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Clin Trials. 2016 Oct;13(5):519-26. doi: 10.1177/1740774516656579. Epub 2016 Jun 30.

Use of administrative data to increase the practicality of clinical trials: Insights from the Women's Health Initiative.

Author information

1
WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA garnet@whi.org.
2
WHI Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
3
Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, PA, USA.

Abstract

BACKGROUND:

To reduce research costs in the context of pragmatic trials, consideration is given to using administrative data (Medicare claims) to ascertain clinical outcomes.

METHODS:

In the historical context of the Women's Health Initiative, the correspondence between selected cardiovascular events derived from Medicare claims was compared to those documented and adjudicated in this large-scale prevention trial.

RESULTS:

Classification performance varies somewhat by type of outcome, but hazard ratios and confidence intervals derived from the two data sources were quite comparable.

CONCLUSION:

These encouraging results provided the needed support to launch a new embedded pragmatic trial of physical activity that will rely heavily on Medicare claims to ascertain cardiovascular disease incidence in the majority of those randomized.

KEYWORDS:

Medicare linkage; Pragmatic trials; claims data; misclassification; mismeasured outcomes

PMID:
27365013
PMCID:
PMC5059108
DOI:
10.1177/1740774516656579
[Indexed for MEDLINE]
Free PMC Article

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