PT - JOURNAL ARTICLE AU - Brian S Alper AU - Peter Oettgen AU - Ilkka Kunnamo AU - Alfonso Iorio AU - Mohammed Toseef Ansari AU - M Hassan Murad AU - Joerg J Meerpohl AU - Amir Qaseem AU - Monica Hultcrantz AU - Holger J Schünemann AU - Gordon Guyatt ED - , TI - Defining certainty of net benefit: a GRADE concept paper AID - 10.1136/bmjopen-2018-027445 DP - 2019 Jun 01 TA - BMJ Open PG - e027445 VI - 9 IP - 6 4099 - http://bmjopen.bmj.com/content/9/6/e027445.short 4100 - http://bmjopen.bmj.com/content/9/6/e027445.full SO - BMJ Open2019 Jun 01; 9 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.