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Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
- Title
- Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
- Authors
- Wang S.V.; Sreedhara S.K.; Schneeweiss S.; Franklin J.M.; Gagne J.J.; Huybrechts K.F.; Patorno E.; Jin Y.; Lee M.; Mahesri M.; Pawar A.; Barberio J.; Bessette L.G.; Chin K.; Gautam N.; Ortiz A.S.; Sears E.; Stefanini K.; Zakarian M.; Dejene S.; Rogers J.R.; Brill G.; Landon J.; Lii J.; Tsacogianis T.; Vine S.; Garry E.M.; Gibbs L.R.; Gierada M.; Isaman D.L.; Payne E.; Alwardt S.; Arlett P.; Bartels D.B.; Bate A.; Berlin J.; Bourke A.; Bradbury B.; Brown J.; Burnett K.; Brennan T.; Chan K.A.; Choi N.-K.; de Vries F.; Eichler H.-G.; Filion K.B.; Freeman L.; Hallas J.; Happe L.; Hennessy S.; Jónsson P.; Ioannidis J.; Jimenez J.; Kahler K.H.; Laine C.; Loder E.; Makady A.; Martin D.; Nguyen M.; Nosek B.; Platt R.; Platt R.W.; Seeger J.; Shrank W.; Smeeth L.; Sørensen H.T.; Tugwell P.; Uyama Y.; Willke R.; Winkelmayer W.; Zarin D.; REPEAT Initiative
- Ewha Authors
- 최남경
- SCOPUS Author ID
- 최남경
- Issue Date
- 2022
- Journal Title
- Nature Communications
- ISSN
- 2041-1723
- Citation
- Nature Communications vol. 13, no. 1
- Publisher
- Nature Research
- Indexed
- SCIE; SCOPUS
- Document Type
- Article
- Abstract
- 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).
- DOI
- 10.1038/s41467-022-32310-3
- Appears in Collections:
- 신산업융합대학 > 융합보건학과 > Journal papers
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