Improving Health Care with Evidence-Based Medicine

1. Improving Health Care • with • Evidence-Based Medicine • Author: dr. Martin Rusnák

2. Guideline Development Methodology • International perspective • What is being done and why? • Steps in guideline methodology • Any evidence for what we do? • What are the challenges ? • What could each of us do ? rusnakm@truni.sk

3. Medical Mistakes • National Institute of Medicine found that medical mistakes kill somewhere between 44,000 and 98,000 people (average: 71,000) in hospitals in the U.S. each year • on average, one out of every 500 people admitted to a hospital in the U.S. is killed by mistake • the chance of being killed in a commercial airline accident is one per 8 million flights rusnakm@truni.sk

4. Healthcare Quality is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge Lohr KN, Harris-Wehling J. Medicare: a strategy for quality assurance. Quarterly Review Bulletin 1991;17,(1):6-9. rusnakm@truni.sk

5. Improving Quality of HC • Creativity and motivation among healthcare workers of all kinds; • Leadership is an essential ingredient of success: senior managers feel personally responsible for each error; • The problem is not fundamentally due to lack of knowledge; we already know far more than we put into practice. Based on Lucian Leape and Donald Berwick: Safe health care: are we up to it? We have to be. Editorials BMJ 2000;320:725-726 ( 18 March ) rusnakm@truni.sk

6. History of Guideline Development • Early guidelines • Consensus methods • Literature reviews not always systematic • Not many systematic reviews rusnakm@truni.sk

7. MY EXPERT OPINION rusnakm@truni.sk

8. rusnakm@truni.sk

9. History of Guideline Development • First evidence based guidelines • Searching for all the evidence • Systematic reviews • Recommendations linked to evidence • Explicit evidence based guidelines • Benefits, harms and costs are presented rusnakm@truni.sk

10. Randomized controlled trial rusnakm@truni.sk

11. Where does EBM come from? • Evidence-based medicine developed from a practical application of clinical epidemiologyto a philosophy of rational clinical decision making. • Epidemiology is concerned with the quantitative research of distribution, determinants & risk factors of health & disease in populations (population groups) & the application of this evidence to control (prevent & treat) disease. rusnakm@truni.sk

12. Where does it all come from? • Modern epidemiology found out i.e. that: • There are huge geographic variations in the treatment of patients with the same health problems. • There is great uncertainty about the effects of medical therapies (only 10-20% of all medical interventions are scientifically sound, e.g. proved by controlled studies); • In the 90’s: a group around David Sackett & Gordon Guyatt, McMaster University, Canada developed a concept, which does not only qualify scientists to understand and interpret research literature. rusnakm@truni.sk

13. What is Evidence-Based Medicine? Conscientious, explicit and rational use of current best evidence in making decisions about the care of individual patients. rusnakm@truni.sk

14. Evidence Based Medicine – Practice The practice of evidence-based medicine means integrating individual clinical expertise and patient values with the best available external clinical evidence from systematic research. Sackett DL et al. Evidence-based medicine: What it is and what it isn‘t, BMJ 312 (1996) 71-72 rusnakm@truni.sk

15. Problems, questions Evaluation of performance The patient Individual experience & external evidence Search for best external evidence Critical appraisal und clinical applicability EBM is the conscientious, explicit and rational use of current best evidence in making decisions about the care of individual patients rusnakm@truni.sk

16. Spread of the idea of evidence Evidence-belt Eminence-belt rusnakm@truni.sk

17. Steps in Guideline Development • Topic Identification • Suitability screen • Form a multidisciplinary working party • Formulate clinical questions • Identify evidence (internal and external) • Evaluate evidence • Develop balance sheet • Develop recommendations • Implementation and dissemination • Update (evaluate and improve) rusnakm@truni.sk

18. 1. Topic Identification • What are the areas where there is a gap between the evidence and current practice ? • Health Status • Patient/Provider Satisfaction • Cost/Utilization • The topic is complex and there is debate • Implementation is feasible rusnakm@truni.sk

19. 2. Suitability Screens • Does the project have a driver/owner? • Is there evidence of a gap? • Can we measure the proposed change? • Is there a suitable guideline that could be identified? • Is there adequate literature to make an evidence based decision about practice? • How much effort would it take to close the gap? • Is there a reasonable likelihood that we could implement the change? rusnakm@truni.sk

20. 3. Multidisciplinary team • Clinicians • Primary and secondary care • Allied health care workers • Consumers, patient representatives • Epidemiologists • Information experts • Health economists • Health managers rusnakm@truni.sk

21. 4. Developing clinical questions • Well developed questions form the basis of the evidence-based guideline structure • Focuses guideline team on important issues & the most relevant evidence • Requires a structured approach PICO PICO: Patients, Intervention, Control, Outcome rusnakm@truni.sk

22. P.I.C.O. Model for Clinical Questions rusnakm@truni.sk

23. When to use the P.I.C.O. modelPatients, Intervention, Control, Outcome • Background questions concern general knowledge. • A question root (who, what, when, where, how, why), and • A disorder, test, treatment, or other aspect of health care. • Often these questions can best be answered by using a textbook or consulting a clinical database. • Foreground questions are specific knowledge questions that affect clinical decisions, including a broad range of biologic, psychological, and sociologic issues. • These are the questions that generally require a search of the primary medical literature and that are best suited to the PICO format. rusnakm@truni.sk

24. Well verbalized question leads to well formulated topic • Does mammography-screening I • In women over 50 years P • Compared with no screeningC • change mortality O • Q: By e.g. 10% ? rusnakm@truni.sk

25. Framing a PICO question rusnakm@truni.sk

26. 5. Identifying the evidence • Comprehensive searching • Avoid applying limitations to reduce publication bias • Non English studies included • Unpublished data sought • Use PICO framework to drive searching • Also includes internal data rusnakm@truni.sk

27. Clinical Search Filters • A method for improving the retrieval of high quality studies applicable to clinical practice is to include search terms that select studies at advanced stages of testing for clinical application. • Including one, or a combination of these terms, in a MEDLINE search strategy will selectively retrieve evidence-based literature that is more likely to answer clinical questions. rusnakm@truni.sk

28. PubMed with Clinical Queries three types of filters Clinical Study Categories filter searches on questions of therapy, diagnosis, etiology, prognosis, or clinical prediction guides by looking for the highest levels of evidence in the literature. These filters can also be limited to a broad or narrow scope. Clinical filters are imposed behind the scenes by the search engine based on the work of B. Haynes, et al, on the best strategies for retrieving clinically relevant information from MEDLINE. rusnakm@truni.sk

29. Clinical Queries Filters Systematic Reviews filter searches for citations identified as systematic reviews, meta-analyses, reviews of clinical trials, evidence-based medicine, consensus development conferences, guidelines, and citations to articles from journals specializing in review studies of value to clinicians. rusnakm@truni.sk

30. Clinical Queries Filters Medical Genetics filter searches for citations on seven different topics in medical genetics (diagnosis, differential diagnosis, clinical description, management, genetic counseling, molecular genetics, or genetic testing) or a combination of all topics in medical genetics. rusnakm@truni.sk

31. 6. Evaluate the evidence • Critical appraisal • Study quality checklists • Develop evidence tables • Quantification • Summarise outcomes rusnakm@truni.sk

32. Evidence Table An Example rusnakm@truni.sk

33. Scales for Quality Assessment? • 35+ scales of composite scores published • Generally agreed that they are not useful in differentiating high and low quality studies • Better approach is to analyse the individual components of study quality • Blinding • Concealment of allocation • Intention to treat analysis rusnakm@truni.sk

34. 7. Balance sheets • Benefits, harms (and costs) considered • for the current situation and if the guideline was implemented • Not a full economic analysis • Simple analysis of projected costs if apply guideline • Delivers the ‘value’ of the Guideline • Resource utilisation • The ‘final chapter’ of an explicit evidence-based guideline rusnakm@truni.sk

35. 8. Developing the Recommendations and Algorithm • Probably the part of the guideline most often read • Considers applicability: • for whom will the intervention do more harm than good ? • to whom should the recommended intervention be offered ? • Each recommendation should advise a course of action, followed by an indication of the strength of the recommendation rusnakm@truni.sk

36. Considered judgment form For each clinical question: • Volume of evidence • Consistency of evidence • Applicability of evidence • Clinical impact of evidence • Evidence Summary with levels/scores • Recommendation with grade rusnakm@truni.sk

37. rusnakm@truni.sk

38. rusnakm@truni.sk

39. rusnakm@truni.sk

40. 9. Implementation & Dissemination • Dissemination/Implementation • Increasingly electronic • Target • Clinicians • Patients • Policy makers rusnakm@truni.sk

41. 10. Update • Update • Evaluation first (quality indicators?) rusnakm@truni.sk

42. Steps in guideline development rusnakm@truni.sk

43. Methodological Challenges in Guideline Development • Incorporating patient preferences • Dealing with uncertainty • Grading levels of evidence/recommendations • Adaptation of guidelines • Updating of guidelines • Incorporating quality indicators • Electronic clinical decision support rusnakm@truni.sk

44. Methodological Challenges in Guideline Development • Incorporating patient preferences • Dealing with uncertainty? • Grading levels of evidence/recommendations • Adaptation of guidelines • Updating of guidelines • Incorporating quality indicators • Electronic clinical decision support rusnakm@truni.sk

45. Patient preferences • Research into barriers to successful guideline implementation • Patients don’t want the recommended treatments • Patients want treatments not recommended by guidelines rusnakm@truni.sk

46. How to get to patient preferences? • Inclusion of consumer representatives on guideline development teams • Formal surveys of patients opinions • Focus groups to seek patient opinions on the clinical questions and implementation • Decision analytic methods • Qualitative approach rusnakm@truni.sk

47. Example of need for more information on patient preferences • Caesarean section: obstetricians report that pregnant women are asking for elective caesarean sections • Survey data of women who had just given birth: • 50% of women felt that c-section was more convenient that normal birth • 30% felt that c-section was safer than normal birth • 15% were planning to ask for c-section in the future (Australian data) rusnakm@truni.sk

48. Methodological Challenges in Guideline Development • Understanding patient preferences • Dealing with uncertainty • Grading levels of evidence/recommendations • Adaptation of guidelines • Updating of guidelines • Incorporating quality indicators • Electronic clinical decision support rusnakm@truni.sk

49. Dealing with uncertainty • If you need to make a recommendation when there is no evidence: • Consensus approach • Wide consultation • Be explicit about what we don’t know • Advise need for more research • Caution rusnakm@truni.sk

50. Methodological Challenges in Guideline Development • Understanding patient preferences • Dealing with uncertainty • Grading levels of evidence/recommendations • Adaptation of guidelines • Updating of guidelines • Incorporating quality indicators • Electronic clinical decision support rusnakm@truni.sk