RT Journal Article
SR Electronic
T1 Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses
JF Canadian Medical Association Journal
JO CMAJ
FD Canadian Medical Association
SP E901
OP E906
DO 10.1503/cmaj.200077
VO 192
IS 32
A1 Schandelmaier, Stefan
A1 Briel, Matthias
A1 Varadhan, Ravi
A1 Schmid, Christopher H.
A1 Devasenapathy, Niveditha
A1 Hayward, Rodney A.
A1 Gagnier, Joel
A1 Borenstein, Michael
A1 van der Heijden, Geert J.M.G.
A1 Dahabreh, Issa J.
A1 Sun, Xin
A1 Sauerbrei, Willi
A1 Walsh, Michael
A1 Ioannidis, John P.A.
A1 Thabane, Lehana
A1 Guyatt, Gordon H.
YR 2020
UL http://www.cmaj.ca/content/192/32/E901.abstract
AB 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 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.