How to assess applicability and methodological quality of comparative studies of operative interventions in orthopedic trauma surgery

Abstract

Purpose: It 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. Methods: We 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. Results: The 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. Conclusion: The 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.