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CONSORT Compliance in Surgical Randomized Trials: Are We There Yet? A Systematic Review

Adie, Sam BSc(Med), MBBS, MSpMed, MPH; Harris, Ian A. MBBS, MMed(Clin Epi), PhD, FRACS; Naylor, Justine M. BAppSc, PhD; Mittal, Rajat BSc(Med), MBBS, MS, MMed(Clin Epi)

doi: 10.1097/SLA.0b013e31829664b9

Objective: We performed a systematic review assessing the reporting quality of trials of surgical interventions, and explored associated trial level variables.

Background: Randomized controlled trials (RCTs) provide clinicians with the best evidence for the effects of interventions, but may not be reported with necessary detail.

Methods: In May 2009, 3 databases (MEDLINE, EMBASE, and CENTRAL) were searched for RCTs that assessed a surgical intervention using a comprehensive electronic strategy developed by the Cochrane Collaboration. The Consolidated Standards of Reporting Trials (CONSORT) checklist was used as a measure of reporting quality. An overall CONSORT score was calculated and expressed as a proportion. This was supplemented with domains related to external validity. We also collected data on characteristics hypothesized to improve reporting quality, and exploratory regression was performed to determine associations.

Results: One hundred fifty recently published RCTs were included. The most commonly represented surgical subspecialties were general (29%), orthopedic (23%), and cardiothoracic (13%). Most (65%) were published in subspecialty surgical journals. Overall reporting quality was low, with only 55% of CONSORT items addressed. Less than half of trials described adequate methods for sample size calculation (45%), random sequence generation (43%), allocation concealment (45%), and blinding (37%). The strongest associations with reporting quality were adequate methods related to methodological domains, an author with an epidemiology/statistics degree, and a longer report length.

Conclusions: There remains much room for improvement for the reporting of surgical intervention trials. Authors and journal editors should apply existing reporting guidelines, and guidelines specific to the reporting of surgical interventions should be developed.

Supplemental Digital Content is Available in the Text.A systematic review of the reporting of recently published surgical intervention trials is presented. There remains much room for improvement, with only half of recommended items reported, and a lack of detail on issues related to generalizability.

South West Sydney Clinical School, University of New South Wales; and Whitlam Orthopaedic Research Centre, Liverpool Hospital, Liverpool, New South Wales, Australia.

Reprints: Sam Adie, MBBS, MSpMed, MPH, BSc(Med), Orthopaedic Department, Liverpool Hospital, Locked Bag 7103, Liverpool BC, NSW 1871, Australia. E-mail:

Disclosure: Dr Sam Adie was supported by scholarship grants from the National Health and Medical Research Council of Australia (Biomedical Postgraduate Scholarship) and the Royal Australasian College of Surgeons (Sir Roy McCaughey Research Fellowship). The funders had no role in the design, data collection, or analysis of this study. The authors declare no conflicts of interest.

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© 2013 by Lippincott Williams & Wilkins.