Development of a risk of bias assessment tool specifically for meta-analysis of trials for surgical site infection

Background: Surgical site infections (SSIs) significantly impact patient outcomes, with rates reaching up to 20% after surgery, leading to higher morbidity, prolonged hospital stays, and increased costs. The assessment of randomized controlled trials (RCTs) related to SSIs has been challenging due to the lack of a specialized Risk of Bias (RoB) tool, as existing tools like the RoB-2 are not surgery-specific. To address this gap, we developed an adapted SSI-specific RoB-2 tool. Methods: This tool was created through a four-stage consensus process involving surgeons, trial statisticians, and methodologists with extensive experience in international SSI trials. Results: The process identified ten critical domains relevant to assessing RCTs on SSI interventions. Of these, eight domains were prioritized as essential for the final tool, while two were considered desirable but less critical due to the challenges of blinding in surgical contexts. Conclusion: The adapted RoB-2 tool is tailored to the unique aspects of SSI trials, offering a more focused and practical means of evaluating RCT quality. It not only improves the assessment of existing studies but also guides the design of future RCTs, enhancing the quality of evidence in SSI research. The tool's application in meta-analyses will likely lead to more reliable and generalizable results, informing clinical practice and policy decisions related to SSI prevention and management.