1. Developing a guideline The EBM workshop A.A.Haghdoost, MD; PhD of Epidemiology Ahaghdoost@kmu.ac.ir

2. A.A.Haghdoost EBM workshopDeveloping guideline Definition Clinical practice guidelines are recommendations for clinicians and consumers about optimal and appropriate care for specific clinical situations

3. A.A.Haghdoost EBM workshopDeveloping guideline When one needs a guideline Institute of Medicine (IOM) criteria – clinical practice guidelines are useful when: –the problem is common or expensive –there is great variation in practice patterns –there is enough scientific evidence to determine appropriate and optimal care (IOM, 1992)

4. A.A.Haghdoost EBM workshopDeveloping guideline Developing methods Single author - expert opinion Single author - systematic literature review Consensus panel using expert opinion only Consensus panel using evidenced-based approach (AHCPR methodology)

5. A.A.Haghdoost EBM workshopDeveloping guideline Recommendation sources Practice Recommendations Education Recommendations Organization & Policy Recommendations

6. A.A.Haghdoost EBM workshopDeveloping guideline EBM guideline “Systematically developed statements (based on best available evidence) to assist practitioner and patient decisions about appropriate health care for specific clinical (practice) circumstances” (Field & Lohr, 1990)

7. A.A.Haghdoost EBM workshopDeveloping guideline Formal or informal guidelines are the basis for all clinical practice Basis for most clinical decisions Foundation of clinical teaching Mental short-cuts and memory aids for common or complex problems Primary method to evaluate care patterns and monitor standards of care

8. A.A.Haghdoost EBM workshopDeveloping guideline Types of recommendations clinical assessment / treatment –management of cardiac arrest (ACLS) risk assessment / prevention –drugs to use in pregnancy (ACOG) administrative –insurance pre-approval for surgery

9. A.A.Haghdoost EBM workshopDeveloping guideline Functions(1) Improve patient care Reduce variation in care Transfer research evidence into practice Promote nursing knowledge base Assist with clinical decision making Identify gaps in research Stop interventions that have little effect or cause harm Reduce cost

10. A.A.Haghdoost EBM workshopDeveloping guideline Functions(2) Improving physician practice –increase effectiveness / decrease harms (better clinical outcomes / cost-effectiveness) Increasing consumer knowledge –understand potential benefits / harms Building quality into healthcare systems –using practice guidelines, quality indicators Guiding government / employer policies –guide programs / policies on healthcare

11. A.A.Haghdoost EBM workshopDeveloping guideline Target groups Practitioners in different scientific levels Patients and their relatives Community Health policy makers Organizations such as insurance companies

12. A.A.Haghdoost EBM workshopDeveloping guideline Types of evidences for users Primary literature –Original research Secondary literature –Systematic reviews, Meta analyses Translation (tertiary) literature –Guidelines, protocols, care plans

13. A.A.Haghdoost EBM workshopDeveloping guideline Internet sources CDC Recommendations: –http://www2.cdc.gov/mmwr/mmwr_rr.html American Academy of Neurology –Practice Advisories, Practice Parameters, Therapeutic and Technology Assessments, Credentialing Guidelines, Ethics Statements and Other AAN Position Statements http://www.aan.com/public/practiceguidelines/list.htm

14. A.A.Haghdoost EBM workshopDeveloping guideline Internet sources American Academy of Pediatrics –Policy Statements http://www.aap.org/policy/pprgtoc.cfm –Clinical Guidelines http://www.aap.org/policy/paramtoc.html American College of Cardiology –http://www.acc.org/clinical/guidelines/index.html

15. A.A.Haghdoost EBM workshopDeveloping guideline Internet sources American Diabetes Association –Clinical Practice Recommendations –http://www.diabetes.org/DiabetesCare/Supple ment199/default.asp Canadian Medical Association - CPG Infobase –http://www.cma.ca/cpgs/index.htm –Search engine –Lists by category, title, titles by developer –Recent additions

16. A.A.Haghdoost EBM workshopDeveloping guideline American Diabetes Association

17. A.A.Haghdoost EBM workshopDeveloping guideline National Guideline Clearinghouse http://www.guideline.gov/index.asp

18. A.A.Haghdoost EBM workshopDeveloping guideline NICE organization in UK www.nice.org.uk

19. A.A.Haghdoost EBM workshopDeveloping guideline NICE organization in UK/public health http://www.nice.org.uk/page.aspx?o=home

20. A.A.Haghdoost EBM workshopDeveloping guideline NICE organization in UK /clinical http://www.publichealth.nice.org.uk/page.aspx?o=home

21. A.A.Haghdoost EBM workshopDeveloping guideline Sign organization in Scotland http://www.sign.ac.uk

22. A.A.Haghdoost EBM workshopDeveloping guideline Finding guidelines in Medline Indexed in the “Publication Type” [PT] field (most accurate) –Practice Guideline –Guideline –diabetes mellitus AND practice guideline[pt]

23. A.A.Haghdoost EBM workshopDeveloping guideline Pubmed

24. A.A.Haghdoost EBM workshopDeveloping guideline Implementation Evaluation Review DevelopmentDissemination Guidelines Developing steps Pilot study revision stakeholders Patients and community

25. A.A.Haghdoost EBM workshopDeveloping guideline Revision Guidelines should be evaluated at least once every three years, although in subject areas that are prone to rapid change this may need to occur more frequently.

26. A.A.Haghdoost EBM workshopDeveloping guideline Steps Define clinical question to be answered (for a specific clinical situation) Find best scientific evidence relevant to the specific clinical question (using systematic methods) Rely on best evidence to guide clinical decision-making

27. A.A.Haghdoost EBM workshopDeveloping guideline Finding the best evidences Find best scientific evidence that is applicable to the specific clinical situation –individual patient’s clinical situation –program or policy decision Use evidence to guide decision-making –does the likelihood of benefit outweigh likelihood of harm enough to justify the cost? –same question applies to individual and society

28. A.A.Haghdoost EBM workshopDeveloping guideline Developing steps define clinical questions of interest develop summary of evidence on: –clinical efficacy (potential benefits) –potential harms / projected costs weigh likelihood of benefit versus likelihood of harms, and consider costs develop finding / recommendation statements document all aspects of the process

29. A.A.Haghdoost EBM workshopDeveloping guideline Strength of evidence ratings for guideline recommendations(1) A = Strong research based evidence –multiple relevant, high quality studies B = Moderate research based evidence –one relevant, high quality study C = Limited research based evidence –one adequate study, somewhat relevant D = Panel opinion –based on information not meeting criteria for A-C

30. A.A.Haghdoost EBM workshopDeveloping guideline Strength of evidence ratings for guideline recommendations(2) Ia Meta-analysis or systematic review of randomized control trials Ib At least one randomized controlled trial IIaAt least one well-designed controlled study without randomization. IIb At least one other type of well-designed quasi-exp. study without randomization III Well-designed non-exp. descriptive studies IV Expert committee reports or opinions and/or clinical experiences of respected authorities

31. A.A.Haghdoost EBM workshopDeveloping guideline Guideline and medical education Background questions – general knowledge about a disorder –Look for info in Reference sources: UpToDate, MDConsult, MICROMEDEX, etc. Foreground questions – specific knowledge about managing a patient or disorder –Apply EBP techniques, use MEDLINE and other EBP resources

32. A.A.Haghdoost EBM workshopDeveloping guideline Guideline and medical practice Clinically relevant research, the literature Practitioner’s knowledge & experience Individual’s characteristics & values

33. A.A.Haghdoost EBM workshopDeveloping guideline Guideline and health related organizations Health ministry –developing or ordering? –raising funds –implementing –distributing Medical Universities –Developing –Adding evidence –Criticizing and evaluation –Educating students Legal system –Justice based on the guidelines Organizations Ordering Raising funds implementing

34. A.A.Haghdoost EBM workshopDeveloping guideline Do we need a special organization to develop guidelines? Yes, even if we do not need to develop Iranian guidelines, because at least we need To prioritize our needs To find the best available recommendations around the world for each topics To develop our methodology To ……