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
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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”
Annex 6 MoH Order nr. 296 from 29.03.2012 on modification and reapproval of the
SWPPFD „Meningococcal infection in children”
Annex 7 MoH Order nr. 297 from 29.03.2012 on modification and reapproval of the
SWPPFD „Influenza in children”
Annex 8 MoH Order nr. 298 from 29.03.2012 on modification and reapproval of the
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
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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.
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
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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)
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
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Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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.
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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.
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_________________________________________________________________________ The Center for Health Strategies and Policies
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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
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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.
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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
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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.
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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)
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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”.
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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 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 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 and adjustments of content targeting other levels of care than PHC level, most
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
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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.
Conclusion: the revision of SWPPFD indicated the need for adjustments of SWPPFD
„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.
Conclusion: the revision of SWPPFD indicated the need for adjustments of SWPPFD
„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).
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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.
Conclusion: the revision of SWPPFD indicated the need for adjustments of SWPPFD
„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
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"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.
Conclusion: the revision of SWPPFD indicated the need for adjustments of SWPPFD
„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.
Conclusion: the revision of SWPPFD indicated the need for adjustments of SWPPFD
„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
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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
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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.
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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
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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
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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
According to data from the National Centre for Public Health and Management (2011), the
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.
According to data from the National Centre for Public Health and Management (2011), the
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
According to data from the National Centre for Public Health and Management (2011), the
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.
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
Inception Report
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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
_________________________________________________________________________ The Center for Health Strategies and Policies
Str. A. Cozmescu 3, Chisinau, Moldova; phone: +373 22 287154
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.