A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses.

Biomedical Research / standards Data Accuracy Humans Meta-Analysis as Topic Randomized Controlled Trials as Topic / standards Research Report / standards
Clinical trials as topic (MeSH) Epidemiologic methods (MeSH) Health care evaluation mechanisms (MeSH) Meta-analysis as topic (MeSH) Precision medicine (MeSH) Subgroup analysis

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
09 2019
Historique:
received: 25 09 2018
revised: 14 05 2019
accepted: 20 05 2019
pubmed: 28 5 2019
medline: 26 5 2020
entrez: 28 5 2019
Statut: ppublish

Résumé

The objective of the study was to systematically survey the methodological literature and collect suggested criteria for assessing the credibility of effect modification and associated rationales. We searched MEDLINE, Embase, and WorldCat up to March 2018 for publications providing guidance for assessing the credibility of effect modification identified in randomized trials or meta-analyses. Teams of two investigators independently identified eligible publications and extracted credibility criteria and authors' rationale, reaching consensus through discussion. We created a taxonomy of criteria that we iteratively refined during data abstraction. We identified 150 eligible publications that provided 36 criteria and associated rationales. Frequent criteria included significant test for interaction (n = 54), a priori hypothesis (n = 49), providing a causal explanation (n = 47), accounting for multiplicity (n = 45), testing a small number of effect modifiers (n = 38), and prespecification of analytic details (n = 39). For some criteria, we found more than one rationale; some criteria were connected through a common rationale. For some criteria, experts disagreed regarding their suitability (e.g., added value of stratified randomization; trustworthiness of biologic rationales). Methodologists have expended substantial intellectual energy providing criteria for critical appraisal of apparent effect modification. Our survey highlights popular criteria, expert agreement and disagreement, and where more work is needed, including testing criteria in practice.

Identifiants

DOI: 10.1016/j.jclinepi.2019.05.014 PMID: 31132471
pubmed: 31132471
pii: S0895-4356(18)30857-6
doi: 10.1016/j.jclinepi.2019.05.014
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

159-167

Commentaires et corrections

Type : ErratumIn

Informations de copyright

Copyright © 2019. Published by Elsevier Inc.

Auteurs

Stefan Schandelmaier (S)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Spitalstrasse 12, 4056 Basel, Switzerland. Electronic address: s.schandelmaier@gmail.com.

Yaping Chang (Y)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Niveditha Devasenapathy (N)

Indian Institute of Public Health-Delhi, Public Health Foundation of India, Plot 47, Sector 44, Institutional Area, Gurgaon, 122002 Haryana, India.

Tahira Devji (T)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Joey S W Kwong (JSW)

JC School of Public Health and Primary Care, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong.

Luis E Colunga Lozano (LE)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Yung Lee (Y)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Michael G. DeGroote School of Medicine, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Arnav Agarwal (A)

Department of Medicine, University of Toronto, 190 Elizabeth Street, R. Fraser Elliott Building, 3-805, Toronto, Ontario M5G 2C4, Canada.

Neera Bhatnagar (N)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada.

Hannah Ewald (H)

Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Spitalstrasse 12, 4056 Basel, Switzerland.

Ying Zhang (Y)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, 11 Bei San Huan Dong Lu, Chaoyang, Beijing 100029, China.

Xin Sun (X)

Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu 610041, China.

Lehana Thabane (L)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Biostatistics Unit, St Joseph's Healthcare - Hamilton, 50 Charlton Street East, Hamilton, Ontario L8N 4A6, Canada.

Michael Walsh (M)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, McMaster University, 1200 Main Street West, Hamilton, Ontario L8S 4L8, Canada.

Matthias Briel (M)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Spitalstrasse 12, 4056 Basel, Switzerland.

Gordon H Guyatt (GH)

Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S 4K1, Canada; Department of Medicine, McMaster University, 1200 Main Street West, Hamilton, Ontario L8S 4L8, Canada.

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Classifications MeSH

questionsmedicales.fr › Disciplines des sciences naturelles › Science › Recherche › Recherche biomédicale › A systematic survey identified 36 criteria for...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Exactitude des données › A systematic survey identified 36 criteria for...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › A systematic survey identified 36 criteria for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méta-analyse comme sujet › A systematic survey identified 36 criteria for...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › A systematic survey identified 36 criteria for...
questionsmedicales.fr › Sciences de l'information › Langage › Arts du langage › Écriture › Rapport de recherche › A systematic survey identified 36 criteria for...