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Registration and publication of emergency and elective randomised controlled trials in surgery: a cohort study from trial registries
  1. Rachael L Morley1,2,
  2. Matthew J Edmondson1,3,
  3. Ceri Rowlands1,
  4. Jane M Blazeby1,3,
  5. Robert J Hinchliffe1,2
  1. 1 Bristol Centre for Surgical Research, Bristol Medical School, University of Bristol, Bristol, UK
  2. 2 North Bristol NHS Trust, Bristol, UK
  3. 3 Bristol Royal Infirmary, Bristol, UK
  1. Correspondence to Rachael L Morley; rm17210{at}bristol.ac.uk

Abstract

Objectives Emergency surgical practice constitutes 50% of the workload for surgeons, but there is a lack of high quality randomised controlled trials (RCTs) in emergency surgery. This study aims to establish the differences between the registration, completion and publication of emergency and elective surgical trials.

Design The clinicaltrials.gov and ISRCTN.com trials registry databases were searched for RCTs between 12 July 2010 and 12 July 2012 using the keyword ‘surgery’. Publications were systematically searched for in Pubmed, MEDLINE and EMBASE.

Participants Results with no surgical interventions were excluded. The remaining results were manually categorised into ‘emergency’ or ‘elective’ and ‘surgical’ or ‘adjunct’ by two reviewers.

Primary outcome measures Number of RCTs registered in emergency versus elective surgery.

Secondary outcome measures Number of RCTs published in emergency versus elective surgery; reasons why trials remain unpublished; funding, sponsorship and impact of published articles; number of adjunct trials registered in emergency and elective surgery.

Results 2700 randomised trials were registered. 1173 trials were on a surgical population and of these, 414 trials were studying surgery. Only 9.4% (39/414) of surgical trials were in emergency surgery. The proportion of trials successfully published did not significantly differ between emergency and elective surgery (0.46 vs 0.52; mean difference (MD) −0.06, 95% CI −0.24 to 0.12). Unpublished emergency surgical trials were statistically equally likely to be terminated early compared with elective trials (0.33 vs 0.16; MD −0.18, 95% CI −0.06 to 0.41). Low accrual accounted for a similar majority in both groups (0.43 vs 0.46; MD −0.04, 95% CI −0.48 to 0.41). Unpublished trials in both groups were statistically equally likely to still be planning publication (0.52 vs 0.71; MD −0.18, 95% CI −0.43 to 0.07).

Conclusion Fewer RCTs are registered in emergency than elective surgery. Once trials are registered both groups are equally likely to be published.

  • surgery
  • emergency

This is an open access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors All authors played a substantial role in the design of the study. RLM synthesised results and wrote the manuscript. RLM and MJE collected data. CR and RJH resolved any conflict in data collection. MJE, CR, JMB and RJH critically revised the manuscript. All authors gave final approval of the version to be published and agree to be held accountable for all aspects of the work.

  • Funding This work was undertaken with the support of the MRC ConDuCT-II (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/K025643/1). This study was supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed are those of the authors and not necessarily those of the UK National Health Service, National Institute for Health Research, or Department of Health.

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Data is available upon request from the corresponding author.

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