Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.
Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands
BMJ Open. 2024 Feb 13;14(2):e075173. doi: 10.1136/bmjopen-2023-075173.
We aimed to identify existing appraisal tools for non-randomised studies of interventions (NRSIs) and to compare the criteria that the tools provide at the quality-item level.
Literature review through three approaches: systematic search of journal articles, snowballing search of reviews on appraisal tools and grey literature search on websites of health technology assessment (HTA) agencies.
Systematic search: Medline; Snowballing: starting from three articles (D'Andrea , Quigley and Faria ); Grey literature: websites of European HTA agencies listed by the International Network of Agencies for Health Technology Assessment. Appraisal tools were searched through April 2022.
We included a tool, if it addressed quality concerns of NRSIs and was published in English (unless from grey literature). A tool was excluded, if it was only for diagnostic, prognostic, qualitative or secondary studies.
Two independent researchers searched, screened and reviewed all included studies and tools, summarised quality items and scored whether and to what extent a quality item was described by a tool, for either methodological quality or reporting.
Forty-nine tools met inclusion criteria and were included for the content analysis. Concerns regarding the quality of NRSI were categorised into 4 domains and 26 items. The Research Triangle Institute Item Bank (RTI Item Bank) and STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) were the most comprehensive tools for methodological quality and reporting, respectively, as they addressed (n=20; 17) and sufficiently described (n=18; 13) the highest number of items. However, none of the tools covered all items.
Most of the tools have their own strengths, but none of them could address all quality concerns relevant to NRSIs. Even the most comprehensive tools can be complemented by several items. We suggest decision-makers, researchers and tool developers consider the quality-item level heterogeneity, when selecting a tool or identifying a research gap.
OSF registration DOI (https://doi.org/10.17605/OSF.IO/KCSGX).
我们旨在确定干预措施的非随机研究（NRSIs）的现有评估工具，并比较工具在质量项目层面提供的标准。
通过三种方法进行文献综述：系统检索期刊文章、系统检索评估工具的综述以及卫生技术评估（HTA）机构网站的灰色文献搜索。
系统检索：Medline；雪球：从三篇文章（D'Andrea、Quigley 和 Faria）开始；灰色文献：国际卫生技术评估机构网络列出的欧洲 HTA 机构的网站。评估工具的搜索截至 2022 年 4 月。
如果工具涉及 NRSIs 的质量问题且以英文发表（除非来自灰色文献），则纳入工具。如果工具仅用于诊断、预后、定性或次要研究，则排除工具。
两名独立研究人员搜索、筛选和审查了所有纳入的研究和工具，总结了质量项目，并对工具是否以及在何种程度上描述了质量项目进行了评分，无论是方法学质量还是报告质量。
49 个工具符合纳入标准，并进行了内容分析。对 NRSI 质量的关注分为 4 个领域和 26 个项目。研究三角研究院项目库（RTI 项目库）和加强观察性研究报告中的观察性研究（STROBE）是方法学质量和报告最全面的工具，因为它们分别针对（n=20；17）和充分描述（n=18；13）了最高数量的项目。然而，没有一个工具涵盖了所有项目。
大多数工具都有自己的优势，但没有一个工具能够解决与 NRSIs 相关的所有质量问题。即使是最全面的工具也可以通过几个项目来补充。我们建议决策者、研究人员和工具开发人员在选择工具或确定研究差距时，考虑质量项目层面的异质性。
OSF 注册号：OSF 注册号 DOI（https://doi.org/10.17605/OSF.IO/KCSGX）。
