Journal Article

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

O'Brien, Sean, Mahaffey, Kenneth, Peterson, Eric D., Curtis, Lesley H., Newby, L. Kristin, Caños, Daniel A., Lokhnygina, Yuliya V., Pencina, Michael J., Alexander, John H., Granger, Christopher B., Roe, Matthew T., Marinac-Dabic, Danica, Califf, Robert M., Normand, Sharon-Lise, Eloff, Benjamin C., Wang, Tracy Y., Ross, Joseph S., Clare, Robert M., Lopes, Renato D., Rao, Sunil V., Patel, Manesh, Brennan, J. Matthew, Wruck, Lisa, Krucoff, Mitchell

2019

Overview

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. 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. 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. 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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Adjudication / Aged / Biomedical Research / Cardiology / Cardiovascular Diseases - epidemiology / Cardiovascular Diseases - mortality / Cardiovascular Diseases - therapy / Cerebral infarction / Clinical outcomes / Clinical trials / Codes / Coronary Artery Bypass - statistics & numerical data / Coronary vessels / Data Accuracy / Data collection / Databases, Factual - statistics & numerical data / FDA approval / Fee-for-Service Plans - organization & administration / Fee-for-Service Plans - statistics & numerical data / Female / Follow-Up Studies / Funding / Government programs / Health maintenance organizations / HMOs / Hospitals / Humans / Inpatients / Insurance Claim Review - statistics & numerical data / Insurance claims / Insurance coverage / Kaplan-Meier Estimate / Male / Medicaid / Medical equipment / Medical Record Linkage - methods / Medical research / Medicare / Medicare - statistics & numerical data / Multicenter Studies as Topic / Myocardial infarction / Myocardial Infarction - epidemiology / Myocardial Revascularization - statistics & numerical data / Patients / Pharmaceutical industry / Randomization / Randomized Controlled Trials as Topic - statistics & numerical data / Retrospective Studies / Stroke / Stroke - epidemiology / United States - epidemiology