GUIDELINES AND RECOMMENDATIONS IN DRUG TREATMENT - The process of developing guidelines : French experience

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1 GUIDELINES AND RECOMMENDATIONS IN DRUG TREATMENT - The process of developing guidelines : French experience E. Nouyrigat Guidelines Department Haute Autorité de Santé (HAS) - French National Authority for Health

2 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.» 2

3 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. 3

4 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. Identifing topics for clinical research 4

5 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) 5

6 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.. 6

7 «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 7

8 «Evidence-based state of the art» 1 st step: 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 nd step: 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? 8

9 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 9

10 Types of information in «real life»? Types of information Medical studies Surveys of clinical practices Professionals opinion Availability? Always (sometimes rare information) Rarely Always Patients opinion Existing regulations Not always Always Ethical questions Rarely 10

11 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).. 11

12 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 12

13 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 13

14 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 14

15 Strength of recommendations in guidelines HAS scale for recommendations concerning treatment High level of scientific evidence (RCT) GRADE A Scientific presumption (RCT with bias, cohort, etc) GRADE B Low level of scientific evidence GRADE C Consensus among experts of the working group Professional agreement 15

16 Main steps of the method «Clinical practice guidelines» Promoter Relevant questions Analysis-Synthesis of studies Organization committee Working group Peer review group 1 st version of guidelines Comments Working group Final version Guidelines 16

17 Main steps of the method «Formal consensus» Steering Group Rating Group Steering Group Peer Review Group Steering Group + Rating Group Comments Relevant questions Analysis- Synthesis of studies 1 st draft 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 Meeting Analyse of comments Finalization of guidelines Short version of Formal consensus Long version, with external review 17

18 «Lickert scale» in Formal consensus Non indication No agreement Uncertainty Indication Agreement HAS uses rules to determinate a strong or a weak agreement 18

19 Consensus conference Promoter Organisation committee Experts Independant review group JURY Public Public meeting JURY Consensus guidelines 19

20 French guidelines on Drug Treatment (HAS with medical societies) Clinical practice guidelines «Reduce misuse of substitution treatment for opiate» (guidelines developed in 2004 with MD without opiate consumers) Consensus conference «Therapeutic strategies dependents to opiates» (guidelines developed in 2004 with MD and consumers among «experts») Public Hearings «Polyconsumption of drugs : strategy of care» (guidelines developed with MD and consumers in the jury) Clinical practice guidelines «Strategy of care for cocaïne consumers» (guidelines in progress with MD and consumers in the working and the reading groups) All these Guidelines are only available in French) 20

21 Perspectives for HAS Systematic impact measurement of guidelines Using the principles of GRADE Collaboration for building evidencebased state of the art 21

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