CONSORT Compliance in Surgical Randomized Trials

Sam Adie · Ian A. Harris · Justine Naylor · Rajat Mittal

68 citations0/0 files storedAnnals of Surgery

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Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Delphi Technique in Research

Abstract

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.

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References

1977The Measurement of Observer Agreement for Categorical Data 2010CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials 1995Empirical Evidence of Bias 1995Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials 2001The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials 1996Improving the quality of reporting of randomized controlled trials. The CONSORT statement 1996Improving the Quality of Reporting of Randomized Controlled Trials 2008Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study

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2015Do surgery journals insist on reporting by CONSORT and PRISMA? A follow-up survey of ‘instructions to authors’2019Research waste in surgical randomized controlled trials 2014The SPIRIT 2013 statement – Defining standard protocol items for trials 2020Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study

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