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Clinical practical guidelines.
Principles of development and
implementation in practice.
Клинические практические руководства
(КПР, clinical practice guidelines)
These are statements developed using a
specific methodology and designed to help
the doctor and the patient make a rational
decision in various clinical situations.
(Committee to Advice the Public Health Service on Clinical Practice Guidelines, Institute of
Medicine.FieldM.J.,Lohr K.N.,eds. Clinical Practice Guidelines: Directions of a new Programm.
Washington, DC: National Academy Press; 1990)
CBG is designed to help the doctor perceive,
evaluate and implement into clinical practice
the most promising direction from the
continuously increasing number of data for
the treatment of a particular patient.
Clinical guidelines (or as they used to be
called - patient management protocols)
were developed earlier. However, most of
them were based on the traditional, for the
former Soviet medicine, descriptive
principle of interpretation of treatment
regimens and diagnostics, based only on
the opinion of recognized leaders of
clinical medicine or research teams,
without analytical study of the best world
publications.
The main objectives of clinical
recommendations
 To introduce into clinical practice standards based on
modern rigorous scientific dataTo facilitate the decision-
making processTo neutralize the influence on the doctor's
decisions of such largely subjective factors as intuition,
qualifications, opinions of reputable colleagues,
recommendations of popular manuals and reference
books, etc. Toserve as a basis for assessing the
professional level and quality of workIncrease the
efficiency of healthcare costs
 However, the CPG should not be used as direct
guidelines or as a textbook that provides
information about different therapy options.
CPG can only help practitioners and other
healthcare professionals to make the right
decision when choosing the necessary
effective treatment method, i.e. it is necessary
to combine the individual clinical experience
of a doctor with the best and independent
clinical evidence from scientific research
Generally accepted criteria for the reliability of the
CPG
 They were developed back in 1990 on the basis of the
"necessary elements of benign CPG" proposed by the
American Institute of Medicine (US Institute of
Medicine). Include:Reliability (a clear link between the
provisions of the CPG and scientific data, scientific and
clinical data should take precedence over expert
assessments) Reproducibility, clinical applicability
Flexibility Clarity (lack of ambiguous
understanding)Participation of representatives of
various specialties in the process of creating the CPG
.Planned revisions and availability of necessary
documentation
 The principles described above for the compilation of benign
CPG are reflected in the document that unifies the assessment
and preparation of clinical guidelines - the International
Questionnaire I AGREE (Evaluation of Research and
Evaluation of Guidelines / Questionnaire on the Examination
and Certification of Guidelines)The report, designed to assess
the quality of the CPG, was developed by leading researchers
from 11 European countries and Canada. In addition, there are
special guidelines for the creation of the CPG (developed by
the SIGN - Scottish Interuniversity Guidelines Network,
NZGG - New Zealand Guidelines Group, WHO - World
Health Organization, etc.)
The AGREE questionnaire consists of 23 items grouped
into 6 sections and a detailed user guide. In each
section, an independent characteristic of the quality of
leadership is considered: Part 1. Scope and objectives
(3 questions)
Part 2. Stakeholder participation (4 questions)
Part 3. Thoroughness of development (7 questions)
Part 4. Clarity of presentation and form of presentation (4
questions)
Part 5. Possibility of implementation (3 questions)
Part 6. Developer Independence (2 questions)
The examination of AGREE clinical
recommendations includes:
assessment of the methods used
in the development of the CPG
assessment of the content of
the final version of the manual
assessment of the factors
associated with their
implementation
The main requirements of AGREE
for clinical guidelines :
 openness and transparency of the development
processcoordination of interests (and opportunities) of
consumers, buyers and manufacturers of medical
servicescompliance of recommended diagnostic and preventive
methods and technologies with the current state of medical
scienceobjectivity and reliability of informationselection of the
most effective costs and medical technologies
AGREE Col-laboration:
http://www.agreecollaboration.org/transl
ations/index.php?lang=ru
What clinical recommendations can
be evaluated using the AGREE
questionnaire?
The AGREE questionnaire is intended for the
examination of clinical recommendations developed
by local, regional, national, international non-
governmental or governmental organizations. These
clinical guidelines include:New clinical
guidelines.Existing clinical guidelines.Updates to
existing clinical guidelines.The AGREE
questionnaire is general in nature and can be used to
evaluate clinical recommendations for the diagnosis,
prevention and treatment of any diseases. The
questionnaire can be used to evaluate clinical
recommendations presented both in printed and
electronic form.
Who can use the AGREE
questionnaire?
The AGREE questionnaire is not intended for
use:Government agencies to help in deciding which
clinical recommendations should be put into practice.
In such cases, the use of the questionnaire should be part
of the official examination process.
To the compilers of clinical recommendations, so that
they follow a structured and rigorous methodology of
development, as well as for self-assessment of the
quality of their recommendations.
Medical professionals for self-assessment of
recommendations before their implementation.Teachers
to help train medical professionals in the skills of critical
perception of published data
 Note The scores for each of the six sections are calculated
independently and are not combined into a single quality
assessment. Scoring by section can be useful when
comparing clinical recommendations and provides
information for deciding whether to use clinical
recommendations or not, however, it is impossible to set a
threshold in points that would divide clinical
recommendations into "good" and "bad". The final score of
the graph for the final score is at the end of the
questionnaire. It contains the following statements: "I
highly recommend", "I recommend (with reservations and
changes)", "I do not recommend", "I am not sure". In the
final assessment, the expert should include his opinion on
the quality of clinical recommendations, taking into account
each of the evaluation criteria
The situation in Kazakhstan
 2006 – methodological recommendations: "Development of
clinical guidelines and protocols for diagnosis and treatment
taking into account modern requirements" (Ministry of
Health of the Republic of Kazakhstan and Scientific Center
for Medical and Economic Problems of Healthcare)
 2010 – signed a contract with the Canadian Society for
International Health consulting company: cooperation on
improving the quality of clinical practice, standardization of
medical services based on evidence-based medicine and the
introduction of medical technology assessment in order to
strengthen the capacity of the healthcare sector in
Kazakhstan to develop and disseminate clinical practice
guidelines based on international standards and assessment
of medical technologies for better clinical and political
decisions
The situation in Kazakhstan
 In Kazakhstan, the development of clinical protocols is
carried out at the Republican Center for Health Development
of the Ministry of Health of the Republic of KazakhstanThe
clinical protocols are based on the recommendations of NICE
(National Institute for Clinical Excellence, UK) and ICSI
(USA)The development and revision of clinical protocols
was carried out taking into account the main priorities in the
field of healthcare, as well as taking into account the
frequency of diseases encountered. The composition of the
working groups and the list of KP topics for development and
revision were approved by the orders of the Ministry of
Health of the Republic of Kazakhstan.
References
 США
US National Guideline Clearinghouse (NGC)
http://www.guideline.gov
Centers for Disease Control and Prevention (CDC)
http://www.phppo.cdc.gov/CDCRecommends/A
dvSearchV.asp
 Великобритания
National Institute for Clinical Excellence (NICE)
http://www.nice.org.uk
 Канада
Canadian Medical Association (CMA)
http://mdm.ca/cpgsnew/cpgs/index.asp

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Medical Documentation

  • 1. Clinical practical guidelines. Principles of development and implementation in practice.
  • 2. Клинические практические руководства (КПР, clinical practice guidelines) These are statements developed using a specific methodology and designed to help the doctor and the patient make a rational decision in various clinical situations. (Committee to Advice the Public Health Service on Clinical Practice Guidelines, Institute of Medicine.FieldM.J.,Lohr K.N.,eds. Clinical Practice Guidelines: Directions of a new Programm. Washington, DC: National Academy Press; 1990) CBG is designed to help the doctor perceive, evaluate and implement into clinical practice the most promising direction from the continuously increasing number of data for the treatment of a particular patient.
  • 3. Clinical guidelines (or as they used to be called - patient management protocols) were developed earlier. However, most of them were based on the traditional, for the former Soviet medicine, descriptive principle of interpretation of treatment regimens and diagnostics, based only on the opinion of recognized leaders of clinical medicine or research teams, without analytical study of the best world publications.
  • 4. The main objectives of clinical recommendations  To introduce into clinical practice standards based on modern rigorous scientific dataTo facilitate the decision- making processTo neutralize the influence on the doctor's decisions of such largely subjective factors as intuition, qualifications, opinions of reputable colleagues, recommendations of popular manuals and reference books, etc. Toserve as a basis for assessing the professional level and quality of workIncrease the efficiency of healthcare costs
  • 5.  However, the CPG should not be used as direct guidelines or as a textbook that provides information about different therapy options. CPG can only help practitioners and other healthcare professionals to make the right decision when choosing the necessary effective treatment method, i.e. it is necessary to combine the individual clinical experience of a doctor with the best and independent clinical evidence from scientific research
  • 6. Generally accepted criteria for the reliability of the CPG  They were developed back in 1990 on the basis of the "necessary elements of benign CPG" proposed by the American Institute of Medicine (US Institute of Medicine). Include:Reliability (a clear link between the provisions of the CPG and scientific data, scientific and clinical data should take precedence over expert assessments) Reproducibility, clinical applicability Flexibility Clarity (lack of ambiguous understanding)Participation of representatives of various specialties in the process of creating the CPG .Planned revisions and availability of necessary documentation
  • 7.  The principles described above for the compilation of benign CPG are reflected in the document that unifies the assessment and preparation of clinical guidelines - the International Questionnaire I AGREE (Evaluation of Research and Evaluation of Guidelines / Questionnaire on the Examination and Certification of Guidelines)The report, designed to assess the quality of the CPG, was developed by leading researchers from 11 European countries and Canada. In addition, there are special guidelines for the creation of the CPG (developed by the SIGN - Scottish Interuniversity Guidelines Network, NZGG - New Zealand Guidelines Group, WHO - World Health Organization, etc.)
  • 8. The AGREE questionnaire consists of 23 items grouped into 6 sections and a detailed user guide. In each section, an independent characteristic of the quality of leadership is considered: Part 1. Scope and objectives (3 questions) Part 2. Stakeholder participation (4 questions) Part 3. Thoroughness of development (7 questions) Part 4. Clarity of presentation and form of presentation (4 questions) Part 5. Possibility of implementation (3 questions) Part 6. Developer Independence (2 questions)
  • 9. The examination of AGREE clinical recommendations includes: assessment of the methods used in the development of the CPG assessment of the content of the final version of the manual assessment of the factors associated with their implementation
  • 10. The main requirements of AGREE for clinical guidelines :  openness and transparency of the development processcoordination of interests (and opportunities) of consumers, buyers and manufacturers of medical servicescompliance of recommended diagnostic and preventive methods and technologies with the current state of medical scienceobjectivity and reliability of informationselection of the most effective costs and medical technologies
  • 12.
  • 13. What clinical recommendations can be evaluated using the AGREE questionnaire? The AGREE questionnaire is intended for the examination of clinical recommendations developed by local, regional, national, international non- governmental or governmental organizations. These clinical guidelines include:New clinical guidelines.Existing clinical guidelines.Updates to existing clinical guidelines.The AGREE questionnaire is general in nature and can be used to evaluate clinical recommendations for the diagnosis, prevention and treatment of any diseases. The questionnaire can be used to evaluate clinical recommendations presented both in printed and electronic form.
  • 14. Who can use the AGREE questionnaire? The AGREE questionnaire is not intended for use:Government agencies to help in deciding which clinical recommendations should be put into practice. In such cases, the use of the questionnaire should be part of the official examination process. To the compilers of clinical recommendations, so that they follow a structured and rigorous methodology of development, as well as for self-assessment of the quality of their recommendations. Medical professionals for self-assessment of recommendations before their implementation.Teachers to help train medical professionals in the skills of critical perception of published data
  • 15.  Note The scores for each of the six sections are calculated independently and are not combined into a single quality assessment. Scoring by section can be useful when comparing clinical recommendations and provides information for deciding whether to use clinical recommendations or not, however, it is impossible to set a threshold in points that would divide clinical recommendations into "good" and "bad". The final score of the graph for the final score is at the end of the questionnaire. It contains the following statements: "I highly recommend", "I recommend (with reservations and changes)", "I do not recommend", "I am not sure". In the final assessment, the expert should include his opinion on the quality of clinical recommendations, taking into account each of the evaluation criteria
  • 16. The situation in Kazakhstan  2006 – methodological recommendations: "Development of clinical guidelines and protocols for diagnosis and treatment taking into account modern requirements" (Ministry of Health of the Republic of Kazakhstan and Scientific Center for Medical and Economic Problems of Healthcare)  2010 – signed a contract with the Canadian Society for International Health consulting company: cooperation on improving the quality of clinical practice, standardization of medical services based on evidence-based medicine and the introduction of medical technology assessment in order to strengthen the capacity of the healthcare sector in Kazakhstan to develop and disseminate clinical practice guidelines based on international standards and assessment of medical technologies for better clinical and political decisions
  • 17. The situation in Kazakhstan  In Kazakhstan, the development of clinical protocols is carried out at the Republican Center for Health Development of the Ministry of Health of the Republic of KazakhstanThe clinical protocols are based on the recommendations of NICE (National Institute for Clinical Excellence, UK) and ICSI (USA)The development and revision of clinical protocols was carried out taking into account the main priorities in the field of healthcare, as well as taking into account the frequency of diseases encountered. The composition of the working groups and the list of KP topics for development and revision were approved by the orders of the Ministry of Health of the Republic of Kazakhstan.
  • 18. References  США US National Guideline Clearinghouse (NGC) http://www.guideline.gov Centers for Disease Control and Prevention (CDC) http://www.phppo.cdc.gov/CDCRecommends/A dvSearchV.asp  Великобритания National Institute for Clinical Excellence (NICE) http://www.nice.org.uk  Канада Canadian Medical Association (CMA) http://mdm.ca/cpgsnew/cpgs/index.asp