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Development of the Instrument to assess the Credibility of Effect Modification Analyses (ICEMAN) in randomized controlled trials and meta-analyses
- Source :
- CMAJ: Canadian Medical Association Journal. August 10, 2020, Vol. 192 Issue 32, pE901, 6 p.
- Publication Year :
- 2020
-
Abstract
- 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.<br />Investigators who conduct randomized controlled trials (RCTs) and meta-analyses of RCTs often perform analyses of effect modification to assess whether intervention effects might vary by another variable such as age, [...]
Details
- Language :
- English
- ISSN :
- 08203946
- Volume :
- 192
- Issue :
- 32
- Database :
- Gale General OneFile
- Journal :
- CMAJ: Canadian Medical Association Journal
- Publication Type :
- Periodical
- Accession number :
- edsgcl.632774784
- Full Text :
- https://doi.org/10.1503/cmaj.200077