Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.
Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.
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DOI：
10.1038/s41467-022-32310-3
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发表时间：
2022-08-31
影响因子：
16.6
通讯作者：
中科院分区：
文献类型：
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作者：
通过分析在临床实践中收集的数字数据来生成关于医疗产品效果的真实证据的研究为监管机构、支付方和其他医疗保健决策者提供了关键见解。确保这些调查结果的可重复性是有效的循证决策的基础。我们使用与原始研究者相同的医疗数据库复制了同行评审期刊上发表的150项研究的结果，并评估了250项研究报告的完整性。原始效应和繁殖效应大小呈正相关（皮尔森相关性= 0.85），这种关系很强，有一些改进空间。效应相对大小的中位数和四分位数范围（例如，风险比（original/hazard ratiorproduction）为1.0 [0.9，1.1]，range [0.3，2.1]。虽然大多数结果都很接近，但有一部分没有。后者的原因是报告和最新数据不完整。与新指南相一致的更高的方法透明度可能会进一步提高可重复性和有效性评估，从而促进循证决策。研究注册号：EUPAS 19636。对数字临床实践数据的真实世界证据的分析为医疗保健决策者提供了重要的见解。在这里，作者测试了150项同行评议研究的可重复性，报告了很强的可重复性，这可以通过在未来的原始研究中更完整的报告来进一步提高
Studies that generate real-world evidence on the effects of medical products through analysis of digital data collected in clinical practice provide key insights for regulators, payers, and other healthcare decision-makers. Ensuring reproducibility of such findings is fundamental to effective evidence-based decision-making. We reproduce results for 150 studies published in peer-reviewed journals using the same healthcare databases as original investigators and evaluate the completeness of reporting for 250. Original and reproduction effect sizes were positively correlated (Pearson’s correlation = 0.85), a strong relationship with some room for improvement. The median and interquartile range for the relative magnitude of effect (e.g., hazard ratiooriginal/hazard ratioreproduction) is 1.0 [0.9, 1.1], range [0.3, 2.1]. While the majority of results are closely reproduced, a subset are not. The latter can be explained by incomplete reporting and updated data. Greater methodological transparency aligned with new guidance may further improve reproducibility and validity assessment, thus facilitating evidence-based decision-making. Study registration number: EUPAS19636. Analyses of real-world evidence from digital clinical practice data provide important insights for healthcare decision makers. Here, authors test reproducibility of 150 peer-reviewed studies, reporting strong reproducibility, which could be further improved through more complete reporting in future original studies
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影响因子：
2.6
作者：
Kurz X;Perez-Gutthann S;ENCePP Steering Group
通讯作者：
ENCePP Steering Group
影响因子：
13.3
作者：
Kim, Seoyoung C.;Solomon, Daniel H.;Schneeweiss, Sebastian
通讯作者：
Schneeweiss, Sebastian
影响因子：
105.7
作者：
Hemkens, Lars G.;Contopoulos-Ioannidis, Despina G.;Ioannidis, John P. A.
通讯作者：
Ioannidis, John P. A.
影响因子：
6.7
作者：
Franklin, Jessica M.;Schneeweiss, Sebastian
通讯作者：
Schneeweiss, Sebastian
影响因子：
--
作者：
Feasby, Thomas E.;Kennedy, James;Ghali, William A.
通讯作者：
Ghali, William A.