Development of quality assessment tool for systematic reviews and meta-analyses of real-world studies: a Delphi consensus survey.

The increasing adoption of real-world studies in healthcare for decision making and planning has further necessitated the need for a specific quality assessment tool for evidence synthesis. This study aimed to develop a quality assessment tool for systematic reviews (SR) and meta-analysis (MA) involving real-world studies (QATSM-RWS) using a formal consensus method. Based on scoping review, the authors identified a list of items for possible inclusion in the quality assessment tool. A Delphi survey was formulated based on the identified items. A total of 89 experts, purposively recruited, with research experience in real-world data were invited to participate in the first round of Delphi survey. The participants who responded in the first Delphi round were invited to participate (n = 15) in the phrasing of the items. Strong level of agreement was found on the proposed list of items after the first round of Delphi. A rate of agreement ≥ 0.70 was used to define which items to keep in the tool. A list of 14 items emerged as suitable for QATSM-RWS. The items were structured under five domains: introduction, methods, results, discussions, and others. All participants agreed with the proposed phrasing of the items. This is the first study that has developed a specific tool that can be used to appraise the quality of SR and MA involving real-world studies. QATSM-RWS may be used by policymakers, clinicians, and practitioners when evaluating and generating real-world evidence. This tool is now undergoing validation process.