Skip to main content
release_alert
Welcome to the new Scholars 3.0! Read about new features and let us know what you think.
cancel
Journal cover image

Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health.

Publication ,  Journal Article
Ma, Q; Chung, H; Shambhu, S; Roe, M; Cziraky, M; Jones, WS; Haynes, K
Published in: Clin Trials
August 2019

BACKGROUND/AIMS: Health plan administrative claims data present a cost-effective complement to traditional trial-specific ascertainment of clinical events typically conducted through patient report or a single health system electronic health record. We aim to demonstrate the value of health plan claims data in improving the capture of endpoints in longitudinal pragmatic clinical trials. METHODS: This retrospective cohort study paralleled the design of the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) trial designed to compare the effectiveness of two doses of aspirin. We applied the ADAPTABLE identification query in claims data from Anthem, an American health insurance company, and identified health plan members who met the ADAPTABLE trial criteria. Among the ADAPTABLE eligible members, we selected overlapping members with PCORnet Clinical Data Research Networks in the 2 years prior to the index date (1 April 2014). PCORnet Clinical Data Research Networks consist of network partners (or healthcare systems) that store their electronic health record data in the same format to support multi-institutional research. ADAPTABLE outcome events-cardiovascular hospitalizations including admissions for myocardial infarction, stroke, or cardiac procedures; hospitalizations for major bleeding; and in-hospital deaths-were evaluated for a 2-year follow-up period. Events were classified as within or outside PCORnet Clinical Data Research Networks using facility identifiers affiliated with each hospital stay. Patient characteristics were examined with descriptive statistics, and incidence rates were reported for available Clinical Data Research Networks and claims data. RESULTS: Among 884,311 ADAPTABLE eligible health plan members, 11,101 patients overlapped with PCORnet Clinical Data Research Networks. Average age was 70 years, 71% were male, and average follow-up was 20.7 months. Patients had 1521 cardiovascular hospitalizations (571 (37.5%) occurred outside PCORnet Clinical Data Research Networks), 710 for major bleeding (296 (41.7%) outside PCORnet Clinical Data Research Networks), and 196 in-hospital deaths (67 (34.2%) outside PCORnet Clinical Data Research Networks). Incidence rates (events per1000 patient-months) differed between available network partners and claims data: cardiovascular hospitalizations, 4.1 (95% confidence interval: 3.9, 4.4) versus 6.6 (95% confidence interval: 6.3, 7.0), major bleeding, 1.8 (95% confidence interval: 1.6, 2.0) versus 3.1 (95% confidence interval: 2.9, 3.3), and in-hospital death, 0.56 (95% confidence interval: 0.47, 0.67) versus 0.85 (95% confidence interval: 0.74, 0.98), respectively. CONCLUSION: This study demonstrated the value of supplementing longitudinal site-based clinical studies with administrative claims data. Our results suggest that claims data together with network partner electronic health record data constitute an effective vehicle to capture patient outcomes since >30% of patients have non-fatal and fatal events outside of enrolling sites.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

August 2019

Volume

16

Issue

4

Start / End Page

419 / 430

Location

England

Related Subject Headings

  • Stroke
  • Statistics & Probability
  • Retrospective Studies
  • Pragmatic Clinical Trials as Topic
  • Outcome Assessment, Health Care
  • Myocardial Infarction
  • Male
  • Longitudinal Studies
  • Insurance Claim Review
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Ma, Q., Chung, H., Shambhu, S., Roe, M., Cziraky, M., Jones, W. S., & Haynes, K. (2019). Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health. Clin Trials, 16(4), 419–430. https://doi.org/10.1177/1740774519846853
Ma, Qinli, Haechung Chung, Sonali Shambhu, Matthew Roe, Mark Cziraky, W Schuyler Jones, and Kevin Haynes. “Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health.Clin Trials 16, no. 4 (August 2019): 419–30. https://doi.org/10.1177/1740774519846853.
Ma Q, Chung H, Shambhu S, Roe M, Cziraky M, Jones WS, et al. Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health. Clin Trials. 2019 Aug;16(4):419–30.
Ma, Qinli, et al. “Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health.Clin Trials, vol. 16, no. 4, Aug. 2019, pp. 419–30. Pubmed, doi:10.1177/1740774519846853.
Ma Q, Chung H, Shambhu S, Roe M, Cziraky M, Jones WS, Haynes K. Administrative claims data to support pragmatic clinical trial outcome ascertainment on cardiovascular health. Clin Trials. 2019 Aug;16(4):419–430.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

August 2019

Volume

16

Issue

4

Start / End Page

419 / 430

Location

England

Related Subject Headings

  • Stroke
  • Statistics & Probability
  • Retrospective Studies
  • Pragmatic Clinical Trials as Topic
  • Outcome Assessment, Health Care
  • Myocardial Infarction
  • Male
  • Longitudinal Studies
  • Insurance Claim Review
  • Humans