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

作者：Stefan Schandelmaier, Matthias Briel, Ravi Varadhan, Christopher H. Schmid, Niveditha Devasenapathy, Rodney A. Hayward, Joel Gagnier, Michael Borenstein, Geert J. M. G. van der Heijden, Issa J Dahabreh, Xin Sun, Willi Sauerbrei, Michael Walsh, John P. A. Ioannidis, Lehana Thabane, Gordon H. Guyatt · 发表于：Canadian Medical Association Journal · 年份：2020 · DOI：10.1503/cmaj.200077 · 被引用次数：766 · 研究领域：Meta-analysis and systematic reviews、Health Policy Implementation Science、Animal testing and alternatives

BACKGROUND: 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). METHODS: 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. RESULTS: 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. INTERPRETATION: The Instrument for assessing the Credibility of Effect Modification Analyses ...