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Subgroup Analysis of Trials Is Rarely Easy (SATIRE) : a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials

Sun, Xin and Briel, Matthias and Busse, Jason W. and Akl, Elie A. and You, John J. and Mejza, Filip and Bala, Malgorzata and Diaz-Granados, Natalia and Bassler, Dirk and Mertz, Dominik and Srinathan, Sadeesh K. and Vandvik, Per Olav and Malaga, German and Alshurafa, Mohamed and Dahm, Philipp and Alonso-Coello, Pablo and Heels-Ansdell, Diane M. and Bhatnagar, Neera and Johnston, Bradley C. and Wang, Li and Walter, Stephen D. and Altman, Douglas G. and Guyatt, Gordon H.. (2009) Subgroup Analysis of Trials Is Rarely Easy (SATIRE) : a study protocol for a systematic review to characterize the analysis, reporting, and claim of subgroup effects in randomized trials. Trials, Vol. 10. p. 101.

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Official URL: http://edoc.unibas.ch/dok/A6007435

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Abstract

BACKGROUND: Subgroup analyses in randomized trials examine whether effects of interventions differ between subgroups of study populations according to characteristics of patients or interventions. However, findings from subgroup analyses may be misleading, potentially resulting in suboptimal clinical and health decision making. Few studies have investigated the reporting and conduct of subgroup analyses and a number of important questions remain unanswered. The objectives of this study are: 1) to describe the reporting of subgroup analyses and claims of subgroup effects in randomized controlled trials, 2) to assess study characteristics associated with reporting of subgroup analyses and with claims of subgroup effects, and 3) to examine the analysis, and interpretation of subgroup effects for each study's primary outcome. METHODS: We will conduct a systematic review of 464 randomized controlled human trials published in 2007 in the 118 Core Clinical Journals defined by the National Library of Medicine. We will randomly select journal articles, stratified in a 1:1 ratio by higher impact versus lower impact journals. According to 2007 ISI total citations, we consider the New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and BMJ as higher impact journals. Teams of two reviewers will independently screen full texts of reports for eligibility, and abstract data, using standardized, pilot-tested extraction forms. We will conduct univariable and multivariable logistic regression analyses to examine the association of pre-specified study characteristics with reporting of subgroup analyses and with claims of subgroup effects for the primary and any other outcomes. DISCUSSION: A clear understanding of subgroup analyses, as currently conducted and reported in published randomized controlled trials, will reveal both strengths and weaknesses of this practice. Our findings will contribute to a set of recommendations to optimize the conduct and reporting of subgroup analyses, and claim and interpretation of subgroup effects in randomized trials.
Faculties and Departments:03 Faculty of Medicine > Departement Klinische Forschung > Clinical Epidemiology and Biostatistics CEB > Klinische Epidemiologie (Bucher H)
UniBasel Contributors:Briel, Matthias
Item Type:Article, refereed
Article Subtype:Further Journal Contribution
Bibsysno:Link to catalogue
Publisher:BioMed Central
ISSN:1468-6708
Note:Publication type according to Uni Basel Research Database: Journal item
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Last Modified:18 Jul 2014 09:09
Deposited On:18 Jul 2014 07:42

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