ArticleAmerican heart journal2019
Validating the use of registries and claims data to support randomized trials: Rationale and design of the Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study.
Article in American heart journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 28 citations in OpenAlex.
- Days at Home After Transcatheter Mitral Valve Repair Versus Medical Therapy Alone in Heart Failure.Journal of the American Heart Association · 2025Trial
- 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
- Estimating the Effects of MTEER in U.S. Practice: A Transportability Analysis of the COAPT Trial.Journal of the American College of Cardiology · 2026Article
- Evaluating Cardiovascular Devices Using Observational Analyses.Circulation · 2026Review
- Linking clinical trial data with real-world data for enhanced clinical evidence generation: methodological considerations and recommendations.Frontiers in pharmacology · 2026Review
- Validation of Medicare Advantage Claims for Long-Term Outcome Assessment in Low-Risk Aortic Valve Replacement.Circulation. Cardiovascular quality and outcomes · 2025Article
- Use of Claims to Assess Outcomes and Treatment Effects in the Evolut Low Risk Trial.Circulation. Cardiovascular interventions · 2025Article
- Days at Home After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.Circulation. Cardiovascular quality and outcomes · 2023Article
- Residential Racial Segregation in Aortic Stenosis Diagnosis and Transcatheter Aortic Valve Implantation Among Medicare Patients.JACC. Advances · 2023Article
- Enriching the American Heart Association COVID-19 Cardiovascular Disease Registry Through Linkage With External Data Sources: Rationale and Design.Journal of the American Heart Association · 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
- Estimation of DAPT Study Treatment Effects in Contemporary Clinical Practice: Findings From the EXTEND-DAPT Study.Circulation · 2022Article
- Role of Frailty in Identifying Benefit From Transcatheter Versus Surgical Aortic Valve Replacement.Circulation. Cardiovascular quality and outcomes · 2021Article
- Applicability of Transcatheter Aortic Valve Replacement Trials to Real-World Clinical Practice: Findings From EXTEND-CoreValve.JACC. Cardiovascular interventions · 2021Article
- Identification of Frailty Using a Claims-Based Frailty Index in the CoreValve Studies: Findings from the EXTEND-FRAILTY Study.Journal of the American Heart Association · 2021Article
- Comparing Baseline Data From Registries With Trials: Evidence From the CathPCI Registry and DAPT Study.JACC. Cardiovascular interventions · 2021Article
- Contemporary use of real-world data for clinical trial conduct in the United States: a scoping review.Journal of the American Medical Informatics Association : JAMIA · 2021Article
- Comparability of Event Adjudication Versus Administrative Billing Claims for Outcome Ascertainment in the DAPT Study: Findings From the EXTEND-DAPT Study.Circulation. Cardiovascular quality and outcomes · 2021Article
- Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement.JACC. Cardiovascular interventions · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 6 institutions in 2 countries.
Funding
Abstract
backgroundRandomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes. METHODS AND
resultsPatient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The concordance between baseline and outcomes data collected within nontrial data sets and trial information, including adjudicated end point events, will be assessed. We will compare the study results obtained using these alternative data sources to those derived using trial-ascertained variables and end points using trial-adjudicated end points and covariates.
conclusionsLinkage of trials to registries and claims data represents an opportunity to use alternative data sources in place of and as adjuncts to randomized clinical trial data but requires further validation. The results of this research will help determine how these data sources can be used to improve our present and future understanding of new medical treatments.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.