Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
- 등재 SCIE, SCOPUS
- OA유형 All Open Access, Gold, Green
- 발행기관 Nature Research
- 발행년도 2022
- URI http://www.dcollection.net/handler/ewha/000000194481
- 본문언어 영어
- Published As https://doi.org/10.1038/s41467-022-32310-3
- PubMed https://pubmed.ncbi.nlm.nih.gov/36045130
초록/요약
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. © 2022, The Author(s).
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