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THIS DISSERTATION WAS WRITTEN AS A REQUIREMENT FOR COMPLETION OF MSc. ADVANCED NURSING PRACTICE
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DECLARATION: This written dissertation is my own unaided work.
Signed:………………………………………………..
Dated: 8th
September, 2011
Word count: 14,550
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Acknowledgements
To begin with, I would like to thank God for how far He has brought me on my journey
in a foreign land.
I express my sincere gratitude to my supervisor, Fiona Bath-Hextall for her support and
guidance in the process of this dissertation and especially for her support during the
entry of data. I could not achieve an experience of nurse-led dermatology clinics in the
UK without the support of my mentor Sandra Lawton, Nurse Consultant, Dermatology
Department- Queen's Medical Centre.
I would also like to show appreciation to my course leader Linda East for her assistance
throughout the various modules of the course.
I would like to acknowledge the help of Wendy Stanton, Faculty Team Librarian in
Greenfield Medical Library with my searching strategy.
Last but not least I would like to thank my sweetheart, Ivan Afram Attafuah, my family
and course mates for their support and useful criticisms during this year of the course.
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Contents
DECLARATION: ...................................................................................................... i
Acknowledgements ................................................................................................ ii
List of Figures ....................................................................................................... v
List of Tables ........................................................................................................ v
Chapter 1 – Introduction ........................................................................................ 1
Aim and Objectives ............................................................................................. 2
1.2 Background .................................................................................................. 4
1.2.1 Epidemiology of dermatology conditions and nurse-led clinics ....................... 4
1.2.3 Impact of dermatological conditions on patients ...................................... 5
1.2.4 Nurse-led Clinics(NLC) in Ghana ............................................................... 6
1.3 Literature Review .......................................................................................... 6
1.3.1 Quality of Life (QOL) ................................................................................ 6
1.3.2 Rationale and Assessment of QOL ............................................................. 7
1.3.3 Dermatology and Quality of Life ................................................................ 8
1.3.4 Patient satisfaction .................................................................................. 8
1.3.5 Severity of condition .............................................................................. 10
1.3.6 Adherence to treatment ................................................................. 11
1.3.7 Cost effectiveness ........................................................................... 12
1.4 Rationale and Justification for this Review ...................................................... 13
1.5 Summary of Chapter ................................................................................... 17
Chapter 2 – Methodology ..................................................................................... 18
2.1 Evidence-based Practice (EBP) ...................................................................... 18
2.2 The Place of Systematic Reviews in Evidence-based Practice ............................ 19
2.3 Justification of the Review Question .............................................................. 22
2.4 Protocol ..................................................................................................... 23
2.5 Search Strategy .......................................................................................... 24
2.6 Selection of Studies ..................................................................................... 25
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2.7 Selection of studies ..................................................................................... 26
2.7.1 Assessment of Methodological Quality ..................................................... 26
2.7.2 Data Extraction .................................................................................. 26
2.8 Summary of Chapter ............................................................................... 27
Chapter 3 – Results ............................................................................................. 28
3.1 Description of studies .................................................................................. 28
3.1.1 Search Results ...................................................................................... 28
3.1.2 Characteristics of included studies ........................................................... 29
3.1.3 Characteristics of excluded studies ....................................................... 32
3.2 Methodological quality of included studies .............................................. 32
3.2.1 Risk of bias in included studies ................................................................ 33
3.3 Effects of nurse-led/nurse follow-up clinics: Primary and Secondary Outcomes 35
3.3.1 Primary Outcome: Quality of Life ........................................................ 35
3.3.2 Secondary outcomes ......................................................................... 37
3.4 Summary of Chapter ............................................................................ 38
Chapter 4 – Discussion ........................................................................................ 39
4.4 Limitations and strengths of the Review .................................................. 43
Chapter 5 – Conclusions ....................................................................................... 45
5.1 Implications for Advancing Nursing Practice .......................................... 46
5.2 Reflection on the Process ................................................................... 47
REFERENCES: ..................................................................................................... 50
INCLUDED STUDIES ............................................................................................ 50
Appendix I- Systematic Review Protocol .................................................................... I
APPENDIX II Search Strategy: .............................................................................. X
Appendix III ...................................................................................................... XIV
Appendix IV ........................................................................................................ XV
Appendix V ........................................................................................................ XVI
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List of Figures Fig. A Hierarchy of evidence ................................................................................................................................. 22
Fig. B Flow diagram of search strategy ................................................................................................................. 29
Fig. C: Forest plots-Quality of life (nurse-led vs dermatologist/general practitioner-led) ................................... 36
Fig. D: Forest plots-severity of condition (nurse-led vs. dermatologist/general practitioner-led) ....................... 38
Fig. E: Forest plots-Patient Satisfaction (nurse-led vs dermatologist/general practitioner-led) .......................... 37
Fig. F: Driscoll's cycle ............................................................................................................................................ 47
List of Tables
Table 1: Characteristics of included studies ........................................................................................................ 31
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ABSTRACT
Aims and Objective:
The existence of nurse-led clinics in developed countries is well known and documented.
However, the effectiveness of these clinics in dermatology has not been systematically
reviewed. The aim of this dissertation was to determine the effectiveness of a nurse-
led/follow-up dermatology clinic on the quality of life, adherence to treatment, severity of
skin condition, and cost of the service to both clients of the dermatology clinic and the
hospital.
Background:
Most dermatology conditions fall into the criteria of chronic diseases as they are mainly
managed and not cured. Although various types of skin conditions affects a large proportion
of the Ghanaian community along with the low number of available dermatologists (8),
nothing has been done to improve the situation. It hoped that an alternate or additional
model of care could be implemented.
Design:
Systematic review [Meta-analysis]
Methods:
Search was conducted through databases, journals, dissertations, theses and discussions
with experts in dermatology to retrieve published as well as grey literature. 5 RCTs were
included in this study with a total of 735 participants. Participants in the trials were
randomly allocated to a dermatologist/general practitioner or a nurse (initial assessment or
follow-up). They were all assessed at baseline and at various intervals of the trials. Extracted
data was analysed using Revman 5.1.
Results:
Participants who received care from the nurse-led clinic demonstrated significantly
improved outcomes in severity of condition(p=0.03) and patient satisfaction rate. Care was
however comparable between the two clinics regarding the outcome quality of life (p=0.11)
Conclusion:
In this review the nurse-led/follow-up dermatology clinic shows potential to
improve the health and well-being of clients who have dermatological conditions.
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KEYWORDS:
Nurse-led, nurse follow-up, dermatology, dermatologist, general practitioner, Randomised
Controlled trial.
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LIST OF ABBREVIATIONS
Atopic Eczema AE
Atopic Dermatitis AD
Body Surface Area BSA
British Association of Dermatology BAD
Central Intelligence Agency CIA
Centre for Review Dissemination CRD
Children’s Dermatology Life Quality Index CDLQI
Client Satisfaction Questionnaire-8 CSQ-8
Cochrane database of Systematic Reviews CDSR
Database of Abstracts and Reviews of Effects DARE
Dermatology Index of Disease Severity DIDS
Dermatology Quality of Life Index DQLI
Ear, Nose and Throat ENT
Eczema Area and Severity Index EASI
European Dermato-Epidemiological Network EDEN
European Task Force on Atopic Dermatitis ETFAD
Evidence-based Practice EBP
General Practitioner GP
Incremental Cost Effectiveness Ratio ICER
Infants’ Dermatitis Quality of Life Index IDQOL
Intention To Treat ITT
International Council of Nurses ICN
Joanna Briggs Institute JBI
Joanna Briggs Institute Meta Analysis of Statistics
Assessment and Review Instrument
JBI-MAStARI
Mean Difference MD
Medical Event Monitors MEMS
Objective Severity Assessment of Atopic -Dermatitis OSAAD
Patient population, Intervention, Comparator,
Outcome
PICO
Quality of Life QOL
Randomised Controlled Trial RCT
Review Manager 5.1 RevMan 5.1
SCORing Atopic Dermatitis SCORAD
Scottish Dermatological Society SDS
Short-Form Health Survey-36 item SF-36
Six-Area, Six-Item Atopic Dermatitis severity score SASSAD
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Systems for Information on Grey Literature SIGLE
Tema General Hospital
United Kingdom
United States of America
TGH
UK
USA
Visual Analogue Scale VAS
World Health Organization WHO
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Chapter 1 – Introduction
The skin is one of the most important organs of the body responsible for protection of
all internal organs. Being an external organ it is exposed to physical, chemical and
environmental harm and needs to be assessed regularly. Most skin diseases may be
overlooked by medical professionals despite being essential indicators of some
underlying internal diseases (Mgonda, and Chale, 2011). Every individual has had one
skin condition or the other, in their lifetime and may have needed medical attention.
However, dermatologists who are trained in this field of medicine are not enough to
care for the entire population. Furthermore, general practitioners do not have the
requisite skills for dermatology care and support (Kernick, Cox, Powell, Reinhold et al.,
2000). The ratio of dermatologists available to the population warrants for an
alternative model of care (Brown, 2005; Richardson and Cunliffe, 2003).
A ‘doctor’- led and nurse-led/nurse follow-up clinics are two common clinics in most
developed countries specifically the UK and USA. It is anticipated that nurse-led
dermatology clinics are as efficient as ‘doctor-led’ clinics by providing safe, effective,
and economical front line management of patients. Both clinics have been said to
provide comparable services (Kinnersley et al., 2000; Miles et al., 2003; Venning et al.,
2000).It is important to support this notion by appropriate evidence gathered through
quality research (Niu and Li, 2005).
Dermatologist-led clinics are the only options available in my hospital and home
country (Ghana) though the available doctors are not sufficient to meet the demands of
the ever growing population. This result in long queues and a reduction in the quality of
services provided. Waiting times for specialty consultations in public healthcare systems
worldwide are lengthy and impose undue stress on patients waiting for further
information and management of their conditions (Sarro, Rampersaud and Lewis, 2010).
Negotiations are being made to set up a nurse-led dermatology clinic at the Tema
General Hospital (TGH)-Ghana. Setting up a nurse-led dermatology clinic fits in with the
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trend of developing programs for patients with chronic diseases to optimise patients’
self-management (Barlow et al., 2002; Warsi et al., 2004).
Measurement of productivity is important in determining the worth or value of a nurse-
led clinic. The development of a nurse-led service that could provide continuity of care
with a nurse who is already part of the patient’s care pathway could be seen as
beneficial. Critiques however do not see the nurse as suitable for the medical role
(Keyzer, 1997). A critical review of the potential pro’s and con’s of developing a nurse-
led clinic is necessary to ensure that significant benefit would be gained by patients, the
organisation and the service provider (Winter, Lavender, Blesing, 2011).
This systematic review is therefore appropriate to inform future development of the
nurse-led dermatology clinic in Ghana.
Aim and Objectives
This dissertation presents a systematic review that seeks to investigate the
effectiveness of nurse-led dermatology clinics in comparison to dermatologist/general
practitioner led clinics, when assessed through patient satisfaction, severity of disease
condition, quality of life of clients, adherence to treatment and cost effectiveness for
both clinics and clients.
The objectives are to:
I. Critically review literature on nurse-led dermatology clinics and their impact on
clients
II. Appreciate the role of systematic review in evidence based practice
III. Undertake a systematic review of studies that compare nurse-led clinics to
dermatologist/general practitioner led clinic in terms of patient satisfaction,
severity of disease condition, quality of life of clients, adherence to treatment
and cost effectiveness
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IV. Reflect on how the findings of the systematic review will advance nursing
practice
V. Make recommendations based on the findings of the systematic review
In the following sections of this chapter, a broad background to dermatological
conditions and nurse-led clinics, including its epidemiology and impact is given.
Literature on quality of life, patient satisfaction, severity of conditions, adherence to
treatment and cost effectiveness encompassing their assessment and relationship with
dermatological conditions, is then reviewed. Finally, the rationale and justification for
this review is provided.
Chapter 2 focuses on the methodology, beginning with a brief discussion of evidence-
based practice, its strengths and its limitations. This is followed by a section on the role
of systematic reviews in evidence-based practice. A justification for the review question
is provided, followed by the protocol for the various stages of this systematic review.
Chapter 3 presents the findings of the systematic review while chapter 4 discusses
these findings. The later sections of chapter 4 discuss the limitations of the review as
well as recommendations for future research. Lastly, I discuss the implications of the
findings to advancing nursing practice, and a reflection on the processes and learning
that has taken place through carrying out this systematic review in chapter 5.
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1.2 Background
1.2.1 Epidemiology of dermatology conditions and nurse-led clinics
About 23-33% of the world’s population, at any one time, have a skin condition that
requires medical attention (Schofield, Grindlay and Williams, 2009). In Europe a quarter
of the population experience skin diseases at any one time (European Dermato-
Epidemiological Network [EDEN], 2007). A study in the United Kingdom shows that,
dermatological conditions affects between a quarter and a third of the populace at any
point in time (Lawton, 2004). A number of other studies confirm that dermatological
conditions are among 15% of cases seen by general practitioners (GP’s) in the region
everyday (British Association of Dermatology (BAD) Guidelines, 2008; McCormick,
Buchman and Maki, 2000; Peters, 2001; Scottish Dermatological Society (SDS), 2010).
Schofield et al., (2009), in their service guidelines, also recorded that about 54% of the
UK population experience a skin condition in a year.
Skin conditions are among the common diseases seen in clinics in the tropical areas
( Hay, Bendeck, Chen, Estrada, Haddix, McLeod and Mahé, 2006). Hot and humid
climates contribute to the circulation of skin conditions. World Health Organization’s
2001 report (WHO, 2005) on the global burden of disease indicated that skin diseases
were associated with mortality rates of 20,000 in Sub-Saharan Africa in 2001. The
prevalence of skin diseases in developing countries ranges from 20% to 80% (Hay, et al.,
2006). This is due to the level of poverty in this region which creates overcrowding in
available places of accommodation. Dermatological diseases affect all age groups of
both sexes; nevertheless, children are more susceptible. Ghana has a population of
about 24,791,073 (CIA, 2011) serviced by about 8 dermatologists, most of them practicing
in urban areas mainly in secondary and tertiary healthcare facilities. A large percentage
of the rural area’s population do not benefit from dermatological care. In fact
dermatological diseases are often ineffectively managed. Efforts need to be made to
address this current situation.
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Nurse-led clinics, also known as nurse managed clinics or nurse-run clinics, are managed
and operated by professional nurses with experience and expert skills in advanced
nursing roles. Nurse follow-up clinics provide services which complement or extend
those provided by doctors (Laurant, Reeves, Hermens, Braspenning, Grol and Sibbald,
2004).
The title of advanced nurse practitioner is however non-existent in my country and this
is a challenge. For this reason, the issue of complete autonomy in leading a clinic is
pending. A review of nurse-led follow-up clinics in addition is relevant in this situation.
The development of nurse-led clinics has increased because it provides an opportunity
to challenge the traditional medical model (Richardson and Cunliffe, 2003):
dermatologist/general practitioner clinic. Hitherto, a systematic review of the
effectiveness of these clinics in dermatology has not been conducted. However, as the
nurse-led clinics have spread, their presence and services have been noticed by service
users and providers in various countries.
In Ghana, these clinics have not been set up despite the low number of dermatologists
available. Medical personnel statistics recorded in 2009 shows that Ghana had 2,033
doctors and 24,974 nurses (WHO, 2011). Notwithstanding the recorded shortage of
nurses in the UK (Bradshaw, 1999; Meadows et al., 2000), nurse led clinics exist.
Considering the number of nurses available, it is eminent that recruiting nurses in
Ghana to deliver nurse-led care in dermatology would not drastically reduce nursing
workforce available to provide some of the essential nursing care; thus maintaining
overall care standards.
1.2.3 Impact of dermatological conditions on patients
It may be argued that skin conditions are not usually life threatening, however, the
resultant disfigurement of the body can negatively impact on one’s sense of being in
relation to the world (Watson & de Bruin, 2006). Skin disease is often visible to others
and social factors in coping and adjustment are highly relevant. Patients, especially
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females, tend to be stressed and depressed about negative changes in their physical
looks. Stress on its own affects the disease condition (Al'abadie, Kent and Gawkrodger,
1994). The outward look of females forms an integral part of the self-esteem. Therefore
a low self-esteem as a result of the physical aspect will have a trickledown effect on
other facets of self such as the spiritual and social aspects (Watson & de Bruin, 2006).
The itch-scratch-itch cycle (Cork and Danby, 2009) which is brought about as a result of
most skin conditions, causes sleep disturbances in both children and adults. As
mentioned earlier, dermatological conditions are important indicators of some
underlying internal diseases. These include chronic renal failure, endocrine disorders,
lymphomas, nutritional deficiencies and HIV/AIDS which are life threatening. Some long
term effects may leave an individual deformed for life.
1.2.4 Nurse-led Clinics(NLC) in Ghana
In Ghana, nurse-led clinics exist in the rural areas of the country where the availability
of doctors is scarce. However, there is none in the field of dermatology. Furthermore,
nurses leading these clinics cannot be said to be qualified to take those roles. It is
necessary in this day and age to have nurse-led clinics in the urban as well as rural
areas. Nevertheless, inadequate or incomplete evidence seriously impedes policy
formulation and implementation (Tranfield, Denyer and Smart, 2003).
1.3 Literature Review
1.3.1 Quality of Life (QOL)
The term ‘quality of life’ has been extensively used however a hypothetical and
intangible elusiveness still persists (Draper and Thompson, 2001) as there has not been
a consensus on its definition (Bowling, 1997). In the health sector, quality of life refers
to the patients perception of the effects of an illness and its treatment on his/her
physical, social, emotional and spiritual well being.
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1.3.2 Rationale and Assessment of QOL
A patient is the best person to provide information regarding his/her quality of life.
However, to minimise bias and subjectivity, tools have been designed as a guide in
assessing this accurately (Finlay, 1997).
Methods
The concept of QOL could be explored either quantitatively (statistically) or qualitatively.
The quantitative approach to assessing QOL is more concrete as numerical values are
generated and bias and interpretation are minimised. It is therefore useful for clinical
trials. Instruments and tools have rapidly emerged as the issue of quality of life of
patients is assessed. Like all others, these tools need to have desirable measurement
properties such as validity, reliability, sensitivity and responsiveness to change over
time (Cox et al., 1992; Fayers and Machin, 2000).
Kinds of Tools
QOL tools are of various kinds. These include the generic (e.g. 36-item Short-Form
Health Survey (SF-36), speciality- specific (e.g. Dermatology Life Quality Index (DLQI) or
SKINDEX, and disease-specific measures (e.g. Quality of Life Index for Atopic Dermatitis)
[Chren, Lasek, Sahay and Sands,2001; Holm, Wulf, Stegmann and Jemec, 2006;Tobita
and Hyde, 2007]. Generic tools measure broad aspects of quality of life and can be used
for several types of diseases at different locations and for different cultural groups
while disease-specific tools are for specific types of diseases or patient groups (Patrick
and Deyo, 1989). A specialty-specific (dermatology) quality of life tool was used to
measure quality of life in the studies analysed.
DLQI
The Dermatology Life Quality Index (DLQI), was developed in 1994. It became the first
dermatology-specific Quality of Life instrument. It is a simple 10-question validated
questionnaire and currently, the most frequently used instrument in studies of
randomized controlled trials in dermatology. The DLQI has been successfully used in 33
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different skin conditions in 32 countries. Its use has been described in over 500
publications including 30 multinational studies.
1.3.3 Dermatology and Quality of Life
Itch, which is a major symptom of most skin conditions, has a profound effect on an
individual’s quality of life. From personal experience, itching can be really unbearable
especially if you have to scratch certain parts of the body in public. Furthermore, a
condition such as acne can affect social and psychological functioning especially for
adolescents. Generally, dermatological conditions can decrease an individual’s quality
of life by interfering with achievement in school, influencing or limiting career choices
and social life (Voegeli, 2010). In addition, they are a common cause of morbidity in
developing countries and account for a high proportion of hospital visits (Nnoruka, 2005;
Morrone, 2007). Morbidity among a country’s population minimises productivity (SDS,
2010).
1.3.4 Patient satisfaction
Patient satisfaction is the major indicator of quality of care provided by a health facility.
Subsequently, the issue of patient satisfaction has been on the rise in this era of
patient-centred care because of the pressure of accountability (Larsen, Attkisson,
Hargreaves, Nguyen, 1979; Thompson, 2006). Patient satisfaction can best be known by
enquiring of the patient group involved and this is necessary to develop or improve on a
service (White, 1999). However, it may be argued that what patients want may be
harmful to their health and some patients have a distorted judgement. Most often
patients consider medical care and information, nursing care and physical environments
of the service when answering questions on satisfaction. The amount of time the
patient spends in the waiting area plays a very significant part in determining the
outcome of patient satisfaction (Prakash, 2010). Patient satisfaction is itself a desirable
outcome, directly related to other positive outcomes. On the other hand, this may
result in unrealistic expectations from answers to questions.
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Assessment of patient satisfaction
This can be assessed anecdotally (general perceptions on issues) or systematically
(questionnaires). Unreliable results are a main criticism of patient satisfaction surveys
but this can be prevented when surveys that meet the standards for statistical reliability
are conducted.
Kinds of patient satisfaction assessment tools
Phone surveys, written surveys, focus groups or personal interviews are many ways of
assessing patient satisfaction. Most institutions prefer to use written surveys, because it
is the most cost-effective and reliable approach. The questionnaires used are most
often than not tested and validated. Question types however do vary. Examples could
be either reports or ratings (e.g. The Likert five-point scale: Agree, disagree, strongly
agree, strongly disagree or neutral). It is important in designing a survey questionnaire
that is concise, precise and consistent (White, 1999). The study (Schuttelaar et al., 2009)
included in this review used a simple survey instrument (Client Satisfaction
Questionnaire-8, CSQ-8) to ascertain patient satisfaction.
CSQ-8
To begin with, parallel, 18-item scales of the CSQ were developed from the initial very
large item set. These scales are designated as the CSQ-18A and CSQ-18B. This went
through a series of tests and retests for reliability before the CSQ-8 was decided on. The
CSQ-18B contains all the items that comprise the CSQ-8 plus 10 additional items.
The CSQ-8 is a self-report statement of satisfaction with health and human services and
can be used in a wide variety of settings. This self administered questionnaire takes
approximately 3-8 minutes to complete. It has 8 items answered on a 4-point Likert.
However, response descriptors differ.To come out with the total score, responses are
summed up. Total score ranges from 8-32, with a higher score indicating higher
satisfaction.
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1.3.5 Severity of condition
Severity of condition primarily affects symptoms and feelings, leisure time activities,
treatment, and daily activities (El-Mongy, El-Shahat, and El-Bahaey, 2006).
Assessment of severity of condition
A wide range of outcome measures have been used to evaluate the severity of
dermatological conditions. Despite their widespread use, many measures have received
little attention with regards to their reliability and validity. Selecting an appropriately
developed measurement tool is therefore of critical importance.
Kinds of severity assessment tools
The Dermatology Index of Disease Severity (DIDS) , Eczema Area and Severity Index
(EASI), Six-Area, Six-Sign Atopic Dermatitis severity score (SASSAD), Objective Severity
Assessment of Atopic Dermatitis (OSAAD) score and SCORing Atopic Dermatitis
(SCORAD) are a few of the assessment tools. DIDS focuses on two factors, the
percentage of involved body surface area (BSA) and functional limitation, in forming a
five-stage scale ranging from stage 0 to stage IV: 0, no evidence of clinical disease; I,
limited disease; II, mild disease; III, moderate disease; IV, severe disease. The OSAAD
which is comparable to the SCORAD (Sugarman, Fluhr, Fowler, Bruckner, et al., 2003) is
however argued not to be reliable and valid (Williams, 2003). The details of the SCORAD
index are given below.
SCORAD
The 2 studies (Moore et al., 2009; Schuttelaar et al., 2009) included in this review both
used the SCORing Atopic Dermatitis (SCORAD) tool to assess the severity of atopic
dermatitis. The European Task Force on Atopic Dermatitis (ETFAD) has developed the
SCORAD index to create a consensus on assessment methods for AD, so that study
results of different trials can be compared. However, modification of the SCORAD index
has led on several occasions to wrong and incorrect use of the system. To measure the
extent of AD, the rule of nines is applied on a front/back drawing of the patient’s
inflammatory lesions. The extent can be graded 0–100. The intensity part of the
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SCORAD index consists of six items: erythema, oedema/papulation, excoriations,
lichenification, oozing/crusts and dryness. Each item can be graded on a scale 0–3. The
subjective items include daily pruritus and sleeplessness. Both subjective items can be
graded on a 10-cm visual analogue scale. The maximum subjective score is 20. All items
should be filled out in the SCORAD evaluation form. The SCORAD index formula is:
A/5 + 7B/2 + C. In this formula A is defined as the extent (0–100), B is defined as the
intensity (0–18) and C is defined as the subjective symptoms (0–20). The maximum
SCORAD score is 103. Based on training sessions by the ETFAD, the SCORAD index was
modified by excluding the subjective symptoms. If these are excluded, the SCORAD is
known as objective SCORAD (score range 0–83).The objective SCORAD consists of just
the extent and intensity items, the formula being A/5 + 7B/2.
A higher score indicates more severe disease. The following cut-off points for objective
SCORAD have been suggested for classification of disease severity: mild AE, score < 15;
moderate AE, score 15–40; and severe AE, score >40. The maximum objective SCORAD
score is 83 (plus an additional 10 bonus points).
1.3.6 Adherence to treatment
The term adherence is also known as compliance. It refers to an agreement between
the patient and physician to achieve the primary goal of optimal treatment outcome.
Low level of compliance to prescribed medical interventions has always been a problem,
especially for patients with a chronic condition (Feldman, Camacho, Krejci-Manwaring,
Carroll, and Balkrishnan, 2007; Greenlaw, Yentzer, O'neill, Balkrishnan, and Feldman,
2010; Hodari, Nanton, Carroll et al., 2006 ; Jones-Caballero, Pedrosa and Peñas , 2008 ;
Richards, Fortune and Griffiths, 2006). Very little literature is available on assessing
adherence in dermatology (Greenlaw et al., 2010). There are many treatment options
for patients with skin conditions, varying from simple topical medication to oral therapy.
Assessing adherence to treatment
Measures of medication adherence such as the pill count and interview methods are
subjective and mostly unreliable in clinical trials. If a pill is reduced by one in the
container does not mean it has been taken. Furthermore, assessment by interviews
only provides results which clients know the health personnel would be content with:
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complete adherence. Until recently, the most precise measures of adherence to
treatment were associated with determining blood levels of the prescribed drug or
measuring urinary excretion of the medication or a metabolic by-product. In the event
that neither the medication nor its by-product can be detected easily in the urine, a
readily detected marker or tracer substance can be added to the prescribed medication
(Zaghloul, and Goodfield, 2004). However, objective adherence assessment has been
improved by electronic monitoring (Hodari et al., 2006; Feldman et al., 2007; Greenlaw
et al., 2010).
Electronic monitoring devices
Electronic monitoring devices, or electronic medication event monitors, use
microprocessors to measure and record data such as the date and time of medication
events. For example, Medical Event Monitors (MEMS, Aardex Corp., Fremont, CA, USA)
have microprocessors in the bottle cap of a standard medication bottle that, each time
the bottle is opened; record the time, date, and interval since the last bottle opening.
MEMS caps can be used to monitor adherence to topical therapy, not just pills. MEMS
caps offer a way of accurately recording missed doses and decreased likelihood of
reporter bias.
Nevertheless, a dermatology-specific instrument for the measurement of adherence
would contribute to improved outcomes (Greenlaw et al., 2010).
1.3.7 Cost effectiveness
Cost effectiveness is an important factor to consider when planning the implementation
of a current healthcare intervention such as nurse-led clinics, in a different locality.
Unfortunately, not all questions can be answered by a randomised controlled trial and
this was the situation of the outcome cost effectiveness. An audit evaluation or
economic evaluation may be a better way to assess cost effectiveness of a clinic to the
hospital or institution. For cost accrued by patients, it is argued that a qualitative
approach to know their views is the best (Kernick et al., 2000). Most studies looking at
costs or cost effectiveness are done in parallel with RCTs looking at quality of life of
13
patients or accessibility of clinics to patents (Kernick et al., 2000; Coast, Noble,
Horrocks, Asim, Peters, Salisbury et al., 2005).
1.4 Rationale and Justification for this Review
Dermatology is an aspect of medicine which has been under researched. In the UK,
about 15% of the cases seen by GP’s are of dermatological conditions (British
Association of Dermatology (BAD) Guidelines, 2008; Scottish Dermatological Society
(SDS), 2010) this is exclusive of those seen by the few dermatologists available.
Although statistics of dermatology conditions in developing countries have not been
generalised, this figure could even be higher. Dermatologists are a precious restricted
resource and their numbers are unlikely to increase in the same proportion as the
incidence of dermatology conditions or public demand for access to investigation and
specialist advice. Considering the current socio-economic factors which have led to poor
hygienic conditions compounded by the fact that dermatology services in this region
have not been developed (Masawe and Samitz, 1976; Doe , Asiedu, Acheampong and
Payne, 2001), a large number of the population have had one dermatological condition
or the other .This is as a result of the small number of dermatologists available (Brown,
2005; Courtenay and Carey, 2006) in addition to general practitioners not having the
requisite skills for dermatological care and support (Kernick, Cox, Powell et al., 2000). It
will therefore not be surprising, if excellent outcomes are not achieved from their
consultations.
In the UK, it has been noted that the demands on dermatologists have led to certain
aspects of their consultation, especially education, being ignored and this has affected
patient outcomes (Brown, 2005). This situation is not different from what can be
witnessed in most developing countries. The issue of waiting times, quality of care,
treatment outcomes all arise out of this situation. It is surprising to know that in
affluent countries like the USA and UK where there are many doctors, nurse-led clinics
exist but are absent in deprived countries. This is attributed to the low number of
dermatologists available and policies need to be drawn to make dermatology more
attractive to doctors. Furthermore, with the impact of dermatological services on
14
individuals in the community, having one type of service is not sufficient in meeting the
needs of the growing population (Brown, 2005).
Nurses with expertise and training are available to bridge this gap in dermatology
services (Chinn, Poyner and Sibley, 2001; Carter and Chochinov, 2007). This
necessitated the emergence of nurse-led clinics (Brown, 2005). Nurse-led clinics sprung
up to assist in the management of a variety of conditions presented by these clients
(Hatchet, 2008). These are clinics where nurses have the upper hand in the
management of clients from initial assessment through till follow-up. However, in some
of these clinics, the nurse only sees a client after the doctor has had the initial
assessment and has provided prescriptions. In such cases, the nurse then does the
follow-up of the client. These clinics are usually led by nurses in advanced level practice.
Although the area of a Nurse Practitioner’s practice varies, he or she must possess the
knowledge and skills to make self-directed decisions regarding selected patient
populations as well as be accountable for his or her actions (Carter and Chochinov,
2007).
However, in Ghana my home country, though there is the existence of nurse-led clinics
in other specialties of medicine (ear, nose and throat [ENT], Eye and General Nursing)
there is none set up in dermatology. Moreover, nurses who lead these clinics do not
have the education/qualification required to act in such a capacity. Therefore, most of
their actions are not justifiable. Also, these are only seen in the rural areas where there
is the shortage of general practitioners. These nurses assess, diagnose and prescribe for
the clients who come to see them. The license to prescribe is not rigid in Ghana as
compared to the situation in the U.K.
In Tema General Hospital, situated about 15 minutes drive from the point of
intersection of the Greenwich Meridian in Ghana, there is a visiting dermatologist who
15
comes once a week or sometimes every other week for 3 hours per visit. Clients have to
wait weeks to see the dermatologist or make do with prescriptions given by General
Practitioners who do not have the required skills for dermatological care. In Ghana,
most clients who visit the hospitals do not have a preference of who sits in the
consulting room when they enter. For this reason, a nurse-led clinic to cater for the
needs of these clients will be well appreciated. Nevertheless, other nurses and those in
managerial positions may not readily succumb to this idea.
In most developed countries like the United States of America and United Kingdom,
nurse-led clinics (Welwyn Hatfield PCT, 2011) and nurse-led follow-up (Gradwell,
Thomas, English and Williams, 2002) clinics have helped minimize the cascade of
workload on dermatologists Research over the last couple of years suggests that nurse-
led clinics improve the quality of life of clients with chronic conditions (example being
most dermatological conditions) as there is the shift from the busy nature of general
hospital setting (Mundinger, Kane, Lenz, Totten et.al, 2000).
Currently, studies have been conducted on the effectiveness of nurse led clinics with
the focus on one outcome or the other but have not looked at it in terms of the
synthesis of outcomes. An intervention review of specialist outreach clinics in primary
care and rural hospital settings was conducted by Gruen, Weeramanthri, Knight, Bailie
in 2003 looking at improving access to care, quality of care, health outcomes, patient
satisfaction and use of hospital services, is one of such. Efforts have been made to find
evidence on which model of service is better in terms of any of the above outcomes.
Most reviews have been qualitative in nature reflecting the reviewer’s impression of
the issue. A case study conducted by Appleby and Lawrence (2001) which looked into
reducing waiting times in a dermatology out-patient department in Newcastle upon
Tyne, is one out of the lot. They acknowledged that, maximising the use of nursing skills
and a willingness to accept innovative models of services, are critical factors in reducing
waiting times. However, a randomized trial by Mundinger, Kane, Lenz et.al (2000) which
16
compared primary care outcomes in patients treated by nurse practitioners or
physicians, did not conclude on which model had a better outcome but just stated that
with all parameters being equal, these models are ‘comparable’.
In Brown and Grimes (1995) meta-analysis of nurse practitioners and nurse midwives in
primary care, an outcome measure: cost-effectiveness was not concluded on. In this
systematic review, however, a conclusion on this measure will be drawn considering the
fact that many more studies have been conducted after 1995.
Horrocks, Anderson and Salisbury, (2002) performed a systematic review to find out
whether nurses working in primary care could provide care equal to that of physicians,
with quality of care and patient satisfaction as outcomes. Both randomized controlled
trials and observational studies were included in this review. It could be argued,
however that, observational study designs have certain attributes that mar the quality
of evidence generated by them. They are postulated to have a potential for biases
because the association between an effect and outcome is not known (Hoffman and
Lim, 2007).
Further examination of a review done by Courtenay and Carey (2007) on the impact and
effectiveness of nurse-led care in dermatology shows that, though it was intended to be
a systematic review it was not rigorously carried out. Search strategy was not indicated
and makes it impossible for another author to carry out the same review. In addition
the scope of review was limited to studies between 1990 and 2005 with 5 of these
studies describing activities of the nurses in these clinics.
This review looked at a description of the activities of nurses and evaluation of nursing
interventions in nurse-led dermatology clinics. Focus was placed on the treatment
options nurses used in the clinic. This review found out that nurses working in primary
care are not confident enough to manage certain conditions especially when invasive
17
procedures like scalp scaling are needed. Also, though these nurses know the
importance of education, their educational needs are not met.
In contrast with Courtenay and Carry (2007), this systematic review seeks to find out
the impact of nurses on clients who attend their clinics irrespective of what
interventions they carry out. Furthermore, the former fails to be classified as a
systematic review as it was not rigorously done.
1.5 Summary of Chapter
Dermatology and nurse-led clinics and the impact of dermatological conditions on the
life of clients have been discussed. The concept of quality of life, patient satisfaction,
severity of disease condition, adherence to treatment modalities and the cost-
effectiveness of nurse-led and nurse follow up clinics has been elaborated. A
justification for this systematic review has been given. The next chapter discusses the
role of systematic reviews in evidence-based practice, justifies the question for this
systematic review, and elaborates the steps involved in the process.
18
Chapter 2 – Methodology
This chapter focuses on the use of quality clinical evidence to enhance patient care. The
strengths and limitations of evidence-based practice are discussed. Particular attention
is given to the role of systematic reviews in evidence-based practice. The question for
this systematic review is then justified, making use of the PICO (Patient population,
Intervention, Comparator, Outcome) framework. The steps for this systematic review,
up to the data extraction process, are explained.
2.1 Evidence-based Practice (EBP)
Evidence-based practice began in the health sector over 20 years ago with medical
doctors being at the fore of its inception (Biesta, 2007; Wall, 2008). In recent times,
evidence-based practice has become a critical concept for liability among other health
professionals (Tranfield, Denyer and Smart, 2003; Avis and Freshwater, 2006; Benton,
2009) such as nurses because of demands by service users for better and individualised
care. The term evidence-based practice has been identified synonymously with
research utilisation (Estabrooks, 1998; Scott-Findlay and Pollock, 2004) over the years.
Nevertheless, there are varying opinions on what should constitute evidence. The
positivist opinion argues that science is the only reliable source of evidence while the
empiricists beg to differ. Science has become an important means by which evidence is
generated and efforts are being made to increase its reliability (Avis and Freshwater,
2006). Avis and Freshwater (2006), who are of the empiricist opinion, suggest that
evidence generated by science should be open to questions to ensure its validity.
Nonetheless, it may be argued that in contexts where there is incomplete or inadequate
research evidence, application of critical reflection in practice is helpful in this era of
EBP.
Evidence-based practice involves the rigorous use of current best evidence from quality
studies, clinicians’ experience, and patients’ preferences to resolve clinical problems
(Fineout-Overholt, Melnyk, Schultz, 2005). An integration of scientific evidence and
clinical expertise promotes individualised patient-centred care (Rosenfeld, 2004).
Evidence-based practice is intended to help health professionals understand and utilize
19
evidence in the context of patient’s situation (Lipman, 2004). However, the debate on
what is considered “evidence” is ongoing (Gupta,2003).
The concept of evidence based practice has its limitations. Not every area of nursing has
been researched into and the few available ones may be under researched. This makes
it difficult to conclude on few valid interventions. Furthermore, using evidence in
practice can sometimes be taunting because the contexts may vary and what worked
well on a group of patients may not be the solution for the patient in question (Lipman,
2004). Another criticism of EBP is that it suppresses critical and creative research while
controlling professional practice (Gough, 2004). In severe cases, healthcare
practitioners may be coerced to follow specific guidelines of which nonconformity may
result in ‘punishment’ (O’Halloran et al., 2010). Other critics argue that knowledge
gained from the basic sciences, and clinical judgement derived from healthcare
personnel’s previous experience may be ignored (Mickenautsch, 2010).
Amidst the deliberations of best evidence to be used in practice, there has been an
elaborate system of hierarchical differentiation of evidence. Highly approved research
designs in this ladder are the quantitative in nature with RCTs labelled the ‘gold
standard’ (Polit and Beck, 2010). It is therefore argued that evidence obtained from
systematic review of relevant randomised controlled trials (RCTs) which provides the
highest quality of evidence on effectiveness, and is regarded as a cornerstone of EBP
( Fineout-Overholt et al., 2005; JBI, 2008; Polit and Beck, 2010) is the best source of
evidence. Randomised controlled trials are the best means of determining if one service
is better than the other (Avis and Freshwater, 2006). This hierarchical ladder is however
not without criticisms.
2.2 The Place of Systematic Reviews in Evidence-based Practice
Systematic reviews espouse a replicable, scientific and apparent process that aims to
minimize bias (Tranfield et al., 2003). They have some advantages over traditional
literature reviews and single studies. For instance, traditional literature reviews are
more subjective, making them liable to bias whereas systematic reviews allow for
objective appraisal of evidence (Egger, Dickerson and Smith, 2001). Single isolated
20
studies, on the other hand, may not provide convincing evidence to fully answer a
research question of interest or detect relevant differences (Jensen and Allen, 1996
cited in Evans and Pearson, 2001; Egger, Smith and O’Rourke, 2001). To be able to
effectively implement an evidence based practice, there are five sequential steps to
follow with the initial step being “asking the clinical question” (Fineout-Overholt et.al,
2005). Without a researchable question there cannot be a research. Polit and Beck
(2008) suggest the use of the PICO framework –Patient population, Intervention,
Comparator and Outcome; to assist in the formulation of the research question. The
four subsequent steps to undertake are searching for best evidence; critically appraising
found evidence; analysing evidence in relation to the question and deciding to
implement or not; finally evaluating the outcome of evidence implementation (Fineout-
Overholt et.al, 2005).
After a researchable question has been framed, the search for best evidence follows.
However, there is still an ongoing debate as to which evidence is best. Evidence can be
classified as best if it is consistently and systematically identified and evaluated.
Although RCTs are considered the “gold standard” (Polit and Beck, 2008), they are not
void of the effects of chance (Webb and Roe, 2008). Intervention bias is a potential
problem of most RCTs (Lindsay, 2004). For this reason an adequate methodological
assessment of their quality is necessary for excellent results.
Research done under this method could either be quantitative (where there is statistical
involvement –Meta-analysis) or qualitative (meta-synthesis/meta-summary) [Polit and
Beck, 2008]. For this reason, a systematic review could be a summary of quantitative
studies where similar methods of research have been used on a common clinical
question (LoBiondo-Wood & Haber, 2006; Burns & Grove, 2007). Generally, it is an
overview which integrates primary research on a particular question and tries to
identify, select, synthesize and appraise almost all research evidence, with similar
methodology, relevant to that question in order to answer it. When this is done, bits of
evidence generated from various research conducted is compiled in one form using a
predefined, explicit methodology, which is reproducible (Tranfield, Denyer and Smart,
21
2003; Polit and Beck, 2008; Webb and Roe, 2008). Meta-analysis offers a statistical
approach for synthesizing findings in order to obtain overall consistency which cannot
be derived from any single study alone.
Primary research carried out are usually of small sample sizes therefore they are most
often not able to answer adequately the research question or questions the user of the
research might have (Webb and Roe, 2008). However, a systematic review carried out
analyses these small sample sizes and inconclusive studies into a more precise one
(Cook, Mulrow and Haynes, 1997). Relatively, it is cheaper to conduct a systematic
review when compared with other methods of research. It also identifies gaps in
practice and prompts further research. Systematic reviews, in which the relevant
research is sought, appraised, summarised and, if appropriate, meta-analysed, provide
the best way to ensure that current evidence is available (Tharyan and Jebaraj, 2006)
because potential for bias is minimal. Nevertheless, searching has to be efficiently done
to retrieve relevant data because of publication bias as selective reporting of trials do
occur. Whilst not a perfect system, systematic reviews are far superior to the traditional
narrative approach, which often allows a lot of good research to be discarded because
of inappropriate methodology. It is therefore not surprising that systematic reviews are
argued to be the most efficient and highest quality method for identifying and
evaluating extensive literatures.
22
Hierarchy of evidence
I-I Systematic review and meta-analysis of two or more double blind randomized
controlled trials.
I-2 One or more large double-blind randomized controlled trials.
II-1 One or more, well-conducted cohort studies.
II-2 One or more, well-conducted case-control studies.
II-3 A dramatic uncontrolled experiment.
III Expert committee sitting in review; peer leader opinion.
IV Personal experience.
Fig. A Hierarchy of evidence
Source: reproduced by kind permission of the publisher from Davies, H. T. O. and S. M. Nutley
(1999). ‘The Rise and Rise of Evidence in Health Care’, Public Money & Management, 19 (1), pp.
9–16.r 1999 Blackwell
2.3 Justification of the Review Question
In view of the low number of medical practitioners training to become dermatologists,
nurses are being urged to take up these vacant positions to help meet the rising
demands of health consumers. Nurse-led clinics have been in operation for decades
now and nurses in advanced practice who lead these clinics have been generally
suggested to act effectively (Mundinger et al., 2000; Pinkerton and Bush, 2000;
Courtenay and Carey, 2007; Courtenay, Carey and Stenner, 2009). However, a
systematic review of the effectiveness of nurse-led dermatology clinics is necessary for
identifying its contribution within the health care system and for justifying its
institutionalization in places where they are none existent (Sidani and Irvine, 1999).
23
Therefore, is a systematic review of quantitative studies that compare nurse-led or
nurse follow-up dermatology clinics with care led by a medical practitioner
(dermatologist/general practitioner), with either of these outcomes: adherence to
treatment, quality of life, patient satisfaction and cost involved. Studies that met the
inclusion criteria were critically appraised and the findings reviewed. Using the PICO
framework, the clinical question for this proposed systematic review is:
‘How effective is a nurse-led/ nurse-follow-up dermatology clinic, compared to usual
care (dermatologist/general practitioner) in relation to client’s adherence to treatment,
satisfaction, quality of life and cost involved (both for health facility and clients)?’.
2.4 Protocol
A protocol is a detailed set of activities for a proposed project and these activities are
supported by evidence from other research and preliminary investigations (Polit and
Beck, 2008). The review question, inclusion and exclusion criteria, search strategy, data
extraction, quality assessment, data synthesis and information on dissemination of final
results are all made available in the protocol. It shows some foresight into what the
systematic review is trying to achieve. Above all, it shows evidence of planning,
including anticipation of potential problems and how they would be dealt with.
However, a protocol is not meant to be rigid. If modifications are made from clearer
understanding of the review, it is permitted but it should be justified and not be made
on the bases of results of individual studies (Centre for Review Dissemination [CRD],
2009).
The protocol for this review has been provided (appendix I). Some modifications were,
however, made to the protocol after a clearer understanding of the review question
and discussions with some methodological experts. For instance, the topic for the
systematic review was changed from ‘the effectiveness of nurse-led dermatology clinics
when compared with care provided by a medical practitioner’ to ‘the effectiveness of
nurse-led and nurse follow-up dermatology clinics in comparison with
dermatologist/general practitioner led dermatology clinics’ to reflect a clearer
understanding of the review question. As stated earlier, autonomy of a nurse in Ghana
24
is not firmly established; therefore the possibility of having a nurse-led follow-up clinic
to start with is high. The rest of the protocol was, however, maintained with some
specific details provided in the subsequent sections.
2.5 Search Strategy
The review was rigorously begun by searching the Database of Abstracts of Reviews of
Effects (DARE) and the Cochrane Database of Systematic Reviews (CDSR) for the
existence of this proposed review. A thorough literature search of the databases and
hand searching of journals for relevant studies was carried out as this is significant in
reducing the impact of publication bias in the systematic review process (CRD, 2009).
It is suggested that limiting searches to English can introduce language bias (CRD, 2009).
However, to prevent translation problems because of the time span for this review, the
search strategy for this systematic review was limited to English. Furthermore, it is
sometimes difficult to have correct translations as not all words have meanings within
every language and this may introduce some extent of bias. The search was carried out
using a variety of search methods to ensure that both published and grey literature is
searched for. As the first step, electronically relevant data was extracted from
databases such as MEDLINE, SCOPUS, CINAHL, and Cochrane Library from their
inception till June, 2011. Alternative spellings (British and American English) as well as
words in relation to the topic such as ‘nurse led’ and ‘nurse managed’ were taken into
account during the search. Text words in the titles and abstract were then examined.
Search strings (synonyms, wild cards) specific to each database were employed to
ensure that relevant studies were retrieved. Subsequently, identified keywords and
index terms were keyed into the databases. Hidden studies from reference lists of
retrieved studies were searched then searched. Experts in the field of dermatology
specifically nurse led clinics were contacted to identify any missing studies (CRD, 2009).
Hand searching through journals, conference reports, dissertation abstracts and theses
of other students was carried out with the intention of retrieving grey literature that
meets the inclusion criteria, however, this was uneventful. The database Systems for
25
Information on Grey Literature (SIGLE) was also searched. Full text for potentially
relevant studies was then retrieved and compiled.
2.6 Selection of Studies
Extensive searching resulted in a large number of potentially eligible studies being
found. However, only a small number was included after assessment for inclusion was
carried out. Articles were selected for inclusion based on the predesigned protocol
containing inclusion criteria specifying the type of subjects, outcomes and type of study
(Tak, Meijer,
de Jonge, and Rosmalen, 2010). Studies were included if they:
I. RCTs
II. Outpatient cases
III. Adults and children
IV. A nurse clinic in the intervention group
V. Dermatologist or general practitioner in the control group
VI. Evaluated either of the following: patient satisfaction, severity of condition, quality of
life, adherence to treatment and cost effectiveness of clinics. As a primary or secondary
outcome with a validated measure, whether generic, disease-specific or both.
Studies were excluded if they:
I. Did not specify tools for measurement of outcomes
II. Had any other intervention aside a nurse
III. Were not in English
26
2.7 Selection of studies
One reviewer (PYA) assessed the titles and abstracts of the search results and excluded articles that clearly did
not meet the inclusion criteria for this review. Full text articles that were retrieved were, again, compared with
the inclusion and exclusion criteria by PYA.
2.7.1 Assessment of Methodological Quality
The quality of a systematic review is defined by the quality of primary studies included
in the study. The existence of bias in included primary studies will mar the quality of the
review. Randomised controlled trials if conducted appropriately, are suggested to be
the most unbiased form of study designs (Herkner, 2006; CRD, 2009).
Two independent reviewers (PYA and FB-H) appraised the quality of the selected
studies. This was done using the standardised critical appraisal checklist from the
Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument –
JBI‐MAStARI (Appendix II).
Following discussion, both reviewers were in agreement on the final papers to be
included in the review.
2.7.2 Data Extraction
Full text articles of studies that met the inclusion criteria were retrieved and reviewed
by two independent reviewers for methodological validity before inclusion in the
review. Standardised critical appraisal instruments from the Joanna Briggs Institute
Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) will be
used for this purpose. Data was extracted by two reviewers (PYA and FB-H)
independently and entered into a modified Cochrane Skin Group data extraction form.
The data extracted included participant numbers and characteristics, place of study,
patient’s demographics, diagnosis, nature of the intervention, loss to follow-up rates
and rationale.
Discrepancies were resolved between the two review authors.
Review authors were not blinded to the names of trial authors, journals or institutions,
specific information on the study methods, populations, interventions and outcome
measures.
27
The extracted data was then entered into the Cochrane collaboration software -Review
Manager (Revman 5.1).
2.8 Summary of Chapter
This chapter has focussed on evidence-based practice and systematic reviews. A
justification for the review question has been provided, using the PICO framework. The
processes involved in this systematic review, up to data extraction, have also been
presented. The subsequent chapter presents the findings of the search strategy in detail.
28
Chapter 3 – Results
The findings of the systematic review are presented in this chapter. It begins with the
results of the search strategy, then characteristics of the included studies as well as
their findings. Figures and tables are used, where necessary, to give a pictorial
presentation of the findings
3.1 Description of studies
3.1.1 Search Results
The literature search resulted in the identification of 160 studies: 157 from the
electronic databases and 3 through searching references of key articles. However, none
was found from grey literature. After examining the titles and abstracts, 9 studies
appeared eligible for this review and, thus, the full articles were retrieved. However,
after comparing those with the eligibility criteria for this review, 4 studies were
excluded (See Table 1). The methodological quality of the remaining 5 studies was
assessed by two independent reviewers and these eventually met the inclusion criteria
(Figure B). The flow diagram for the searches retrieved throughout this review is shown
on the ensuing page.
29
FLOW DIAGRAM OF SEARCH STRATEGY
Fig. B Flow diagram of search strategy
3.1.2 Characteristics of included studies
As detailed in Table 1, only randomised controlled trials were considered in this
systematic review. Four of the included trials were randomised parallel group trials with
a minimum interval assessment of one month. The other study (Moore, Williams,
Manias et al,2009) which did not state what RCT design was used had a trial duration of
four weeks with assessment being done at the fourth week. The total length of these
trials was 34 months and 2 weeks.
It was noted that all included studies were undertaken in developed countries. One
study was conducted in Melbourne, Australia (Moore, Williams, Manias, Varigos and
Donath, 2009), another in the Netherlands (Schuttelaar, Vermeulen, Drukker, and
Potentially relevant papers identified by
literature search (n= 160)
Papers retrieved for detailed examination
(n=9)
Papers excluded after
evaluation of abstract (n=151)
Papers assessed for methodological quality
(n=5)
Papers included in systematic review (n=5)
Papers excluded after review
of full paper (n=4)
30
Coenraads, 2009) and the remaining in England. Among the included studies, there was
none from Ghana or any African country.
The studies all looked at various skin diseases with some limiting their trials to specific
conditions while others made it open (irrespective of which skin condition). All the
included studies had at least a diagnosis of eczema as an inclusion criterion. Two of
these considered a diagnosis of psoriasis for inclusion. One study included patients
seeking repeat prescriptions for a diagnosis of eczema. Anyone who had a previous
treatment of eczema, has been involved in similar studies or has relatives involved in
similar studies was excluded from most of the included studies. However, 2 studies did
not state any exclusion criteria. The total number of randomised participants in the 5
trials was 735 and 593 were analysed. Participants’ ages ranged from 0 to 65 years. In
the studies which categorized participants according to their gender, the total number
of males involved in all the studies outnumbered that of the females. Nonetheless, total
number of females was more in the nurse-led clinic than the dermatologist/ general
practitioner led clinic.
Almost all the studies recruited participants irrespective of the severity of their
condition and did not state this except Gradwell, Thomas, English and Williams (2002)
who despite randomization had participants with moderate to severe skin diseases in
the nurse led group. None of the studies included the duration of the participant’s
condition.
Most of the studies (n=4) compared the quality of life of participants attending a nurse-
led clinic with a dermatologist or usual clinic (which could be led by a general
practitioner). Two looked at the severity of eczema among these participants.
Surprisingly, only one (Schuttelaar, Vermeulen, Drukker, and Coenraads, 2009) looked
at the patients satisfaction as an outcome assessment.
31
Table 1: Characteristics of included studies
Study Method Country Number of
participants
Age of
participants
(years)
Year of
publication
Duration
of study
(months)
Outcome measure
of interest
Tool for
measuring
outcome Beginnig Completion
Chinn, Poyner, and
Sibley, (2002).
RCT Middlesbrough,
UK
235 197 0.5 -16 2002 12 QOL DQLI
Gradwell, Thomas,
English, and Williams
(2002)
RCT (randomised
parallel group)
Nottingham, UK 66 64 ≥14 2002 1.5 QOL DQLI
Kernick, Cox, Powell,
et.al.(2000)
RCT Exeter, UK 109 81 18≤ x ≤ 65 2000 4 QOL, Cost
effectiveness
DQLI,
Schuttelaar, Vermeulen,
Drukker, and
Coenraads,( 2009)
RCT Groningen,
Netherlands
160 152 ≤ 16 2009 12 QOL,
Eczema severity,
Patient satisfaction
DQLI,
SCORAD,
CSQ-8
Moore, Williams,
Manias, Varigos, and
Donath, (2009)
RCT Melbourne,
Australia
165 99 ≤ 16 2009 1 Eczema severity Objective
SCORAD
QOL- Quality Of Life; DQLI- Dermatology Quality of Life Index; SCORAD- Scoring Atopic Dermatitis; CSQ-8- Client Satisfaction Questionnaire-8
32
3.1.3 Characteristics of excluded studies
Of the 4 studies excluded after retrieving full papers of 9, one was a cohort study ( Cork,
Britton, Butler, Young et.al, 2003) and another a literature review (Courtenay and Carey,
2007). None of these qualified as a randomised controlled trial. The other 2 studies
although were RCTs were excluded because the intervention in one was being given by
a senior medical student and not a nurse(Shaw, Morrel and Goldsmith, 2008) and the
other did not have any of the expected characteristics for included studies (van Os-
Medendorp H, Ros WJ, Eland-de Kok PC, et al.,2007). A complete list of the excluded
studies and reasons for their exclusion has been provided in Appendix III: Table 2.
3.1.4 Ongoing studies
After search was conducted, there have been ongoing studies on one of the outcomes
of interest: cost effectiveness (Schuttelaar, Vermeulen and Coenraads, 2011). In this
study, Schuttelaar et al., (2011) estimated the healthcare costs, family costs and general
costs in other sectors in relation to the quality of life and patient satisfaction to
determine incremental cost effectiveness ratio (ICER). They concluded that substituting
NPs for dermatologists in the treatment of eczema in children provides savings in both
healthcare costs and family costs.
3.2 Methodological quality of included studies
Assessing the methodological quality of randomised controlled trials is an essential
aspect of systematic reviews (Juni , Altman and Matthias , 2001; Moja, Telaro, D'amico,
Moschetti, Coe and Liberati, 2005) as defects in the conduct of primary studies can
result in bias (CRD, 2009). For this reason, the author assessed the individual studies
included in this review for quality.
33
3.2.1 Risk of bias in included studies
Randomisation and allocation concealment
The method of randomisation and allocation concealment, was clearly specified in all
(n=5) the studies included in this review. Four of the studies (Chinn, Poyner, and Sibley,
2002; Gradwell, Thomas, English, and Williams 2002; Kernick, Cox, Powell, et.al.
2000;Schuttelaar, Vermeulen, Drukker, and Coenraads, 2009) randomised participants
using computer generated scheme with decodes placed in sealed, opaque envelopes
which were opened by the participants in the presence of the investigator, while Moore
et al., (2009) randomised using sequentially numbered sealed, opaque envelopes.
Blinding of participants, clinicians and outcome assessor
In view of the nature of the comparison intervention (nurse-led/nurse follow-up vs.
dermatologist/general practitioner clinic) double blinding was not possible. The two
clinics have different styles of managing patients and it was almost impossible to blind
participants and the clinicians involved to the treatment group. The dermatology nurse
in two of the studies (Kernick, Cox, Powell, et al., 2000; Gradwell, Thomas, English, and
Williams, 2002 ) was not aware of allocation. However, the outcome assessor was
blinded in four of the studies.
Intention to treat (ITT)
Intention to treat analysis helps to minimise biases in quantitative research but can only
be performed when there is complete outcome data available from randomised
participants(Hollis and Campbell, 1999). Four studies (Chinn, Poyner, and Sibley, 2002;
Gradwell, Thomas, English, and Williams 2002; Kernick, Cox, Powell, et.al.
2000;Schuttelaar, Vermeulen, Drukker, and Coenraads, 2009), analysed their results on
an ITT basis by taking into consideration the data of all randomised participants
irrespective of whether they completed the trial or not. The other study (Moore et al.,
2009) which did not state ‘intention-to-treat analysis’ was found not to have included
data of participants lost to follow-up.
34
Loss to follow-up
121 participants out of the 735 randomised participants were lost to follow-up for one
reason or the other. Studies identified indicated number lost to follow-up and gave
reasons where possible. In all 5 studies, break down of follow-up reasons is: n=27[Did
not want appointment], n=3[study demanding too much effort on the part of
participants], n=10 [missed the triage of the study], n=4[migrated]. However, a large
number of participants who dropped off before completion gave no reason [n=77].
Other potential sources of bias
Levels of severity of the various dermatological conditions between the two clinics
varied in all the studies. Despite randomisation, some studies reported having
participants with moderate to severe eczema in the dermatologist/general practitioner-
led clinic and this could be a bias. Some studies also failed to provide exclusion criteria
and may have recruited participants who had been involved in similar trials and knew
what was expected. Therefore such participants would provide responses they think
would make the investigator ‘happy’.
Although most of the studies had a mixture of mainly eczema and psoriasis, they report
a greater number of eczema participants and this may affect the generalization of their
results.
35
3.3 Effects of nurse-led/nurse follow-up clinics: Primary and Secondary
Outcomes
3.3.1 Primary Outcome: Quality of Life
Tools for measuring Quality Of Life
The Dermatology Life Quality Index (DLQI) was used to assess quality of life across the
studies. Where appropriate it was modified to suit the ages. Hence there was the
Infants’ Dermatitis Quality of Life Index (IDQOL) for children aged ≤ 4 years, and by the
illustrated version of the Children’s Dermatology Life Quality Index (CDLQI) for children
aged 4–16 years. One study (Kernick, Cox, Powell, et al., 2000) used an additional
instrument: the visual analogue scale (VAS) from the Euroqol instrument to detect
changes in overall quality of life. A detailed description of the DLQI tool has been
provided in the ‘assessment of QOL’ section of the literature review.
Results for Quality of Life [QOL: nurse-led vs. dermatologist/general practitioner-led]
A. Infants
Using the infants dermatology quality of life tool, two studies (shown in the forest plot
below) achieved no significant difference in quality of life of infants treated either by a
nurse or a dermatologist/general practitioner. Their pooled estimate gave an evidence
of this MD -0.62(95% CI, -2.05 to 0.81). [Illustrated in 1.1.1 IDQoL of Fig. C]
B. Adults
Quality of life of participants above 16 years from 3 studies using the CDQoL, was
recorded under 1.1.2 in Fig. C. The individual studies showed no significant differences
in the quality of life of the participants in either group. Overall score for the participants
in the 3 studies showed no significant difference, MD -0.74 (95%CI, -1.82 to 0.34).
36
C. Adults and Infants
As illustrated in Fig. C, the pulled estimate in QOL scores between nurse led
dermatology clinics and dermatologist/ general practitioner led clinics for both adults
and children was not statistically significant in 3 of the studies MD -0.70 (95% CI, -1.56
to 0.16).
Forest plots- Quality of life (nurse-led vs. dermatologist/general practitioner-led)
Study or Subgroup
1.1.1 IDQoL
Chinn et.al, 2002
Schuttelaar et. al,2009Subtotal (95% CI)
Heterogeneity: Chi² = 0.74, df = 1 (P = 0.39); I² = 0%
Test for overall effect: Z = 0.85 (P = 0.39)
1.1.2 CDQoL
Chinn et.al, 2002
Kernick et.al, 2000
Schuttelaar et. al,2009Subtotal (95% CI)
Heterogeneity: Chi² = 0.94, df = 2 (P = 0.63); I² = 0%
Test for overall effect: Z = 1.35 (P = 0.18)
Total (95% CI)
Heterogeneity: Chi² = 1.70, df = 4 (P = 0.79); I² = 0%
Test for overall effect: Z = 1.59 (P = 0.11)
Test for subgroup differences: Chi² = 0.02, df = 1 (P = 0.90), I² = 0%
Mean
5.44
5.7
9.74
4.6
4.9
SD
5.1
5.4
3.5
4.7
3.5
Total
55
3792
50
35
35120
212
Mean
6.61
5.6
9.98
6.2
5.6
SD
4.4
3.9
5.1
5.2
4.2
Total
42
3476
50
46
35131
207
Weight
20.7%
15.6%36.3%
25.2%
15.8%
22.6%63.7%
100.0%
IV, Fixed, 95% CI
-1.17 [-3.06, 0.72]
0.10 [-2.08, 2.28]-0.62 [-2.05, 0.81]
-0.24 [-1.95, 1.47]
-1.60 [-3.76, 0.56]
-0.70 [-2.51, 1.11]-0.74 [-1.82, 0.34]
-0.70 [-1.56, 0.16]
Nurse dermatologist/medical pr Mean Difference Mean Difference
IV, Fixed, 95% CI
-2 -1 0 1 2nurse dermatologist/general pra
Fig. C: Forest plots-Quality of life (nurse-led vs dermatologist/general practitioner-led)
Results for Quality of Life [QOL: nurse follow-up vs. dermatologist/general
practitioner-led]
With only one study retrieved for a comparison of nurse follow-up clinics with
dermatologist/ general practitioner led clinics a strong conclusion could not be drawn
on the QOL scores. However, there was no statistically significant difference in quality
of life of participants attending either clinic MD-0.30 (95% CI, -2.48 to 1.88) [Fig. Ci]
37
Forest plots -Quality of life (nurse follow-up vs. dermatologist/general practitioner-
led)
Study or Subgroup
Gradwell et.al, 2002
Mean
7.5
SD
5.4
Total
37
Mean
7.8
SD
3.9
Total
34
IV, Fixed, 95% CI
-0.30 [-2.48, 1.88]
Nurse dermatologist/medical pr Mean Difference Mean Difference
IV, Fixed, 95% CI
-2 -1 0 1 2nurse dermatologist/general pra
Fig. Ci
3.3.2 Secondary outcomes
I. Results for Severity of condition using the Objective SCORAD
For the 2 studies (Moore et al., 2009; Schuttelaar et al., 2009) that considered the
severity of eczema, the objective Scoring of Atopic Dermatitis (SCORAD) was the tool
for assessment (refer to Assessment of severity section in Chapter one for details of the
SCORAD).
There was a recorded significance in the objective SCORAD score between participants
in the nurse-led clinics and those in the dermatologist/ general practitioner-led clinic
(pooled estimates of 2 studies, MD-2.33 (95% CI, -5.60 to 0.93] )as per Fig. D.
Forest plots –Severity of condition (nurse -led vs. dermatologist/general practitioner-
led)
Study or Subgroup
Moore et.al, 2009
Schuttelaar et. al,2009
Total (95% CI)
Heterogeneity: Chi² = 0.08, df = 1 (P = 0.78); I² = 0%
Test for overall effect: Z = 2.20 (P = 0.03)
Mean
38
19
SD
11
11
Total
49
73
122
Mean
42
22.1
SD
15
11.9
Total
50
70
120
Weight
34.6%
65.4%
100.0%
IV, Fixed, 95% CI
-4.00 [-9.17, 1.17]
-3.10 [-6.86, 0.66]
-3.41 [-6.45, -0.37]
Nurse dermatologist/medical pr Mean Difference Mean Difference
IV, Fixed, 95% CI
-10 -5 0 5 10nurse dermatologist/general pra
Fig. D:
II. Patient Satisfaction
The study by Schuttelaar et al., (2009) was the only one that had patient satisfaction as
an outcome. As illustrated in Fig. E below, between-groups comparison shows that,
there were more participants satisfied with care provided by a nurse than a
dermatologist/ general practitioner. Statistically significant difference is therefore seen
in the 2 groups MD 2.10 (95%CI, 0.34 to 3.86).
38
Forest plots-Patient satisfaction (nurse-led vs. dermatologist/general practitioner-
led)
Study or Subgroup
Schuttelaar et. al,2009
Mean
26.9
SD
4.9
Total
53
Mean
24.8
SD
4.3
Total
52
IV, Fixed, 95% CI
2.10 [0.34, 3.86]
Nurse dermatologist/medical pr Mean Difference Mean Difference
IV, Fixed, 95% CI
-10 -5 0 5 10dermatologist/general pra nurse
Fig. E
III. Adherence to treatment
None of the trials reported on this outcome.
IV. Cost effectiveness to health facility and patients
None of the trials reported on this outcome.
3.4 Summary of Chapter
This chapter has recorded the characteristics and results of the 5 included studies
looking at QOL, severity of condition and patient satisfaction as the outcomes. In
summary, there is no statistically significant difference in care provided by a nurse or a
dermatologist/general practitioner with respect to QOL of patients who have
dermatological conditions (mainly eczema and psoriasis in the studies included).
Nonetheless, there was significant difference in the severity of the patient’s condition
and general satisfaction rates in favour of nurse-led/nurse follow-up clinics. No results
were recorded for the outcomes ‘adherence to treatment’ and ‘cost effectiveness’ as
there were imprecise conclusions or no trials reported on them. These findings are
discussed further in the next chapter.
39
Chapter 4 – Discussion
This chapter discusses the findings of this review. The later sections present the
limitations and strengths of this review, implications for future practice and research.
4.1 Summary of main results
To my knowledge this is the first meta-analysis (systematic review) on the effectiveness
of nurse-led/nurse follow-up dermatology clinics compared to a dermatologist/general
practitioner-led clinic. A critical finding of this review is that only 5 of the 160 studies
retrieved were randomised controlled trials with the outcomes of interest (see Table 1).
This meta-analysis has shown that care provided by a nurse compared to that given by a
dermatologist/general practitioner is comparable in many ways although it was
hypothesized that there would be much difference in favour of nurse-led clinics
( Schuttelaar et al., 2009). However, there was evidence of decreased severity of
dermatological condition and greater patient satisfaction rates with care provided by
nurses in the studies analysed.
4.2 Quality of evidence
Participants at the beginning of the trial were comparable in demographic
characteristics in both groups. Despite the lack of blinding of participants and clinicians
trials, most trials (n=4) had a strict exclusion criteria and had their outcome assessors
blinded. However, low statistical power was reported for one study (Chinn et al.,2002)
for QOL because non-responders to the study had a worse quality of life than those
who did and sample size was also small. The quality of the evidence provided by this
meta-analysis is therefore moderate.
4.3 Agreements’/disagreements with other studies /reviews
4.3.1 Quality of life
With the above results, it is apparent that nurse-led/nurse follow-up clinics do not
worsen the plight of patients. Moreover, there is an indication that information and
40
care given to participants in the two groups are not conflicting but rather could be
complementary. This can be accomplished through a concerted approach by nurses and
dermatologists working together to develop nursing skills in the community (Ersser &
Penzer, 2000).
In the trial by Gradwell et al. (2002) which concluded that the quality of life of
participants in the nurse follow-up clinic had no significant difference in comparison
with the dermatologist/general practitioner-led clinic, it is recorded that the patients
were assessed before being sent for a follow-up by the nurse. The method of
assessment and expected outcomes of the assessment were however not revealed and
makes the results on quality of life a bit dicey. However, a study by Ben-Gashir, Seed
and Hay (2004) suggests that the impact in quality of life of individuals is greatest in
moderate to severe conditions. It is therefore possible that only patients with moderate
to severe conditions were sent to both study groups (Brown and Grimes, 1995) hence
the resulting no significant difference.
This meta-analysis provides validity for a systematic review [not meta-analysis]
conducted by Horrocks , Anderson and Salisbury (2002) which reported that an analysis
of seven RCTs comparing nurse-led clinics and general practitioner led clinics with
quality of life or health status as an outcome revealed no significant difference in
patients outcome.
It is argued that health education improves the quality of life (Ross and Willigen, 1997).
However, in all 5 trials comparing nurse-led clinics to dermatologist/general practitioner
led clinic, education was an aspect of the care provided by the nurse in the nurse-led
clinic, yet quality of life in the two groups was not significantly different.
4.3.2 Severity of condition
The severity of eczema of participants in the nurse-led clinic was significantly improved
at completion of the trials compared to those in the dermatologist/general practitioner
41
led clinic. This adds to the review conducted by Courtenay and Carey (2005) which
concluded that nurse-led clinics brought a reduction in the severity of conditions of
dermatology patients. The duration of consultation for nurses in these clinics could be a
contributing factor as education on condition and application of treatment is usually
demonstrated unlike in the dermatologist/general practitioner clinic where there is
pressure on the doctors because of time. For example in the UK where doctors are paid
according to the number of consultations, this could be a problem. The problem exists
in Ghana although for a different reason as salaries of doctors and nurses are fixed
irrespective of the number of hours worked. Nevertheless, with the low number of
dermatologists available and the high incidence of dermatological conditions,
consultation time is never adequate for patients because the waiting queue is long and
a lot of consultation must be done by the dermatologist within the allocated period.
Therefore in Ghana and other developing countries, improved severity of
dermatological conditions will take a longer time if an alternate dermatology clinic is
not implemented.
Generally, quality of life and severity of condition have been shown to have a positive
correlation (Ben-Gashir, Seed and Hay, 2004) but this was not indicated by this meta-
analysis.
4.3.3 Patient satisfaction
While it is commonly remarked that patient satisfaction scores opt in favour of nurse-
led clinics (Horrocks et al., 2002; Krothe and Clendon, 2006), only few RCTs have
evidence of this. This meta-analysis shows proof of this as it had only one RCT with
patient satisfaction as an outcome.
In a cross-sectional survey of 741 patients carried out in Saudi Arabia by Alzolibani
(2011) which assessed various aspects of patient satisfaction, satisfaction rate for
overall quality of dermatology services was 66.1%. High levels of satisfaction were
expressed about the general maintenance and hygienic conditions of the clinic. About
38% of patients indicated their dissatisfaction regarding the waiting time for
appointment and about 40% were not satisfied with the information they received
42
about their problems. About 48% felt that the consultation time was inadequate and
36.7% felt that they were not allowed to express their symptoms in detail. It is argued
that nurses tend to have longer consultations than doctors, and patient satisfaction is
higher with longer consultations (Freeman, Horder, Howie, Hungin et al., 2002).
However, having health education during consultation helps the patients in the
management of their condition and provides a form of psychological therapy. The
results underscore the importance of proper psychological assessment and treatment
of dermatological conditions in addition to the standard dermatological treatment.
Poor communication with dermatologists/general practitioners and the lack of empathy
could be a possible cause of low patient satisfaction rates in the dermatologists/general
practitioner led clinic. Nonetheless, satisfaction rates in the nurse-led clinic could be
related to the acuity of the patient’s condition. This meta-analysis gave an evidence of
decreased severity of patients’ condition. It could however be criticised with the view
that patients with more ‘serious’ conditions would prefer to see a doctor than a nurse
(Laurant et al., 2004).
No RCTs were identified that compared patients adherence to treatment after
attending either a nurse-led/nurse-follow-up clinic or dermatologist/general
practitioner led clinic. However, in a prospective study by Storm, Benefedt, Serup et al.
(2008) on adherence of patients to topical drugs, they confirmed that studying
adherence in dermatology is very complicated as it is difficult to determine especially in
the case of topical treatments. It is arguable that with the incorporation of education in
nurse-led/nurse follow-up clinics, demonstration of application of topical treatments
would improve and increase adherence among patients. Nevertheless, RCTs are needed
to help make a valid inference.
Evidence of cost effectiveness of nurse-led dermatology clinics when compared to
dermatologists/general practitioner led clinics is imprecise and prevents a meta-analysis
to be carried out on this outcome. This is a confirmation of the review conducted by
Brown and Grimes (1995) which concluded that although some studies may have been
conducted looking at costs and cost effectiveness, authors fail to provide data on their
43
conclusions and for those who do have data, it cannot be used in a meta-analysis
(Brown and Grimes, 1995). A cost analysis conducted by Lattimer, Sassi, George,
Turnbull et al. (2000), was in favour of nurse telephone consultations out of hours.
However, this result would be impractical as evidence in a developing country like
Ghana because not every patient has access to a phone.
4.4 Limitations and strengths of the Review
This systematic review is not without its own limitations. The main limitation of this
review is that the reviewer is inexperienced and may have faltered one way or the
other. Secondly, in most of the studies participants and clinicians were not blinded.
However, the studies which provided a protocol with precise inclusion and exclusion
criteria would help to minimize this bias. Another limitation is that, some studies might
have been missed because of the larger number of studies that are usually involved in
systematic reviews, especially, of non-randomised studies. Nevertheless, the range of
subject headings used across the included databases increased the sensitivity of the
search strategy. It is noticed that studies were from developed countries where
resources a readily available. Although implementation is possible in developing
countries like Ghana the issue of inadequate resources can prolong this. Lastly, limiting
the search strategy to articles published in English Language only might, also, have
contributed to the exclusion of some eligible studies resulting in language bias.
The main strength of this review is the fact that meta-analysis (statistical integration of
several similar quantitative studies) is the best approach for this systematic review as it
generates explicit conclusions that are convincing enough to be used as evidence in
clinical practice.
4.5 Recommendations for Future research
Cost, particularly cost involved for patients, has not been well investigated despite the
extensively held view that nurse-led care will generate savings. Future studies of
effectiveness of nurse-led dermatology clinics need to give more attention to the
financial aspects of care; taking into consideration cost of educating the nurse and that
of the dermatologist/general practitioner.
44
4.6 Summary of Chapter
The findings as well as limitations of this systematic review have been discussed
extensively in this chapter. Studies which have been conducted in other health sectors
looking at similar outcomes were compared with this meta-analysis, and some major
recommendations have been made towards future research. The next chapter provides
a conclusion to the whole review process and discusses its implications for advancing
nursing practice. A personal reflection on the learning process that has taken place in
conducting this systematic review, and on my journey for a degree of Master of Science
in Advanced Nursing are, then, provided.
45
Chapter 5 – Conclusions
With the current practice of evidence-based practice, hearsay is not acceptable.
Therefore decisions are made based on rigorous and valid research. There are many
study designs as seen in Fig A. (Chapter 1). However, systematic reviews and better still
meta-analysis of randomised controlled trials are preferred.
The main focus of this dissertation was to look at the impact of nurse-led dermatology
clinics on quality of life, adherence to treatment, cost (for institutions as well as
patients), severity of condition and satisfaction rate. There was a critical appraisal of
randomised controlled trials involving nurses leading dermatology clinics and their
medical counterparts (dermatologist/ general practitioner). There was a wide search of
databases as well as hand searching through journals and other dissertations and theses
to locate available and relevant data. Trials that compared the nurse and the
dermatologist/general practitioner with reference to the quality of life of patients, their
adherence to treatment modalities, severity of condition, cost involved or the patient
satisfaction of either clinics, and met the inclusion criteria for this systematic review
were critically analysed. A meta-analysis of their findings, showed no difference in the
quality of life of patients in either clinics. However, the impact of the nurse was felt by
patients in the nurse-led clinic as evidenced by a reduction in the severity of their skin
condition hence a report of higher satisfaction rates in the same group. This implies that
nurses leading dermatology clinics can work as effectively as doctors if not better
(Rafferty,). Yet, threats to the development of nurse led dermatology clinic are marked
– doctors unwillingness to relinquish certain aspects of their role, such as decision
making, the training and recruitment of nurses, identifying future sources of funding
and expounding administrative preparations (Cable, 1995).
46
5.1 Implications for Advancing Nursing Practice
For many years, the debate on the meaning and roles of advanced nursing practice
(Carnwell and Daly, 2003; Mantzoukas and Watkinson, 2006) is still ongoing. As a result,
there is no agreement on this concept; while some believe that it is the shifting of
medical roles (McGee, 1998b; Tye and Ross, 2000; Pearson and Peels, 2002), others
claim that it is the development of the nursing profession (Rolfe, 1998b; Fulbrook, 1998;
Castledine, 1998a). The findings suggest that appropriately trained nurses can produce
as high quality care as dermatologists/general practitioners and achieve good health
outcomes for patients. For most of the studies, nurse practitioners (NP) were the
leaders in the clinics. However, without a consensus on the definition of who a nurse
practitioner is, the title could have just been conferred on the nurses involved in the
trials.
An advanced level practitioner according to the ICN (2002) is
“a registered nurse who has acquired the expert knowledge base, complex skills and
clinical competencies for expanded practice, the characteristics of which are shaped by
the context and/or country in which s/he is credentialed to practice. A Masters degree
is recommended for entry level”
Manley (1997) describes four sub-roles for the advanced nurse practitioner; expert
practitioner, educator, researcher and consultant roles. My opinion on advancing
nursing practice is that nurses are able to identify areas of care that need amendment,
through reflection, and take the necessary actions, including research and collaboration
to bring about successful changes in practice and improve patient outcomes. As an
expert practitioner, I would now be a position to offer quality client-centred care to
attendants of dermatology clinic. With the knowledge received through this review I
hope to achieve improved adherence to treatment on the part of clients as a result of
sufficient education on management thereby reducing severity of the condition.
47
5.2 Reflection on the Process
Reflection is a teaching and learning process that allows individuals to critically analyse
their experiences during a course or practical professional programme, and learn from
them (Durgahee, 1996). The ‘what-so what-now what’ reflective framework by Borton
(1970) modified by Driscoll (2007) was used as a guide during this process.
Driscoll’s cycle
Fig. F: Driscoll's cycle
What?
In my pursuit of personal and professional development, I enrolled in the MSc.
Advanced Nursing program, and chose to focus on improving the quality of life of
dermatology clients through setting up a nurse-led clinic (reasons are obvious in the
preceding chapters). I first and foremost needed to find out if these clinics would be
effective. This exposed me to many germane issues involved in the setting up and
running of a nurse-led clinic as well as the requirements needed to lead such clinics and
has fully prepared me for addressing such issues.
So what?
48
It is therefore appropriate that as an advanced nurse practitioner with an interest in this
area, I know more about nurse-led clinics in general and specifically in the field of
dermatology to initiate this project. I set out to carry out this systematic review to
determine the effectiveness of existing nurse-led dermatology clinics and provide a
reliable evidence to be used during the negotiation process of setting up the nurse-led
dermatology clinic. The several advantages of systematic reviews over other sources of
evidence imply that many healthcare professionals and service users will, at a point in
time, rely on them for guiding practice and decision-making. Moreover, personal and
professional development may imply that healthcare professionals should be
conversant with generating and/or utilising quality evidence in their clinical practice.
Now what?
This systematic review not only contributes significantly to evidence-based practice but,
also, serves as an indication of my personal and professional development. Undertaking
this systematic review has given me a better understanding of research methods. It has
also enhanced my ability to critique research articles and make sense of their findings.
With these, the use of clinical evidence will be a kingpin in my nursing practice. I also
believe that I can play significant roles in assisting other colleagues in the process of
undertaking and utilising research. It is anticipated that the findings of this systematic
review will influence the initiation of a nurse-led dermatology clinic in my hospital in
Ghana. Some of the challenges that may be encountered have been discussed in the
section on implications for advancing practice section. However, my belief is that its
introduction may provide an alternative service of care for clients who have
dermatology problems.
In the course of this dissertation, I undertook visits to nurse-led dermatology clinics that
enhanced my understanding on various activities that went on at such clinics. I also
interacted with a nurse consultant dermatologist. I anticipate that all these experiences
will make me very instrumental in leading a nurse-led dermatology clinic in Ghana. Now
that the impact of the service has been established, several obstacles need to be
overcome, including the issue of funding the clinic. As specialty clinics expand, on-going
49
evaluation should be considered to ensure the quality of care and patient satisfaction
with the consultation.
50
REFERENCES:
INCLUDED STUDIES
Chinn, D., Poyner, T. and Sibley, G. (2002) Randomized controlled trial of a single
dermatology nurse consultation in primary care on the quality of life of children with
atopic eczema. British Journal of Dermatology 146:pp. 432–439
Gradwell, C., Thomas, K. S., English, J. S. C. and Williams, H. C. (2002) A randomized
controlled trial of nurse follow-up clinics: do they help patients and do they free up
consultants' time? British Journal of Dermatology 147 :pp 513-517.
Kernick, D., Cox, A., Powell, R., Reinhold, D., Sawkins, J. and Warin, A. (2000) A cost
consequence study of the impact of a dermatology-trained practice nurse on the quality of
life of primary care patients with eczema and psoriasis. British Journal of General Practice
50:pp. 555-558.
Moore, E. J., Williams, A., Manias, E., Varigos, G. and Donath, S. (2009) Eczema workshops
reduce severity of childhood atopic eczema. Australasian Journal of Dermatology
50: pp.100–106.
Schuttelaar, M., Vermeulen, K., Drukker, N. and Coenraads, P. (2009) A randomized
controlled trial in children with eczema: nurse practitioner vs. dermatologist. British
Journal of Dermatology 162: pp.162–170.
EXCLUDED STUDIES
Cork, M. J., Britton, J., Butler, L., Young, S., Murphy, R. and Keohane, S. G. (2003)
Comparison of parent knowledge, therapy utilization and severity of atopic eczema before
and after explanation and demonstration of topical therapies by a specialist dermatology
nurse. British Journal of Dermatology 149:pp. 582-589
51
Courtenay, M. and Carey, N. (2007) A review of the impact and effectiveness of nurse-led
care in dermatology. Journal of Clinical Nursing 16:pp.122-128
Shaw, M., Morrell, D. S. and Goldsmith, L. A. (2008), A Study of Targeted Enhanced Patient
Care for Pediatric Atopic Dermatitis (STEP PAD). Pediatric Dermatology 25: pp.19–24.
van Os-Medendorp, H., Ros, W.J., Eland-de Kok, P.C., et al. (2007) Effectiveness of the
nursing programme 'Coping with itch': a randomized controlled study in adults with
chronic pruritic skin disease. British Journal of Dermatology 156(6):pp. 1235-1244.
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I
Appendix I- Systematic Review Protocol
The Effectiveness of Nurse-Led/Nurse Follow-Up Dermatology Clinics
Background
With the impact of dermatological services on individuals in the community, just having
one type of service is not sufficient in meeting the needs of the growing population
(Brown, 2005). The issue of waiting times, quality of care, treatment outcomes is an
evidence of this.
Nurses with expertise and training are available to bridge this gap in dermatology
services (Chinn, Poyner and Sibley, 2001). This initiated the emergence of nurse-led
clinics (Brown, 2005). Nurse-led clinics have been in the United States and the United
Kingdom since the 19th century (Turkeltaub, 2004). Though these clinics have been in
existence for decades, a rigorous search for evidence on their effectiveness in
outpatient dermatology settings has not been carried out.
In Ghana my home country, though there is the existence of nurse-led clinics in other
specialties of medicine (ear, nose and throat [ENT], Eye and General Nursing), there is
none set up in dermatology. Also, these are only seen in the rural areas where there is
the shortage of general practitioners. In the hospital where I work in Ghana, there is a
visiting dermatologist who comes once a week or sometimes every other week for 3
hours per visit. Clients have to wait weeks to see the dermatologist or make do with
prescriptions given by general practitioners who do not have the required skills for
dermatological care.
Setting up a nurse-led dermatology clinic after my training as an advanced nurse
practitioner, is one of the targets I look forward to achieve. It is therefore anticipated
that this systematic review when carried out will identify available evidence from
II
randomised controlled trials, the pros and cons of nurse-led clinics in dermatology and
if it is beneficial to start such a clinic.
Review Question:
How effective is a nurse-led outpatient dermatology clinic when compared to the usual
care (dermatologist/general practitioner)?
Objective
To determine the effectiveness of nurse-led dermatology clinics on patient’s adherence
to treatment, the quality of life, patient satisfaction, severity of condition and cost.
Inclusion Criteria
Types of participants
I. Adults and children of either gender seen at dermatology Outpatient departments
II. Nurse could be nurse practitioners, clinical nurse specialists and advanced practice
nurses
III. Medical practitioner could be a general practitioner or dermatologist
Types of interventions
All or part of care delivered by a nurse practitioner compared to the usual care (medical
practitioner managed) in a dermatology clinic.
Types of outcome measures
I. Adherence to treatment,
II. Quality of life,
III. Patient satisfaction
IV. Severity of condition
V. Cost involved
III
Types of studies (study designs)
Randomised controlled trials (RCTs) comparing nurse-led dermatology clinics to clinics
run by a dermatologist/ general practitioner (usual care) with quality of life, adherence
to treatment, patient satisfaction, severity of condition or cost involved as a primary or
secondary outcome, will be considered for inclusion in this review. Other research
designs such as non-randomised controlled trials and observational studies will be
considered for inclusion in a narrative summary, in the absence of RCTs. This is to
ensure that the current best evidence on the effectiveness of nurse-led clinics as
compared to usual care in improving quality of life, adherence to treatment, waiting
times and minimizing cost among patients in the dermatology clinic, is identified.
Search strategy for identification of studies
The search strategy (limited to English to prevent translation problems as this may be
bias) will be in 3 steps to ensure that both published and grey literature is searched for.
Electronically, relevant data will be extracted from databases such as MEDLINE,
SCOPUS, CINAHL, and Cochrane Library as the first step. Text words in the titles and
abstract will then be examined. Searching will be efficiently carried out by ensuring that
inclusive search strings (synonyms, wild cards) specific to each database are employed.
The second step involves keying in identified keywords and index terms into the
databases. In the third step, hidden studies from retrieved references will be searched.
Hand searching through journals, conference reports, dissertation abstracts and theses
of other students will also be done to retrieve grey literature that meets the inclusion
criteria. The database Systems for Information on Grey Literature (SIGLE) will also be
searched. Full text for potentially relevant studies will be then retrieved.
Initial keywords for the search will be:
a. Nurse-led clinics
b. Nurse managed clinic
c. Nurse-led care
IV
d. Dermatology
e. Out Patient/ ambulatory care
f. Effectiveness of care
g. Quality of care
h. Patient satisfaction
i. Cost effectiveness
Methods of the review
Eligibility
Two independent reviewers will screen the articles for inclusion. Studies should involve
clinics led by nurses in outpatient dermatology. Participants in these studies could be
either children or adults. Any disagreement that arises between the reviewers will be
resolved through discussion and a final consensus. Where relevant, authors of the
studies will be contacted for clarification.
Data extraction
Data will be extracted by two reviewers independently and entered into a data
extraction form. The extracted data will then be entered into the Cochrane
collaboration software -Review Manager (Revman 5.1).
Assessment of methodological quality
Full text articles of studies that meet the inclusion criteria will be retrieved and
reviewed by two independent reviewers for methodological validity before inclusion in
the review. Standardised critical appraisal instruments from the Joanna Briggs Institute
Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) will be
used for this purpose. The two independent reviewers will assess the quality of the
search results and exclude articles that do not meet the inclusion criteria of this review.
V
For quality of the randomized controlled trials, the following will be noted:
a. How was randomization done?
b. Where participants comparable at baseline?
b. Method of allocation concealment
c. Which parties were blinded?
d. Was there an indication of Intention to treat?
e. Measurement tools used in defining outcome measures
•Analysis
Analysis will be done using the Review manager software. Studies with similar
outcomes will undergo meta-analysis. The results will be expressed as odds ratio (OR)
for dichotomous outcomes and weighted mean differences for continuous outcomes
with 95% confidence intervals (CI) for either outcomes. Heterogeneity will be assessed
using I2. The result will also be expressed as number needed to treat (NNT) where
appropriate, for a range of plausible control event rates. Where it is not possible to
perform a meta-analysis the findings will be summarized in a narrative form.
VI
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dermatology out-patient waiting times. Clinical and Experimental Dermatology 26:pp. 548-
555.
Benton, D. (2009) All in a generation. International Nursing Review 56:p. 284
British Association of Dermatologists (2005) Guidelines for use of biological interventions in
psoriasis. British Journal of Dermatology 153:pp.486-497
Brown, M. H. (2005) A nurse-led clinic, in chronic and allergic contact dermatitis. British
Journal of Nursing 14(5) pp.260-263
Brown, S. A and Grimes, D. E. (1995) A metaanalysis of nurse practitioners and nurse
midwives in primary care. Nursing Research 44: pp.332339.
Burns, N. and Grove, S. K, (2007) Understanding Nursing Research: Building an Evidence-
Based Practice. 4th ed. Saunders Elsevier: Philadelphia.
Carter, A. J. E. and Chochinov, A. H. (2007) A systematic review of the impact of nurse
practitioners on cost, quality of care, satisfaction and wait times in the emergency
department. Canadian Journal of Emergency Medicine 9(4):pp.286-295.
Chinn, D. J., Poyner, T. and Sibley, G. (2002) Randomized controlled trial of a single
dermatology nurse consultation in primary care on the quality of life of children with atopic
eczema. British Journal of Dermatology 146: 432-439.
Courtenay, M. and Carey, N. (2007) A review of the impact and effectiveness of nurse-led
care in dermatology. Journal Of Clinical Nursing 16:pp.122-128.
VII
Courtenay, M., Carey, N. and Stenner, K. (2009) Nurse prescriber-patient consultations: a
case study in dermatology. Journal Of Advanced Nursing 65:pp.1207-1217.
Doe, P. T., Asiedu, A., Acheampong, J. W. and Payne, C. M. E. (2001) Skin diseases in Ghana
and the Uk. International Journal Of Dermatology 40:pp.323-326.
Fineout-Overholt, E. and Johnston, L. (2005) Teaching Evidence based practice: A challenge
for educators in the 21st century. Worldviews on Evidence-Based Nursing 2: pp. 37-39.
Gruen, R.L, Weeramanthri, T.S., Knight, S.S. and Bailie, R.S.(2003) Specialist outreach clinics
in primary care and rural hospital settings. Cochrane Database of Systematic Reviews
Hatchett, R. (2008) Nurse-led clinics: 10 essential steps to setting up a service. Nursing
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Methods in molecular biology: Topics in biostatistics. Humana Press Inc., Totowa: New
Jersey, pp. 19-31
Horrocks, S., Anderson, E. and Salisbury, C. (2002) Systematic review of whether nurse
practitioners working in primary care can provide equivalent care to doctors. British
Medical Journal 324:pp. 819-823.
International Council of Nurses (ICN) (2005) Definition and characteristics of the Advanced
Practitioner Nurse role. In: Clinical Nurse Specialists and Nurse Practitioners in Canada :A
Decision Support Synthesis ,June 2010
Kernick, D., Cox, A., Powell, R. et.al (2000) A cost consequence study of the impact of a
dermatology-trained practice nurse on the quality of life of primary care patients with
eczema and psoriasis. British Journal of General Practice 50:pp. 555-558.
VIII
Lobiondo-Wood, G. and Haber, J. (Eds.) (2006) Nursing research, methods and critical
appraisal for evidence-based practice. pp. 78-110. Philadelphia: Mosby Elsevier.
Masawe, A. E. J. and Samitz, M. H. (1976) Dermatology in Tanzania: a model for other
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W. T., Siu, A. L. and Shelanski, M. L. (2000) Primary care outcomes in patients treated by
nurse practitioners or physicians. Journal Of The American Medical Association 283:pp. 59-
68.
Pinkerton, J.-A. & Bush, H. A. (2000) Nurse practitioners and physicians: patients' perceived
health and satisfaction with care. Journal Of The American Academy Of Nurse Practitioners
12:pp. 211-217.
Polit, D.F. and Beck, C.T. (2008) Nursing research: generating and assessing evidence for
nursing practice. 8th ed. Philadelphia: Lippincott.
Polit, D.F. & Beck, C.T. (2010) Essentials of Nursing Research: Appraising Evidence for
nursing Practice. 7th ed. Philadelphia: Lippincott Williams & Wilkins.
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Sidani, S. & Irvine, D. (1999) A conceptual framework for evaluating the nurse practitioner
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of Dermatology 162: 162–170.
IX
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evidence informed palliative care. Indian Journal of Palliative Care 12:pp.39-41
Tranfield, D., Denyer , D. and Smart, P. (2003) Towards a methodology for developing
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reviews. Blackwell Publishing Ltd.
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March 7, 2011)
X
APPENDIX II Search Strategy:
Embase <1980 to 2011 Week 21>
1 randomised controlled trials.mp. (9376)
2 randomized controlled trials.mp. or Randomized Controlled Trial/ (301164)
3 Controlled Clinical Trial/ (173464)
4 randomised controlled trial*.mp. (17669)
5 randomized controlled trial*.mp. (310633)
6 randomized controlled trial.pt. (0)
7 controlled clinical trial.pt. (0)
8 1 or 2 or 3 or 4 or 5 or 6 or 7 (347019)
9 (nurse adj led adj clinic*).mp. [mp=title, abstract, subject headings, heading word,
drug trade name, original title, device manufacturer, drug manufacturer, device trade
name, keyword] (237)
10 (nurse adj2 clinic*).mp. [mp=title, abstract, subject headings, heading word, drug
trade name, original title, device manufacturer, drug manufacturer, device trade name,
keyword] (10078)
11 (nurse adj run adj clinic).mp. [mp=title, abstract, subject headings, heading word,
drug trade name, original title, device manufacturer, drug manufacturer, device trade
name, keyword] (14)
12 (nurse adj practitioner adj led adj3 clinic*).mp. [mp=title, abstract, subject
headings, heading word, drug trade name, original title, device manufacturer, drug
manufacturer, device trade name, keyword] (6)
XI
13 (nurse adj follow adj up adj clinic*).mp. [mp=title, abstract, subject headings,
heading word, drug trade name, original title, device manufacturer, drug manufacturer,
device trade name, keyword] (3)
14 9 or 10 or 11 or 12 or 13 (10082)
15 Dermatology/ (19400)
16 exp Skin Diseases/ (879957)
17 15 or 16 (890162)
18 8 and 14 and 17 (53)
Medline
Database: Ovid MEDLINE(R) <1948 to July Week 4 2011>
Search Strategy:
1 randomised controlled trials.mp. (7528)
2 randomized controlled trials.mp. or Randomized Controlled Trial/ (393031)
3 Controlled Clinical Trial/ (83249)
4 randomised controlled trial*.mp. (14009)
5 randomized controlled trial*.mp. (395490)
6 randomized controlled trial.pt. (314972)
7 controlled clinical trial.pt. (83249)
8 1 or 2 or 3 or 4 or 5 or 6 or 7 (476801)
XII
9 (nurse adj led adj clinic*).mp. [mp=protocol supplementary concept, rare disease
supplementary concept, title, original title, abstract, name of substance word, subject
heading word, unique identifier] (159)
10 (nurse adj2 clinic*).mp. [mp=protocol supplementary concept, rare disease
supplementary concept, title, original title, abstract, name of substance word, subject
heading word, unique identifier] (8888)
11 (nurse adj run adj clinic).mp. [mp=protocol supplementary concept, rare disease
supplementary concept, title, original title, abstract, name of substance word, subject
heading word, unique identifier] (12)
12 (nurse adj practitioner adj led adj3 clinic*).mp. [mp=protocol supplementary concept,
rare disease supplementary concept, title, original title, abstract, name of substance word,
subject heading word, unique identifier] (5)
13 (nurse adj follow adj up adj clinic*).mp. [mp=protocol supplementary concept, rare
disease supplementary concept, title, original title, abstract, name of substance word,
subject heading word, unique identifier] (2)
14 9 or 10 or 11 or 12 or 13 (8892)
15 Dermatology/ (11820)
16 exp Skin Diseases/ (716404)
17 15 or 16 (724398)
18 8 and 14 and 17 (26)
Web of science (looking through all databases)
# 14 5 #12 AND #10 AND
#5
# 13 #12 AND #11 AND #5
XIII
6
# 12 >100,000 Topic=(dermatology) OR Topic=(skin clinic)
# 11 991 Topic=(nurse led clinic) OR Topic=(nurse run clinic) OR Topic=(nurse managed clinic) OR
Topic=(nurse practitioner led clinic)
# 10 706 Topic=(nurse follow-up clinic) OR Topic=(nurse follow up clinic)
# 9 491 Topic=(nurse managed clinic) OR Topic=(nurse run clinic) OR Topic=(nurse led clinic) AND
Topic=(nurse practitioner led clinic)
# 8 309 Topic=(nurse managed clinic)
# 7 135 Topic=(nurse run clinic)
# 6 605 Topic=(nurse led clinic)
# 5 >100,000 #4 OR #3 OR #2 OR #1
# 4 >100,000 Topic=(randomized controlled trials/)
# 3 73,618 Topic=(random allocation/)
# 2 >100,000 Topic=(controlled clinical trial)
# 1 >100,000 Topic=(randomi?ed controlled trial)
XIV
Appendix III
Table 2: Characteristics of excluded studies
List of excluded studies Reason for exclusion
Cork, Britton, Butler, Young et.al,
2003
Cohort study
Courtenay and Carey, 2007 Literature review
Shaw, Morrel and Goldsmith, 2008 Intervention given by a medical
student not a nurse
van Os-Medendorp H, Ros WJ,
Eland-de Kok PC, et al.,2007
After close reading discovered that
none of the interested outcomes
was an outcome in the trial
XV
Appendix IV
JBI MAStARI Critical Appraisal Tool for Experimental Studies
Study:
Reviewer: Date: Record Number:
1. Was the assignment to treatment groups truly random?
Yes No Unclear
2. Were participants blinded to treatment allocation?
Yes No Unclear
3. Was allocation to treatment groups concealed from the allocator?
Yes No Unclear
4. Were the outcomes of people who withdrew described and included in the analysis?
Yes No Unclear
5. Were those assessing outcomes blind to the treatment allocation?
Yes No Unclear
6. Were the control and treatment groups comparable at entry?
Yes No Unclear
7. Were groups treated identically other than for the named interventions?
Yes No Unclear
8. Were outcomes measured in the same way for all groups?
Yes No Unclear
9. Were outcomes measured in a reliable way?
Yes No Unclear
10. Was appropriate statistical analysis used?
Yes No Unclear
Overall Appraisal: Include Exclude Seek further information
Rationale:
XVI
Appendix V
Cochrane Skin Group data extraction template (modified)
DESCRIPTION OF INTERVENTIONS
Intervention
DERMATOLOGIST/GENERAL
PRACTITIONER
Intervention NURSE
PRACTITIONER
Period for consultation
Education during
consultation
Were adequate instructions
given to patients regarding
using medications
Y/N/Unsure Y/N/Unsure
PARTICIPANTS
Inclusion criteria
a) diagnosis
b) Referred by
c) severity of eczema
d) duration
Exclusion criteria
Setting (eg primary or
secondary care, country,
number of centres)
XVII
Baseline demographic data Intervention
DERMATOLOGIST
Intervention
NURSE
PRACTITIONER
Total Note
s
Age
Duration of condition
Severity of condition
Severe
Moderate
Mild
Male
Female
Number of participants
randomised
Losses to follow –up -
reasons
distance
stressful
none
Number lost to follow up
% lost to follow up
Final number of
participants evaluable
Intention to treat analysis yes / not stated / no
XVIII
Primary outcome measures
1. Quality of life
Methods of assessing primary outcome measures
1. Infants’ Dermatitis Quality of Life
Index (IDQOL)
2. Children’s Dermatology Life Quality Index (CDLQI)
3. Dermatitis Family Impact Questionnaire, (DFI)
Secondary outcome measures
1. adherence to treatment
2. Patient satisfaction
3. Severity of condition
4. Cost involved
Methods of assessing secondary outcome measures
1. Electronic monitoring
2. Client satisfaction questionnaires
3. Objective SCORAD
4. Cost analysis
XIX
OUTCOME MEASURES
RESULTS
Intervention
DERMATOLOGIST
Intervention NURSE
PRACTITIONER
Notes
Quality of life (IDQOL).
mean (SD) N= Total
number @
Time point:0-4/0-12
weeks
Quality of life (CDQOL).
mean (SD) N= Total
number @
Time point:0-4/0-12
weeks
Family impact of
childhood atopic
dermatitis. mean (SD)
N= Total number @
Time point: 0-4/0-12
weeks
XX
METHODS
Design: parallel group / cross over / other (describe)
Duration of trial: Interval of assessment:
METHODOLOGICAL QUALITY OF STUDY
Major Criteria Method
1. Generation of randomisation sequence
Any information given? Y/ N / unsure
2. Allocation concealment
A Adequate - e.g. third party or opaque sealed
envelopes
B Unclear - insufficient details provided
C Inadequate - e.g. open list or day of week
D Not used
3. Blinding
Participant Y/ N / unsure
Clinician Y/ N / unsure
Outcome assessor Y/ N / unsure
4. Loss to follow-up
Were all randomised participants included in the
analysis in the groups to which they were
randomised? Y/ N / unsure
Funding body
XXI
Declared: Y/ N / unsure Name:
Comments
xxii
