Article

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

German Cochrane Centre, Institute of Medical Biometry & Medical Informatics, University Medical Centre Freiburg, Freiburg/Br., Germany.
BMJ Open (Impact Factor: 2.27). 12/2011; 1(2):e000430. DOI: 10.1136/bmjopen-2011-000430
Source: PubMed

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.

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    • "However, the International Committee of Medical Journal Editors began promoting trial registration in 2005 and defined July 1, 2005 as the key date for prospective trial registration (http://www.icmje.org). A recent evaluation found that the vast majority of published trials in the field of urology (83%) have been registered since 2006 [14]. Therefore, we are confident that our evaluation considers a representative overview of the international landscape of uro-oncological study. "
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