A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals

Luke Farrow · William Timothy Gardner · Andrew D. Ablett · Vladislav Kutuzov · Alan J. Johnstone

14 citations0/0 files storedEuropean Journal of Orthopaedic Surgery & Traumatology

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

Abstract

INTRODUCTION: The recent past has seen a significant increase in the number of trauma and orthopaedic randomised clinical trials published in "the big five" general medical journals. The quality of this research has, however, not yet been established. METHODS: We therefore set out to critically appraise the quality of available literature over a 10-year period (April 2010-April 2020) through a systematic search of these 5 high-impact general medical journals (JAMA, NEJM, BMJ, Lancet and Annals). A standardised data extraction proforma was utilised to gather information regarding: trial design, sample size calculation, results, study quality and pragmatism. Quality assessment was performed using the Cochrane Risk of Bias 2 tool and the modified Delphi list. Study pragmatism was assessed using the PRECIS-2 tool. RESULTS: A total of 25 studies were eligible for inclusion. Over half of the included trials did not meet their sample size calculation for the primary outcome, with a similar proportion of these studies at risk of type II error for their non-significant results. There was a high degree of pragmatism according to PRECIS-2. Non-significant studies had greater pragmatism that those with statistically significant results (p < 0.001). Only 56% studies provided adequate justification for the minimum clinically important difference (MCID) in the population assessed. Overall, very few studies were deemed high quality/low risk of bias. CONCLUSIONS: These findings highlight that there are some important methodological concerns present within the current evidence base of RCTs published in high-impact medical journals. Potential strategies that may improve future trial design are highlighted. LEVEL OF EVIDENCE: Level 1.

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2019RoB 2: a revised tool for assessing risk of bias in randomised trials 1998The Delphi List 2006Does a "Level I Evidence" rating imply high quality of reporting in orthopaedic randomised controlled trials?2018The Robustness of Trials That Guide Evidence-Based Orthopaedic Surgery 2019Poor quality patient reported outcome measures bias effect estimates in orthopaedic randomized studies 2020An Assessment of Randomized Controlled Trial Quality in The Journal of Bone & Joint Surgery 2019Overview of randomised controlled trials in orthopaedic research: search for significant findings

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