Summary
This paper describes the development and validation of ICEMAN (Instrument for assessing the Credibility of Effect Modification Analyses), a structured tool designed to evaluate the reliability of subgroup effect claims in RCTs and meta-analyses. The instrument was developed through systematic literature review, expert consensus, and iterative refinement involving trial investigators, systematic review authors, and journal editors. ICEMAN provides explicit, standardised guidance for researchers, reviewers, and editors assessing whether reported effect modifications represent genuine biological interactions or are spurious findings arising from multiple testing and data-driven subgrouping.
UK applicability
This methodological tool is applicable to UK-based and UK-relevant clinical research, systematic reviews, and editorial processes across all medical disciplines. It supports improved evidence appraisal practices within the UK National Health Service, research institutions, and journal editorial boards evaluating claims of differential treatment efficacy by patient subgroup.
Key measures
Number and type of core questions, response options, credibility rating scale (visual analogue scale from very low to high), user-friendliness feedback from 17 potential users
Outcomes reported
Development and validation of ICEMAN, a structured instrument for assessing the credibility of subgroup effect claims in randomised controlled trials and meta-analyses. The instrument includes preliminary considerations, core questions (5 for RCTs, 8 for meta-analyses), response options, and a credibility rating scale.
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