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Inception Report

_________________________________________________________________________ The Center for Health Strategies and Policies

Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154

REPORT COVER PAGE

MINISTRY OF HEALTH OF REPUBLIC OF MOLDOVA

HEALTH SERVICES AND SOCIAL ASSISTANCE PROJECT

Project Title: Component 1: Health System Modernization Component

Sub-component 1.3: Primary Health Care Development

DEVELOPMENT AND IMPLEMENTATION OF CLINICAL STANDARDIZED WORK

PLACE PROTOCOLS FOR FAMILY DOCTORS

Country: Moldova

Beneficiary Consultant

Name: Ministry of Health The Centre for Health

Strategies and Policies

Address: 2, str. Vasile Alecsandri 3, str. A Cozmescu

2009 Chisinau 2009 Chisinau

Moldova Moldova

Tel. number: +373 22 73 5487 +373 22 28 71 54

Fax number: +373 22 73 8781 +373 22 72 30 00

Contact person: Andrei Usatii Mihai Ciocanu

- Minister - - Project Director -

Signatures: ___________________ ___________________

Date of report: 27 March 2012

Reporting period: 30 January 2012 – 31 March 2012

Author of report: Dr Mihai Ciocanu, Dr Inga Pasecinic

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List of Annexes

Annex 1 Qualitative research results- Analysis of the applicability of existing

CSWPFD

Annex 2 Quantitative research results - Analysis of the applicability of existing

CSWPFD

Annex 3 Disposition of the MoH nr. 40- D from 03.02.2012 on establishment of

Working Group

Annex 4. Order of the MoH nr. 248 from 19.03.2012 on establishment of Author

Groups for development of SWPPFD

Annex 5 MoH Order nr. 295 from 29.03.2012 on modification and reapproval of the

SWPPFD „Community acquired pneumonia in adults”


SWPPFD „Meningococcal infection in children”


SWPPFD „Influenza in children”


SWPPFD „Adenoviral infection in children”

Annex 9 MoH Order nr. from .03.2012 on modification and reapproval of the

SWPPFD „Acute viral hepatitis B in adults”

Annex 10 The list of the priority health conditions most often encountered by family

doctors for developing of the SWPPFD

Annex 11 Plan for development of Standardized Working Place Protocols for Family

Doctors

Annex 12 Disposition of the MoH nr. 105 –d from 26.03.2012 on organizing and

carrying out the seminar “Clinical Protocols in Primary Health Care. Awareness and

capacity building in developing and implementing SWPPFD”

Annex 13 The modified SWPPFD “”Dyslipidemia”

Annex 14 The workshop “Strengthen knowledge of groups of authors in CSWPFD

development area to improve their quality and applicability in practice” materials

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Abbreviations

AG Author Group

CFD Centre of Family Doctors

CME Continuous Medical Education

CP&G Clinical Protocols and Guidelines

EBM Evidence Based Medicine

EC European Commission

ECD European Commission’s Delegation to

Moldova, Chisinau

EU European Union

EUD European Union’s Delegation to

Moldova, Chisinau

FD Family Doctor = General Practitioner =

Family Physician

GP General Practitioner = Family Doctor =

Family Physician

HC Health Centre

HIF Health Investment Fund

HIS Health Information System

HIV Human Immunodeficiency Virus

HR Human Resources

HSSAP Health Services and Social Assistance

Project

IS Information System

IT Information Technology

M&E Monitoring and Evaluation

MoH Ministry of Health

NCHM National Centre of Health Management

NGO Non-governmental Organisation

NHIC National Health Insurance Company

NHP National Health Policy

NSO National Statistics Office

OFD Office of Family Doctor

PHC Primary Health Care

SHC Secondary Health Care

SMPhU State Medical and

Pharmaceutical University

”Nicolae Testemiţanu”

SWOT Strength, Weakness,

Opportunities, Threats

SWPPFD Standardized Working Place

Protocol for Family Doctors

TACIS Technical Assistance to

Commonwealth of

Independent States

TC Training Centres

ToR Terms of Reference

NCPHC PMSI University Clinic of

Primary Health Care of the

State Medical and

Pharmaceutical University

”Nicolae Testemiţanu”

WB World Bank

WG Working Group

WHO World Health Organization

Inception Report



Contents

LIST OF ANNEXES ................................................................................................... 2

1. PROJECT SYNOPSIS ........................................................................................ 5

1.1. Overall Project Objective: ............................................................................. 5

1.2. Special objectives ......................................................................................... 5

1.3. Expected outcomes in inception phase ........................................................ 5

1.4. Project activities in inception phase .............................................................. 6

2. SUMMARY OF THE PROJECT PROGRESS SINCE THE START .................... 7

2.1. analysis of project – relevant project environment ........................................... 7

2.2. Context for development and implementation of Clinical Standardized Work

Place Protocols for family doctors in Moldova ......................................................... 9

2.3. Fundamental problems concerning Clinical Protocols in PHC ....................... 10

2.4. Situation with the main counterparts and stakeholders .................................. 11

3. PROJECT PROGRESS IN INCEPTION PERIOD............................................. 12

3.1. Activity 1 - Analysis of the applicability of existing CSWPFD and impact of

their implementation in medical practice. .............................................................. 12

3.1.1. Qualitative research ................................................................................. 12

3.1.2. Quantitative research .............................................................................. 13

3.2. Activity 2 - Review and adjustment of SWPPFD ............................................ 14

3.2.1. Detailed description of revision and modification of SWPPFD ................ 17

3.3. Activity 3 - Identification and selection of information sources, involved

stakeholders to set priorities with the purpose to develop CSWPFD. ................... 23

3.3.1. Identification and selection of involved stakeholders to set priorities with

the purpose to develop CSWPFD ..................................................................... 24

3.3.2. Set up Working Group and Authors Groups according to identified

priorities of SWPPFD development. .................................................................. 26

3.4. Activity 4 - Establishment of priorities and areas within which CSWPFD are to

be developed ............................................................................................................................................. 29

3.4.1. The important priority health conditions in the country that are most often

encountered by family doctors ..................................................................................................... 30

3.4.2. The availability of NCP targeting priority health conditions most often

encountered by family doctors ........................................................................... 36

3.5. Activity 5 - Strengthening the knowledge of AGs in development of clinical

protocols ............................................................................................................... 40

4. SPECIFIC ACTIONS NEEDED FROM THE BENEFICIARY ............................ 42

5. LESSONS LEARNT AND RECOMMENDATIONS ........................................... 43

5.1. Lesson learnt ................................................................................................. 43

5.2. Recommendations ......................................................................................... 44

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1. Project Synopsis

Project Title: HEALTH SERVICES AND SOCIAL ASSISTANCE PROJECT

Component 1: Health System Modernization Component

Sub-component 1.3: Primary Health Care Development

DEVELOPMENT AND IMPLEMENTATION OF CLINICAL STANDARDIZED WORK

PLACE PROTOCOLS FOR FAMILY DOCTORS

Country: Moldova

1.1. Overall Project Objective:

The overall objective of the consultancy is to assist the Ministry of Health in the development,

printing/multiplication, dissemination and implementation of at least 60 Standardized clinical

protocols for family doctors, and monitoring and evaluating their implementation.

The developed protocols will be focused on preventing activities and detecting the most

common non-communicable diseases (cardiovascular and cancer). At the same time, the

family doctors will be trained to implement adequately the protocols developed and approved

in practice.

1.2. Special objectives

The implementation of the following specific objectives would contribute to effective coverage

throughout the Republic of Moldova with quality primary health care services and would have

an impact on solving major health problems, ensuring equitable access and improve the

efficiency and quality of health services provided at PHC level.

Support provided to MoH to implement reforms initiated in PHC in Moldova, in

particular the implementation of tools to improve and evaluate the performances and

quality of healthcare services provided at PHC level through the development and

implementation of Standardized clinical protocols for family doctors.

Support institutions to develop, review, approve and implement clinical protocols,

especially for major health problems in PHC sector.

Coordination of activities and cooperation with the relevant state health institutions,

donors and other projects currently in progress.

1.3. Expected outcomes in inception phase

Assessing the impact on the quality of care provided at the primary care level.

Update the relevant clinical protocols (FD work place protocols) wherever necessary.

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Sources of information, involved stakeholders to set priorities to develop the identified

and selected CSWPFD.

To organize and conduct a Seminar with the participation of experts in the related

area with the purpose to strengthen knowledge of groups of authors in CSWPFD

development area to improve their quality and applicability in practice.

List of priority diseases, most common encountered in family doctor practice which

shall be developed and approved, focused on preventing and detecting the most common

diseases. Established and approved groups of authors to develop CSWPFD.

1.4. Project activities in inception phase

Inception stage included the analysis of the situation in the related area, identification and

selection of the information sources, involved stakeholders, and setting priorities by areas,

within which Standardized Clinical Protocols for Family Doctors are to be developed.

Analysis of the applicability of existing CSWPFD and impact of their implementation in

medical practice.

Identification and selection of information sources, involved stakeholders to set

priorities with the purpose to develop CSWPFD.

Strengthening the knowledge of groups of authors in development of clinical protocols

through organizing and conducting a seminar with the participation of experts in the

field, to improve the quality and applicability in practice of the mentioned protocols.

Organize and conduct a seminar involving all relevant stakeholders regarding the

establishment of priorities and areas within which CSWPFD are to be developed.

Target group: Ministry of Health; major stakeholders of PHC issues at national, rayon and

local levels; University, training centres and trainees; general public

Project starting date: 30 January 2012

Project duration: January 2012 – August 2013 (19 months)

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2. Summary of the Project Progress since the start

2.1. Analysis of project – Relevant Project Environment

A Clinical Standardized Work Place Protocol for Family Doctors (CSWPPFD) is a document

that contains recommendations about health interventions. It provides guidance for family

doctors about evidence-based options for diagnosis and care of patients. This may include

prevention, screening, diagnostics, pharmaceutical treatment, surveillance, rehabilitation,

patient education strategies, and other types of choices. It provides the information that

guides choices between different interventions that may have an impact on health and that

have an influence on resource use.

General Physicians in Moldova as in other countries increasingly use CSWPPFD to improve

patient care and health outcomes. CSWPPFD help health professionals to offer the best

possible care for their patients by recommending treatment based on scientific evidence and

expert clinical opinion.

The overall aim of CSWPPFD development is to increase the application of evidence based

prevention in PHC by implementing and evaluating clinical protocols that contribute to

support and reinforcement of PHC in Moldova.

The CSWPPFD will be designed to apply to common conditions and to provide flexibility for

physician judgement in uncommon situations. They aim to improve patient care by

developing recommendations for clinical practice in Primary Health Care settings.

The CSWPPFD are intended to provide practical and easy-to-follow advice to general

practitioners for effective patient care. They should be based on scientific evidence and have

to:

Encourage appropriate responses to common medical situations

Recommend actions that are sufficient and efficient, neither excessive nor deficient`

Permit exceptions when justified by clinical circumstances

There is an emergent need for further development and implementation of CSWPFD

covering the priority conditions most often met in routine family doctor clinical practice. This

will lead to the improvement of quality of provided health care services within PHC through

assisting family doctors to concentrate on actions for prevention, screening, diagnostics,

pharmaceutical treatment, surveillance, rehabilitation, patient education strategies based on

comprehensive approach of all aspects related to a particular disease in a short pathway

mode.

The CSWPFD is foreseen as quality improvement and measurement tool and while

developed and implemented may be considered one of the most appropriate and effective

instrument to improve quality of patient care allowing practical application of the following:

Inception Report



regulatory / legal remedies;

rewards / penalties;

system strategies (e.g., referral mechanisms);

peer review, audit, and feedback;

training/ instructions.

Before starting the process of CSWPFD development the objectives for the CSWPFD have

been considered and whether a clinical protocol is really the best approach to reach the

stated objectives.

During the protocols development and approval process the inclusion of clinical evidence

need to be considered. The use of international resources for clinical evidence synthesis is

encouraged. It is likely that CSWPFD development in Moldova will be based on two

conditions:

1. the important priority health conditions in the country that are most often encountered

by family doctors

2. the availability of National Clinical Protocol describing this health condition

management and treatment at all stages of the Health System, including PHC.

The last condition is foreseen as mandatory because CSWPFD are pathways providing

possibilities for the most efficient, quick and timely interventions and choices while National

Clinical Protocols are extensive documents providing comprehensive information on this

particular health condition management at all levels of the health system. So, a family doctor

may consult a National Clinical Protocol, if needed and such is available, for deeper

information and more extensive knowledge of a particular health condition approached by

CSWPFD on a short note.

The CSWPPFD should be based on scientific evidence, and should be modified for

circumstances. The CSWPPFD are intended to give an understanding of a clinical problem,

and outline one or more preferred approaches to the investigation and management of the

problem. The CSWPPFD are not intended as a substitute for the advice or professional

judgment of a health care professional, nor are they intended to be the only approach to the

management of clinical problems.

The process for CSWPPFD development has to be fully transparent, carefully considered,

and created in close cooperation with all stakeholders. The process does not end with

approval of the clinical protocol; further action is needed to ensure that the CSWPPFD is

implemented not only in practice, but that it’s stated objectives are achieved.

Inception Report



2.2. Context for development and implementation of Clinical Standardized Work Place Protocols for family doctors in Moldova

Clinical Standardized protocols are generally accepted as an important tool for improving the

quality of clinical care provided by health professionals, as well providing guidance to ensure

the quality use of medicines and health technologies.

Beginning in 2008 and continuing through 2009-2010, the Ministry of Health together with the

health care institutions in Moldova, having the quality of the health services as the main goal,

have supported and carried out the development and implementation of National Clinical

Protocols and Clinical Standardized Work Place Protocols for family doctors. There was an

agreed and approved Regulation on the methodology of development, approval and

implementation of Clinical Institutional Protocols (CIP) and Clinical Workplace Protocols for

the health-care sector developed by the by Ministry of Health, which is also accepted by the

Moldovan medical professional societies.

Since 2008, overall 162 National Clinical Protocols that also include the Primary Health Care

(PHC) level have been developed and approved. According to the Regulation on the

methodology of development, approval and implementation of Clinical Institutional Protocols

(CIP) and Clinical Workplace Protocols, CIP determines the content and requirements for

organizing and providing health care for a disease/syndrome or clinical situation in a specific

health facility by specialists of the respective subdivisions. They are developed in two

formats: a) Clinical Institutional Protocols (full text) b) Clinical Workplace Protocols.

Clinical Workplace Protocols in PHC are the Clinical standardized workplace protocols for

family doctors (CSWPFD), which were developed with the support of European Commission

Project„ Strengthening of Primary Health Care”; and the Threshold Country Program

„Millennium Challenges” in the period 2008-2010. Based on the list of priority diseases, 47

CSWPFD were developed, tested and approved at all stages and implemented at country

level. CSWPFD approved, based on MoH Orders were printed and distributed in 2300

folders, then distributed to all PHC facilities for all family doctors in the country.

Due to the fact that there is uniformly accepted single Moldovan national approach to

protocols development, this resulted in a standardized protocol format. In 2011, a

comprehensive assessment of the situation was made by the World Bank, the MoH and

national and international experts in an effort to streamline and harmonize the principles and

continue the processes of CSWPPFD development in Moldova from 2011 onwards.

It has to be highlighted that in the process of SWPPFD development the following criteria will

be further considered as per existing methodology:

style and presentation of the SWPPFD adoption

clarity of definitions

language and format.

Inception Report



Therefore, SWPPFD should be written in unambiguous language and should define all terms

precisely. The format for presenting Clinical Protocols and Guidelines will not vary as target

group consists of family doctors and the intended use of them is in Primary Health Care

settings. End users will be consulted regarding the most appropriate method of presentation

for them. The SWPPFD will include the following parts (variations may occur depending on

the volume of provided care at the PHC level for a particular condition): screening, primary

prevention, secondary prevention, detection (diagnostics), treatment, surveillance,

rehabilitation, emergency care (for particular conditions). Within the main body of the

SWPPFD the structure would as far as possible reflect the methodological process that the

author group will follow.

Furthermore it was agreed to produce a laminated double-sided page per working place

protocol.

The protocols development methodology suggests that developed clinical protocols should

be pilot-tested prior to publication. It is considered that the pilot-testing phase is more

appropriately carried out at a local level as part of the local implementation process, as

testing the feasibility of implementation in one environment may not be applicable to another.

The SWPPFD development and implementation process is intended to bring together the

experience gathered thus far and the current internationally accepted methods for developing

clinical protocols. It intends to cover all aspects of clinical protocols development, starting

with assessing the need for protocols and finishing with the distribution, implementation, and

updating of protocols.

2.3. Fundamental problems concerning Clinical Protocols in PHC

Lack of scientific evidence-based CSWPPFD to provide practical and easy-to-follow

advice to family doctors for effective patient care.

Lack of CSWPPFD to assist family doctors and offer them the best possible care for their

patients by recommending treatment based on scientific evidence and expert clinical

opinion.

The existing CSWPPFD are reflecting a limited number of health conditions most often

met in family doctors routine practice. Respectively family doctors, especially those in

remote areas, in order to adopt quick and correct clinical decisions or seeking a second

opinion are lacking necessary and evidence based information.

Lack of encouragement of appropriate responses to common medical situations.

Exceptions are permitted when justified by clinical circumstances.

Developed National Clinical Protocols are targeting all health care system levels and are

too comprehensive and difficult to be used in daily practice by family doctors in PHC

settings.

Inception Report



The above mentioned developed National Clinical Protocols need proper review and

adjustment to up to date diagnostic, treatment and prevention innovations that occurred

during last period of time.

Due to high variability and diversity of pathologies encountered in clinical practice of family

doctors, due to existing opportunities to improve practice, quality of rendered services and

respectively, improve the outcomes and as well, due to increased interest of family doctors to

apply clinical protocols with the purpose to cover a larger number of most encountered

common pathologies by the family doctors in practice, there is a strident need to support the

further development of clinical protocols.

National Clinical Protocols and CSWPFD developed under the direction and joint supervision

of the Experts Council and the Medical Personnel Management, Performance and Quality of

Health Services Department of the Ministry of Health are available on-line at:

http://www.ms.gov.md/public/debates/protocolss/ .

2.4. Situation with the main counterparts and stakeholders

The MoH plays a major role in approving clinical protocols as developed by projects or any

other bodies. The MoH will be the key counterpart of the project in this respect. The close

collaboration with the Medical Personnel Management, Performance and Quality of Health

Services Department, Family Medicine Department of the SUMPh “N. Testemitanu”, the

Primary Health Care University Clinic, relevant departments of the SUMPh “N. Testemitanu”

in correspondence with the prioritized fields for SWPPFD development and other

stakeholders is established.

Close collaboration was established and is maintained with the project’s environment. As

major partners have been identified: Ministry of Health, Ministry for Informational

Development, National Centre for Health Management, National Health Insurance Company,

State Medical and Pharmaceutical University ”Nicolae Testemiţanu”, University Centre of

Primary Health Care State Medicine & Pharmaceutical University "N. Testemitanu", “AMT”

Centru, National College for Medicine and Pharmacy, Moldovan Association of Family

Medicine, Moldovan Association of Nurses. In addition, the project has held meetings in

Chisinau and selected rayons with head doctors of health centres, family physicians, and

nurses as well as with other stakeholders working in the field of health care reform in

Moldova.

The working group (WG) was formed for the supporting the analysis of the situation in the

related area, identification and selection of the information sources, and setting priorities by

areas, establishing and supporting the approval by MoH of groups of authors to develop

CSWPFD. The relevant stakeholders are represented in the working group (WG) (See Annex

nr nr. 3 Disposition of the MoH nr. 40- D from 03.02.2012).

The author groups (AGs) have been established by the project with the purpose to develop

the working place protocols and to increase capacity in this regard (See Annex nr.4 Order of

the MoH nr. 248 from 19.03.2012). Based on principles established together with MoH to

http://www.ms.gov.md/public/debates/protocolss/

Inception Report



base the formulation of WPP for GPs, clinical protocols are developed by main specialists

from the field jointly with Primary Health Care representatives, including relevant physician

groups and other health care providers as appropriate.

3. Project Progress in Inception Period

Inception stage included the analysis of the situation in the related area, identification and

selection of the information sources, involved stakeholders, and setting priorities by areas,

within which Standardized Clinical Protocols for Family Doctors are to be developed.

3.1. Activity 1 - Analysis of the applicability of existing CSWPFD and impact of their implementation in medical practice.

WPPs for Family Physicians have been developed, disseminated, and implemented to assist

health providers and patients to make clinical decisions, reduce unwarranted variations, and

assure and improve the quality of care. WPPs may serve as a means of strengthening PHC

in Moldova.

In Moldova little is known about general practitioners' attitudes to clinical protocols and

behaviour concerning clinical protocols. A range of qualitative interviews was carried out and

a pilot study was conducted in order to investigate this under-researched area and assess

implementation.

3.1.1. Qualitative research

A range of qualitative interview was performed in order to analyse the gap between

SWPPFD and current practice (See Annex 1 – Qualitative research results). For this reason,

an audit of medical records was conducted based on a range of developed, published,

distributed and implemented SWPPFD. These are as follows: “Chronic Viral Hepatitis B in

Adults”, “Compensated Hepatic Cirrhosis in Adults”, “Ascities in Hepatic Cirrhosis in Adults”,

“Iron Deficiency Anaemia in Adults”, “Chronic Renal Insufficiency in Adults”, “Chronic

Piyelonephritis in Adults”, “Bronchial Asthma in adults”, “Adenoviral Infection in Children”,

“Bronchial Asthma in Children”.

In order to evaluate the implementation of this disease management tool in medical sanitary

institutions based on the approved SWPPFD, the related activity of the following PMSI been

assessed: PMSI CFD Balti, PMSI CFD Anenii Noi, PMSI CFD Orhei, PMSI CFD Hincesti,

PMSI CFD Donduseni, PMSI CFD Ocnita, PMSI CFD Straseni, PMSI CFD Cimslia.

It was found that all the family doctors in the PMSI have the mentioned protocols. Medical

staff was trained in usage of SWPPFD and there have been required suggestions and

comments regarding the above mentioned protocols. Family doctors are well trained how to

work with SWPPFD and also it was noticed an environment of cooperation of specialists and

an initiative of knowing more about the field of activity.

Inception Report



Information of patients about paediatric diseases is being performed sufficiently; patients are

counselled about the disease they suffer by the medical staff; family doctors are well trained

how to work with SWPPFD.

Parents of sick children are familiar with the respective Guidelines for patients and are

familiar with the respective Guidelines for patients and are informed about the treatment

performed in compliance with SWPPFD.

It was also found that supply of the institution with medications as required by MSDT and

SWPPFD is satisfactory.

In order to execute the MoH orders, through which the above mentioned SWPPFD have

been approved, the National Council for Evaluation and Accreditation in Health included

these protocols as quality criteria in the main standards and these are monitored by experts

in evaluation of PMSI for accreditation purposes.

Information of patients about heart diseases is being performed well; patients are counselled

by medical staff; family doctors are well trained how to work with SWPPFD.

Regarding the evaluation of the above mentioned SWPPFD implementation, it was

performed the review of outpatient medical records and found that the prevention, diagnostic

and treatment procedure according to SWPPFD was partially observed for “Breast Benign

Diseases”, “Chronic Renal Insufficiency in Adults”, “Adenoviral Infection in Children”.

Regarding the implementation of the medical audit system within the reviewed PMSI, the

members of the commissions found that the majority of managers were familiar with order

no. 519 of 29.12.2008 “With regard to medical internal audit system”, all of them have

implemented medical internal audit and established the medical internal audit group based

on the order of the first manager of the institution. They developed the regulations and

activity plan, including systemic evaluation of SWPPFD implementation. These data could be

used to design intervention strategies to reduce barriers and facilitate SWPPFD

implementation.

In conclusion it could be mentioned, that within the reviewed medical sanitary institution, to a

great extent diagnostics, treatment and prevention of the above mentioned diseases is

performed partially according to requirements of SWPPFD and Medical Standards for

diagnostic and treatment, it is recommended to perform audit regarding management of

diseases based on MSDT and SWPPFD.

3.1.2. Quantitative research

A pilot study based on developed and tested questionnaire was conducted among Family

Physicians in a range of PHC facilities across the country (Cimislia, Hicesti, Orhei, Balti). It

has been found that most doctors are supportive of Clinical Protocols, finding them to be

useful, educational, and likely to improve the quality of care. This positive attitude, however,

does not automatically translate into practice changes. A report on Clinical Protocols

Inception Report



implementation monitoring and evaluation and end users satisfaction was produced. The

results have shown that most doctors are supportive of Clinical Protocols, finding them to be

useful, educational, and likely to improve the quality of care. It has to be noted that all PHC

institutions from the country, including autonomous and private once, utilize SWPPFD.

A questionnaire on clinical protocols was distributed to 200 general practitioners. The

questionnaire consisted of attitude statements and open questions on clinical protocols as

well as surveying characteristics and behaviour of respondents.

Of the 200 general practitioners filled in questionnaires. Many respondents (78%) reported

having been involved in writing institutional clinical protocols. A few respondents reported

having participated in clinical audit. Respondents were generally in favor of clinical protocols,

with mean response scores indicating a positive attitude to clinical protocols in 4 of the 6

statements, a negative attitude in one and equivocation in one. The majority of respondents

felt that clinical protocols were effective in improving patient care (69%). A substantial

minority (over a quarter) of general practitioners were concerned that clinical protocols may

be used for setting performance-related pay, or that they may lead to reduced clinical

freedom or stifled innovation. There was also concern that clinical protocols should be

scientifically valid.

This study suggests that the positive attitude of general practitioners supports the process of

developing, implementing and evaluating clinical protocols in PHC. The question of whether

incorporation of clinical protocols into clinical audit is an effective means to disseminate

systematic research-based clinical protocols warrants further study. Many general

practitioners in the PHC settings across Moldova participated in producing institutional

clinical protocols. This is largely sustained by positive attitudes about the effectiveness and

benefits of clinical protocols.

Yet no single method of implementing WPPs has been shown to be reliably effective in all

settings and circumstances. Anyhow, the study has shown that involving PHC doctors in the

process of developing WPPs enhanced their use in daily practice. In addition, the format of

WPPs strongly influence the attitudes towards them, hence more thought have been put into

making WPPs user-friendly and attractive. As Clinical Protocols development is expensive,

time and skill-demanding, centrally developed WPPs are more likely to facilitate the

concentration of resources for a comprehensive and trustworthy output. To conclude, the

study has shown that implemented, evidence-based WPPs can potentially improve quality of

care and Family Physicians are supportive of WPPs. Further studies are needed to identify

the strategies that are most significant, relevant and likely to have an impact on WPPs

implementation within PHC settings in Moldova (See Annex 2 – Quantitative research

results).

3.2. Activity 2 - Review and adjustment of SWPPFD

Up to date there have been reviewed 72 National Clinical Protocols, out of which 21 National

Clinical Protocols have been modified. Corresponding Ministry of Health Orders have been

issued and public medico sanitary institutions and practitioners have been informed.

Inception Report



The reviewed and modified National Clinical Protocols are as follow:

(During 2011)

1. “Acute middle ear infection (otitis media) in children” (MoH order nr. 541 from

30.06.2011)

2. “Bronchial asthma in adults” (MoH order nr. 542 from 30.06.2011)

3. “Mental and behavioural disorders caused by opioid consumption” (MoH order nr. 544

from 30.06.2011)

4. “Mental and behavioral disorders caused by alcohol consumption” (MoH order nr. 544

from 30.06.2011)

5. “Chronic tonsillitis in children” (MoH order nr. 545 from 30.06.2011)

6. “Chronic Obstructive BronchoPneumopathy” (MoH order nr. 546 from 30.06.2011)

7. “Ischemic stroke” (MoH order nr. 921 from 30.11.2011)

8. “Dyslipidemia” (MoH order nr. 923 from 30.11.2011)

9. “Acute myocardial infarction” (MoH order nr. 936 from 06.12.2011)

10. “Atrial fibrillation” (MoH order nr. 971 from 15.12.2011)

11. “Stable Angina pectoris” (MoH order nr. 9 from .12.2011)

(During 2012)

12. „Acute heart failure” (MoH Order nr. 71 from 30.01.2012)

13. „Chronic heart failure” (MoH Order nr.72 from 30.01.2012, reapproved)

14. „Infectious miocarditis in adult” (MoH Order nr.77 from 31.01.2012)

15. „Meningococcal infection in children” (MoH Order nr. 147 from 23.02.2012)

16. „Enteroviral infection in children” (MoH Order nr. 148 from 23.02.2012)

17. „Viral hepatitis A in children” (MoH Order nr. 149 from 23.02.2012)

18. „Community pneumonia in adult” (MoH Order nr. 229 from 14.03.2012)

19. „Acute viral respiratory infections in children (adenovirus, parainfluenza virus, human

respiratory syncytial virus) (MoH Order nr. nr. 233 from 15.03.2012)

20. „Influenza in children” (MoH Order nr. 234 from 15.03.2012)

http://www.google.md/url?sa=t&rct=j&q=chronic%20obstructive%20bronhopmneumopathy&source=web&cd=1&sqi=2&ved=0CC4QFjAA&url=http%3A%2F%2Fwww.acronymfinder.com%2FChronic-Obstructive-BronchoPneumopathy-%28COBP%29.html&ei=LuNhT9-ZHefW0QXtxKyeCA&usg=AFQjCNGkdO39ysmFqENsTe4Bb7nv6XOAUg&cad=rja

http://www.wordmagicsoft.com/dictionary/en-es/parainfluenza%20virus.php

http://www.google.md/url?sa=t&rct=j&q=respiratory%20sicitial%20virus&source=web&cd=1&sqi=2&ved=0CCYQFjAA&url=http%3A%2F%2Fen.wikipedia.org%2Fwiki%2FHuman_respiratory_syncytial_virus&ei=cdtpT6jEA8Xc4QSgqqWeCQ&usg=AFQjCNGqIQyHuHq2WG4Xd1YWMo1SNL0XDQ&cad=rja


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21. „Acute viral hepatitis B in adult” (MoH Order nr. 235 from 15.03.2012)

Out of revised and modified 21 National Clinical Protocols there are 15 Standardized

Working Place Protocols for Family Doctors covering similar priorities. According to existing

approved by MoH methodology these Standardized Working Place Protocols for Family

Doctors have been developed based on National Clinical Protocols. Therefore, the following

Standardized Working Place Protocols for Family Doctors covering the same topics as

revised and modified National Clinical Protocols have been supposed to revision and

modification were necessary. The MoH Orders on modification of reviewed SWPPFD have

been issued and PMSI and practitioners have been informed on that.

These are as follow:

1. SWPPFD “Bronchial asthma in adults” – reviewed, adjustments not necessary

2. SWPPFD “Chronic Obstructive BronchoPneumopathy” – reviewed, adjustments

not necessary

3. SWPPFD “Dyslipidemia” – reviewed and modified

4. SWPPFD “Acute myocardial infarction” – reviewed, adjustments not necessary

5. SWPPFD “Atrial fibrillation” – reviewed, adjustments not necessary

6. SWPPFD “Stable Angina pectoris” - reviewed, adjustments not necessary

7. SWPPFD „Chronic heart failure” – reviewed, adjustments not necessary

8. SWPPFD „Meningococcal infection in children” - reviewed and modified (MoH

Order nr. 296 from 29.03.2012) (See Annex nr. 6)

9. SWPPFD „Enteroviral infection in children” – reviewed, adjustments not

necessary

10. SWPPFD „Viral hepatitis A in children” – reviewed, adjustments not necessary

11. SWPPFD „Community pneumonia in adult” - reviewed and modified (MoH Order

nr. 295 from 29.03.2012) (See Annex nr. 5)

12. SWPPFD SWPPFD „Adenoviral infections in children” - reviewed and modified

(MoH Order nr. 298 from 29.03. 2012) (See Annex nr. 8)

13. SWPPFD “Parainfluenza virus and Respiratory syncytial virus in children” -

reviewed, adjustments not necessary

14. SWPPFD „Influenza in children” - reviewed and modified (MoH Order nr. from

2012) (MoH Order nr. 297 from 29.03.2012) (See Annex nr. 7)




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15. SWPPFD „Acute viral hepatitis B in adult” - reviewed and modified (See Annex

nr.9 MoH Order nr.308 from 30.03.20122012).

3.2.1. Detailed description of revision and modification of SWPPFD

1. SWPPFD “Chronic Obstructive BronchoPneumopathy”

Revision: As a result of modification of National Clinical Protocol “Chronic Obstructive

BronchoPneumopathy” two Annexes have been included (Annex nr. 11 “COBP evaluation

test” and Annex nr.12 “Stratification of COBP evaluation test”). To be mentioned here that

these Annexes are part of chapter for patients (final chapter) of National Clinical Protocol

“Chronic Obstructive BronchoPneumopathy”. As the result of consultations with authors of

National Clinical Protocol and WPPFD, it has been commonly agreed that newly introduced

Annexes from National Clinical protocol “Chronic Obstructive BronchoPneumopathy” are not

tangent developed, approved and implemented SWPPFD “Chronic Obstructive

BronchoPneumopathy”.

Conclusion: the revision of SWPPFD “Chronic Obstructive BronchoPneumopathy” indicates

that there are no needs for adjustment of SWPPFD “Chronic Obstructive

BronchoPneumopathy”.

2. SWPPFD “Bronchial asthma in adults”

Revision: As a result of modification of National Clinical Protocol “Bronchial asthma in

adults” one more chapter has been included (“Asthma test”). To be mentioned here that

SWPPFD contains already the chapter “Asthma test”. The SWPPFD has been developed an

approved thereafter National Clinical Protocol “Bronchial asthma in adults”, so authors

considered important to introduce the above mentioned chapter already at the stage of

development of SWPPFD “Bronchial asthma in adults”.

Conclusion: the revision of SWPPFD “Bronchial asthma in adults” indicates that there are

no needs for adjustment of SWPPFD “Bronchial asthma in adults”.

3. SWPPFD “Dyslipidemia”

Revision: It has to be pointed out that the developed, approved and implemented in 2009

National Clinical Protocol “Dyslipidemia” has been repealed in 2011. The issue is that the

new “European guidelines on dyslipidemia have been issued in 2011. This newly issued

document consists of totally new information on dyslipidemia management, including levels,

management, risks, etc. Consequently, the revision of the developed approved and

implemented in 2009 National Clinical Protocol “Dyslipidemia” performed in 2011 based, on

new “European guidelines on dyslipidemia” resulted in a totally changed document,

modifications comprising more than 50%. Significant changes occurred in the provided

information on dyslipidemia management, including levels, management, risks, etc, factors

that essentially affect the dyslipidemia management at the PHC level in special. After

multiple consultations with the authors and relevant experts from the field it has been











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commonly concluded to repeal the developed, approved and implemented in 2009 National

Clinical Protocol “Dyslipidemia” and approve the totally revised and changed document as

new National Clinical Protocol “Dyslipidemia”.

It has to be pointed out that the issue of a new National Clinical Protocol “Dyslipidemia”

considerably affected the content of earlier developed, approved and implemented

SWWPFD “Dyslipidemia”. Consequently, significant changes occurred in the provided

information on Dyslipidemia management, including levels, management, risks, etc, factors

that essentially affect the dyslipidemia management at the PHC level in special.

Considering all mentioned above, the Consultant recommends repelling the earlier

developed, approved and implemented SWWPFD “Dyslipidemia” due to its discrepancy with

the newly approved National Clinical Protocol “Dyslipidemia”. The SWWPFD “Dyslipidemia”

has been revised and modified group according to newly approved National Clinical Protocol

“Dyslipidemia”. It has to be pointed out that modified SWWPFD “Dyslipidemia” resulted in a

totally changed document, modifications comprising more than 50%. In this context the

Consultant recommends the approval and implementation of modified SWWPFD

“Dyslipidemia”.

Conclusion: the revision and modification of SWPPFD “Dyslipidemia” indicates the need for

repealing the earlier developed, approved and implemented SWPPFD “Dyslipidemia”. The

SWWPFD “Dyslipidemia” has been revised and modified group according to newly approved

National Clinical Protocol “Dyslipidemia”. The modified SWWPFD “Dyslipidemia” is attached

(Annex nr. 13). The Consultant recommends the approval and implementation of modified

SWWPFD “Dyslipidemia”. This action will require additional costs, in special for

implementation that includes publication (2000 copies) and training of FD. In case of

availability of assets, the Consultant recommends the implementation of SWWPFD

“Dyslipidemia” in adition to those 60 SWPPFD planned to be developed and implemented.

4. SWPPFD “Acute myocardial infarction”

Revision: The modification of National Clinical Protocol “Acute myocardial infarction”

consisted of changes and adjustments of content targeting other levels of care than PHC

level. Some insignificant changes occurred in the presentation of table concerning acute

chest pain – differential diagnostics, consisting of different order of listing the types of chest

pain than in developed, approved and implemented SWPPFD. To be mentioned here that

SWPPFD “Acute myocardial infarction” contains all the information included in revised NCP

“Acute myocardial infarction”. After consultations with the authors and relevant experts from

the field it has been commonly concluded that the developed, approved and implemented

SWPPFD “Acute myocardial infarction” corresponds by content to reviewed and adjusted

NCP “Acute myocardial infarction” and there are no requirements for its modification.

Conclusion: the revision of SWPPFD “Acute myocardial infarction” indicates that there are

no needs for adjustment of SWPPFD “Acute myocardial infarction”.

Inception Report



5. SWPPFD “Atrial fibrillation”

Revision: The modification of National Clinical Protocol “Atrial fibrillation” consisted of

changes and adjustments of content targeting other levels of care than PHC level, most

changes being related to Emergency and Hospital Care levels. Some insignificant changes

occurred in the presentation of classification of tromboemboly risk and diagnostics examples

(additional information has been introduced) presented in developed, approved and

implemented SWPPFD “Atrial fibrillation”. To be mentioned here that SWPPFD “Atrial

fibrillation” “contains all the information included in revised NCP “Atrial fibrillation”. After

consultations with the authors and relevant experts from the field it has been commonly

concluded that the developed, approved and implemented SWPPFD “Atrial fibrillation”

corresponds by content to reviewed and adjusted NCP “Atrial fibrillation” and there are no

requirements for its modification.

Conclusion: the revision of SWPPFD “Atrial fibrillation” indicates that there are no needs for

adjustment of SWPPFD “Atrial fibrillation”.

6. SWPPFD “Stable Angina pectoris”

Revision: The modification of National Clinical Protocol “Stable Angina pectoris” consisted of


changes being related to Emergency and Hospital Care levels. Some insignificant changes

occurred in the presentation of table related to treatment consisting of different order of listing

the drug groups than in developed, approved and implemented SWPPFD. It has to be

pointed out that drugs groups, drugs and doses of drugs included in revised NCP correspond

to those from SWPPFD “Stable Angina pectoris”, while the order of listing is different. To be

mentioned here that SWPPFD “Stable Angina pectoris” contains all the information included

in revised NCP “Stable Angina pectoris”. After consultations with the authors and relevant

experts from the field it has been commonly concluded that the developed, approved and

implemented SWPPFD “Stable Angina pectoris” corresponds by content to reviewed and

adjusted NCP “Stable Angina pectoris” and there are no requirements for its modification.

Conclusion: the revision of SWPPFD “Stable Angina pectoris” that there are no needs for

adjustment of SWPPFD “Stable Angina pectoris”.

7. SWPPFD „Chronic heart failure”

Revision: The modification of National Clinical Protocol „Chronic heart failure” consisted of


changes being related to Emergency and Hospital Care levels. To be mentioned here that

SWPPFD „Chronic heart failure” contains all the information included in revised NCP

„Chronic heart failure”. After consultations with the authors and relevant experts from the field

it has been commonly concluded that the developed, approved and implemented SWPPFD

“Atrial fibrillation” corresponds by content to reviewed and adjusted NCP „Chronic heart

failure” and there are no requirements for its modification.

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Conclusion: the revision of SWPPFD „Chronic heart failure” indicates that there are no

needs for adjustment of SWPPFD „Chronic heart failure”.

8. SWPPFD „Meningococcal infection in children”

Revision: The modification of National Clinical Protocol „Meningococcal infection in children”

consisted of insignificant changes and adjustments of content targeting in general other

levels of care than PHC level (epidemiology, emergency and hospital care). The only

insignificant change targeting PHC level and thus earlier developed, approved and

implemented SWPPFD „Meningococcal infection in children” consists of provision of

additional information within the component "Treatment of meningococcal meningitis in pre

hospital phase". The point "antipyretic" is completed with a new subpoint (as alternate option)

and additional information is provided. After a range of consultations with the authors and

relevant specialist from the field it has been decided to modify SWPPFD Protocol

„Meningococcal infection in children” according to revised National Clinical Protocol.

Necessary adjustments concerning treatment of meningococcal meningitis in pre hospital

phase have been made.

Conclusion: the revision of SWPPFD indicated the need for adjustments of SWPPFD

„Meningococcal infection in children”. The necessary adjustments have been performed. The

consequent MoH order on modification of SWPPFD „Meningococcal infection in children” has

been issued (see Annex 6 nr. the MoH order nr. 296 from 29.03.2012).

9. SWPPFD „Enteroviral infection in children”

Revision: The modification of National Clinical Protocol „Enteroviral infection in children”

consisted of insignificant changes and adjustments of content targeting other levels of care

than PHC level (epidemiology and hospital care). To be mentioned here that SWPPFD

„Enteroviral infection in children” contains all the information included in revised NCP

„Enteroviral infection in children”. After consultations with the authors and relevant experts

from the field it has been commonly concluded that the developed, approved and

implemented SWPPFD „Enteroviral infection in children” corresponds by content to reviewed

and adjusted NCP „Enteroviral infection in children” and there are no requirements for its

modification.

Conclusion: the revision of SWPPFD „Enteroviral infection in children” indicates that there

are no needs for adjustment of SWPPFD „Enteroviral infection in children”.

10. SWPPFD „Viral hepatitis A in children”

Revision: The modification of National Clinical Protocol „Viral hepatitis A in children”

consisted of insignificant changes and adjustments of content targeting other levels of care

than PHC level (epidemiology and hospital care). To be mentioned here that SWPPFD „Viral

hepatitis A in children” contains all the information included in revised NCP „Viral hepatitis A

in children”. After consultations with the authors and relevant experts from the field it has

been commonly concluded that the developed, approved and implemented SWPPFD „Viral

Inception Report



hepatitis A in children” corresponds by content to reviewed and adjusted NCP „Viral hepatitis

A in children” and there are no requirements for its modification.

Conclusion: the revision of SWPPFD „Viral hepatitis A in children” indicates that there are

no needs for adjustment of SWPPFD „Viral hepatitis A in children”.

11. SWPPFD „Community pneumonia in adult”

Revision: As a result of modification of National Clinical Protocol „Community pneumonia in

adult” a range of modifications targeting PHC level and thus, earlier developed, approved

and implemented SWPPFD „Community pneumonia in adult” have been introduced. These

concern the alternative antibacterial treatment of the community pneumonia at the PHC level.

The SWPPFD has been developed an approved thereafter National Clinical Protocol

„Community pneumonia in adult”, so authors considered important to introduce the

necessary changes in SWPPFD „Community pneumonia in adult”. After a range of

consultations with the authors and relevant specialist from the field it has been decided to

modify SWPPFD according to revised National Clinical Protocol „Community pneumonia in

adult”. Necessary changes concerning antibacterial therapy of community pneumonia at

PNC level have been made. In particular, these consist of exclusion of a group of high

toxicity antibiotics from the antibacterial therapy of community pneumonia at PHC level.


„Community pneumonia in adult”. The necessary modifications have been performed. The

consequent MoH order on modification of SWPPFD „Community pneumonia in adult” has

been issued (see Annex nr. 5 the MoH order nr. 295 from 29.03.2012).

12. SWPPFD „Adenoviral infections in children”

Revision: The modification of National Clinical Protocol „Adenoviral infections in children”

consisted of insignificant changes and adjustments of content targeting in general other

levels of care than PHC level (epidemiology, emergency and hospital care). The only

insignificant change targeting PHC level and thus earlier developed, approved and

implemented SWPPFD „Adenoviral infections in children” consists of provision of additional

information within the component "The treatment and supervision at home of mild forms of

adenoviral infections in children". The point "antipyretic" is completed with a new subpoint (as

alternate option) and additional information is provided. After a range of consultations with

the authors and relevant specialist from the field it has been decided to modify SWPPFD

Protocol ”Adenoviral infections in children” according to revised National Clinical Protocol.

Necessary adjustments concerning treatment of meningococcal meningitis in pre hospital

phase have been made.


„Adenoviral infections in children”. The necessary adjustments have been performed. The

consequent MoH order on modification of SWPPFD „Adenoviral infections in children” has

been issued (see Annex nr. 8the MoH order nr, 298 from 29.03.2012).

Inception Report



13. SWPPFD “Parainfluenza virus and Respiratory syncytial virus in children”

Revision: The modification of National Clinical Protocol “Parainfluenza virus and Respiratory

syncytial virus in children” consisted of insignificant changes and adjustments of content

targeting other levels of care than PHC level (epidemiology and hospital care). To be

mentioned here that SWPPFD “Parainfluenza virus and Respiratory syncytial virus in

children” contains all the information included in revised NCP “Parainfluenza virus and

Respiratory syncytial virus in children”. After consultations with the authors and relevant

experts from the field it has been commonly concluded that the developed, approved and

implemented SWPPFD “Parainfluenza virus and Respiratory syncytial virus in children”

corresponds by content to reviewed and adjusted NCP „Viral hepatitis A in children” and

there are no requirements for its modification.

Conclusion: the revision of SWPPFD “Parainfluenza virus and Respiratory syncytial virus in

children” indicates that there are no needs for adjustment of SWPPFD “Parainfluenza virus

and Respiratory syncytial virus in children”.

14. SWPPFD „Influenza in children”

Part 1

Revision: The modification of National Clinical Protocol „Influenza in children” consisted of

insignificant changes and adjustments of content targeting in general other levels of care

than PHC level (epidemiology, emergency and hospital care). The only insignificant change

targeting PHC level and thus earlier developed, approved and implemented SWPPFD

„Influenza in children” consists of provision of additional information within the component

"The treatment and supervision of patients with mild forms of influenza". The point

"antipyretic" is completed with a new subpoint (as alternate treatment option) and additional

information is provided. After a range of consultations with the authors and relevant specialist

from the field it has been decided to modify SWPPFD Protocol „Influenza in children”

according to revised National Clinical Protocol. Necessary adjustments concerning treatment

of meningococcal meningitis in pre hospital phase have been made.


„Influenza in children”. The necessary adjustments have been performed. The consequent

MoH order on modification of SWPPFD „Influenza in children” has been issued (see Annex

nr. 7 the MoH order nr, 297 from 29.03.2012).

Part 2

Revision: The modification of National Clinical Protocol „Influenza in children” consisted of

insignificant changes and adjustments of content targeting in general other levels of care

than PHC level (epidemiology, emergency and hospital care). The only insignificant change

targeting PHC level and thus earlier developed, approved and implemented SWPPFD

„Influenza in children” consists of provision of additional information within the component

"Treatment of children with severe form of influenza at pre-hospital phase”. The point
















Inception Report



"antipyretic" is completed with a new subpoint (as alternate treatment option) and additional

information is provided. After a range of consultations with the authors and relevant specialist

from the field it has been decided to modify SWPPFD Protocol „Influenza in children”

according to revised National Clinical Protocol. Necessary adjustments concerning treatment

of meningococcal meningitis in pre hospital phase have been made.


„Influenza in children”. The necessary adjustments have been performed. The consequent

MoH order on modification of SWPPFD „Influenza in children” has been issued see Annex

nr. 7 the MoH order nr, 297 from 29.03.2012).

15. SWPPFD „Acute viral hepatitis B in adult”

Revision: The modification of National Clinical Protocol „Acute viral hepatitis B in adult”

consisted of changes and adjustments of content targeting other levels of care than PHC

level, most changes being related to Emergency and Hospital Care levels. Some insignificant

changes occurred in the NCP „Acute viral hepatitis B in adult” targeting PHC level related to

revaccination against hepatitis B virus as required measure. After a range of consultations

with the authors and relevant specialist from the field it has been decided to modify earlier

developed, approved and implemented SWPPFD according to revised National Clinical

Protocol „Acute viral hepatitis B in adult”. Necessary changes concerning information on

revaccination against hepatitis B virus have been made.


„Acute viral hepatitis B in adult”. The necessary modifications have been performed. The

consequent MoH order on modification of SWPPFD „Acute viral hepatitis B in adult” has

been issued (see Annex nr. 9 the MoH order nr. 308 from 30.03.2012).

3.3. Activity 3 - Identification and selection of information sources, involved stakeholders to set priorities with the purpose to develop CSWPFD.

The principal approach towards SWPPFD development is to provide a reference tool that

may be used by individual family doctors in their daily practice. SWPPFD are intended for

healthcare practitioners who are inevitably busy and with limited time available to read

publications such as National Clinical Protocols and Guidelines.

Clinical Protocols developers have an increasing obligation to be transparent about the

methods they have used to develop their documents. An approach to consider towards

Clinical Protocols and Guidelines development is to allow users to see how documents are

developed. This will instil confidence that the potential biases of guideline development have

been addressed adequately, and that the recommendations are internally and externally

valid, and feasible for practice.

The Project supports the relevant national institutions in developing and implementing

SWPPFD for the most important health issues in the PHC. In order to fulfil these activities

Inception Report



there have been identified priority fields for developing WPPs for Family Physicians. List of

priority fields and most frequent health issues met in PHC in which Clinical Protocols had to

be developed had been identified. Set of priority fields and most frequent health issues met

in PHC for Clinical Protocols development agreed.

The Working Group (WG) and 75 Authors Groups (AGs) have been established by the

project with the purpose to develop the WPPs and to increase capacity in this regard.

The general practitioners will be as well involved in the development, testing, implementation

and also the monitoring of CSWPPFD implementation. The work involved in development

and monitoring should be recognised for Continuing Medical Education as this is problem

based learning, keeping doctors at the avant-garde of medical development. It will also

stimulate medical research in Moldova in the future. It is clear understandable that the

Medical Professional Association of Moldova should take responsibility for protocols for their

own specialty.

3.3.1. Identification and selection of involved stakeholders to set priorities with the purpose to develop CSWPFD

For performing situational analysis a number of meetings with main stakeholders from the

field have been carried out for identifying achievements up to date and stakeholders

implementing activities in the field. This activity is completed.

Ongoing meetings with MoH, counterparts and relevant stakeholders:

In addition to daily short meetings with MoH representatives, more than 10 meetings with

MoH and relevant stakeholders have been conducted: Deputy- Minister of Health, Head

of Medical Personnel Management, Performance and Quality of Health Services

Department of MoH, representatives of National Health Insurance Company SUMPH “N.

Testemitanu”, etc

working group has been established and 2 WG meetings were held

authors groups have been established and information seminar and seminar held

Ministerial orders relevant to our project were issued concerning

working group

health priorities

author groups

SWPPFD modification

information seminar and seminar

Inception Report



The MoH plays a major role in approving and implementing developed CSWPPFD. Further,

close collaboration with the department of family medicine of the University, the PHC

University Clinic and other stakeholders is needed.

In the Republic of Moldova currently National Clinical Protocols (NCP) and CSWPPFD are

developed under the guidance and joint supervision of the Experts Board of the MoH and

Medical Personnel Management, Performance and Quality of Health Services Department of

the MoH.

The Experts Board consisting of main specialists of the MoH from different fields has been

established within the MoH as an advisory council. The responsibility for supervision of the

development process and approval of developed Clinical Protocols and Guidelines for health

services is mandated by order of the Ministry of Health nr. 06-p § 3 from 22.01.2008.

The Expert’s Board is co-chaired by well-known high-level specialists in different clinical

fields, academic world representatives and practising clinicians. To carry out its

responsibilities, the Experts Board entails 37 experts and 20 Profile Scientific –

Methodological Commissions.

The Medical Professional Association approves draft Clinical Protocols and Guidelines for

external review and the Expert’s Board of the Ministry of Health approves final Clinical

Protocols for submission to the MoH for approval and adoption in health care institution

countrywide. The Expert’s Board, jointly with the Medical Personnel Management,

Performance and Quality of Health Services Department of the MoH, also coordinates

strategies to implement and evaluate Clinical Protocols implementation. Established under

the MoH, the Experts Board unites the efforts of the Professional Associations, Main

Specialists from different fields and the MoH to contribute to effective management of

medical services.

In the process of CSWPPFD development consensus among consultant, beneficiary and

main stakeholders from the field has to be built. This will play a very important role in

balancing the procedure and achieving the best results. It assumes greater importance in

actual CSWPPFD development and prospective implementation process.

Throughout the meetings and discussions with the MoH representatives and relevant

stakeholders the agreement on joint actions for assuring support to the relevant national

institutions and develop a sustainable mechanism for developing, revising, approving and

implementing CSWPPFD for the most important health issues in the PHC sector has been

established.

The MoH is actively promoting the use of National, Institutional and Working Place Clinical

Protocols and a monitoring regime. Protocols development groups are being established at

the institutional level and there is foreseen a supervision and regulation of these groups

activities for improving standardization between them.

Inception Report



All activities to be performed by consultant in the field of CSWPPFD development is carried

out with involvement of MoH and SUMPh “N.Testemitanu” representatives. The ‘Ownership’

of CSWPPFD by the professionals will be as important in Moldova as it is elsewhere.

Close collaboration was established and is maintained with the project’s environment. As

major partners have been identified: Ministry of Health, National Centre for Health

Management, National Health Insurance Company, State Medical and Pharmaceutical

University ”Nicolae Testemiţanu”, in particular with the relevant departments, University

Clinic of Primary Health Care, Primary Health Care Public Medico Sanitary Institutions,

Moldovan Association of Family Medicine, relevant Moldovan Medical professional

Associations, etc. In addition, the project has held meetings in Chisinau and selected rayons

with head doctors of health centres, family physicians, and nurses as well as with other

donors and projects working in the field of health care reform in Moldova.

The general practitioners are as well involved in the development, testing, implementation

and also the monitoring of CSWPPFD implementation. The work involved in development

and monitoring should be recognised for Continuing Medical Education as this is problem

based learning, keeping doctors at the avant-garde of medical development. It will also

stimulate medical research in Moldova in the future. It is clear understandable that the

Medical Professional Association of Moldova should take responsibility for protocols for their

own specialty.

3.3.2. Set up Working Group and Authors Groups according to identified priorities of SWPPFD development.

The Working Group (WG) has been established by the project with the purpose of

coordinating the development of standardized clinical protocols in priority areas that are most

frequently encountered in the family doctor practice. The activity performed by the Working

Group and Consultant is coordinated by the representatives of Medical Personnel

Management, Performance and Quality of Health Services Department of the Ministry of

Health - responsible for developing tools to improve and evaluate quality of health care,

including clinical protocols.

The working group provides ongoing support to the Consultant carrying out planned

activities, ensures access to basic documents in the form of policies, studies, reports, norms,

guidelines, regulations, normative acts and facilitates the organisation of meetings with the

key stakeholders.

The Working Group (WG) and 75 Authors Groups (AGs) have been established by the

project with the purpose to develop the WPPs and to increase capacity in this regard. There

have been set speciality AGs, one in each of the Primary Health Care priority areas, such as

cardiovascular disease, cancer, etc. The role of each AG consists of developing SWPPFD

according to selected topics, supporting their implementation and to network with others to

promote SWPPFD use. Based on principles established together with MoH to base the

formulation of SWPPFD are developed by main specialists from the field jointly with Primary

Health Care representatives, including relevant physician groups and other health care

Inception Report



providers as appropriate. Each group consists of members, representatives from

professional specialized fields (e.g. cardiology, oncology, etc) and PHC Department of the

SUMPh ”N. Testemitanu” and PHC Pubic Medico sanitary Institutions with a particular

interest in the topic of the SWPPFD development.

Membership of the AGs group is made up of three - four elected by MoH members, at least

one of whom must be high qualified specialist in a professional field (e.g. cardiology,

neurology, etc), at least one current holder of Primary Health Care qualification, members of

Medical professional Association and SUMPh ”N. Testemitanu” Department of Family

Medicine, Project Working Group representation.

Meetings are carried out with part of chairmen of AGs and also attended by some of the

members of AGs based on well defined schedule, twice per month in order to initiate

guidelines development process and follow the achieved progress. Studies have shown that

the balance of disciplines within authors’ development groups has considerable influence on

the clinical protocol recommendations. Establishing a multidisciplinary development group

ensured following:

all relevant groups are represented, providing expertise from all stages in the

patient’s journey of care

all relevant scientific evidence is located and critically evaluated

practical problems with using the guideline are identified and addressed

stakeholder groups see the guideline as credible and will cooperate in

implementation.

Speciality AGs consider all scientific information and applied skills, prioritise them using a

suitability screening and scoring tool and submit the drafts of SWPPFD to the Project. The

AGs representatives and project consultants perform suitability screening and identify the

extent to which the SWPPFD development fulfils the criteria listed in, make an assessment of

the extent of evidence on which to base the SWPPFD and consider whether the benefits that

were likely to accrue from successful implementation of the protocols recommendations

would outweigh the efforts required to develop them.

AGs members together with Project consultants determine the overall direction of clinical

protocols development and play a key role in shaping the protocols development process.

They are also actively involved in aspects of the protocols development process - as

members of AGs, or on the editorial group for specific guidelines, or as chairs or members of

individual protocol development groups - and all provide input into the selection of topics for

protocol development and the composition of guideline development groups

In putting together an AG, psychosocial factors, including the problems of overcoming

professional hierarchies that can affect small group processes have been considered. The

life span of each AG is for the whole duration of SWPPFD development process, with groups

Inception Report



meeting on average once every 1-2 weeks, although some groups may form subgroups

which meet more frequently. Despite the fact that most tasks are ongoing processes,

sequencing of activities may vary.

The SWPPFD development groups explore, within the clinical area of the guideline, all of the

situations for which there may be a need to offer recommendations. Although the topic has

been pre-defined, in the first meeting the group is asked to confirm their acceptance of both

the clinical content of the areas of the SWPPFD and the scope of the questions to be

answered within it. This ensures a shared view of group aims between the group and the

research team and enables the group leader to challenge deviation from the task in hand.

From a practical viewpoint, a review of the evidence began before the first meeting.

However, the group has the option of extending, restricting or refining the scope of the

evidence for clinical protocol development.

The project is managing the content development in due time. The development process is

organized as follows:

Regular meetings with AGs members within particular departments and project office;

Literature review

o the literature is identified according to an explicit search strategy

o selected according to defined inclusion and exclusion criteria

o evaluated against consistent methodological standards.

Submission of first draft of SWPPFD to external referees

Reconvene the guideline development group if important omissions are identified or

adjustment is needed

Nevertheless, the essential elements of systematic review are met.

When developing SWPPFD AGs members look at medicines, interventions and technologies

that are also the subject of individual review with authorities responsible for approving their

use in the health system at the PHC level. In this respect AGs and project consultants take

account of the reviews carried out by the main relevant stakeholders and the MoH. The close

relationship between MoH and other important stakeholders facilitates these processes. The

highest standards of patient care and improved outcomes are the ultimate goal.

In the process of SWPPFD development consensus among Project, beneficiary and main

stakeholders from the field is built and this plays a very important role in balancing the

procedure and achieving the best results. It assumes greater importance in actual protocols

and guidelines development and prospective implementation process.

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Throughout the meetings and discussions held with MoH representatives, other stakeholders

and representatives there was established agreement on joint actions for assuring support to

the relevant national institutions and develop a sustainable mechanism for developing,

revising, approving and implementing Clinical Protocols and Guidelines for the most

important health issues in the PHC sector.

The Ministry of Health is actively promoting the use of National, Institutional and Working

Place Clinical Protocols and a monitoring regime. Protocols development groups are being

established at the institutional level and there is foreseen a supervision and regulation of

these groups activities for improving standardization between them.

All activities performed by project in the field of WPP for GPs development are carried out

with involvement of MoH and SUMPh “N.Testemitanu” representatives. It has been

commonly agreed that ‘Ownership’ of protocols by the professionals will be as important in

Moldova as it is elsewhere. The general practitioners will be also involved in the

development, testing, implementation and also the monitoring of SWPPFD. The work

involved in development and monitoring should be recognised for Continuing Medical

Education as this is problem based learning, keeping doctors at the avant-garde of medical

development. It will also stimulate medical research in Moldova in the future. It is clear

understandable that the Medical Professional Association of Moldova should take

responsibility for protocols for their own specialty.

3.4. Activity 4 - Establishment of priorities and areas within which CSWPFD are to be developed

As essential action the prioritization process started with revising and updating existing

protocols, with the target of renewing protocols, where necessary, due to medical

developments.

Methodology for CPs was given according to which the process of developing and approving

the clinical protocols have merged and become centralized (MoH Order No.124 dated 21

March 2008 „Regarding the method of development and approval the National Clinical

Protocols” and MoH Order No.429 dated 21 November 2008 On methodology of

development, approval and implementation of Institutional Clinical Protocols and Clinical

Workplace Protocols”).

Health issues selected as being more common for PHC settings reflect health status of the

population in Moldova. Diseases prioritization analysis has been performed jointly with the

representatives of the MoH Medical Personnel Management, Performance and Quality of

Health Services Department, WG members, representatives of PHC PMSI across the

country.

Qualitative methods have been used to identify particular aspects of Primary Health Care. At

present, there is no mechanism for incorporating such studies in the evidence base. Some

progress has been made on methods of identifying qualitative studies, and in evaluating their

methodological quality. The use of qualitative evidence to identify issues of concern to

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patients and to help identify key questions to be addressed in the SWPPFD will be the

milestone of applied existing methodology of protocols development.

SWPPFD topics selection was based on diseases for which NCP have been developed and

disease prioritization derived from health indicators and statistics for the year 2011. As MoH

expressed the opinion that SWPPFD should be firstly developed for those topics for which

NCP have been developed it could be the case that some of conditions for which NCP have

been developed may not reflect priority conditions most frequently met in PHC settings. With

regard to that, the stage and progress of development NCP reflecting priority conditions

should be further identified and followed allowing inclusion of these topics in the list of

Working Place Protocols to be developed with support of SPHC project.

It is likely that CSWPFD development in Moldova will be based on two conditions:

the important priority health conditions in the country that are most often encountered

by family doctors

the availability of National Clinical Protocol describing this health condition

management and treatment at all stages of the Health System, including PHC.

The last condition is foreseen as mandatory because CSWPFD are pathways providing

possibilities for the most efficient, quick and timely interventions and choices while National

Clinical Protocols are extensive documents providing comprehensive information on this

particular health condition management at all levels of the health system. So, a family doctor

may consult a National Clinical Protocol, if needed and such is available, for deeper

information and more extensive knowledge of a particular health condition approached by

CSWPFD on a short note.

3.4.1. The important priority health conditions in the country that are most often encountered by family doctors

Prior to the process of CSWPFD development, there have been considered what the

objectives are for the CSWPFD and whether a clinical protocol is really the best approach to

reach the stated objectives.

During the protocols development and approval process the inclusion of clinical evidence

need to be considered. The use of international resources for clinical evidence synthesis is

encouraged.

Selection of topics for SWPPFD development was built upon the basis of the burden of

disease, the existence of variation in practice, the potential to improve outcome and the

developed and implemented National Clinical Protocols. The following criteria have been

considered in selecting and prioritising topics for development of SWPPFD:

1. Conditions where effective treatment is proven and where mortality or morbidity

can be reduced.

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2. Conditions that are widely spread among the population and contribute to a high

burden of disease among the population

3. Clinical priority areas for PHC in Moldova: presently these are coronary heart

disease and stroke, cancer, etc. The strategic aims of Moldovan Health System

should also be considered. These are improving health and tackling inequalities,

especially with regard to children and young people, developing primary and

community care and reshaping hospital services.

4. Areas of clinical uncertainty as evidenced by wide variation in practice or

outcomes.

5. The perceived need for the guideline, as indicated by a network of relevant

stakeholders.

6. Iatrogenic diseases or interventions carrying significant risks.

Moldova has a double epidemiological burden as rates of communicable diseases have

increased while noncommunicable diseases, such as cardiovascular diseases and cancers,

have also increased as a cause of premature mortality. Poverty, alcohol and tobacco are

the key health determinants for most Moldovans and mortality and morbidity from these

factors account for a sizeable burden on society. The main causes of death in Moldova are

diseases of the circulatory system (57%), followed by cancer, diseases of the digestive

system and injury and poisoning.

According to data from the National Centre for Public Health and Management (2011), the

highest incidence is attributed to respiratory diseases (35,8%), followed by injury and

poisoning (9,8%), digestive system diseases (7,4%), communicable diseases (7,3%), genital-

urinary diseases (6,2%), diseases of skin and subcutaneous tissue (5,7%), cardiovascular

diseases (4,8%) (Table 1). (National Centre for Public Health and Management 2011).

Table 1. Diseases incidence, 2011. The incidence structure according to total number

of new registered cases in 2011

Absolute num %

Total 1258229 100 %

Respiratory diseases 450792 35,8

Injuries, poisoning 123033 9,8

Digestive tract disease 93125 7,4

Infectious and parasitic diseases 91970 7,3

Diseases of the genitourinary tract 78107 6,2

Diseases of skin and subcutaneous tissue 71212 5,7

Cardiovascular diseases 60173 4,8

Diseases of the joint and bones, muscle and connective tissue 54656 4,3

Pregnancy, birth and confinement 49456 3,9

Eye disease and its annexes 34497 2,7

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Blood and hematopoietic organs diseases 27590 2,2

Endocrine, nutritional and metabolic diseases 26319 2,1

Ear disease 25895 2,1

Nervous system diseases 24127 1,9

Mental and behavioural disorders 22239 1,8

Tumours 14688 1,2

Diseases of the perinatal period 5069 0,4

Congenital malformations, deformations and chromosomal abnormalities 4268 0,3

Symptoms, signs and abnormal investigations results 1013 0,1

Figure 1. Diseases incidence, 2011. The incidence structure according to total number

of new registered cases in 2011


highest prevalence is attributed to respiratory diseases (19,6%), followed by cardiovascular

diseases (17,5%) digestive system diseases (12,8%), genital-urinary diseases (6,7%),mental

and behavioural disorders (6,1%), endocrine and metabolic disease (5,3%), communicable

diseases (4,7%) (Table 2). (National Centre for Public Health and Management 2011).

Table 2. Disease prevalence, 2011. The prevalence structure according to total number

of registered diseases in 2011.

Absolute numb %

Total 2700290 100 %

Respiratory diseases 529692 19,6

Cardiovascular diseases 471552 17,5

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Digestive tract diseases 346434 12,8

Genital –urinary tract diseases 182147 6,7

Mental and behavioural disorders 165090 6,1

Endocrine and metabolic diseases 142268 5,3

Communicable diseases 127132 4,7

Diseases of the joint and bones, muscle and connective tissue 125309 4,6

Injury and poisoning 124148 4,6

Tumours 92289 3,4

Eye disease and its annexes 91229 3,4

Diseases of skin and subcutaneous tissue 80138 3,0

Nervous system diseases 64534 2,4

Blood and hematopoietic organs diseases 52944 2,0

Pregnancy, birth and confinement 49456 1,8

Ear disease 34778 1,3

Diseases of the perinatal period 14176 0,5

Congenital malformations, deformations and chromosomal abnormalities 5527 0,2

Symptoms, signs and abnormal investigations results 1447 0,1

Figure 2. Disease prevalence, 2011. The prevalence structure according to total

number of registered diseases in 2011.

The special consideration in prioritizing conditions most often met in PHC practice was given

to the second cause of mortality in Moldova, attributed to cancer (%). The high mortality

attributed to cancer is associated with the detection of the diseases in advanced stages,

mainly at the other levels than PHC level, contributing as well to increased costs and

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financial burden to health system. Therefore, for selecting the important priority health

conditions in the country that are most often encountered by family doctors for developing of

SWPPFD the cancer incidence and prevalence structure has been specially considered. To

be mentioned here that this is in line with the availability of National Clinical Protocols, out of

the 162 existing NCP 18 are revealing management of different forms of cancer.


highest incidence is attributed to breast cancer (11,08%), followed by tracheal, bronchial,

lung cancer (11,05%), malignant skin tumours (9,70%), rectal, rectosigmoide junction, anal

cancer (6,57%), haemoblastosis (6,04%), colon cancer (5,99%), gastric (5,41%) and cervical

cancer (3,95%) (Table 3). (National Centre for Public Health and Management 2011).

Table 3. Incidence of malignant tumours, 2011

Incidence of malign tumours, 2011 %

other locations 11,98%

breast 11,08%

tracheal, bronchial, lung 11,05%

other malignant skin tumours 9,70%

rectal, rectosigmoide junction, anal 6,57%

haemoblastosis 6,04%

colon 5,99%

gastric 5,41%

cervical 3,95%

uterine body 3,85%

prostate 3,56%

oral cavity and pharynx 3,55%

thyroid gland 3,00%

liver 2,95%

urinary bladder 2,90%

larynx 2,09%

ovaries 1,76%

skin melanoma 1,30%

malignant tumour of the lip 1,16%

mesotelial tissue and soft tissue 1,05%

oesophagus 0,67%

bone and joint cartilage 0,40%

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Figure 3. Incidence of malignant tumours, 2011


highest prevalence is attributed to breast cancer (19,34%), followed by skin cancer (11,49%)

cervical (9,07%), cancer of other locations (7,18%), haemoblastosis (6,54%), uterine body

(5,32%), colon cancer (5,15%) (Table 4). (National Centre for Public Health and

Management 2011). It has to be pointed out that NCP covering the above mentioned health

conditions have been developed and approved at all stages.

Table 4. Prevalence of malignant tumours, 2011

Prevalence of malignant tumours, 2011 %

Breast 19,34%

skin 11,49%

cervical 9,07%

other locations 7,18%

haemoblastosis 6,54%

uterine body 5,32%

colon 5,15%

rectal, rectosigmoide junction, anal 5,07%

thyroid gland 5,00%

tracheal, bronchial, lung 4,19%

urinary bladder 3,08%

gastric 3,01%

malignant tumours of lip 2,89%

prostate 2,58%

ovarian 2,15%

oral cavity and pharynx 2,04%

skin melanoma 1,68%

larynx 1,56%

mesotelial tissue and soft tissue 1,02%

bones and joint cartilage 0,79%

liver 0,62%

oesophageal 0,22%

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Figure 4. Prevalence of malignant tumours, 2011

The increasing number of children being registered as disabled has also been cause for

concern, especially as health and social services for these children are not well developed

(National Centre for Public Health and Management 2011). There have been considered a

range of priority health conditions most often encountered by family doctors in children.

Among these are diseases of digestive tract, respiratory diseases and cardiovascular

diseases.

3.4.2. The availability of NCP targeting priority health conditions most often encountered by family doctors

Up to present, 162 National Clinical Protocols that also include the Primary Health Care

(PHC) stage have been developed and approved. According to the Regulation on the

methodology of development, approval and implementation of Clinical Institutional Protocols

(CIP) and Clinical Workplace Protocols, CIP determines the content and requirements for

organizing and providing health care for a disease/syndrome or clinical situation in a specific

health facility by specialists of the respective subdivisions. Based on the list of priority

diseases and existing NCP, 47 CSWPFD were developed, tested and approved at all stages

and implemented at country level in 2009-2010. The list of remaining NCP have been

reviewed and put in line with the analysed and resultant list of priority conditions outlined by

mortality, diseases prevalence and incidence in 2011.

Currently there are 115 NCP targeting topics for which SWPPFD have not been developed

yet. After multiple consultations with the WG members, representatives of the relevant

clinical departments of the SUMPh “N. Testemiatnu”, representatives of the PHC PMSI, out

of available (developed and approved) 115 NCP there have been identified 51 topics

corresponding to priority health conditions most often encountered by family doctors and also

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being in line with priority conditions outlined by mortality, diseases prevalence and incidence

in 2011.

Table 5. Selected available NCP targeting priority health conditions most often

encountered by family doctors

Nr NCP Topic

1. NCP - 7 Juvenile idiopathic arthritis

2. NCP - 8 Febrile seizures in children

3. NCP - 11 Otitis media in children

4. NCP - 13 Ischemic stroke

5. NCP - 14 Chronic tonsillitis in children

6. NCP - 20 Mental and behavioral disorders related to alcohol

7. NCP - 28 Vesicoureteral reflux in children

8. NCP - 44 Alcoholic liver disease

9. NCP - 48 Cerebral palsy in children

10. NCP - 53 Acute rheumatic fever in children

11. NCP - 55 Tuberculosis in children

12. NCP - 56 Hepatic encephalopathy in adults

13. NCP - 59 Acute pyelonephritis in adults

14. NCP - 67 Acute diarrheal disease in children

15. NCP - 70 Measles in children

16. NCP - 71 Luxant malformation of the hip

17. NCP - 77 Benign prostatic hyperplasia (BPH)

18. NCP 79 Atopic dermatitis in children

19. NCP - 80 Infectious endocarditis in adults

20. NCP - 83 Nephrotic syndrome in adults

21. NCP - 88 Urolithiasis in adults

22. NCP - 95 Neonatal jaundice

23. NCP - 98 Acute obstructive bronchitis in children

24. NCP - 100 Community acquired pneumonia in children

25. NCP - 101 Chronic bronchitis in children

26. NCP - 102 Breast cancer

27. NCP - 105 Rickets in children

28. NCP - 106 Hemorrhagic vasculitis in children

29. NCP - 111 Iron deficiency anemia in children

30. NCP - 114 Acute glomerulonephritis in children

31. NCP - 115 Acute pyelonephritis in children

32. NCP - 116 Affective disorders (mood) in adults

33. NCP - 118 Malignant lung tumors

34. NCP - 123 Tuberculosis in adult

35. NCP - 124 Gastric and duodenal ulcer in children

36. NCP - 125 Gastrtis and duodenitis in children

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37. NCP -128 Gastro esophageal reflux in children

38. NCP -130 Colon cancer

39. NCP -131 Anorectal cancer

40. NCP -135 Cancer pain palliative care

41. NCP - 137 Chickenpox in children

42. NCP - 138 Allergic rhinitis in children

43. NCP - 139 Endometrial cancer

44. NCP - 140 Ovarian cancer

45. NCP - 141 Vulvar cancer

46. NCP - 142 Cervical cancer

47. NCP - 145 Acute viral myocarditis in children

48. NCP - 146 Heart valves and vascular obstructive malformations not associated

with shunt in children

49. NCP - 148 Pulmonary thromboembolism

50. NCP - 158 Whooping cough

51. NCP - 159 Prostate cancer

Table 6. Identified topics of NCP to be developed in 2013 targeting priority health

conditions most often encountered by family doctors

1. Pulmonary hypertension in adults

2. Treatment with oral anticoagulants

3. Cardiomyopathies adult

4. Adult cardiovascular rehabilitation

5. Pregnancy induced hypertension

6. Essential hypertension in children

7. Skin malignant melanoma

8. Soft tissue tumors

9. Pancreatic cancer

10. Primary liver cancer

11. Thyroid cancer

12. Kidney cancer

13. Urinary bladder cancer

14. Larynx cancer

15. Gastroesophageal reflux disease in adults

16. Ulcer disease in adults

17. Hepatic steatosis in adults (fatty liver disease)

18. Nonspecific ulcerative colitis in adults

19. Malnutrition in children

20. Chronic pancreatitis in children

21. Idiopathic interstitial lung disease adult

22. Chronic hives in adults

23. Atopic dermatitis in adults

24. Food allergy

The draft list of priority health conditions most often encountered by family doctors

comprising both: selected NCP (available and to be developed) targeting priority health

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conditions and priorities outlined by statistic indicators (mortality, diseases prevalence and

incidence in 2011) has been provided for public debates. The draft list of priorities reflecting

health conditions most often met by GPs in their routine practice for developing SWPPFD

has been submitted to WG members, representatives of the relevant clinical departments of

the SUMPh “N. Testemiatnu” and to all PHC PMSI across the country. It has to be pointed

out that all WG members and consulted representatives of the relevant clinical departments

of the SUMPh “N. Testemiatnu” in general agreed with the set up priority list. It has been

suggested to exclude two topics being considered not priorities for PHC. These are earlier

suggested topics for developing SWPPFD “Neonatal seizures” and “Management of

congenital heart malformations in newborns”. It has been mentioned that these health

conditions are targeting rather specialized care (neonatology) than PHC.

Of all PHC PMSI across the country provided with the draft priority list for developing

SWPPFD, 12 PHC institutions provided feedback. These are as follows: PMSI CFD

Cantemir, PMSI CFD Anenii Noi, PMSI CFD Hicesti, PMSI CFD Causeni, PMSI CFD Stefan

Voda, PMSI CFD Orhei, PMSI CFD Briceni, PMSI CFD Riscani, PMSI CFD Floresti, PMSI

CFD Balti, PMSI MTA Centru and PMSI MTA Botanica. To be mentioned here that PHC

institutions representatives agreed in general with the provided draft priority list. There have

been submitted proposals to include additional topics targeting rehabilitation and long term

care conditions, as well as 3 emergency conditions in paediatrics, to be covered by

REPEMOL project.

After considering the opinion and suggestions of the WG members, representatives of the

relevant clinical departments of the SUMPh “N. Testemiatnu”, representatives of the PHC

PMSI across the country, the list of the priority health conditions most often encountered by

family doctors for developing of the SWPPFD has been approved by MoH (see Annex nr. 10)

There have been selected and approved 75 topics for developing SWPPFD instead of at

least 60 as per ToR. The first reason for this is due to the fact that the protocols are

developed by AGs in different periods of time and different durations. This is connected to

human factor and human resources. It has to be specified that some authors work quicker,

while others slowly. The time devoted to a CSWPFD development depends on particular

authors’ availability, quickness and readiness of involvement, the availability of information

and evidence, the necessity of translation of specific evidence from other language into

Romanian, and, finally, but very important, on topic for which the CSWPFD is developed. For

instance, when developing a CSWPFD covering cardiovascular screening compared to a

CSWPFD devoted to leaver cirrhosis management at PHC level, the first one will require less

time and effort than the second. In addition, the primary content of the first protocol will be

not so huge as content of the second one. If considering previous experience, sometimes

there were huge amount of primary information provided by authors, which had to be

“compressed” in order to be placed on 2 pages of A4 format but, in the same time, to keep all

essential information. The second reason for including 75 topics in the priority list is

connected to the fact that out of these 75 identified topics 24 are related to NCP in

development process or to be developed in 2013, while the mandatory condition for

developing SWPPFD is availability of the NCP. Based on that the SWPPFD development

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plan has been set up (see Annex nr. 11). So, it is very important to set up a cycling

continuous process of CSWPFD development, testing, design, editing, approval and

implementing that will permit the most efficient utilization of human and financial resources.

3.5. Activity 5 - Strengthening the knowledge of AGs in development of clinical protocols

For strengthening the knowledge of AGs in development of clinical protocols and improving

the quality and applicability in practice of the mentioned protocols there has been organized

and carried out at the MoH the seminar “Clinical Protocols in Primary Health Care.

Awareness and capacity building in developing and implementing SWPPFD” involving all

relevant experts from the prioritized clinical fields for development of SWPPFD (see Annex

nr. 12). The seminar was aimed at disseminating the methodology of evidence-based

SWPPFD development and adaptation of international guidelines for national/local use.

The seminar took place on 28th of March 2012 with the participation of MoH and project

representatives, involving a number of important stakeholders and healthcare professionals

and others interested in the SWPPFD development process and end results, including PHC

representatives, from across Moldova. Promoting the seminar and preliminary results was

targeted on those professional most likely to have an interest in the topic.

The seminar was conducted in collaboration and with the official support of the MoH and

medical associations of the Republic of Moldova and served as instrument for raising

awareness about both international and national experience – opportunities and limitations -

in the field of development and implementation of Clinical Protocols and as a stimulus to the

process of SWPPFD development and implementation.

The seminar was organized as stimulus to the process of SWPPFD development and

implementation. It offered the opportunity to relevant experts from the prioritized clinical fields

to discuss the achievements, progress and further steps within the process of SWPPFD

development and implementation. This took place whilst the SWPPFD started to be

developed and gave the AGs and main stakeholders the opportunity to present their opinion,

preliminary results and conclusions to a wider audience.

The benefits of the seminar were twofold:

1. the AGs obtained valuable feedback and suggestions for additional evidence which

group members might consider, or alternative interpretation of that evidence

2. the participants were able to contribute to and influence the form of the final protocol,

generating a sense of ownership over the protocols across geographical and

disciplinary boundaries.

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The seminar was aimed:

to support establishing a partnership and network of experts in development and update

of SWPPFD

to build national capacities in the field of evidence based medicine and

development/review of standards/guidelines/protocols

to facilitate preparing plans to develop/review, maintain/update and implement SWPPFD.

to discuss and plan implementation, monitoring and evaluation of the developed ,

approved and implemented SWPPFD.

The seminar aimed also at disseminating the methodology of evidence-based Clinical

Protocols development, and adaptation of international and national evidence for

national/local use. The national experts who cover the key expertise and have some

experience in the development, updating, and use of clinical guidelines and protocols

participated at this seminar. As part of the implementation of the component of the project,

participants will form the core group of professionals who will carry out the task of

development/update/use of a key set of clinical protocols at national level.

The seminar’s activities started with discussions on the role of guidelines and protocols in

selection of most appropriate policies and practices for improving quality of medical care.

Appropriately developed clinical guidelines increase the likelihood that practitioners and

policy makers will use recommendations and policies based on best available evidences and

will not be misled by bias and the play of chance. Differences and commonalities of two kinds

of instruments – guidelines and protocols were considered. It was stressed that

recommendations included in guidelines and protocols are not intended to dictate an

exclusive course of management or treatment and that they must be evaluated with

reference to individual patient needs, available resources and limitations unique to the

region, institution and variations in local populations.

Benefits of guidelines use, such as improving quality of care, improving information about

optimal care, producing a summary of research findings, serving as a basis for teaching,

education and for interdisciplinary cooperation have been detailed. Limitations of guidelines

were also emphasized: professional resistance, concern for legal consequences and loss of

clinical autonomy, unrealistic expectations etc.

Effectiveness of the implementation of guidelines\protocols was also raised: there are many

examples when EBM guidelines and protocols exist, but these documents have a small

impact on current practices and policies and are not able to improve quality of care. Issue of

guidelines implementation was considered most important by majority of participants.

Importance of good quality evidence for development of clinical practice guidelines approach

for assessment of quality of evidence and strength of recommendations was discussed in the

second part of the seminar.

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Participants had the possibility to obtain skills in:

systematic protocol development methods: including the methodology of prioritizing

and selecting protocol topics, formulating questions for making evidence-based

recommendations, searching for the evidence and synthesizing data in evidence

tables, and grading recommendations;

critical appraisal of protocols;

methods of adaptation of international/external evidence and protocols;

implementing protocols provisions in clinical practice;

auditing the use and impact of protocols in practice;

teaching basic terms and methods of protocol development and evidence-based

practice to protocols developers and consumers;

organizational and financial aspects of protocols development and implementation

It has to be pointed out that as a result of undertaken actions by the project in a view of

SWPPFD development and implementation a number of significant changes are underway in

the way that clinical medicine is practiced, and some of these, like the move to logging of

care, have potentially profound implications for all parts, authors, decision makers, health

managers and end users.

The seminar involving all relevant stakeholders served as milestone for SWPPFD

development and implementation process.

4. Specific actions needed from the Beneficiary

All activities performed by project in the field of SWPPFD development are carried out with

involvement of MoH, main stakeholders from the field and SUMPh “N. Testemitanu”

representatives. In the process of protocols development consensus among Project,

beneficiary and main stakeholders from the field is built and this plays a very important role in

balancing the procedure and achieving the best results. It assumes greater importance in

protocols development and implementation process.

During the inception phase several issues requiring the Beneficiary consideration and

approval aroused. The first issue of concern is related to the developed, approved and

implemented SWWPFD “Dyslipidemia”. The Consultant recommends repelling the earlier

developed, approved and implemented SWWPFD “Dyslipidemia” due to its discrepancy with

the newly approved National Clinical Protocol “Dyslipidemia”. The SWWPFD “Dyslipidemia”

has been revised and modified group according to newly approved National Clinical Protocol

“Dyslipidemia”. It has to be pointed out that modified SWWPFD “Dyslipidemia” resulted in a

totally changed document, modifications comprising more than 50%. In this context the

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Consultant recommends the approval and implementation of modified SWWPFD

“Dyslipidemia”.

The revision and modification of SWPPFD “Dyslipidemia” indicates the need for repealing the

earlier developed, approved and implemented SWPPFD “Dyslipidemia”. The SWWPFD

“Dyslipidemia” has been revised and modified group according to newly approved National

Clinical Protocol “Dyslipidemia”. The modified SWWPFD “Dyslipidemia” is attached (Annex

nr 13). The Consultant recommends the approval and implementation of modified SWWPFD

“Dyslipidemia”. This action will require additional costs, in special for implementation that

includes publication (2000 copies) and training of FD. In case of availability of assets, the

Consultant recommends the implementation of SWWPFD “Dyslipidemia” in addition to those

60 SWPPFD planned to be developed and implemented.

The second issue of concern is related to the situation with a SWPPFD to be developed

(“Acute diarrhoeal disease in children”). The problem is that the primary information collected

for the reason of SWPPFD development shows the impossibility to place the all necessary

for FD information on this disease management on 2 pages A4. Coming from previous

experience, there are 2 developed, approved and implemented protocols consisting of 2

parts – 4 pages A4 (“Meningococcal infection in children” and “Influenza in children”).

Consequently, the consultant recommends to foresee the possibility to develop SWPPFD

“Acute diarrhoeal disease in children” consisting of 2 parts (4 pages A4). This action will

require additional costs, in special for implementation that includes publication (2000 copies).

5. Lessons learnt and recommendations

Healthcare system that provide services, and government bodies and NHIC that pay for

them, have to find that Clinical Protocols may be effective in improving efficiency (by

standardising care) and optimising value for money. Implementation of certain Clinical

Protocols reduces admissions to hospitals, outlays for hospitalisation, drugs prescription,

surgery, and other procedures. Confirming devotion to Clinical Protocols may also improve

public image, sending messages of commitment to excellence and quality. Such messages

can promote good will, political support, and healthcare system revenue. It could be stated

that the economic motive behind clinical protocols is the principal reason for their popularity.

General practitioners frequently fail to follow Clinical Protocols despite evidence that Clinical

Protocols improve clinical practice. It has been said that it is easier to write Clinical Protocols

than to implement them and this is partly because of factors that determine change in

behaviour, such as a doctor's attitudes. Attitudes and behaviour may be strongly influenced

by peer pressure and custom.

5.1. Lesson learnt

As clinical protocol development is expensive, time- and skill-demanding, centrally

developed protocols are more likely to facilitate the concentration of resources for a

comprehensive and trustworthy output.

Inception Report



If Clinical Protocols end users are involved, any central institution/department set up

to adapt international and review national Clinical Protocols is likely to be more

efficient and credible. Further studies are needed to identify the strategies that are

most significant, relevant and likely to have an impact on Moldovan Clinical Protocols

development policy.

Family Physicians do indeed need Clinical Protocols in their work. The quality of

information behind the Clinical Protocols must be stated clearly, and the Clinical

Protocols need to be updated regularly. Most importantly, the Clinical Protocols must

be easy to use during a busy practice session or a remote rural area with lack of

second opinion.

Non-adhering doctors are those who are not aware of, or not familiar with Clinical

Protocols; who do not have the self-confidence to apply the recommendations; who

do not expect to achieve good outcomes by following Clinical Protocols; who want to

stick to their previous practices; and who are constrained by external barriers, such

as lack of resources.

Specific attributes of Clinical Protocols determine whether they are used in practice

Precise definitions of recommended performance improve the use of Clinical

Protocols

People setting evidence based Clinical Protocols need to understand the attributes of

effective Clinical Protocols. Evidence based recommendations are better followed in

practice than recommendations not based on scientific evidence

Testing the feasibility and acceptance of Clinical Protocols among the target group is

important for effective implementation

Organizational factors (e.g. large number of AGs and members, a great array of meetings,

lack of time, etc) may present a challenge for successful development and implementation of

SWPPFD. Implementation process, as most important one, may be most difficult to achieve

and indicators foreseen to measure guidelines implementation and improved patient care

may improve or change during long period of time.

5.2. Recommendations

Moldovan stakeholders have demonstrated strong eagerness to collaborate with the project.

It is strongly recommended that senior stakeholders and decision makers make it clear to all

health professionals, managers, and population that health reform will be ongoing – as in all

other countries. Health professionals, managers, and administrators have to learn and

understand that health reform is one of the origin duties of the MoH and senior stakeholders.

A considerable number of working place protocols has been produced for PHC in Moldova.

Implementation has taken place by Ministerial Orders. Introductive training sessions are

Inception Report



conducted nationwide. The working place protocols are appreciated at all levels.

Improvement of the health status of the population also very much depends on “living” the

protocols – ownership.

For fulfilling the tasks and meet the objectives with regard to development of SWPPFD the

following actions will be undertaken:

Assure regular ongoing support to Authors Groups members involved in the process

of CP development

Monitor progress of the Clinical Protocols development

Advise the Authors Groups members regarding any concerns they may have with the

development of specific protocols

Direct specialty subgroups as they seek information for nominated topics

Review WPP drafts and discuss necessary changes

Discuss of feedback on WPP for GPs from appointed stakeholders responsible for

provision of certification of conformity

Adjust WPP content and designed content according to provided recommendations

Edit content of designed of WPP for GPs

Finalize draft of WPP for GPs and submit for certification on conformity and approval

Reconvene the guideline development group if important omissions are identified or

adjustment is needed

Given the amount of work often involved, decisions to alter the scope of work should remain

centred upon the value of subsequent information in deriving recommendations for WPP

development, review and adjustment.

Implementation by clinicians of WPPs can be influenced in many ways. These include

education, financial incentives, management strategies (such as collection and feedback of

comparative data to clinicians), performance expectations or benchmarks, and alteration of

structural aspects of the clinical environment.

To face the challenges of developing clinician motivation in SWPPFD implementation,

together with balancing competing demands, and treating patients with complex medical

conditions, all within time constraints, MoH, top health managers together with SUMhP “N.

Testemitanu” as well as School of Public Health Management need to design education

activities that have leadership support, reflect compelling evidence, use multiple strategies

and teaching techniques, and engage Family Physicians in skill building and problem solving.

Inception Report



Implementation of Clinical Protocols requires a variety of skills, including assessment,

appropriate delineation of a treatment and monitoring plan, patient tracking, and patient

counselling and education skills. Continuing education strategies must reflect the content and

teaching methods that best match the learning objectives. The pressures of current-day

practices place limits on the resources, particularly clinician time that are available for

continuing education. Organizational resources must be committed to build the

complementary supportive systems necessary for improved clinician practice.

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