Credibility of claims of subgroup effects in randomised controlled trials : Systematic review
Sun, Xin (McMaster University (Canadà))
Briel, Matthias (University Hospital Basel (Basilea, Suïssa))
Busse, Jason (Institute for Work and Health)
You, John J. (McMaster University (Canadà))
Akl, Elie A. (State University of New York)
Mejza, Filip (Jagiellonian University School of Medicine)
Bala, Malgorzata M. (Jagiellonian University School of Medicine)
Bassler, Dirk (University Children's Hospital Tuebingen)
Mertz, Dominik (McMaster University (Canadà))
Diaz-Granados, Natalia (McMaster University (Canadà))
Vandvik, Per Olav (Innlandet Hospital Trust)
Malaga, German (Universidad Peruana Cayetano Heredia)
Srinathan, Sadeesh K. (University of Manitoba)
Dahm, Philipp (College of Medicine)
Johnston, Bradley C. (Hospital for Sick Children)
Alonso-Coello, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Hassouneh, Basil (McMaster University (Canadà))
Walter, Stephen D. (McMaster University (Canadà))
Heels-Ansdell, Diane (McMaster University (Canadà))
Bhatnagar, Neera (McMaster University (Canadà))
Altman, Douglas G. (University of Oxford)
Guyatt, Gordon (McMaster University (Canadà))
Universitat Autònoma de Barcelona

Data:	2012
Resum:	Objective: To investigate the credibility of authors' claims of subgroup effects using a representative sample of recently published randomised controlled trials. Design: Systematic review. Data source: Core clinical journals, as defined by the National Library of Medicine, in Medline. Study selection: Randomised controlled trials published in 2007. Using prespecified criteria, teams of trained reviewers independently judged whether authors claimed subgroup effects and the strength of their claims. Reviewers assessed each of these claims against 10 predefined criteria, developed through a search of existing criteria and a consensus process. Results: Of 207 randomised controlled trials reporting subgroup analyses, 64 (31%) made claims for the primary outcome. Of those, 20 were strong claims and 28 claims of a likely effect. Authors included subgroup variables measured at baseline in 60 (94%) trials, used subgroup variable as a stratification factor at randomisation in 13 (20%), clearly prespecified their hypotheses in 26 (41%), correctly prespecified direction in 4 (6%), tested a small number of hypotheses in 28 (44%), carried out a test of interaction that proved statistically significant in 6 (9%), documented replication of a subgroup effect with previous related studies in 21 (33%), identified consistency of a subgroup effect across related outcomes in 19 (30%), and provided a compelling indirect evidence for the effect in 14 (22%). In the 19 trials making more than one claim, only one (5%) checked the independence of the interaction. Of the 64 claims, 54 (84%) met four or fewer of the 10 criteria. For strong claims, more than 50%failed each of the individual criteria, and only three (15%) met more than five criteria. Conclusion: Authors often claim subgroup effects in their trial report. However, the credibility of subgroup effects, even when claims are strong, is usually low. Users of the information should treat claims that fail to meet most criteria with scepticism. Trial researchers should report the conduct of subgroup analyses and provide sufficient evidence when claiming a subgroup effect or suggesting a possible effect.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article de revisió ; recerca ; Versió publicada
Publicat a:	BMJ, Vol. 344 Núm. 7852 (14 2012) , p. e1553, ISSN 1756-1833

DOI: 10.1136/bmj.e1553
PMID: 22422832

9 p, 357.1 KB

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