ArticleJACC. Cardiovascular interventions2020
Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.
Article in JACC. Cardiovascular interventions, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
22 citing papers in PubMed.
- Association Between Claims-Defined Frailty and Outcomes Following 30 Versus 12 Months of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention: Findings From the EXTEND-DAPT Study.Journal of the American Heart Association · 2023Trial
- Prognosis of Claims- Versus Trial-Based Ischemic and Bleeding Events Beyond 1 Year After Coronary Stenting.Journal of the American Heart Association · 2021Trial
- Transcatheter Aortic Valve Replacement (TAVR) in Medicare Advantage and Medicare Fee-for-Service: Differences in Patient Characteristics, Utilization, and Outcomes.Circulation. Population health and outcomes · 2026Article
- Antithrombotic strategy following valve-in-valve transcatheter aortic valve replacement. A German Statutory Health Claims data analysis.Clinical research in cardiology : official journal of the German Cardiac Society · 2026Article
- Evaluating Cardiovascular Devices Using Observational Analyses.Circulation · 2026Review
- Improving classification of myocardial infarction with machine learning in a diverse population.American journal of epidemiology · 2026Article
- Long-Term Outcomes Following Left Atrial Appendage Occlusion in Medicare Beneficiaries: Outcomes From the National Cardiovascular Data Registry.Journal of the American Heart Association · 2025Article
- Validation of Medicare Advantage Claims for Long-Term Outcome Assessment in Low-Risk Aortic Valve Replacement.Circulation. Cardiovascular quality and outcomes · 2025Article
- Observational
- Effectiveness of electronic medical record-based strategies for death and hospital admission endpoint capture in pragmatic clinical trials.Journal of the American Medical Informatics Association : JAMIA · 2025Article
- Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial.Circulation. Cardiovascular interventions · 2025Article
- Competing risk analysis to estimate amputation incidence and risk in lower-extremity peripheral artery disease.Vascular medicine (London, England) · 2024Article
- An Artificial Intelligence Algorithm for Detection of Severe Aortic Stenosis: A Clinical Cohort Study.JACC. Advances · 2024Article
- Long-Term Mortality Predictors Using a Machine-Learning Approach in Patients With Chronic Limb-Threatening Ischemia After Peripheral Vascular Intervention.Journal of the American Heart Association · 2024Article
- Progression of Frailty and Cardiovascular Outcomes Among Medicare Beneficiaries.medRxiv : the preprint server for health sciences · 2024Article
- Validation of administrative claims to identify ultrasound enhancing agent use.Echo research and practice · 2024Article
- Risk-related short-term clinical outcomes after transcatheter aortic valve implantation and their impact on early mortality: an analysis of claims-based data from Germany.Clinical research in cardiology : official journal of the German Cardiac Society · 2022Article
- Outcomes of stroke events during transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2022Article
- Clinical outcomes and cumulative healthcare costs of TAVR vs. SAVR in Asia.Frontiers in cardiovascular medicine · 2022Article
- Cardiovascular outcomes after initiating GLP-1 receptor agonist or basal insulin for the routine treatment of type 2 diabetes: a region-wide retrospective study.Cardiovascular diabetology · 2021Observational
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9 authors.
Funding
Abstract
objectivesThe aim of this study was to evaluate the performance of administrative claims in ascertaining trial clinical events committee-adjudicated outcomes in the U.S. CoreValve studies.
backgroundReal-world data offer tremendous opportunity to improve outcome ascertainment in clinical trials. However, little is known about the validity of outcomes ascertained using real-world data to capture trial endpoints.
methodsPatients enrolled in 3 pivotal trials and 2 pre-market continued-access studies evaluating transcatheter aortic valve replacement were linked to Medicare fee-for-service inpatient claims. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and kappa agreement statistic of claims to detect clinical endpoints and procedural complications in trial patients were calculated.
resultsClaims accurately identified trial-adjudicated deaths (sensitivity, specificity, PPV, and NPV all >99.6%; kappa 1.00). Claims had good performance in identifying trial-adjudicated permanent pacemaker implantation (sensitivity 92.2%, specificity 99.1%, PPV 96.1%, NPV 98.2%, kappa 0.93) and aortic valve reintervention (sensitivity 84.4%, specificity 99.6%, PPV 69.1%, NPV 99.8%, kappa 0.76). Claims had more modest performance in ascertaining trial-adjudicated myocardial infarction (sensitivity 63.6%, specificity 97.2%, PPV 29.9%, NPV 99.3%, kappa 0.39) and acute kidney injury (sensitivity 70.2%, specificity 85.4%, PPV 38.2%, NPV 95.7%, kappa 0.41) and the poorest performance for identifying trial-adjudicated bleeding events (sensitivity 86.4%, specificity 36.8%, PPV 35.0%, NPV 86.3%, kappa 0.16).
conclusionsCompared with trial-adjudicated outcomes, claims data performed well in ascertaining death and outcomes with procedural billing codes and more modestly in identifying other outcomes. Claims may be cautiously and selectively used to augment data collection in future cardiovascular device trials.
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