| Autor: |
Faridi, Kamil F., Tamez, Hector, Butala, Neel M., Song, Yang, Shen, Changyu, Secemsky, Eric A., Mauri, Laura, Curtis, Jeptha P., Strom, Jordan B., Yeh, Robert W. |
| Jazyk: |
angličtina |
| Rok vydání: |
2021 |
| Předmět: |
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| Zdroj: |
Circ Cardiovasc Qual Outcomes |
| Popis: |
BACKGROUND: Data from administrative claims may provide an efficient alternative for endpoint ascertainment in clinical trials. However, it is uncertain how well claims data compares to adjudication by a clinical events committee in trials of patients with cardiovascular disease. METHODS: We matched 1,336 patients ≥65 years old who received percutaneous coronary intervention in the Dual Antiplatelet Therapy (DAPT) Study with the National Cardiovascular Data Registry (NCDR) CathPCI Registry linked to Medicare claims as part of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study. Adjudicated trial endpoints were compared to Medicare claims data with ICD-9 codes from inpatient hospitalizations using time-to-event analyses, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa statistics. RESULTS: At 21-month follow-up, the cumulative incidence of major adverse cardiovascular and cerebrovascular events (combined mortality, myocardial infarction [MI], and stroke) was similar between trial-adjudicated events and claims data (7.9% vs. 7.2%, respectively; p = 0.50). Bleeding rates were lower using adjudicated events compared with claims (5.0% vs. 8.6%, respectively; p |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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