Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions.

Autor: Wang SV; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA. swang1@bwh.harvard.edu.; Department of Medicine, Harvard Medical School, Boston, MA, USA. swang1@bwh.harvard.edu., Sreedhara SK; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA., Schneeweiss S; Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, MA, USA.; Department of Medicine, Harvard Medical School, Boston, MA, USA.
Jazyk: angličtina
Zdroj: Nature communications [Nat Commun] 2022 Aug 31; Vol. 13 (1), pp. 5126. Date of Electronic Publication: 2022 Aug 31.
DOI: 10.1038/s41467-022-32310-3
Abstrakt: 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 ratio original /hazard ratio reproduction ) 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.
(© 2022. The Author(s).)
Databáze: MEDLINE
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