Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses

Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modificati...

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Bibliographic Details
Published in:Canadian Medical Association journal (CMAJ) Vol. 192; no. 32; pp. E901 - E906
Main Authors: Schandelmaier, Stefan, Briel, Matthias, Varadhan, Ravi, Schmid, Christopher H., Devasenapathy, Niveditha, Hayward, Rodney A., Gagnier, Joel, Borenstein, Michael, van der Heijden, Geert J.M.G., Dahabreh, Issa J., Sun, Xin, Sauerbrei, Willi, Walsh, Michael, Ioannidis, John P.A., Thabane, Lehana, Guyatt, Gordon H.
Format: Journal Article
Language:English
Published: Canada Elsevier Inc 10.08.2020
Joule Inc
CMA Impact, Inc
Subjects:
Analysis
Clinical trials
Consensus
Credibility
Health care policy
Humans
Internal Medicine
Literature reviews
Medical research
Meta-analysis
Meta-Analysis as Topic
Patients
Periodical publishing
Randomized Controlled Trials as Topic
Research Design - standards
Surveys
Systematic review
ISSN:0820-3946, 1488-2329, 1488-2329
Online Access:Get full text
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Summary:Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup effect or interaction), in which the effect of an intervention varies by another variable (e.g., age or disease severity). Assessing the credibility of an apparent effect modification presents challenges; therefore, we developed the Instrument for assessing the Credibility of Effect Modification Analyses (ICEMAN). To develop ICEMAN, we established a detailed concept; identified candidate credibility considerations in a systematic survey of the literature; together with experts, performed a consensus study to identify key considerations and develop them into instrument items; and refined the instrument based on feedback from trial investigators, systematic review authors and journal editors, who applied drafts of ICEMAN to published claims of effect modification. The final instrument consists of a set of preliminary considerations, core questions (5 for RCTs, 8 for meta-analyses) with 4 response options, 1 optional item for additional considerations and a rating of credibility on a visual analogue scale ranging from very low to high. An accompanying manual provides rationales, detailed instructions and examples from the literature. Seventeen potential users tested ICEMAN; their suggestions improved the user-friendliness of the instrument. The Instrument for assessing the Credibility of Effect Modification Analyses offers explicit guidance for investigators, systematic reviewers, journal editors and others considering making a claim of effect modification or interpreting a claim made by others.
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ISSN:0820-3946
1488-2329
1488-2329
DOI:10.1503/cmaj.200077