External validity in distributed data networks.
Journal
Pharmacoepidemiology and drug safety
ISSN: 1099-1557
Titre abrégé: Pharmacoepidemiol Drug Saf
Pays: England
ID NLM: 9208369
Informations de publication
Date de publication:
Dec 2023
Dec 2023
Historique:
revised:
20
05
2023
received:
05
12
2022
accepted:
04
07
2023
medline:
14
11
2023
pubmed:
19
7
2023
entrez:
18
7
2023
Statut:
ppublish
Résumé
While much has been written about how distributed networks address internal validity, external validity is rarely discussed. We aimed to define key terms related to external validity, discuss how they relate to distributed networks, and identify how three networks (the US Food and Drug Administration's Sentinel System, the Canadian Network for Observational Drug Effect Studies [CNODES], and the National Patient Centered Clinical Research Network [PCORnet]) deal with external validity. We define external validity, target populations, target validity, generalizability, and transportability and describe how each relates to distributed networks. We then describe Sentinel, CNODES, and PCORnet and how each approaches these concepts, including a sample case study. Each network approaches external validity differently. As its target population is US citizens and it includes only US data, Sentinel primarily worries about lack of external validity by not including some segments of the population. The fact that CNODES includes Canadian, United States, and United Kingdom data forces them to seriously consider whether the United States and United Kingdom data will be transportable to Canadian citizens when they meta-analyze database-specific estimates. PCORnet, with its focus on study-specific cohorts and pragmatic trials, conducts more case-by-case explorations of external validity for each new analytic data set it generates. There is no one-size-fits-all approach to external validity within distributed networks. With these networks and comparisons between their findings becoming a key part of pharmacoepidemiology, there is a need to adapt tools for improving external validity to the distributed network setting.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1360-1367Informations de copyright
© 2023 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.
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