Reporting of analyses from randomized controlled trials with multiple arms: a systematic review
1 INSERM, Paris, U738, France
2 AP-HP (Assistance Publique des Hôpitaux de Paris), Hôpital Hôtel Dieu, Centre d’Epidémiologie Clinique, Paris, France
3 Université Paris Descartes, Faculté de Médecine, Paris, France
4 Centre de Médecine Fondée sur les Preuves (EHESP, HAS, INSERM, AP-HP), Paris, France
5 Department of Epidemiology, Columbia University Mailman School of Public Health, New York, NY, USA
BMC Medicine 2013, 11:84 doi:10.1186/1741-7015-11-84Published: 27 March 2013
Multiple-arm randomized trials can be more complex in their design, data analysis, and result reporting than two-arm trials. We conducted a systematic review to assess the reporting of analyses in reports of randomized controlled trials (RCTs) with multiple arms.
The literature in the MEDLINE database was searched for reports of RCTs with multiple arms published in 2009 in the core clinical journals. Two reviewers extracted data using a standardized extraction form.
In total, 298 reports were identified. Descriptions of the baseline characteristics and outcomes per group were missing in 45 reports (15.1%) and 48 reports (16.1%), respectively. More than half of the articles (n = 171, 57.4%) reported that a planned global test comparison was used (that is, assessment of the global differences between all groups), but 67 (39.2%) of these 171 articles did not report details of the planned analysis. Of the 116 articles reporting a global comparison test, 12 (10.3%) did not report the analysis as planned. In all, 60% of publications (n = 180) described planned pairwise test comparisons (that is, assessment of the difference between two groups), but 20 of these 180 articles (11.1%) did not report the pairwise test comparisons. Of the 204 articles reporting pairwise test comparisons, the comparisons were not planned for 44 (21.6%) of them. Less than half the reports (n = 137; 46%) provided baseline and outcome data per arm and reported the analysis as planned.
Our findings highlight discrepancies between the planning and reporting of analyses in reports of multiple-arm trials.