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Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.

Publication ,  Journal Article
Brennan, JM; Wruck, L; Pencina, MJ; Clare, RM; Lopes, RD; Alexander, JH; O'Brien, S; Krucoff, M; Rao, SV; Wang, TY; Curtis, LH; Newby, LK ...
Published in: Am Heart J
December 2019

BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. METHODS: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. RESULTS: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. CONCLUSIONS: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2019

Volume

218

Start / End Page

110 / 122

Location

United States

Related Subject Headings

  • United States
  • Stroke
  • Retrospective Studies
  • Randomized Controlled Trials as Topic
  • Myocardial Revascularization
  • Myocardial Infarction
  • Multicenter Studies as Topic
  • Medicare
  • Medical Record Linkage
  • Male
 

Citation

APA
Chicago
ICMJE
MLA
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Brennan, J. M., Wruck, L., Pencina, M. J., Clare, R. M., Lopes, R. D., Alexander, J. H., … Peterson, E. D. (2019). Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. Am Heart J, 218, 110–122. https://doi.org/10.1016/j.ahj.2019.09.002
Brennan, J Matthew, Lisa Wruck, Michael J. Pencina, Robert M. Clare, Renato D. Lopes, John H. Alexander, Sean O’Brien, et al. “Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.Am Heart J 218 (December 2019): 110–22. https://doi.org/10.1016/j.ahj.2019.09.002.
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, et al. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. Am Heart J. 2019 Dec;218:110–22.
Brennan, J. Matthew, et al. “Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials.Am Heart J, vol. 218, Dec. 2019, pp. 110–22. Pubmed, doi:10.1016/j.ahj.2019.09.002.
Brennan JM, Wruck L, Pencina MJ, Clare RM, Lopes RD, Alexander JH, O’Brien S, Krucoff M, Rao SV, Wang TY, Curtis LH, Newby LK, Granger CB, Patel M, Mahaffey K, Ross JS, Normand S-L, Eloff BC, Caños DA, Lokhnygina YV, Roe MT, Califf RM, Marinac-Dabic D, Peterson ED. Claims-based cardiovascular outcome identification for clinical research: Results from 7 large randomized cardiovascular clinical trials. Am Heart J. 2019 Dec;218:110–122.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

December 2019

Volume

218

Start / End Page

110 / 122

Location

United States

Related Subject Headings

  • United States
  • Stroke
  • Retrospective Studies
  • Randomized Controlled Trials as Topic
  • Myocardial Revascularization
  • Myocardial Infarction
  • Multicenter Studies as Topic
  • Medicare
  • Medical Record Linkage
  • Male