PDF(Pubmed)
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.
摘要：
越来越多地采用现实世界的医疗保健研究来进行决策和计划，这进一步需要一种特定的质量评估工具来进行证据综合。本研究旨在使用正式共识方法开发涉及现实世界研究（QATSM-RWS）的系统评价（SR）和荟萃分析（MA）的质量评估工具。根据范围审查，作者确定了可能包含在质量评估工具中的项目列表.根据确定的项目制定了德尔菲调查。共有89位专家，故意招募，有研究经验的真实世界的数据被邀请参加第一轮的德尔福调查。在第一轮Delphi中做出回应的参与者被邀请参加（n=15）项目的措辞。在第一轮Delphi之后，在拟议的项目清单上找到了很强的协议。使用≥0.70的一致性率来定义要在工具中保留哪些项目。出现了适合QATSM-RWS的14项清单。这些项目分为五个领域：导言，方法,结果，讨论,和其他人。所有与会者都同意拟议的项目措辞。这是第一项研究开发了一种特定工具，可用于评估涉及现实世界研究的SR和MA的质量。QATSM-RWS可能会被决策者使用，临床医生,和实践者在评估和生成真实世界的证据时。此工具现在正在进行验证过程。
