ArticleCirculation2020
Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement: Findings From the EXTEND Study.
Article in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.
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
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.
- Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study.BMJ (Clinical research ed.) · 2021Pooled it
- 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
- 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
- Validation of Medicare Advantage Claims for Long-Term Outcome Assessment in Low-Risk Aortic Valve Replacement.Circulation. Cardiovascular quality and outcomes · 2025Article
- Linkage of Clinical Trial Data to Routinely Collected Data Sources: A Scoping Review.JAMA network open · 2025Article
- 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
- Use of Discharge Disposition to Determine Stroke Severity After TAVR.Circulation. Cardiovascular interventions · 2024Article
- Days at Home After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients.Circulation. Cardiovascular quality and outcomes · 2023Article
- Comparison of Unibody and Non-Unibody Endografts for Abdominal Aortic Aneurysm Repair in Medicare Beneficiaries: The SAFE-AAA Study.Circulation · 2023Article
- Data Challenges for Externally Controlled Trials: Viewpoint.Journal of medical Internet research · 2023Article
- Harnessing Real-World Evidence to Advance Cancer Research.Current oncology (Toronto, Ont.) · 2023Review
- Ten-year outcomes of surgical aortic valve replacement with a contemporary supra-annular porcine valve in a Medicare population.JTCVS open · 2022Article
- Association of Socioeconomic Disadvantage With Mortality and Readmissions Among Older Adults Hospitalized for Pulmonary Embolism in the United States.Journal of the American Heart Association · 2021Article
- GLASS(Y) Half-Full: Moving Towards Greater Pragmatism in Outcome Ascertainment for Clinical Trials.Circulation. Cardiovascular quality and outcomes · 2021Article
- Bias Implications of Outcome Misclassification in Observational Studies Evaluating Association Between Treatments and All-Cause or Cardiovascular Mortality Using Administrative Claims.Journal of the American Heart Association · 2020Observational
Corrections and comments
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Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundWhether passively collected data can substitute for adjudicated outcomes to reproduce the magnitude and direction of treatment effect observed in cardiovascular clinical trials is not well known.
methodsWe linked adults ≥65 years of age in the HiR (US CoreValve Pivotal High Risk) and SURTAVI trials (Surgical or Transcatheter Aortic Valve Replacement in Intermediate-Risk Patients) to 100% Medicare inpatient claims, January 1, 2011, to December 31, 2016. Primary (eg, death and stroke) and secondary trial end points were compared across treatment arms (eg, transcatheter aortic valve replacement [TAVR] versus surgical aortic valve replacement [SAVR]) using trial-adjudicated outcomes versus outcomes derived from claims at 1 year (HiR) or 2 years (SURTAVI).
resultsAmong 600 linked HiR participants (linkage rate, 80.0%), the rate of the trial's primary end point of all-cause mortality occurred in 13.7% of patients receiving TAVR and 16.4% of patients receiving SAVR at 1 year by using both trial data (hazard ratio, 0.84 [95% CI, 0.65-1.09];
conclusionsIn the HiR and SURTAVI trials, ascertainment of trial primary end points using claims reproduced both the magnitude and direction of treatment effect in comparison with adjudicated event data, but nonfatal and nonprocedural secondary outcomes were not as well reproduced. Use of claims to substitute for adjudicated outcomes in traditional trial treatment comparisons may be valid and feasible for all-cause mortality and certain procedural outcomes but may be less suitable for other end points.
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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.