Developing a guideline

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

2. Definition • Clinical practice guidelines are recommendations for clinicians and consumers about optimal and appropriate care for specific clinical situations Developing guideline

3. 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) Developing guideline

4. 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) Developing guideline

5. Practice Recommendations Organization & Policy Recommendations Education Recommendations Recommendation sources Developing guideline

6. 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) Developing guideline

7. 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 Developing guideline

8. 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 Developing guideline

9. 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 Developing guideline

10. 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 Developing guideline

11. Target groups • Practitioners in different scientific levels • Patients and their relatives • Community • Health policy makers • Organizations such as insurance companies Developing guideline

12. Types of evidences for users • Primary literature • Original research • Secondary literature • Systematic reviews, Meta analyses • Translation (tertiary) literature • Guidelines, protocols, care plans Developing guideline

13. 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 Developing guideline

14. 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 Developing guideline

15. Internet sources • American Diabetes Association • Clinical Practice Recommendations • http://www.diabetes.org/DiabetesCare/Supplement199/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 Developing guideline

16. American Diabetes Association Developing guideline

17. National Guideline Clearinghousehttp://www.guideline.gov/index.asp Developing guideline

18. NICE organization in UKwww.nice.org.uk Developing guideline

19. NICE organization in UK/public healthhttp://www.nice.org.uk/page.aspx?o=home Developing guideline

20. NICE organization in UK /clinicalhttp://www.publichealth.nice.org.uk/page.aspx?o=home Developing guideline

21. Sign organization in Scotland http://www.sign.ac.uk Developing guideline

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

23. Pubmed Developing guideline

24. Evaluation Implementation Review Dissemination Development Guidelines Developingsteps stakeholders Patients and community revision Pilot study Developing guideline

25. 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. Developing guideline

26. 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 Developing guideline

27. 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 Developing guideline

28. 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 Developing guideline

29. 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 Developing guideline

30. 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 • IIa At 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 Developing guideline

31. 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 Developing guideline

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

33. 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 Developing guideline

34. 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 …… Developing guideline