Teaching Evidence Assimilation for Collaborative Healthcare

New York Academy of Medicine, 6 August 2014

Going from evidence todecisions

Andy Oxman, Global Health Unit, Norwegian Knowledge Centre for the Health Services

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

Evidence is essential to inform decisions,but not sufficient

Judgements are needed, including judgements about each factor that needs to be considered

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

NYAM EBHTEACH Task Force

Question:

From the perspective of an HMO should dabigatran be recommended for patients with atrial fibrillation?

Question details

Background

Criteria

Judgements

Research evidence

Additional considerations

Subgroups

Conclusions

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)

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

Implications of strong and weak recommendations for

clinicians

• 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

Questions?

Is the problem a priority?A. Don’t know

B. Varies

C. No

D. Probably No

E. Probably Yes

F. Yes

12 %

5 %

39 %

44 %

0 %0 %

Is there important uncertainty about or variability in how much people value the

main outcomes?

A. No known undesirable outcomes

B. Important uncertainty or variability

C. Possibly important uncertainty or variability

D. Probably no important uncertainty or variability

E. No important uncertainty or variability

0 %

23 %

9 %

19 %

49 %

What is the overall certainty of the evidence of effects?

A. No included studies

B. Very low

C. Low

D. Moderate

E. High

0 % 0 %

16 %

82 %

3 %

How substantial are the desirable anticipated effects? A. No included studies

B. Varies

C. Trivial

D. Small

E. Moderate

F. Large

0 % 0 %

19 %

54 %

27 %

0 %

How substantial are the undesirable anticipated effects? A. No included studies

B. Varies

C. Large

D. Moderate

E. Small

F. Trivial

0 % 0 %3 %

50 %47 %

0 %

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

A. No included studies

B. Varies

C. Favours the comparison

D. Probably favours the comparison

E. Does not favour either the intervention or the comparison

F. Probably favours the intervention

G. Favours the intervention

0 % 0 % 2 %

12 %

71 %

10 %5 %

• Less treatment burden • Uncertain risk of rare severe adverse effects• Compliance might be a problem• Currently no antidote

What is the certainty of the evidence of resource requirements (costs)?

A. No included studies

B. Very low

C. Low

D. Moderate

E. High

0 %

20 %

0 %

24 %

56 %

• Extrapolation• Changing prices

200 parameters each with its own uncertainty

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

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

How large are the resource requirements (costs)?

A. Don’t know

B. Varies

C. Large costs

D. Moderate costs

E. Negligible costs or savings

F. Moderate savings

G. Large savings

4 %0 %

70 %

0 %0 %0 %

26 %

Does the cost-effectiveness of the intervention favour the

intervention or the comparison?

A. No included studies

B. Varies

C. Favours the comparison

D. Probably favours the comparison

E. Does not favour either the intervention or the comparison

F. Probably favours the intervention

G. Favours the intervention

0 % 0 %

18 %

0 %

64 %

9 %9 %

A. We recommend warfarin

B. We suggest warfarin

C. We suggest either warfarin or dabigatran

D. We suggest dabigatran

E. We recommend dabigatran

4 % 4 % 0 %

68 %

24 %

What do you recommend?

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

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%

Results by quartileMean TTR per centre

Should we use the subgroup estimates or the overall estimates

for this subgroup?

A. Subgroup estimates

B. 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?

What is the overall certainty of the evidence of effects?

How substantial are the desirable anticipated effects?

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

Resource requirements & cost-effectiveness

A. We recommend warfarin

B. We suggest warfarin

C. We suggest either warfarin or dabigatran

D. We suggest dabigatran

E. We recommend dabigatran

What do you recommend for patients who are well controlled with warfarin?

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

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

A. We recommend warfarin

B. We suggest warfarin

C. We suggest either warfarin or dabigatran

D. We suggest dabigatran

E. We recommend dabigatran

What do you recommend from the perspective of

individual patients?

Everything should be made as simple as

possible, but not simpler.Albert Einstein

Questions or comments?