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

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


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.

Publication types

  • Comparative Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Cardiovascular Diseases / epidemiology
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / statistics & numerical data*
  • Female
  • Humans
  • Incidence
  • Insurance Claim Review / statistics & numerical data*
  • Medicare / statistics & numerical data*
  • Middle Aged
  • United States / epidemiology
  • Women's Health / statistics & numerical data*