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Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial.

Publication ,  Journal Article
Rymer, JA; Mulder, H; Wruck, LM; Muñoz, D; Kripalani, S; Effron, MB; Gupta, K; Handberg, E; Jain, S; Girotra, S; Whittle, J; Hess, R; Roe, MT ...
Published in: JAMA Cardiol
September 1, 2024

IMPORTANCE: Pragmatic randomized clinical trials (RCTs) often use multiple data sources to examine clinical events, but the relative contribution of data sources to clinical end-point rates is understudied. OBJECTIVE: To assess the contribution of data sources (electronic health records [EHRs], public/private insurance claims, and/or participant-reported data) to clinical end points among ADAPTABLE participants who had available data. DESIGN, SETTING, AND PARTICIPANTS: The ADAPTABLE study was an open-label, pragmatic RCT from April 2016 through June 2019 conducted in research networks within clinical practice. Participants had existing atherosclerotic cardiovascular disease and available data to analyze. The characteristics of patients by combinations of data source availability were compared to examine the contribution of each of the data sources to end-point ascertainment. Data for this prespecified analysis were examined from January 2022 to June 2023. EXPOSURES: Randomized exposure to 81 mg or 325 mg of aspirin daily. MAIN OUTCOMES AND MEASURES: Number of events for the primary end point (composite of death, hospitalization for myocardial infarction, and hospitalization for stroke) that were contributed by EHR or claims data and then number of events contributed by each additional data source. RESULTS: Of 15 006 participants randomized with at least 1 other source of data available beyond participant-reported data, there were 8756 (58.3%) with participant-reported and EHR data; 4291 (28.6%) with participant-reported, EHR, and claims data; 1412 (9.4%) with EHR-only data; 262 (1.7%) with participant-reported and claims data; 202 (1.3%) with EHR and claims data; and 83 (0.6%) with claims-only data. Participants with EHR-only data were younger (median age, 63.7 years; IQR, 55.8-71.4) compared with the other groups (range, 65.6-71.9 years). Among participants with both EHR and claims data, with or without participant-reported data (n = 4493), for each outcome, most events (92%-100%) were identified in the EHR or in claims data. For all clinical end points, participant-reported data contributed less than 10% of events not otherwise available from claims or EHR data. CONCLUSIONS AND RELEVANCE: In this analysis of a pragmatic RCT, claims and EHR data provided the most clinical end-point data when compared with participant-reported events. These findings provide a framework for collecting end points in pragmatic clinical trials. Further work is needed to understand the data source combinations that most effectively provide clinical end-point data in RCTs.

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Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

September 1, 2024

Volume

9

Issue

9

Start / End Page

852 / 857

Location

United States

Related Subject Headings

  • Stroke
  • Pragmatic Clinical Trials as Topic
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Information Sources
  • Humans
  • Hospitalization
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Rymer, J. A., Mulder, H., Wruck, L. M., Muñoz, D., Kripalani, S., Effron, M. B., … Jones, W. S. (2024). Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol, 9(9), 852–857. https://doi.org/10.1001/jamacardio.2024.2019
Rymer, Jennifer A., Hillary Mulder, Lisa M. Wruck, Daniel Muñoz, Sunil Kripalani, Mark B. Effron, Kamal Gupta, et al. “Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial.JAMA Cardiol 9, no. 9 (September 1, 2024): 852–57. https://doi.org/10.1001/jamacardio.2024.2019.
Rymer JA, Mulder H, Wruck LM, Muñoz D, Kripalani S, Effron MB, et al. Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):852–7.
Rymer, Jennifer A., et al. “Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial.JAMA Cardiol, vol. 9, no. 9, Sept. 2024, pp. 852–57. Pubmed, doi:10.1001/jamacardio.2024.2019.
Rymer JA, Mulder H, Wruck LM, Muñoz D, Kripalani S, Effron MB, Gupta K, Handberg E, Jain S, Girotra S, Whittle J, Hess R, Benziger CP, Knowlton KU, Curtis LH, Roe MT, Hammill BG, Rothman RL, Harrington R, Hernandez A, Jones WS. Contribution of Clinical Trial Event Data by Data Source: A Prespecified Analysis of the ADAPTABLE Randomized Clinical Trial. JAMA Cardiol. 2024 Sep 1;9(9):852–857.

Published In

JAMA Cardiol

DOI

EISSN

2380-6591

Publication Date

September 1, 2024

Volume

9

Issue

9

Start / End Page

852 / 857

Location

United States

Related Subject Headings

  • Stroke
  • Pragmatic Clinical Trials as Topic
  • Platelet Aggregation Inhibitors
  • Myocardial Infarction
  • Middle Aged
  • Male
  • Information Sources
  • Humans
  • Hospitalization
  • Female