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

• DOI: 10.1503/cmaj.200077
• Publication Date: 2020-08-10T09:25:20Z
• Authors: Stefan Schandelmaier; Matthias Briel; Ravi Varadhan; Christopher H. Sc...; Niveditha Devasen...; Rodney A. Hayward; Joel Gagnier; Michael Borenstein; Geert J.M.G. van ...; Issa J. Dahabreh; Xin Sun; Willi Sauerbrei; Michael Walsh; John P.A. Ioannidis; Lehana Thabane; Gordon H. Guyatt
• Keywords: Evidence-Based Medicine

<h3>BACKGROUND:</h3> Most randomized controlled trials (RCTs) and meta-analyses of RCTs examine effect modification (also called a subgroup or interaction), in which the an intervention varies by another variable (e.g., age disease severity). Assessing credibility apparent presents challenges; therefore, we developed Instrument for assessing Credibility Effect Modification Analyses (ICEMAN). <h3>METHODS:</h3> To develop ICEMAN, established detailed concept; identified candidate considerations systematic survey literature; together with experts, performed consensus study to identify key them into instrument items; refined based on feedback from trial investigators, review authors journal editors, who applied drafts ICEMAN published claims modification. <h3>RESULTS:</h3> The final consists set preliminary considerations, core questions (5 RCTs, 8 meta-analyses) 4 response options, 1 optional item additional rating visual analogue scale ranging very low high. An accompanying manual provides rationales, instructions examples literature. Seventeen potential users tested ICEMAN; their suggestions improved user-friendliness instrument. <h3>INTERPRETATION:</h3> offers explicit guidance reviewers, editors others considering making claim interpreting made others.