Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions

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.

Systematic review: Outcome reporting bias is a problem in high impact factor neurology journals

“…One particular form of bias, known as outcome reporting bias, occurs when trialists fail to report prespecified outcomes, report primary outcomes that were not prespecified, report statistically significant secondary outcomes as primary outcomes, or report nonsignificant primary outcomes as secondary outcomes [1,2]. This form of bias is well documented in the medical literature [3,4,5,6,7,8,9]. Dwan et al found that 40 to 62% of reviewed trials had at least one primary outcome that was changed, omitted, or newly introduced [10].…”

Research waste in surgical randomized controlled trials

“…Second, the RCTs included in this study represent a sample; although http://clinicaltrials.gov is a comprehensive registry of trials, the WHO endorses several other country‐specific registries which were not considered. In addition, previous evidence suggests that only 83 per cent of surgical trials are registered, and some studies may surpass their anticipated completion date. It is therefore possible that some trials remain excluded from the scope of this study.…”

Letter to the Editor, “Clinical Trial Registration in Oral Health Journals”

“…Trial registration has been proposed as a potential solution to prevent biased reporting in clinical trials (Hardt et al 2013). It aimed at reducing 2 main sources of bias: publication bias and selective reporting (Wager et al 2013), the latter having been included in one of the 6 domains of the Cochrane Collaboration Risk of Bias (RoB) tool (Higgins and Altman 2008;Higgins et al 2011).…”