Development of the instrument to assess the credibility of effect modification analyses (ICEMAN) in randomized controlled trials and meta-analyses
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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.
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We used the ICEMAN tool to determine whether subgroup differences were credible.
“The Instrument to Assess the Credibility of Effect Modification Analyses (ICEMAN)21 recently introduced 8 criteria that we used to determine whether or not subgroup differences were credible.”
From Aerobic Exercise and Weight Loss in Adults (2024) · cites this paper as [21]
The Results say ICEMAN can be used to evaluate the credibility of effect-modification claims, supporting its use to assess subgroup differences. They also specify 8 core questions for meta-analyses but only 5 for individual RCTs; the citing sentence omits that qualification. (LLM, conf=0.85)
Experimental — accuracy not yet measuredUp-to-date meta-analyses evaluating the effects of therapeutic interventions across clinically important subgroup populations were assessed for credibility using relevant guidance.
“Up-to-date meta-analyses evaluating the effects of therapeutic interventions across clinically important subgroup populations were assessed in terms of their credibility using relevant guidance (7,8).”
The credibility of statistically significant subgroup effects was assessed using the Instrument to assess the Credibility of Effect Modification Analyse (ICEMAN) criteria.
“We assessed the credibility of statistically significant subgroup effects (P value for test of interaction <0.05) using Instrument to assess the Credibility of Effect Modification Analyse (ICEMAN) criteria.43”
From Management of chronic pain secondary to temporomandibular disorders: a systematic review and network meta-analysis of randomised trials (2023) · cites this paper as [43]
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Self-citationSystematic reviews of the literature: an introduction to current methods
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Self-citationProphylaxis against covid-19: living systematic review and network meta-analysis
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Self-citationTriple vs Dual Inhaler Therapy and Asthma Outcomes in Moderate to Severe Asthma
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Heterogeneous Treatment Effects of Therapeutic-Dose Heparin in Patients Hospitalized for COVID-19
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How to design high quality acupuncture trials—a consensus informed by evidence
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Inhaled Reliever Therapies for Asthma
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Augmented Enteral Protein During Critical Illness
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Bleach baths for atopic dermatitis
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How effects on health equity are assessed in systematic reviews of interventions
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Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis
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Noninvasive Oxygenation Strategies in Adult Patients With Acute Hypoxemic Respiratory Failure
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Self-citationSodium–Glucose Cotransporter-2 Inhibitors in Patients With Heart Failure
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Self-citationMineralocorticoid receptor antagonists and atrial fibrillation: a meta-analysis of clinical trials
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Effect Modifiers and Statistical Tests for Interaction in Randomized Trials
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Ketamine or Etomidate for Tracheal Intubation of Critically Ill Adults
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Obesity as an independent risk factor for COVID-19 severity and mortality
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Cannabis Use During Adolescence and Young Adulthood and Academic Achievement
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Self-citationAntiviral Medications for Treatment of Nonsevere Influenza
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Medications for adults with type 2 diabetes: a living systematic review and network meta-analysis
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- Authors
- Schandelmaier, S., Briel, M., Varadhan, R., Schmid, C. H., Devasenapathy, N., Hayward, R. A., Gagnier, J., Borenstein, M., van der Heijden, G. J. M. G., Dahabreh, I. J., Sun, X., Sauerbrei, W., Walsh, M., Ioannidis, J. P. A., Thabane, L., & Guyatt, G. H.
- Affiliations
- Johns Hopkins University (US)
- ORCID
- Venue
- Canadian Medical Association Journal
- Publisher
- CMA Impact Inc.
- Published
- 2020-08-09
- Volume
- 192
- Issue
- 32
- Pages
- E901-E906
- ISSN
- 0820-3946 (ISSN-L)
- 1488-2329
- PMC
- PMC7829020
- OpenAlex
- W3047950129
- Cited by
- 749
- References
- 50
- Citations by year
- 2026: 151 · 2025: 144 · 2024: 177 · 2023: 130 · 2022: 98 · 2021: 36 · 2020: 12
- FWCI
- 41.92
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Canadian Medical Association Journal (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- VU Research Portal (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Brown University
- Hamilton Health Sciences
- Freiwillige Akademische Gesellschaft
- McMaster University
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
- Universiteit van Amsterdam
- Vrije Universiteit Amsterdam
- Albert-Ludwigs-Universität Freiburg
- Sichuan University
- Gottfried und Julia Bangerter-Rhyner-Stiftung
- West China Hospital, Sichuan University
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Advanced Causal Inference Techniques
- Keywords
- effect modification, subgroup analysis, interaction, credibility assessment, Iceman, instrument development, randomized controlled trials, meta-analysis, reporting quality, visual analogue scale, expert consensus
- MeSH terms
- Humans, Research Design, Meta-Analysis as Topic, Randomized Controlled Trials as Topic, Consensus
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