GUIDELINES AND RECOMMENDATIONS IN DRUG TREATMENT
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The process of developing guidelines : French experience
E. Nouyrigat Guidelines Department Haute Autorité de Santé (HAS) - French National Authority for Health
Guidelines – Definition
Most common definition (Institute of Medicine, USA, 1990) :
Guidelines are « systematically developed statements to assist
practitioner and patient decisions about appropriate health care for specific clinical circumstances. »
.../…
« The guidelines contain systematically developed statements that include recommendations, strategies, or information that
assist practitioner and patient decisions… »
HAS definition : Les recommandations de bonnes pratiques professionnelles sont des « propositions développées selon une méthode explicite,
destinées à aider le professionnel de santé et le patient à rechercher les soins les plus appropriés dans des circonstances cliniques données. »
What are guidelines ?
► Guidelines are tools for health care professional (HCP) - not only MD - and patient shared decision making and for improving quality of care.
► Guidelines are generally developed at first from the point of view of and for health care professionals. But, patient preferences should be
collected, discussed and considered.
► Guidelines are not mandatory standards of practice, but proposals: HCP can follow them or not. But HCP should be able to explain why they did not follow the guidelines, for instance as part of professional practices evaluation or clinical audit.
► Guidelines are not developed to assist health authorities about public health decisions. But guidelines may have an impact on health
authorities decisions: for instance suggestion of a new health care organization, new regulations, reimbursement, etc.
General objectives of guidelines
• Providing HCP with a systematic apraisal and a critical synthesis of the available surveys specifing their level of evidence: « Evidence-based state of the art »
• Providing HCP with guidance that distinguishes evidence-based from consensus-based recommendations
• Providing HCP with practical tools to improve their decision making (lists of recommendations, algorithm, reminders, etc)
• Improving the quality of care
• Producing practical tools to assess the quality of care (lists of quality of care criteria, quality of care indicators, etc)
• Promoting HCP education and training
• Informing patients and their family to improve their knowledge, decision making and adherence to health care
• Informing health authorities of the evidence-based state of the art, and suggesting new regulations, reimbursement, etc.
Main steps of guidelines development
Chose the topic of the guidelines and identify the clinical relevant questions
Systematic search and critical apraisal of avalaible studies Synthesis of evidences : « evidence-based state of the art »
Discussion of the synthesis by groups of HCP (« experts »)
Guidelines:
set of evidence-based or consensus-based recommendations
(strength of recommendations)
Topics of guidelines
Guidelines may concern :
• Diagnosis
• Treatment
• Follow up
• Prevention
• Coodination between HCP or between HCP and social workers
• Security of health care
• Information
• …..
« Evidence-based state of the art »
Guidelines concern often complex health care strategies with several possible interventions at each step.
At each step, each intervention must be assessed and compared to other possible intervention at short and long term :
• Efficacy
• Effectiveness
• Efficiency (optional)
• Side effects
• Quality of life
• Acceptability
• Benefits/risks ratio
« Evidence-based state of the art »
1
ststep: systematic apraisal of the available studies
► Building “tables of evidence”
► Specifing the “level of evidence” of each study
► Specifing the “benefits/risks ratio” of each intervention
2
ndstep: critical synthesis of the available studies
► What is proved and not yet proved (positively or negatively) ?
► What is now appropriate, non-appropriate, or no more appropriate ?
► What is still in debate ?
What information is necessary to develop guidelines ?
• Medical surveys (first with the best design for the question asked):
► evidence-based state of the art?
• Surveys of clinical practices: descriptive surveys of practices and care organizations, follow up of quality of care indicators, etc
► do bad or obsolete practices exist?
► objectives for better quality of care?
► impact of guidelines?
• Professionals: groups of experts
► professionals opinion?
► consensus among experts?
• Patients: qualitative surveys, quality of life studies
► patients opinion and preferences?
► expert patients in groups of experts?
• Existing regulations
• Ethical questions
Types of information in « real life » ?
Always
Existing regulations
Always
(sometimes rare information)
Medical studies
Rarely
Ethical questions
Not always
Patients opinion
Always
Professionals opinion
Rarely
Surveys of clinical practices
Availability ?
Types of information
Who are the « experts » ?
• HCP concerned by the topic:
• « academic experts » (publications, surveys, opinion leader, etc)
• « grass-roots experts », in particular GP
• named by their professional society
• Representatives of patients
• named by patients associations concerned by the topic
• problems if no association: how to choose patients representative ?
• more and more often patients representatives are present in experts groups in France
• Social workers (optional)
• Representatives of health authorities (optional)
• Economist (optional)
• Specialist of methodology of surveys
• Jurist (optional)
• Specialist of ethics (optional)
• …..
Information and documents produced
• Synthesis of available data (« Argumentaire scientifique »)
• Protocols of data banks analysis
• Selection criteria of publications and data
• Synthesis of selected publications – Level of evidence of each study – Tables of evidence
• Critical conclusion from publications
• Experts opinion – Patients opinion
• Guidelines
• Implementation tools
• Practical synthesis of main recommendations
• List of reminders, algorithms, etc
• List of quality criteria for professional pratices evaluation and clinical audit
• Quality indicators
Methods for guidelines development used in France
• Clinical practice guidelines
• Common international method (IOM 1990)
• Complex strategy with many interventions and relevant questions
• Multidisciplinary topic
• Many publications available with heterogeneous level of evidence
• Formal consensus
• Close RAND/UCLA method + external peer-review (reading group)
• Limited strategy with limited number of relevant questions
• No multidisciplinary topic (« expert topic »)
• Rare or no publications available with low level of evidence
• Rapid method (6-12 months)
• Consensus conference and Public Hearings
• Limited number of relevant questions (4-6)
• Topic with highprofessional controversy
• Usefulness of a public debate among professionals
• Available publications with low level of evidence
Quality of Guidelines
• 23 Criteria of the AGREE Collaboration (Appraisal of guidelines Research and Evaluation)
• HAS currently uses AGREE criteria to
assess its own guidelines and guidelines
of French medical societies
Strength of recommendations in guidelines
HAS scale for recommendations concerning treatment
High level of scientific evidence (RCT)
Scientific presumption (RCT with bias, cohort, etc)
Low level of scientific evidence
Consensus among experts of the working group
GRADE C GRADE A
GRADE B
Professional agreement
Main steps of the method « Clinical practice guidelines »
Promoter
Organization committee Working group
Peer review group
Working group Guidelines
Comments Final version
1st version of guidelines Relevant questions
Analysis-Synthesis of studies
Main steps of the method « Formal consensus »
• Relevant questions
• Analysis- Synthesis of studies
• 1stdraft of guidelines
• 1st individual rating
• Meeting
• 2 st individual rating
• Analyse of responses of the Rating Group
• Finalization of
guidelines or sending on Peer Review Group
Rating Group
Steering Group Steering
Group
Peer Review
Group
Steering Group +
Rating Group
• Meeting
• Analyse of comments
• Finalization of guidelines
Short version of Formal consensus Long version,
with external review
Comments
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