Abstract
BackgroundTrial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available.MethodsThe ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register.ResultsThe search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database.ConclusionsAlthough still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor.
Highlights
Trial registration and the reporting of trial results are essential to increase transparency in clinical research
We reviewed whether the registration number was specified in the title, abstract, or main text, since the Surgery Journal Editors Group (SJEG) member journals as well as the International Committee of Medical Journal Editors (ICMJE) demand specifications of the trial registration number in the abstract as evidence of registration [7]
The search for Randomized controlled trial (RCT) published between 1 June 2012 and 31 December 2012 retrieved 588 citations
Summary
Trial registration and the reporting of trial results are essential to increase transparency in clinical research. Both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were registered, and whether the study results of registered RCTs had been submitted to the trial register and were publicly available. Public electronic access to all trials could inspire researchers to collaborate and could support trial recruitment [3]
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