Volume 14 Supplement 1

2nd Clinical Trials Methodology Conference: Methodology Matters

Open Access

Compliance of randomised controlled trials in trauma surgery with the consort statement: a systematic review

  • Seon-Young Lee1,
  • Penelope Teoh1,
  • Christian Camm2, 3 and
  • Riaz Agha1
Trials201314(Suppl 1):P121


Published: 29 November 2013


Randomized controlled trials (RCTs) are the criterion standard for assessing new interventions. However bias can result from poor reporting which also makes critical appraisal and systematic review challenging. The CONSORT criteria for non-pharmacological trials (CONSORT NPT) published in 2008 provided a set of 23 mandatory items that should be reported in an RCT. This is the first study to assess the compliance of RCTs in Trauma with CONSORT NPT criteria.


The Medline database was searched using the MeSH term “wounds and injuries” for English language papers published between January 2009 and December 2011. Relevant papers were scored by two reviewers and compared against surrogate markers of paper quality (such as journal impact factor).


83 papers were deemed suitable for inclusion. The mean CONSORT score was 11.2/23 items (48.5%, range 3.38-18.17). Compliance was poorest for items relating to the adherence of care providers (0%), abstract (4.8%) and implementation of randomisation (6.0%). There was a significant correlation between the CONSORT Score and the Impact Factor of the publishing journal (rho=0.37, p=0.0006) but not for the number of patients or authorsor single vs multi-centre trials.


The reporting quality of RCTs in Trauma surgery needs improvement. We suggest ways this could be improved including; better education, awareness and a cohesive strategy amongst all stakeholders and the hard-wiring of compliance through electronic journal submission systems.

Authors’ Affiliations

Faculty of Medicine, University of Southampton
New College, University of Oxford
Department of Plastic Surgery, Stoke Madeville Hospital


© Lee et al; licensee BioMed Central Ltd. 2013

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.