How Reliable are Patient-Reported Rehospitalizations? Implications for the Design of Future Practical Clinical Studies.
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2016-01-25
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BACKGROUND: Longitudinal clinical investigations often rely on patient reports to screen for postdischarge adverse outcomes events, yet few studies have examined the accuracy of such patient reports. METHODS AND RESULTS: Patients with acute myocardial infarction (MI) in the TRANSLATE-ACS study were asked during structured interviews at 6 weeks, 6 months, and 12 months postdischarge to report any rehospitalizations. The accuracy of patient-reported rehospitalizations within 1 year of postdischarge was determined using claims-based medical bill validation as the reference standard. The cumulative incidence of rehospitalizations was compared when identified by patient report versus medical bills. Patients were categorized by the accuracy in reporting events (accurate, under-, or over- reporters) and characteristics were compared between groups. Among 10 643 MI patients, 4565 (43%) reported 7734 rehospitalizations. The sensitivity and positive predictive value of patient-reported rehospitalizations were low at 67% and 59%, respectively. A higher cumulative incidence of rehospitalization was observed when identified by patient report versus medical bills (43% vs 37%; P<0.001). Overall, 18% of patients over-reported and 10% under-reported the number of hospitalizations. Compared with accurate reporters, under-reporters were more likely to be older, female, African American, unemployed, or a non-high-school graduate, and had greater prevalence of clinical comorbidities such as diabetes and past cardiovascular disease. CONCLUSIONS: The accuracy of patient-reported rehospitalizations was low with patients both under- and over-reporting events. Longitudinal clinical research studies need additional mechanisms beyond patient report to accurately identify rehospitalization events. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT01088503.
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Krishnamoorthy, Arun, Eric D Peterson, J David Knight, Kevin J Anstrom, Mark B Effron, Marjorie E Zettler, Linda Davidson-Ray, Brian A Baker, et al. (2016). How Reliable are Patient-Reported Rehospitalizations? Implications for the Design of Future Practical Clinical Studies. J Am Heart Assoc, 5(1). 10.1161/JAHA.115.002695 Retrieved from https://hdl.handle.net/10161/15005.
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Kevin J. Anstrom
My research interests include clinical trial design, causal inference, coordinating centers, data monitoring, and pragmatic clinical research.
Daniel Benjamin Mark
Dr. Mark is a clinical cardiologist with the rank of Professor of Medicine (with tenure) as well as Vice Chief for Academic Affairs in the Division of Cardiology, Department of Medicine at Duke University Medical Center. He is also the Director of Outcomes Research at the Duke Clinical Research Institute. He has been on the full-time faculty at Duke since 1985. Prior to that he completed his cardiology fellowship at Duke, his residency and internship at the University of Virginia Hospital, and received his medical degree from Tufts University and his Master’s degree from Harvard. In 1998, he was given the honor of being elected to the American Society for Clinical Investigators and in 2002 he was honored by election to the Association of American Physicians. These organizations are the two most prestigious honor societies in academic medicine. In 2009, Dr. Mark was awarded the American College of Cardiology Distinguished Scientist Award.
Dr. Mark's major research interests include medical economics and quality of life outcomes, outcomes research, and quality of medical care. Currently, Dr. Mark is directing a number of outcomes analyses for ongoing clinical trials including PROMISE (anatomic versus functional testing for coronary artery disease, NIH), CABANA (catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation, NIH), ISCHEMIA (percutaneous coronary intervention versus optimal medical therapy for moderate-severe ischemia), and STICH (CABG +/- ventricular reconstruction versus medical therapy for ischemic heart disease, NIH). He was the principal author of the AHCPR Unstable Angina Guidelines and is a co-author of both the American College of Cardiology Guideline on Exercise Testing and their Coronary Stent Consensus Guideline. He is also the Editor of the American Heart Journal. Dr. Mark has published over 270 peer-reviewed articles, two books, and 80 book chapters. He lectures widely in the US, as well as in Canada, South America, and Europe.
Keywords: cost-effectiveness analysis, disease management, quality of life assessment, resource use.
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