Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA 02120, United States.
Department of Medicine, Harvard Medical School, Boston, MA 02115, United States.
Am J Epidemiol. 2024 Nov 4;193(11):1625-1631. doi: 10.1093/aje/kwae087.
Real-world evidence (RWE) studies are increasingly used to inform policy and clinical decisions. However, there remain concerns about the credibility and reproducibility of RWE studies. While there is universal agreement on the critical importance of transparent and reproducible science, the building blocks of open science practice that are common across many disciplines have not yet been built into routine workflows for pharmacoepidemiology and outcomes researchers. Observational researchers should highlight the level of transparency of their studies by providing a succinct statement addressing study transparency with the publication of every paper, poster, or presentation that reports on an RWE study. In this paper, we propose a framework for an explicit transparency statement that declares the level of transparency a given RWE study has achieved across 5 key domains: (1) protocol, (2) preregistration, (3) data, (4) code-sharing, and (5) reporting checklists. The transparency statement outlined in the present paper can be used by research teams to proudly display the open science practices that were used to generate evidence designed to inform public health policy and practice. While transparency does not guarantee validity, such a statement signals confidence from the research team in the scientific choices that were made.
真实世界证据 (RWE) 研究越来越多地被用于为政策和临床决策提供信息。然而，人们仍然对 RWE 研究的可信度和可重复性存在担忧。虽然人们普遍认为透明和可重复的科学至关重要，但在药物流行病学和结局研究中，尚未将许多学科共有的开放科学实践的构建模块纳入常规工作流程。观察性研究人员应通过在发表每一篇报告 RWE 研究的论文、海报或演示文稿时提供一份简明的研究透明度声明，突出其研究的透明度水平。在本文中，我们提出了一个明确的透明度声明框架，该框架声明了给定的 RWE 研究在 5 个关键领域实现的透明度水平：（1）方案，（2）预先注册，（3）数据，（4）代码共享，和（5）报告清单。本文中概述的透明度声明可由研究团队使用，自豪地展示用于生成旨在为公共卫生政策和实践提供信息的证据的开放科学实践。虽然透明度不能保证有效性，但这样的声明表明研究团队对所做的科学选择有信心。
