RT Journal Article SR Electronic T1 Defining certainty of net benefit: a GRADE concept paper JF BMJ Open JO BMJ Open FD British Medical Journal Publishing Group SP e027445 DO 10.1136/bmjopen-2018-027445 VO 9 IS 6 A1 Alper, Brian S A1 Oettgen, Peter A1 Kunnamo, Ilkka A1 Iorio, Alfonso A1 Ansari, Mohammed Toseef A1 Murad, M Hassan A1 Meerpohl, Joerg J A1 Qaseem, Amir A1 Hultcrantz, Monica A1 Schünemann, Holger J A1 Guyatt, Gordon A1 YR 2019 UL http://bmjopen.bmj.com/content/9/6/e027445.abstract AB Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology is used to assess and report certainty of evidence and strength of recommendations. This GRADE concept article is not GRADE guidance but introduces certainty of net benefit, defined as the certainty that the balance between desirable and undesirable health effects is favourable. Determining certainty of net benefit requires considering certainty of effect estimates, the expected importance of outcomes and variability in importance, and the interaction of these concepts. Certainty of net harm is the certainty that the net effect is unfavourable. Guideline panels using or testing this approach might limit strong recommendations to actions with a high certainty of net benefit or against actions with a moderate or high certainty of net harm. Recommendations may differ in direction or strength from that suggested by the certainty of net benefit or harm when influenced by cost, equity, acceptability or feasibility.