Reporting of analyses from randomized controlled trials with multiple arms: a systematic review
- PMID: 23531230
- PMCID: PMC3621416
- DOI: 10.1186/1741-7015-11-84
Reporting of analyses from randomized controlled trials with multiple arms: a systematic review
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusions: Our findings highlight discrepancies between the planning and reporting of analyses in reports of multiple-arm trials.
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References
-
- Cook RJ, Farewell VT. Multiplicity considerations in the design and analysis of clinical trials. J R Statistic Soc A. 1996;159(1):93–110. doi: 10.2307/2983471. - DOI
-
- Committee for Proprietary Medicinal Products. Points to consider on multiplicity issued in clinical trials. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guidelin....
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