Teaching Evidence Assimilation for Collaborative Healthcare

1. Going from evidence to decisions Teaching Evidence Assimilation for Collaborative Healthcare New York Academy of Medicine, 6 August 2014 Andy Oxman, Global Health Unit, Norwegian Knowledge Centre for the Health Services

2. Healthcare decisions are complex Many different factors need to be considered, including: • How important the problem is • The balance between desirable and undesirable effects • Whether the net benefits are worth the costs • Impacts on health inequities • Acceptability • Feasibility

3. Evidence is essential to inform decisions,but not sufficient Judgements are needed, including judgements about each factor that needs to be considered

4. Evidence to Decision (EtD) framework Can help guideline panels (and decision makers) move from evidence to a recommendation or decision by • Informing judgements about the pros and cons of each option (intervention) that is considered • Ensuring that important factors that determine a decision (criteria) are considered • Providing a concise summary of the best available research evidence to inform judgements about each criterion • Helping to structure discussion and identify reasons for disagreements • Making the basis for decisions transparent to target audiences

5. NYAM EBHTEACH Task Force Question: From the perspective of an HMO should dabigatran be recommended for patients with atrial fibrillation?

6. Question details

7. Background

8. Criteria

9. Judgements

10. Research evidence

11. Additional considerations

12. Subgroups

13. Conclusions

14. Types of recommendations Although the degree of confidence is a continuum, we suggest using two categories: strong and weak. Strong recommendation: the panel is confident that the desirable consequences of adherence to a recommendation outweigh the undesirable consequences. Weak*recommendation: the panel concludes that the desirable consequences of adherence to a recommendation probably outweigh the undesirable consequences, but is not confident. Recommend   Suggest   *Alternative terms for weak: conditional, discretionary, or qualified or suggest (and recommend)

15. Implications of strong and weak recommendations for patients Strong - Most people in your situation would want the recommended course of action and only a small proportion would not Weak - The majority of people in your situation would want the recommended course of action, but many would not

16. Implications of strong and weak recommendations forclinicians Strong - Most patients should receive the recommended course of action Weak - Be prepared to help patients to make a decision that is consistent with their own values

17. Questions?

18. Is the problem a priority? • Don’t know • Varies • No • Probably No • Probably Yes • Yes

19. Is there important uncertainty about or variability in how much people value the main outcomes? • No known undesirable outcomes • Important uncertainty or variability • Possibly important uncertainty or variability • Probably no important uncertainty or variability • No important uncertainty or variability

20. What is the overall certainty of the evidence of effects? • No included studies • Very low • Low • Moderate • High

21. How substantial are the desirable anticipated effects? • No included studies • Varies • Trivial • Small • Moderate • Large

22. How substantial are the undesirable anticipated effects? • No included studies • Varies • Large • Moderate • Small • Trivial

23. Does the balance between desirable and undesirable effects favour the intervention or the comparison? • No included studies • Varies • Favours the comparison • Probably favours the comparison • Does not favour either the intervention or the comparison • Probably favours the intervention • Favours the intervention • Less treatment burden • Uncertain risk of rare severe adverse effects • Compliance might be a problem • Currently no antidote

24. Extrapolation • Changing prices What is the certainty of the evidence of resource requirements (costs)? Key reasons for different results across economic analyses include assumptions about costs associated with intracranial haemorrhage and the costs of warfarin monitoring and disability following events 200 parameters each with its own uncertainty • No included studies • Very low • Low • Moderate • High Low and high estimates of the difference between the cost of dabigatran and warfarin are 611 and 6,135 kr/yr Between 66,0000 and 82,000 patients in Norway with atrial fibrillation. Uncertain how many are likely to be treated with new oral anticoagulants

25. How large are the resource requirements (costs)? • Don’t know • Varies • Large costs • Moderate costs • Negligible costs or savings • Moderate savings • Large savings

26. Does the cost-effectiveness of the intervention favour the intervention or the comparison? • No included studies • Varies • Favours the comparison • Probably favours the comparison • Does not favour either the intervention or the comparison • Probably favours the intervention • Favours the intervention

28. What do you recommend? • We recommend warfarin • We suggest warfarin • We suggest either warfarin or dabigatran • We suggest dabigatran • We recommend dabigatran

29. What about the subgroup of patients who are well controlled with warfarin?

31. Sub-group: warfarin control • Calculated mean time in the therapeutic range (TTR) in each centre • included 906/951 sites • Quartiles: • < 57.1% • 57·1–65·5% • 65·5–72·6% • > 72·6%

32. Results by quartileMean TTR per centre

33. Should we use the subgroup estimates or the overall estimates for this subgroup? • Subgroup estimates • Overall estimates • Can chance explain the apparent subgroup effect? • Is the effect consistent across studies? • Was the subgroup hypothesis one of a small number of hypotheses developed a priori with direction specified? • Is there strong indirect evidence that makes the subgroup plausible? • Is the evidence supporting the effect based on within- or between-study comparisons?

34. What is the overall certainty of the evidence of effects?

35. How substantial are the desirable anticipated effects?

36. Does the balance between desirable and undesirable effects favour the intervention or the comparison?

37. Resource requirements & cost-effectiveness

39. What do you recommend for patients who are well controlled with warfarin? • We recommend warfarin • We suggest warfarin • We suggest either warfarin or dabigatran • We suggest dabigatran • We recommend dabigatran

40. What would you recommend from the individual patient’s perspective?

41. Individual patient’s perspective • Priority of the problem likely to vary • The only costs that are likely to be important are out-of-pocket costs, which might be slightly less with dabigatran • Equity is unlikely to be an important consideration • Only the patient, family and healthcare provider’s acceptability and feasibility are likely to be important

42. What do you recommend from the perspective of individual patients? • We recommend warfarin • We suggest warfarin • We suggest either warfarin or dabigatran • We suggest dabigatran • We recommend dabigatran

43. Everything should be made as simple as possible, but not simpler. Albert Einstein

44. Questions or comments?