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

ABSTRACT

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.