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

Canadian Medical Association journal (CMAJ), 2020-08, Vol.192 (32), p.E901-E906 [Peer Reviewed Journal]

2020 Joule Inc. or its licensors. ;COPYRIGHT 2020 Joule Inc. ;Copyright Joule Inc Aug 10, 2020 ;2020 Joule Inc. or its licensors 2020 ;ISSN: 0820-3946 ;EISSN: 1488-2329 ;DOI: 10.1503/cmaj.200077 ;PMID: 32778601

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  • Title:
    Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses
  • Author: 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
  • Subjects: Analysis ; Clinical trials ; Credibility ; Health care policy ; Literature reviews ; Medical research ; Medicine, Experimental ; Meta-analysis ; Patients ; Periodical publishing ; Surveys ; Systematic review
  • Is Part Of: Canadian Medical Association journal (CMAJ), 2020-08, Vol.192 (32), p.E901-E906
  • Description: 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.
  • Publisher: Canada: Joule Inc
  • Language: English
  • Identifier: ISSN: 0820-3946
    EISSN: 1488-2329
    DOI: 10.1503/cmaj.200077
    PMID: 32778601
  • Source: ProQuest One Psychology
    Open Access: DOAJ Directory of Open Access Journals
    Open Access: PubMed Central
    Geneva Foundation Free Medical Journals at publisher websites
    AUTh Library subscriptions: ProQuest Central
    Alma/SFX Local Collection
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