The influence of study characteristics on reporting of subgroup analyses in randomised controlled trials: systematic review
Por:
Sun, X, Briel, M, Busse, JW, You, JJ, Akl, EA, Mejza, F, Bala, MM, Bassler, D, Mertz, D, Diaz-Granados, N, Vandvik, PO, Malaga, G, Srinathan, SK, Dahm, P, Johnston, BC, Alonso-Coello, P, Hassouneh, B, Truong, J, Dattani, ND, Walter, SD, Heels-Ansdell, D, Bhatnagar, N, Altman, DG, Guyatt, GH
Publicada:
28 mar 2011
Resumen:
Objective To investigate the impact of industry funding on reporting of subgroup analyses in randomised controlled trials.
Design Systematic review.
Data sources Medline.
Study selection Randomised controlled trials published in 118 core clinical journals (defined by the National Library of Medicine) in 2007. 1140 study reports in a 1: 1 ratio by high (five general medicine journals with largest number of total citations in 2007) versus lower impact journals, were randomly sampled. Two reviewers, independently and in duplicate, used standardised, piloted forms to screen study reports for eligibility and to extract data. They also used explicit criteria to determine whether a randomised controlled trial reported subgroup analyses. Logistic regression was used to examine the association of prespecified study characteristics with reporting versus not reporting of subgroup analyses.
Results 469 randomised controlled trials were included, of which 207 (44%) reported subgroup analyses. High impact journals (adjusted odds ratio 2.64, 95% confidence interval 1.62 to 4.33), non-surgical (versus surgical) trials (2.10, 1.26 to 3.50), and larger sample size (3.38, 1.64 to 6.99) were associated with more frequent reporting of subgroup analyses. The strength of association between trial funding and reporting of subgroups differed in trials with and without statistically significant primary outcomes (interaction P=0.02). In trials without statistically significant results for the primary outcome, industry funded trials were more likely to report subgroup analyses (2.29, 1.30 to 4.72) than non-industry funded trials. This was not true for trials with a statistically significant primary outcome (0.79, 0.46 to 1.36). Industry funded trials were associated with less frequent prespecification of subgroup hypotheses (31.3% v 38.0%, adjusted odds ratio 0.49, 0.26 to 0.94), and less use of the interaction test for analyses of subgroup effects (41.4% v 49.1%, 0.52, 0.28 to 0.97) than non-industry funded trials.
Conclusion Industry funded randomised controlled trials, in the absence of statistically significant primary outcomes, are more likely to report subgroup analyses than non-industry funded trials. Industry funded trials less frequently prespecify subgroup hypotheses and less frequently test for interaction than non-industry funded trials. Subgroup analyses from industry funded trials with negative results for the primary outcome should be viewed with caution.
Filiaciones:
Sun, X:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Sichuan Univ, W China Hosp, Chinese Evidence Based Med Ctr, Chengdu 610064, Peoples R China
Briel, M:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Univ Basel Hosp, Basel Inst Clin Epidemiol & Biostat, Basel, Switzerland
Busse, JW:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Inst Work & Hlth, Toronto, ON, Canada
You, JJ:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
McMaster Univ, Dept Med, Hamilton, ON L8N 3Z5, Canada
Akl, EA:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
SUNY Buffalo, Dept Med, Buffalo, NY 14260 USA
SUNY Buffalo, Dept Family Med, Buffalo, NY 14260 USA
Mejza, F:
Jagiellonian Univ, Sch Med, Dept Pulm Dis, Krakow, Poland
Bala, MM:
Jagiellonian Univ, Sch Med, Dept Internal Med 2, Krakow, Poland
Bassler, D:
Univ Childrens Hosp Tuebingen, Dept Neonatol, Tubingen, Germany
Univ Childrens Hosp Tuebingen, Ctr Pediat Clin Studies, Tubingen, Germany
Mertz, D:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
McMaster Univ, Michael G DeGroote Inst Infect Dis, Hamilton, ON L8N 3Z5, Canada
Diaz-Granados, N:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Vandvik, PO:
Norwegian Knowledge Ctr Hlth Serv, Oslo, Norway
Johnston, BC:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Hassouneh, B:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Walter, SD:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Heels-Ansdell, D:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Guyatt, GH:
McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON L8N 3Z5, Canada
Green Published, Hybrid Gold
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