Do urology journals enforce trial registration? A cross-sectional study of published trials

Abstract

Objectives: (1) To assess endorsement of trial registration in author instructions of urology-related journals and (2) to assess whether randomised controlled trials (RCTs) in the field of urology were effectively registered. Design: Cross-sectional study of author instructions and published trials. Setting: Journals publishing in the field of urology. Participants: First, the authors analysed author instructions of 55 urology-related journals indexed in 'Journal Citation Reports 2009' (12/2010). The authors divided these journals in two groups: those requiring and those not mentioning trial registration as a precondition for publication. Second, the authors chose the five journals with the highest impact factor (IF) from each group. Intervention: MEDLINE search to identify RCTs published in these 10 journals in 2009 (01/2011); search of the clinical trials meta-search interface of WHO (International Clinical Trials Registry Platform) for RCTs that lacked information about registration (01-03/2011). Two authors independently assessed the information. Outcome measures: Proportion of journals providing advice about trial registration and proportion of trials registered. Results: Of 55 journals analysed, 26 (47.3%) provided some editorial advice about trial registration. Journals with higher IFs were more likely to mention trial registration explicitly (p=0.015). Of 106 RCTs published in 2009, 63 were registered (59.4%) with a tendency to an increase after 2005 (83.3%, p=0.035). 71.4% (30/42) of the RCTs that were published in journals mentioning and requiring registration, and 51.6% (33/64) of the RCTs that were published in journals that did not mention trial registration explicitly were registered. This difference was statistically significant (p=0.04). Conclusions: The existence of a statement about trial registration in author instructions resulted in a higher proportion of registered RCTs in those journals. Journals with higher IFs were more likely to mention trial registration.