1. Making guidelines for communicable disease prevention and control Preben Aavitsland Department of Infectious Disease Epidemiology Norwegian Institute of Public Health at EpiTrain V, Vilnius, October 22 2007

2. Contents Background –Bad practice –Varying practice –The need for evidence Ten steps for making guidelines

3. Good guidelines? If he vomits, hes more likely to choke the vomitus. Also, he tends to keep his head turned to the same side – usually toward the centre of the room. This may flatten the side of his head.

4. SIDS mortality in England and Wales

5. From text books... Recommended sleeping position in books on child care

6. Variation in prescribing of antibiotics for acute otitis media Froom J et al. Diagnosis and antibiotic treatment of acute otitis media: report from International Primary Care Network. BMJ 1990;300:582-6.

7. Experience

8. Many questions Disinfection of apartments of tuberculosis patients? How many doses of BCG vaccine? Disinfestation of madrass of persons with headlice? Postexposure prophylaxis against HIV? Regular screening of dairy workers for Salmonella? And teachers? Antibiotics to contacts of meningococcal disease patients?

9. Why do we do what we do? Directive from Ministry? Learnt in medical school? Read in text-books? Tradition? Logic? Discussions with colleagues? Read in medical journals?

10. Why are guidelines needed? Variation in practice Practice ineffective or worse Guidelines must be based on the best evidence available

11. Ten steps 1.Justify need and refine subject 2.Set up project and working group 3.Identify previous guidelines 4.Define objectives and users 5.Identify and assess evidence 6.Translate evidence into guidelines 7.Get external review 8.Plan and conduct implementation 9.Plan evaluation 10.Plan updating

12. 1. Justify need and refine subject Justify need based on –Size of problem (morbidity, mortality, costs) –Lack of consensus and variation in practice –Evidence of poor application of evidence –Evidence of ineffective services Refine the subject –What is actually needed? –Specify the problem area –Talk to users of guidelines

13. 2. Set up project and working group Define a project –Resources, mandate, time frame Identify stakeholders –Everyone whose activities will be covered by the guidelines Set up project group –Stakeholders –Experts from several disciplines (multidisciplinary) –Patient groups? NGOs? Clarify commercial and other conflicts of interest

14. 3. Identify previous guidelines Ask stakeholders Search Internet and books –www.who.int –www.cdc.gov –www.ecdc.europa.eu If found, assess relevance and quality –If ok, maybe you do not need to continue

15. 4. Define objectives and users Objectives Describe problem, situations and desired change Define relevant evaluation indicators –Process –Quality –Outcome Methods How will the guidelines be developed? Transparent Users Whom are the guidelines for?

16. 5. Identify and assess evidence Find evidence Look first for systematic reviews (Cochrane Library) and other reviews Then look for controlled trials (PubMed) Check references Ask group members Assess evidence Is the evidence relevant to our objectives? Is the evidence valid? (Are the studies sound?) Grade the evidence

17. Hierarchy of evidence 1.Systematic review of randomised controlled trials 2.Individual randomised controlled trial 3.Non-randomised trial 4.Observational study (case-control, cohort) 5.Expert opinion (unsystematic review) 6.Personal experience

18. Searching for systematic reviews Cochrane library www.mrw.interscience.wiley.com/cochrane Search Cochrane Database of Systematic Reviews For instance: Are antibiotics helpful against conjunctivitis?

23. Searching for randomised trials Search PubMed www.ncbi.nlm.nih.gov/entrez/ Limit to randomised controlled trials

27. 6. Translate evidence into guidelines Intepret evidence –The quality (grade) –The applicability to our objectives –Costs versus benefits –Knowledge of health care system –Beliefs and values of group members

28. Grading of recommendations Very strong recommendation –Grade 1 evidence + applicability + benefits outweighs costs Strong recommendation –Grade 2 evidence + applicability + benefits outweighs costs Medium strong recommendation –Evidence of grade 3 + applicability + benefits outweighs costs Weak recommendation –Evidence of grade 4 or lower + applicability + benefits outweighs costs

29. 7. Get external review Extra check of validity, clarity and applicability Include either individuals or organisations –Experts in the area sensible? –Experts in guidelines making sound method? –Potential users useful? May improve acceptability

30. 8. Plan and conduct implementation Many guidelines are useless and do not work Health care personells behaviour is very difficult to change Identify and address barriers and opposition to change Use sufficient resources for implementation Make an implementation strategy

31. Factors to help implementation Ownership Stepwise implementation Local adjustments Economical incentives Supervision from above Support Design of guidelines Use of Internet Integration in continuing education Opinion leaders Mass media

32. 9. Plan evaluation Consider the objectives of the guidelines Measure effect –Compare groups or time periods (quantitatively) –Measure users compliance and satisfaction –Measure patient outcomes?

33. 10. Plan updating Updating is always needed –Assure quality and relevance –Include new evidence, new comments and evaluation results –Remove old truths –Keep the users trust Authors are responsible, but simpler process Make a plan for update and inform users Starting point either –when new evidence becomes available, –when evaluation is finished, or –at specified time Www guidelines are easier to update, but how announce?

34. Outline of guidelines Background Objectives of guidelines Users of guidelines Methods for making the guidelines Guidelines Updating plan (Implementation plan) Literature

35. Conclusions Guidelines are needed We need guidelines based on evidence We should follow the ten steps for making guidelines Good implementation is crucial