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

Luke Farrow* (Corresponding Author), William T. Gardner, Andrew D. Ablett, Vladislav Kutuzov, Alan Johnstone

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

1 Citation (Scopus)

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.
Original languageEnglish
Pages (from-to)1469–1479
Number of pages11
JournalEuropean Journal of Orthopaedic Surgery & Traumatology
Volume32
Early online date6 Oct 2021
DOIs
Publication statusE-pub ahead of print - 6 Oct 2021

Keywords

  • Trauma
  • Orthopaedics
  • Trial
  • RCT
  • Quality
  • Review

Fingerprint

Dive into the research topics of 'A review of trauma and orthopaedic randomised clinical trials published in high-impact general medical journals'. Together they form a unique fingerprint.

Cite this