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BMJ Open. 2019 Jun 4;9(6):e027445. doi: 10.1136/bmjopen-2018-027445.

Defining certainty of net benefit: a GRADE concept paper.

Author information

EBSCO Health, DynaMed Plus, EBSCO Information Services Inc., Ipswich, Massachusetts, USA.
Department of Family and Community Medicine, University of Missouri-Columbia School of Medicine, Columbia, Missouri, USA.
Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Duodecim Medical Publications Ltd., Helsinki, Finland.
The Finnish Medical Society, Helsinki, Finland.
Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.
School of Epidemiology, Public Health and Preventive Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Evidence-Based Practice Center, Mayo Clinic, Rochester, Minnesota, USA.
Institute for Evidence in Medicine, Medical Center - University of Freiburg, Freiburg, Germany.
Cochrane Germany, Cochrane Germany Foundation, Freiburg, Germany.
Department of Clinical Policy, American College of Physicians, Philadelphia, Pennsylvania, USA.
Karolinska Institute, Stockholm, Sweden.
Statens beredning for medicinsk utvardering, Stockholm, Sweden.
Departments of Health Research Methods, Evidence, and Impact and of Medicine, McMaster University Health Sciences Centre, Hamilton, Ontario, Canada.


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.


clinical decision making; decision analysis; evidence synthesis; evidence-based medicine; guideline development

Conflict of interest statement

Competing interests: All authors are members of the GRADE Working Group and conduct scholarly activity or professional services related to the concepts in this article. BSA and PO are employed by EBSCO Information Services and IK is employed by Duodecim Medical Publications Ltd.

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