GRADE guidelines: 12. Preparing Summary of Findings tables - Binary outcomes

Gordon H. Guyatt, Andrew D. Oxman, Nancy Santesso, Mark Helfand, Gunn Vist, Regina Kunz, Jan Brozek, Susan Norris, Joerg Meerpohl, Ben Djulbegovic, Pablo Alonso-Coello, Piet N. Post, Jason W. Busse, Paul Glasziou, Robin Christensen, Holger J. Schünemann

Research output: Contribution to journalArticle

340 Citations (Scopus)

Abstract

Summary of Findings (SoF) tables present, for each of the seven (or fewer) most important outcomes, the following: the number of studies and number of participants; the confidence in effect estimates (quality of evidence); and the best estimates of relative and absolute effects. Potentially challenging choices in preparing SoF table include using direct evidence (which may have very few events) or indirect evidence (from a surrogate) as the best evidence for a treatment effect. If a surrogate is chosen, it must be labeled as substituting for the corresponding patient-important outcome. Another such choice is presenting evidence from low-quality randomized trials or high-quality observational studies. When in doubt, a reasonable approach is to present both sets of evidence; if the two bodies of evidence have similar quality but discrepant results, one would rate down further for inconsistency. For binary outcomes, relative risks (RRs) are the preferred measure of relative effect and, in most instances, are applied to the baseline or control group risks to generate absolute risks. Ideally, the baseline risks come from observational studies including representative patients and identifying easily measured prognostic factors that define groups at differing risk. In the absence of such studies, relevant randomized trials provide estimates of baseline risk. When confidence intervals (CIs) around the relative effect include no difference, one may simply state in the absolute risk column that results fail to show a difference, omit the point estimate and report only the CIs, or add a comment emphasizing the uncertainty associated with the point estimate.

Original languageEnglish (US)
Pages (from-to)158-172
Number of pages15
JournalJournal of Clinical Epidemiology
Volume66
Issue number2
DOIs
StatePublished - Feb 2013

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Guidelines
Observational Studies
Confidence Intervals
Patient Advocacy
Uncertainty
Control Groups
Therapeutics

Keywords

  • Confidence in estimates
  • Evidence profile
  • GRADE
  • Quality of evidence
  • Summary of findings
  • Systematic reviews

ASJC Scopus subject areas

  • Epidemiology

Cite this

Guyatt, G. H., Oxman, A. D., Santesso, N., Helfand, M., Vist, G., Kunz, R., ... Schünemann, H. J. (2013). GRADE guidelines: 12. Preparing Summary of Findings tables - Binary outcomes. Journal of Clinical Epidemiology, 66(2), 158-172. https://doi.org/10.1016/j.jclinepi.2012.01.012

GRADE guidelines : 12. Preparing Summary of Findings tables - Binary outcomes. / Guyatt, Gordon H.; Oxman, Andrew D.; Santesso, Nancy; Helfand, Mark; Vist, Gunn; Kunz, Regina; Brozek, Jan; Norris, Susan; Meerpohl, Joerg; Djulbegovic, Ben; Alonso-Coello, Pablo; Post, Piet N.; Busse, Jason W.; Glasziou, Paul; Christensen, Robin; Schünemann, Holger J.

In: Journal of Clinical Epidemiology, Vol. 66, No. 2, 02.2013, p. 158-172.

Research output: Contribution to journalArticle

Guyatt, GH, Oxman, AD, Santesso, N, Helfand, M, Vist, G, Kunz, R, Brozek, J, Norris, S, Meerpohl, J, Djulbegovic, B, Alonso-Coello, P, Post, PN, Busse, JW, Glasziou, P, Christensen, R & Schünemann, HJ 2013, 'GRADE guidelines: 12. Preparing Summary of Findings tables - Binary outcomes', Journal of Clinical Epidemiology, vol. 66, no. 2, pp. 158-172. https://doi.org/10.1016/j.jclinepi.2012.01.012
Guyatt, Gordon H. ; Oxman, Andrew D. ; Santesso, Nancy ; Helfand, Mark ; Vist, Gunn ; Kunz, Regina ; Brozek, Jan ; Norris, Susan ; Meerpohl, Joerg ; Djulbegovic, Ben ; Alonso-Coello, Pablo ; Post, Piet N. ; Busse, Jason W. ; Glasziou, Paul ; Christensen, Robin ; Schünemann, Holger J. / GRADE guidelines : 12. Preparing Summary of Findings tables - Binary outcomes. In: Journal of Clinical Epidemiology. 2013 ; Vol. 66, No. 2. pp. 158-172.
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