Brian Alper is a family physician and the founder of DynaMed, a point-of-care clinical reference with a rigorous evidence-based approach to evidence and guidelines. Peter Oettgen is a cardiologist and the editor-in-chief for DynaMed.
Determination of the Certainty of Net Benefit when making recommendations for clinical practice guidelines
09:00 wednesday June 21st
Objective: An evidence-based approach to clinical practice guidelines includes expressing the confidence that the desirable consequences outweigh the undesirable consequences for a particular recommendation. This is often done by expressing the strength of recommendation and the quality of evidence. The overall quality of evidence rating however is not the same thing as the confidence in the evidence that the summation of beneficial effects outweighs the summation of harmful effects. The objective is to more clearly express this concept and how to do it.
Methods: Members of the GRADE Working Group struggling with how to convey the concept of Overall Certainty of Evidence for a concept when fully contextualized in the guideline development process came to realize that directly expressing Certainty of Net Benefit would be clearer and more useful for guideline users. The workshop facilitators have actively developed a protocol for determining the Certainty of Net Benefit and applied it to numerous examples.
Results: The 7-step process to determine the Certainty of Net Benefit is:
1) determine the outcomes to be combined for a net effect estimate;
2) determine the relative importance for each outcome to be combined;
3) determine the importance-adjusted effect estimate for each outcome to be combined;
4) determine the net effect estimate upon combining the importance-adjusted effect estimates;
5) consider the precision of the net effect estimate and its influence on the certainty of net benefit or harm;
6) consider which outcomes are potential differentiators for the likelihood of net benefit and the certainty of effect estimates for potentially differentiating outcomes; and
7) consider the range of relative importance for outcomes and if the net effect estimate across the range of relative importance changes the Certainty of Net Benefit rating
Conclusion: The Certainty of Net Benefit is a clearer way of expressing the overall confidence that the benefits outweigh harms for a particular decision or recommendation. The 7-step process allows guideline developers to reproducibly determine and rate the certainty of net benefit. Workshop participants will determine the Certainty of Net Benefit for a recommendation to convey the certainty that the benefits outweigh the harms.