• Kim Luijken, van de WallBryan J MBJM0000-0003-1882-8626Department of Orthopedic and Trauma Surgery, Cantonal Hospital of Lucerne, Lucerne, Switzerland.Department of Health Sciences and Medicine, University of Lucerne, Lucerne, Switzerland., Lotty Hooft, LeenenLuke P HLPH0000-0001-8385-1801Department of Trauma Surgery, University Medical Center Utrecht, Utrecht, The Netherlands., R Marijn Houwert, GroenwoldRolf H HRHH0000-0001-9238-6999Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands., and on behalf of the NEXT Study Group.
• Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, The Netherlands. k.luijken@umcutrecht.nl.
• Eur J Trauma Emerg Surg. 2022 Dec 1; 48 (6): 494349534943-4953.

PurposeIt is challenging to generate and subsequently implement high-quality evidence in surgical practice. A first step would be to grade the strengths and weaknesses of surgical evidence and appraise risk of bias and applicability. Here, we described items that are common to different risk-of-bias tools. We explained how these could be used to assess comparative operative intervention studies in orthopedic trauma surgery, and how these relate to applicability of results.MethodsWe extracted information from the Cochrane risk-of-bias-2 (RoB-2) tool, Risk Of Bias In Non-randomised Studies-of Interventions tool (ROBINS-I), and Methodological Index for Non-Randomized Studies (MINORS) criteria and derived a concisely formulated set of items with signaling questions tailored to operative interventions in orthopedic trauma surgery.ResultsThe established set contained nine items: population, intervention, comparator, outcome, confounding, missing data and selection bias, intervention status, outcome assessment, and pre-specification of analysis. Each item can be assessed using signaling questions and was explained using good practice examples of operative intervention studies in orthopedic trauma surgery.ConclusionThe set of items will be useful to form a first judgment on studies, for example when including them in a systematic review. Existing risk of bias tools can be used for further evaluation of methodological quality. Additionally, the proposed set of items and signaling questions might be a helpful starting point for peer reviewers and clinical readers.© 2022. The Author(s).

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