Enhancing Scientific Validity by Integrating EHR and Claims Data in the National Clinical Cohort Collaborative
Year: 2026
Type: preprint
Study design: Observational Study
Abstract: Purpose: Accurately capturing a patient's health journey is essential for ensuring the validity of scientific and public health studies. Electronic health records (EHR) and administrative claims are commonly used in healthcare research, albeit separately. Previous research has demonstrated that EHR and claims capture different aspects of patient history and care, potentially introducing bias when used alone. In this study, we leveraged the largest public US EHR resource, the National Clinical Cohort Collaborative (N3C), alongside Centers for Medicare & Medicaid Services (CMS) claims data to compare their information coverage and agreement. Methods: We integrated N3C EHR and CMS data to create one cohesive dataset and quantified the proportion of key variables present in EHR alone, CMS alone, and the overlap present in both data sources. Overlap in information coverage was quantified pre- and post-landmark diagnosis of COVID-19. To evaluate the impact of data coverage differences, we conducted a case study evaluating the effect of COVID-19 vaccination on ischemic stroke using both data sources alone and in combination. Results: CMS data helped identify many individuals that were duplicated among EHR identifiers. Examination of the overlap showed that CMS data more completely captured conditions, while EHR data more completely captured medications after COVID-19 diagnosis. Some variables exhibited marked differences over time after landmark COVID-19 diagnosis. Using target trial emulation and self-controlled case series methods, we found that data capture variations altered effect estimates: EHR data alone yielded lower risk of ischemic stroke after vaccination in the target trial emulation (odds ratio 0.47, 95% CI 0.28-0.79), with a smaller, non-significant reduction in the self-controlled case series (incidence rate ratio 0.81, 95% CI 0.64-1.02), whereas analyses using CMS data alone or both sources combined yielded estimates close to the null in both designs. Conclusions: Results indicated that when using either a national database combining multiple EHR sources, or CMS claims data alone, patients' medical histories are less completely captured compared to when these data sources are combined. Case study results highlighted the value of combining data sources for not only yielding fuller patient health histories and valid scientific results, but for identifying and explaining biases that may emerge in research studies that rely on a single data source.
Source: medRxiv
Language: English
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
Funders: U.S. Department of Health and Human Services, Bill and Melinda Gates Foundation, Yale University, University of Southern California, Brown University, Children's Hospital of Philadelphia, University of Nebraska Medical Center, Vanderbilt University, University of Miami, Ohio State University, Emory University, Tufts Medical Center, NYU Langone Medical Center, University of Wisconsin-Madison, Northwestern University, George Washington University, Wake Forest University, Cincinnati Children's Hospital Medical Center, Vanderbilt Institute for Clinical and Translational Research, University of Chicago, University of Minnesota, Washington University in St. Louis, University of Michigan, Harvard Catalyst, Loyola University Chicago, University of Utah, University of Washington, University of Texas Medical Branch, Tulane University, Johns Hopkins University, Institute for Translational Medicine and Therapeutics, Institute of Clinical and Translational Sciences, University of Rochester, University of Cincinnati, Pennsylvania State University, Carilion Clinic, University of Arkansas for Medical Sciences, Rush University, University of South Carolina, Aurora Health Care, Virginia Commonwealth University, Southern California Clinical and Translational Science Institute, West Virginia University, Montana State University, Rutgers, The State University of New Jersey, MedStar Health Research Institute, Georgetown-Howard Universities Center for Clinical and Translational Science, University of Texas Health Science Center at Houston, NorthShore University HealthSystem, Vanderbilt University Medical Center, Institute of Translational Health Sciences, Georgia Clinical and Translational Science Alliance, Penn State Clinical and Translational Science Institute, Children's National Hospital, Louisiana Clinical and Translational Science Center, Ochsner Health, West Virginia Clinical and Translational Science Institute, Stony Brook University, National Institutes of Health, University of Illinois at Urbana-Champaign, Institute for Clinical and Translational Research, University of Wisconsin, Madison, University of California, Los Angeles, Weill Cornell Medical College, University of California, Davis, Oregon Clinical and Translational Research Institute, University of North Carolina at Chapel Hill, University of California, San Diego, University of Oklahoma Health Sciences Center, University of California, San Francisco, University at Buffalo, Michigan Institute for Clinical and Health Research, University of Texas Health Science Center at San Antonio, University of California, Irvine, Leonard M. Miller School of Medicine, Center for Clinical and Translational Research, School of Medicine, Indiana University, University of Colorado Denver, Center for Clinical and Translational Science, University of Massachusetts, Center for Clinical and Translational Science, Mayo Clinic, Center for Clinical and Translational Sciences, University of Texas Health Science Center at Houston, Irving Medical Center, Columbia University, Translational Research Institute, University of Arkansas for Medical Sciences, South Carolina Clinical and Translational Research Institute, Medical University of South Carolina, Clinical and Translational Science Institute, University of Florida, Clinical and Translational Science Institute, Boston University, Frontiers Clinical and Translational Science Institute, University of Kansas, Clinical and Translational Science Center, University of New Mexico, National Institute of General Medical Sciences, National Center for Advancing Translational Sciences, Institute for Integration of Medicine and Science, Colorado Clinical and Translational Sciences Institute, Yale Center for Clinical Investigation, Yale School of Medicine, Institute for Clinical and Translational Science, University of California, Irvine, Wake Forest Clinical and Translational Science Institute, Wake Forest School of Medicine, Accelerated Innovation Research Initiative Turning Top Science and Ideas into High-Impact Values
Awards: G1003362385, G1008333784, G1034546755, G1063645443, G1074397124, G1110702752, G112449207, G1133842343, G1172658771, Center for Clinical and Translational Sciences (CCTS), G1198907661, G1217414008, G1252910802, G1261923283, G1331425082, The OSU Center for Clinical and Translational Science: Advancing Today's Discoveries to Improve Health, G1360421342, G1387563045, G1393127330, G1426198371, G1513836106, G1541329599, G1570942818, G1576582908, G1585841855, G1599055349, University of Massachusetts Center for Clinical and Translational Science, G1699415014, G171052541, G1717162763, G1756254663, G17630474, G1843193268, G1843992630, Wake Forest Clinical and Translational Science Award, G1862468807, G1897526822, G1936027380, G1944099974, G1954726022, Together: Transforming and Translating Discovery to Improve Health, G1979916807, Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS), G2008237588, Duke CTSA, G2049072053, G2100657707, G2101559773, G210617772, G2118698080, G2130928551, G213118816, G2152875133, G216896791, G2191929784, G2202983096, G2228636686, G2277157578, G2285413653, G2289923368, G232649080, G235420648, G237123860, G2373284513, G2451391735, G2507118478, G2508192175, G2529322290, G2592540264, G2610614086, G2615776415, G2635992203, G2714998049, G2719763103, G2724403125, G2737784225, G2740763107, G2761940466, G2788747769, G2879529664, Center for Clinical and Translational Science, G2922236389, G2927251591, G2951042450, The Harvard Clinical and Translational Science Center, G2985381359, Stanford Center for Clinical & Translational Education and Research (Spectrum), G3015141988, G3019850867, G3027042729, G3064378824, G3075846822, G3125251562, G3137464953, G3140511870, G3155718658, G3187757946, UNM HSC Clinical and Translational Science Center, University of Minnesota Clinical and TranslationalmScience Institute (UMN CTSI), G3410214985, G3433290244, G3455473179, G3534013791, G3552346897, G3573251375, G3667826151, G3695477739, G3724516993, Institute for Clinical and Translational Science, G3825745767, G3876554349, Tufts Clinical and Translational Science Institute, G4033363860, G4045563614, G4091522973, G4159580532, G4169670960, G4171111769, G4304223347, G432001851, G4386518065, G4410787187, G4437163022, G4529922095, G4688203610, G4689947851, The integrated Translational Health Research Institute of Virginia (iTHRIV): Using Data to Improve Health, MSHS Translational Science Hub, A National Center for Digital Health Informatics Innovation, G476308836, G477963360, Northwestern University Clinical and Translational Science Institute (NUCATS), G4811095511, G4823677270, G4839989308, G4851974581, G4852991764, G4900725235, G4924162002, G4925418384, G4927993327, G4950870472, G4990941765, G5031973872, Center for Clinical and Translational Research, G5049613280, G5059334661, G5086723997, G5159529264, G5205876097, G5227613151, G5234653271, G5258278944, Center for Clinical and Translational Science and Training, G5286663980, G5298196723, G5309353569, G5317805653, G5352274017, G536197267, G5379868350, G5385890486, G5409860367, G5430408733, G5555614831, G55941084, G5619247364, G5627382572, Miami Clinical and Translational Science Institute, G5644123735, G566154585, G5682055150, G5698066196, G5712103013, G572024221, G572238928, G5740473806, G584478153, G5849810213, Expanding Translational Research in Arkansas, G5952210540, Utah Center for Clinical and Translational Science, G6036981074, G6074586241, G6090519289, G6107751520, G611660658, G6122274444, G614564937, G6162566926, G6180245261, G6245908341, G625544220, G6292001676, G6370383993, G6392775737, G6399155424, G6516828695, G6523867696, G6551353892, G6576913434, Clinical and Translational Science Award, North Carolina Translational and Clinical Science Institute (NC TraCS), Sage Bionetworks - to evaluate the signs and symptoms of COVID-19 in a data-consortium approach to inform better clinical decision making for diagnosis, G6720719670, G678423687, G6831857590, G687203789, G6950051772, G6979210571, Michigan Institute for Clinical and Health Research (MICHR), G707880362, G7157803174, G7199445640, G7242922321, G7303504860, G7406577712, G7426992108, G7473568262, Scripps Translational Science Institute, New Jersey Alliance for Clinical Translational Science: NJ ACTS, G758486712, G761346317, Clinical and Translational Science Institute at Childrens National, G7672581523, G7695494419, G7696170246, G7707125228, The University of Rochester Clinical and Translational Science Award Hub, G775159726, G7758172473, Indiana Clinical and Translational Sciences Institute, G7768549844, G7793727360, G7818101325, Clinical and Translational Science Award, Clinical and Translational Science Award, Johns Hopkins Institute for Clinical and Translational Research, The University of Iowa Clinical and Translational Science Award, G7903016689, University of Buffalo Clinical and Translational Science Institute, G791875132, Institute for Integration of Medicine & Science: A Partnership to Improve Health, G7985746753, G8013765, G8021374757, G8031621368, G8063391433, G810497687, Colorado Clinical and Transational Sciences Institute, G8238115196, G8241404708, South Carolina Clinical & Translational Research Institute (SCTR), G8300140112, Boston University Clinical and Translational Science Institute, G8387357155, G8484679439, G8536079613, G8599329124, G8613635691, G8659778970, G8681400831, G8685909333, G870076036, UC San Diego Clinical and Translational Research Institute, G8853943025, G8908676624, G9000004369, Frontiers Clinical and Translational Science Institute at the University of Kansas, Advance Clinical and Translational Research (Advance-CTR), Clinical and Translational Science Award, UC Davis Clinical and Translational Science Center, Northern New England Clinical and Translational Research Network, University of Wisconsin Institute for Clinical and Translational Research, Clinical and Translational Science Center, Mayo Clinic Center for Clinical and Translational Science (CCaTS), West Virginia Clinical and Translational Science Institute: A Statewide Organization Building Research Excellence and Engaging Communities to Improve Health, Vanderbilt Institute for Clinical and Translational Research (VICTR), Oregon Clinical and Translational Research Institute, Clinical and Translational Science Award, Oklahoma Shared Clinical and Translational Resources, Great Plains IDeA-CTR, Delaware Clinical and Translational Research ACCEL Program, Penn State Clinical and Translational Science Institute, Southern California Clinical and Translational Science Institute, Institutional Clinical and Translational Science Award, Washington University Institute of Clinical and Translational Sciences, Mississippi Center for Clinical and Translational Research, The Institute for Translational Medicine, Georgia Clinical & Translational Science Alliance (Georgia CTSA), Institute of Translational Health Sciences, Louisiana Clinical and Translational Science Center, Yale Clinical and Translational Science Award, Kentucky Center for Clinical and Translational Science, Developing, Demonstrating, and Disseminating Innovative Programs to Achieve Translational Success, UCLA Clinical and Translational Science Institute, Clinical and Translational Science Institute, G9000923843, UTMB Clinical and Translational Science Award, G948394472, G967263443
OpenAlex ID: W7221942840