced in June 1993 with the first teachingsession being given to senior neonatal nurses. There was agreement amongst all theparties to the Inquiry that the changes were:

(a) Nurses introduced to the provision of chest physiotherapy by being trained in thetechnique of positioning and percussion.

(b) The frequency of nCPT increased from a maximum of four times a day to amaximum of six times a day. This represented at 50% increase, as submittedby the parents, to the availability of nCPT from June 1993.

81 B7, p.17 Health Professional 382 NWH Vol 1, p81-283 NWH Vol 1, p.73 and B12 p. 18 Health Professional 684 NWH volume 1, page 41-52; B12 p19 Health Professional 6. For the purposes of this report we refer to “P+P” asthe technique of percussion.85 NWH volume 1, page 34, B13 p. 22 Health Professional 6

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It was further submitted by the parents that other changes also took place. Theadministration of the treatment was no longer the sole domain of the physiotherapist;the increased frequency of nCPT increased staff workload with a consequent increasein documentation including treatment guidelines, and there was additional handling ofthe neonates. It was submitted that as a result of the increased treatment, therenecessitated a corresponding increase in the need to monitor and observe the effect oftreatment.

There was no dispute about the two principal changes which were introduced namely,the treatment was available 24 hours a day, and nurses were trained to undertake it. Ofthe other matters raised, they comprised the consequences of the changes. Thoseconsequences resulted in guidelines for nurses being drafted in April 1993 withfinalisation of nursing standards of care in December 1993.86

Physiotherapy service documents were updated in April 1994, with standards forphysiotherapists being completed in August 1993, a treatment protocol in January 1994,post extubation protocols being updated in August 1993, and postural drainage charts inApril 1993 and April 1994.87

As a further consequence of the change there was additional handling of the pre-terminfants and an increased nursing staff workload.88

First Term of Reference

The first term of reference requires a finding as follows:

1. Whether changes were introduced to the provision of nCPT provided topre-term babies at National Women’s Hospital (NWH) in or around April1993.

Changes were introduced to the provision of chest physiotherapy (“the treatment”)provided to pre-term babies at NWH. These changes were:

(a) The treatment of chest physiotherapy was available 24 hours a day, namely amaximum of six times a day, compared to a maximum of four times a day forthe period 1989 to 1993 and a maximum of five times a day between 1985 to1989.

(b) Nurses were introduced to the provision of chest physiotherapy by being trainedin the technique of positioning and percussion. Those nurses (andphysiotherapists) undertook this technique, following completion of the training ofthe nurses, the first of which occurred in June 1993.

Why the Change?

In addressing the change in treatment under the first term of reference, it is relevant toconsider the reasons for the change, and term of reference 2(c) will be addressed inthis section of the report.

86 Documents 22 and 20 of Nursing and Physiotherapy documentation folder87 Documents 4,6,7,10,13,16,17, Nursing and Physiotherapy documentation folder88 NWH volume 1, pages 010 – 023; T492 Health Professional 9

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The Inquiry is required to find under Term of Reference 2(c):

Why did NWH change its policy on the administration of this form oftreatment?

The reasons for the change in policy were motivated by the desire to improve the careof very premature babies and make chest physiotherapy available for them 24 hours aday. As Health Professional 3 told us:

“the change was instituted because previously nCPT was not available overnight and wesaw babies deteriorate through not having the treatment.”89

Health Professional 3 continued by describing that:“…[in] 1993, chronic lung diseasewas an enormous problem in neonatal intensive care. Very premature babies werealmost inevitably ventilated and needed to be on a ventilator for a prolonged period.This lead to many of them developing lung damage (termed ‘chronic lung disease’)which resulted in a need for more assisted ventilation. This ventilation therapy createdproblems with secretions, with frequent episodes of lung collapse or consolidation andinfection. Much of our effort as neonatologists was spent in dealing with these babies.”90

Change in Frequency

The evidence from the medical, nursing and physiotherapy staff at NWH wasunanimous that the change in frequency to the provision of chest physiotherapy wasmade because of the clinical concerns for the care of the babies in the neonatal unit.Many observed91 the deterioration of babies overnight and there was a desire that thesebabies should benefit from the opportunity of having treatment overnight.

At its first meeting, the respiratory Physiotherapy Working Party noted in its minutes92

“We all agree that at times our infants care is compromised (by lack of nightphysio) and that we should start by looking at extubation and night-time physio.”

We were told medical, nursing and physiotherapy staff had wanted 24 hour nCPT to beavailable for many years and when, in 1989 the availability of the treatment was reducedfrom up to five treatments a day to four a day for financial reasons, “this was thought tobe clinically undesirable and to risk increased complications in ventilated babies.” 93

It is axiomatic that in implementing 24 hour availability of nCPT, the clinical staff at NWHbelieved chest physiotherapy to be an important part in the treatment of ventilatedbabies. As Health Professional 3 told us … “it was widely accepted to be effective andsafe. (Many still think this to be the case. NWH staff does not).”94

Health Professional 3 described how nCPT had been carried out at the hospital formany years with beneficial effects being seen from its application. He/she producedthree sets of x-rays on three babies which showed the improvement in lung volume and

89 B7 p.1890 B31 p.12691Health Professionals 3, 17 T444, 12, 18, 10, 6, 9 p.47992 Working Party Minutes & Notes November 1991 pp 74-82 NWH Volume 193 B34 p.129 Health Professional 3, NWH volume 1, page 95, letter from Health Professional 3 dated March 198994 B31 p.127 Health Professional 3

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revolution of lung collapse and consolidation, which was attributed to nCPT.95 It wasalso believed that the change in providing 24 hour availability of the treatment, wouldbring NWH into line with the treatment offered at many other neonatal units.

Treatment by Nurses

The reason for the introduction of nurses providing the treatment was two-fold:

(a) it allowed the overnight treatments to commence(b) it overcame the limited physiotherapy staff resources available.

It was in November 1984 that the suggestion was first made to have nursing stafftrained to undertake some basic physiotherapy as happens in Australasia and in theNorthern Hemisphere.96 It did not happen at that time.The introduction of nurse training in the percussion technique has already beendescribed,97 but by 1989 the shortage in resources lead to a restriction of theavailability of the treatment and by 1991, the physiotherapy department staff andfinances were stretched to the point that the availability of nCPT was likely to bereduced further. 98

The most comprehensive reasons with regard to the decision to train nurses inproviding the treatment was elaborated on by Health Professional 6. Whilst believingthat physiotherapists were the best people to undertake nCPT, Health Professional 6was aware of the stress on the physiotherapy staff having to provide so many extrahours outside their normal working times and said … “also I was aware of the realities ofthe situation with regard to the health reforms in the early 1990’s requiring changes inefficiencies.” 99

Health Professional 6 gave the following “key points” in introducing the change:

(a) there were limited physiotherapy staff resources;(b) there was a problem of recruitment and retention of skilled physiotherapy staff

who were able to work in the neonatal unit;(c) to train a fulltime physiotherapist to be clinically competent and to practise safely

in the neonatal unit without supervision took four months, whereas nursing staff,being already skilled “only needed to be taught a technique, that of positioningand percussion”;

(d) a nurse could provide nCPT at a time suitable for the baby on a cue based carerather than strictly according to routines by the clock;

(e) the physiotherapists “had to heed the advice of those Auckland Area HealthBoard Managers who were involved in the changes in health delivery and providethe service that was wanted and needed (or contracted to provide), not what wethought they should have”.

(f) the fiscal pressures and budgetary restraints requiring restrictions to overtime,penal rates and call-backs in the provision of nCPT.

To understand (d) above, an understanding of “cue-based” care is instructive.

Cue-based Care

95 B 31-33 Health Professional 396 Minutes NWH Volume 1, p.105; B34 p.128 Health Professional 397 Chapter 398 B34 p.s 130 and 131 Health Professional 3 and Memo September 1991 NWH Volume 1, pp91-9299 B12 p.20 Health Professional 6

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This involves the administration of care to babies at a time that accommodates the babyrather than the nurse. Cares which would cause the baby to wake are given to coincidewith a baby’s wakeful phase, if possible. This means that there is some flexibilityaround the timing of these cares, which include breastfeeding, changing of nappies,blood tests, medicine administration, temperature checking, changing feeding tubes andchanging breathing attachments.

The alternative is “major handling times” and in this model, all tasks are completed at aset time, in a quick time frame. As a result, the baby can expect to lie undisturbed untilthe next major handling time – usually three or four hourly, but may of course be wokenfrom a deep sleep in order to have these tasks performed.

There are a number of interventions undertaken to babies which are not aligned witheither model. Other staff (doctors, x-ray technicians, physiotherapists, laboratory staff)perform duties on the babies irrespective of the babies’ phase, including ultrasounds, x-rays and the insertion of intravenous lines).

Similarly the physiotherapists would undertake physiotherapy on the baby at a time tosuit them, not the baby, in order to reach all the babies that needed such intervention.Once the bedside nurse could undertake the physiotherapy, it was possible for thistreatment to be incorporated into the cue-based care philosophy.

Other factors

It should also be noted, that in introducing the changes for the reasons outlined above,NWH believed that the introduction of nurses undertaking nCPT brought the unit at NWHinto line with other units. This was demonstrated by the collection of protocols,guidelines and procedures that were in use in other units both in New Zealand andoverseas.100

The Inquiry was urged that whilst there were some financial issues, the concern of theclinical staff and the change of policy was not financially motivated. The Inquiry acceptsthat the overriding concern of the clinical staff at NWH was clinically motivated to extendthe availability of what was perceived to be a beneficial treatment in response to theobserved deterioration overnight in the condition of pre-term babies on life support.However, fiscal constraints were a factor in the introduction of nursing staff to undertakethe treatment and this is considered in detail below.

Financial Pressures

One of the factors which was instrumental in introducing the change of personnel toundertake the treatment of nCPT was the financial pressure which was experienced inthe 1991-1993 period. This combined with a shortage of physiotherapists was evident inthe 1989 period101 and appeared to have had an influence on initial discussionsregarding nurses being trained to undertake neonatal chest physiotherapy. The situationwas similar in the 1992 period and raised the need for the re–introduction of training fornurses in percussion and positioning, as it became known. The documents reveal thesituation faced by the Physiotherapy department in attempting to provide a service toNICU.102

100 Refer NWH documents Vol 2, Pt IV and refer chapter 5 Key Differences in Treatments.101 NWH volume 1, p.95102 NWH volume 1, p.39

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“ the physio department have neither the staff or the resources to provide a 24hour, 7 day a week service. In light of this we decided to look at the issue again,focussing on what the benefits would be to the baby if the nurses involve somephysiotherapy in their role….The successful implementation of this proposalrequires careful and considerable planning, and consultation with the nursingstaff of the neonatal service”.

It was clear that National Women’s Hospital identified the potential issues and thePhysiotherapy Working Party comprising both physiotherapists and nurses was formed,with their major focus being the provision of training. There were concerns by thePhysiotherapy Working Party expressed in 1991103 foreshadowing a concern thatchanging the status quo of the quality of service to the infant may be compromised forwhat appears to be very little cost saving. The Working Party required more informationon the savings to be achieved.

From the documents made available to him/her by NWH, Parent 3a gave evidencebefore the Inquiry that in his/her view the financial pressure was a contributing factor tothe resulting damage to the 13 babies affected.104

“It identifies that this was a cost driven exercise which made no mention of the need toconform with International practices”, further supported by “the driving force behind thechange was a directive from Auckland Hospital Board to reduce costs…..budgetcontrols” 105

In his/her brief of evidence106, the history of reduction of available physiotherapy timeHealth Professional 3 outlined “ reduced for financial reasons”107 “In 1991 thephysiotherapy department staff and finances were stretched and there was talk ofreducing the availability of nCPT further”. In paragraph 138 he/she detailed “ thefinancial considerations were secondary and unimportant to neonatal unit staff ”.

In his/her supplementary brief108 Health Professional 3 outlined “ the clinical motive wasto improve care, whilst managers were concerned with industrial and financial issues”.

It was submitted to the Inquiry that whilst there were some financial issues these werenot the concern of the clinical staff and that the change of policy was not financiallymotivated. It was but one factor of many and was a factor that was rightly the concernand domain of those NWH staff whose concern was budget and financial.109

After carefully examining the evidence, and considering the submissions, we find thatthere were pressures placed on the clinicians, who were expected to make costsavings and these placed considerable demands on those health professionals whoseprimary concern was delivery of care to sick pre-term babies. However, given theevidence on the clinical reasons for the change, and the desire to provide better 24 hourcare for sick pre-term babies, we find that the financial considerations which resulted inlimited physiotherapy resources were secondary to the clinical reasons for the change.

103 NWH volume 1, p.73, p.3104 B10, p.57105 T129, lines 15 to 16106 B34, p.129, 131107 B34, line 4108 Page 20, p.106 to 198109 Page 6, p. 2

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Summary and Conclusions

2(c) Why did NWH change its policy on the administration of this form oftreatment?

NWH changed its policy on the administration of this form of treatment to provide 24hour care to the babies to prevent overnight deterioration of their condition. The financialconsiderations and physiotherapy resources were secondary to the clinical reasons forthe change.

IMPLEMENTATION OF CHANGE

2f. Were the changes in treatment implemented as planned by NWH.

The changes in treatment, as previously described in this chapter were implemented asplanned. However the extent of the training of nurses appeared to take longer than hadoriginally been anticipated. On the evidence before the Inquiry, it took 18 months to train76 nurses, and it was envisaged by some of the witnesses before the Inquiry that thiswould occur more rapidly.

It was submitted that among other things the change resulted in a considerably higherworkload for the nurses,110 and an inability for Health Professional 6 to carry out therequired teaching.111 It was further submitted that the treatment resulted in a reductionof rest periods for the babies, which was a concern of the nurses.112 Whilst some ofthese criticisms were raised during the time of the implementation of the change intreatment, the change in treatment did take place as planned. The tension between theminimal handling policy, namely the need to leave the babies to rest and the need todeal with the chronic lung problems experienced by these babies was already debatedand decided before the changes were implemented. The actual implementationtherefore did occur as planned by NWH. The only absence of a planned occurrencewas the clinical audit which was to take place during 1994. There was no evidence ofany preparation for such clinical audit and it had not taken place at the cessation of thetreatment in January 1995.

ConclusionThe changes in treatment were implemented as planned with two exceptions.(a) The training of the nurses appeared to take longer than had originally been

anticipated.(b) The clinical audit planned for 1994 did not take place.

110 Submission on behalf of parents p23 (ACC 00260)111 Ibid ACC 00272, 00274112 ACC 00260, ACC 00261

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CHAPTER FIVE:

KEY DIFFERENCES IN TREATMENT

This chapter deals with term of reference 2(a), namely:

What key differences were there in the way in which the treatment wasperformed prior to April 1993 and during the period April 1993 andDecember 1994, including comparisons with other selected hospitals?

To address the key differences in the way in which treatment was performed at NWH incomparison with other hospitals, it is appropriate to address the different types of chestphysiotherapy, the styles of physiotherapy at NWH before and after the change, and thecomparison with other hospitals in relation to each of the aspects of chestphysiotherapy.

In this chapter, we also consider the impact of the change in treatment and theoccurrence of the brain lesion, and finish with a comparison of the protocols in place atthe relevant time. The sequence of sections within this chapter are as follows:

TYPES OF CHEST PHYSIOTHERAPYSTYLES OF CHEST PHYSIOTHERAPY AT NWH

(a) NWH Before June 1993(b) NWH After June 1993

COMPARISONS BETWEEN NEW AND OTHER HOSPITALSTYPEVIGOUR

• The Videotapes• Parental Impressions• Reassurance• Measuring Vigour• The Video Compared with Other Hospitals• Other Hospitals• Summary

FREQUENCYPERCUSSION RATEDURATION OF TREATMENTVARIABILITYTHE DECLINING NEED TO TREATPERSONNELHEAD HOLDINGSTABILITYBEDDINGGENERAL COMMENTSTHE IMPACT OF THE ‘CHANGE’ AND THE OCCURRENCE OF THE BRAIN LESION

The Question of CausationThe Limits of Case Control StudiesThe Link With Chest PhysiotherapySomething DifferentCombination of FactorsBeddingShaking InjurySize of NWH Neonatal ServiceFrequencyVigourVariabilityConclusion

Term of Reference 2(a) – Finding

PROTOCOL COMPARISONS (Term of Reference 2(b))

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Intensity of VigourDurationTypeRateIndications for TreatmentConclusion

Term of Reference 2(b) - finding

TYPES OF CHEST PHYSIOTHERAPY

There are many ways by which neonatal chest physiotherapy can be described. Thereare various types of physiotherapy, which differ in their use among units both in NewZealand and overseas and the literature that was presented to the Inquiry addressed anumber of different types of neonatal physiotherapy. For completeness, the followingpresents a description of the various types that were available, although the techniqueswhich are the subject and focus of this Inquiry, have been also described in the previouschapter.113

TypeThe modes of therapy used differed between units, and the literature that was presentedto the Inquiry addressed a number of different types of neonatal physiotherapy.

Positioning - In nursing terms, this would generally mean the sequentialplacement of the baby in different positions for comfort. In physiotherapy terms,it is also known as “postural drainage” where the caregiver lies the baby in acertain position that favours the gravitational clearance of secretions form aparticular lobe or segment of the lung. Nurses are regularly involved inpositioning babies, although the specific positions for particular segmentdrainage are unlikely to be known by nurses, whereas physiotherapists wouldregularly know this.Suctioning - The caregiver uses a narrow plastic tube attached to a negativepressure device to suction the secretions from the baby. This is usuallyperformed after physiotherapy, although it can be performed at any stage whensecretions are thought to be problematic. In an intubated baby, the suctioning isperformed through the endotracheal tube, and in the mouth and nose. If the babyis not intubated, the suctioning can only be performed in the mouth and nose.This procedure is performed by both nurses and physiotherapists.Percussion - This refers to the tapping of the chest wall in order to generate ashaking of the lung beneath. The secretions within the lung which are mobilisedare transferred to larger airways where they can be retrieved by suctioning.There are a number of percussion methods:By Cupping: A mask is actually a device used in artificial ventilation of patients,but it has proved useful as a physiotherapy tool. Two type of masks are used,Bennett’s and Laerdal masks, and each come in various sizes. There is a holein the top of the mask which may or not be plugged during physiotherapy. Ifplugged, this can be with a finger, or with a stopper.By Tenting: The index and ring fingers are held together with the middle finger ontop of them (tented). The fingers are then tapped against the chest wall in apercussive manner.

113 See chapter 4

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By Finger tapping (also known as finger percussion): The index and middlefingers are percussed against the chest wall.Contact Heel Percussion - The heel of the hand is applied to the chest wall,causing a depression of 1-2 cm, using pressure appropriate for the size of theinfant.Vibration - The fingers are applied to the chest over a particular lobe andshaken rapidly and finely to produce a vibration movement of the chest wall. Thistechnique is generally performed by physiotherapists, and not by nurses.Electric Toothbrush - A rapidly vibratory movement from an electric toothbrushis applied to the chest wall.

Comparing key differences in treatment at NWH in relation to types of neonatal chestphysiotherapy, certain terms are used which require clarification at the outset. Theyare:

Frequency – refers to how often physiotherapy was given to infants. The frequency ofthe physiotherapy interventions were often at 4 hourly intervals in many units.Rate - refers to the percussion rate in beats per minute. E.g. from 40 per minute to 200per minute.Vigour - refers to the strength or force of the of the percussion tapping.Duration – there were three ways in which the term duration was used in the Inquiry

(a) the duration of a particular percussive treatment for a particular lungsegment(between 30 seconds and 3 minutes),

(b) the total duration of the physiotherapy treatment (between 3 and 20minutes), and

(c) the total days of treatment.Segments – refers to the segments of the lung which may require specific treatment.Variability – this is the degree of individual variation between operators performingphysiotherapy.Personnel - the professional staff that were able to administer chest physiotherapy.Indications – are the listed situations in which physiotherapy would be undertaken.Propensity to treat – this refers to the likelihood that a particular service, or individualwould order the commencement of physiotherapy treatments.Cautions - many units had a list of conditions that would post a contraindication tophysiotherapy and another list of conditions in which care should be exercised whendeciding upon physiotherapy.Stability - refers to the limits of physiological stability of the baby, dictating whetherphysiotherapy should continue or stop. The physiological parameters used todetermine stability generally were heart rate and oxygen saturation recordings.Bedding - It was suggested that the surface on which the physiotherapy wasundertaken was important in terms of the effect of the therapy on the baby. The Inquiryheard evidence about this from many units.

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STYLES OF CHEST PHYSIOTHERAPY AT NATIONAL WOMEN’S HOSPITAL

(a) National Women’s Hospital Before June 1993

For the reasons canvassed in chapters 3 and 4 of this report, nCPT by percussion hadbeen undertaken at NWH since November 1985.

Chest physiotherapy types consisted of postural draining, suctioning, percussion(cupping), and vibrations114. Nurses would also perform suctioning, as it wasconsidered part of a nurse’s role. The other techniques were by physiotherapist only.Percussion was the most common technique, using a Laerdal mask with a stopper inthe opening. Vibrations were used infrequently, such as when a new Central VenousLine had been inserted115.

The personnel were 2 full-time physiotherapists employed at NWH, and in addition afurther 5 physiotherapists were employed part-time to assist with the evening duties.Physiotherapy availability was up until 2000 hours each day116, although provision forcall-back of the duty physiotherapist in exceptional circumstances was available. Therewere specific indications for physiotherapy.

Chest physiotherapy frequency was 4 hourly in most instances, although it waspermissible to administer it 2 hourly in the case of extubation physiotherapy andtreatment for lobar collapse / consolidation117. As the babies condition improved, it wascommon for physiotherapy to be given less frequently than 4 hourly, as it was graduallycurtailed.

The percussion rate was said in the protocols to be at a rate of 160-200 percussionsper minute, although Health Professional 6 said that in reality each operator found a ratethat was comfortable for them118.

There were no standards for assessing the vigour of the percussions although someof the doctors said that they were aware that the NWH vigour was greater than in someother units119. The protocols called for wrist action.

Percussion duration according to the protocol was for 2-3 minutes in each drainageposition120, and in each treatment session there were up to (and usually) 4 suchpositions treated121. The actual areas to be treated in each session dependedsubstantially on the position that the baby was lying in.

There was no caution about specifically holding the head during physiotherapy,although it was common practice for this to happen if a second person (often a mother)was present. It was also common that a second person would not be present.

The baby’s stability was measured by oximetry, such that if the oxygen saturationdropped significantly, a “rest” (brief pause) or a cessation would occur. A rest would

114 B5-7 p.3-5 Health Professional 6115 T374 Health Professional 6116 B9 p.26 Health Professional 3117 B11 p.36 Health Professional 3118 B14 p.23 Health Professional 6119 T237 Health Professional 3, T263 Health Professional 3, T303 Health Professional 5, T379 Health Professional 6120 NWH Nursing and Physiotherapy Documentation 1&2121 NWH Nursing and Physiotherapy Documentation 3&4

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occur if the oxygen saturation dropped below 80%122, but not if the saturation wasmaintained at a level of 81% or more123.

The bedding used was a sheepskin on a mattress, with sheets overlying in parts, andadditional nappy rolls to assist in positioning the baby124. It was thought that in 1992 aparticularly soft and deep type of sheepskin was obtained125.

(b) National Women’s Hospital After June 1993

At this time, physiotherapy personnel were changing. Nurses were being graduallytrained to perform the positioning and percussion, although initially the number of nursestrained was very low. The type of physiotherapy available was the same as before, butnurses were not trained in techniques “other than P+P”126 (percussion). Thereforepercussion remained the dominant mode of physiotherapy. The duration was only twominutes in each area for nurses127, although the number of areas remained the same.The total duration of each session was variously said to be 15-20 mins128 and 10-15mins.129 Rate and vigour were supposedly the same, allowing for individualvariation.

The frequency remained four hourly predominantly, but as more night-shift nurseswere trained in the technique, this allowed for up to six treatments per 24 hour period,compared to the previous maximum of four. In early 1994, some of the nursesexpressed concern at the taxing number of tasks that they had to complete,130 andHealth Professional 3 reinforced that it would be reasonable to forgo one of the nightphysiotherapy sessions, thus enabling some babies to receive five treatments per dayrather than six.131

Some comments about propensity to treat were also received. It was agreed that ofthe five specialists responsible for the unit, there was a difference in their tendency torequest commencement of physiotherapy132. Health Professional 3 and HealthProfessional 19 were said to order this treatment more often than the others, and HealthProfessionals 7 and 8 were said to order it less often (Health Professional 5 was in themiddle).

Health Professional 7 said that he/she had not actually appreciated at the time thathis/her propensity to treat was any different from others,133 and Health Professionals 7and 8 both spoke of a mild concern about the lack of strong evidence in favour ofphysiotherapy.134

In addition some data about a direct comparison with another hospital was available. Inthis, published evidence from Overseas Hospital 1 was contrasted with NWH data by

122 T499 Health Professional 9123 T533 Health Professional 10124 T496 Health Professional 9125 T485 Health Professional 9126 B15 p.24 Health Professional 6127 SB 18 p.94 Health Professional 3128 T165 Parent 3a, T491 Health Professional 9129 B6 p.19 Health Professional 11130 NWH Vol 1, 10-12131 NWH Vol 1, 14132 T254 Health Professional 3133 T435 Health Professional 7134 T434 Health Professional 7, T459 Health Professional 8

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Health Professional 3. In the gestational age group 24-29 weeks, 62% of NWH babiesreceived chest physiotherapy compared with 45% at Overseas Hospital 1135. This mayindicate a greater propensity to treat, although Health Professional 3 conjectured that itmay also have represented the slightly greater complexity of the NWH admissions.Hospital 1 data was not comparable, due to the differences in the baselinecharacteristics of the babies.

Issues relating to indications, cautions, stability, and bedding remained the same asbefore.

COMPARISONS BETWEEN NATIONAL WOMEN’S HOSPITAL AND OTHERHOSPITALS

Detailed information about particular physiotherapy practices was available from eightother hospitals. They were four New Zealand hospitals and four overseas hospitals.136

Comparisons are now made between NWH and the eight other hospitals on the basis oftype, vigour, frequency, percussion rate, duration of treatment, variability, the decliningneed to treat, personnel, head-holding, stability and bedding. They are dealt withrespectively.

TYPE

Of the nine units, seven used cupping, ie percussion with a Bennett or Laerdel mask, todeliver physiotherapy. The two who did not use cupping were Hospital 4137 andOverseas Hospital 1138. At Hospital 1, the use of cupping was declining during the 1992-1994 period in favour of a finger percussion technique139. This was largely due tochanges in physiotherapy personnel who had different preferences. At Hospital 3,cupping was used sparingly140, and at Overseas Hospital 4, cupping was a rare form ofphysiotherapy and only used if the alternate techniques of positioning and suctioningwere insufficient to control the secretion problem141. National Women's Hospital usedcupping as a major form of therapy at each session.

For those units who used cupping, there was a variable practice regarding the closureof the hole in the top of the cup. At National Women's, Hospital 1 and OverseasHospital 3, a stopper or plug was placed in the hole which enabled the cup to be held byits outer rim142. At Overseas Hospital 2, and Overseas Hospital 4, the hole was blockedby using the finger of the percussing hand143. In Hospital 3, the hole was not occludedat all144. It was thought possible by one witness that the use of the finger to block thehole reduced the ability of the wrist to deliver forceful percussions, thereby assuring thatover-vigorous physiotherapy would not be applied145.

135 B25 p.10 Health Professional 3136 [identifable detail not included].137 B2 p4 Expert 3138 T638 Expert 4139 B page 3 Expert 7140 T388 Expert 6141 T873 Expert 17142 B page 3 Expert 9, T866 Expert 16143 T826 Expert 13, Video Expert 17144 T397 Expert 6145 T826 Expert 13

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ConclusionNWH was not significantly different from other units in its choice of physiotherapy type.

VIGOUR

The Videotapes

National Women’s HospitalA video that depicted chest physiotherapy at NWH was available to the Inquiry, and allwitnesses were given an opportunity to view it. Those that did were able to contrast thestyle of physiotherapy depicted with that of their own experience. In the case of theparents, their experience was largely what they recalled from having their own childrenreceive the physiotherapy treatment. In the case of the health professionals, theirexperience referred to any exposure to chest physiotherapy in their own units orelsewhere.

There were concerns raised about viewing the video from NWH. It was submitted thequality of the reproduction was not good. It depicted babies who were considerablylarger and more mature than those represented at the Inquiry. Two of the babies on thevideo received the physiotherapy treatment at a time other than the period in question.Many of the participants were viewing this physiotherapy years after their last exposureto the treatment, and it was submitted this affected the accuracy of their recall andevidence.

Health Professional 6’s evidence summarises these concerns:146

(a) The parents observed the treatment 4 to 5 years ago.(b) At the time they were all under considerable emotional distress.(c) It was and still is quite normal for parents to be somewhat shocked or

surprised when first observing the technique.(d) The families have all viewed the video together and their shared

experience may have given rise to a common view taken rather than therecollection of individual perceptions of the time.

(e) One of the focal points of this inquiry is the intensity of treatment and thatissue looms large in everyone’s minds, possibly being given aprominence that is not warranted.

Nevertheless, we invited witnesses to view the video, as a reference point for theirevidence. The video was used as a guide from which comparisons could be drawn bymany of the witnesses in describing aspects of the percussion treatment as practisedat the relevant period.

The video consisted of many video clips, and they required some explanation by thewitnesses who had knowledge of them.147 148 It was clear to all involved that the tape 146 SB 6 p.2.8 Health Professional 6147 T 18 Health Professional 3; B3, p.2.2 Health Professional 6148 The first few clips had dates and times attached: 30/9/94, 1945 hrs: A term baby at 12 days of age. Thebirthweight was 3.9kg, and the baby had serious lung and heart problems. The baby was on a heat table, andreceiving percussion physiotherapy.30/9/94, 1951 hrs: same baby, receiving percussions2/10/94, 1707 hrs: same baby, receiving percussions3/10/94, 1912 hrs: same baby, receiving percussions4/10/94, 1623 hrs: Baby 9 (one of the affected babies) is shown, but not receiving physiotherapy. The baby is initiallyheld in the arms of one parent, and then is shown with Kangaroo care.

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represented babies of a much larger weight than those that were the subject of thisinquiry. The first seven clips were of a term baby, and the eighth and ninth were ofpreterm babies of approximately 1,500 grams in weight.

Overseas Hospital 4Expert 17, made available to the Inquiry a teaching video tape which he/she had usedfor teaching purposes. He/she had used it on numerous occasions in his/her teachingsince 1981. It showed a single session of physiotherapy, using the technique ofpercussion by cupping.

Overseas Hospital 3A videotape was also sent from this hospital, which showed Expert 16 administeringphysiotherapy by the percussion technique firstly on a doll, and secondly on a baby.

The question of vigour was a principal issue raised during the course of this Inquiry,following the finding of the Medical Misadventure Advisory Committee. All of the clinicalwitnesses were asked to comment on vigour as recalled from their own experience andcompare it with that seen on the video from NWH. It also assumed an importance inassessing differences in technique, following the publication of the 1998 paper, whichdrew an analogy between the brain lesion (ECPE) and a head-shaking injury.

Parental Impressions

The parents were able to recount their recollections of the vigour of the treatment.The nature of the physiotherapy drew significant reaction from the parents. Many ofthem were concerned about their babies, particularly when first observed. We set outthe evidence as follows:

Parent 1a: “During the treatment [my baby] was bouncing around on [the] bed,[and the] head and parts of [the] body which were not restrained were all moving....it was like they were on a little trampoline” 149

Parent 1b: “I was upset the first time I saw it done. it looked very rough to me.[The baby] was bouncing around [the] bed and [the baby’s] head, legs, and armwhich was not restrained were moving” 150

Parent 2b: “I thought it seemed a very harsh treatment for a very young babybecause [the baby] was bumped around by the treatment all the time. ... Itseemed to me that during the treatments all the unsupported parts of [thebaby’s] body moved quite vigorously.”151

10/10/94, 1356 hrs: the same original tem baby, receiving percussions, although the camera angle prevents much ofthe style being observed.12/10/94, 1309 hrs: the same baby, receiving percussions. Some of the preceding 6 treatments were performed bynurses, and some by 2 physiotherapists, including Health Professional 6.1992: a preterm baby born in June 1992 at 29 weeks gestation with a birthweight of 1435g. the age of the baby atthe time is not known. This baby had cystic fibrosis. The physiotherapist was Health Professional 6.1990: A preterm baby at 32 weeks gestation, receiving physiotherapy at 10-14 days of age. This infant went on todevelop chronic lung disease. The physiotherapist was Health Professional 6.

149 B2 p7150 B1 p3151 B2 p9-10

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Parent 2a: “The first time I saw it, because of the violence of the treatment [thebaby] was receiving, I thought [the baby] must have had a heart attack and thephysiotherapist was giving CPR. On each occasion I saw the chest treatmentscarried out [the baby’s] head and other parts of [the] body were shaking.”152

Parent 3b: “A dear friend left the unit in tears after witnessing physio treatmenton [the baby]. Another friend felt uneasy and at the time I reassured her that it isgood for them.”153

Parent 3a: “When I walked into the nursery and saw the physiotherapist banging[the baby’s] chest with [the baby] shaking like a jelly on a plate I called out “Whatare you doing to our baby!” I couldn’t believe it. My reaction was that we are toldnever to shake a baby and yet here it was happening in hospital.”154

Parent 4a: “The nurse was tapping [the baby’s] back quite rapidly, and to me itappeared to be quite vigorously…I could see [the] head was moving…I did notthink this procedure could be good, with the baby’s head moving.”155

Parent 4b: “The sight and sound of seeing [the baby] being treated upset me. ...While the treatment is described as tapping, I felt at times it was much strongerthan that because it caused movement in [the] legs and head when [the baby]was lying in a prone position, and when on [the] back it seemed to me that thetapping caused [the] chest to compress quite a bit”156

Parent 5a: “I thought the treatment seemed harsh for such a small baby.”157

Parent 5b: “I thought it looked harsh because [the baby’s] whole body wouldmove including [the] head.”158

Parent 6a: “I saw the first treatment carried out and while I was not upset by thetreatment I was concerned about it, but I believed that the nursing staff knewwhat they were doing and I was happy for them to do it if it would help [the baby].... During their treatment [the baby’s] head would move a lot, it looked to me asif [the baby] had little spasms running through [the] body”159

Parent 7b: “I found the physiotherapy distressing. When the cupping wascarried out I felt that one of [the baby’s] bones was going to break. I could feel[the baby’s] pain. I used to go into the Church everyday asking God if they couldstop the treatment because [the baby] was too tiny.”160

Parent 7a: “I was concerned how rough it appeared on such a small and fragilebaby. Because I had complete trust in the doctors, nurses, and physiotherapistsI did not query the treatment.”161

152 B1 p4153 B2 p7154 B2 p13155 B2, p11 Parent 4a156 B1 p7-8157 B2 p9158B1 p6159 B2 p5-6160 B2 p8161 B1 p6

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Parent 8b: “When [the baby] was tapped even slightly by the physiotherapist itwas like a stone tossed into a pond and the ripples went out through [the] body.... I felt that people were being too rough in handling [the baby].”162

Parent 8a: “When I saw it being done the physiotherapist explained thetreatment to me, the reasons for it and tapped the back of my hand to show howgentle the treatment was.” 163

Parent 9a: “I held [the baby’s] head because my parental gut instinct told me toand I kept seeing in my mind the old TV advertisement of ‘never shake a baby’....I questioned this therapy on many occasions referring to it as cruel andbarbaric. I was always given assurance it was harmless. I was asked to leave onoccasion during treatment because I was becoming distressed. ... My babywas hurting and I could do nothing ... I found the therapy very distressing tomyself. I knew it was wrong.”164

Parent 9b: “The first time I witnessed a physiotherapy session I was horrified. Itlooked so rough and hard .. [The baby’s] head was moving too much for mycomfort and I felt better holding [it]”165

Reassurance

Parents and staff said that reassurance was given both by explanation and by ademonstration of the cupping pressure on the forearm or hand of the parent. Anexample of this was seen on the videotape. The belief of the staff at the time was thatthe noise and appearance were misleading, and that the soft nature of the Laerdal maskled to an impression of vigour that was deceptive166.

Most of the parents described that this demonstration had occurred without furthercomment,167 but there were two additional opinions given:

Parent 8b: “The physiotherapist took my hand and showed by tapping the cupon that back of it how gentle it was. I remember thinking that it didn’t seem verygentle as it caused my arm to jump.”168

Parent 9b: “[Health Professional 6] told me it was painless and safe, [and] thengrabbed my hand and tapped the back of it with the plastic cup thing. I am agrown man so of course it would not hurt.”169

Measuring Vigour

Notwithstanding the fact that the staff at NWH consistently reassured the concernedparents about the cupping, it is apparent that the technique did involve some degree ofvigour. The question then arises whether this degree of vigour was different from that 162 B2 p11163 B1 p.3 Parent 8a164 B3-4 p23,24,27165 B1-2 p9-10166 SB 1.6 Health Professional 6167 B2 p7 Parent 1a, B1 p3 Parent 1b, B2 p9 Parent 5a, B2 p5 Parent 6a, B2 p6 Parent 7b, B1 p3 Parent 8a, Parent 4blB1 p7.168 B2 p10169 B1 p9

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practised elsewhere by different physiotherapists and nurses, and more particularly if itwas sufficiently vigorous to cause head-shaking injury. It was suggested that this was adifficult matter to resolve as there were no standards for measuring vigour.

Health Professional 3 explained170 that it was very difficult to know how vigorous nCPTshould be. The NWH physiotherapists had based their vigour on that of OverseasHospital 2. Health Professional 3 said “it is important to remember that there were nostandards for vigour and no objective way of measuring it”.

Health Professional 7: “I don’t believe we can accurately measure vigour, and wedidn’t.”171

The Inquiry heard subsequently that there have been at least two attempts to measurethe pressure generated by the cupping. The first was at Overseas Hospital 2, wherethere was a specific effort to standardise the pressure of cupping after the NWH newsrelease in 1995.172 Three experienced physiotherapists measured their percussionpressure as being 5 cm water on an inflated ambubag. They then circulated guidelinesto other hospitals indicating that individuals could check their pressure in this way.Health Professional 3 suggested however that this technique would not be easilyreproducible173.

The second attempt to measure pressure was by Expert 6 (Hospital 3), who hadpreviously participated in an assessment of physiotherapy at NWH for the MedicalMisadventure Advisory Committee (MMAC) specifically in regard to Babies 3 and 10. Inthis capacity and at that time Expert 6 had viewed part of the video. The MMAC gavefinal advice to the Corporation (ACC) in March 1998, finding Medical Error had occurredin the case of Baby 3 and Baby 10. In the records of that decision, there are details offive meetings that were held to reach this recommendation, the fifth meeting occurringon 13 February 1998. Expert 6 was a committee member at this (and the fourth)meeting. The record of that fifth meeting concludes:174

“The conclusion is that it was the vigorous nature of the chest physiotherapycombined with the frequency employed at NWH during the relevant period whichled to neurological damage to the preterm infants which has been described.This has since been qualified as a difference between five centimetres of waterat [Overseas Hospital 1] and 15 to 20 centimetres in NWH, which is consistentwith the technique viewed on the video supplied by NWH.”

It should be noted that an error was contained in the above record, in the reference toOverseas Hospital 1. The pressure should have been attributed to Overseas Hospital2, who had revised their new protocol after the NWH findings. The new protocolincluded a recommendation that percussion force be standardised by tapping on arubber bag with a manometer attached, so that the force required to generate apressure of 5 cm water pressure could be achieved.175

Expert 6 gave evidence to this Inquiry that he/she had carried out 20 separate tests on18-19 August 1997, in order to quantify the pressures seen on the video176. It was

170 B21 p88 Health Professional 3171 T442 Health Professional 7172 B page 3 Expert 13, B page 3 Expert 12.173 T241 Health Professional 3174 ACC docs p.00008175 NWH Vol 2 446176 B2 p. 14 Expert 6

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apparent that Expert 6 had access at that time to the video of the term baby only, andnot the video of the preterm babies when carrying out these tests.177

Expert 6 told the Inquiry:

“I carried out the tests on the following manner…“An air-filled model was constructed using a rubber “lung” attached to a pressuremanometer. Using three different latex masks the movement of each therapiston the video were copied and the pressure readings were recorded. Eachtherapist’s actions, when copied like this, gave surprisingly constant readingsand varied from almost 15 to almost 60 cm of water pressure.“Results were the same when the model was cradled in an arm or on a flatsurface.”178

Expert 6 performed a demonstration of the model for the Inquiry, and showed that whenthe wrist is used with the forearm staying still, forces of between 5 cm water (gentle),and 15 (hard wrist percussions) were visible. When the whole forearm was used, aswas present in the video viewed, pressures of between 15 cm of water and 60 cm ofwater were visible.” 179

Expert 6 said that the increase in pressure delivered to the model with each percussionwas therefore between 3 and 12 times greater when the forearm was used comparedthe wrist180.

There was some discussion as to whether the observations from the model could beapplied directly to the baby. Expert 6 accepted that the initial inflation pressure of themodel would have a significant impact on the readings, and chose a low inflationpressure because of the range of the manometer used.181 With regard to themagnitude of the change, it was unclear whether the simulation could accuratelyrepresent the complexity of the chest of a baby.182

177 T400 Expert 6178 B2 p. 17-19 Expert 6179 T385 Expert 6180 T412 Expert 6181 T393 Expert 6182 T413-4 Expert 6

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The Video Compared with Other Evidence

There were a number of different visual demonstrations of the technique available to theInquiry. In addition to the videos from NWH, Overseas Hospital 3, and OverseasHospital 4, simulations on dolls were given by Health Professional 6 and Expert 13. TheInquiry members noted a substantial difference in the style of cupping evident betweenthe NWH video and the other demonstrations, including Health Professional 6’ssimulation on a doll. Whereas his/her technique on the doll before the Inquiry wasgentle with wrist movement only, the technique on the video was significantly morevigorous.

It was said that the pressure used on a very small baby, such as the ones involved inthis Inquiry, would have been less than shown on the video183 as the video babies werelarger than the Inquiry babies. Notwithstanding that assertion, much of the evidencesuggested otherwise. The parents all saw the video. We are mindful in assessing theircomments, of the cautions raised about the accuracy of their recall.184

Seven of the parents said that the technique observed on the video, and applied to thepremature babies was similar to that given to their own babies.185 Five of them saidthey recalled that cupping given to their babies was more vigorous or resulted in greaterbody movement than the two premature babies on the video.186 None of the parentstold the Inquiry their babies received nCPT that was of less vigour than was depicted onthe video.

All the parents from whom comparisons were sought, considered that thephysiotherapy on their babies was undertaken with the same level of vigour as the videobabies.

In addition the NWH staff were able to provide some information on this matter. HealthProfessional 3 agreed that the intensity of treatment on the 1990 baby on the videorepresented the intensity used in 1993-1994 for a 32 week infant.187 Two nursesagreed that the video vigour was the same as they had administered.188

On the basis of this evidence, and taking into account the parents viewing of the videotogether some five to six years after the event, we conclude that the video vigour was amore accurate indicator of actual vigour used than the simulation performed by HealthProfessional 6.

This is also supported in part by the indication from some NWH staff that they hadbecome aware that the degree of vigour in their unit was possibly greater than in otherunits.

Health Professional 3: “I think from my observations it (vigour) was similar to some. Itwould have been more vigorous than others189”

183 SB6 p17 Health Professional 3184 Refer previous section on “The Videotapes”: SB6 p28 Health Professional 6185 T48 Parent 5a, T63 Parent 6a, T66 Parent 6b, T69 Parent 7b, T76 Parent 7a, T79 Parent 8b, T84 Parent 8a.186 T21 Parent 1a, T22 Parent 1b, T31 Parent 2a, T41-2 Parent 4a, T96 Parent 9b.187 T224 Health Professional 3188 T557 Health Professional 12, T570 Health Professional 11189 T237 Health Professional 3

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Health Professional 5:“From discussions, my impression is that at NWH was probablymore vigorous but I have not watched in other nurseries enough to be able tocomment.190”

Health Professional 7, referring to nCPT in general “there could have been somethingdifferent about the way we gave physiotherapy that contributed. But I have to say that, atthe time, we were totally unaware that we were giving physiotherapy in a different way, ifwe were.191”

Health Professional 11, speaking about the response from nurses from other units “Ithink the attitude of the nurses was that they would not have done it (physiotherapy) asmuch as we did at NWH.192”

Health Professional 6 was not entirely of that view. Whilst of the view that there were“differences between NWH and the rest of New Zealand193,” Health Professional 6believed the technique used and that of the other physiotherapy staff was not toointense194. He/she had never received negative feedback about his/her intensity fromothers in New Zealand195.

Other Hospitals

Witnesses from other hospitals were asked for specific comments about the vigourobserved on the video. It should be noted that some witnesses were more familiar withother forms of physiotherapy.

Hospital 3Although Expert 6 was called to give evidence primarily in regard to his/her pressuresimulations, he/she did make some brief comments about the vigour seen on the videotape:

“I have witnessed face mask physiotherapy both here and overseas but I havenever witnessed it as shown on the video.196”

“Those babies were receiving physiotherapy in a more vigorous and over amore prolonged period than babies I have seen personally, ...”197

With regard to the vigour, Expert 6 was of the opinion that the head would not moveuntil a threshold of cupping pressure was reached, and that that threshold would likelyvary with the size of the baby198.

190 T303 Health Professional 5191 T441 Health Professional 7192 T575 Health Professional 11193 T379 Health Professional 6194 B22 p39, Health Professional 6195 B22 p41 Health Professional 6196 B2, p11 Expert 6197 T388 Expert 6198 T394-5 Expert 6

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Hospital 1Expert 9 explained that he/she used subjective measures to determine the correctintensity. He/she watched the degree of movement or “jigging” effect of the baby duringpercussion, and adjusted his/her pressure in order to keep this at a reasonable level199.Expert 9 felt that some of the video evidence showed a greater vigour than he/she wouldhave used.200 He/she also said that he/she had observed percussion being given atNWH, and at Overseas Hospital 2, and felt that the percussion used at NWH was firmerthan at either Overseas Hospital 2 or Hospital 1201.

Expert 7 had not had extensive experience of cupping, but in comparison with themethod of finger percussion, Expert 7 believed that the treatments on the video babiesshowed more bouncing than he/she was accustomed to in his/her own practice202.

Hospital 4It should be noted that chest physiotherapy was an uncommon procedure at Hospital 4.The vigour of the percussions on the video made Expert 3 feel uncomfortable,203 andwas different to a large degree from what he/she was familiar with in both the Hospital 4unit, and in his/her overseas experience in 1989.204

Hospital 2The vigour of the percussions was less in Hospital 2 than as seen on the video 205

Overseas Hospital 1This Hospital did not use the cupping technique, but Expert 4 had seen percussivephysiotherapy at a nearby hospital and was able to draw comparisons between thevigour of that technique and the video technique, in regard to the term baby. Expert 4believed that the two techniques were similar, saying also, however, that the bodymovement of the preterm babies on the video was greater than the movement of similarbabies in Overseas Hospital 1 when receiving vibration physiotherapy.206

Overseas Hospital 2The video from NWH was seen by Expert 13 and Expert 12. The former felt that thevigour on the NWH video of the cupping technique was greater than he/she would havepractised in the case of the first preterm baby, and far greater in the case of thesecond.207 Expert 12 agreed that both babies received cupping at a vigour that was inexcess of that provided at Overseas Hospital 2, but was unable to say that the videoshowed excessive vigour in the case of the first preterm baby.208 Both witnesses saidthat the wrist movement should be used, and Expert 13 was specific that elbowmovement should not be used, even on a heat table.209 These comments areparticularly relevant in light of Health Professional 3’s assertions that the NWH degree ofvigour was based on that used at Overseas Hospital 2210.

199 B page 5 Expert 9200 B page 8 Expert 9201 T731 Expert 9202 B8 p11 Expert 7203 T601 Expert 3204 T601 Expert 3205 B4 p. 12 Expert 14206 T639 Expert 4207 B p. 8 Expert 13208 B5, p. 8 Expert 12, T780 Expert 12209 T810 Expert 13210 B21 p88 Health Professional 3

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Expert 12 and Expert 13 had previously commented on the video vigour in theproceedings before the Medical Misadventure Advisory Committee (MMAC). It wassubmitted that their previous comments differed from the evidence given at this Inquiry,in that those comments indicated that they were less certain of excessive vigour at thattime211. Their joint letter to the MMAC inquiry in 1997 was at the request of NWH, andaddressed a similar question with regard to vigour that was put to them in this Inquiry.

On both occasions they gave critical comment about the vigour of the cupping, whichwas consistent, although in the latter evidence the criticism was stronger. On thisoccasion they prepared a brief, in response to a request from Counsel Assisting, theyreviewed the video and their evidence was examined before the Inquiry. Expert 12specifically addressed the earlier written opinion he/she had given in 1997, telling theInquiry that the present comments were additional to those previously given.

In relation to Baby A, Expert 12 said “opinions were divided as to whether this constitutedexcessive vigour for 1993. It was certainly in excess of what we usually provided at thattime.”212 Expert 12 described the use of the elbow in relation to Baby B, (32 weeks ofage) consistent with [Expert 12’s] earlier opinion and noted that the use of the elbowwas possibly related to the use of a cork rather than a finger over the hole in the mask.Expert 12 acknowledged under examination from Counsel that the degree of vigour willalways depend on the size and condition of the baby and how it is handling thetreatment, “[b]ut there is an extreme beyond a certain point it can’t be justified.”213

Expert 12 described the technique on the preterm Baby A as “bangingrather than bouncing”214, and deferred to Expert 13 to explain these terms. Expert 13indicated that ‘banging’ indicated the use of the whole hand from elbow action, whereasbouncing referred to the flicking movement of the wrist215. This is further discussed inchapter six. We had an opportunity to hear and examine both witnesses on oath andwe were impressed with their evidence which was detailed and extensively examined.

On receipt of the brain lesion information from NWH in early 1995, Overseas Hospital 2produced quidelines for all perinatal units in Australasia216. These guidelines included acaution to keep the cupping pressure at no more than 5cm water, (along with someguidelines on duration and number of segments). Clearly, at that time OverseasHospital 2 had identified that the pressure of the cupping should be contained at a safelevel.

Expert 13, in discussing the need for head-holding, had some comments pertinent tovigour which bore similarities to the threshold statement of Expert 6:

“In my opinion we were never hitting the babies hard enough for it to make adifference. It is my opinion that the head needs to be stabilised in the event ofvigorous or over-vigorous treatment and so when you have reports of somepeople holding the head, some not holding the head, the bottom line is how hardwere you hitting that you needed to hold the head.”

211 Submission from NWH after reviewing the draft document212 B5 p8 Expert 12: T776 l13-15213 T795 l25-27214 B6 p8 Expert 12215 T827 Expert 13216 attached to Expert 13’s brief

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Overseas Hospital 3The vigour of the treatment on the video was noted by Expert 15 to be significantlydifferent from the Overseas Hospital 3 style, in that the movements of the babies duringphysiotherapy on the video would not have occurred217. Expert 15 felt that the babies inAuckland were more vulnerable than the Overseas Hospital 3 babies because of thismovement. Expert 16 also said that the video showed elbow movement, whereas theOverseas Hospital 3 procedure involved wrist movement218.

Expert 16 provided a video showing him/her undertaking percussions on a doll, and thenon a baby. Expert 16 kept his/her forearm on the bed, and supported the baby’s headwith his/her other hand. He/she used wrist movement, and gave the percussions for 1minute. There was no noise with this percussion, due in part to the fact that the infantwore a vest. The percussions were considerably more gentle than those seen on theNWH video.

Overseas Hospital 4Expert 17 viewed the video, and commented:219

“By comparison with my practice in 1993-4, the video demonstrates prolonged,vigorous percussion without apparent pauses to allow re-assessment andrecovery. Had I seen these infants being treated in this way in my unit I wouldhave intervened to stop the treatment.”

Expert 17 provided a video of his/her own which demonstrated percussivephysiotherapy of a very different style to that observed on the NWH video. The infantappeared to be approximately 1500g in weight. By comparison, the percussions weremild, using wrist movement, and for a shorter time frame (25 seconds). He/she blockedthe hole in the mask with his/her forefinger.

Summary

Some NWH staff agree that the videoclips were accurate depictions of the vigour onbabies of the gestation shown. The parents largely identified the video degree of vigourto be the same as that observed on their own babies, who were initially considerablysmaller than the babies shown on the video. On balance, we conclude the video’sdepiction of vigour is closely representative of that received by the babies who were thesubject of this Inquiry.

Evidence from the other units revealed that there was strong concern about theexcessive vigour depicted on the video from staff of Hospital 3, and Overseas Hospitals2, 3, and 4. Discomfort was expressed from staff of Hospitals 1, 4 and 2.

ConclusionNWH administered physiotherapy of greater vigour than at other hospitals.

FREQUENCY

Four hourly sessions were the rule at most centres, although there was considerablevariability around this. Two hourly physiotherapy was given for specific indicationsand/or for short periods in some centres (National Women's, Hospital 1, Overseas

217 T853 Expert 15218 B p. 8 Expert 16219 B5 p. 16 Expert 17

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Hospital 2, and Overseas Hospital 3)220. Both Hospital 4 and Overseas Hospital 4 hadno fixed routine or frequency221.

If four hourly physiotherapy was the order, then six treatments per 24 hours wasavailable at National Women's, Hospital 1, Hospital 2, Overseas Hospital 1, OverseasHospital 2, and Overseas Hospital 3. In the case of Overseas Hospital 1, this was rareas physiotherapists needed to be called in for the night treatments222. In the case ofNWH prior to the change, the treatments could only be administered four times a day.Following the change, they were available six times a day. In 1994 however, because ofworkload pressures, one of the night time sessions was abandoned, so five treatmentsa day became relatively common223.

ConclusionNWH was not significantly different from other units in its choice of frequency.

PERCUSSION RATE

The percussion rate at National Women's Hospital was between 160-200 beats perminute,224 at Hospital 1, 200 beats per minute,225 at Hospital 2, 40-60 beats perminute,226 at Overseas Hospital 2’s 120-180 beats per minute,227 at Overseas Hospital3, 60-100 beats per minute,228 and at Overseas Hospital 4, 200 beats per minute.229

ConclusionThere was a wide range of variability in percussion rate but NWH was consistent with 3other hospitals in having a high percussion rate.

220 B11 p9 Health Professional 3, B page 4 Expert 9, B page 3 Expert 12, B para 3 Expert 16221 T600 Expert 3, T872-3 Expert 17222 T638 Expert 4223 NW Vol 1, 14224 B14 p23 Health Professional 6225 B page 2-3 Expert 9226 B pages 2-3 Expert 14227 B page 3 Expert 12, B page 3 Expert 13228 B para 3 Expert 16229 video Expert 17

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DURATION OF TREATMENT

At National Women's Hospital the regular duration of cupping was for two minutes ineach of three to four segments.230 Physiotherapists would occasionally give treatmentfor up to three minutes, whereas nurses would not.231

At Hospital 1, the cupping treatment was initially one to two minutes in each of threepositions,232 although in the later period it changed to finger tapping (up to 2 minutes for2-3 positions).233 In Hospital 2, it was one to two minutes for two segments.234 At theOverseas Hospital 2, the cupping treatment was one to two minutes for one to twosegments.235 At Overseas Hospital 3, it was one to two minutes in one position only,236

and at Overseas Hospital 4, it was a half a minute in one to three segments.237

The cupping time at each session could therefore be calculated as: National Women’sHospital up to 8 minutes, Hospital 1, 6 minutes, Hospital 2, 4 minutes, OverseasHospital 2, 4 minutes, Overseas Hospital 3, 2 minutes, Overseas Hospital 4, 1½minutes.

The treatment duration of a session was variable. At NWH the duration was between10 and 20 minutes;238 at Hospital 1 it was 10 to 15 minutes;239 at Hospital 3 it was 1 to3 minutes;240 at Overseas Hospital 2 it was 10 to 15 minutes;241 at Overseas Hospital3 it was 2 to 3 minutes242 and at Overseas Hospital 4 it was 5 to 10 minutes.243

The duration of treatment in terms of days was not readily available. Overseas Hospital1 had published data which indicated that physiotherapy treatment was given there for amedian of 57 days, and the assessment at National Women's indicated precisely thesame median for the same gestational age group.244 At Hospital 1, evidence was giventhat there was a frequent intention to curtail the physiotherapy within three days ofstarting, but no evidence was available to indicate how often this happened.245

ConclusionThere was a greater duration of cupping at National Women's Hospital compared withother hospitals, and the total duration of each treatment was longer than at most otherhospitals.

230 NWH Nursing and Physiotherapy Documentation 1-4231 SB 17 p87 Health Professional 3232 B page 4 Expert 9233 B2p6(a) Expert 7234 B page 2-3 Expert 14235 B3 p3(a) Expert 13236 B para 3 Expert 16237 B3 p11 Expert 17238 T165 Parent 3a, T491 Health Professional 9, B6 p19 Health Professional 14239 B page 2 Expert 9240 T394 Expert 6241 B3 p3(a) Expert 13242 B para 3 Expert 16243 B3 p11 Expert 17244 B25 p110 Health Professional 3245 T664 Expert 7

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VARIABILITY

A number of witnesses attested to variation in technique by different staff, beingwitnesses from National Women's Hospital, Hospital 1, Hospital 2, and OverseasHospital 2.246 Most of the clinical witnesses had the impression that nurses tended tobe less vigorous than physiotherapists. Health Professional 6 disagreed with HealthProfessional 3 in this regard when he/she indicated that he/she believed the range ofvigour displayed by nurses was similar to the range displayed by physiotherapists.247

ConclusionThere was variability at NWH, as at other hospitals, in the way the technique of cuppingwas performed.

THE DECLINING NEED TO TREAT

A number of witnesses from different hospitals gave evidence that the requirement forphysiotherapy seemed to be reducing during the period in question due to otheradvances in the condition of chronic lung disease. This evidence was received fromHospital 1, Hospital 2, and Overseas Hospital 2.248

Expert 12 said of the period 1992-1995:

“Undoubtedly the requirement for active physiotherapy was declining throughthat period of time. We saw much less in the way of severe collapseconsolidation and overall the requirement for active chest physiotherapy wasdeclining.”

Witnesses from Overseas Hospital 4 and Hospital 3 did not observe this indicating thatphysiotherapy (cupping in the case of Overseas Hospital 4) was rare and remainedrare.249 National Women's Hospital gave no evidence regarding the reducing need forphysiotherapy, but did indicate that there was a variability in the tendency of the differentspecialists to order commencement of the treatment.250

ConclusionIt appears other units who had frequently used cupping as a technique were finding lessneed for it, whereas the level of physiotherapy provided at National Women's Hospitalwas not decreasing. The availability of chest physiotherapy was in fact increasing.

PERSONNEL

At National Women's Hospital, physiotherapy was provided by both physiotherapistsand nurses. The same situation applied at Hospital 1,251 and Overseas Hospital 2.252

In Hospital 4, Hospital 2 and Overseas Hospital 3, physiotherapy was performed solelyby nurses,253 and in Overseas Hospital 4 it was mostly by nurses.254 In Overseas

246 T274 Health Professional 3, T745 Expert 11, T834 Expert 14, B page 4 Expert 12247 T416 Health Professional 6248 B page 3 Expert 7, T839 Expert 14, T777 Expert 12249 T601 Expert 3, T874 Expert 17250 T254 Health Professional 3251 B4 p7 Expert 7252 B page 4 Expert 12253 B2 p4 Expert 3, B3 p8(a) Expert 14, B para 4 Expert 16

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Hospital 1, it was only performed by physiotherapists,255 and in Hospital 3 it was rare fornurses to perform it.256

Physiotherapy was available 24 hours a day at NWH after the change and in five otherunits.

ConclusionFrom the evidence received National Women's Hospital was not out of step with otherunits in having 24 hour availability of nCPT whether or not nurses were performing chestphysiotherapy. However, it was certainly common in units for nurses to perform thistask.

HEAD HOLDING

Only at Overseas Hospital 3 was there a specific caution about holding the head of thebaby during physiotherapy.257 This caution was unwritten, but there were in fact nowritten protocols regarding physiotherapy at that hospital at that time. The hospital didexperience the brain lesion in 1988-1990, and following this the instructions aboutholding the head were reinforced.258 At none of the other hospitals was there a specificcaution about holding the head. The Hospital 2 protocol contained a specific referenceto the possible danger of excessive head movement,259 but there was still no instructionto hold the head during physiotherapy. The caution in that situation regarded avoidingphysiotherapy that was vigorous enough to cause head movement.

ConclusionThe practice at National Women's Hospital was consistent with other hospitals in thatthere was no instruction or caution regarding holding the head.

STABILITY

During physiotherapy and other procedures, the general condition of babies ismonitored in order to determine their ability to cope with the intervention. The particularintervention may continue, pause, or cease, depending on the stability of the baby. Thisstability is monitored by a variety of means, including the general appearance of thebaby, the heart rate, and the oxygen saturation level. The latter is measured by meansof a pulse oximeter which is an electronic device with a probe attached to the baby. Thepulse oximeter gives a display of the saturation reading which indicates the amount ofoxygen being carried in the blood. A reading of 100% indicates a high oxygen carriage,whereas a reading of 60% would be a low reading. There are dangers with both highand low levels, and accordingly most NICU’s have a target range in which theyendeavour to keep the saturations. At NWH, this target range was said to be between90% and 95%.260

It is inevitable that the saturations will stray from this target range, and this occursduring certain procedures (of which physiotherapy is one). Additionally, the shaking

254 B4 p12(a) Expert 17255 T638 Expert 4256 T388 Expert 6257 B para 7 Expert 16258 B page 5 Expert 15259 Attached to Expert 14’s brief260 T533 Health Professional 10

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movement of physiotherapy can give rise to movement which makes it difficult toproperly interpret the display. However, a brief pause in the cupping will generally allowthe reading to stabilise and give a reliable reading.

Documents were available to the Inquiry which recorded the saturations of Baby 10during physiotherapy.261 It was apparent that on occasion, the baby’s saturation levelsdeclined to 60% during physiotherapy. The records were not sufficiently specific toallow a clear understanding of these circumstances, and it is quite possible that the lowsaturations recorded indicated a brief decline during the suctioning phase of thephysiotherapy rather than the cupping phase. Such a decline would be more likelyduring suctioning, and if so is likely to have been very brief.

Evidence was given262 that at NWH the saturations during the cupping phase ofphysiotherapy were maintained above 80%. A decline below this would occasion apause in the cupping, and a further decline below 60% would cause the cessation ofthat treatment263. If the saturations were maintained at 81% or greater, then thecupping would continue.264

The evidence from other hospitals was that their saturation levels were different, in thatthe minimum acceptable saturation limit during cupping was higher than at NWH.These were Hospital 1, 88%, Hospital 2, 85%, Overseas Hospital 2, 89%, OverseasHospital 4, 85%. Expert 4 from Overseas Hospital 1 was unable to say whether theNWH saturations caused him/her concern.

ConclusionNWH was at variance with other hospitals in allowing the stability limits to deviate furtherthan tolerated in other units.

BEDDING

A suspicion was raised by National Women's Hospital witnesses that the brain lesionarose because of a particularly soft form of bedding that they used. In answer to aquestion on causation, Health Professional 3 suggested:265

“It is a combination of the physiotherapy and the bedding in my view. We havesaid at the outset to the parents and everyone that we think it was a shakinginjury and therefore our babies heads were moving more or were moving enoughto cause this shaking injury.”

Sheepskins were used, but there was a recollection that in 1992 a particularly soft formof sheepskin may have become available.266 No confirmatory evidence was available inthis regard. Sheepskins were also used in Hospital 1, Hospital 2, Overseas Hospital 2,Overseas Hospital 3 and Overseas Hospital 4.267 Hospital 4 had used sheepskins in thepast, but did not do so now, and Hospital 3 had not used sheepskins.268

Conclusion

261 Document 9262 T532 Health Professional 10263 T499 Health Professional 9264 T533 Health Professional 9265 T258 Health Professional 3266 T485 Health Professional 9267 B2 p9 Expert 11, B4 p14 Expert 14, B page 6 Expert 12, B para 9 Expert 16, B5 p17 Expert 17.268 T606 Expert 3, T441 Expert 6

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NWH was not at variance in the use of sheepskins as bedding for its pre-term infants.

GENERAL COMMENTS

Having listened carefully to the evidence from all centres and evaluated the particularstyles of physiotherapy evident within each, we conclude that physiotherapy treatmentat NWH was substantially different from other units. This is largely detailed in thepreceding breakdown of the physiotherapy parameters. In addition, the Inquiryconsiders that there was a milieu of therapy at NWH in which nCPT appeared to havegreater prominence than elsewhere. The treatments were more vigorous of longerduration and for longer periods. In spite of the acknowledged reluctance on the part oftwo of the specialists at NWH to refer babies for nCPT it still appeared to the Inquiry thatNWH was considerably more focussed on active cupping than elsewhere.

THE IMPACT OF THE ‘CHANGE’ AND THE OCCURRENCE OF THE BRAINLESION

The Question of Causation

The facts and the issues raised by this Inquiry inevitably have touched on the issue ofcausation. As has been submitted to the Inquiry,269 the terms of reference seem tohave been formulated on the assumption that the changes were the cause of thelesions. It was submitted that the validity of that assumption is open to serious questionand in the course of the evidence it was clear that the first three babies with the brainlesion could not be explained by the change in treatment, as they had developed thelesion prior to any impact of the change.270

The Inquiry has received considerable evidence, dealing with the differences in the waythat chest physiotherapy was performed in different Units but which also touched on theissue of causation. Submissions have been received, which address the evidence andthe issue of causation.

Although a finding of causation is not specifically required in the terms of reference, it isimportant to address the premise upon which the terms of reference are based and theevidence which is relevant. For this reason, we set out aspects of the evidence whichare relevant in this regard, particularly in light of our findings on the vigour with whichpercussion was given.

When Health Professional 5 first confirmed the link between chest physiotherapy andthe brain lesion, he/she had clearly not considered the impact of the change oftreatment. As he/she told the Inquiry:271

“It wasn’t until mid-January when we were sure enough that this phenomenonwas real … that we told [Health Professional 6] and the paediatricians and thesenior management, and it was not until then that they said to me ‘but that waswhen we changed policy.’ I had not recognised the date at all at that time.”

As Health Professional 5 told us: 272… 269 NWH submissions p.3 p. 6270 As addressed in Chapters 3 & 4 the change refers to June 1993 to December 1994, where nurses undertook alimited form of chest physiotherapy during evening and night shifts, namely the technique of percussion.271 T301 Health Professional 5

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“the focus on the change of treatment has really only arisen with the ACCinquiry over the last 2 years or so. … I have to say that the detail of whether thechange was part of the explanation for the cluster and the fact that it could notexplain all of it has really only come to light in the last year or so with thisdetailed investigation.”

It was submitted on behalf of NWH that:

“It is similarly tempting to conclude that the changes which did occur from June1993 at National Women’s Hospital lie at the heart of the cause of these lesions.This assumption has been made in formulating the terms of reference for thisinquiry. Careful reflection and consideration of the facts demonstrates that thereare flaws in this reasoning.”

Several reasons were advanced:- much more physiotherapy was given in earlier years without ECPE- there was no change in physiotherapy when the first 3 cases occurred- there was reduced physiotherapy given at the time of the first 3 cases,

compared with pre 1989- the video evidence shows no change in vigour from 1990 to 1994- the same happened in Overseas Hospital 3 without an apparent change.

It was then submitted:

“In summary, National Women’s Hospital maintains the view that chestphysiotherapy is a major factor in the occurrence of the lesions. However, likeOverseas Hospital 3, they do not consider that it is the only factor. Moreimportantly, for the purposes of this inquiry, the occurrence of these lesionscannot be attributed entirely to the change at National Women’s Hospital fromJune 1993 onwards.”

The Inquiry members accept that the occurrence of the lesions cannot be attributedentirely to the change in treatment from June 1993 onwards. However, the evidencedemonstrates that the differences in undertaking nCPT at NWH, namely the vigour andthe duration of the percussion, became more apparent after the change in treatmentand combined with the variability of technique of staff, contributed to the occurrence ofthe lesion.

We set out the relevant evidence under each of the following headings:1. The limits of Case Control Studies2. The link with chest physiotherapy3. Something different4. Combination of factors5. Bedding6. Shaking injury7. Size of NWH neonatal service8. Frequency9. Vigour10. Variability

272 T300 Health Professional 5

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The Limits of Case Control Studies

In explaining the relevance of a case control study to determine causation, HealthProfessional 5 was clear that:

“A case control study is not able to determine causation. It can only revealassociations.273

However the association can be tested against the standard set of criteria and mostimportantly no more cases of the lesion were seen once chest physiotherapy ceased.

Health Professional 5 describes this:

“If differences are found between the groups, the association can be testedagainst a standard set of criteria called “criteria for causation.” The relationshipbetween physiotherapy and ECPE at NWH satisfied many of these criteria, themost obvious being that no more cases of ECPE were seen once chestphysiotherapy was stopped. The other associations (hypotension, breechdelivery) did not satisfy these criteria, and were not thought to be causative.”274

Whilst there is no firm proof that chest physiotherapy did cause the lesions, and that it ispossible chest physiotherapy treatment was not the true cause of the damage, this wasseen as unlikely.275

Expert 3 acknowledged that it does seem physiologically plausible that the associationwas causal.276

The Link With Chest Physiotherapy

From the evidence the Inquiry received about chest physiotherapy being conducted inother neonatal units by the same technique of percussion, it is clear that neonatal chestphysiotherapy alone is not the complete answer to causation. It was, and is performedin many neonatal units where this lesion is not seen.

Most of the control babies referred to in the 1998 paper had physiotherapy, and some ofthem had more physiotherapy sessions than the affected 13 babies.

This leads to the obvious conclusion that there was some aspect of physiotherapytreatment at NWH which was markedly different. Health Professional 5 summarises itbest:

“I have said that I am still of the opinion that some aspect of physiotherapytreatment at National Women’s did cause these lesions, but that that was not theonly factor”.277

273 Health Professional 5 B19 pg 5274 Health Professional 5 B20 pg 5275 “We should acknowledge that it remains possible that chest physiotherapy treatment was not the true cause ofthe damage, and merely provided a marker or intermediary for injury precipitated by some other factor which has notyet been identified. I think it is unlikely…”276 “It probably does need to be said that there is still no firm proof that chest physiotherapy did cause these lesionsalthough it does seem physiologically plausible that the association was causal.”277 T301 Health Professional 5

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“In summary, I think that chest physiotherapy was the most likely cause of thebrain damage in the babies being considered, but this is not the only possibility.We are unlikely to ever know for sure why these cases occurred at NWH in1993/4.” 278

This was amplified by Expert 3, who told the Inquiry:

“If chest physiotherapy was indeed the cause of the lesions, then it could be thatNational Women’s Hospital utilised more chest physiotherapy and the effect wascumulative, or it could be some combination of the positioning of the infant or thebedding that was used..”279

In response to the observation that the lesion had not been apparent at NWH once thephysiotherapy treatment had stopped, Expert 3 said:

“..it adds weight perhaps to the theory that the way physiotherapy was carriedout at National Women’s may have been a causal factor in that brain lesion” 280

The Inquiry heard from Health Professional 8, who told the Inquiry:

“…physiotherapy is probably being used as an all-embracing term. There aremany factors that go to make up that, it may be the frequency, the duration, theinfants themselves, the range of personnel, but the only thing we can do isspeculate because there is no way of teasing out those components.” 281

The Inquiry also heard from Expert 15, of Overseas Hospital 3, where the lesion hadbeen observed and the link was made between chest physiotherapy and the brainlesion, following contact with clinicians at the overseas hospital. Expert 15 told theInquiry:

“The point I’m trying to make all along is that none of us have ever believed thatit was just chest physiotherapy” 282

What then was different about chest physiotherapy at NWH?

Something Different

As is clear from the findings in this chapter, there were differences in the way that NWHgave its physiotherapy compared with other hospitals.

This was acknowledged by Health Professional 7 at NWH, who acknowledged:

“.. - there could have been something about the way we gave the physiotherapythat contributed. But I have to say that, at the time, we were totally unaware thatwe were giving physiotherapy in a different way, if we were.” 283

278 B31 pg 9 Health Professional 5279 Expert 3, B18, pg8280 Expert 3, T614, L27-29281 Health Professional 8, T462, L12-16282 Expert 15, T860, L.23-24283 Health Professional 7, T441, L8-11

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Health Professional 3, in response to the observation that other units have notencountered the lesions acknowledged that: “there was something different at[Overseas Hospital 3] and National Women’s.” 284

Similarly, Health Professional 5, in response to a question about whether there was adifferent aspect of treatment, specific to NWH and perhaps Overseas Hospital 3, said:“I think that is the obvious deduction. There may be more than one aspect of course.”285

Expert 6, who had earlier involvement with these issues286 was called by the Inquiryand said:

“If no other infants had been identified with such brain lesions elsewhere and theresearch data for NWH identified physiotherapy as responsible, I wasconcerned that there must be something different about the way it was done atNWH from all other units.” 287

Combination of Factors

In addition to the evidence specifically about the technique of physiotherapy, the Inquiryhad evidence about possible combinations of factors in addition to chest physiotherapy.Health Professional 5 described the other factors as bedding, positioning and individualsusceptibility:

“We still do not know the exact combination of treatment , bedding andpositioning, and individual susceptibility which produced the brain damage, andindeed, we are never likely to.” 288

Expert 15, from Overseas Hospital 3, was adamant that they did not believe that it wasthe chest physiotherapy alone which was causative of the brain lesions and he/sheintroduced three remedies, being improving the conditions of the babies at birth,improving the blood pressure in the first hours and days after birth and supporting thebaby’s head during percussive chest physiotherapy more conscientiously. With theseremedies, the lesion disappeared.289

Expert 15 gave evidence regarding the relative importance of the three factors: “Ibelieve that most important were the first two – namely, getting the baby’s condition atbirth and managing initial hypotension more vigorously.” 290

Expert 15 also gave evidence that the extensive brain lesions seen were a combinationof two specific injuries, the deeper one being Peri-Ventricular Leukomalacia (PVL) andthe superficial one being cortical (surface) injury from head-shaking. Expert 15 furthersuggested that if the shaking injury had not occurred the cases would still have suffered

284 Health Professional 3, T263, L6-7285 Health Professional 5, T301, L12-13286 Expert 6 was a member of the Medical Misadventure Advisory Committee at ACC287 Expert 6, B10, pg 2288 B27, pg 8, Health Professional 5289 “We did not believe that it was the chest physiotherapy alone, and as I have said, by introducing a three prongedattack of improving the condition of the babies at birth, by improving the blood pressure in the first hours and daysafter birth and by supporting the baby’s head during percussive chest physiotherapy even more conscientiously, thelesion disappeared.”290 T850 Expert 15

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from PVL. There was a strong possibility that they would still have had a disability even ifthey had not received physiotherapy:

“I believe that the deeper lesion is already present and that the shaking of thevulnerable softened brains makes it more likely that you get a surface injury andthat the surface injury can then meet up with the softened PVL producing a fullthickness injury….291. We do not believe the deep lesion in the brain, ie the PVLlesion, is caused or related to percussive chest physiotherapy.” 292

The susceptibility of low birthweight babies to develop haemorrhage with the vibration ofthe head in chest physiotherapy was also raised by Expert 4 who commented on thepredisposition as follows:

“Whether these very low gestation infants are predisposed to develophaemorrhage in association with the vibration of the head which naturally occursduring chest physiotherapy, by previous episodes of hypotension (which arecommon in these infants) is uncertain. This is a plausible explanation.” 293

Bedding

The issue of bedding was also raised in relation to causation of the lesion, contributingto increased head movement during physiotherapy.

The Inquiry was told both by Health Professional 5 and Health Professional 3 that NWHuse very soft sheepskins which combined with regular chest physiotherapy treatment,allowed the head to move resulting in a damage. Health Professional 3 told the Inquirythat as a result of the babies’ heads being able to move during the treatment:

“… Our theory is that in these extremely premature babies who already hadfactors known to be associated with poor outcome (breech and hypotension),this small movement resulted in these lesions.” 294

Although the Inquiry was told that the bedding became softer and bulkier, the preciseintroduction of softer sheepskins was not demonstrated, apart from Health Professional9, who told the Inquiry that in 1992 there had been a donation of some fluffiersheepskins, but the precise introduction of those was unknown.“We’ve had them for years. In 1992 there was a donation of some sheepskins whichwere a lot fluffier than the usual ones that we used.” 295

Health Professional 3: “We did know that over the years our bedding got softer andbulkier, but we do not know exactly when.”296

The issue of bedding had to be seen in relation to the overall occurrence of the injury asHealth Professional 5 agreed :

“The issue is not the bedding, but the movement of the head, which brings usback to the question of did the heads of babies in our unit move more than inother units, and the bedding issue relates to that question”.297

291 T847 Expert 15292 T847 Expert 15293 P. 5 of Expert 4’s letter, NWH Vol 2 pg 563294 B21 p. 90 Health Professional 3295 T483 Health Professional 9296 T259 Health Professional 3

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Shaking Injury

As a result of Health Professional 5’s publication likening the brain lesion to a shakinginjury, the Inquiry heard evidence of the characteristics of a head shaking injury and theanalogy between shaken baby syndrome and the brain lesion.

The evidence of two of the parents, indicated their awareness of the need to keep thebabies head still.

Parent 3a, told the Inquiry:

“..when I walked into the nursery and saw the physiotherapist banging [thebaby’s] chest with [the baby] shaking like a jelly on a plate I called out “What areyou doing to our baby!” I couldn’t believe it. My reaction was that we are toldnever to shake a baby and yet here it was happening in hospital.” 298

In addition, Parent 9a told the Inquiry:

“I held [the baby]’s head because my gut instinct told me stop and I kept seeingin my mind the old TV advertisement of “never shake a baby”. [The baby’s]head, when not held, would bounce in time with the tapping.” 299

In his/her paper, Health Professional 5 had said:

“The pathological findings are consistent with those seen in older infants withshaking injuries as a result of non-accidental injury.”

The Inquiry heard from Expert 8, who when asked if he/she would discount the issue ofrepeated minor shaking as a contributor, said:

“I have not come across such evidence but would be willing to be educated onthat. In shaken baby syndrome I would discount it because I think its beenclearly established that it requires more than that. I could not discount it in ECPEbecause I think the immaturity of the brain makes it an entirely differentsituation” 300

Expert 8 said further of the analogy between Shaken Baby Syndrome and the brainlesion,:

“I have great difficulty accepting the analogy because I think the difference is sogreat, but I acknowledge that the temporal association between stopping thephysiotherapy and disappearing is a strong one and the physiotherapy may wellbe related to the ECPE. But I’m not sure that the mechanism is analogous to theshaken baby syndrome.” 301

When asked of his/her reaction to the video and the parents’ reaction, HealthProfessional 5 told the Inquiry that the possibility of shaking injuries never occurred toanyone at the time and said:

297 T309 Health Professional 5298 B2 p. 13 Parent 3a299 B3 p. 18 Parent 9a300 T704 Expert 8301 T704 Expert 8

5 July 1999 77

“It seems incredible to us all in retrospect that we did not consider the possibilityof shaking injuries. But I reiterate that I did not recall anybody parents included,ever raising shaking as an issue. 302

Size of National Women’s Neonatal Service

The large size and complexity of the service at National Women’s was suggested bysome as influential in the detection of ECPE, suggesting that the lesion had occurredelsewhere but had not been detected.

Health Professional 5:

“this type of brain damage may indeed occur elsewhere but not be recognised.”303

“The large number of extremely premature babies treated at NWH may alsohave contributed to our recognition of the problem, since NWH has one of thethree largest neonatal units in Australasia.” 304

Expert 3, regarding causation305:

“there are many possibilities. Firstly National Women’s is easily the largestNeonatal Unit in New Zealand and one of the largest in Australasia. If some rareevent is to be recognised it is much more likely to be recognised in a large unitwith many more babies. Even though we, and I believe other units, havereviewed our existing cranial ultrasounds when we first heard of this lesion in1994 and did not detect any lesions, it is quite possible that the lesion hasoccurred and has not been recognised..”

Health Professional 7306:

“I think National Women’s looks after a smaller and more vulnerable group ofbabies than most other units. I think our survival figures would show that we areamong - we are up with the rest of the world in terms of getting some babiesthrough that many other units would not even attempt. That’s one reason. I thinkthat we have looked harder at these cerebral scans of our babies than smallerunits might, and an example might be when we looked retrospectively wereclassified some scans that had not originally identified these lesions. It ispossible other units may have missed such cases.”

Frequency

Frequency refers to how often physiotherapy was given to infants, and the Inquiry heardof various frequencies depending on the Unit and the baby, from two hourly to 24 hourly.National Women’s Hospital used four hourly treatments in general, but only between0800 and 2000 hours each day (ie four treatments per day). After nurses had been

302 T312 Health Professional 5303 B8 p. 28 Health Professional 5304 B8 p. 29 Health Professional 5305 T604-5 Expert 3306 T440-1 Health Professional 7

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trained to perform percussions, physiotherapy was able to be given right through the 24hour period, ie six treatments per day. On some specific occasions, it was given twohourly.

Health Professional 5 had identified frequency of treatment as a risk factor, but in thiscontext was referring the study findings which assessed the number of treatments perweek, and over the first four weeks.

Health Professional 5:

“when I discovered the apparent cluster had coincided with an apparent increasein frequency, I thought that was probably an important explanation.”307

...I believe a combination of factors is most likely, and I have suggested that thefrequency and the bedding are amongst the most likely of those. 308

...I believe I’ve already said that I think frequency is most likely to be important,from a physiological viewpoint, but cannot be the whole explanation, and thefrequency most definitely did change for some babies over that time”. 309

In contrast, Health Professional 7 was not of the view that increased frequency wouldhave made a difference.310

Health Professional 3, however, agreed with Health Professional 5, that:

“the introduction of increased frequency of treatment probably affected thechance of occurrence of the lesion in subsequent babies.” 311

Vigour

Health Professional 5’s publication had drawn an analogy between the brain lesion anda head shaking injury. We have found that the vigour of percussive physiotherapy wasgreater at NWH than other units.312 The question then arises whether this degree ofvigour could have been sufficient to cause a head-shaking injury.

Parent 3b:

“A dear friend left the unit in tears after witnessing physiotherapy treatment on[the baby]. Another friend felt very uneasy and at the time I reassured her that itis good for them. I was also told that [the baby] enjoyed it so much that it put[the baby] to sleep. I was not to know that a year later I would be told it would bethe cause of [the baby’s] death.” 313

Health Professional 3:

“The vigour was one factor.” 314

307 T302 Health Professional 5308 T304 Health Professional 5309 T305 Health Professional 5310 T442 Health Professional 7311 T238 Health Professional 3312 See previous section on Vigour313 B2 p. 7 Parent 3b314 T276 Health Professional 3

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“the vigour of treatment which we could not quantify, therefore we could notstudy, and the frequency and other factors, one of which may be bedding, addedtogether to cause the lesion. 315

Health Professional 5, regarding vigour as the cause of the lesion:

“I cannot exclude that possibility but I think it most unlikely… If vigour was partof the story, I can see no rationale for why the timing was so striking, in that ifvigour was going to change I think it is least likely to have changed during aperiod when it was so carefully monitored and studied and thought about andwatched by so many members of staff over that period.” 316

Health Professional 7:

“I didn’t observe increased vigour of physiotherapy. But that’s possible. Becauseregardless of what other people may have said about measuring vigour, I don’tbelieve that we can accurately measure vigour, and we didn’t.”317

Variability

With the issues surrounding vigour of physiotherapy and the evidence on the analogywith a head shaking injury, a further issue arose regarding the variability of personsundertaking the technique of percussion, giving rise to an increased chance of over-vigorous physiotherapy being given on some occasions.

The fact that only 13 babies were affected when in fact many more receivedphysiotherapy suggests that physiotherapy of sufficient vigour to produce brain injurywas not a regular event.

Expert 8, whilst indicating that classical head-shaking injury as seen in older infantsoccurs from a single major shaking rather than repeated minor shaking, was unable tocategorically say that this would be the case in these preterm infants.318 It is possiblethat the injury arose from one treatment, but equally it could have arisen from more thanone treatment.

The observation in Health Professional 5’s study that the brain lesion was associatedwith a larger number of treatments given, lends some support to the multiple treatmenttheory.

It is apparent that there were three cases of the lesion occurring before the “change intreatment” took place, but the majority of cases matched the increase in the number ofnurses able to perform nCPT. By the end of 1994, there were 76 nurses trained toadminister nCPT, compared with seven physiotherapists in June of 1993.

Health Professional 3 had indicated that in general the nurses were more variable withtheir technique, but tended to be more gentle than physiotherapists.319 On the otherhand, Health Professional 6 said that the range of vigour by nurses was the same asthat by physiotherapists. It was clear, that for reasons canvassed in Chapter Six, some

315 T277 Health Professional 3316 T303 Health Professional 5317 T442 Health Professional 7318 T704 Expert 8319 T274 Health Professional 3

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nurses were performing the technique incorrectly, resulting in complaints of neck andshoulder pain.320

That there was variability is attested to by a number of witnesses. The Inquiry heardfrom Parent 6a:

“When the other physios and nurses did the treatment, they all seemed to hold[the baby] differently and they did not support [the] head. During their treatment[the baby’s] head moved a lot, it looked to me as if [he/she] had little spasmsrunning through [his/her] body.321

320 Refer Chapter Six321 B2 p. 6 Parent 6a

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Parent 9a:

“Each therapist had a different tapping technique but most appeared to use theirelbows as fulcrums. All the tapping was fast and vigorous making a loudclapping sound”322

“on the whole the nurses appeared to be very vigorous, very rushed, it cameacross that the physiotherapy was almost a nuisance, they had other things todo.”323

Parent 7b:

“the wrist movement was by [Health Professional 6], and the other was from thewhole arm movement used to be from the nurses. But as [the baby] grew up abit, about two months later, [Health Professional 6] used to do some armmovements as [the baby] got a bit bigger.”324

That individual variation was inevitable, is demonstrated by the example of thepercussion rate Health Professional 6 said:

“Percussion was suggested to be at a rate of approximately 160-200percussions per minute, but in reality each person developed a natural rhythmof their own.” 325

Two of the neonatal paediatricians in the unit also made observations with regard to thevariability of persons undertaking the treatment. Health Professional 7 told us:

“I wasn’t aware really that the baby’s heads moved around more than at anyother time, and although I had observed that vigour would vary according towhom was giving the physiotherapy, I was never concerned that it wasinappropriate.”326

Health Professional 8 told the Inquiry:

“… no two people are going to be exactly the same, but I can’t say I could recalla specific person being at variance to others.” 327

“It may be that with more people doing it the variation may have increased, butthat’s speculating.” 328

Health Professional 9 agreed:

“I think that everybody would have a slight variation in their technique that no twonurses would do it exactly identical.” 329

Parent 3a told the Inquiry:

322 T3 p20 Parent 9a323 T88 Parent 9a324 T70 Parent 7b325 B14 p. 23 Health Professional 6326 T435 Health Professional 7327 T461 Health Professional 8328 T462 Health Professional 8329 T498 Health Professional 9

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“There were people who undertook physio with our children who were morevigorous one than the other … I recall many people treated the childrendifferently.”330

The treatment at NWH was performed with greater vigour than elsewhere, and giventhat many more staff were administering nCPT by 1994, with the inevitable variabilitybetween them and the use of an incorrect technique, there was a greater likelihood of aparticular treatment being given over vigorously. The clustering of the 10 affected babiesbetween June 1993 and December 1994 supports this.

It is also supported by the fact that the lesion was not seen after nCPT wasdiscontinued.

ConclusionThe occurrence of the lesions cannot be attributed solely to the change at NWH fromJune 1993 to December 1994. Three cases occurred prior to the commencement ofthe change in treatment and the remainder occurred following the change. Thedifferences in undertaking nCPT at NWH, and in particular the vigour with which thepercussion was undertaken, and the duration of the percussion, combined with thevariability of technique by staff, which became more apparent after the change intreatment, all contributed to the occurrence of the lesion.

Term of Reference 2(a)

What key differences were there in the way in which the treatment wasperformed prior to April 1993 and during the period April 1993 and December1994, including comparisons with other selected hospitals?

The reference to April 1993 is not particularly relevant as the change in practice beganto be phased in from June 1993.

(a) There were two changes at NWH after June 1993 as indicated under Term ofReference One: the treatment was available 24 hours per day, and nursesbegan to perform the treatment, namely chest physiotherapy by the technique ofpercussion.

(b) The percussions were given with greater vigour at NWH than at other hospitals.(c) The duration of percussion was greater at NWH than at other hospitals.(d) The stability limits of the baby during physiotherapy were allowed to vary to a

greater degree than at other hospitals.(e) The trend of decreasing need for physiotherapy during 1992-1994 at other

hospitals was not evident at NWH.

330 T107 Parent 3a

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PROTOCOL COMPARISONS

Term of Reference 2(b)

Did the changes result in patients being given treatment in a manner whichfailed to meet the protocols which existed at that time either in New Zealand orinternationally governing the intensity and duration of this form of treatment?

A commendable effort was made by the staff at NWH to seek information from otherhospitals before embarking on the change of treatment. Information was obtained fromHospital 2, Hospital 4, and Hospital 1 about chest physiotherapy, the availability of chestphysiotherapy on a 24 hour basis and the training of nursing staff.331 NWH did notspecifically request copies of the protocols from each of these units, and therefore werenot aware of their existence or contents.

At the time of introducing the changes they did however have access to someprotocols. These were their own protocols from previous years, and those of OverseasHospital 2 from 1986, along with some notes from Overseas Hospital 5 from 1983,Overseas Hospital 6 and Overseas Hospital 2, both from the mid 1980’s.332

Protocols for the delivery of physiotherapy in the period 1993-1994 were available to theInquiry Team from some hospitals. These hospitals were NWH,333Hospital 2,334 andOverseas Hospital 1.335 A protocol from Overseas Hospital 2 was available from1991,336 along with some 1995 guidelines337 which were circulated to other units afterthe association with the brain lesion was publicised. There had been a 1993 OverseasHospital 2 protocol which was not available, but was said to be similar to the 1995guidelines.338 However the comparisons with NWH’s protocol here are made with the1991 protocol, as the 1995 guidelines are clearly influenced by the NWH news release.A Hospital 1 protocol was also available for 1995, which was said to be identical to thepre-existing protocol of 1994, apart from one specified clause.339 The Hospital 1protocol from 1993 was not available.

Intensity or VigourIn general, there were no objective instructions in the protocols regarding intensity. TheHospital 2 protocol contained a statement about the dangers of excessive vigour, but itappears that the staff at NWH were not aware of this caution.

331 NWH Vol1 pp30-33332 NWH Vol 2, pp447-511.333 NWH Nursing and Physiotherapy documentation334 attached to brief of Expert 14335 attached to brief of Expert 4336 attached to brief of Expert 12337 attached to brief of Expert 13338 B page 4 Expert 12339 NWH Vol2 page 434

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DurationThe protocols did often contain reference to the duration of the cupping technique, asfollows:NWH 2-3 minutes per segment, 3-4 segmentsHospital 1 30 seconds each position initially, building up as tolerated.

There was no mention of the number of positions, and theinstruction applied to the finger percussion method.

Hospital 2 1-2 minutes over the area to be percussedOverseas Hospital 1 not stated, and did not use the cupping techniqueOverseas Hospital 2 2-3 minutes if only 1 segment being treated, 1½ minutes if 2 or

more segments treated

(these prescriptions represent the protocol details, not what was said to have actuallyhappened).

It is apparent that NWH did have a protocol which represented the greatest duration oftreatment of units available for comparison. However the references to duration in thedifferent protocols are sufficiently vague to make it difficult to draw direct comparisons,and the evidence of the witnesses from each centre was often at slight variance to theirwritten protocol.

The NWH evidence was consistently that the maximum duration of percussion in eachsegment when given by nurses was 2 minutes, not 2-3, which brought their practicecloser (but still in excess according to the protocols) to others. It became apparent forthe first time that there was a discrepancy in the duration of treatment between thepractice and the protocol. All the NWH nurses told the Inquiry that each segment of thelung was percussed for 2 minutes,340 however the nursing protocol used at the time,stated 2-3 minutes per segment. Health Professional 3 was not aware of the mistakeuntil this Inquiry.341

TypeBoth Hospital 2 and Overseas Hospital 2 specified the cupping technique, whereasHospital 1 and Overseas Hospital 1 used different techniques. NWH was not atsignificant variance in this regard.

RateOnly the Hospital 2 protocol specified a percussion rate, and this was markedly differentat 40-60/minute from NWH (160-200). Given that only one other protocol specified arate, NWH could not be said to be significantly at variance.

Indications for Treatment1. NWH

Creps on auscultation Palpable – audible creps Increased volume Viscosity Purulence of secretions suctions Radiological changes – collapse, consolidation, pneumonia Post surgery

2. Hospital 1 340 T 178 l26 Health Professional 9, T 359 l6-10 Health Professional 12, B6 p18 Health Professional 11, B3 p5 HealthProfessional 2341 B18 p 94, T255 l6-14 Health Professional 3

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X-ray changes of lobular consolidation or collapse Copious secretions affecting his/her ventilation, it doesn’t improve with regularsuctioning

3. Hospital 2

Not stated 4. Overseas Hospital 1 (for pre-term infants)

Excessive or tenacious secretions whilst on vent. Support. Copious secretions from oropharynx but scant from ETT Tenacious secretions with plugs liable to occlude tube Collapsed/consolidated lung or lobe – lung infections

5. Overseas Hospital 2

Excessive secretions in the lung noted during suction procedures or byadventitial sounds heard during auscultation or obstructive apnoea.Radiological changes such as collapse, consolidation, addilectusus. Fluid filledcysts, aspiration.All babies within EDT in situ specially if greater than 36 to 48 hours after birthInfants with poorly developed cough, suck, swallow reflexes.Infants undergoing thoracic or abdominal surgery.

It is apparent that indications in all of the units included x-ray changes and copioussecretions. In addition, NWH had a criteria for surgical babies after operation whichwas similar in the Overseas Hospital 2 protocol, the latter protocol also had a referral toprophylactic physiotherapy for all babies ventilated for greater than 48 hours whichExpert 13 said was not applied in practice342.

The indications for physiotherapy at NWH were not significantly different fromelsewhere.

Conclusion

2(b) Did the changes result in patients being given treatment in a mannerwhich failed to meet the protocols which existed at that time either in NewZealand or internationally governing the intensity and duration of thisform of treatment?

The changes did not result in patients being given treatment in a manner that failed tomeet the protocols in New Zealand or internationally at the time.

The protocols were of variable quality. Although the physiotherapy treatment at NWHwas substantially different from the treatment in other units, this difference would nothave been apparent from inspection of other protocols.

342 B p. 7 Expert 13

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CHAPTER SIX:

THE ASSESSMENT OF THE TREATMENT

The term of reference which relates to assessment by NWH of the change in theprovision of treatment is divided into four main sections in this chapter namely, clinicalassessments, risk assessments, training needs and parental consent. For ease ofreference the chapter is set out as follows:

2(d)(i) CLINICAL ASSESSMENTSSteps taken before the changes in treatment were introduced

Chronic Lung DiseaseClinical Deterioration OvernightReview of Protocols, Practices and Research

Steps taken after the changes in treatment were introduced

2(d)(ii) RISK ASSESSMENTSWhat was Knowna) No adverse risks were reportedb) Concept of Minimal HandlingWhat was Not Knowna) The Birmingham Articleb) Holding the Headc) The Hospital 2 ProtocolSteps Taken to Minimise Known Risksa) Protocol Developmentb) Regular Meetings and Reviewsc) Record Keeping

Factors that May Have Indicated RiskFailure to Planned Clinical AuditRib FracturesRegistrar’s ComplaintIVH - Physiotherapy Working Party 16 March 1994The Incorrect Technique

• The Video Comparisons• The Use of the Elbow• Neck and Shoulder Pain

Analysis of the Factors

2(d)(iii) TRAINING NEEDSNursing TrainingSteps taken Before the Changes Were Introduced

• The Theoretical Part of the Training• The Practical Training

Steps taken After the Changes were Introduced• Individual Assessment• Level III Competency

Physiotherapy Staff TrainingTraining of Health Professional 6

2(d)(iv) PARENTAL CONSENT Consent for Treatment Consent for Change in Treatment

CONCLUSIONS 2(d) (i) – (iv)

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CLINICAL ASSESSMENTS

2(d) What steps were taken before and after the changes in treatment wereintroduced, including the:

(i) clinical assessments (if any) which were carried out of the need orreason for the change, or any review of the treatment;(The remainder of this term of reference is set out in the chapterfollowing and will be answered under each relevant segment. )

Steps taken before the changes in treatment were introduced

To a large extent, this term of reference mirrors the reasons for the change, which wasaddressed under Term 2(c), particularly the reason for the increase in frequency of thetreatment, namely up to six times a day as opposed to four times a day.

Chronic Lung Disease

Chronic lung disease was an increasing problem in neonatology in the late 1980’s andearly 1990’s.343 This was due to the increasing survival of very premature babies andthe ventilation techniques which were used to achieve this. More babies were receivingprolonged ventilation and with this came increasing problems with managing theendotrachial tube, with a build-up of thick secretions, a blocked endotrachial tube whichcould cause obstruction to babies airways, with lobar (lung) collapse and consolidationoften resulting.344

Clinical Deterioration Overnight

Reference has already been made,345 to the concern of the medical nursing andphysiotherapy staff at the observation of the deterioration of babies overnight, whennCPT was not available. Those staff viewed nCPT as “helping the babies, in particularwith clearing thick, copious, viscid secretions and avoiding or treating focal lungproblems”. 346

These observations and the attribution to the lack of chest physiotherapy causing thedeterioration, has been submitted as the clinical concerns and assessment of the needor reasons for the change. No specific clinical assessments were made of the need,but the evidence from the medical,347 nursing348 and physiotherapy349 witnessesindicated it was clinically motivated.

Counsel for the parents has submitted that there was little (if any) evidence that aproper clinical assessment was undertaken of the need for change and there was anacknowledgement by Counsel for Health Professional 6 that there was no specificclinical assessments made of the need for change.

343 See Chapter 2 of this Report344 B35 p. 140 Health Professional 3345 Refer Chapter 3 of this Report346 B36 p. 141 Health Professional 3347 Health Professional 3, Health Professional 7,348 Health Professionals 9, 11, 12349 Health Professionals 10, 6

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Health Professional 3 says of the change350

…”the change was instituted because previously nCPT was not availableovernight and we saw babies deteriorate through not having the treatment. Itwas very carefully planned, with involvement of nurses, physiotherapists anddoctors. Great care was taken with the introduction, with thorough teaching andcareful documentation.”

Health Professional 7 also describes the change as

…”an increase in availability of chest physiotherapy treatment, so that babiescould be given chest physiotherapy around the clock instead of just during theday. We believed it was a good and safe treatment and so it made sense togive it at night as well as during the day. It was logical that if the baby benefitedfrom the treatment during the day, then it would also benefit at night.”

The view formed by clinicians and staff of NICU that babies deteriorate overnight wasone based on clinical judgment. The evidence of Health Professional 3, who producedphotographs of lung improvement in a pre-term infant was support for this view.351

There was no study completed or formal clinical assessment made at the time. HealthProfessional 5’s evidence is of assistance in this regard:

… “it is true that there were, and still are, no large well designed studies showinglong term benefits and/or risks of this treatment. This does not mean that thereare no risks or benefits. It simply reflects the fact that the studies have not beendone. In the absence of such long term studies, the evidence of short termstudies, together with extensive clinical experience of clinical benefit and safety,was considered an adequate basis for using the treatment in most units inAustralia.”.

Review of Protocols, Practices and Research

The Respiratory Physiotherapy Working Party undertook a review of the protocols andpractises of other units in New Zealand.352 To this end, letters were written on behalf ofthe working group to other neonatal units to ascertain whether nurses undertook nCPT.Three written replies were received and one unit responded by telephone call. Of thosefour, two units indicated that there was 24 hour availability of nCPT and in one unit,nurses did all the nCPT after the usual day shift of the physiotherapist.353

In addition, the experience of Health Professional 6 of visiting numerous units overseasincluding England, Scotland, USA and Australia, was that nurses undertook nCPT bothoutside of ordinary working hours, or in some cases, by the nurses “completely”. TheInquiry was referred to the Australian practice which was known from the literature;354 areview of physiotherapy and neonatal intensive care units in Australia,355 in which waspublished a result of the survey that of fourteen units in Australia, all used nursing staffand all provided a 24 hour service for chest physiotherapy.

350 B7 p. 18 Health Professional 3351 B32 p. 127 Health Professional 3352 See Chapter 3 for more detail353 B10 p. 30 Health Professional 3, NWH Volume 1, p.53354 Lewis et al 1992355 J. Paediatrics; Child Health 1992 28.2.97 – 308 (p.694-697 NWH Volume 2)

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The Inquiry’s attention was drawn consistently to the conclusion of this research. Thearticle, in fact notes:

… “despite the fact that these studies suggest that physiotherapy may be ofbenefit, the issue remains controversial. The comparison of results fromdiffering studies is difficult because of the varying physiotherapy regimens anddiffering samples utilised in each study”.356

The research article concludes:

… “that there is a need for further research in this area to compare the benefitsof the various methods of chest physiotherapy in the neonate.”357

In addition to obtaining information on the provision of chest physiotherapy from otherneonatal units in New Zealand, the working party sought and received some protocolsfrom other units, and compared those to protocols received from hospitals fromoverseas, namely Overseas Hospital 2.

It is evident that some protocols of other neonatal units together with the informationgathered, were reviewed in introducing both the guidelines and protocols for nurses andphysiotherapists respectively, before the changes were fully introduced andimplemented.

Regular Review of Outcomes

As is common in neonatal units, ongoing audit is maintained by monitoring rates ofdeath and complications. These are usually standardised by birthweight and orgestation. Health Professional 3 made some of this available to the Inquiry.358 A grosschange in outcome can be detected by this means, but the number of babies with thisbrain lesion was far too small to have any noticeable impact on the annual data. It isevident that in spite of the problem with the brain lesion, NWH was producing goodresults at the time.

Another method of detecting a problem such as this is the recognition that a cluster ofcases has occurred. This is what happened in this case, although it is a mechanismthat requires attention to detail. In February 1994 the staff were aware of four caseswhich were unusual but similar. The fact that there were already eight cases by thattime was only realised a year later. Nevertheless, the NWH staff deserve praise forstarting an investigation into 4 affected babies, which ultimately proved vital.

356 ibid p.298 (NWH Volume 2, p.695)357 299 ibid 696 ibid358 B4 para 4 Health Professional 3

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Steps taken after the changes in treatment

After the implementation of the treatment, there was no specific review of the change.Health Professional 7 said:

“We didn’t formally study that (the impact of the change). As you are probablyaware, there are always a number of prospective studies going on in a hospitallike NWH. You might ask why didn’t we formally do a study – well I think thereare many reasons for that, but it wasn’t one of our priorities at that time to studythat.”359

One of these was a planned clinical audit and the other was a review by HealthProfessional 6 of the percussion technique of the nurses after completion of theirpractical training in the technique. These are considered in detail in the followingsections on the assessment of risk.

Under the assessment of risk, we have grouped a number of factors which were raisedduring the Inquiry as indications of the risk of the treatment. In dealing with this matter in1999, factors which appear obvious in hindsight as clear indications of risk have to becarefully evaluated with regard to their state of knowledge and the relevant time, namely1993 to 1994. For this reason the following section has been divided into what wasknown at the time, what was not known and what might have been known at therelevant time.

RISK ASSESSMENTS

2(d) (ii) assessments (if any) of the risks associated with the change intreatment including the steps taken to minimise any risks;

What Was Known

a) No adverse risks were reported.At the time of implementing the change, Health Professional 3 examined the position, inNew Zealand and internationally.

“World-wide, nCPT was considered to be a safe treatment with no long term sideeffects ever suggested. Short term side effects were not serious and were lessproblematical than, for instance, those associated with endotrachial suctioning.”360

He/she further asserted that “none of the protocols for nCPT that we have seen includea section on risks of nCPT,” indicating that any risks associated with the treatment werenot considered serious. Reference has already been made in the previous section tothe publication361 which indicated that the benefits of physiotherapy remainedcontroversial as at 1992.362

359 T440 Health Professional 7360 B p.37 p.149 Health Professional 3361 By Lewis et al

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b) Concept of Minimal HandlingAt the time of the introduction of the change in treatment, there was a tension betweenthe agreed need for minimal handling of pre-term babies, the multiple handling havingpossible detrimental consequences to the babies and a physiotherapy treatment whichwas viewed as beneficial.

On examination of Health Professional 3, it was revealed that this tension manifesteditself among the neonatal Paediatricians at NWH by their attitude and rate of referrals forbabies for nCPT. Of the five Paediatricians, two were classed as in favour of thetreatment, two favoured less physiotherapy and one Paediatrician was assessed asbeing in the middle.363

What was not known

a) the 1992 ArticleParent 3a, on behalf of the parents, drew the Inquiry’s attention to the fact that at thetime the change in treatment was being introduced to NWH, an article had beenpublished in 1992, identifying the brain lesion and its association with neonatal chestphysiotherapy. On the evidence of Parent 3a, the information should have beenavailable to the hospital through a Medline search and such literature should have beenchecked prior to the introduction of the change to increased frequency in chestphysiotherapy.364

The article emanated from Overseas Hospital 3, entitled “Post-natal encephaloclasticporencephaly – a new lesion?”365 in which a previously unrecognised and distinctivepattern of severe brain injury in extreme pre-term neonates was observed. On thebasis of this article it was suggested366 NWH clinicians could have telephonedOverseas Hospital 3 to understand the suggested cause of the brain lesion. It shouldbe noted that the article, whilst describing the brain lesion and the occurrence in pre-term neonates, does not describe the association between the brain lesion and neonatalchest physiotherapy.

The association between the NWH cases and the Overseas Hospital 3 cases wasmade following the presentation of the case control studies from NWH by HealthProfessional 5 in 1994. Following the suggestion from one of the members of theaudience, Health Professional 5 rang Overseas Hospital 3 and discovered the linkbetween chest physiotherapy and the brain lesion.

The tenor of the evidence from the parents was that the clinicians should have beenaware of the risks of the development of such a brain lesion and made contact withOverseas Hospital 3 to ascertain the potential cause prior to the introduction of thechange in treatment at NWH.

It was clear that none of the staff at NWH knew of the significance of the article in 1993or 1994. Expert 15 from Overseas Hospital 3 confirmed that the doctors at NWH couldnot reasonably have known of the link between chest physiotherapy and the brain lesion(ECPE), as the Overseas Hospital 3 group had not published it.367

363 T254 L.4-8364 T178, Parent 3a365 Cross,J H, Harrison C J, Preston P R, Rushton D I, Newall S J, Morgan M E I, et al. “Postnatal encephaloclasticporencephaly – A new lesion?” Arch Dis Child 1992; 67: 307-11 and refer to Chapter 3 for full discussion on thearticle.366 T178, l10-12367 T849

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It is ironic that whilst the medical staff did not discover the article in the course of theirsearch, Parent 3a was able to find it using the words from the x-ray reports of his/herchildren368 using the words “porencephaly” and “neonate”, and as a result obtained 10references, one of which was the Overseas Hospital 3 article. The doctors werefocussed on causation of the brain lesion, and used key words that reflected their bestguess of the cause, such as “infarction, thrombosis”.369 A more open-mindedapproach may have disclosed the article. It is uncertain whether this would have beenhelpful, as the article made no mention of the link with chest physiotherapy. In thecircumstances as the staff at NWH had never seen a lesion as described in the article,and there were no conclusions as to the possible cause of such a lesion, it was not astep which was taken by NWH at the time.

b) Holding the HeadIn seeking information from other neonatal units outside New Zealand, the Inquiry heardfrom Expert 16, advanced neonatal nurse practitioner, in the UK who asserted that from1989, the infants head was always held during chest physiotherapy (although there wasno written protocol until much later). Expert 15 was also very clear that that inOverseas Hospital 3 there had been a clear policy of holding the head duringphysiotherapy, and this policy was reinforced following the detection of the brain lesion(ECPE) in 15 of their babies between 1988 and 1990370. Expert 16 said that holding thehead was a regular part of practice in other hospitals also, having observed this at twoother hospitals in the UK371.

Contrary evidence was obtained from Expert 17, a very experienced and leadingneonatal physiotherapist in the UK, who was unaware that this had been arecommendation anywhere in the UK, and doubted that it was commonly known372.However whilst it was common for Expert 17 to instinctively support the head, Expert 17had the view that physiotherapy as [Expert 17] practiced it did not result in headmovement373.

In Australia and New Zealand, there appeared to be no recognition of the possibility ofbrain injury, apart from the reference in the protocol from Hospital 2 (see next section).

The inquiry also heard from Expert 13 in this regard who said:

“I think head holding represented due care and attention to the baby. We weren’tholding it because we knew it was dangerous not to. It just seemed the commonsense thing to do in a tiny frail baby to hold the head as we could.”374

He/she acknowledged that “it was more of a comfort, caring thing at that time ratherthan a safety issue in my mind”.375

Apart from the reference to the need for further research to compare the benefits of thevarious methods of chest physiotherapy376, the published literature also revealed noknown risks of chest physiotherapy by percussion. 368 T132369 T323370 T846 Expert 15371 T865 Expert 16372 T869-70 Expert 17373 T869 Expert 17374 T817 l.22-25375 T817 l.28-30; T818 l.1-2376 Refer Lewis et al 1992 article supra

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c) The Hospital 2 ProtocolIn the protocol from the Hospital 2 Neonatal Unit, specific reference is made to the risksof vigorous chest physiotherapy.377 Expert 14 produced the protocol from the Hospital 2Neonatal Unit which was dated from the late 1980’s. In the section entitled “Problemsassociated with Physiotherapy”, para 3 states:

“Vigorous chest physiotherapy may cause rapid movement of the intracranialstructures leading to central system injury especially in the extremely prematureinfant.”378

This evidence was heard at the conclusion of the hearing and subsequent affidavitswere filed, both from NWH and Hospital 2. Those affidavits were directed to thequestion of whether NWH received this protocol at the time of the introduction of thechanges to the provision of nCPT. On the evidence available to the Inquiry, it isuncertain whether the protocol was received by NWH. It does seem apparent that thestaff at NWH were unaware of this specific caution.

However, despite the reference in the protocol to central nervous system injury, itappears that no medical personnel in New Zealand was alert to this issue.

Steps taken to minimise risks

Protocol DevelopmentThe protocols which were developed since 1989 at NWH and were redrafted in 1993379,contained protocols, guidelines and responsibilities for respiratory physiotherapy, whichwere in use at NWH. In reviewing the protocols, Expert 4 recorded “this protocol is quiteimpressive and consistent with the current protocol designed by [Overseas Hospital 2]in late 1995.”380

Similarly Expert 12 concurred, noting that the protocols at Overseas Hospital 2 andNWH were essentially similar.

In collecting the protocols and cross-checking the practice (as written in the protocols atthe relevant time), NWH staff undertook their formulation of the protocols and guidelinesfor NWH thoroughly and in the belief that the practice at NWH was consistent with otherneonatal units both in New Zealand and in Australia.

It was submitted to the Inquiry381 that NWH was aware that the treatment may not becarried out appropriately. This possibility was minimised in the following ways:

(a) Only nurses with proven skills and experience in the neonatal intensive care unitwere trained.

(b) Comprehensive protocols in the nursing standards were prepared.(c) A systematic training programme was established which was targeted at the

individual training needs of the senior nursing staff involved.(d) Ongoing assessment of the physiotherapy treatment was undertaken by the

medical and physiotherapy staff on the daily ward rounds, during the day of each

377 See also Chapter 5378 B Expert 14 Appendix 1 pg 5379 Refer below nursing and physiotherapy documentation 1989-1993/4,380 Letter dated 19.7.96 NWH docs, vol 2, page 561381 Submission of NWH p.16 p. 55

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treatment by the physiotherapist, by the physiotherapist who would assess eachbaby in the afternoon and leave written instructions on overnight treatment, andby the nurses who would re-assess the need for treatment overnight for eachbaby.

(e) All treatments were thoroughly documented on the physiotherapy charts tofacilitate assessments of the baby’s likely tolerance of treatment

The contrary view was also submitted382, namely that there were risks and they wereassessable but that the knowledge of such risks was not communicated to the nurseswho were to undertake the chest physiotherapy and on a perusal of protocols of theother hospitals in New Zealand, it can be seen that NWH was out of step. To supportthis view, reference is made to the evidence of Health Professional 3, who said: 383

“… without a prospectively designed research project, we were unable to clearlydemonstrate efficacy. This is the case with almost all treatment protocols thatare introduced into clinical units, and is why treatments are introduced wherepossible as a result of prior research, usually from other units. Many treatmentprotocols evolve as a result of clinical experience, both in the unit changingthem and in other units….”

It was submitted that on this basis, there was no justification for Health Professional 3’sassertion that with nCPT “great care was taken to assess the effect that the change inprotocol was having on the babies”.384

At the relevant time, NWH did take appropriate steps to access relevant knowninformation in developing their protocols.

Regular meetings and reviews

Whilst the absence of the planned clinical audit has been identified, there were anumber of regular meetings and reviews which were undertaken in the unit at NWH.Expert 4 summarised these as follows:385

i. Daily radiology review in the unit during the week, which included a review ofhead ultrasound results.

ii. A weekly journal club which is a meeting of medical and some nursing staff.iii. Weekly grand round – in which a case or topic is reviewed with all staff involved.iv. Perinatal morbidity weekly meeting – involving paediatric, obstetrics and

gynaecology staff discussing cases where there had been morbidity (illness).v. Perinatal mortality review – a multi-disciplinary group which reviews any deaths

in the unit, with a presentation for teaching purposes or quality assurance. Thisis carried out at the monthly perinatal mortality meeting which all staff attend.

vi. Six weekly – a combined obstetrics, gynaecology and paediatric journal clubwhere indomethacin given for pre-term labour was discussed as a possiblecause of these lesions.

vii. Additional activities including paediatric staff attending on post-mortems. Ofparticular relevance, the pathology staff dealing with the deaths of the babies orwith the brain lesions communicated with their clinical colleagues over possiblecauses for the lesions.

382 Submission of the parents p18383 B50 p. 230 Health Professional 3384 Ibid385 Letter dated 19 July 1996 to NWH; NWH Vol 2, page 564

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Expert 4 noted that all these activities indicated that the newborn service wasundertaking appropriate quality assurance activity, which ultimately did detect theseunusual brain lesions and led to its investigation in identifying the causal link.

These reviews were of course conducted as part of the intensive care unit’s routineprocedures. It should be noted they were not specific for physiotherapy butconcentrated on overall outcomes including death rates and incidence of illness(morbidity). The Inquiry was reminded that there was a twice daily physiotherapyclinical assessment of each baby involving a review of the baby’s chest x-ray at the“daily radiology round with the medical staff and radiologist and frequent discussion withthe medical and nursing staff at the ward round”386 regarding frequency and tolerance totreatment, particularly if there was an unstable baby.

The daily checks on the pre-term babies progress, particularly with regard to therespiratory progress was the main focus of the reviews. With the emphasis onreducing chronic lung disease, the advances achieved by the use of nCPT was theprincipal focus of physiotherapy assessment. Without any knowledge or suspicion ofthe link between chest physiotherapy and the brain lesion, these assessments on adaily basis did not assist detection.

Record keeping

One of the factors which did assist in assessing the risk and led to the ultimatedetection of the lesion, were the records that were kept of the physiotherapy treatments.These records were designed by and kept at the instigation of Health Professional 6.The records included the date and time that the physiotherapy was undertaken, thesegments of the lung percussed, the observations of the baby during physiotherapy,and the level of oxygenation during the treatment.387

The records drew praise from Expert 12: 388

“I think NWH must be commended for the excellence of record keeping. It isabsolutely first class, exemplary record keeping.”

This was echoed by Expert 4, who said:389

“Each of the treatments is clearly documented, including what was done andother comments about the responses. This is a standard practice and has beenwell documented in these cases.”

The insistence on record keeping by Health Professional 6 was commendable andensured that staff adhered to providing full notes of their treatments to their respectivebabies. It led ultimately to the identification of the link between chest physiotherapy andthe brain lesion. As Health Professional 6 told the Inquiry:390

“It was because of these detailed records that [Health Professional 5] was ableto exactly count the number of treatments each baby had received andundertake [a] retrospective case control study.”

386 B16, p28 Health Professional 6387 NWH Vol 1, page 110388 T782, lines 9-12389 T563390 B17, p28 Health Professional 6

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Health Professional 3 described how he/she carried out an audit of nCPT on babies of30 weeks gestation from one year from November 1993 to October 1994 by chartreview.

“The records of each treatment are full and complete. The physiotherapistsroutinely recorded the treatment orders and the assessments of the babies,together with the reasons for commencement and cessation of treatment.”

Factors that may have indicated risk

Failure of Planned clinical audit

A clinical audit was planned to be undertaken on the implementation of the change intreatment. This did not happen. From June 1993 through to December 1994, no stepswere taken to prepare for a clinical audit. In the minutes of the Physiotherapy WorkingParty391 on 7 April 1994 it was noted:

“a clinical audit will be done later in the year. In the meantime [HealthProfessional 6] is available to all nurses who wish to have an informal check oftheir P+P skills or go over a specific area of treatment.”

It should be noted that the planned clinical audit was to be a specific assessment on aclinical basis of the safety and efficacy of the change in treatment. There was noevidence or documentation of any preparation that was undertaken for such a clinicalaudit and it never occurred.

391 NWH, Vol 1, page 9

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Rib fractures

During the Inquiry, reference was made to two of the affected babies who had ribfractures. Rib fractures were known to be a potential complication of contact heelpercussion, a form of neonatal physiotherapy.392

Baby 1 had multiple rib fractures which were diagnosed at 42 days of age. At 15 daysof age, an x-ray of Baby 1’s hands and knees showed the occurrence of a conditionknown as osteopenia, which is described more fully in Chapter 2. This condition is acommon bone disease seen in very preterm infants, caused by post natal phosphatedeficiency. Baby 1’s last chest physiotherapy treatment was on 9 August 1993, beforethe fractured ribs were diagnosed. There was a suggestion during the Inquiry that therib fractures may well have been an indication that physiotherapy as applied to thesebabies was too vigorous. With such early on-set of metabolic bone disease, Baby 1was at risk of fractured ribs from normal handling and it is unclear whether the fracturedribs occurred as a result of the physiotherapy treatment received.

Baby 7 had a fractured right seventh rib diagnosed at 42 days of age and also had ahigh alkaline phosphatace.393 Again, it is unclear whether the fractured rib is a clearindication of the vigour of physiotherapy.

The Inquiry was told that the overall incidence of rib fractures in NICU is very low and ofall the low birthweight babies in 1994, only two had fractured ribs. This was a lowincidence of a condition that had previously been more common.394 It is therefore notpossible to conclude that the rib fractures alone were indicators of excessive vigour.

Registrar’s complaint

The Inquiry was told that in January 1994, a registrar on duty in the neonatal unit at NWHcomplained about the intensity or vigour of Health Professional 10’s physiotherapytechnique.395 He/she was new to the unit, and had not had prior experience of neonatalchest physiotherapy. He/she had observed Health Professional 10 performing chestphysiotherapy on a term baby, considered that Health Professional 10 was too vigorous,and asked him/her to stop. This occurred at a time in which Health Professional 6 wason holiday.

On his/her return, Health Professional 6 spoke to Health Professional 3, the nursingstaff involved, the charge nurse and Health Professional 10 about the incident. As aresult of the registrar’s complaint, a review of physiotherapists’ technique wasundertaken to ensure that they were all practising within safe standards.396

In evidence, Health Professional 6 acknowledged that the incident was of someconsequence,397 having been raised by Health Professional 3, the acting seniorphysiotherapist, the charge nurse and ultimately involving Health Professional 6. HealthProfessional 6 told the Inquiry he/she reviewed Health Professional 10’s technique andfound that he/she was practising within the parameters as described within the protocol,ie the baby was well oxygenated, had no adverse effects and was properly handled.

392 Contact heel percussion is described in Chapter 4; B37, p15 Health Professional 3393 642 at 17 days and 720 at 23 days.394 Health Professional 3 T217 l28-30/T218 l1-3395 B7 p.23 Health Professional 10396 T419, l21-24; T528, l13-17397 T419

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However as there were no criteria for assessing intensity, Health Professional 6conceded there was no objective way of assessing that, apart from observing thedifferences among the various practitioners, noting:398

“That’s the problem we keep coming to – I had no objective measure forintensity of treatment.”

Subsequently, it has been submitted that the likely time of this incident was June 1994,not January, as the evidence disclosed at the hearing. It should be noted that the Inquirydid not hear from the Registrar, and nor was there any documentation of the review.Despite the Inquiry’s request for detail, there appeared to have been no written record ordocumentation of either the complaint or the outcome of the review.

It was further submitted that the Registrar’s concern needs to be viewed in the contextthat over a period of nine years in which this treatment had been given at NWH, this wasthe only occasion when there had been any criticism of the intensity of the treatmentgiven.399

We consider that this complaint was appropriately managed at the time, with theexception of the failure to record the incident in a written form. Given the fact that therehad been no other such complaints, and that the Registrar was new to neonatology, theNWH response was reasonable. It now appears that this issue was an indicator thatthe technique was significantly vigorous.

IVH – Physiotherapy Working Party 16 March 1994

In March 1994, at a meeting of the Physiotherapy Working Party, an issue of concernwas raised during the course of the meeting. It was expressed in the minutes ofWednesday 16th March 1994 as follows:400

“IVH Some staff expressed concern that “all that bouncing” may cause an IVH.There is no evidence to support this in the current literature. Risk of IVH is inthe first 72 hours, and most of our little babies don’t commence physio untilabout 10-14 days.”

Health Professional 3 acknowledged there was discussion about the risk of IVH fromnCPT, saying: 401

“Prophetically, the question was raised whether there was a risk of IVH with “allthat bouncing”. The answer was that there was no evidence to support this in thecurrent literature. The risk of IVH was in the first 72 hours and most babies didnot start physiotherapy until about 10-14 days of age. This answer is as truetoday as it was in 1994.”

Health Professional 3 also acknowledged that the response as printed in the minutes ofthe Physiotherapy Working Party was his/her response, after the matter had beenbrought to his/her attention by Health Professional 6. Health Professional 3 regrettedthe reply, and acknowledged that in retrospect this was a warning.402

398 T421, l528399 B22, p40400 NWH documents, Vol 1, page 15401 B39 p160 Health Professional 3402 T248, l8-13

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During the Inquiry, the possibility was raised that the IVH term was being used looselyby the “staff” to refer to the brain lesions seen in babies in January 1994, and which waslater classified as ECPE (the brain lesion).403 If that were the case, the link betweenchest physiotherapy and the brain lesion was being suspected by these staff ninemonths prior to the physiotherapy being stopped.

As was described to the Inquiry, IVH is an abbreviation for “intra-ventricularhaemorrhage”. The Inquiry was told that the term, when used precisely, refers to acomplication of preterm babies where spontaneous haemorrhage occurs within orbeside the ventricle of the brain. As Health Professional 3 informed the Inquiry, thisoccurs within the first 72 hours of life.

Health Professional 7 expected that nurses would use the term IVH to indicate itsprecise meaning404, rather than as a more loose descriptor of brain haemorrhaging at alater stage as seen in ECPE (the brain lesion).

No one identified the staff who expressed such concern, and nor were the variousnurses and physiotherapists who were called to the Inquiry able to explain who wouldhave raised the problem.

The nursing staff that were called from NWH, all denied that this was a concern oftheirs,405 and insisted repeatedly that as nurses would know the precise definition ofIVH,406 the reference to IVH could not have been attributed to the possible connectionbetween brain lesion and neonatal chest physiotherapy. The Inquiry was told thatnurses fully understood the difference between IVH and the brain lesion.407

It was also submitted to the Inquiry that because the known cause of IVH was related toblood flow not movement, it was not viewed as a genuine problem.408

Submissions have been received409 criticising any connection between chestphysiotherapy and the unusual brain lesions, on the grounds that the evidence wasclear that no one suggested such a connection.

Despite the fact that the staff from NWH who were called did not identify any of the staffexpressing such concern at the time, it is clear that some staff were concerned inMarch 1994 about “all that bouncing” and a brain related injury, which was termed IVH.The identification of the particular brain lesion (ECPE) was not made until December1994.

On the evidence before the Inquiry, two things are clear. First, IVH occurs within thefirst 72 hours of life. The second, is that physiotherapy normally starts about 10-14days of age. Physiotherapy was started on the babies in this Inquiry between days 4-16. Thus, if as we were told,410 the nurses fully understood the difference between IVHand the brain lesion (ECPE), they would not have raised the concern. The fact thatsome did, suggests they were using the term in an imprecise way. This is supported bythe need for Health Professional 3’s written clarification in the minutes.

403 T439404 T438 Health Professional 7405 T493, l27-29; T558, l6-10; T569, l20-28; T570, l1-11; T586, l19-28; T587, l1-20406 T571, l23-28; T572, l1-2407 T635, l18-24408 NWH submissions, page 25, p. 89409 Submissions from counsel for NWH and Health Professional 6 in response to draft Report410 T438, Health Professional 7; T635 Health Professional 13; NWH subs on Draft Report P9 para 44

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Given that the unusual brain lesions were identified in February 1994, following a clusterof unusual cases in January 1994, it gives rise to the inference, based on the evidencebefore the Inquiry, that some staff were clearly expressing concern about the effects of“all that bouncing” and the possibility of a brain trauma. The imprecise use of the termIVH in that context would describe the type of brain trauma, which the staff had seen intheir practice, prior to the identification of the actual brain lesion. Otherwise, there wouldhave been no reason to mention IVH in conjunction with “all that bouncing” becausephysiotherapy was not started within the first 72 hours (3 days) of a baby’s life.

As Health Professional 3 said, “Prophetically, the question was raised whether there wasa risk of IVH with ‘all that bouncing’”. This suggests to us that some staff wereattempting to identify the problem in making the connection between chestphysiotherapy and the unusual brain lesion.

The incorrect technique

A key factor which was not recognised or realised by anyone at NWH, was the incorrecttechnique of the expert, Health Professional 6, who was also in charge of the training ofthe nurses, several of whom also used an incorrect technique. We have reached thisview on the totality of the evidence that was presented to the Inquiry and our reasonsare as follows:

• A comparison of the techniques as represented on the respective videos highlightsthe more vigorous way in which the technique was undertaken at NWH. We referalso to our finding on vigour.

• The criticism that the elbow was used instead of the wrist in performing thetechnique.

• The nurses complaint of neck and shoulder pain identifying that they were using thetechnique improperly.

Dealing with each of these in turn:

The video comparisons

The Inquiry received three separate videos depicting the use of percussion by cuppingfrom NWH, Expert 17, senior physiotherapist of Overseas Hospital 4, and Expert 16 ofOverseas Hospital 3. As identified in Chapter 5, there were differences in undertakingthe technique, but overall, the important difference was that the technique undertaken byNWH appeared more vigorous than the other two.411

The Inquiry heard evidence from two international experts, both pioneers in the field ofthe relevant technique in pre-term babies. They were Expert 13, the seniorphysiotherapist in the neonatal unit in Overseas Hospital 2 and Expert 17, seniorphysiotherapist with experience primarily from Overseas Hospital 4 from June 1980 toSeptember 1993. Both of these international physiotherapists had extensivephysiotherapy experience in neonatal intensive care unit, were both pioneers in thetechnique of percussion by cupping and had published widely. We heard evidence fromExpert 13 who attended the Inquiry in person and from Expert 17, who gave evidence byvideo link. Both witnesses impressed us with their experience and in the manner inwhich they gave their evidence.

411 Refer Ch.5, Sections “video” and “vigour”. It should be noted that problems identified with the video from NWH hasbeen taken into account and referred to more explicitly in Chapter 5.

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In addition, a number of witnesses were asked to view the NWH video and compare thecupping technique in the video with their own practice. Similarly, a number of NationalWomen’s witnesses were asked their reaction to viewing the video in 1999.

Although the comments of witnesses from other hospitals are set out in Chapter 5, theevidence of the two senior international physiotherapists are set out here.412 Expert 13from Overseas Hospital 2 told the Inquiry:413

“The cupping technique was more vigorous than I would have practised at thattime. There was no head stabilisation and the head appeared to be bouncing….The pressure used on this baby [Baby B] was far in excess of what I would haveused…”

Expert 17 in comparing his/her practice in 1993 – 1994 with the video from NWH, toldthe Inquiry:

“It ‘demonstrates’ prolonged, vigorous percussion without apparent pauses toallow re-assessment and recovery. Had I seen these infants being treated inthis way in my unit I would have intervened to stop the treatment.”414

It should be noted that both Expert 15 and Expert 16 from Overseas Hospital 3commented that the vigour of the treatment on the video was significantly different fromthe Overseas Hospital 3 technique and that the movements of the babies duringphysiotherapy on the video would not have occurred in Overseas Hospital 3. This isrelevant, in light of the submissions that the same brain lesion as occurred at NWHoccurred in Overseas Hospital 3, although they had always taken care to steady thebaby’s head during physiotherapy.

The evidence was that the practice at Overseas Hospital 3 was different to that seen inthe video and Expert 15 noted that:415

“Our babies heads were not being jiggled as much as the Auckland babiesheads, and, consequently, if jiggling is part of the multi-factorial aetiology ofencephaloclastic porencephaly [ECPE], then, on that point, the Auckland babieswould be more vulnerable.”

In addition to the evidence from witnesses of other hospitals in New Zealand as well asoverseas, the viewing of the video by NWH staff focused attention on the babies head416

and produced the reaction identified by the parents to want to stop it.417

We have carefully considered all the evidence from the witnesses who commented onthe NWH video. We have also taken into account that no one suggested to NWH staffincluding Health Professional 6, that the technique was unduly vigorous despite visits byothers to NWH and the lectures and demonstrations which Health Professional 6 gaveto physiotherapists throughout New Zealand.

412 Refer for other comments on vigour Chapter 5 section on vigour413 B8, Expert 13414 B5 p. 16 Expert 17415 T854, l5-9416 T311, l18-22417 T244, l1-5. Refer also T513, l25-27 and T514, l1-6 Health Professional 9 - “in hindsight looking back I think weshould have insisted on having two nurses”

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The weight of evidence before the Inquiry, particularly from the international witnesses,including the senior physiotherapist experts Expert 13 and Expert 17, identifies thetechnique as undertaken on the NWH video by Health Professional 6 as being morevigorous than the technique practised in their respective units. We were particularlyimpressed with the evidence of Expert 13 and Expert 17 in this respect and we accepttheir evidence.

The Use of the Elbow

The protocols regarding the application of the percussion by cupping technique allemphasised wrist movement. Health Professional 6 knew this and emphasised theneed to use wrist movement only, in his/her teaching and training both thephysiotherapists and nurses.418

The reason for wrist action is to ensure that the wrist is used as a fulcrum.419 Thereason for the wrist-use only, and not the elbow, is to minimise intensity or vigour ofpercussion.420 The NWH nurses and physiotherapists gave evidence that HealthProfessional 6 placed emphasis on maintaining a wrist action and one nurse wasrequired to undertake extra teaching lessons because they were having difficultymastering the wrist action.421

We accept the evidence and submissions that Health Professional 6 emphasised to allstaff who were to undertake the technique, that it was to be done by wrist action.However, it appears that what Health Professional 6 taught and understood to be thecorrect technique, was not necessarily carried out at NWH in practice.

This was first identified by Expert 12 and Expert 13 in December 1997 in providing anopinion on the NWH video. Expert 12 made several observations including that thetechnique of cupping was predominantly banging rather than bouncing the chest,422 thatthe technique was excessively vigorous in comparison to known practice at OverseasHospital 2 in 1990 and involved the use of elbow, shoulder and wrist.423

At the time of the Inquiry, further evidence was given of the inappropriate use of theelbow as identified in the NWH video. Expert 13 described “a great deal of shouldermovement involved on Baby A in the video and on Baby B, the technique involved verylittle wrist movement, with most movement coming from the elbow.” He/she referred tothe mask as being corked, which made the use of the fine tripod grip more difficult,encouraging elbow and shoulder movement.424 Expert 13 also described the differencebetween “banging” the chest, involving “the whole hand movement from elbow actionand even arm if you were standing using the mask” and “clapping” the chest whichinvolves “a flicking movement of the wrist which is a sharp tap rather than a firmbang.”425 The use of the “elbow action” was also noted by Expert 16 in makingobservations of the video.

Health Professional 6 whilst emphasising the use of wrist movement, conceded thatuntil receipt of Expert 12’s comments on his/her technique in the video in 1997, Health 418 T419, l1-6419 Submission on draft report page 6, p. 15(b) Counsel for Health Professional 6420 T414 l.9-15 and wrist action is prescribed in all the treatment protocols421 T340, T369, T494, T475, T518, T525, T556 and T580422 Page 581 NWH docs Vol 2. This was in reference to Baby A, 29 weeks of 1435g; the physiotherapy wasconsidered to be consistent with common practice at that time.423 Page 581 NWH docs Vol 2, Baby B424 B. p8 Expert 13 and T826-827425 T827 l20-24. [NB the word “tap” appears as “cap” in the transcript]

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Professional 6 was not aware of using the elbow.426 During the course of the Inquiry,Health Professional 6 said it was unavoidable that an elbow movement on a large termbaby on a heat table would be required to some extent. The question of painfulshoulders in staff undertaking nCPT occurred, if a nurse attempted to percuss solelyfrom the wrist without stabilising the elbow joint on the edge of the incubator porthole.Health Professional 6’s view was that this was more difficult on the heat tables, leadingto resulting neck and shoulder pain because the muscles around the shoulder joint hadto work excessively to stabilise the shoulder and the elbow joints.427 The height of thenurse in relation to the incubator or heat table made this ergonomically more difficult.

The relevance of the heat table was that the video clips showed percussion beingundertaken on a heat table rather than an incubator, where the forearm is supported. Ithas been submitted that there was support for Health Professional 6’s evidence aboutelbow movement. The evidence from NWH’s witnesses, including Health Professional9, explained that with a heat table, the difference in the height of nurses could beaccommodated by sitting on a high stool at the heat table, dropping the plastic side andresting the elbow on the mattress.428 Health Professional 9 did not have any problemswith the heat table.429

Health Professional 10 confirmed that the height could not be adjusted on heat tableswhich made physiotherapy ergonomically more difficult and put a tall or a very shortnurse at a mechanical disadvantage.430 Health Professional 12 also acknowledgedthere was an ergonomic and mechanical problem with the varying heights of nursesundertaking percussion at the heat table although in relation to painful shoulders he/shehad not experienced painful shoulders but other nurses had.431Health Professional 9,the first nurse trained by Health Professional 6 and a level IV expert nurse in thenewborn service noted in answer to questions on the difficulties in height adjustment onthe heat tables that “we didn’t have a lot of babies on heat tables…”.

It was submitted that consideration should be given to the evidential support for HealthProfessional 6’s evidence about elbow movement, from the foregoing witnesses andExpert 7.

Expert 7 described undertaking percussion by use of tenting of the fingers and hand andthat the “movement mainly comes from your wrist”. When asked if it could come fromthe elbow, Expert 7 said “you have some elbow movement but most comes from yourwrist.” Expert 7 then described that the elbow movement would be obvious if theneonate baby was towards full term. In that case a more open handed part of the handis used and the baby would be placed on the physiotherapist’s knee. Expert 7 said “butwe are talking full term babies with chronic lung disease, not neonates under 1500g.”432

We have given careful consideration to the evidence from Health Professional 6, theNWH nurses and Expert 7. Expert 7 is describing a technique which uses the fingers ina tenting position not a face mask, and confines his/her comments regarding elbows toalmost full term or full term babies, not neonate babies under 1500gms in weight. HealthProfessional 9 was of the view that there were not many babies on the heat tables and

426 T419, l7-9427 SB3, p1.8 Health Professional 6428 T508, l13-16429 T508, l19-23430 T540, l5-9431 T560, l25-29432 T666, l7-11. [NB the word “are” appears as “ware” in the transcript]

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the other witnesses confirm in part that there were ergonomical difficulties dealing withthe heat tables.

In addition to the evidence from Expert 13 and Expert 16, Expert 17 confirmed thatpercussion as his/her was taught and as he/she has practised it has always been witha loose wrist. Expert 17 did not agree there was any exception to the use of the wrist-only movement during percussion and for babies in the neonatal unit there were notimes at which the use of the elbow was permitted in the use of percussion in his/herpractice.433 When specifically asked about any distinctions between undertakingpercussion in an incubator as opposed to a heat table Expert 17 acknowledged therewill always been a small amount of elbow movement “probably, but you are not meantto be percussing from the elbow, you are meant to be percussing from the wrist.”434

Assessing all the evidence, and noting that there is no strictly empirical evidenceavailable to the Inquiry, the weight of evidence particularly from the overseasindependent experts, identifies the inappropriate use of the elbow by Health Professional6 in the NWH video and we accept that evidence. It is clear, that Health Professional 6believed that he/she was using her wrist, taught physiotherapists and nurses to usetheir wrist only, but in the practical applicationof the technique used his/her elbow, whichhe/she did not discover until 1997, on receipt of the opinion from Expert 12.

Neck and shoulder pain

Health Professional 6 told the Inquiry that following the implementation of nursesundertaking the treatment:435

“There arose the problem of nursing staff developing aching neck/shouldermuscles on their dominant hand side during P+P – this was put down to nursingstaff utilising elbow muscles excessively rather than wrist muscles duringpercussion, but other factors such as an inappropriate heat table/incubatorheight would have contributed. For those affected I reviewed their technique andsuggested some changes in the positioning of the nurse’s arm to assist withmaintenance of wrist action during percussion. A remedial stretchingprogramme was also introduced.”

Health Professional 6 wrote a memorandum in July 1994 outlining numerous factorsthat may be causing such pain. One of those factors was that the wrist was not relaxedduring percussion. Health Professional 6 notes: “if the wrist is not relaxed, yourpercussion is mainly elbow movement, hence the muscles around the shoulder girdleand neck have to work harder to provide stability of that area.” 436

In the memorandum, Health Professional 6 noted that “several people have beencomplaining of neck/shoulder pain” and he/she prescribed stretching exercises forthose that suffered from pain. Health Professional 6 told the Inquiry, “I only knew aboutthe pain in the nurses shoulders and necks when it was referred to me.”437

It was submitted438 after the hearing that the number of nurses complaining of pain wasonly 3 out of 76 and the problem was extremely minor in scale. There was no evidence

433 T870, l24-29434 T871, l5-8435 T283436 NWH Vol 1, page 006-007437 T346 l24-25 Health Professional 6438 Submissions from Counsel for Health Professional 6; Submissions on circulation of Draft Report

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before the Inquiry as to how many nurses were complaining of pain, and in givingevidence at the Inquiry, Health Professional 6 did not specify that only 3 nurses wereinvolved, one of whom suffered only wrist pain.439

The evidence we received indicates the detailed memorandum from HealthProfessional 6, addressing the fact that several people had been complaining ofneck/shoulder pain; the “problem of nursing staff developing aching neck/shouldermuscles” as identified in the brief of evidence, and in the supplementary brief ofevidence Health Professional 6 refers to the question of “painful shoulders in staff”.440

Whilst those references do not identify particular numbers, they are suggestive ofseveral nurses complaining of pain. There was no evidence presented to the Inquirythat the nurses affected numbered three only, despite the opportunity to adduce furtherevidence at the end of the hearing.

From the evidence referred to and the documentation issued at the time, which wasindeed thorough and detailed, we have drawn the inference that in the absence ofnamed nurses and their specific numbers, there appeared to be a problem experiencedby nurses undertaking the technique in July 1994.

Expert 13 was firm in the view that any person complaining of neck and shoulder painduring or from percussion was not undertaking the technique properly.441 This meantthat the person was using the elbow and not the wrist. Expert 13 said further:442

“the comment that I would make in all honesty is that nurses should not havebeen complaining of neck/arm pain during positioning and percussion and Iwould question either their posture, their technique or the vigour with which theywere doing the technique.”

Expert 13 also told the Inquiry:443

“I would suggest that if they are experiencing shoulder and arm pain that theyare using large muscles in that area and perhaps overusing them, either inlength of time that they are doing the technique or in the way they are applyingthe technique in terms of pressure…”

In making this comment, Expert 13 acknowledged that his/her professional experiencewas in neonatal paediatrics and not adult musculo-skeletal, but said further:

”I cannot see how if you are using just wrist movement for the length of time withwhich we would be applying the technique on our babies that you would haveneck and shoulder pain requiring treatment. But bear in mind the limitations ofmy experience in adult physiotherapy areas.”444

There had been no nurses complain of shoulder pain in Expert 13’s unit in using thetechnique445 as he/she taught it and it should be noted here that Expert 13 did not drawany distinction between the use of the technique on a baby in an incubator as opposedto a heat table. This distinction had been drawn by Health Professional 6. Expert 13’s

439 Refer submission from counsel for Health Professional 6, page 5, p. 14b440 SB3 p1.8 Health Professional 6441 T810, l12-23442 T815, l12-17443 T810, l17-22444 T815, l24-28445 T815, l6-8

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response was that “it should not follow that the operator uses elbow on a heat table, theyshould still use only wrist movement.”446

Expert 17, the senior physiotherapist from Overseas Hospital 4 and formerly at twoother UK hospitals, had never heard of nurses complaining of shoulder pain as a resultof doing physiotherapy treatment in the units in which he/she had worked, and said inanswer to the following question:447

Q. Would you be concerned if they did complain of shoulder pain as a result ofgiving physiotherapy treatment?

A “Well, yes. I wouldn’t see why the shoulder should be sore. It would indicate tome that they were not doing it properly.

It has been submitted that in the absence of any evidence addressing the possiblecauses of the shoulder pain or the extent of the pain, there is insufficient evidence thatthe application of the techniques were inappropriate. It has also been submitted that assoon as the problems of neck and shoulder pain were experienced by the nurses, theyraised the problem and action was taken to address the concerns as they arose.Whilst it is accepted that opportunities were available to staff to provide feedback aboutthe changes in treatment, and action was taken to address them, from the evidence wehave heard and preferred from Expert 13 and Expert 17, it is evident that the techniqueby several nursing staff was being undertaken either inappropriately or for too long aduration.

Although Health Professional 6 gives a careful explanation as to why painful shoulderscould occur, if percussion was undertaken from the wrist without stabilising the elbowjoint, the evidence from the two international physiotherapist experts, Expert 13 andExpert 17, both confirm that if nurses were complaining of shoulder pain as a result ofgiving physiotherapy treatment, this was an indication they were not undertaking thetechnique properly. This is supported by the fact that Health Professional 6 tookcorrective action on these complaints by issuing instructions to use the wrist only andalso prescribed correcting exercises. However, with Health Professional 6 not awarethat he/she was using his/her elbow in undertaking the technique, the practicalapplication of the technique in the unit by the staff, as taught by Health Professional 6,appears to be incorrect.

Analysis of the Factors

In assessing any risks associated with the change in treatment, NWH staff actedcarefully and appropriately in gathering relevant known information from other units inNew Zealand from Australia, to check appropriate procedures before formulating theirguidelines and protocols.

In implementing the change in treatment, NWH selected only senior nurses withneonatal intensive care training, to undertake the technique of percussion by cupping,and formulated comprehensive nursing protocols and standards. All the treatmentswere required to be thoroughly documented and the record keeping by NWH staff wasexemplary. In addition, there was an assessment of the physiotherapy treatment ofeach baby, undertaken by medical and physiotherapy staff at daily ward rounds.

446 T810, l7-10; T815, l29-31447 T876, l23-29

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These steps taken by NWH in implementing the change were thorough, appropriate andwere undertaken to minimise any attendant risks of the change in treatment.

When the Registrar raised the concern about a physiotherapist’s vigorous treatment,this was referred to Health Professional 3 and Health Professional 6, who undertook areview of all physiotherapists in the unit. In reviewing their techniques HealthProfessional 6 had regard to the detail in the protocol, which had no criteria for vigour ofintensity of percussion.448

When the nurses complained of neck and shoulder pain, their complaint was actionedby Health Professional 6, who issued a direction to use wrist-action only, prescribedstretching exercises, cautioned about posture and elbow support and reviewed thosenurses who wished to have their technique checked.

When the concern was raised by concerned staff that “all that bouncing” caused IVH, awritten response was provided by Health Professional 3, to reassure them that IVHcould not occur as a result of the treatment.

In each of these three instances, when issues were raised, NWH staff actedappropriately in addressing them and correcting techniques where appropriate.

The underlying problem on the evidence we heard however, was that HealthProfessional 6 who implemented the treatment, was not applying the techniqueproperly, namely, he/she appeared to use his/her elbow inappropriately, instead ofhis/her wrist only. The staff member banged the chest rather than “clapped” it andpractised a percussion technique was of greater vigour than that practised at otherhospitals. Health Professional 6 became the acknowledged and most experiencedneonatal chest physiotherapist expert in New Zealand and had trained the majority ofphysiotherapists in New Zealand for several years.

Thus, when the Registrar raised the complaint about vigour and the nurses complainedabout neck and shoulder pain, it was Health Professional 6 who undertook the review ofthe techniques and gave directions about its application. He/she was not aware that theapplication was not done correctly or was of greater vigour than elsewhere. There hadbeen no one in lectures and demonstrations in New Zealand who had raised concernsabout it.

There was no peer review available throughout 1985-1994, and without the benefit ofreview by a peer of equivalent seniority, Health Professional 6 believed the treatmenthe/she undertook was correct and beneficial. We are cognisant that HealthProfessional 6 had been undertaking this treatment since 1985. No records before1992 were reviewed at NWH, and consequently the Inquiry’s attention was focussed onthose cases since 1992. We do not discount the possibility that at times the applicationof the technique of Health Professional 6 may have been within acceptable limits. Onthe video evidence before the Inquiry however, the technique was consistently criticisedby international and respected experts.

At the relevant time, NWH staff were concerned to reduce the problem of chronic lungdisease. Without knowing of any detrimental effects of the physiotherapy treatment andwithout effective scrutiny of the technique of percussion of Health Professional 6, thepotential indicators of risk were not recognised.

448 T421 l.1-8

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TRAINING NEEDS

2(d) (iii) Assessments carried out of the training needs of the staff whowould be called upon to provide the treatment.

The Inquiry heard evidence of the training of nursing staff to undertake the percussion(cupping). The specifics of the training are described fully in chapter eight.There are two categories of steps taken before and after the change.

(a) Steps taken for training before the changes.

Considerable evidence was adduced, including documentary evidence of training ofnurses and physiotherapists detailing the work undertaken by the PhysiotherapyWorking Party prior to the change being introduced, and the training material utilised.449

This documentation included copies of the 1993 records of attendance for nursingstaff,450 accepted by Health Professional 6 to be an incomplete record.451 Learningobjectives were produced along with copies of journal articles on neonatal chestphysiotherapy. Lecture notes and handouts for each session had been compiled byHealth Professional 6 for the training of nurses. We find them to be very detailed incontent.

The training was to include one theoretical session and practical “cot-side’ sessions foreach nurse452, accompanied by a self directed learning package.453 Focus was placedon the teaching in June 1993.

“this month we are blitzing ‘ respiratory therapy for nurses’ or positioning andpercussioning as it is to be known. You need only attend one of these sessions,but please remember that you need to have an individual bedside tuition beforepractising this treatment”. 454

In giving evidence, Health Professional 6 referred to the hand written objectives for the‘short-sharp session – length 25 minutes’. Health Professional 6 submitted

“ the nursing staff had at least two cot-side sessions to learn positioning andpercussion (P+P) all of which were taught by me” 455

and further detailed how records of attendance, lists of orientated nurses and literaturefolders were kept “to extend their knowledge beyond the teaching session”.456

The Theoretical Part of the Training

All nurses were able to give evidence regarding their training in some detail.457 HealthProfessional 2 outlined that the training programme was developed by the working party,

449 NWH Volume 1 pp172-424 contained copies of the documentation used at various stages of training of bothnurses and physiotherapists from 1986 onwards.450 Ibid page 184451 T 343-L.2-8452 NWH Volume 1 page 34453 T 472 L.1-4454 NWH Volume 1 page 186455 B.14 p.23 Health Professional 6456 B.14 p.26 Health Professional 6457 For further detail on Training, see chapter 8

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(which included Health Professional 6458) the details of which were consistent withthose detailed by Health Professional 6 in relation to preparation and training.

Health Professional 11 outlined the training 459 as did Health Professional 12460 “ I feltthe training was excellent and I can’t fault [Health Professional 6]’s training”. HealthProfessional 11 confirmed the requirement to attend a lecture followed by practicalteaching sessions with Health Professional 6. Health Professional 9 was more specificabout the training itself, and was the first nurse to be trained in the positioning andpercussion treatment. The brief of evidence states:

“the chest physiotherapy training programme for nurses was undertaken by[Health Professional 6] in the Newborn service. Having only one person doingthe training was aimed at ensuring a consistently high standard in training andinformation provision”.461

The formal content of the training sessions appeared to have been considered andplanned. Health Professional 3 stated:

“the staff involved identified their training needs……A group of the two neonatalphysiotherapists and senior nurses was set up to plan and implement the training ofnurses. The training process was planned.” 462

Health Professional 9 detailed the lecture, articles and initial practical trainingundertaken, and also provided feedback and comments to the Physiotherapy WorkingParty including “ a few ideas how to get more staff trained on P+P”463

Health Professional 10 was also a member of the Physiotherapy Working Party, andconfirmed that the working party developed the training package, adapted from thephysiotherapy standards and protocols 464. Only experienced nurses were to be trainedin the technique, after at least 13 months neonatal experience.

The Practical Training

Health Professional 6 undertook the majority of practical teaching sessions. The NWHphysiotherapists and nurses who gave evidence at the Inquiry confirmed that thepractical training sessions included a demonstration on the forearm of the nurse duringtheir training session. It was not clear how many practical teaching sessions eachnurse was to have, and their content. Most nurses stated they received at least twosessions465 but no documentation could be produced to substantiate what was includedand how many sessions were undertaken by each nurse. Health Professional 6 wasvague about the length of practical training sessions, accepting that it would be anythingfrom 8 minutes to half an hour or longer.

There was a general approach undertaken in regard to the preparation for training, asopposed to individual assessments and given the large numbers of staff expected to

458 B6 p.19 Health Professional 2459 B5 p.5 Health Professional 11460 B.4 p10 Health Professional 12461 B.3 p.13 Health Professional 9462 T.351, L.10-25463 B13 Appendix dated 12th March 1993, handwritten note to the P+P Group, Health Professional 9464 B5 p.16. Health Professional 10465 Health Professional 9, Health Professional 2 T.342/343

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undergo training in percussion and positioning, this general approach was acceptable.Protocols for treatment were developed by the Physiotherapy Working Party466 andutilized by the nurses when providing the treatment. These were commented on byexpert witnesses as being “impressive“467 and “of a very high standard”.468 We concurwith these views.

(b) Steps taken after the changes were introduced

Assessment of Training

For such a major change in approach and after expending substantial energies ontraining nursing staff, the assessments made after training were severely limited.

Individual Assessment

It was planned to review nurse’s techniques at 10 to 14 days. Health Professional 10,confirmed having undertaken some of the assessments. 469

“Approximately two weeks after being signed off, [Health Professional 6] or I wouldreassess the nurses during a treatment session. This was regarded as fine tuning;we would check the nurse’s technique and correct if necessary”.

Health Professional 9 confirmed that he/she was assessed on two occasions and waslater observed by Health Professional 6 whilst working a day duty:470

“I was personally assessed on two occasions (the second time 23 June 1993) andthen later observed by [Health Professional 6] when I worked on day duty”

Most nurses stated they received at least two practical sessions471. Health Professional3 stated “nurses were sought out by [Health Professional 6] two weeks after training toidentify any problems and assess if necessary”. 472 Health Professional 6 submitted:473

“generally, approximately 10 to 14 days later I reviewed the nurses P+P technique”.

However on questioning474 Health Professional 6 was vague about the follow upassessment.475 A formal follow up assessment was not organised, rather “ that nurseswere invited to refer themselves if they (a) felt they were rusty (b) they wanted aninformal check of their P+P skills or (c) go over a specific area of treatment”. HealthProfessional 6 agreed to having been unable to give a reliable assessment of reviewingnurses techniques after 10 to 14 days, and that it would be less than complete followup.476

466 NWH Vol1, pp 115-117467 NWH Vol 2, p562 Letter from Expert 4, dated 19.7.96, point 2468 B3 p7 P Expert 16469 B.6.P.18 Health Professional 10470 B4, p.graph 14471 Health Professional 9, Health Professional 2– T342-343472 B.49, P.173 Health Professional 3473 B.15, P.21. Health Professional 6474 T345 l. 1-11, 346475 T 358 l. 10-25476 T376 L.13-23

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Those nurses wishing Health Professional 6 to review their skills could voluntarily askfor a review of their technique, but otherwise no formal process was in place to cross-check the technique or audit the practice. It was submitted to the Inquiry that thetraining of the nurses was “thoroughly planned, carefully documented and appropriatelydirected to the particular needs of the senior nursing staff concerned…”477 In addition tothe fact that senior nurses were being trained in the technique, it was also submittedthat nurses were not permitted to perform the treatment unsupervised until they hadsatisfied Health Professional 6 that their technique was appropriate and in accordancewith the protocols

Whilst Health Professional 6 was the person who reviewed the nurses techniques(when the nurses asked to be reviewed) and signed off the competency records forLevel III nurses, the evidence shows that the review of treatment practices was notmaintained because of Health Professional 6’s heavy workload, which included clinicalwork, teaching requirements and the review process. It was clear that HealthProfessional 6 was unable to carry out a review of every nurse’s technique.478

Level III Competency

Nurses within the Auckland Healthcare Organisation were required to progress along acompetency pathway. New nurses would start at level1, and generally would expect toreach level II after 6-12 months experience. Level III indicated an expert nurse andspecific criteria were established to set a standard at this level. Nurses who wished toreach level III would undergo performance assessments to evaluate their readiness forthis level.

The ability to perform chest physiotherapy was initially adjudged to be consistent withlevel III competency, and therefore nurses would approach Health Professional 6 tohave their skills in P&P checked.

Health Professional 6 referred to the Level III competency assessment for nurses asevidence of a review of the nurses technique in percussion,479 and told the Inquiry:“…but numerous nurses – I don’t remember how many – were formally reviewed fortheir level 3 competency by me.”480

“ Then I recall watching the nurse do a whole treatment. Then she had to fill in thedocumentation and if she completed all of that I would sign her off.” 481

On reviewing the competency assessment pages relevant to the level three RegisteredNurse in Newborn Intensive Care Unit, the stated review needs were:

1. Read the physiotherapy information and standards package.2. Complete ‘ Respiratory Physiotherapy training programme for Nurses’ and

document on performance review and update card.3. Discuss the:

(a) aims of treatment (b) indications for treatment (c) contra-indications for the treatment (d) precautions for the treatment.

477 NWH submissions, page 22478 T358 and T376479 B.15 p.24 Health Professional 6480 T 359 l.20-22481 T 361 l.13-24

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4. Demonstrate the correct documentation on the level 3 chart following treatment.5. Explain / demonstrate the use of the physiotherapy charts :

(a) postural drainage chart NW 160/4(b) post – extubation : physiotherapy / Nursing regime NW 160/1(c) physiotherapy treatment chart GL/NW 160(d) discuss documentation of handling, air entry and secretion.

Health Professional 9 gave evidence that the Level III competency workbooks were notfinalised until June 1994482 and appeared to give the view that the assessment for LevelIII included the two cotside / practical assessments previously undertaken:

“There appears to be no evidence here that a practical assessment of thetechnique was required to have this competency ticked off….. I think because onnumber 2 it has got complete respiratory programme for nurses that would haveincluded your two practical sessions” 483

With particular reference to the competency books, Health Professional 9:

“This was for the nurses that were getting their levelling book completed; it wouldhave been after June 1994 when the book was written, and when [HealthProfessional 6] had done the two practical sessions [he/she] would have signed atnumber 2.” 484

Health Professional 9 undertook training in June 1993, along with several other nursesat or around that time.485 However, no formal review of nursing staff for Level IIIcompetencies occurred before June 1994, when the Level III competency booklet wasfinally made available. This is supported by Health Professional 9’s evidence that thereview for Level III competency after June 1994, focused more on the theoreticalknowledge of nursing staff, rather than their practical technique. The practicalassessment of the nurses skill was a key factor once training had been commenced,and should have been formally assessed and monitored within the time frames set byHealth Professional 6. The Level III competency assessment did not achieve this.

482 T 470 l.2-6483 T 471 l.7-10484 T 484 l.16-19485 NWH vol 1, p184

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Physiotherapy staff training assessment

It was unclear how many physiotherapists were assessed and trained by HealthProfessional 6 before they commenced neonatal chest physiotherapy treatments.Health Professional 10 gave evidence of training at Middlemore Hospital in neonatalchest physiotherapy in 1989/1990486. However Health Professional 10 was vague inrecollecting how his/her technique was first assessed when appointed to the staff onNational Womens Hospital:

“… I honestly can’t remember. I don’t remember [Health Professional 6] sayinganything vastly negative or I would have remembered”.487

It took an average of four months on a part time basis to train a full time physiotherapistto be clinically competent and to practice safely in the neonatal unit withoutphysiotherapy supervision.488 They were reviewed annually once they participated inthe provision of treatment within the newborn unit.489

Training of Health Professional 6

This important issue is covered in detail in chapter 8. It is sufficient here to record thatthe Inquiry members were concerned that Health Professional 6’s own training andsupervision in neonatal chest physiotherapy was insufficient. Given that it was HealthProfessional 6 who was considered by all to be the expert, there was a generalacceptance and replication of that style of physiotherapy.

PARENTAL CONSENT

(iv) Assessments made of the need to seek parental consent for the changein treatment proposed.

Consent for Treatment

The steps taken by NWH to assess the need to seek parental consent is bestsummarised by the evidence of Health Professional 3:

“nCPT was an integral part of ventilatory care of babies in the neonatal unit atNWH, and had been since the mid 1980’s. Consent was not sought for thedifferent aspects of that care: for instance, we did not seek consent forsuctioning as we could not have successfully ventilated a baby without it. If ababy was being ventilated, he needed intubation, fastening of the tube, airwaycare including suctioning, good humidification, blood-gas monitoring, oxygenmonitoring, periodic ET tube changes, chest x-rays, etc. Separate consent forall these components of care, including nCPT was neither indicated norsought.”490

486 T. 515 L.9-14; T521 L.20-21487 T.525 l. 9-12488 B12, p20c Health Professional 6489 T. 534 l. 4-5490 B41 P. 174 Health Professional 3 (underlining added)

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In addressing this term of reference, evidence and submissions were directed at thepractice of Neonatal Intensive Care Units obtaining parental consent for all proceduresundertaken in a NICU, including that of nCPT, and the national standard for EthicsCommittees which were established to review research and ethical aspects ofhealthcare. In relation to the practice in NICU’s throughout New Zealand, apart fromobtaining a blanket consent at the time a baby is admitted into NICU, 491 a practicewhich was severely criticised,492 consent was not obtained for the many changes inmethods of care which have taken place during the early 1990’s, on the basis that itwould be unrealistic to obtain consent both for each aspect of treatment and anychange in the method of administering such treatment. After describing many of thechanges introduced in the early 1990’s, Health Professional 3 stated:

“All these changes are part of the gradual evolution and improvement ofneonatal care at NWH as well as elsewhere. It would be unrealistic to expect usto obtain consent for each.”493

Consent to Change in Treatment

With regard to the issue of parental consent to the change in treatment, NWH did notundertake this. Whether this was appropriate or reasonable has to be viewed in light ofthe standards for Ethics Committees regarding new, untried, or unorthodox treatments.These issues are addressed fully in the following chapter on Ethical issues.

Conclusions

(d) What steps were taken before and after the changes in treatment wereintroduced, including the:

(i) clinical assessments (if any) which were carried out of the need orreason for the change, or any review of the treatment;

Conclusion

(a) No specific clinical assessments were made of the need, but the evidence fromthe medical, nursing and physiotherapy witnesses indicated it was clinicallymotivated.

(b) The only clinical assessment or review of the treatment after the change wasthe informal review of nurses following their training.

(ii) assessments (if any) of the risks associated with the change intreatment including the steps taken to minimise any risks;

Conclusion

491 Expert 3 T609, L1-7, where Expert 3 describes obtaining consent in the Hospital 4 Neonatal Unit for all proceduresundertaken in their NICU.492 Expert 2 T 715, L.14-29493 B43, p. 180 Health Professional 3

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(a) Before the changes were introduced there was an assessment of the risksassociated with the change. They were that nursing staff, untrained inphysiotherapy would carry out the chest physiotherapy technique of positioningand percussion, and that the treatment might not be carried out appropriately.Steps taken to minimise these risks were that only senior nurses undertook thetraining, there was a planned training programme for nurses, and detailednursing protocols were developed. In addition, detailed record keeping wasrequired, and the daytime physiotherapist would leave written instructionsregarding the overnight chest physiotherapy to be performed by the nurses.

(b) After the change there were no assessments of the risk of the chestphysiotherapy treatment until December 1994 when the association wassuspected. This is regrettable because a variety of factors arose which inhindsight can be seen to be indicators of risk. These were the Registrar’scomplaint, the IVH comment, and the neck and shoulder pain of the nurses.

At the time, NWH did not perceive any risk from the treatment, as evidenced byits omission from the 50 factors identified in the first case-control study.Once the association with the treatment was suspected, a detailed assessmentof the risk of the treatment was undertaken.

(iii) assessments carried out of the training needs of the staff whowould be called upon to provide the treatment;

Conclusion

In June 1993 there were three categories of staff providing the treatment:

(a) Health Professional 6 did not have any formal assessment carried out, either oftheir training or practice. Informally Health Professional 6 had visited overseasUnits but no assessment of his/her practice occurred.

(b) Other Physiotherapists were assessed by Health Professional 6 on an annualbasis.

(c) The nurses had their training needs assessed and set by the PhysiotherapyWorking Party prior to the change and Health Professional 6 provided thetraining.

(iv) assessments made of the need to seek parental consent for thechange in treatment proposed.

Conclusion

There were no such assessments made.

CHAPTER SEVEN

ETHICAL ISSUES

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This chapter deals with ethical issues as they arose during the Inquiry. It alsoaddresses term of reference 2(e) which specifically requires a finding on:

2(e) Whether the steps taken by NWH, before and after introducing thechange in the way in which the treatment was performed, wereconsistent with relevant New Zealand or international clinical orethical guidelines for effecting changes to treatment protocols.

It was under this term of reference that the following issues emerged:

TREATMENT PROTOCOLSChange to Treatment and Treatment Protocols

Whether the change in treatment and/or the treatment protocolsshould have been submitted for ethical review to the EthicsCommittee.

PARENTAL CONSENT TO TREATMENTConsent to Change in Treatment

Whether there should have been consent sought from the parents tothe change in treatment

Informed Consent to TreatmentNeonatal TreatmentsInformation to ParentsInformed Consent in an Intensive Care Neonatal Unit

TRAINING AND PARENTAL CONSENTWhether parental consent should have been obtained for staff beingtrained in the chest physiotherapy technique on their babies.

PARENTAL CONSENT TO RESEARCHWhether the research should have been submitted to the EthicsCommittee prior to:• It being undertaken; and• It being published

Whether parental consent should have been obtained to:• The research undertaken by Health Professional 5 in respect of

the 13 babies who developed a brain lesion; and• The 26 babies, being the control group.

PATIENT ADVOCACY SERVICEThe Role of the Patient Advocacy Service in liaising with consumerand clinician

PEER REVIEWThe Need for Effective and Regular Peer Review

ETHICS OF NZ SOCIETY OF PHYSIOTHERAPISTS INC.The Relevance of any ethical rules of the Society

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TREATMENT PROTOCOLS

The History of Treatment Protocols

The case for “treatment protocols” was squarely confronted and addressed in the 1988Report of the Cervical Cancer Inquiry (“the Cartwright Report”). It is pertinent thereforeto consider the findings and recommendations of the Cartwright Report, to which manywitnesses referred, in addressing the issues and the evidence in this Inquiry.

A treatment protocol, as defined in the Cartwright Report:494

“…will reflect generally accepted standards of management or treatment in ahospital at a particular time, given the knowledge of the condition and availableskills and resources for treating that condition in that hospital. In order todevelop a treatment protocol, senior staff must be prepared to debate and reachconsensus which will be generally acceptable to them all.”

Judge Cartwright recommended that treatment protocols (for gynaecological disease)should be developed and maintained to provide the basis for communicating informationto various health professionals and for verbal communication with patients.

She further recommended that, “significant shifts in treatment or management ofgynaecological malignancy should receive both ethical and scientific assessment andapproval”…

and “in-hospital audit procedures should be encouraged and external audit of clinicalstandards seriously considered. Quality assurance programmes involving the patientshould be developed.”495

In her report, Judge Cartwright warned that the development of a treatment protocolmust not take the place of formal peer review. She also warned that a protocol shouldbe regularly reviewed and that a timetable for reviewing those protocols at regularintervals is agreed upon.496

While many of the recommendations in the Cartwright Report applied specifically toNWH, a number of the recommendations, such as the establishment of EthicsCommittees and Patient Advocacy were extended nationally and led to extensivereforms within the Health Sector. Those reforms that New Zealand undertook “made it aworld leader in patient’s rights.”497

In the period following the release of the Cartwright Report, the then Auckland AreaHealth Board established a Cartwright Taskforce in 1989, which was to investigateways of, and ensure the implementation of the recommendation of the CartwrightReport. The Taskforce made its final report in October 1991.498

In 1989 the Auckland Area Health Board established an evaluation team toindependently assess the progress the Board had made towards implementing therecommendations of the Cartwright Report. This team made its final report in October

494 Cartwright Report p.152495 Cartwright Report p.213496 Cartwright Report p.153497 B5 Expert 2498 Implementation of recommendations affecting the Area Health Board from the report of the Cervical Cancer Inquiry1988; B6 p. 54 Expert 2

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1991, noting that the Auckland Area Health Board had made a determined effort toimplement the recommendations of the Cartwright Report and noted the need for“attitudinal changes” still being required by some medical staff.499

In addition, the Hospital Medical Committee at NWH set up a number of working partiesin September 1988 to consider issues arising from the Report, including those whichwere relevant to the neonatal paediatric service.

As a result a special working party chaired by Health Professional 3 was established tostudy the implications of the Cervical Cancer Inquiry on Neonatal Paediatrics. Inparticular, certain terms of reference of the Cartwright Inquiry were deemed to berelevant to this working party. They included:

(a) the approval of research and/or treatment and its surveillance(b) the protection of patient’s rights during research and/or treatment(c) the information on treatment and options for patients(d) the relationship between the clinical and academic units at NWH500

All the working parties reported to an extraordinary meeting of the NWH MedicalCommittee in November 1988, and the meeting resolved that the reports should bereferred to the Auckland Area Health Board and also to the Director General of Healthand the Minister of Health.

The Auckland Area Health Board and Treatment Protocols

A Working Party on treatment protocols was established by the Auckland Area HealthBoard which reported in August 1992. It was observed that the Working Party did notconsider the issues raised significant shifts in treatment and believed the process itrecommended obviated the need for review by an Ethics Committee. It raised doubtthat the Ethics Committee would have sufficient resources to scrutinise the largenumber of treatment guidelines each year that would be developed by the AucklandArea Health Board.501

As treatment protocols were the subject of National Standards, it is appropriate for us toconcentrate on the issues raised by this Inquiry in relation to the application of theNational Standards for Ethical Committees, which were established to review researchand ethical aspects of healthcare.

Treatment Protocols at a National Level

It is important to address the confusion Judge Cartwright referred to between researchor treatment procedures.

Judge Cartwright said, “In my view there should be no artificial classification in ethicsbetween research or treatment procedures. Attention must be focussed on the outcomefor patients and on their protections. Ethical standards must be applied rigorously toresearch and treatment protocols on behalf of patients.” 502

499 B6 p. 57 Expert 2500 B7 p.s 58 and 60 Expert 2501 B8 p. 74 Expert 2502 Cartwright Report p.152

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In the Cartwright Inquiry, the confusion in the minds of some of the witnesses to theInquiry about the distinction between research and treatment arose because of thenature of the proposal to withhold treatment to patients. In this Inquiry, although wereceived evidence from Parent 3a503 referring to the belief that, “our babies were usedfor training and research without our consent” it is clear that nCPT was beingadministered to those babies only who had received a referral for physiotherapy.

The compilation of the data for the published article occurred during 1994, with theresulting conclusions being reached in December 1994. Unlike the Cartwright Inquiry,there is not the same confusion between research or treatment procedures. Nor is thisa case where treatment was given or withheld for research purposes. The witnessesbefore the Inquiry have been clear that there is a requirement to refer researchproposals to Ethics Committees, but this is viewed quite distinctly from the need to refertreatment procedures. Unless the treatment procedure was “new, unorthodox oruntried”, treatment protocols or changes in treatment are not being referred to EthicsCommittees.

It is evident therefore that the referral of treatment protocols is not viewed as beingnecessary or required, and nor is it being undertaken in practice. There are thereforetwo issues arising:

(a) are treatment protocols required to be sent to Ethics Committees?(b) did the change in treatment in 1993 require to be approved or reviewed by Ethics

Committees.

Are Treatment Protocols Required to be Sent to Ethics Committees?

Following the Cartwright Inquiry, a standard for Ethical Committees was promulgated.This was the 1988 Standard for Ethical Committees Established to Review Researchand Treatment Protocols. It had four requirements in respect of treatment protocols.They were:

(1) Proposed significant shifts in treatment or management from establishedtreatment protocols shall be submitted for approval.

(2) Treatment protocols shall be submitted for ethical review prior to their formaladoption.

(3) If a responsible member of the public or a health professional has cause todebate the value of the application of a novel procedure in a particular instance,the planned use of that procedure shall be submitted for ethical consideration.

(4) Applications for review of treatment protocols need not be on a standard form,but will include specific details which will be set down by the Board eg: theprocess used to arrive at the protocol, the scientific base of the protocol, patientinformation material prepared for use with the protocol.504

In 1988 it was clearly envisaged from the wording of the 1988 Standard for EthicalCommittees that treatment protocols should have been submitted for ethical reviewprior to their adoption.505 However in the period between 1988 and 1991, hospitals didnot send treatment protocols to Ethics Committees for approval. The reasons for thishas been described as follows:506

503 B12 p68 Parent 3a ACC 00401 “our children were used for teaching and research purposes”504 Refer 1988 Standard for Ethical Committees p. s5.1.2; 5.1.3; 5.1.4; 5.2.2505 T 762 Expert 5506 T 761 Expert 5

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“There was a lot of debate about what treatment protocols might be. There waswidespread wringing of hands about dismantling the healthcare ship while it wasafloat on the ocean, and submitting every standard practice to ethical approvaland the widespread concerns that a literal interpretation of the rather hastilydrawn up 1988 Standard would bring healthcare in New Zealand to a grindinghalt, led us to try and re-formulate the requirement in the 1991 Standard in a waythat would then be practicable. Having said that, I must add that since 1991 thisrequirement has been more honoured in the breach than the observance.”

In 1991, a new Standard for Ethics Committees was established, “To review researchand ethical aspects of healthcare.” It is clear on a perusal of the paragraphs and acomparison with the 1988 Standard, that the requirement to submit treatment protocolsfor ethical review prior to their formal adoption was omitted. The emphasis in the 1991Standard was on new, untried or unorthodox treatments.

The shift in emphasis between the 1988 Standard and the 1991 Standard is marked.The Standard does not deal with treatment protocols in the same way as the earlierStandard, but suggests the following matters should be referred to Ethics Committees,and in particular:

4.1.2 New untried or unorthodox treatments or procedures shall besubmitted to the Ethics Committee for ethical review prior to their adoption.

4.1.3 If a member of the public or a health professional has cause to debatethe application of a new, untried or unorthodox procedure/s in a particularinstance, the planned use of that procedure shall be submitted for ethicalconsideration.

4.3.2 Applications for review of new untried or unorthodox treatmentinitiatives need not be on a standard form but will include specific details whichwill be set down by the Board, eg: the process used to derive the protocol, thescientific basis for the protocol, patient information material prepared for use withthe protocol etc. (1991 Standard)

Following the introduction of the 1991 Standard, medical witnesses507 were clear thattreatment protocols were not required to be sent to Ethical Committees for approval,either by the requirements in the 1991 Standard or by the practice of the medicalprofession since 1988.

Did the change in treatment in 1993 require to be approved or reviewed byEthics

Committees?

From the evidence presented to the Inquiry, it is clear that the neonatal unit undertookthe recommendations of the Cartwright Report seriously. Treatment protocols weredeveloped for nurses and physiotherapists, together with guidelines from 1989,508 andthey were reviewed regularly.509 It was during the relevant period namely April 1993 toDecember 1994 that the treatment protocols were being revised and finalised. Thisreview was being undertaken to accommodate the changes to include nurses

507 Expert 5, Expert 3 and Health Professional 3508 There were guidelines in place from as early as 1984, refer NWH Nurses and Physiotherapy Protocols andGuidelines, numbers 156-171 Vol. 1509 T 478 l27 Health Professional 9 and refer ibid

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undertaking the treatment of nCPT, but it was also part of the practice of NICU at NWH,in reviewing their treatment protocols on a regular basis. 510

Should the treatment protocol for chest physiotherapy in NICU, given its changesnamely in frequency and personnel undertaking the physiotherapy, have been referredto the Ethics Committee for review?

To answer this requires a close examination of clause 4.1.2 of the 1991 Standard. Thecritical issue therefore is whether the treatment was new, untried or unorthodox.

During the evidence the two sides of the debate emerged. For the parents, evidencewas adduced that the changes in the delivery of physiotherapy treatment at NWHrepresented a change from the practice in the past. Firstly, for the first time nurseswere to be trained to carry out physiotherapy which was formerly solely the preserve ofqualified physiotherapists. Secondly, the frequency of treatment was to be available 24hours a day, not just during working hours.511

Reference was made to the Ministry of Health treatment protocols guidance512 where itstates: “the organised use of procedures, treatment methods or treatment protocols,which are new or novel, or untried or unorthodox in the context planned for their use.” Itwas then argued that the chest physiotherapy treatment methods and protocols plannedat NWH were new and untried “in the context planned for their use”, because it was thefirst time this procedure was being carried out in this way at NWH. Expert 2 gavefurther evidence that the protocol did not simply formalise what had already beenoccurring, but gave instructions to cover a situation that was new. The evidence wasthat the change in protocol involved planning and preparation. There were expressionsof concern by the staff and these expressions of concern, it was argued, provided acompelling reason why the protocol should have been referred for ethical review.

The Inquiry was urged that taken together, the requirements of the Cartwright Reportand the two National Ethical Committee Standards namely 1988 and 1991 meant that itwas necessary or at the very least prudent, to seek ethical review.513

The contrary view was that the change in protocol did not need to be referred to anEthics Committee as the change in the nCPT protocol was not new, not untried and notunorthodox.514 Health Professional 3 told the Inquiry:

“The change in nCPT treatment was not large; one extra treatment a day wasbeing made available compared to that done in 1987 to 1989. We were notoffering a new treatment. We had been using this treatment safely for 7 years.We did not change the technique of nCPT. We were not offering the treatmentmore frequently than we knew to be the norm in other units … the intensity oftreatment remains the same.” 515

To support this view, Health Professional 3 explained that in 1993 the Neonatologists atNWH who had been trained in Canada, Australia, United States and United Kingdom,had all worked in units where nurses carried out nCPT and they believed it wasstandard for nurses to carry out nCPT on new born infants. He/she further explained

510 T479 1-6 (Health Professional 9 describes 2 year policy review)511 B10 p. 86 Expert 2512 Durham, 1989, p16513 B10 p.s 84 and 90 Expert 2514 B44 p. 191 Health Professional 3515 B45 p. 191 Health Professional 3

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that before starting to train nurses, the staff on the unit documented that nurses didnCPT in at least three of the New Zealand Units and nurses in all 14 Australian NICU’scarried out nCPT. Health Professional 3 relies on the visits made by Health Professional6, who had visited numerous Units overseas (England, Scotland, USA and Australia),and described the respiratory physiotherapy being done by nurses out of ordinaryworking hours, or in some cases, by nurses completely.

Health Professional 3 then says: “We knew that our training was to be better and morethorough than any of the other three New Zealand Units that had replied to us.”516

Of the practice in referring proposals to the Ethics Committee, Health Professional 3was of the view that no other clinical unit in Auckland would have referred a similarchange in a treatment protocol to an Ethics Committee in 1993, and of the 191 newproposals, 3 were for clinical purposes and 188 were for distinct audit researchprojects. The 3 for clinical proposals involved ethical concerns and one of safety.517

Expert 5, as a member of the working party who drew up the 1991 National Standardsfor Ethics Committees, and the subsequent 1994 revision, gave evidence that thechange in physiotherapy at NWH in 1993 would not be regarded as significant enough,before the event, to warrant referral to an Ethics Committee as a new protocol orinnovative treatment.518

The issue in relation to relevant New Zealand ethical guidelines in terms of reference2(e) is whether the change in treatment and/or the treatment protocols should havebeen submitted for ethical review to the Ethics Committee, and that turns on whether ornot those changes amounted to “new, untried or unorthodox treatment or procedures”.The evidence discloses clearly that the treatment was not new, not untried and notunorthodox. The procedure, such as it was believed to be carried out in 1993, wasbeing carried out in other Units both in New Zealand and overseas. At the time ofintroducing the changes to the treatment, NWH staff believed it was carrying it out in thesame manner as other Units.519

The change in treatment was the training of the nurses and the implementation for themto undertake nCPT. Was this new, untried or unorthodox? Given that nurses wereundertaking neonatal physiotherapy both overseas and in New Zealand, the indicationsto NWH staff who had undertaken a review of practice both in New Zealand andoverseas, was that it was not new, untried or unorthodox.520

ConclusionThe Inquiry has given careful consideration to the evidence and submissions andconclude that it would have been outside standard practice to seek ethical review at the

516 B45 p. 192 Health Professional 3517 Two of the clinical proposals submitted because of ethical concerns, not clinical ones involved 1 being guidelineson resuscitation on how to decide to whom resuscitation would be offered, and the other was on the use of donoroocytes in the IVF Programme. The 3rd clinical proposal was from the Blood Transfusion Service seeking approval touse an unregistered blood product because of the unavailability of the registered alternative. This decision wouldhave involved questions of safety; B45 p. 195 Health Professional 3518 Compare Expert 1, who is of the opinion that the change in personnel undertaking the treatment alone should havenecessitated a referral to the Ethics Committee. It should be noted that this witness had not seen the December 1991Standard for Ethics Committees, nor considered the issue in light of p. 4.1.2. These views were based on the expert’sknowledge of the philosophy of medical ethics.519 For the purposes of this term of reference, questions as to whether the treatment was being reviewed or hadindependent scrutiny is discussed in Chapter 9, under assessment of the safety and efficacy of the treatment.520 This does not take into account the provisions of the Physiotherapy Act, which is discussed in Chapter 7 undersection “Ethics of the NZ Society of Physiotherapists” and which has not fallen specifically under the terms ofreference of this Inquiry to deal with in relation to prosecution for such offences or otherwise.

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time of implementing the change in treatment. The implementation of the changes didnot require ethical review or approval, on the wording of the 1991 National Standard,which was applicable in 1993, as the change in treatment was not “new, untried orunorthodox”.

Reference was made to the changing practice of tasks, formerly the province ofdoctors, becoming the province of nurse practitioners.521 The change in personnelfrom other disciplines to undertake a procedure or treatment is not a matter whichwould normally be referred to the Ethics Committee. In light of the evidence and thepractice throughout the medical profession, it appears to the Inquiry that the steps takenby NWH were consistent with the 1991 Ethical Standard.

However, for any future changes of treatment where personnel from other disciplinesare to undertake a treatment, it would seem prudent that such a review or approval wassought from an Ethics Committee or appropriate professional bodies prior to itsintroduction, to ensure the planning, preparation and training was appropriate and otherethical issues were addressed.

In this Inquiry, the industrial bodies, the PSA and New Zealand Nurses Organisationwere involved prior to the change in personnel undertaking the treatment, namely, fromphysiotherapists to nurses. However, to ensure that the relevant disciplines orprofessional organisations are fully involved, appropriate bodies such as New ZealandNursing Council, the Physiotherapy Registration Board and other relevant bodies,which oversee the regulation of their respective professions should be notified andconsulted.

International Ethical Guidelines for Effecting Changes to Treatment Protocols

In the absence of receiving any evidence in relation to the international ethical guidelines(if any) for effecting changes to treatment protocols, the Inquiry did ask Expert 4’s viewson implementing changes to treatments in his/her Unit at Overseas Hospital 1. Expert 4informed the Inquiry that that Unit did not implement changes to enable positioning andpercussion, as practised at Overseas Hospital 2 or at NWH, because: 522

“… there is no good logical reason why cupping was not adapted [adopted] … inour Unit, except that our physiotherapist has always been extremely cautiousand anxious about introducing a treatment and I guess meets a lot of resistancefrom the clinicians about introducing a new treatment where that requires adifferent level of activity with the baby.”

When asked whether clinicians have a say in the introduction of new treatments, Expert4 informed the Inquiry:

“In general I work in a Unit that is very conservative and reluctant to take on newthings unless there is good evidence. I think physiotherapy is one area wherethere is a lot of variation and practice variation often gives you the underlyingfactor [if the evidence is not strong one way or another]. So many areas inclinical care have a large variation in practice which is difficult to explain …”523

If a new treatment was to be introduced to the Unit, Expert 4 told the Inquiry there wouldbe a rigorous procedure to demonstrate its benefits. The distinction Expert 4 drew 521 T 746 L.28-29 Expert 11.522 T649 l.27-30; T650 l.1-13523 T650 l.1-10

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between the introduction of a new treatment and a change to an existing treatment, aswas the case at NWH, meant a difference in approach. He/she explained as follows:

“In 1993 we would have asked [him/her] to do a presentation to the whole groupbeing the nurses, the doctors and the other physiotherapists, so if you like thenursery staff, about why [he/she] wanted to change. We would be looking at theevidence behind it, we would be looking at what other people were doing aroundAustralia and in fact we have just one survey at that time, the Lewis Paper listedin the notes, so we already had a good idea of what people were doing aroundAustralia and then if the benefits outweighed the harms including costs, then wewould have considered introducing it. If there was no clear answer to benefitsand harms we may have examined the possibility of introducing it as a researchprotocol or a randomised trial. ….If it was going to be introduced then thattherapy would be monitored. We may include it in our database –physiotherapist has a database of numbers of treatments which [he/she] canlink to our database – so we would want outcomes to be followed if treatment waschanging. Cupping would be new to us unlike Auckland where it was an existingtreatment. I am not sure there is an analogy there. I think the setting is verydifferent, the purpose in Auckland was to make sure during the night period wascovered and for fiscal reasons the way that could be done would be to train thenurses which seemed a normal practice in other parts of the world.”

Apart from the evidence from Expert 4, on the evidence before the Inquiry, thereappeared to be no international or New Zealand guidelines for effecting changes totreatment protocols.

PARENTAL CONSENT TO TREATMENT

Should there have been consent sought from the parents to the change intreatment

It is evident, for the reasons outlined in the preceding section, that NWH did not considerthe change in the way in which the treatment (nCPT) was performed was “new, untriedor unorthodox”. In the same way that the change in treatment was not submitted forethical review to the Ethics Committee, NWH did not seek the consent of the parents tohave the treatment undertaken.

In addressing this term of reference, it should be noted that the term of reference isdirected to “the ethical guidelines for effecting changes to treatment protocols”. Thequestion of parental consent for the treatment itself must also be considered, althoughnot specifically raised in this term of reference. There was considerable evidence onthe point, and the issue arises in the context of this Inquiry particularly as to whetherparental consent should be sought for such treatment and for any change in thetreatment proposed.524

Informed Consent to Treatment

The starting point for an analysis of informed consent must be the Cartwright Inquiry. Inher recommendations. Judge Cartwright found that patients in the context of her Inquiry

524 Term of reference 2(d)(iv) should also be considered.

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had not always been properly informed of the treatment and options available tothem.525 Accordingly she recommended that:

“…there must be greatly improved communication with all patients andimproved information available and in particular that prior written consent mustbe sought from patients:

(a) for all procedures conducted under anaesthetic, be they for the benefit ofthat patient and/or for teaching purposes… and;

(b) for significant departures from generally accepted treatment…”526

In her reasons, written consent for any treatment or procedure, be it surgical, diagnosticor teaching, which takes place under anaesthetic must have the prior written consent ofthe woman concerned and the consent forms should have sufficient information anddetail to provide the patient with a written summary of possible risks, and from itscontent, describe what the patient has been told and to what she has consented.527

The situations in which verbal consent can be obtained was also examined. HerHonour notes:

“There are a multitude of minor treatment options, procedures and diagnostictests which are conducted as an ordinary part of routine patient care. It would beunnecessary to demand that each of these have the patient’s written consent.Not only would the patients become irritable, but the work of the hospital wouldgrind to a halt.”

The fact that a patient is conscious, and the patient knows in general terms the natureof her condition and the treatment procedure or diagnostic tests which she is likely to beoffered then on most occasions the nurse or doctor conducting the procedure couldensure why a particular examination or treatment is necessary and obtain her verbalconsent.528

In May 1991, the Department of Health, following the report of a Working Party oninformed consent, issued a standard entitled “Principles and Guidelines for InformedChoice and Consent: For All Health Care Providers and Planners”. The standardestablished a number of principles for informed consent and they included Principle 1,Autonomy which in turn includes effective communication, adequate information, theright to refuse proposed treatments and/or procedures and advocacy. The secondPrinciple is Responsibility and Principle 3 is Accountability which involves impliedconsent, general consent, spoken consent, written consent and documentation of theinformed choice process.

Our attention was drawn to paragraph 1.7.3 of the standard which says:

“These guidelines recognise that parents and guardians are the naturaladvocates of their children and have considerable powers of consent on theirbehalf.”529

525 1988 Cartwright Report, page 215, 6(a).526 Ibid, p.graph 6(b)527 Ibid, page 157528 Ibid, page 158 Since the Cartwright Report, a number of standards and guidelines have emerged. At the time ofthis Inquiry, the Code of Health and Disability Services Consumers Rights had been promulgated and the Health andDisability Sector Standards were being issued in draft. As they have been issued some years after the relevantperiod of the inquiry, they fall outside the ambit of this Inquiry.529 Page 13, Principles and guidelines for informed choice and consent, May 1991 (refer Appendix C.B. Expert 2)

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The standard requires effective communication before any proposed treatment,procedure, examination, teaching or research commences. In relation to impliedconsent, the guidelines state it should not be assumed that implied consent is informedchoice and consent.

Neonatal Treatments

In assessing the need to seek parental consent for the change in treatment at NWH, it isnecessary to assess whether consent is required for the various aspects of care withinthe neonatal unit at NWH and whether consent to nCPT was required. It flows from thisexamination as to whether it was necessary to obtain parental consent to any change inthe treatment.

The different aspects of care which are provided to babies in the neonatal unit weredescribed in detail during the Inquiry and are the subject of examination in chapter 3 ofthis report.530 Thus ventilation of a baby, intubation, fastening of the tube, airway careincluding suctioning, good humidification, blood gas monitoring, oxygen monitoring,periodic ET tube changes, chest x-rays and scans were described as all beingcomponents of care within an intensive care unit, for which separate consent was notsought or given. It was described to us that nCPT was “an integral part of ventilatorycare of babies on the neonatal unit at NWH, and had been since the mid-1980s.” Justas consent was not sought for the different aspects of the care in the neonatal unit,consent was not sought for nCPT.531

A distinction was drawn between consent and information. The Inquiry was told thatnCPT, along with all other treatments, was explained to parents at NWH and that it waspart of the overall care of babies on ventilators.532

Health Professional 3 explained further:

“the neonatal unit at NWH prides itself in involving parents in the care of theirbabies. However, both then and now, it would be quite unrealistic to requirehealth providers to obtain specific consent for every change in treatmentprotocol, especially where there are no known serious risks and the changeswere to bring local practice into line with established treatment methods. Toexpect otherwise would bring the health system to a grinding halt.”

This approach was strongly criticised on the basis that entry into NICU at NWH “wasseen as de facto consent to everything that was to occur including chest physiotherapy,scans, x-rays and so on.”533

The Inquiry heard from Expert 3, who told the Inquiry that “in most neonatal units inAustralasia, but not all, parents are asked to give consent for neonatal intensive carefollowing the birth of their infant.”534 Expert 3 acknowledged there are potential problemswith “blanket consent”, although the neonatal unit at Hospital 4 does obtain suchconsent from the parents at the admission of their babies to the neonatal unit. Incomparison, the Auckland Area Health Board Informed Consent Guidelines require that

530 See also B41, p. 174 Health Professional 3; Expert 3, Health Professional 5531 B41, p. 174 Health Professional 3532 Ibid, p. 175533 B13 p. 110 Expert 2534 B3 p. 7 Expert 3

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informed consent must be obtained for each treatment or procedure proposed and thatthere is no support for the idea of general consent which would permit anything to bedone without further discussion or approval.535 Expert 3 further highlighted the “potentialproblems with this issue because parents are presumably not free to withhold consentfor standard treatment where the outcome is expected to be very good”.536

Consent for some procedures are obtained. These include the trial of selenium, bloodtransfusions and nitric oxide use.537 The need to obtain consent is assessed either onthe degree of risk of the treatment proposed538 or for research purposes.539 It isstandard practice for specific consent to be obtained for blood transfusions in babies.540

Consent is also obtained for research projects, such as the trial of selenium, which wasa research project as well as a treatment. It was clear that consent was not sought fortreatment options, which the staff considered to be routine, in the care of prematureinfants.

However, nCPT was not considered by the staff at NWH to be a treatment, for whichparental consent should be obtained. Consent from parents was not obtained toadminister nCPT, either before or after the change in treatment took place at NWH. AsnCPT was considered to be an integral part of ventilatory care of babies since the mid-1980s at NWH, it was an aspect of the overall care of the baby in the neonatal unit, forwhich specific consent was never sought.541 It is clear to the members of the Inquiry,that because consent was never sought to nCPT before the change in treatment wasproposed, it was not seen as necessary to obtain any consent to the change intreatment. It was not perceived that NWH were offering a new treatment, it was notoffered more frequently than was perceived to be the norm in other units and was acontinuation of “a long established practise”.542 As one of the nurse witnesses told theInquiry, consent to this treatment was “not something that any of us identified as anissue”.543

Information to Parents

Rather than consent being obtained, the Inquiry was told that nCPT, along with all othertreatments, was explained to the parents. “It was explained that it was part of ouroverall care of babies on ventilators. It was indicated to help clear secretions when theywere a problem, when there was lung collapse or for extubation.”544 In addition thetechnique was demonstrated to the parents, by the use of cupping on the parentsforearm. This was accompanied by an explanation that the pressure actuallytransmitted to the baby was much less than seemed to be the case from observing thetreatment, “as the mask was very soft cushioning much of the impact.”545

The parents’ reaction to seeing nCPT performed was one of distress,546

concern,547 and upsetting,548 and when questioned by the parents, the respective

535 Expert 2 B107, Appendix B Auckland Area Health Board Informed Consent Guidelines, July 1990, p. 3.536 B3 p. 7 Expert 3537 T610, L.1-14 and B8 p.20 B. Expert 3538 B180, p43, Health Professional 3539 T.611 L.27-30; B20, P.171, 172, Expert 2540 T743 Expert 11541 B41-42, p. 174, Health Professional 3542 B42, p. 177, Health Professional 3543 B11, Health Professional 12544 B42, p. 175, Health Professional 3545 Ibid546 B6, Parent 7b

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nurses or physiotherapists would demonstrate the technique on the parents’ arms withthe explanation as set out above.

When their babies were admitted to NICU, the parents were handed an informationbooklet.549 The booklet entitled Newborn Nursing Services Parent Information,describes the newborn units at NWH with descriptions of the staff at the unit, tips to newparents on newborn babies and how to assist them, a description of the support groupsand professional teams available at the hospital and a section on the physiotherapist.Included in the description of a physiotherapist is the reference to chest physiotherapy.It provides:

”Respiratory – if your baby is on a ventilator she/he may need some respiratoryphysiotherapy to help bring up mucus from the lungs. A small face mask isused to loosen the mucus (this is called percussion). This looks vigorous butgenerally most babies enjoy it.”

As has been submitted to the Inquiry550 the booklet does not discuss parents rights oraddress the issue of parental consent or informed consent. Health Professional 3 toldthe Inquiry that the Unit has been developing parent information since 1993 andalthough:

“It is better now than it was in 1993, it’s not perfect yet. This is a difficult area.And around that time we were developing a booklet for parents of prematurebabies. We were also writing a 1994, pamphlets on specific conditions, and theparent information written material was being steadily developed.” 551

The timing of parents receiving a booklet on the admission of their baby to NICU, at atime of great stress, raises questions about the ability of parents to absorb theinformation or understand its significance.

Unless the parents had read this booklet, or had raised their concerns with staffundertaking nCPT on their babies, the parents were not informed prior to theadministration of the treatment. It was submitted to the Inquiry that if questions areraised by a parent, this places even more obligation on the health professional toanswer those questions fully and ensure that he or she is carrying out a procedure withconsent. The demonstration of the technique on the parents arm was more aimed atmollifying the parent rather than ensuring the parent could make an informeddecision.552

Informed Consent in an intensive care neonatal unit

For NWH, it was submitted that the practise in neonatal units in New Zealand, Australiaand the United Kingdom all reveal that parental consent is not sought for chestphysiotherapy treatment.

547 B6 Parent 7a548 B7 Parent 4b549 NWH Newborn Nursing Services Parent Information – undated but exhibit copy has March 1994 written on thecover. This was written by the staff within Newborn Unit with multidisciplinary input, T.487 L17-27550 B16-17, Expert 2551 T268 l.17-22 Health Professional 3552 B14, p. 116, Expert 2

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nCPT was not considered to be a treatment requiring parental consent. There does notappear to be any requirement that individuals need to consent to a change in atreatment protocol that is intended to be for all patients. Thus, obtaining parentalconsent to a change in treatment was not necessary.

However, the issue of obtaining parental consent to procedures within an intensive careunit for their children is an issue which should be addressed. It is clear that the parentswere given no choice as to whether this treatment could be continued on their children,once they had seen it performed. There was an expectation that they would understandthe beneficial effects which such a treatment was expected to produce and this wasaccompanied by a demonstration of the technique, when any question about thetreatment was raised.

As was evident from a parent who questioned the treatment, there was no question thatthe treatment would not continue. Parent 3a did not recall receiving “any information inadvance,” or “any written information highlighting the staff involved553” and did not recallreceiving the information booklet on the babies’ admission to NICU occurred. Further,the information which the parents were given with respect to the nCPT being carried outon their babies was not adequately described in the information booklet which theyreceived on admission of their child to NICU. The additional explanations by staffaddressed the immediate concerns of the parents, provided that the parents werepresent and were able to ask relevant questions of the staff.

Where a sick neonatal infant is admitted into the intensive care unit, some proceduresare urgent and are required to be undertaken without delay. The very sick or very pre-term babies are in the unit for a prolonged period and parents are not always presentwhen the procedures have to be done. This raises questions about the timing ofconsents and the procedures which should normally require consent. Otherprocedures which are more routine, such as head ultrasound and physiotherapy, havebeen undertaken without the requirement to obtain consent. Where the patient cannotconsent and the parents are not always available, and the setting is in intensive careunit of the hospital, the issues of informed consent on behalf of infants is vexed. Apossible solution to improve the current difficulties in obtaining consent for treatmentwas given by Expert 2 which deserves addressing.

Two suggestions were made to improve the current difficulties in obtaining consent fortreatment.554 Firstly the NICU should set up a working party which would include someof the parents of children who were seen in NICU, and work through the ways in whichconsent issues could be handled so that parents feel that they are making decisionsand the efficiency of the unit is not impeded.

Secondly attention to careful introduction of the parents to the unit along with writteninformation about particular procedures would lessen the time taken to deal with eachissues.

We commend the suggestion which was made by Expert 2 to establish a working party,involving parents who have had experience within the unit and clinical staff from the Unit,to address the vexed issue of consent in an intensive care neonatal unit. Informedconsent is imperative in modern medicine, but it must also be practical. It is asafeguard, both for parents who are wishing to act in the best interests of their children

553 T186 l.24-27 Parent 3a554 T716 Expert 2

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as well as the medical staff, who have a duty to act in the best interests of their patients,but obtain consent appropriately in doing so.

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Conclusion

Parental Consent

(a) For treatment or the change in treatment:Parental consent was not obtained for either the treatment of nCPT or for the change intreatment. The consent for a change in treatment was not required, but the issue ofconsent to treatments given or undertaken needs to be addressed. Apart fromtreatments which contain a degree of risk or treatments being used for researchpurposes, the present practice of NWH and other units in New Zealand is not to seekconsent for treatment. The issue of informed consent from parents on behalf of theirbabies, particularly in a neonatal intensive care unit needs to be properly addressed forthe future. The various treatments and procedures undertaken in a neonatal intensivecare unit, given the exigency of the situation and the developing technology requires theissue of consent to be properly addressed.

(b) For staff trainingInformation surrounding the techniques and procedures being used is necessary andimportant. Adequate information is therefore necessary to enable parents to understandthe treatments or procedures being carried out on their infants and provide a suitablebasis to give informed consent when required.

TRAINING AND PARENTAL CONSENT

In June 1993, when the first of the nurses was trained in the technique of P&P, thepractical demonstration of the technique required a cot-side training session with HealthProfessional 6.555 These cot-side sessions were conducted on babies in the neonatalunit. The consent of the parents of the babies was not sought, and the purpose of thecot-side session was essentially a teaching or training one, to ensure that the nursewas carrying out the technique appropriately. This was done of course under thesupervision of Health Professional 6. On the evidence before the Inquiry, the nurseswere not qualified to practice unsupervised until their course was completed.

The Inquiry was referred to a number of guidelines for informed consent. The 1991Principles and Guidelines for Informed Choice and Consent by the Department of Healthat para 1.2.4 provides:

“The health care provider should give the name and relevant status of theperson who will carry out the procedure. Information should also be given aboutthis person’s experience, and whether they are under supervision.”

Those guidelines note that further work needs to be done on research, teaching andobservers.556 The Auckland Area Health Board pamphlet “Your Rights” states that “allpatients are entitled to know the name, position and role of any staff treating them…”and to “give their prior consent to involvement in teaching sessions.”557

In the Auckland Area Health Board informed consent guidelines, it is noted thatconsumers are entitled to know “the name and status of the person who will carry outthe procedures and that patients have the right to consent to or decline involvement inteaching.” In the July 1991 Ethical Guidelines for the Involvement of Patients in Clinical 555 Refer chapter 6556 Appendix C, B Expert 2, page 11557 Appendix D, B Expert 2

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Teaching, also issued by the Auckland Area Health Board, consent for children under 16must be sought by an appropriate means from a parent or a guardian.

It was submitted to the Inquiry, that the introduction of chest physiotherapy was clearly ateaching situation and that the nurses in undertaking their training on the babies in theneonatal unit without parental consent, did not comply with the various guidelines thatwere in place at the time.

Health Professional 5 drew a distinction between teaching with the student not involvedin the clinical team, and teaching where the trainee is involved in the team and theprocedure is therapeutic. Health Professional 5 was of the view that consent needed tobe obtained when the student was not part of the clinical team, but otherwise noconsent was required.558 In respect of the training of nurses in the technique ofpercussion, Health Professional 5 gave evidence that consent was not required as thenurses were neonatal nurses working with the babies in the unit and were undertaking anew procedure under supervision.559 In Health Professional 5’s view, consent was notrequired. NWH is a training hospital and it was urged on the Inquiry that there willalways be staff in training, be they medical personnel, nurses or any member of a multi-disciplinary team. New qualified doctors and registrars require training in techniquesand procedures and these are carried out under supervision on patients within thehospital.

In canvassing the evidence in relation to consent for training purposes, the two opposingviews were expressed. On the basis of the Auckland Area Health Board pamphlet, theAuckland Area Health Board Consent Guidelines and by reference to the NationalGuidelines, the view on behalf of the parents was that all people entering NWH shouldbe made aware that firstly it was a teaching hospital, secondly that the status of staffshould be made clear to the patient and thirdly the patient has a right to know theexperience of the person treating him or her.560 In applying these factors to the relevantfacts of this Inquiry, none of these factors were met and nor was consent obtained forthe training being undertaken. Because the situation involved a supervisor overseeing aperson training on a baby, it was emphasised that special care needed to be taken toget consent as the trainee was clearly on a learning curve.561

The contrary view from NWH, is that, from time to time, a need to convey techniques ornew procedures to either new members of a team or existing members who need toincrease their skills, is done as part of normal procedure and is not subject to specialrequirements for written consent.562 Again, the distinction is drawn between the in-service training of staff members which is “usually part of the fairly free and informalcommunication between staff and patients that should be part of any well functioninghealth care context” and the situation where patients are subjected “to someprocedures solely for the purpose of such training in which case special consent andthe right to refuse to participate in such a training exercise are the accepted norm.”563

The concern was expressed by the medical witnesses in particular, that if consent wasrequired for every staff member in a hospital who was learning a new technique orprocedure, when they were part of the in-service team of a ward and part of the clinical

558 SB6 p.14 Health Professional 5, Appendix 1, SB “ethical guidelines for the involvement of parents in clinicalteaching and School of Medicine, The University of Auckland Teaching Programme, 5th

559 SB6 p.15 Health Professional 5560 T718 L.1-18561 T 718-719 Expert 2562 B 3, p. 12 Expert 5563 Ibid

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staff, the efficient functioning of hospitals would diminish. Further, the need to trainqualified staff in practical procedures would be seriously impaired.

It is clear that this issue is one that requires further scrutiny and attention by both clinicalstaff and consumers at a national level.

The particular facts of this Inquiry reveal parents openly questioning and expressingtheir concern about the techniques and purpose of the chest physiotherapy procedures,without any ability to refuse the continuation of the treatment. Many parents gaveevidence of observing the neonatal nurses (who were senior qualified nurses)undergoing training in the new technique on their babies, without their permission orconsent being obtained,564 particularly for the training of the nurses undertaking it. Itshould be noted here, that a number of the parents observed that the nurses appearedmore gentle in their handling of the babies.565

In hearing the evidence of physiotherapists from other New Zealand hospitals,a suggested model for how the consent process for training might work in practice wasgiven by a physiotherapist from another New Zealand Hospital. He/she told the Inquirythat new nurses were trained by [that expert] in the technique and in undertaking nCPTon infants, demonstrations of the technique were arranged for the parents and theirconsent was sought for the trainee nurses to undertake it.566 This consent processwas verbal and usually by the physiotherapist directing this request to them whilst theywere present. Clearly, such a course of action was not required of the physiotherapist,but was a matter of personal preference.

Ethical Approval of Research Proposal

Should the research have been referred to the Ethics Committee?

Following identification of the three children with brain lesions in February 1994, HealthProfessional 5 conducted three studies in NICU in an attempt to identify the cause of theunexpected lesions in the three babies during the period 1993 to early 1994.567 Theresults of the case control studies were presented at the Annual Meeting of the PerinatalSociety of New Zealand in December 1994 and were submitted for publication with thearticle finally being published in the Journal of Paediatrics in 1998.568 Prior to itspublication in 1998, the article had been submitted to a number of respected medicaljournals but was rejected.

During the course of this Inquiry strong criticism was made of the fact that the researchwas never presented for ethical review by Health Professional 5. To assess the validityof this criticism, it is necessary to examine the applicable Standard for EthicsCommittees and the relevant standard in force at the time.

Relevant Standards For Ethics Committees

564 B3 p26 Parent 9a reference re training and consent B2 p6 Parent 1b, B2 p12 Parent 2b, B1 p3 Parent 8a, B2 p11 Parent 4a, B1 p6 Parent 4b, B2 p7 Parent 7b, B1 p 7Parent 5a, B2 p13 Parent 9a, ACC 00237/00241 – references to not giving consent to treatment. No direct referencesfor nurses training565 T42 l8-9 “the physiotherapists appeared to be more confident in performing the treatment”. T100 l9-10physiotherapists more confident; T88 l24-26 Parent 9a “on the whole, the nurses appeared to be very vigorous, veryrushed…” T82 l25-27/83 l1-7 Parent 8b talked about nurses rough handling.566 T734, Expert 9567 Refer Chapter 3: “The Problem - What Happened”568 (Journal of Paediatrics 1998; 132:440-4)

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The relevant Standards for Ethics Committees, during 1993–1994 were the 1991 andthe 1994 Standards. It should be noted that Ethics Committees were established toreview research and ethical aspects of health care.

Paragraph 4.1 of the 1991 Standard provides:

“Proposals which shall be referred to the Ethics Committee for ethical approvalinclude:

4.1.1 All proposed health research investigations (whether of Biomedical orHealth Systems origin) must be submitted for approval where theinvestigation:

…

ii) involves access to confidential health records for purposes otherthan direct patient care or internal clinical audit.”

Clause 4.2 further provides that:

“No research proposal may proceed before:

4.2.1 It is approved by an Ethics Committee;4.2.2 The applicant is advised in writing by a properly authorised person that

the proposal may proceed.

It should also be noted that health professional licensing bodies require thatpractitioners submit research protocols for ethical review.”

The 1994 Standard included:

“Any access to health information should be in accordance with the provisions ofthe Privacy Act 1993, (and any applicable Code of Practice issued under theAct”).

There are certain “matters not requiring ethics committee appraisal” and these arecontained in Appendix II of the 1991 Standard. One of those matters note requiringEthics Committee approval is internal clinical audit. Internal clinical audit is defined asbeing:

“where the audit is undertaken by or under the supervision of senior members ofthe health care team directly responsible for the care of that group of health anddisability support service consumers, and where there is no access toconfidential medical information by persons who do not owe a professional dutyof confidentiality to those consumers.”

Case Control Study – Internal Clinical Audit or Research?

In undertaking the case control studies, Health Professional 5 gave evidence that theydid not consider it was necessary to refer their research to the Ethics Committee, as itwas “a clinical audit and the National Standard on Ethics Committees does not requireaudits to go to an Ethics Committee.” The article by Health Professional 5 and the detail

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contained within it, attracted different labels from different witnesses. Some569

described the article and the abstracts preceding the publication of the article asresearch. Others, including Health Professional 5, described it as internal clinicalaudit.570 It was also described as a case control study and not research.571

On a plain reading of paragraph 4.1 of the National Standard, where confidential healthrecords are accessed for purposes other than direct patient care or internal clinicalaudit, such investigations or studies are research within the meaning of the NationalStandard. In this case, the magnitude and detail of the work involved and theconsequences of the findings lead the Inquiry members to the conclusion that this wasresearch. In addition, the development of the paper for publication was “internal clinicalaudit” as defined in the 1991 and 1994 Ethical Standard, and the Inquiry sees no conflictin these two classifications, (indeed medical audit can reasonably be defined asresearch). Under the 1991 and 1994 Standard, the study did not require referral to theEthics Committee. The issue is whether there is any change to this definition, whenthe study is to be published. Should ethical approval be sought at that stage. Whilst theaudit can be seen to be no longer internal, the definition of internal clinical audit is notaltered by publication. On this matter the Standard is silent.

The way in which the study emerged for publication is however relevant to this question.

• The study was retrospective• It did not involve the provision of different treatment or the withholding of treatment.• It involved access to medical records already in the Unit• Access was by senior members of the Health Care Team directly responsible for

those patients and records in the unit.• There was no access by persons who had no duty of confidentiality• The research was anonymised and complied with the Privacy Act.

As the brain lesions were occurring in NICU, the clinicians were becoming increasinglyworried and concerned. In an attempt to identify the cause of such occurrences, a casecontrolled study was undertaken by Health Professional 5, comparing the affectedbabies with other babies within the unit, whom were labelled controls. This involved anextensive search through records held by NICU, being both case notes, brain scans andscan reports.

In undertaking the case control study, Health Professional 5 and colleagues did notundertake the consent of the parents of the affected babies or of the 26 babies whowere labelled as the controls.

At the time of undertaking the study, Health Professional 5 was unsure of the identifyingcausal link and initially came to preliminary conclusions, which did not identify the nCPTas a factor.

During the course of undertaking this study, to identify any causal link, HealthProfessional 5 and colleagues did not consider the need to refer the investigation to theEthics Committee.

Expert 3 gave evidence that in an investigation he/she wished to carry out, involvingcollecting anonymous data for the purpose of audit, he/she referred the matter to the

569 Professor Dr Robert Beaglehole p00397 ACC Volume; Expert 2, B19, p. 164; Expert 1, Brief (2) p.6 p. 20/21.570 Health Professional 5 B p. 25, Expert 5 T765 L.23-30,/766 L.1-3571 T.613 L.12-14

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Ethics Committee in the area. It was returned with the comment that the project was aninternal clinical audit and did not require Ethics Committee consent.572 This examplewas given to the Inquiry, to demonstrate that in practice, it was unlikely that even if theresearch proposal had been forwarded to the Ethics Committee, the Ethics Committeewould not have considered it to be research.

It was acknowledged that the responses from different Ethics Committees in NewZealand may differ widely, due to the submission of multi centre proposals in differentsites.573 It was acknowledged574 that the responses from Ethics Committeesthroughout New Zealand is variable and not necessarily consistent.

Royal College of Physicians Working Party

It was submitted to the Inquiry, that in a report of a Working Party to the Royal College ofPhysicians Committee on Ethical Issues in Medicine published in 1994575 in which twocategories of epidemiological activity that do not require individual patient consent orindependent ethical review include:

(a) medical practice (medical audit; epidemiological surveillance; inquiries designedto establish indices of morbidity or mortality; outbreak investigations); and

(b) research that involves personal record review without personal contact,registers and the use of stored biological samples.

It was submitted that the “Working Party” considered the key issue to be confidentialitywhich can be satisfactorily assured and enforced through existing professional ethicalcodes of conduct and, if necessary, by disciplinary procedures by the appropriateprofessional body. The Working Party also was aware that it is an exception to thegeneral rule that all research should be subject to independent ethical review, but madethis recommendation provided that confidentiality and anonymity are maintained. It wassubmitted, on the basis of the Working Party’s report and summary of itsrecommendations, that there is a duty to use available information for the general goodwhere this can be done without detriment. This wording is taken from the WorkingParty’s summary where it says further:

“It is, in principle, ethically acceptable to use personal medical records withoutapproaching or involving the patients concerned, provided that confidentialityand anonymity are preserved; such use does not require independent ethicalapproval provided that confidentiality is assured and subject to safeguardsdescribed below.”

The reference to the English Working Party’s report was not raised during the hearing ofthe Inquiry nor was it able to be put to any of the witnesses who were called to giveevidence on the ethical issues before the Inquiry. The Working Party proposals andreport were included in the Royal College of Physicians “Guidelines on the Practice ofEthics Committees” and “Medical Research involving Human Subjects Guidelines”576

which was finally published in 1996.

For the purposes of this Inquiry, the relevant standards are those set out in the nationalstandards applicable to New Zealand. In light of the Royal College of Physicians in

572 T.612 L.25-30/613 L.1-7573 T.614 Expert 3574 Expert 5 and Expert 2575 Journal of the Royal College of Physicians of London, vol 28, no.5, September/October 1994576 Refer p21 NWH submissions and annexure

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London adopting its Working Party Guidelines as set out, the Inquiry members urge thatconsideration be given to full debate and discussion on the appropriate amendments tothe New Zealand Ethical Standards.

Guidelines for Giving Consent

One of the main reasons for referrals of research to the Ethics Committee, was toensure that the issue of consent, to be obtained or otherwise, is properly addressed. Aswas told to us during the Inquiry:

“All the guidelines in existence stressed the importance of taking special carewith research involving children where parents or guardians must give consent.I appreciate that the research made no difference to the treatment the childrenreceived. However none of the consent guidelines limit consent to situationswhere a difference will be made to treatment. The basic concept is of autonomyand a person’s right to know.”577

Conclusion:

The NWH team were acting within the definition of “internal clinical audit” as theybelieved it applied at the time. In reaching our conclusion on this part of the terms ofreference, we conclude that the case control study was research and was an internalclinical audit, as it is defined in the 1991 and 1994 Standards. We are mindful also ofthe particular facts surrounding the publication of this case control study. It should notbe overlooked, that but for Health Professional 5’s research, the identification of thecausal link between chest physiotherapy and the brain lesions would not have beenidentified. Further, NWH did not hesitate to publicise the results, in an effort to ensurethat other units did not have the same tragedy occur to their neonatal babies. NWHmade a news media release, and made strenuous efforts to ensure publication of thearticle in respected medical journals.

The Inquiry members commend NWH in openly disclosing its findings, in an effort toensure the tragedies did not reoccur. This openness should be an example to otherhospitals to acknowledge error for the overall public good. It supports an amendment toany future National Ethical Standard, where a retrospective case study highlightingadverse effects from treatment or a problem, where confidentiality and anonymity areassured, should be available to Ethics Committees to approve and consider the issue ofconsent on each case. The role of the Ethics Committee in this regard should bestrengthened rather than diminished. They should provide the capacity to overview anyresearch or control study available for publication and weigh the public good and thenecessity to ensure informed patient consent are properly balanced and kept underscrutiny.

PARENTAL CONSENT TO RESEARCH

The question of obtaining parental consent to research was also raised in the context ofpublication of the case control study undertaken by Health Professional 5. The issueinvolved the principal question of whether the research should have been referred to theEthics Committee. This in turn would have clarified whether consent should have beenobtained from the parents.

577 B20, Expert 2

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For the reasons explained in the foregoing section, we have concluded that theresearch in this particular case, being a retrospective case control study, complying thewith the definition of “internal clinical audit” did not require referral to the EthicsCommittee. The question then arises whether the staff at NWH should have obtainedconsent from the parents in seeking to publicise the results of the study. The study wasretrospective, namely it involved obtaining information from medical charts only, whichwere kept within the neonatal unit at NWH and were accessed by the clinicians andmedical staff, who were involved in the clinical management of the unit. There was noidentifying information when the results were publicised, as all references to thenumbers of babies within the unit were anonymised and there was no identifyingfeatures or detail available in the published data.

The Inquiry heard evidence from both sides of the debate and it is important in thecontext of this report, to address the tension between the two opposing views. On theone hand, the clinicians and medical staff involved were concerned to publish theresults of the research, to alert others of the dangers of undertaking the technique ofpercussion as NWH had done. If consent had been required and was not obtained,then the results would not have been significant, as small numbers were involved in thecase control study (eg: if two or three parents had refused to give consent, the impacton publishing the results of ten of the affected babies would have an impact on itsstatistical significance.)

On the other hand, the importance of ensuring that confidential information such asmedical records and personal medical data relating to individual patients, should berespected and the parents in this case had a right to know and to give their consent, ondisclosure of all the information and the research data. More pertinently, it wasobserved that if the case control study had been forwarded to the Ethics Committee forpermission to publish and whether consent was required, would have been a safeguardwhich would ultimately have protected the clinicians and staff at NWH.

Given our conclusion that the research did conform to the definition of internal clinicalaudit and was not required to be referred to the Ethics Committee, the Inquiry memberslooked to assistance from the National Ethical Guidelines as to whether consent shouldhave been obtained to publish the anonymised data from the research. On the basis ofthe Standards in place, this does not appear to have been a requirement on NWH’s staffand for this reason parental consent to the research, given that it was anonymised dataand was collected from recorded medical notes in the unit, by appropriate staff, consentwas not required.

Prior to publication however, NWH staff did inform the parents of the affected babies,both of the results and of the intention to publish. In the circumstances, we concludethat those steps were appropriate. However, the issue of publication of anonymiseddata or internal clinical audit results should be addressed at a national level in theNational Ethical Standards, particularly where the publication of data may serve toinform of risk and enhance knowledge.

PATIENT ADVOCACY SERVICE

During the course of the Inquiry, reference was made to the Patient Advocacy Serviceand the omission by NWH to refer parents to the patient advocate at relevant times.

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In dealing with the ethical issues that have arisen during the Inquiry, it is pertinenttherefore to consider the relevance of the role of the patient advocate in the context ofthis Inquiry.

The Cartwright Report recommended that a patient advocate responsible to theDirector-General of Health should be employed at NWH:578

“(a) to ensure that patients who are included in research or teaching, or undergoingtreatment, are protected;

(b) to help develop material for the information or, where appropriate, for theeducation of patients; and

(c) to provide the patient with a means of obtaining more information.”

It was envisaged that “she should be an independent and powerful advocate for thepatient and that her powers included referring complaints to a disciplinary body, herreports to the Director-General of Health should be disseminated to the HealthCommissioner and to the Auckland Hospital Board and that before research involvingpatients is undertaken, she must be informed of those who are to be included andafforded the opportunity to comment. She was also to be a member of the EthicalCommittee where possible.”579

Following the Cartwright Report, 1989, the Inquiry was informed that a patient advocatewas appointed in September 1989 and the incumbent held the position until December1991.

In 1991, an independent evaluation of the advocacy service was undertaken and itappeared at that time that there was resentment and hostility by a number of medicalstaff at NWH towards the findings in the Cartwright Report and resentment of thePatient Advocacy Service.580

In 1991, the Auckland Area Health Board issued guidelines on the Patient AdvocacyService, which stated that the aims of the service were:

(a) To protect and uphold the legal and human rights of patients. These rights arepredominantly covered in the Board’s Code of Rights and Obligations,associated guidelines, internal memoranda and policies.

(b) To empower patients individually or collectively to know and self-advocate theirrights and health care needs.

The Inquiry was told that the first underlying principle was that “the advocate must beaccessible to patients.”

In 1994, with the enactment of the Health and Disability Commissioner Act, theoversight of advocates passed to the Director of Advocacy and the Office of the HealthCommissioner. This occurred after the events and the time frame, which are the focusof this Inquiry.

During the relevant time period, namely 1993-1994, there was a Patient AdvocacyService at NWH under the control of the Auckland Area Health Board.

578 Page 213, Report of the Cervical Cancer Inquiry 1988579 Pages 213-214 Ibid580 B17, p. 148, 149, S Coney and Macky 1991 p2, 14

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During the sequence of events in 1993 to 1994, and the subsequent visits by the twoclinicians and the social worker on the parents in early 1995, when the parents were toldof the NWH findings of the association between the brain lesion and nCPT, no mentionwas made of the Patient Advocacy Service. It appears there was no information givento the parents informing them of the existence of the Patient Advocacy Service, or ofany detail as to how to access the advocacy service. It is notable also that in theinformation booklet available to parents and given to them on the admission of theirchildren to NICU, no mention is made of the Patient Advocacy Service in the NWHNewborn Services Parent Information booklet or of any contact details includingtelephone numbers.

When questioned as to the reason for omitting all reference to the Patient AdvocacyService, particularly when the parents first received the information about the brainlesion from NWH, the social worker involved was unable to give an explanation. TheInquiry was told brochures would have been available describing the advocacy servicebut the social worker did not provide them.581

The access by a parent to the Patient Advocacy Service, particularly on receipt of thenews from NWH would have been a particularly appropriate resource available to theparents at a time of great distress and when more information was being sought bysome of the parents in particular.

Parent 3a described to the Committee the frustration that no one from NWH gave theparents the full information about all the events that led to the discovery of theassociation between nCPT and the brain lesion and [Parent 3a felt] entitled to be toldthe full details of what had occurred.582

The relationship between the Patient Advocacy Service and its interaction with the staffat NWH was not detailed to the Inquiry, despite the criticisms that had been made of thisrelationship in the past. The absence of referrals to the Patient Advocacy Service in thisInquiry by the staff at NWH is regrettable. Positive steps must be taken to ensure thatreferrals of patients, including parents receiving news such as in this Inquiry, to thePatient Advocacy Service is undertaken and encouraged to ensure full accessibility bypatients to a service which may assist them in obtaining information and liaising with theclinicians of the relevant section of the Hospital. The positive role which the PatientAdvocacy Service can play in assisting patients should be encouraged.

PEER REVIEW

During the course of the Inquiry and on consideration of all of the evidence, the Inquirymembers have examined one further ethical issue which arises in the context of thisInquiry and that is the issue of peer review.

For reasons that are addressed in chapter 8 under Training and Supervision, the issueof peer review becomes relevant in the context of this present Inquiry.

The Cartwright Inquiry identified two requirements of peer review. They were first anability for a doctor to analyse his or her own work and learn from past professionalexperiences and secondly the ability to know when consultation is necessary ordesirable and the will to do this.583 Whilst focusing on the requirements of the medicalprofession, professional development and multidisciplinary teams, including the 581 SB2 p.2 Health Professional 1582 T182 l8-17, T187 l5-134, T192 l1-29 Parent 3a583 The Report of Cervical Cancer Inquiry, 1988, p129

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requirement for peer review of other professionals within the hospital systems has beenclearly identified.584

As the Cartwright Inquiry noted,585

“…there has long been an ethical obligation known as peer review that a doctorseek and accept criticism and advice from professional colleagues. There isalso a strong obligation to maintain realistic self scrutiny. It is not a conceptpeculiar to the medical profession. Many disciplines require full exchange anddiscussion of ideas as a form of supervision or quality control of the serviceoffered or product manufactured. No one person can hold the completeknowledge and wisdom needed to treat a patient who has a difficult medicalcondition…

The concept itself is common sense; but the gravest difficulty has always beenin implementing peer review.”(emphasis added)

In this Inquiry, a multi-disciplinary team within the neonatal unit at NWH introduced anew technique of neonatal chest physiotherapy to help solve the problem of chronic lungdisease, which threatened any preterm infant on ventilators. Motivated by the bestintentions, Health Professional 6 implemented a system, with the agreement of theneonatal paediatric team (including Health Professional 3), as a beneficial solution toone of the most frustrating problems in treating preterm babies.

Health Professional 6 became the expert and leading exponent in the technique, taughtit to physiotherapists and ultimately nurses; undertook the use of the technique and rancourses nationwide, at which other physiotherapists attended. Health Professional 6became the expert on the technique, and was respected for hard work, enthusiasm anddedication in ensuring the technique was understood and applied. Health Professional 6was attentive to detail, as evidenced by the thorough and scrupulous notes kept of thephysiotherapy treatments, including the times, the duration, and observations at the timethe percussion was carried out, by both Health Professional 6 and all who had beentrained by him/her.

In becoming the principal practitioner and exponent of the technique, the trainer and theexpert, Health Professional 6 did not have the benefit of any peer review. Whilst manyphysiotherapists attended the lectures and training sessions, it is evident that this wasnot the forum for peer review. It appears to the members of the Inquiry, that no one evercross-checked the method undertaken by Health Professional 6, observed his/heractual technique in a critical capacity or were able to pass on to the health professionalthe comments and criticisms which we received through the Inquiry. These are set outmore fully in chapter 4 of this report586 but clearly Health Professional 6 was using theelbow as part of the technique of percussion, as were the nurses who complained ofneck pain, all of which clearly indicated the wrong use of the technique. At no stagefrom 1985 through to 1994, was Health Professional 6 subject to peer review andscrutiny in an area of practice in which he/she was acknowledged to be the senior andforemost expert in this field in New Zealand.587

584 Refer Best Practice Standards – Nursing585 Page 130, supra586 Refer Vigour section chapter 5587 NWH subs p.6 p. 21

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In our view, this Inquiry illustrates the risks associated with a practitioner becoming theonly senior expert in an area of practice, without the benefit of effective scrutiny andcriticism by peers. Where a practitioner is solely responsible for the practice, or ofimplementing, supervising, training and overseeing one specific area of practice,safeguards must be put in place to ensure that peer review is available or able to beaccessed by the practitioner. Although there may be difficulties in a small country suchas New Zealand, where senior specialist experts practice, peer review should also beavailable for them. In New Zealand, this may require access to overseas experts toundertake such scrutiny from time to time.

The lessons to be learned from the omission to provide peer review has beensummarised aptly in the Cartwright Report.588

“An inquiry into medical practice is one form of peer review, albeit enforced. It isalso the most disastrous for the profession, for patients and for the public purse.I believe that unless the profession can establish adequate peer review ….Then there will be a continuing succession of inquiries of this nature.”

ETHICS OF THE NEW ZEALAND SOCIETY OF PHYSIOTHERAPISTS

After the Inquiry had closed,589 a letter was received from the Physiotherapy Board,bringing to the attention of the Inquiry sections 23 and 26 of the Physiotherapy Act 1949.These sections prescribe offences for the appointment of persons carrying out duties ofa physiotherapist, when they are not registered physiotherapists. The letter wasreferred to Counsel for the parties and submissions were received.

Given the terms of reference for this Inquiry, it is important that the Physiotherapy Act1949 and the Rules of the New Zealand Society of Physiotherapists Incorporated, towhich we were referred, are applied appropriately and where relevant. It is notappropriate for this Inquiry to make findings on whether offences have occurred underthe Physiotherapy Act 1949. Evidence was not directed towards those issues, astandard of proof is required in respect of the offence provisions and an inquiry is notthe appropriate forum for such determinations.

However, our attention has been drawn to the Rules of the New Zealand Society ofPhysiotherapists Incorporated590 containing Rule 55 with the heading “Ethics” whichprovides:

“…(b) the practitioner – patient – client relationship requires the informedconsent of the patient to treatment.

(c) a practitioner shall always act in the best interests of the health of thepatient.”

It has been submitted on behalf of the parents that neonatal chest percussionphysiotherapy is physiotherapy within the meaning of s2 of the Physiotherapy Act, whichwas undertaken by nurses who were not registered physiotherapists and thesubmission that the change of treatment in 1993 to be submitted for Ethics Committee

588 The Report of the Cervical Cancer Inquiry 1988 (Cartwright Report p.132)589 The evidence of the Inquiry concluded on 11 March 1999 and all submissions were received on 19 March 1999.The letter from the Physiotherapy Board was dated 25 March and was received on 29 March 1999.590 The 1991 Rules were valid to 15 May 1993 and the 1993 Rules were valid 15 May 1993 to 1995.

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approval together with the need for informed consent to the treatment, is reinforced bythe Rules of the New Zealand Society of Physiotherapists.

The submissions on behalf of NWH and Health Professional 6 submitted the Rules andthe Act were not relevant to the terms of the Inquiry. It was submitted that the NewZealand Society of Physiotherapists is a voluntary organisation and its Rules require anestablishment of an Ethical Committee to advise on matters of professional ethics andpractice and to consider complaints against members of the Society relating to ethicalmatters. It was further submitted that the nurses who performed the percussiontechnique were not members of the Society nor registered as Physiotherapists and theSociety has no authority to consider complaints regarding the events that occurred atNWH. As the nurses who performed percussion were not appointed to the Hospital tocarry out those duties and nor did they hold themselves out as being qualifiedphysiotherapists, neither offences section could apply in any event. Reliance wasplaced on s26(2)(a) of the Act which is exempted from the offence provision of s26.

The only relevance for the purposes of this Inquiry is a consideration of the ethics rule ofthe New Zealand Society of Physiotherapists in relation to this term of reference. Forreasons already stated, it is not appropriate for the Inquiry members to make findings inrespect of the offence provisions.

It is clear that the New Zealand Society of Physiotherapists Inc. is a voluntaryorganisation and its Rules provide for the appointment of an Ethical Committee. Rule55 applies to members of the Society and the responsibility to patient/clients requiresthe practitioner to obtain the informed consent of the patient or client to treatment.

It is clear the nurses before this Inquiry were not members of the Society and the statusof Health Professional 6’s membership is unknown. In the circumstances, the Rulescannot be specifically applied to those witnesses and practitioners at NWH who are thesubject of this Inquiry.

The Rules do however raise the importance of informed consent to treatment, an issuewhich was raised during the Inquiry and has been dealt with in the foregoing sections.

CONCLUSIONS

2(e) Were the steps taken by NWH, before and after introducing the change inthe way in which the treatment was performed, consistent with relevantNew Zealand or international clinical or ethical guidelines for affectingchanges to treatment protocols?

Treatment ProtocolsThe implementation of the changes did not require ethical review or approval, on thewording of the 1991 National Standard, which was applicable in 1993. It would havebeen outside standard practice to seek ethical review at the time of implementing thechange in treatment.

Parental Consent

(a) For treatment or the change in treatment.

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Parental consent was not obtained for either the treatment of chest physiotherapy or forthe change in treatment. The consent for a change in treatment was not required, butthe issue of consent to treatments given or undertaken needs to be addressed. Apartfrom treatments which contain a degree of risk or treatments being used for researchpurposes, the present practice of NWH and other units in New Zealand is not to seekconsent for treatment. The various treatments and procedures undertaken in a neonatal intensive care unit,given the exigency of the situation and the developing technology, requires the issue ofinformed consent from parents on behalf of their babies, particularly in a neonatalintensive care unit, to be properly addressed for the future at a national level. (b) For training

Parental consent for training was not sought. The relevant guidelines require parentalconsent for training, although no distinction is drawn between training of clinical staffand training of students.

Because of the divergence between national practice and the guidelines, furtherclarification of this issue at a national level is required.

ResearchThe case control study being a retrospective review of medical records was researchbut also conformed to the definition of “internal clinical audit” contained the 1991-1994Ethical Standard. It therefore did not require referral to the Ethics Committee.

Patient AdvocacyThe Patient Advocacy Service was not involved in assisting the parents in this Inquiry.Positive steps must be taken to ensure that referrals of patients, including parentsreceiving news such as in this Inquiry, to the Patient Advocacy Service is undertakenand encouraged to ensure full accessibility by patients to a service which may assistthem in obtaining information and liaising with the clinicians of the relevant section of theHospital. The positive role which the Patient Advocacy Service can play in assistingpatients should be encouraged.

Peer ReviewTo ensure safe practice at all levels within the health profession including specialistsenior experts, effective peer review must be undertaken, even if access to overseasexperts is required in some circumstances.

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CHAPTER EIGHT:

TRAINING AND SUPERVISION

In this Chapter we consider the issues arising under Term of Reference 2(g) relating totraining and supervision. For ease of reference the chapter is set out as follows:

TRAININGThe Training of Health Professional 6The Training of Other PhysiotherapistsThe Training of Nursing StaffRelevant Protocols and Practice in New Zealand and Internationally

SUPERVISIONSupervision of Health Professional 6Supervision of the Other PhysiotherapistsNurses SupervisionRelevant Protocols in New Zealand and Internationally

2(g) Was there any training and ongoing supervision provided to staffcarrying out the treatment and was this training and supervision inaccordance with relevant New Zealand or International standards?

The majority of the training of all nursing staff at NWH and the technique of percussionby cupping was provided by Health Professional 6, in the Newborn Intensive Care Unit.Before scrutiny of the training of the nurses is undertaken, it is important to examineHealth Professional 6’s initial training in the technique.

THE TRAINING OF HEALTH PROFESSIONAL 6.

Health Professional 6 visited the Overseas Hospital 2 in 1985, and when there firstobserved the technique of cupping (called percussion) at NWH.591 Overseas Hospital 2was described as the centre of excellence researching the technique at the time.592

Health Professional 6 had no recollection of being specifically taught the technique bythe physiotherapist there and apart from observations of the technique, was unable toconfirm having ever been formally trained in neonatal cupping techniques.

Health Professional 6 stated that the cupping technique was an extension of theclapping technique taught to physiotherapists593, and that clapping was part of aphysiotherapist’s repertoire of skills. He/she confirmed having undertaken a Bobathcourse,594 which is specific to the handling of children with cerebral palsy, not newbornbabies with respiratory problems.

It is pertinent to note Health Professional 6’s comment following this visit to OverseasHospital 2 : “My lasting impressions at that time were the intensity of the cupping (percussion) andthe frequency of treatment”.595

591 B 6 p. 4 Health Professional 6592 Closing submission Health Professional 6, p.22 p. 73593 T350 lines 20 to 21594 T 354 lines 27 to 29595 B 7 p. 4 Health Professional 6

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On his/her return Health Professional 6 discussed the technique with the senior medicalstaff at National Women’s Hospital and subsequently introduced the technique toNational Women’s Hospital, and was the main provider of physiotherapy within theNeonatal Intensive Care Unit from 1985 to 1993.

Health Professional 6 referred to ongoing development as including overseas visits toobserve and discuss nCPT as well as other physiotherapy roles.596 Many of these visitswere made whilst Health Professional 6 was overseas on holiday, when he/she took theopportunity to visit nine neonatal units in the UK and the USA, from August 1987 toJanuary 1988. Although noting that nursing staff provided the treatment as well asphysiotherapists in all of the neonatal units, and that in three units the nurses did all thechest physiotherapy treatment including the training of the nurses, Health Professional 6did not see nCPT being performed in three of the hospitals. Health Professional 6’smemory of percussion as used at three UK hospitals was its similarity to NWH.However regarding Overseas Hospital 4, Health Professional 6 told the Inquiry, “I recallwatching percussion on a pre-term ventilated infant, the percussion being so gentle thatit would have had no effect in loosening secretions.”597 Health Professional 6 furthernoted having been shown around Overseas Hospital 4 by Expert 17, from whom theInquiry heard,598 but did not observe Expert 17 doing any treatment. Similarly at thethird hospital visited, Health Professional 6 did not observe any nCPT being undertakenat the time he/she was visiting.

Pressed about his/her training in the technique of cupping, Health Professional 6explained that he/she did not perform the technique in Overseas Hospital 2 becausehe/she felt it inappropriate to handle babies in overseas nurseries. Health Professional 6referred to the three week Bobath Course which he/she undertook in 1998, for whichregistration in Australia was a prerequisite.599 Expert 13 believed that opportunitieswere available for visiting physiotherapists to perform the cupping technique on a babyduring a visit to the Overseas Hospital 2 unit, including visiting New Zealandphysiotherapists.600

The precise requirement for visiting physiotherapists to gain registration before beingable to undertake treatment on a baby either in 1985 or in 1993 is unclear, on theevidence presented to this Inquiry. The technique however could have been undertakenon a doll, as was demonstrated to the Inquiry, in the event that there was anycomplication with regard to handling of babies from overseas visiting professional staff.

Expert 12 told the Inquiry that visits from overseas physiotherapists occurred at theOverseas Hospital 2, a point confirmed by Expert 13. The visits would frequentlyinclude “learning and comparing protocols”601 and that if the physiotherapists wereinterested, demonstrations of cupping including the correct use of the mask, wouldoccur.602

In considering the appropriateness of Health Professional 6’s lack of training beforeintroducing the chest physiotherapy technique to National Women’s Hospital, it ispertinent to consider how other physiotherapists both within New Zealand and overseaswere introduced to the technique, then incorporated it into their practice.

596 B18 p. 3 Health Professional 6597 B9 p. 11598 Parker AE (1985) Chest Physiotherapy in the Neonatal Intensive Care Unit. Physiotherapy 71, 63-65599 T351 l.5-8600 T 808 l.26-30601 T807 l.26602 T808 l.1-5

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THE TRAINING OF OTHER PHYSIOTHERAPISTS

The evidence from two New Zealand trained physiotherapists confirmed that there wasno formal training available in neonatal chest physiotherapy. Expert 7 stated receivingtraining “on the job” 603 from another physiotherapist and revealed the shortage oftraining in specialist fields in physiotherapy604. Neonatal chest physiotherapy was one ofthe fields lacking in formal training. Expert 9 gave evidence that he/she was trained byHealth Professional 6 605 which included one on one training.606

Two physiotherapists who had pioneered the techniques in neonatal chestphysiotherapy, were available to give evidence to the Inquiry. These physiotherapists,from Australia and England, described a similar situation. Expert 13 from OverseasHospital 2 told the inquiry he/she learnt the cupping technique from reading thepublished papers, respectively published in 1969 and 1978 before learning the cuppingtechnique “by trialling it. By taking hold of the cup and using it”.607 It should be notedthat Expert 13, together with Expert 12 published an article in 1980 entitled “Techniquesof physiotherapy in intubated babies with the respiratory distress syndrome”, in whichthree techniques were described, including percussion by cupping.

Expert 17, formerly of Overseas Hospital 4, confirmed that cupping was a basictechnique taught as a student 608 but that he/she “tried using the facemask and found iton a purely subjective basis to be more useful than trying to percuss with the fingers.”609

Following the publication by Expert 12 and Expert 13 in 1980, Expert 17 developed thetechnique of cupping. It has been submitted to the Inquiry that unlike Expert 17 andExpert 13, who were both self taught, Health Professional 6 learnt the technique in 1985by visiting Overseas Hospital 2 and observing the technique. It is also submitted thatthe technique is an adaptation of other techniques of chest physiotherapy which areroutinely taught to physiotherapists during training.610

By 1985, not only were there several publications available, including that of Expert 12and Expert 13, but units such as Overseas Hospital 2 had trialled the technique andwere undertaking it. In 1985, when Health Professional 6 observed the technique, thepractical application of the technique was already under way and in practice atOverseas Hospital 2.

After its introduction at NWH, where Health Professional 6 lectured and trained otherphysiotherapists within New Zealand, and was considered to be an expert in his/herfield, there was no monitoring or checking of technique by either visits to OverseasHospital 2 or elsewhere. It should be noted that the visits which Health Professional 6undertook as late as 1991, visiting two neonatal units in Melbourne, were self fundedand informal. There has been no opportunity or arrangement for review.

603 T 658 lines 5 to 9604 T 659 lines 1 to 3605 T 720 lines 25 to 26606 T 721 line 8607 T 825 lines 3 to 5608 T 871 lines 14 to 16609 T 871 lines 20 to 22610 T871, T521, T350

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On the overseas visits undertaken by Health Professional 6 to the United Kingdom, itappears that at no stage, was the technique viewed by any of the other experts (such asExpert 17) or of other practitioners in the same field.

Health Professional 10, who gained his/her initial training in another unit before comingto NWH and working with Health Professional 6 for four years, gave evidence thatHealth Professional 6 undertook teaching sessions with Health Professional 10 in 1991,in neonatal chest physiotherapy and neurodevelopmental problems and feedingdisorders for example.611 Health Professional 10 also referred to a video clip presentedto the physiotherapy staff on neonatal chest physiotherapy612 and that one otherphysiotherapist had been trained by Health Professional 6. How the remainingphysiotherapists who provided the treatment were trained in the technique, was notspecifically addressed at the Inquiry, although Health Professional 6 did undertake nCPTtraining of physiotherapists as well as nurses.

THE TRAINING OF NURSING STAFF

Health Professional 6 provided the majority of the training of nursing staff. HealthProfessional 3 in a letter to the PSA dated 16 September 1992 confirmed:“I certainly agree with your statement that nurses should be trained by physiotherapists.[Health Professional 6] is convinced that it is important to maintain a high standard and Ifully support [him/her] on this.” 613

The Physiotherapy Working Party was established in March 1993 to consider, amongother matters, the issue of training. A timeframe of three months was planned, to writeto neonatal units throughout New Zealand to find out how they provided a 24 hourservice as opposed to the 12 hour service NWH offered, and to initiate the training ofnurses. The physiotherapy working party consisted of physiotherapists andexperienced neonatal nurses and the training plan was an adaptation of that provided tophysiotherapists by Health Professional 6, adapted from the Standards and Protocolswritten for physiotherapists by Health Professional 6.614

Health Professional 3 further outlined the training provided 615 and that no timetable wasset to train nurses, rather that the training would be undertaken at a pace that wouldachieve good quality training. Health Professional 3 considered the training as plannedwould be superior to that undertaken elsewhere.616

The Physiotherapy Working Party requested information from other tertiary units in NewZealand (Waikato, Wellington, Christchurch and Dunedin), as to how they provided a 24hour service. Health Professional 10617 confirmed that as a member of thePhysiotherapy Working Party none of the members attempted to source any trainingmaterial from New Zealand or overseas units. The training plan was based upon thephysiotherapy standard already in existence at National Women’s Hospital.

The theoretical part of the training

611 T 525 l.3-8 Health Professional 10612 T546 l.20-23 Health Professional 10613 NWH vol1 p.41614 B 5 p 16 Health Professional 10615 B 48 p. 213-214 Health Professional 3616 SB 21 p. 111 Health Professional 3617 T 519 lines 26 to 29

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Considerable effort was taken in the theoretical aspect of the training. The first teachingsession was given on 3 June 1993 consisting of a lecture618 and nurses were givenhandouts following the session. Health Professional 9 was the first nurse to be trainedand was a member of the Physiotherapy Working Party which had decided that onlyexperienced neonatal nurses were to be trained. These nurses would have had aminimum of 12 months experience in the Special Care Baby unit before rotating intoNewborn Intensive Care areas for a period of five months. This rotation would be theone most likely to involve their training.619 The training in neonatal chest physiotherapyfor nurses included the following:

• A lecture on chest physiotherapy from Health Professional 6. This lecture coveredtechniques as well as the contra-indications and precautions of chestphysiotherapy.

• Articles620 were provided for the nurses to read and increase their knowledge baseof physiotherapy.

• Practice by nurses of cupping using the latex mask on our arm to feel what wasappropriate pressure.

• A ‘one-on-one’ session with Health Professional 6 to assess the individual nurse’sknowledge and discussion of the contra-indications and precautions of chestphysiotherapy.

• Two (or more) initial practice sessions carried out by the nurse on a baby, observedby Health Professional 6. Additional competence assessments were madedepending on the confidence of the nurse and Health Professional 6’s confidence intheir ability.

• Health Professional 6 then followed up with the nurse to ensure that they werepractising at an acceptable standard.621

It was confirmed that only experienced neonatal nurses were trained after at leastthirteen months neonatal experience, 622 and that the topics covered in the lectureconsisted of:

• The indications for chest physiotherapy;• The contra-indications;• The precautions;• The actual treatment to be provided (positions for treatment, frequency, duration,

technique etc);• Monitoring the stability of the baby (signs of distress) during treatment;• When not to treat (specified conditions had to be treated by a physiotherapist);• The initial assessment and treatment which had to be given by a physiotherapist;• The documentation to be completed; and• Post extubation protocol.623

Health Professional 6 provided the lectures to nurses, which lasted around twenty fiveminutes624 and attendance was mandatory at one session .625 The nurses who gaveevidence to the Inquiry were able to confirm their training included the foregoing detail.

618 NWH volume 1 page 188 -190619 B 3 p. 12 Health Professional 9620 E.g. the functioning of the lungs621 B 4 p. 15 Health Professional 9622 B 5 p. 17 Health Professional 10623 B 6 p. 17 Health Professional 10

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The practical training

Following the twenty five minute lecture, practical cotside sessions were held for staff.Health Professionals 9, 2, 12, and 11 all confirmed they had received a minimum of twocotside training sessions before being assessed as competent to undertake thetreatments. Health Professional 6 stated the training was individualised, but noevidence was produced of objectives, content or length of the practical sessions. HealthProfessional 6 confirmed that the length of each session varied according to the timethe nurse had to give 626 and that he/she responded to the individual learning needs ofeach nurse.627

Health Professional 6628 and Health Professional 9629 confirmed that before training, thenurses had observed the treatment being performed by the physiotherapists on manyoccasions. This ‘observation’ was considered an adequate basis for assuming a levelof knowledge before being trained.

Health Professional 6 also confirmed having no recollection of guidelines that would beincluded in a practical session, including the length of the session. There were noguidelines and I responded to the individual learning needs of the nurse. I suppose theycould have been anything from I suppose, probably half an hour …. that would not behands on, that would be discussion, to I don’t know how long.630

No formal plan was made for the practical training. It is apparent that it was known thatdifferent nurses would require different levels of training in the practice, and that eachnurse would receive a minimum of two such practical sessions.631

As the training concerned the wrist technique a nurse would use during treatments, thiswas a crucial part of the overall training. The correct use of the wrist was critical andsome nurses confirmed they had problems with their techniques, necessitating severalsessions to perfect the technique.

Health Professional 2 told the Inquiry, “I had problems with the correct wrist movementand I practised only on my arm and dolls to correct this to [Health Professional 6]’ssatisfaction until I felt competent that I could provide chest physiotherapy safelyaccording to the protocols.”632

The nurses giving evidence emphasised that they were taught to use the wrist action“only” and it would appear that this was indeed a focus of these sessions. HealthProfessional 11 confirmed:633

“I did not start chest physiotherapy on my own until I felt entirely comfortable andconfident with the technique and procedure. It was emphasised to us that whenwe gave the chest physiotherapy we needed to use a relaxed wrist movementonly”

624 NWH volume 1 page 186, 187625 NWH volume 1 page 186626 T341 lines 24 to 26627 T 343 lines 13 to 14628 B T 343 line 18 Health Professional 6629 T476 lines 23 to 29630 T 351 lines 13 to 18631 T343 Health Professional 6; T473 Health Professional 9632 B6 p19 Health Professional 2633 B5 p. 16 Health Professional 11

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The sessions also included the correct positioning of the baby during treatment, as wellas the duration of treatment. Health Professional 12 confirmed the practical sessions:.“This was followed by practical teaching sessions with [Health Professional 6]. Wewould watch [him/her] first and be taken through the process very carefully.”

Two of the nurses who gave evidence were experienced neonatal nurse educators, whoconfirmed they were satisfied with the level of training they received and the content ofthese sessions.

A hand-written record of nurse training was available to the Inquiry. It was not a definitivelist , in that it did not refer to the full period in question, and not all of the nursessubsequently trained were listed on it. Each nurse referred to on this list had the date oftheir practical sessions recorded, It was evident that thirteen such nurses had receivedtwo sessions, and five nurses had received more. In addition, another four nurses werelisted as having had only one such session, but it is not clear from this list in fact thatany of these nurses were approved to give the treatment.

The accuracy of this list was also called into question during the evidence of HealthProfessional 9. Whereas Health Proressional 9’s practical sessions were listed asbeing on the 20th and 29th of June 1993, it was apparent from the records of theinvolved babies that Health Professional 9 had administered and recorded suchtreatment on 11/6/93. There was no satisfactory explanation for this discrepancy, butHealth Professional 9 was adamant that he/she had not performed the treatment beforehe/she was entitled to.634 This then called into question the accuracy of the hand-written list.

There were 31 nurses trained and approved to perform the treatment by the end of1993, and a total of 76 had been trained and approved when the treatment was largelydiscontinued in December 1994.

The theoretical material and the formal documentation and records required to becompleted of the treatments were produced to the Inquiry. The treatment records werecommented upon by Expert 12 as being “ first class”.635

Did the training comply with other relevant protocols

None of the other New Zealand units had developed protocols for training of chestphysiotherapy in 1993. Many New Zealand neonatal units protocols for the 1992 to 1993period were updated following the release of information from NWH about the brainlesion. The protocols used at Hospital 1 during this time were similar to those at NWHwritten by Health Professional 6.636 Expert 9 confirmed that his/her unit worked to awritten protocol but was referring to the actual treatment protocol used, not trainingprotocols. As there were no national training protocols at the time when nCPT wasintroduced by NWH, the NWH staff set the training system to meet their needs.

Did the training comply with relevant practice elsewhere

634 T502 Health Professional 9635 T 782 l.9-12 D. Expert 12636 T 726 l2-7

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The training provided was largely similar to that which occurred in other units. HealthProfessional 3637 believed that the training at NWH was superior to that of other NewZealand units. The training was similar to that of other New Zealand units, from theevidence presented at the hearing. Nurses and physiotherapists from Hospital 1, andExpert 14 all commented on aspects of nurse-training at their hospitals. At Hospital 1this included an orientation period with a lecture, and demonstration of chest clearancetechniques.638 All new staff spent some observation time with the physiotherapist priorto performing the technique under supervision. This was supported by a lectureprovided during the neonatal unit course.639Expert 9 (Hospital 1)640 said the formallectures were approximately one hour long, including demonstration of the cuppingtechnique on a one on one basis.641 Expert 10 (Hospital 1) confirmed that orientationincluded a one hour session on physiotherapy to instruct nurses on the technique andsuctioning.642 In Hospital 2, nurses were trained by nurses, during orientation.643

International protocols

There were no standards or protocols for training in 1993, as confirmed by HealthProfessional 3.644.

“There were and are no international standards or protocols on training andsupervision of staff carrying out nCPT on newborn babies that we know of.”“…There are no standards that were generally applicable. We know of no localstandards anywhere for teaching nCPT to nurses.”

Expert 13 (Australia) and Expert 17 (England) referred to the protocols in relation totreatment but neither stated there were International training standards. Expert 16produced the treatment protocol for Overseas Hospital 3, but again did not refer totraining standards. As there was no training protocols, an International comparison isunhelpful.

International practice

Expert witnesses from Australia and England outlined their training processes, whichwere unique to their respective units, although not dissimilar to those used by NWH.

Expert 13 commented that new nursing staff were trained at the cotside bydemonstration and by supervision of the physiotherapist.645 Expert 13 also confirmedthe training would include lectures of one hour followed by one to two cotside sessions.

Expert 16, an advanced neonatal nurse practitioner from England revealed a similarsituation of cotside training and regular updates. New nurses were taught and assessedby senior nurses in the unit.646

637 SB 21 p. 111 Health Professional 3638 B 4 p. 7a Expert 7639 B 5 p. 4a Expert 9640 T 729 lines 4 to 28641 B1 p 4a Expert 10642 T 736 lines 5 to 27643 B3 p8a Expert 14644 B46 p201 Health Professional 3645 B4 p4 Expert 13646 B2 p4 Expert 16

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Also from England, Expert 17, confirmed orienting new staff training to undertake chestphysiotherapy and suction. Until the sessions were complete, nurses were not allowedto undertake treatments until they had undergone an assessment of competence.647

Expert 17 confirmed that training was variable for each nurse, some needing moresessions than others, for their own confidence648

“It was variable for different nurses… so generally speaking the nurses on thecourse would need more than one. Some would need several, for their ownconfidence often, and others .. may need only one, perhaps two to actuallydiscuss the philosophy and the principles etc, of the actual physiotherapy. Butcertainly, every nurse that came on the unit had my training as part of theirinduction.”

Conclusion

With regard to the theoretical sessions, the training was planned and recorded. It didreflect the individual training needs of the staff. The practical training records wereincomplete but nurses were not permitted to perform treatments unsupervised until theycould satisfy Health Professional 6 that their technique was appropriate and within theparameters of the set protocols.649

At the time, Health Professional 6 was undertaking the training along with normal dutiesand the responsibility for the training became predominantly that of Health Professional6.

The principle of the training sessions at NWH was not at all dissimilar to that practisedelsewhere . Health Professional 6 emphasised training was individualised for eachnurse and a formal teaching session was followed by practical cot side sessions. Wefind the training undertaken at NWH was comparable to that of other units.

SUPERVISION OF STAFF FOLLOWING TRAINING

In this section, the supervision of Health Professional 6 is examined on a comparativebasis, both in New Zealand and internationally. In the relevant period 1993 to 1994, it isevident that there were no requirements on physiotherapists to undertake peer review.This also appeared to be the situation internationally.

SUPERVISION OF HEALTH PROFESSIONAL 6

Health Professional 6 introduced percussion by cupping to National Women’s Hospitalfollowing observation of the technique at Overseas Hospital 2 in 1985. HealthProfessional 6 had no memory of being trained in the technique as noted previously,and had no formal monitoring of practice and no peer review.650

“I would have welcomed peer review if it had been available. Peer review was notpart of paediatric physiotherapy practice in 1993-1994. I was only introduced topeer review in 1998”

647 B4 p12a Expert 17648 T875 l9-22 Expert 17649 Closing submission page 22 p. 74650 SB 8 p5. Health Professional 6

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… One of the problems for me at NWH was that I often felt isolated as aneonatal paediatric physiotherapist nationally. This is why I took everyopportunity when I was overseas to visit neonatal units. I did have the benefit ofa paediatric physiotherapy colleague from 1986 on and there was an enormousamount of interchange of knowledge and reading as a result of this relationship.”

The visits overseas were undertaken by Health Professional 6 on an informal and selffunded basis. These had not been arranged as visits for the purposes of peer reviewand no monitoring or observation of Health Professional 6’s technique was undertakenon those visits.

Health Professional 6 did however have contact with a senior Hospital 1 physiotherapistand the younger physiotherapists who replaced him/her. He/she considered:“this lack of staff continuity made it very difficult to maintain consistent contact withpeers” 651

As the foremost New Zealand expert in neonatal chest physiotherapy techniques, HealthProfessional 6 ran national physiotherapy courses. The Inquiry was told that there was“a great deal of inter-change of information”652 at these courses and both HealthProfessional 3653 and Health Professional 6654 deposed there had never been anynegative feedback received during or following these courses. When questioned as towhether Health Professional 6 recalled ever inviting feedback on the treatment thathe/she was giving, Health Professional 6 replied:

“I don’t recall inviting it, but all the physiotherapists on those courses spent asmuch time as they wished each morning during the course at the beginning ofthe day observing our chest physiotherapy. They had every [comment] to saywhat they wished and we would come back and say ‘are there any comments, isthere anything you want to ask’. They would watch for up to an hour eachday.”655

There was no system available to Health Professional 6 to engage in practice review oraccess peer review or supervision from any other physiotherapists either in NewZealand or elsewhere.

It is pertinent therefore to have regard to the requirements or direction from the relevantprofessional bodies. There was no direction or requirement within the relevant rules ofthe New Zealand Society of Physiotherapists Incorporated to which we were referred bythe Physiotherapy Board, requiring physiotherapists to undertake peer review orsupervision. We are unaware of any practice direction or guideline from the NewZealand College of Physiotherapy or the Physiotherapy Board regarding peer review ormonitoring of practice during the relevant period 1993 to 1994. On a practical levelExpert 9 (Hospital 1) worked in the paediatric area for six years and attended courses atNational Women’s Hospital run by Health Professional 6. Expert 9 said that peer reviewwas not well established for senior physiotherapists, up until June 1993 when he/sheleft.

It is relevant to compare the peer review of the other senior physiotherapists who wererecognised for pioneering the neonatal chest physiotherapy technique.

651 SB 9 p5.3652 SB p.9 p. 5.3 Health Professional 6653 B 20 p86 Health Professional 3654 B 22 p. 41655 T349 l.1-2

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Expert 13 had from early professional life travelled to another unit to view the techniquepractised there. This was Overseas Hospital 5 in the 1970’s.656 Expert 13 stated that itwould have been possible for a physiotherapist from a unit introducing the technique tomake contact with another physiotherapist to cross check the technique that had beendeveloped.657 Expert 13’s own practice was reviewed at multidisciplinary meetings inan informal way. As well: :

“Our practice at [Overseas Hospital 2] has constantly been reviewed asevidenced by the number of trials that we have performed since 1980, right theway through to the current one that we are running. These trials have involvedthe use of the cupping technique looking as secretion removal, oxygenation andintra-cranial haemodynamics. And we have presented those papers are variousConferences.”.658

In 1980, Expert 13 published with Expert 12 the results of an early trial which is referredto in Health Professional 6’s teaching material.659 Expert 12 confirmed that visitorsattended the Overseas Hospital 2 unit and that he/she would meet these visitors and beaware to a degree of their educational programme for the visit.660

It should also be noted, that Expert 13 worked in conjunction with Expert 12 who wasnot only Clinical Director of the unit at the time, but closely involved in the research andpublication of the technique. As a neonatal paediatrician with a special interest innCPT, it is clear that Expert 12 had an ongoing involvement with the technique and wasaware of its practice.

Expert 17 first gained experience in treating pre-term infants whilst working at Englishhospitals, where he/she developed his/her skills in paediatric and neonatal intensivecare. Expert 17 told the Inquiry of having gained most experience at Overseas Hospital4, from June 1980 to September 1993.661 In response to a question about peer review,Expert 17 identified three ways in which the treatment was reviewed.

At first, before going to Overseas Hospital 4, Expert 17’s practice of physiotherapy wasassessed and taught by people with more experience. (This was prior to his/her use ofthe technique of percussion by cupping). Secondly after introducing the technique ofpercussion by cupping Expert 17 prepared a video and undertook lectures as well aspublishing articles on both the technique and the results. Expert 17 told the Inquiry thatpeople felt able to criticise his/her technique where it did not fit with the practice of theindividual physiotherapist, nurse or member of the audience. Thirdly, as a result ofhis/her international publications,

“People came to spend time with me on my unit at [Overseas Hospital 4] (fromother units) to discuss about this type of physiotherapy. Not just from the UK,but I had people visiting from Europe and also Australia. So it’s not so much aquestion of me saying, ‘well, this is how I do it, and you know, this is the rightway,’ this was something that was discussed with a lot of people that I had and I

656 T817 l.11-13 Expert 13657 T 821 l. 6-12 Expert 13658 T824 l.23-30 Expert 13659 NWH vol 1 page 204660 T786 l.20-24. Expert 12661 B1 p. 4 Expert 17

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suppose the amount of visitors that I had varied over the years, and I might wellhave ten or so visitors a year from different places.” 662

In comparing the three senior expert physiotherapists namely, Health Professional 6,Expert 13 and Expert 17 there are the following similarities and differences, which arerelevant to the issue of monitoring or peer review.

The similarities are:• They were all senior health professionals within their units.• They were all highly regarded in their countries• They all learnt the technique by self teaching• They all taught other physiotherapists and nurses.• They did not have formal peer review.

The following are the differences:• Expert 13 and Expert 17 were internationally renowned and were widely

published.• Expert 13 and Expert 17 were not as vigorous in their technique.663

• Practice oversight in the case of Expert 13, was undertaken by a seniorneonatologist with considerable expertise and publications in the area. Thosepublications which were undertaken jointly with Expert 13 published the results oftrials in and around the technique of percussion. There were manyphysiotherapists visiting the unit “upskilling or comparing techniques”. Practiceoversight in the case of Expert 17 involved visitors to the unit both nationally andinternationally, who spent time with him/her on the unit at Overseas Hospital 4.In the case of Health Professional 6, there were visiting New Zealandphysiotherapists to his/her unit.664

From these comparisons, it was evident that there was no formal peer reviewundertaken by the other two leading international physiotherapist experts at the relevanttime. It has been submitted that Health Professional 6 was regularly observedperforming the technique over nine years by a large number of neonatologists,paediatric registrars and nurses. It was further submitted that many of those hadobserved nCPT in other units both in New Zealand and overseas. The most relevantevidence is that of Health Professional 3, who told the Inquiry that the technique andintensity of cupping at NWH was similar to that seen in a number of overseas hospitalsincluding Brisbane, Melbourne and New York.665

Given that Health Professional 3 and Health Professional 6 worked together in the unitand were both involved in the introduction and implementation of the change intreatment, Health Professional 3’s position was also considered. Health Professional 3confirmed witnessing the physiotherapy treatment at times but would not have seen allstaff who gave the treatment. However when asked about peer review HealthProfessional 3 stated :

“I can’t be involved in the review of the physiotherapists technique.”666 HealthProfessional 3 confirmed that physiotherapists were part of the support services

662 T876 l.12-18663 Expert 17’s video, B5 p. 16 Expert 17; B p. 8 Expert 13; T813 l.2-6664 T821 l10-12665 B 21 p. 87 Health Professional 3666 T.265 l.14-15 Health Professional 3

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for the hospital and that they were responsible for peer review of staff, that no-one in the neonatal unit could do that.667

In making the above comparisons of senior experts working in a very specialised area ofpractice, it is clear that the absence of peer review or supervision for HealthProfessional 6 was consistent with the standards of the day. When one examines thecircumstances of the international experts, their practice techniques and research wereavailable by publication for scrutiny and as a result, led to wider discussion at aninternational level and review. However they were not formally supervised at therelevant time, nor did they have formalised peer review.

SUPERVISION OF OTHER PHYSIOTHERAPISTS

The Inquiry was told Health Professional 6 was responsible for the supervision andmonitoring of Health Professional 10’s practice which included undertaking treatmentssimultaneously.668

The giving treatments at parallel times raises questions as to the adequacy ofsupervision or monitoring of practice. However Health Professional 10 explained he/shehad an annual review of his/her physiotherapy technique to ensure his/her practices andrecord keeping met protocols and standards set by Health Professional 6.669 On oneoccasion a registrar within NICU questioned Health Professional 10’s technique, namelythe vigour of treatment. No paperwork could be produced to demonstrate whathappened to rectify this complaint. A meeting was held with Health Professional 3 and aCharge Nurse but not the registrar.670 The complaint occurred whilst HealthProfessional 6 was on annual leave, and a review of physiotherapists techniques wasundertaken following this incident.671 There is no written record of the review, but HealthProfessional 6672 confirmed the review:

“I spoke with everyone concerned and reviewed the nCPT techniques of allphysiotherapy staff who performed nCPT and was confident that all thetreatment was being given within the safe parameters of the protocol. Whileorientating one junior staff member I recall needing to correct her technique”

ConclusionIt appears that an annual review of physiotherapists was undertaken which includedadherence to written protocols. It is not clear if a review of actual practice formed part ofthis review.

NURSES SUPERVISION

As previously outlined, a formal review of the nurses techniques 10 to 14 days afterinitial training was planned. There was no formal process established to ensure thisoccurred. A clinical audit was planned and never eventuated. Nurses were unclearabout their follow up, some stating they requested a review:673

667 T 264 l.17-19 Health Professional 3668 B7 p28 Health Professional 10669 B7 p25 Health Professional 10670 B7 p23 Health Professional 10671 T420 l21-24672 B22 p40 Health Professional 6673 B8 p25 Health Professional 2, B5 p16 Health Professional 11

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Health Professional 6 was frequently in the unit and observed techniques informally atthese times.674 On occasions, nurses would monitor other nurses practice in relationto nCPT and in a situation where a practice is well established amongst thatprofessional group, this may be acceptable. However, in a situation where staff newtrained in a technique, are expected to monitor other staff when carrying out other dutiesin the Unit, can hardly constitute adequate review. Health Professional 9 was clearabout having had “sometimes” monitored other nurses techniques, when he/she wasthe senior nurse on a duty. 675

Health Professional 9 felt confident providing this supervision for the nurses because forthe first three months only 9 people were trained in the technique. The three clinicalcharge nurses also monitored practice but it was not possible to ascertain when theyundertook their training from the records presented.676

It appeared that total responsibility in relation to training and supervision of nursing staffhad been placed upon Health Professional 6. Health Professional 6 confirmed it wasdifficult at times and that if the unit was busy it would compromise his/her ability toteach.677 This was clearly a heavy burden which was undertaken within the confines ofnormal duties.

Relevant protocols – New Zealand

Whilst lack of supervision of practice was evident, this situation was not vastly differentfrom that which occurred in units within New Zealand during the relevant period 1993–1994. Expert 7 (Hospital 1) confirmed that nursing staff were monitored by othernurses678 and Expert 9 confirmed that nurses practice was monitored in the 1993 –1994 period by observation during work in the unit. Expert 9 was concerned thatmonitoring was by observation only and requested a review of technique to become apart of a nurses annual appraisal.679

Expert 11 (Hospital 1) confirmed that the physiotherapist at the bedside would monitornurses techniques informally and that shortcomings in techniques would be pointed outby the more experienced nurses on duty, and the nurse shown the correct technique astaught by the physiotherapists.680 Expert 10 (Hospital 1) confirmed the process formonitoring nurses techniques was informal and was carried out by experiencednurses.681

The review of technique as practised at NWH was similar to that of other neonatal unitswithin New Zealand. No evidence was given of formal training protocols within NewZealand. Most witnesses recalled their training and supervision without reference toformal training protocols. Clearly formal and nationally recognised training protocols didnot exist then or now, for neonatal chest physiotherapy training or supervision in NewZealand.

674 B5 p15 Health Professional 12675 T 473 l14 – 16676 T 490 l7 – 13677 T 376 l6 – 12 and l14-15678 B4 p7a,b Expert 7679 B6 p4b,c Expert 9680 B1 p4a,b Expert 11681 B2 p4b,c Expert 10

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Relevant International protocols and practice

Expert 16 (England) revealed a similar situation in England, where nurses were taughtby senior nurses, and commented that the National Women’s Hospital nursingprotocols were of a very high standard.682

Expert 13 stated there was no formal monitoring of practice in his/her unit683. Expert 13complimented National Women’s Hospital on the comprehensiveness and attention todetail of their nursing protocols.684

Expert 17 stated that nurses practice was monitored and that either he/she, or seniornurses when Expert 17 was not available, would monitor junior nurses685. Expert 17would also review nursing charts to determine whether infants were receiving treatmentappropriately and ensure that physiotherapy treatment was not becoming routine.

CONCLUSION

2(g) Was there any training and ongoing supervision provided to staffcarrying out the treatment and was this training and supervision inaccordance with relevant New Zealand or International standards.

(a) (i) The training of nurses at NWH in the treatment was thorough.(ii) The supervision of the nurses was informal and inconsistent.(iii) The training and supervision of the staff physiotherapists was

satisfactory.(iv) Health Professional 6 learnt the treatment by observing other pioneers in

the technique and introducing it to NWH. Health Professional 6 did nothave supervision of his/her technique nor peer review, which was notrequired in any relevant New Zealand Code of Ethics or practice guidelineat the relevant time. This was consistent with the international practice,in that international standards did not appear to require ongoingsupervision for physiotherapists.

(b) There are no relevant standards and protocols for training and supervision ofstaff carrying out this treatment.

682 B3 p4 Expert 16, B3 p7 Expert 16683 B4 p4 Expert 13684T811 l9 – 15685 B4 p2b,c Expert 17

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CHAPTER NINE:

ANALYSIS OF THE TREATMENT

2h. What steps were taken by NWH (if any):i) To assess the safety and efficacy of the treatment provided

during April 1993 to December 1994, andii) To inform and support parents with respect to the onset of

brain damage in their children if such steps were necessary.

The first part of this term of reference namely the steps taken by NWH to assess thesafety and efficacy of the treatment provided during the relevant period, has alreadybeen substantially dealt with in Chapter Six under term of reference 2d(ii),686 As thesetwo terms of reference overlap, the principal discussion of risk assessment and stepstaken to assess the safety and efficacy of the treatment provided is explored in depth inChapter Six. This chapter will then focus on the steps taken by NWH to identify theefforts made by NWH to publish the results.

The second part of the term of reference deals with the information and support of theparents

(a) when the babies were originally diagnosed with brain damage; and(b) when the link was made between chest physiotherapy and the brain lesion.

ASSESSMENT OF THE SAFETY AND EFFICACY OF TREATMENT

It was submitted by NWH under this term of reference, that there were opportunities forstaff to provide and receive feedback regarding the treatment introduced into NICU andthis was supported by documentation, in which the staff recorded their concerns andthese concerns were addressed at the Physiotherapy Working Party.687

For the parents, it was submitted it was of significance that there was no independentaudits, monitoring of the chest physiotherapy programme or the way in which theprotocols were being observed apart from the Physiotherapy Working Party, whosemembership comprised physiotherapists and nurses, but no paediatrician.

It was clear in the instance of the meeting of the 16th March 1994, that the concerns withregard to IVH were raised with Health Professional 3, by Health Professional 6 followingthe meeting.688 For the reasons examined in Chapter Six, the potential risk indicatorsthat in retrospect pointed to a problem with nCPT as practised on the unit, were notrecognised.

The keeping of detailed records of the chest physiotherapy treatments however didenable the retrospective case control study to be undertaken and the link established.689

686 Namely “What steps were taken before and after the changes in treatment were introduced including the 2(d)(ii)assessments, if any, of the risks associated with the change in treatment including the steps taken to minimise anyrisks.”687 NWH Vol 1, p10-13, p6688 Refer Chapter 6 and Health Professional 3 T248, l8-13.689 Refer Chapter Six, under “Record Keeping”

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The quality control measures summarised by Expert 4690 led to the detection of thebrain lesions after the cluster of cases in January 1994. The steps taken by NWH topromulgate their ultimate findings and publish the results was an extremely importantstep in informing both the medical profession and the world at large of the detrimentsuffered there as a result of the nCPT treatment.

STEPS TAKEN BY NWH TO PUBLISH AND INFORM

The case control study by Health Professional 5 was undertaken to investigate thecause of the brain lesion. As soon as a likely cause was identified, NWH made adecision to publicise the results to inform others of their findings and to alert the medicalcommunity to avert any further tragedy.

NWH decided to issue a press release, and before doing so wished to inform theparents of the affected babies personally. The steps taken by NWH to inform theparents are set out in the next section.

The steps NWH took in disseminating the information are worthy of special comment.The notification of the results of the study was made before the study was reviewed byother experts in the field, by way of peer review. This was contrary to normal practiceand drew criticism from professional colleagues in other centres.691

Health Professional 5 told the Inquiry despite being criticised by some people “.. we wereconcerned that other babies may be needlessly put at risk during this delay, and thusprovided our data to other nurseries immediately.”

The steps which NWH took to alert the neonatal community of the association betweenchest physiotherapy and the brain lesions were timely and appropriate. We echo thesentiments of Expert 3 in this regard who told the Inquiry:

“This aspect of the story is one where I believe clinicians at NWH are deservingof praise and certainly the thanks of many neonatologists and their patients inNew Zealand and elsewhere. It is certainly not easy to recognise that something‘new’ has arisen in any branch of medicine and neonatal intensive care is noexception.” 692

…The recognition of a possible association between a standard practice in theNeonatal Intensive Care Unit and such a serious outcome must have beendevastating for all the staff at NWH. In such circumstances, it is perhaps notalways easy to be totally open about the situation, but NWH went to greatlengths to advise specifically the patients involved and the public about what hadhappened.” 693

STEPS TAKEN BY NWH WHEN BABIES ORIGINALLY DIAGNOSED WITH BRAINLESION

The senior medical staff who gave evidence at the inquiry, detailed the processes usedwhen parents were informed of adverse findings on ultrasound scans of the head in 690 Refer Chapter Six, under “Regular Meetings and Reviews” and NWH Vol 2, pages 564, 565691 B53 p. 255 Health Professional 3; B4 p. 10 Health Professional 5692 B4 p. 9 Expert 3693 B.5 p..12 Expert 3

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particular. The steps were relevant to the inquiry, because the babies involved hadbeen diagnosed with an abnormality, such as intraventricular haemorrhage, in their earlydays of life.

Health Professional 3 deposed:

“At the time of onset of brain damage there are a number of priorities and anumber of different staff involved. This is a reasonably frequent occurrence on abusy neonatal unit, with the commonest causes being severe intraventricularhaemorrhage in very preterm infant and severe birth asphyxia in term infants.

The first priority is to tell the family. This is usually done by the specialist caringfor the infant in an arranged interview. Several interviews may be arranged.Depending on the individual situation, a senior nurse, the bedside nurse, thesocial worker, a cultural advisor and an interpreter will be present. Extendedfamily and support people may well attend. The specialist’s role is to provide thebest information possible and to explain the implications to the family. He/shewill explain the cause. With ECPE we did not know the cause and this wasexplained. In several of the scenarios, we would have been discussing unusualinfections and middle cerebral artery occlusion as these were what the scanswere suggesting to us at the time.” 694

Health Professional 3 very clearly laid out the routine process and detailed further therole of the senior and bedside nurses and the social worker. Ongoing support wasgiven, which included referral to developmental services or transfer of requirements tothe hospital near the domicile of the infant in some cases. The true link was madebetween the brain lesion and chest physiotherapy, the eight surviving infants werealready being followed up by the appropriate health services. These services continuedto be responsible after the parents were informed of the findings of association betweenthe lesion and chest physiotherapy by National Womens Hospital staff. 695

Health Professional 8 echoed similar processes, pointing out that initial discussions inhigh risk neonates were undertaken and in the first instance kept to a ‘general nature’.696

Health Professional 8 confirmed that communication generally was prompt to theparents when there was worrying news.

Health Professional 7 was also very clear about initial onset of brain injury and theprocess he/she used in general and stated:

“I am aware during the discussions that the parents and often the mother inparticular (e.g. if toxaemic) will not be able to take all of this information in and willneed to go over it again. I would prompt such a follow up discussion” 697

Health Professional 7 further outlined that these discussions would be held with aregistrar or senior nurse present, so the parents have other follow up points of contact,clarifying that the staff will be honest with parents throughout.698 Of particular note ishis/her admission:

694 B51 p237,238 Health Professional 3695 B52 p245 Health Professional 3696 B5 p14 Health Professional 8697 B8 p24 Health Professional 7698 B8 p25 Health Professional 7

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“Once we start to see abnormalities in the baby we would raise these issues withthe parents. These lesions were rare and unusual enough for me to tell theparents that I was confused about their aetiology…..although I tried to be honestwith the parents I am also careful not to make predictions which I cannot beconfident about…. So sometimes with these babies we could not give theparents the information they wanted to know. This could potentially lead tosuspicion on the part of the parents that we were withholding information fromthem. In fact, we had no idea at the time as to the cause of these unusuallesions.”699

Health Professional 7 confirmed that a social worker would also be part of thediscussions to provide ongoing support.

From the parent’s viewpoint, there was little doubt that early discussions had takenplace with a variety of the senior medical staff giving evidence, but the parent’s deposeddegrees of ‘uncertainty’ in relation to the explanations they were given. This supports thestatement made by Health Professional 7 in making mention of some material notalways being taken in by parents in the first instance.

Parent 2b was critical of Health Professional 3’s approach, believing Health Professional3 was ‘dismissive and blunt’.700 Parent 7b was told by the nursing staff to speak withthe doctors, but in his/her words ‘was reluctant to do this and received no explanationconcerning the ultrasound’.701 Health Professional 3 refuted this and referred the Inquiryto notes of a meeting of 19 September 1994 with a social worker and another doctorwhere the findings were explained in detail. A further meeting was held that day tofollow up on the explanation at the ‘mothers request’,702 and these discussions weredocumented in the baby’s notes.

There were two parents who were most critical of the medical staff in relation to theoriginal brain lesion discussions, and in particular focussed their criticism on one of theneonatal paediatricians within the unit. This related to the way in which they wereinformed that the lesion their baby had was very rare and that NWH had never seenanything like it before.

The parents believed that the explanation was lacking and that the paediatrician was“glib”. In response the paediatrician told the Inquiry that he/she believed it wasirresponsible to raise possibilities that were theory only and believed that he/she hadcommunicated with the parents as appropriately as he/she could in the circumstances.The paediatrician confirmed that at the time of the discussions, he/she initially did nothave a clue what the lesion was.703 “.. unless we have absolute evidence that what wewere seeing was linked, then it would be irresponsible to raise possibilities that weretheory only”.704

Although some parents were critical of medical staff’s attitudes and explanations, itappeared that all senior medical staff followed a similar process when initially informingparents of adverse findings. They ensured support from nursing staff and socialworkers in the early period, and for ongoing support, referred the parents to hospital orrelated agencies.

699 B9 p28 Health Professional 7700 B2 p13 Parent 2b701 B3 p11) Parent 2b702 B12 p59,60) Health Professional 3703 T 450 l 13 –15704 T page 452 l 26 – 28

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At the initial diagnosis of brain damage, the support from the medical and multi-disciplinary team was appropriate.

STEPS TAKEN BY NWH TO INFORM PARENTS OF RESEARCH RESULTS

The staff at NWH determined to contact all the parents of the affected babies, andmake appointments to attend on the parents personally to tell them of the findings.

The steps taken were an initial phone call to arrange an appropriate time to visit theparents and the persons who were to undertake the task of imparting the information orone of two neonatologists and a counsellor or social worker. The task of attending onthe families fell to Health Professionals 3 and 7.

On attendance with the parents, an information sheet for parents was prepared 705

together with a follow up letter, inviting further contact with the counsellor orpaediatrician, a phone contact for a coordinated group involving other parents in thesame position, and a general offer of support. In addition, the parents were given a formand information to enable a claim for compensation to be made to ACC.

Some of the parents were very critical of the way in which they were informed.706 Theywere critical of the timing at which they were informed (“we were not met with until theday the article was already in the newspaper”),707 and of the offers of support.708

For one set of parents, the timing of the notification occurred on the first anniversary ofthe death of their baby, and this was unfortunate.

It was accepted amongst the criticisms, that telephone contact had initially been made,to inform the parents that NWH staff wished to speak to them and to arrange a suitabletime.709

Two sets of parents in particular were critical that there had been a failure to disclose allthe information710 and one described it as a “cover up” which commenced after theinitial contact with the neonatalogist and continued through to the meeting informing theparents of the research.711

In addition to the criticism that NWH staff failed to disclose all the information, Parent 3aurged that the process of disclosure should have been fully explained, and told theInquiry:

“…. I think they should have outlined the whole process. I think they shouldhave outlined the intention of the use of the material by way of subsequentpublications etc. I think they could have presented an argument based on theurgency that you have raised, which would have given comfort that here wasmost unfortunate circumstances that has been addressed professionally,

705 NWH docs vol 2 p.729706 T89 l.18-21 Parent 9a. “it was a very vague explanation. The meeting … was a long meeting, my [spouse]particularly was extremely angry. Questions were basically avoided. The answers were not forthcoming, theywere cloudy answers trying to direct us away. I never got an answer”707 T.90 l.19; T.91 l.1-9708 T.97 l.8-14Parent 9b– e was not offered any support following the home visit.709 T90 l.29 Parent 9a710 T181 l.6-17711 T97 l.27-28; T98 l.1-2

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promptly and honestly all the way through. And I don’t think that information wasforthcoming”.712

Parent 3a conceded that the information needed to be in the public arena 713 but hadconcerns regarding the scientific release of the records as he/she believed the parentsshould have been informed of the research when it was being undertaken and havebeen taken through the information gathering. “… Step by step, just quietly”. 714

In response, Health Professional 3 told the Inquiry that there was no cover up anddetailed the sequence of events in relation to the release of the research findings andinforming the parents. 715

The Inquiry has considered the evidence and perused the information sheets and letterswhich were given to the parents at the meeting with NWH staff. The letter to the parentsfollowing the visits stated:

“Please remember you have an open invitation to contact [Health Professional3] or me if you need more information, or if you think it could be helpful to talkthrough any of the issues.” 716

In addition, the letter drew attention to the offer by one of the parents to coordinate agroup for parent support.

No reference was made however to the Patient Advocacy Service and its ability toprovide ongoing support for the parents.

The Inquiry heard from Health Professional 1, a social worker who had been involved asa contact and home visits. Health Professional 1 gave evidence of the steps taken byNWH on the discovery of the link and the acknowledgment of the need to notify parents.

Health Professional 1 gave evidence of the specific steps taken by National Women’sHospital on the discovery of the brain lesion (ECPE) and the acknowledgment of theneed to notify parents717 which consisted of:

(a) Establishing a multi disciplinary team to explore the most effective way to informand support the families affected.

(b) Provide information to concerned members of the public, after the media

release, to support other parents whose babies were in or had been in NewbornServices.

It was decided to undertake both of these steps by:

(i) Personally contacting and visiting the affected families as soon as possiblebefore the media release.

(ii) Establish an 0800 line, staffed for 10 hours per day by informed social workers.

712 T182 l.3-25713 T.183 l.19-23; T182 l.28-31714 T187 l.16-20715 SB 23 p.127-130716 NWH vol 2 p.730717 B4, p20-22 Health Professional 1

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Initial telephone contact was made by two social workers with considerable experiencein the Newborn Service and an appointment time was made at the earliest convenienceof the parents. These visits included meetings in the evening and out of town.

It appeared that ‘strenuous efforts were made to contact families’,718 and only onefamily remained untraced.

Health Professional 1 outlined the visits and the information covered which was:

- An explanation of Neonatologist’s (Health Professional 5) findings and a writtensummary.

- Contact numbers for ACC claim.- Contact numbers for ongoing support for hospital personnel.- Permission sought to inform the GP and pediatrician, as appropriate.- Checked whether the family wished the staff to contact any other significant

people.- An assurance that specific information would remain confidential. Individual

families would not be identified by name, by the media.- Possible emotions were predicted, it was assumed findings would trigger painful

memories for the parents. An open invitation to contact both Neonatologist andsocial worker was given.

- An information sheet was provided.719

Following the visit, Health Professional 1 gave evidence that further phone contract wasmade, and that counselling was offered. He/she stated that ongoing telephone contact,depending on the individual need for support, continues for approximately six to eightweeks, the period generally acknowledged as the most acute and critical time of anycrisis.720

A final letter was sent to families and stressing the availability of the Neonatologist andsocial worker,721 both of whom were contacted by parents during this period.

Health Professional 1 confirmed also that families were referred to Income Support todeal with the issues of respite care, appropriate benefits and/or other assistance:“Yes I gave the families the form for the handicapped child allowance and alsoinformation regarding the respite care which is again funded not through ACC butthrough the Income Support.”722

There was however no referral by NWH staff of the parents to the Patient AdvocacyService. This omission was criticised and the Inquiry was told that NWH did not have asatisfactory relationship with the advocacy service.723 The Inquiry was referred to a1991 Report,724 where it was noted that there was a lack of awareness amongstpatients of the existence of the service and the resentment that a number of seniormedical staff had toward the Patient Advocacy Service, following the Cartwright Report.

The criticism that the parents were not referred to the advocacy service and that nomention was ever made of advocacy service, was confirmed by Parent 3a and by

718 B4, p22 Health Professional 1719 B5, p23 Health Professional 1720 B5, p25 Health Professional 1721 T 591 L 19-22722 T 591 L 11-14723 Patient Advocacy Chap 7724 Brief 17,p.147-149 Expert 2

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Health Professional 1. The latter told the Inquiry that brochures describing the advocacyservice and how to use it would have been available to parents during 1993 to 1994,725

but Health Professional 1 did not raise this possibility with the parents nor refer them tothis service.

Given the role of the Patient Advocacy Service, the criticisms which have been made ofNWH staff to disclose all information and make it readily available, could have beendealt with by the Patient Advocacy Service. Instead of a parent consistently requestingmeetings and asking for further information, (a process which took some considerabletime), the additional stress could have been averted by the use of the patient advocateto liaise with the neonatal unit at NWH and obtain the information as required.

CONCLUSION

2(h) What steps were taken by NWH (if any):

(i) To assess the safety and efficacy of the treatment provided duringApril 1993 to December 1994:

ConclusionThe steps taken by NWH to research and publicise the results of the link between chestphysiotherapy treatment as practised at NWH and the brain lesion were timely andappropriate. NWH deserve commendation for their openness in acknowledging thetragic occurrence within their unit, to alert others of the potential consequences.

(ii) to inform and support parents with respect to the onset of braindamage in their children if such steps were necessary.

Conclusion

(a) The initial steps taken by NWH staff to inform parents of the brain damage totheir children were appropriate, professional and timely, with the exception of theomission to involve the Patient Advocacy Service.

(b) Referral to the Patient Advocacy Service could have assisted in providing furtherinformation and support to those parents requiring it.

725 SB2, p2 Health Professional 1

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CHAPTER TEN

WHAT LESSONS CAN BE LEARNED

In the course of this Inquiry, reference has been made to issues which arose in thereport of the Cervical Cancer Inquiry, namely the Cartwright Report. It is important insuggesting the lessons to be learned from this Inquiry, to place the Cervical CancerInquiry and the issues of medical practice at that time, in context.

From the Cartwright Inquiry, four matters of concern are relevant to this Inquiry. Theywere:

• There was professional disagreement among clinicians about the treatment andresearch being undertaken by one clinician.

• The type of research was prospective and undertaken without patient consent.• The principal Clinician undertaking the research failed to collate the final data to

assess the overall results.• The response from NWH to the data which was published, was negligible.

It is clear to us that these concerns of the Cartwright Inquiry were not relevant to thisInquiry. It is to be expected that modern ethical standards would prevail in any case.However, to draw direct comparison with the Cartwright concerns:

• There was no disagreement about the introduction of the planned change intreatment procedures. The change in treatment was planned and involvedconsultation with the multi-disciplinary teams of medical staff, physiotherapists andnursing staff. It was undertaken with careful regard to practice at other hospitals.

• This Inquiry did not involve prospective research being undertaken in respect oftreatment to be applied or withheld. The research in this Inquiry was a retrospectiveclinical audit of medical records accessed by appropriate personnel andanonymised in its published form. This research was published to alert otherhospitals and neonatal intensive care units of the adverse effects experienced atNWH.

• Once the link with chest physiotherapy was suspected in December 1994, therelevant clinicians worked hard and with speed to identify the cause and to collatethe data as rapidly as possible.

• NWH staff published the results and outcomes of the tragic occurrences within theirunit to ensure other neonatologists were warned of the potential risks and to fosterconfidence and trust in the medical profession. This openness of NWH inacknowledging the tragic occurrence within their unit, and widely publishing that fact,should not be overlooked in the outcome of this Inquiry. These actions followprecisely the lessons to be learnt from the Cartwright Inquiry, and provide acreditable example for others in the medical profession to do likewise. Public faithand confidence in the medical profession require it.

We trust that in highlighting these differences, it is evident that these lessons werelearnt and followed from the Cartwright Inquiry.

The following are lessons which flow from this Inquiry, which may be of assistance toboth the medical profession and the wider health sector.

Lesson One: Peer Review:

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The warning contained in the Cartwright Report is worthy of repetition in this Inquiry.

“An Inquiry into medical practice is one form of peer review, albeit enforced. It isalso the most disastrous for the profession, for patients and for the publicpurse…. Unless the profession can establish adequate peer review andadequate systems to cope with the inevitable mistakes or problems caused byincompetence, then there will be a continuing succession of Inquiries of thisnature.”

As the Cartwright Inquiry recommended, the obligation to undertake peer review is tomaintain realistic self scrutiny and to seek and accept criticism and advice fromprofessional colleagues. It is not a concept solely for the medical profession and mustbe applied to all health professionals.

This Inquiry has highlighted that senior practitioners working at an expert level, butisolated from others of the same level of equal competence, must have access toadequate peer review, even it means accessing relevant personnel or professionalsoutside New Zealand. This includes practitioners within a busy larger service, such asa senior health professional in a neonatal unit.

All health professionals who have responsibility for patient care must have effective andregular peer review. By effective peer review it is intended that there should be a regularreview of a practitioner’s clinical and practical skills, including direct observation. Thisreview should be by a suitable peer, and is to be in addition to current standards of peerreview. This matter should be referred to and regulated by the appropriate professionalbodies, responsible for the registration and discipline of the health professionals.Anything less than peer review by direct observation would not have uncovered theproblem at NWH.

In this way, practitioners including experts, will have the benefit of supervision andscrutiny of their practice.

Lesson Two: Adequate Information of Outcome

The parents of the infants in this Inquiry were largely unaware of the risk of disabilityfrom pre-term birth, in spite of assurances from the medical staff that this topic wasroutinely raised.

The issue of adequate information regarding medical intervention, its potential outcomeand risks requires constant vigilance, to ensure that the consumers of the healthsystem understand the nature of the medical intervention. This is fundamental to theprovision of consent, where required, and to the ability of the consumer to deal with theoutcomes of such intervention.

The possible adverse outcomes for most procedures are predictable, and it is essentialthat health professionals impart this information to consumers.

In Neonatal Intensive Care, the adverse risks for very low birthweight babies are wellknown by clinical staff, and quantifiable. It is necessary for the parents of these babiesto be adequately informed of the potential outcomes, at the earliest opportunity.

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The imparting of information in stressful and difficult circumstances requires carefulattention and where necessary, follow-up professional assistance. It is clear from thisInquiry, that despite parents being told of adverse outcomes, the stress of the situationdid not enable the information to either be retained or understood.

Particular care needs to be taken with parents of pre-term infants to ensure that theyhave been informed of the risk of adverse events, in clear and understandable language.

Lesson Three: Detailed Clinical Record Keeping:

The detailed and the thorough records that were kept of the treatments provided byNWH in this Inquiry received commendation. The thoroughness and accuracy of suchrecords are deserving of praise and provide a good example to others for good clinicalpractice.

The standard of record keeping at NWH enabled the association between chestphysiotherapy and the brain lesion to be made.

The importance of records, including the name and time at which treatment isundertaken, the observations of the person performing the treatment, the clinicalaspects of such treatment are all features of good and competent clinical practice. Thisis recommended as good practice for all health professionals.

Lesson Four: Parental Consent in neonatal intensive care units:

The issue of informed consent needs further clarification with regard to the NationalEthical Guidelines.

The issues of consent for complex and prolonged admission with consequent multipletreatments, particularly in an intensive care unit deserves special attention. Themedical procedures to be undertaken and the necessity for obtaining consent to anyone of those procedures needs to be addressed in a cohesive and consistent waynationally.

A committee comprising consumers of the neo natal intensive care unit, clinicians andmembers of multi-disciplinary teams should confer to provide a standard approach toconsent, given the range of procedures and the complexity of treatments undertaken ina neo natal intensive care unit, such as that at NWH.

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Lesson Five: Consent for Training

Parental consent for training at NWH was not sought. On a perusal of the relevantguidelines, parental consent for training was specifically required and compliance withthe informed choice and consent guidelines should have been followed, namely that theparents were advised the hospital was a training hospital, that the position and role ofthe staff should have been explained and that the parents had a right to know theexperience of the person treating their baby.

There is a distinction in present practice between a specific training situation, in whichconsent must be obtained, and an in-service clinical environment, where staff will betrained in new techniques and procedures. However, the guidelines and the practiceand procedures currently undertaken need to be consistent. If a distinction is to beaccepted in practice, this should be reflected in any current guidelines or ethicalstandards.

Lesson Six: Clarification of Publication of Internal Audits and EthicsCommittee Approval

One of the issues identified in the Inquiry is whether the research outcomes from theinternal clinical audit should have been sent to the Ethics Committee for approval, priorto its publication. In this Inquiry, as a result of the comparisons undertaken within NWHNeonatal Unit of its medical records and data, an article was prepared which identifiedthe link between the lesion and chest physiotherapy. In the interests of the public good,and as a warning to other units, NWH published this article.

The issue raised before this Inquiry is whether such data or research should have beenreferred to the Ethics Committee for approval prior to publication. On the basis of thepresent guidelines, it would appear that such research came within the definition ofinternal clinical audit. Whether the intention to publish the research meant it was nolonger an internal audit was the matter at issue.

To prevent issues of this nature arising in other such inquiries, it would be appropriate toclarify the status of such research data, particularly where the data is to be published.

In the interests of guidance for health professionals and also in the interests of researchbeing published for the public good, this issue should be clarified in the NationalStandard for Ethics Committees.

Lesson Seven: Patient Advocacy Services

One of the issues arising in this Inquiry is the nature of distressing information beingimparted to parents of affected babies and the impact upon the parents of receivingsuch information. The approach by NWH to personally attend on parents and toprovide them with some written information is to be commended. However someparents wished to seek further information and detail regarding the facts surrounding theinvestigation and its outcomes.

The difficulty facing an individual or individuals obtaining information from personnel atHospitals should not be under-rated. The referral of consumers, such as the parents inthis Inquiry, to a Patient Advocacy Service, would have been of assistance to theparents, to provide a liaison between the parents and the neonatal unit and facilitate thedisclosure of information.

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It is recommended that all health professionals be urged to refer consumers to thePatient Advocacy Service, to assist in any outstanding inquiries or needs, which theymay have. In this respect, the role of the Patient Advocacy Service should bestrengthened.

Lesson Eight: Research in Neonatology

Health Professional 5 pointed out that many of the neonatal treatment choices are notbased on firm scientific evidence, and expressed concern that common practices suchas this one which have developed without good supportive research can still, and willstill, be found to have unexpected, severe sometimes, adverse effects.726

“I think I’m on published record as having described these phenomena asfrequent and disastrous, but given that a large proportion of medicine is notbased on sound research but it based on practices which are widely acceptedand thought to be clinically beneficial, I fear that we will continue to see thesedisasters. They are very well documented in neonatal intensive care, partlybecause it is a new speciality, and partly because outcomes are carefullyreviewed, which they are not in many other branches of medicine, and partlybecause there is a great deal of active research in neonatal medicine whichprovides constant contrast to those aspects of our care that are not wellresearched. At the time of presenting our findings to my colleagues at NWH Irecall vividly saying to them I believe this is yet another common, well-respectedtreatment, without good basis, which has turned out to be disastrous. There havebeen many – I believe there will be many more. I do not believe they are allpreventable, but I do believe they should become less frequent with time,because more of our practice will be better based on research and becausepresumably tragedies lying in wait, if you will, will come to the surface.”

Health Professional 3 drew attention to the wide variations in practice evident in differentunits, sometimes even contradictory practice,727 and also observed that well-established treatments can give rise to previously unrecognised complications.728

Expert 3 made clear the role of audit in neonatology in being able to detect differences inoutcome between units and allow for review of practice where warranted. Expert 3 said“..the collection of basic data on mortality and morbidity is precisely the tool that isneeded to monitor changing neonatal practices.” (B7 p16)

The identification of the adverse consequences of chest physiotherapy at NationalWomen’s Hospital is an example of the importance of audit and research in thisspeciality. Whilst a high degree of ethical rigour must be maintained in undertaking suchresearch, it is imperative that the scientific questioning process continues. Ongoingneonatal audit and research is to be encouraged and supported.

726 T314727 B29-30, p120-1728 B54 256

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APPENDIX I

Physiotherapy treatments of the babies in the first 28 days.

Case 1 2 3 4 5 6 7 8 9 10 11 12 13D1 0 0 0 0 0 0 0 0 0 0 0 0 0D2 0 0 0 0 0 0 0 0 0 0 0 0 0D3 0 0 0 0 0 0 0 0 0 0 0 0 0D4 3 0 0 0 0 4 5 0 0 0 0 0 0D5 1 0 0 0 0 0 6 0 0 0 0 0 0D6 4 0 0 0 0 5 6 0 0 0 0 0 0D7 4 0 0 0 0 6 6 0 0 0 0 0 0D8 2 0 0 4 0 6 6 0 0 0 0 0 0D9 4 0 0 5 3 2 6 0 0 0 0 0 0D10 4 0 0 6 4 3 5 0 0 0 0 0 0D11 4 0 0 4 5 2 5 5 0 0 0 0 0D12 4 0 2 5 4 1 6 6 0 4 0 4 0D13 4 0 8 1 4 0 6 6 0 5 0 5 0D14 4 0 8 4 4 0 6 7 4 5 4 5 4D15 3 0 4 6 5 0 8 5 6 5 5 4 4D16 4 3 4 6 5 0 3 5 6 5 5 5 5D17 2 4 4 5 5 0 4 6 5 5 5 5 4D18 3 4 4 6 5 0 d 5 5 5 5 5 4D19 4 4 4 5 5 0 d 4 5 5 5 5 5D20 2 4 4 4 5 0 d 4 5 5 5 5 5D21 3 4 4 4 3 0 d 4 5 5 5 6 6D22 3 4 4 4 1 0 d 4 5 7 5 5 4D23 2 4 4 6 2 0 d 5 5 4 5 5 5D24 2 4 4 0 0 0 d 4 5 6 5 5 5D25 4 4 4 2 4 0 d 5 6 5 5 5 5D26 4 4 4 1 4 0 d 0 5 4 5 6 5D27 4 4 4 0 2 0 d 0 3 4 5 5 4D28 4 4 4 0 2 0 d 0 5 5 5 7 5

1st 28 daysDays of physiotreatment

25 13 17 18 17 8 14 14 15 17 15 17 15

Number oftreatments

82 51 74 78 72 29 78 75 75 84 74 87 70

WholeadmissionDays of physiotreatment

49 24 31 18 18 15 14 14 17 24 47 29 38

Number oftreatments

160 93 83 78 73 52 78 75 84 112 207 139 164

NurseTreatments

0 1 4 18 18 14 24 24 37 24 76 52 58

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APPENDIX II

CASE DETAILS OF THE INDIVIDUAL BABIES

Case 1 - Baby 11

This baby was born in Gisborne. The gestation was 26 weeks, and the birthweight 900grams. The baby was transported to National Women's Hospital by the WaikatoHospital transport team.

The baby suffered many complications of prematurity, and subsequently died on Day56.

The baby’s first head ultrasound was performed on Day 2, and was normal. However,on Day 5 a large Periventricular Haemorrhage was obvious on the left side. By Day 18,there were cysts evident in the white matter adjacent to the ventricle, and by Day 22 thecystic appearances had increased.

Physiotherapy was started on Day 4 and continued through to Day 52. Baby 11 died ofrespiratory failure on Day 56, and a Post Mortem was performed.

The inclusion of this baby in the ECPE Cases is somewhat questionable as indicatedby Health Professional 5. The brain lesion appeared to evolve from an early Grade IVPeriventricular Haemorrhage which is a readily recognised problem in prematurebabies. The Post Mortem findings were not particularly characteristic of ECPE. None-the-less the ultrasound appearances in October were certainly consistent with ECPE.

Case 2 - Baby 12

This baby was born at National Women's Hospital. This baby’s gestation was 24weeks, and his birthweight 680 grams. Baby 12 did not have Hyaline MembraneDisease, but did require ventilation for apnoeas. Baby 12 progressed on to ChronicLung Disease.

The baby’s ultrasound scans showed no significant abnormality on the sixth day, but afurther scan performed on Day 36, showed major cerebral destruction consistent withECPE. Because of the degree of cerebral damage, intensive care treatment waselectively withdrawn and the baby died.

Physiotherapy was started on Day 16. With the exception of one physiotherapytreatment, all such treatments were carried out by physiotherapists. The one exceptionwas a nurse who performed physiotherapy for one session during the day. There wereno night physiotherapy sessions given.

Case 3 - Baby 1

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This baby was born in 1993 at National Women's Hospital. Baby 1’s gestation was 27weeks and birthweight 695 grams. The baby suffered Hyaline Membrane Diseaseprogressing on to Chronic Lung Disease. The baby also suffered multiple otherproblems, Osteopenia was recognised at an early stage which was unusual, butincreased the likelihood of fractures.

An ultrasound was performed on Day 2 and again on Day 14 and both were normal.However, on Day 41, characteristic findings of ECPE were observed on the left side.

Physiotherapy had started on Day 12 and stopped on Day 41 which was the same daythat the large ECPE lesion was detected. There were four treatments performed bynurses, all within normal working hours. On the second and third day of physiotherapy,the baby received treatments eight times each day. This was a specific order becauseof the collapse/consolidation evident on the baby’s chest x-ray, and all of thesetreatments fell between 0800 and 2000 hours. On the following day the presence of ribfractures were noted.

This baby was discharged. Regarding the baby’s outcome, the mother reported:

“[Baby 1] is at school. [Baby 1] is getting on well, with no current indication ofbeing affected intellectually. [Baby 1] is bright but is physically disabled. [Baby1] has difficulty in writing, difficulty with physical education, but [Baby 1] does notneed any special assistance at school, at present, apart from the extra effort theteachers have put in with [Baby 1].”

“It has been recommended that [Baby 1] has a special chair at school ... [Baby1] is toilet trained, but can't wipe [his/her] own bottom. [Baby 1] can only feed[him/herself] with one hand. [Baby 1] can not hold, for example a yoghurt pot orsomething like that, so [Baby 1] feeds [him/herself] with difficulty. Grasp in theright hand is not good. [Baby 1] can not dress [him/herself] properly, can not tieshoe laces, he/she falls over a lot for a child of [that age]. [Baby 1] can balanceon [his/her] left leg but not on [his/her] right leg and overall [his/her] balance isnot brilliant. [Baby 1] is restricted in [his/her] physical activities in spite of tryingvery hard and of course can't run properly.”

Case 4 - Baby 2

This baby was born in 1993 at National Women's Hospital. The baby’s gestation was27 weeks with a birthweight of 885 grams. [Baby 2] did not have Hyaline MembraneDisease but did need to be ventilated for apnoeas.

Ultrasound examinations began on Day 3 and abnormalities were detected right at thestart. The initial abnormalities Day 3 and Day 9 were echogenic flares. In addition in thelatter scan, there was some degree of ventricular asymmetry. On Day 42 a new andsevere lesion was detected affecting both sides of the brain. This was confirmed onsubsequent scans.

Physiotherapy was started on Day 8 and stopped on Day 26. Baby 2 was the first toreceive regular overnight treatments, at four hourly intervals, and the overnighttreatments were given by nurses.

Baby 2 was discharged. The mother said of Baby 2’s progress -

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“[Baby 2] has responded well at the [Home] but [he/she] still needs a lot ofphysiotherapy. While there is nothing wrong with [his/her] mind, [he/she] can't sit up on[his/her] own, [he/she] can't walk at all unsupported and has difficult hand grasps.Basically [he/she] has a lack of motor control. To look at [him/her] you wouldn't thinkthat [he/she] has any disability. [He/she] has limited speech. [Baby 2] can't createsentences, only simple words, and [he/she] probably has a total vocabulary of about tensingle words. [Baby 2] is not toilet trained. [He/she] has to wear glasses and has hadan operation to correct a squint. [He/she] also had an operation on a muscle at the topof [his/her] legs because they were crossing and they cut the muscles to loosen them.[His/Her] left hip is out. [He/she] sees an Orthopaedic Surgeon every six months, and[he/she] will need hip surgery as [he/she] gets older. [He/she] dribbles continuously,[he/she] has to be turned at least twice a night, [he/she] can't do anything for[him/herself], and it is unlikely that [he/she] will ever be able to walk by [him/herself].”

Case 5 - Baby 8

This baby was born in 1993 at National Women's Hospital. The baby’s gestation was27 weeks and the birthweight 750 grams. He/she suffered Hyaline Membrane Diseaserequiring ventilation.

Ultrasounds were performed, and on Day 5 there were no abnormalities seen.However, by Day 23 there was a left-sided full thickness brain injury, and on Day X right-sided changes were seen as well. This lesion was consistent with ECPE.

Physiotherapy had been started on Day 9, and ceased on Day 29.

Baby 8 was discharged. Of Baby 8’s progress, the mother said -"[Baby 8 ] is now aged [X] years. [Baby 8’s] biggest problems are the pain and fatigue.[He/she] gets very tired very quickly ... [He/she] has gained [his/her] balance and canwalk unsupported as a result of the various therapies, including riding and swimming.Other major problems are the loss of motor function and co-ordination especially in theleft arm and leg. [Baby 8] also has a speech impediment, making [him/her] difficult tounderstand at times ... [He/she] can't dress or undress [him/herself] because [he/she]has only one hand so can not undo buttons or put on socks. [He/she] can put on[his/her] shoes but [he/she] can not tie them up. [He/she] feeds [him/herself] with[his/her] left hand but [he/she] can not cut food, [he/she] only manages cups with ahandle. The left hand is weak and low muscle tone."

Case 6 -Baby 3

This baby, one of twins, was born in 1994, at National Women's Hospital. The baby;sgestation at birth was 26 weeks, and birthweight was 990 grams. The baby had mildHyaline Membrane Disease and apnoeas requiring ventilation.

Baby 3 had ultrasounds on Days 2, 6,11 & 18. All were normal. On Day 31 a brainlesion was noted on the left side, by Day 33 this was evident on both sides. Thisprogressed to become the ECPE lesion.

Physiotherapy had started on D4 and continued until D12. It was restarted on D34 for afurther eight days.

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Baby 3 was in hospital for eight months, finally being discharged from Starship Hospitaldue to an airway problem which required treatment there. The mother said -"[Baby 3] is now [X years old] and with a teacher aide attends ... school. [He/she] has atough start to life. Thankfully [he/she] never had the same amount of physio treatmentas [his/her] [sibling], [Baby 10]. [He/she] lived but [he/she] will never run like otherchildren or hope to keep up physically with [his/her] peers. [His/Her] damage isdescribed as Ataxia, low muscle tone, the loop from the brain to [his/her] muscles isdelayed, and as a result [he/she] is not a fluid as [he/she] should be."

Case 7 - Baby 10

This baby, twin of Baby 3, was born in January 1994, at National Women's Hospital.The baby’s gestation at birth was 26 weeks, and his/her birthweight was 880 grams.Baby 10 had moderate to severe Hyaline Membrane Disease requiring ventilation.

Baby 10 had ultrasounds on Day 2 & Day 6 with satisfactory appearances. On D13 alarge right-sided lesion was detected, and on D16 this was seen to be evident on bothsides of the brain.

Physiotherapy was started on Day 4, and continued through until Day 17.

As a result of this severe brain lesion, intensive care support was withdrawn and he/shedied on Day 20.

Case 8 - Baby 4

This baby was born in 1994, in Whangarei Hospital. He/she was transported to NationalWomen's Hospital by the National Women's Team. His/her gestation was 26 weeks,and his/her birthweight was 1090 grams. He/she had moderately severe HyalineMembrane Disease requiring ventilation.

Baby 4 had ultrasounds performed regularly through the month of birth and on D5 aPeriventricular Haemorrhage was seen on the right side. On D25 ECPE changes onboth sides of the brain were evident.

Physiotherapy had started on Day 11. Because of his/her severe brain injury, theintensive care treatment was stopped and he/she died on D28.

Case 9 -Baby 13

This baby was born in 1994, at National Women's Hospital. His/her gestation was 25weeks, and his/her birthweight 735 grams. The baby was born in poor condition,requiring resuscitation and ventilation.

Ultrasounds were performed throughout the month of birth, and on D29 the ECPElesion was noted on both sides of the brain.

Physiotherapy had started on Day 14.

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Baby 13 died on D34.

Case 10 -Baby 5

This baby, one of twins, was born in 1994, at National Women's Hospital. The baby’sgestation was 27 weeks and birthweight was 1040 grams. Baby 5 suffered HyalineMembrane Disease, requiring ventilation, and a number of other complications.

Ultrasounds were performed on Day 1, 7, & 14. These were all normal. A further scanon Day 31 showed an abnormality on the left side of the brain which was consistent withECPE.

Physiotherapy had been started on Day 12.

Baby 5 was discharged in 1994. Of her progress -"My [son/daughter] has been slower at physical development than [his/her][sibling] and is behind [him/her] in all other regards. [Baby 5] gets veryfrustrated and has more temper tantrums than a normal child [his/her] age.[Baby 5] has speech difficulties and has problems with the names of colours andcan only combine up to a maximum of four or five words in a sentence. [Baby5] is able to dress [him/herself] in pants and tee shirt, but needs assistance witha sweatshirt and [he/she] is not aware of the front and back of clothes. [Baby 5]can not brush [his/her] teeth and whilst [he/she] is toilet trained during the day[he/she] can't wipe [his/her] own bottom, and [he/she] wets [his/her] bed at night.[Baby 5] has trouble with some activities, particularly drawing, although [he/she]can walk up steps and can kick a ball and things like that. [Baby 5] can't hop orstand on one foot for two seconds. Generally, as I have said, [he/she] is far lessdeveloped than [his/her] [sibling], is less active and outgoing than [he/she] is,and slow to respond to instructions."

The twin sibling did not suffer the ECPE lesion.

Case 11 - Baby 7

This baby was born in1994, at National Women's Hospital. The baby’s gestation at birthwas 24 weeks and his/her birthweight was 730 grams. He/she did not develop HyalineMembrane Disease, but did require ventilation for his/her prematurity. He/she had anumber of other complications including a fractured rib.

He/she had ultrasounds performed on D3 & D10 which were both normal. On D24 anabnormality on the left side was detected which progressed to left-sided ECPE.

Physiotherapy had been started on Day 14 and continued on to Day 62.He/she was transferred to the Starship Children’s Hospital on day 112, and was finallydischarged home on day 235.

Of Baby 7’s subsequent progress the mother said –

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"[Baby 7 ], now aged [X] years, lives with me. I can not work and I spend all mytime looking after [him/her]. [He/she] can crawl but needs support to walk.[His/her] left side and right side are useless because [he/she] has no centre(balance), [his/her] speech is restricted, and [he/she] can not put two or morewords together. For example if [he/she] is trying to say "come here mum" -[he/she] will say "come". Because [he/she] can not put [his/her] thoughts intosentences, I often can not understand [him/her].

[Baby 7] has temper tantrums on a daily basis, during which [he/she] sometimesinjures [him/herself]. [He/she] is not able to feed [him/herself] very well.[He/she] can only partially dress [him/herself]. [He/she] can put [his/her] armsthrough the arm holes of clothes, and [he/she] can pull on [his/her] pants once Ihave pulled them over [his/her] knees. [Baby 7] is still in nappies. [He/she]can't read or write, and [he/she] does not know [his/her] colours. [He/she]certainly can not do what a normal four year old can do.

[Baby 7] has physiotherapy twice a week and is under the care of a number ofspecialists. [He/she] has had an operation in the last few days for throat and willbe in intensive care at Starship Hospital for another two weeks. It will be severalweeks before it is known if this is successful. [Baby 7] is also likely to have afurther operation on [his/her] hips."

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Case 12 - Baby 6

This baby was born in1994, at Waikato Hospital, and was transferred to NationalWomen's Hospital by the Waikato Team. This baby’s gestation at birth was 26 weeks,and birthweight 870 grams. Baby 6 had severe Hyaline Membrane Disease, andrequired ventilation for this.

This baby had ultrasound scans on Day 1, 3 & 8, which were satisfactory. On Day 26the ECPE brain lesion was seen to be developing.

Physiotherapy was started on D12, and continued through until Day 40.

Baby 6 was discharged home, and of the baby’s progress, his/her mother said –

"We consider ourselves very lucky that [he/she] has not been as badly affectedas other children. [Baby 6] is very mobile and [his/her] balance is good. [Baby6] climbs and jumps off things and runs around. We continue to seeimprovement in [him/her] as [he/she] gets older. [Baby 6] is a little smaller thanan average child of [his/her] age. [He/she] can go to the toilet and look after[him/herself] in all regards during the day, but at night [he/she] has to wearnappies. [Baby 6] has no eating problems or handling knives and forks, cupsetc., and has a good appetite. To date we have not been made aware that[he/she] has any problems with [his/her] joints or hips or indeed what problemsof any sort [he/she] may face in the future ... [He/she] has a speech difficulty, …we have [him/her] do mouth and jaw exercises and they are going well. At all thehospital re-checks they say [he/she] is progressing well."

Case 13 - Baby 9

This baby was born in 1994, at National Women's Hospital. This baby’s gestation atbirth was 26 weeks, and birthweight was 725 grams. He/she suffered mild HyalineMembrane Disease and required ventilation. He/she had a number of other problemsalso.

His/Her ultrasound scans were performed on Day 1, 14 & 22, all of which were normal.On Day 32 an abnormality on the right side was seen, and on Day 38 a left-sided lesionwas also seen. These were consistent with the ECPE brain lesion.

Physiotherapy was started on the Day 14, and continued on until Day 50.

He/she was transferred to Rotorua Hospital, and then discharged home. Of his/herprogress the mother said -

"[Baby 9] is now aged [x] years and [x] months old. [He/she] is very small for[his/her] age. [He/she] did not walk until two and a half and walks in a fashion allof [his/her] own. [He/she] has left-sided hemiplegia, suspected righthemiparesis, cerebral palsy, central and obstructive apnoea, generalisedepilepsy, absence epilepsy, partial epilepsy, severe social disabilities ([he/she]bites and screams), learning disabilities, speech disabilities, is only partially

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toilet trained and has suppressed sensation on the left side. [He/she] has noidea in regard to the consequence of [his/her] actions.

[Baby 9] often requires oxygen, [he/she] still desaturates without reason,[he/she] can not feed [him/herself] or drink from a cup properly, [he/she] can notcontrol [his/her] body temperature and this must be done environmentally,[he/she] has reduced skin integrity and is very clumsy. [He/she] is verysusceptible to infection and injury. [He/she] requires 24 hour supervision, as[he/she] is a danger to [him/herself]. [He/she] is very fond of head-banging.[He/she] has apnoea monitors, humidifier, oxygen bottles, pulse oximeter,electronic thermometer etc and sleeps in a specially modified room. My wholehome has been modified to meet [his/her] needs and safety requirements.[He/she] requires daily medication for [his/her] epilepsy and apnoea. [He/she]will in all probability require surgery in the near future to correct [his/her] left foot."

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APPENDIX IV

PROCEDURE OF THE INQUIRY

On the 22nd January 1999, the Director-General of Health appointed Helen Cull QC, DrPhil Weston and Jan Adams to conduct an inquiry under section 47 of the Health andDisability Services Act 1993 into the provision of chest physiotherapy treatment (thetreatment) provided to pre-term babies at National Womens Hospital in or around April1993. Specifically, the various matters into which the inquiry was to be conducted, wereextensively set forth in terms of reference which are fully set out at the beginning of thisreport.

A preliminary meeting was held on the 29th January 1999, at which the inquiry membersheard from both lawyers instructed by interested people or parties and with people whoultimately would be witnesses at the hearing. During the course of this meeting, a bodyof witnesses, namely the parents of the affected pre-term babies, appointed one lawyerto represent their group. Each of the lawyers present sought party status and a right tobe heard at the hearing on behalf of their respective clients.

During the course of this meeting, full minutes were taken and as a result of mattersraised by those present, decisions were made as to the procedure to be adopted inconducting the inquiry. Those decisions were recorded and distributed as rulings of theinquiry team together with the minutes of the meeting. The rulings of the inquiry teamare annexed as Appendix V and the minutes are annexed as Appendix VI.

Pursuant to section 47(5) Health and Disability Services Act 1993, the inquiry teamdetermined that the inquiry would be conducted in an inquisitorial manner, with each ofthe members of the inquiry team asking questions of each of the witnesses. Thelawyers representing the parties were entitled to be present throughout the hearing butwere to be given no right of cross-examination. If the lawyers of the parties wished toraise questions with any witness, they were given the opportunity of directing thosequestions either through the inquiry team or directly to the witness with the leave of theinquiry team.

Each witness to the inquiry was to provide a written statement or brief of evidence inadvance of the inquiry and at the commencement of their evidence, witnesses werepermitted to read their briefs before answering questions from the inquiry team andcounsel for the parties, where appropriate. The inquiry was conducted in a formalmanner with witnesses giving their evidence on oath or by affirmation and the evidencewas recorded and transcribed. This transcript of evidence was made available tocounsel appearing before the inquiry. There are references throughout this report to thetranscript of evidence which the inquiry hearing. The references appear in the text ofthe report as follows: “T.51” which means transcript page 51.

Public Hearing

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During the preliminary meeting, the question of whether the inquiry should be a public orprivate hearing and the extent of the ability to suppress names of witnesses and detailsof medical records or evidence, was raised.

After hearing submissions on the issue, the inquiry team determined unanimously thatgiven the nature of the inquiry, it was important that the inquiry be held in public, with theability of members of the public and the media to attend. This was to ensure that theprocesses carried out by the inquiry were transparent and open.

However in the interests of ensuring privacy, particularly to those family members whoindicated they may wish to seek it during the inquiry and in fairness to all medicalpersonnel involved, a suppression order with regard to the names of the witnesses orany person named during the inquiry was granted to all. Accordingly, the ruling of theinquiry was that to ensure overall fairness and to enable the inquiry team to proceedwith the inquiry, the hearing was to be open to the public, but that names of witnessesand any person named during the course of the inquiry would be suppressed. Similarly,if private personal medical details required to be suppressed, the lawyers were invited tomake an application for suppression of those details during the course of the inquiry.

In its ruling, the inquiry specifically noted that no suppression order could affect thereport or its subsequent release. The ruling related only to the procedures to beadopted during the course of the inquiry and prior to the issue of a report. Thisdetermination was made by way of a written decision dated 4 February 1999, a copy ofwhich is contained in Appendix IV.

Suppression Orders

Mindful of its ruling and of its power to control its own procedures, the Inquiry teammade the rulings known for distribution to the media.

During the course of the hearing, counsel for the parents sought and was granted asuppression order with regard to the evidence detailing the ongoing medical conditionsof the children affected by “the treatment”.

A further issue arose towards the conclusion of the inquiry with regard to the possibilityof publication of matters which had been ruled inadmissible. In a brief of evidenceprepared for an expert witness, portions of the brief were ruled inadmissible on anumber of grounds. They were:

1. the brief contained assertions of fact2. it contained submissions3. it provided opinion, expressed outside the scope of the witnesses expertise; and4. a number of matters raised within the brief constituted a professional attack on

two witnesses amongst others, who had appeared before and co-operated withthe inquiry. These matters had not been put to those witnesses during thecourse of their evidence and they had given their evidence prior to the expertwitness being called.

As a result of objections raised to those particular aspects of the brief, counsel for theparties was invited to revise the brief and concentrate on areas which containedrelevant issues and were of concern to the inquiry team. A revised brief was prepared,and objection was raised in relation to four parts of the brief which infringed the former

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ruling. Accordingly the inquiry ruled that those parts were inadmissible, but in theinterests of expediency, asked that those parts of the brief not be read.

It became evident, following the hearing of the witness, that the draft brief or briefs hadbeen given to the media and accordingly, Counsel assisting the inquiry was invited toconfer with other counsel and inform the appropriate media as to the position. Therewas a direction from the Inquiry that those items which had been ruled inadmissibleshould not be published, as they had not been heard as evidence before the inquiry andwould not attract the privilege attaching to such evidence.

Counsel Assisting

As the inquiry team comprised Dr Weston, a neo-natal paediatrician and Ms JanAdams, a director of nursing, both of whom were experts in their field, it did not appearnecessary to appoint counsel assisting at the outset of the inquiry, as each of themembers of the inquiry team were to undertake examination of the witnesses.

Given the extent of the terms of reference and the proposed witnesses which theparties indicated they would call, it became evident that the inquiry should hear evidencefrom a number of witnesses, including experts in New Zealand and overseas andrelevant witnesses from other neo-natal units in New Zealand. The inquiry teamconvened a meeting of counsel and advised that it wished to appoint counsel to assist,namely to locate witnesses, brief them in accordance with specific questions which themembers of the inquiry had formulated and call their evidence.

[Material deleted to retain confidentiality of witnesses]

Submissions

By the close of the inquiry, counsel indicated their willingness to submit submissions inwriting. A timetable was set in place, allowing counsel time to complete thosesubmissions, submit them to the inquiry team and make them available to other counseland a further time in which to reply to other parties’ submissions. This process wascompleted by 19th March 1999.

Following the preliminary meeting, counsel wished to clarify whether they had the abilityto make submissions in the event of any adverse findings. The inquiry team hadindicated that in the normal course, an opportunity for written comment or writtensubmission would be available, with timeframes in place, for counsel to respond to anyadverse comment or findings within the inquiry’s report.

During the course of the inquiry, all relevant medical records relating to the babiesinvolved, were made available both to the parents to assist in the preparation of theircase and to the members of the inquiry team. Those records, together with copies ofscan reports and scans were held by the members of the inquiry. Access to thoserecords was made available to Expert 8, who wished to peruse the scans and the scanreports. At the close of the inquiry, those records will be returned to counsel for NationalWomens Hospital, which made them available to the inquiry. The medical details inreference to the details relating to each of the babies was suppressed, on the groundsof personal and private information and medical privilege.

After the inquiry had closed and the members of the inquiry were in the process ofdeliberations, a letter was received from the Registrar of the Physiotherapy Board,

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bringing to its attention sections 23 and 26 of the Physiotherapy Act 1949. Section 23makes it an offence for any person in charge of a hospital to appoint any person to carryout the duties of a physiotherapist unless that person is a registered physiotherapist andsection 26 makes it an offence for any person not registered under the PhysiotherapyAct to practice physiotherapy. Counsel assisting the inquiry was asked to provideadvice as to the impact if any this advice had on the terms of reference.

Following receipt of the advice, the inquiry notes the advice from the Registrar of thePhysiotherapy Board and makes its determination on the terms of reference asprovided by the Director-General. If any disciplinary action follows as a result of theinquiry or if there are any charges brought by the Physiotherapists Board following theinquiry, those are matters which are within the control of both the PhysiotherapistsBoard and any professional body overseeing the conduct of its members. It should benoted, that in the context of this hearing, neo-natal chest physiotherapy is carried out bypersons other than physiotherapists, both within New Zealand and overseas. In theevidence produced before the inquiry, the essential training is in the handling of smallpre-term neo-natal infants, which is a prerequisite for any person, physiotherapist ornurse, undertaking neo-natal chest physiotherapy.

Following receipt of the submissions, one further affidavit was tendered to the inquiry bycounsel assisting. The affidavit addressed an outstanding issue arising from the receiptof protocols by National Womens Hospital from Hospital 2’s Neo-Natal Unit in 1993.The affidavit was circulated to counsel for the parties, and a replying affidavit was filedby National Womens Hospital.

After written submissions were received and after the affidavit from Hospital 2’sneonatal unit and the reply from NWH was received, the Chair of the Inquiry received aletter dated 25 March 1999 from the Physiotherapy Board. The Board, through itsRegistrar, wished to bring to the attention of the Inquiry s23 and s26 of thePhysiotherapy Act 1949. These are offence provisions, dealing with the appointment ofunregistered physiotherapists to carry out the duties of a physiotherapist andunregistered persons practising physiotherapy implying they are qualified to practicephysiotherapy. The letter was forwarded to Counsel assisting the Inquiry for advice asto its relevance to this Inquiry and as a result of receiving her advice, Counsel wereinvited to make submissions in regard to the letter, but in particular to the Rules of theNew Zealand Society of Physiotherapists Incorporated. Counsel for the parties madesubmissions in writing and they were received on the 6th May 1999.

On completion of the draft report, the report was circulated to Counsel for NWH andCounsel representing Health Professional 6 with the opportunity for comment in relationto the findings of the Inquiry, as it affected their respective clients. In the interests offairness and of natural justice, our report was referred to Counsel for the parents, but nosubmissions or comment was sought, as the question of adverse findings was notrelevant to its clients. Following receipt of the further written submissions of Counselfor NWH and Health Professional 6 the report was completed in its final form.

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APPENDIX V

INQUIRY UNDER S47 OF THEHEALTH AND DISABILITY SERVICES ACT 1993

INTO THE PROVISION OF CHEST PHYSIOTHERAPYTREATMENT PROVIDED TO PRE-TERM BABIES AT

NATIONAL WOMEN’S HOSPITAL

RULINGS OF THE INQUIRY TEAM

Following a meeting held at Quay West Apartments, Auckland, on Friday 29th January1999, the inquiry team comprising Helen Cull QC, Dr Phil Weston and Jan Adams(absent at the meeting but conferred with subsequently) made the following rulings:

1. The Inquiry under s.47 of the Health and Disability Services Act 1993 wouldcommence on Monday 15th February 1999.

2. Terms of reference for the Inquiry have been distributed to all parties andpersons involved in the Inquiry and witnesses to the Inquiry are asked to prepareanswers in respect of each of the terms of inquiry in presenting their evidence toit.

3. The meeting, consisting of the parents group, staff of National Women’sHospital, clinicians and legal representatives, involved a discussion of theprocedures to be adopted at the Inquiry. Minutes were taken of this meeting andthey are annexed to these Rulings as a record of the discussions which tookplace.

4. As a result of those discussions, the inquiry team has made the followingdeterminations or rulings. They are:

(a) The Inquiry is to be held at Quay West Apartments, Auckland, in theSullivan Room on the 5th floor.

(b) The Inquiry will be open to the public, including members of the media.However, names of witnesses who give evidence at the Inquiry and/ornames of persons involved in the subject matter of the Inquiry will besuppressed, from publication during the Inquiry. If private, personal ormedical details are to be suppressed, counsel are invited to make anapplication for suppression of those details during the course of theInquiry.

This ruling is made in the interests of fairness to all parties required to attend atthis Inquiry and the nature and detail of some of the medical evidence which willbe heard at the Inquiry. Transcripts of the evidence of the Inquiry will remainunder the control of the inquiry team and will not be available to members of thepublic or to the media. No such suppression order can be granted in respect ofthe report, which is to be forwarded to the Director General of the Ministry ofHealth.

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5. The Inquiry will be conducted in a formal manner, with witnesses giving theirevidence on oath (or by affirmation) and the evidence will be recorded andtranscribed for the purposes of the inquiry team and counsel representing theparties.

6. There will be no right of cross-examination, but representatives of parties to theInquiry wishing to raise questions with certain witnesses, will have theopportunity of directing those questions through the inquiry team to be asked ofwitnesses as appropriate.

7. Each witness to the Inquiry is to provide a written statement or brief of evidencein advance of the Inquiry. The timetable for briefs of evidence to be madeavailable is as follows:

(a) Briefs of witnesses are to be delivered to all persons involved in the Inquiry by2.00pm on Friday 12th February 1999.

(b) Briefs of expert witnesses are to be delivered to all persons involved in theInquiry on Friday 19th February 1999.

8. For clarification of times of calling witnesses and accessing transcripts, theinquiry team directs that all parties should contact the administration officer andstenographer of this Inquiry, Ms Grace Rogers, for a witness list and indicatedtimes of giving evidence.

9. The Inquiry will sit for 5 days a week from 10.00am to 1.00pm, and 2.00pm to5.00pm. Witnesses will be permitted to read their briefs of evidence if they wishto do so before answering questions from the inquiry team.

10. All medical records and records relating to each of the patients affected by theInquiry shall be disclosed and forwarded to the solicitor acting for the parents ofthose patients. The inquiry team also directs that copies of the Ministry ofHealth folder be made available to each of the three parties’ legalrepresentatives.

11. At the close of the Inquiry, submissions will be completed in writing by each ofthe parties’ legal counsel, with the right reserved to counsel to make oralsubmissions within strict timeframes.

Helen Cull QCChair

APPENDIX VI

MINUTES OF MEETING WITH THE INQUIRY TEAMHELD AT THE QUAY WEST APARTMENTS, AUCKLAND

FRIDAY 29 JANUARY 1999

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Commencing at 10.00 a.m.

1. INTRODUCTION

The Chair welcomed everyone to the meeting and invited the respective partiesto identify themselves and outline their roles and degree of attendance at theforthcoming Inquiry. Committee members: Ms Helen Cull, QC - Chair Dr Phil Weston Ms Jan Adams [absent]

Grace Rogers - Minute Secretary andStenographer for the inquiry

2. TERMS OF REFERENCE:

Tabled. No discussion ensued. 3. IDENTIFICATION OF PERSONS TO BE INVOLVED IN THE INQUIRY and

PRESENCE OF REPRESENTATIVES • Mr Edwards to collate and manage the briefs of parents if so instructed.

• A list of the medical personnel and their particular bearing on the inquiry

to be provided, plus an indication of the length of their evidence-in-chief.

• Expert witnesses to be scheduled in as soon as possible.

• All main interest groups will have legal representation.

4. INQUIRYa) Public or Privateb) Suppression Order

In response to questions from the floor the Chair advised that if a ruling is madeto the effect that the Inquiry is to be conducted in private and that only the peopleinvolved in the Inquiry will attend, this will necessitate a suppression order inrelation to the transcripts. Consequently, if they aren't to be made available,there will be no publication of what has taken place in the inquiry room.Conversely a public Inquiry can be held with a suppression order, suppressingnames and personal details, and transcripts would not be available to the media.Publication of the report is the final result.

[To be discussed further during the morning adjournment]

5. TYPE OF INQUIRY

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The role of the inquirers is to hear all relevant evidence in a formal way. Briefs ofevidence will be presented and available to people who wish to see what theevidence is going to be, then each of the inquiry team will clarify or ask questionswithin the competence of the particular witness. Clarification of any questionsput to witnesses should be directed through the Chair. Fairness to all parties isof utmost importance, particularly with regard to cross-examination, and allquestions must be relevant

6. PROCEDURE OF THE INQUIRY

Briefs of evidence:To be provided in advance of the hearing.

Availability of transcript:A full transcript to be provided of the day’s evidence, with several printouts ateach break for photocopying and further distribution. Discs to be provided ifrequired.

Evidence to be recorded and given on oath - timing to be determined during themorning adjournment.

Documents disclosed to the Inquiry team:• One article from the Lancet;• A file of correspondence from the Ministry of Health, including

correspondence from the ACC;• Three video tapes from the Ministry of Health marked National

Women's Hospital.

Videos:Reference was made to the relevance of the videos as one was of a term babyrather than pre-term, and the remainder fell outside the inquiry.

[The Inquiry team to view the videos and give an indication as to their relevance]

Involvement of parties:Witness order to be determined after further discussion.

Report and distribution:The Chair to report to the Director of Health by 30 April.

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Matters arising:Answering a question from Dr Weston, the Chair stipulated that the Inquirywould be confined to the terms of reference in relation to the evidence before it,not a re-visitation of whether it is medical mishap or medical error.

Contact person:Grace to be the contact person at the hearing for any duties of an administrativenature.

Issue of briefs of evidence:Witness’ briefs to be supplied by 2.00p.m. Friday 12 February. One copy toeach of the three groups, one copy to each Inquiry member and one to thestenographer.

Recipients of briefs:[Attached]

[The meeting adjourned at 11.30 a.m. to enable parties to discuss the aforementionedmatters.]

The meeting resumed at 1.00p.m.

Public v Private Inquiry:Mr Edwards expressed the view that his clients would find great comfort if the Inquirywere conducted in public, with the proviso that any persons wishing to avoid publicitywould have the right to apply to the Committee for name suppression - including parentsand medical persons. He added that, during the adjournment, he had receivedinstructions to act for all parents present.

Auckland Healthcare’s preference was that the Inquiry be held in private, principallybecause of the distraction created by the media interest and the possibility of “trial bymedia”. They supported and welcomed the families’ suggestion that there besuppression for any individual, albeit a party or a witness. Mr Gilbert suggested that anypublication could await the conclusion of the Inquiry and the availability of the report.

It was agreed that a protection order be available to those who wanted it, whether it befor themselves or for the children. At the time of calling witnesses consideration wouldbe given to suppression of medical details and details of the persons involved.

Mr Everard agreed with the suggestion that the Inquiry be heard in private but expresseda concern that if there were suppression orders, which in themselves could be quitedifficult to define - particularly concerning medical information covered by the PrivacyAct, there could be unbalanced reporting.

The Chair explained the responsibility of the media in a private versus public Inquiry,adding that once the report is delivered to the Director-General it is usually made publicas a matter of course, although the Director-General can determine how muchinformation is to be made public. It does not necessarily follow that if name suppressionis granted a participant’s evidence will be suppressed.

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Although the families were the most vulnerable in this situation, Parent 3a felt that theywould be able to handle any media presence as they were anxious to find the truth.

[The Chair invited further submissions on the matter, indicating that a ruling would bemade by 3 February 1999.]

In terms of witness orders, it was agreed that the parents proceed first, followed by themedical group.

Action: Briefs from all witnesses to be received no later than 2pm on 12 February.Expert witnesses to be confirmed by Friday 19 February.

Inquiry Times:It was agreed that the Inquiry would sit 5 days a week from 10.00a.m. – 1.00p.m. and2.00p.m. - 5.00p.m., with flexibility to sit longer if necessary. Cross-examinationpermitted only through the Chair. It was further agreed that the witnesses should readtheir briefs of evidence.

Medical Records:To alleviate the situation outlined by two of the parents regarding poor communicationand difficulty in gaining access to medical records, the Chair directed that theappropriate records be sent direct to Mr Edwards. A direction was also made thatcopies of the Ministry of Health folder be made available to each of the three parties.

Order of witnesses and length of Inquiry:

After reviewing matters, it was felt that the Inquiry would be completed within 2 to 3weeks.

A parent voiced concern, through Mr Edwards, regarding an imbalance of resourceswith the calling of overseas witnesses. The Chair gave an assurance that fairnesswould be maintained in order to achieve balance and that other people could be calledor articles produced. In fact, the Inquiry Team may wish to call other paediatriciansfrom National Women’s Hospital.

Closing submissions:Submissions in writing with the right reserved to counsel to make oral comment withinrestricted bounds.

GeneralThe Chair to issue a ruling, by or about mid-day Wednesday 3 February 1999, as towhether the Inquiry will be held in public or privately.

THE MEETING CONCLUDED AT 1.35 P.M.

APPENDIX VII

INQUIRY UNDER S47 OF THEHEALTH AND DISABILITY SERVICES ACT 1993

INTO THE PROVISION OF CHEST PHYSIOTHERAPY

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TREATMENT PROVIDED TO PRE-TERM BABIES ATNATIONAL WOMEN’S HOSPITAL

DECISION OF THE INQUIRY TEAMREGARDING A PUBLIC OR PRIVATE HEARING

During the preliminary meeting of the inquiry team with prospective witnesses to theInquiry and their legal representatives, an issue was raised as to whether the Inquiry intophysiotherapy services at National Women’s Hospital should be a public or privateinquiry.

Counsel and their clients were invited to make submissions with regard to this issueamong other matters that were raised by way of procedural matters for the Inquiry.

On all other procedural matters, counsel were in agreement apart from the question ofwhether the Inquiry should be conducted publicly or privately.

The inquiry team, comprising the Chair, Helen Cull QC and Dr Phil Weston, (JanAdams being absent at the preliminary meeting) heard submissions firstly from MrEdwards the lawyer representing the parents of the babies involved in the Inquiry. Hissubmission was that his clients would be comforted if the Inquiry were conducted inpublic, with the proviso that any persons wishing to avoid publicity would have the rightto apply to the inquiry team for name suppression, including parents and medicalpersons.

Mr Gilbert for Auckland Healthcare, submitted that it was his client’s preference that theInquiry be held in private, principally because of the distraction created by the mediainterest and the possibility of “trial by media”. He noted that his client supported andwelcomed the family suggestion that there be suppression for any individual, whether itbe a party or a witness. Mr Gilbert further suggested that any publication could await theconclusion of the Inquiry and the availability of the report. He further submitted that atthe time of calling witnesses consideration would be given to suppression of medicaldetails and details of the persons involved.

Mr Everard, counsel for Health Professional 6, submitted that the Inquiry be heard inprivate as he was concerned that if there were suppression orders it may be difficult todefine them and that in relation to medical information covered by the Privacy Act thereshould not be publication. He also expressed a concern about unbalanced reporting.

The inquiry team comprising Dr Weston, Jan Adams and the Chair, gave considerationto each of these submissions.

The inquiry team reached a unanimous conclusion that given the nature of the Inquiry, itwas important that the Inquiry be held in public, with the ability of members of the publicand the media to attend. The reason for this was to ensure that the processes carriedout by the Inquiry were transparent and open.

However, in the interests of ensuring privacy particularly to those family members whomay seek it during the Inquiry, and in fairness to all medical personnel involved, a

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suppression order with regard to the names of the witnesses or any person namedduring the Inquiry should be granted to all.

The inquiry team were mindful of the fact that if some witnesses sought namesuppression and others did not, it will be difficult to ensure compliance with thesuppression order, particularly if members of the public and/or the media were notpresent throughout all of the Inquiry hearing, noting which witnesses soughtsuppression orders.

The inquiry team was also mindful of the powers of the inquiry team under s.47 of theHealth and Disability Services Act 1993 as the Inquiry cannot offer the immunity fromactions for defamation which the Courts and other statutory bodies may enjoy. (RePergamon Press Ltd [1971] CH 388 at 404)

To ensure overall fairness and to enable the inquiry team to proceed with the Inquiry, aruling has been issued that the Inquiry will be open to the public, but that names ofwitnesses and any person named during the course of the Inquiry, will be suppressed.

If private personal medical details are to be suppressed, counsel are invited to make anapplication for suppression of those details during the course of the Inquiry.

For the sake of completeness, it should be noted that no suppression order can affectthe report or its subsequent release. This ruling only relates to the procedures to beadopted during the course of the Inquiry and prior to the issue of a report.

Helen Cull QCChair of the Inquiry 4 February 1999