{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,24]],"date-time":"2025-11-24T04:49:39Z","timestamp":1763959779797},"reference-count":8,"publisher":"American Medical Association (AMA)","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Cardiol"],"published-print":{"date-parts":[[2024,9,1]]},"abstract":"Importance<\/jats:title>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.<\/jats:p><\/jats:sec>Objective<\/jats:title>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.<\/jats:p><\/jats:sec>Design, Setting, and Participants<\/jats:title>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.<\/jats:p><\/jats:sec>Exposures<\/jats:title>Randomized exposure to 81 mg or 325 mg of aspirin daily.<\/jats:p><\/jats:sec>Main Outcomes and Measures<\/jats:title>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.<\/jats:p><\/jats:sec>Results<\/jats:title>Of 15\u202f006 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\u2009=\u20094493), 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.<\/jats:p><\/jats:sec>Conclusions and Relevance<\/jats:title>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.<\/jats:p><\/jats:sec>","DOI":"10.1001\/jamacardio.2024.2019","type":"journal-article","created":{"date-parts":[[2024,7,24]],"date-time":"2024-07-24T16:22:29Z","timestamp":1721838149000},"page":"852","source":"Crossref","is-referenced-by-count":1,"title":["Contribution of Clinical Trial Event Data by Data Source"],"prefix":"10.1001","volume":"9","author":[{"given":"Jennifer A.","family":"Rymer","sequence":"first","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hillary","family":"Mulder","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lisa M.","family":"Wruck","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Mu\u00f1oz","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunil","family":"Kripalani","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mark B.","family":"Effron","sequence":"additional","affiliation":[{"name":"John Ochsner Heart and Vascular Institute, University of Queensland\u2013Ochsner Clinical School, New Orleans, Louisiana"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kamal","family":"Gupta","sequence":"additional","affiliation":[{"name":"University of Kansas School of Medicine, Kansas City"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eileen","family":"Handberg","sequence":"additional","affiliation":[{"name":"University of Florida, Gainesville"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sandeep","family":"Jain","sequence":"additional","affiliation":[{"name":"University of Pittsburgh, Pittsburgh, Pennsylvania"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Saket","family":"Girotra","sequence":"additional","affiliation":[{"name":"University of Iowa, Iowa City"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Whittle","sequence":"additional","affiliation":[{"name":"Medical College of Wisconsin, Milwaukee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rachel","family":"Hess","sequence":"additional","affiliation":[{"name":"University of Utah, Salt Lake City"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine P.","family":"Benziger","sequence":"additional","affiliation":[{"name":"Essentia Health, Duluth, Minnesota"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kirk U.","family":"Knowlton","sequence":"additional","affiliation":[{"name":"Intermountain Health, Salt Lake City, Utah"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lesley H.","family":"Curtis","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthew T.","family":"Roe","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bradley G.","family":"Hammill","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Russell L.","family":"Rothman","sequence":"additional","affiliation":[{"name":"Vanderbilt University Medical Center, Nashville, Tennessee"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Harrington","sequence":"additional","affiliation":[{"name":"Stanford University, Stanford, California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian","family":"Hernandez","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"W. Schuyler","family":"Jones","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"10","reference":[{"issue":"21","key":"hoi240040r2","doi-asserted-by":"publisher","first-page":"1981","DOI":"10.1056\/NEJMoa2102137","article-title":"Comparative effectiveness of aspirin dosing in cardiovascular disease.","volume":"384","author":"Jones","year":"2021","journal-title":"N Engl J Med"},{"issue":"12","key":"hoi240040r3","doi-asserted-by":"publisher","first-page":"1235","DOI":"10.1001\/jamacardio.2022.3844","article-title":"Concordance between patient-reported health data and electronic health data in the ADAPTABLE trial.","volume":"7","author":"O\u2019Brien","year":"2022","journal-title":"JAMA Cardiol"},{"issue":"5","key":"hoi240040r4","doi-asserted-by":"publisher","first-page":"598","DOI":"10.1001\/jamacardio.2020.0116","article-title":"Rationale and design of the aspirin dosing: a patient-centric trial assessing benefits and long-term effectiveness (ADAPTABLE) trial.","volume":"5","author":"Marquis-Gravel","year":"2020","journal-title":"JAMA Cardiol"},{"issue":"17","key":"hoi240040r8","doi-asserted-by":"publisher","first-page":"1477","DOI":"10.1161\/CIRCULATIONAHA.114.013829","article-title":"Comparison of self-reported and Medicare claims-identified acute myocardial infarction.","volume":"131","author":"Yasaitis","year":"2015","journal-title":"Circulation"},{"volume-title":"International Classification of Diseases, Ninth Revision (ICD-9).","year":"1977","author":"World Health Organization","key":"hoi240040r5"},{"volume-title":"International Statistical Classification of Diseases, Tenth Revision (ICD-10)","year":"1992","author":"World Health Organization","key":"hoi240040r6"},{"unstructured":"NIH Pragmatic Trials Collaboratory. 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