ArticleCirculation2014
Rethinking composite end points in clinical trials: insights from patients and trialists.
Article in Circulation, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 2 of them syntheses that pooled it.
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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.
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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
50 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- A systematic review and meta-analysis of the cerebrovascular event incidence after transcatheter aortic valve implantation.Clinical research in cardiology : official journal of the German Cardiac Society · 2022Pooled it
- Stroke Severity in Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement: A Systematic Review and Meta-Analysis.Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association · 2021Pooled it
- User-defined outcomes of the Danish cardiovascular screening (DANCAVAS) trial: A post hoc analyses of a population-based, randomised controlled trial.PLoS medicine · 2024Trial
- Trial
- Ten-year all-cause death after percutaneous or surgical revascularization in diabetic patients with complex coronary artery disease.European heart journal · 2021Trial
- Impact of established cardiovascular disease on 10-year death after coronary revascularization for complex coronary artery disease.Clinical research in cardiology : official journal of the German Cardiac Society · 2021Trial
- A comprehensive analysis of the effects of rivaroxaban on stroke or transient ischaemic attack in patients with heart failure, coronary artery disease, and sinus rhythm: the COMMANDER HF trial.European heart journal · 2019Trial
- Exploring methodology for investigating Chinese coronary artery disease patient values and preferences: A methodological study protocol.Global health research and policy · 2026Article
- Long-term neurological outcomes after transcatheter aortic valve replacement in high-volume cardiovascular care center.Cardiology journal · 2026Article
- Adding the patient perspective: the necessity of patient reported outcomes in cardiac surgery clinical trials.Current opinion in cardiology · 2025Review
- Do patients' and doctors' perceptions about cardiovascular outcomes coincide? A one-to-one survey at in-hospital and outpatient level.BMJ open · 2025Article
- The advantages and challenges of disability-free survival as outcome measure in clinical studies.Nature aging · 2025Article
- Assessment of Revascularization Preferences With Best-Worst Scaling Among Patients With Ischemic Heart Disease.Journal of cardiac failure · 2025Article
- Article
- Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints.Journal of clinical and translational science · 2025Review
- The effect of treatment timing on repeat revascularization in patients with stable ischemic heart disease.JTCVS open · 2024Article
- Health-related quality of life after minimal-invasive treatment of aortic valve stenosis in the elderly.Journal of thoracic disease · 2024Article
- Chronological vs Biological Age in Interventional Cardiology: A Comprehensive Approach to Care for Older Adults: JACC Family Series.JACC. Cardiovascular interventions · 2024Review
- Effect of statin add-on therapy on cardiovascular mortality.Frontiers in cardiovascular medicine · 2024Review
- Impaired mobility and MRI markers of vascular brain injury: Atherosclerosis Risk in Communities and UK Biobank studies.BMJ neurology open · 2024Article
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8 authors.
Funding
Abstract
backgroundMany clinical trials use composite end points to reduce sample size, but the relative importance of each individual end point within the composite may differ between patients and researchers. METHODS AND
resultsWe asked 785 cardiovascular patients and 164 clinical trial authors to assign 25 "spending weights" across 5 common adverse events comprising composite end points in cardiovascular trials: death, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina. We then calculated end point ratios for each participant's ratings of each nonfatal end point relative to death. Whereas patients assigned an average weight of 5 to death, equal or greater weight was assigned to myocardial infarction (mean ratio, 1.12) and stroke (ratio, 1.08). In contrast, clinical trialists were much more concerned about death (average weight, 8) than myocardial infarction (ratio, 0.63) or stroke (ratio, 0.53). Both patients and trialists considered revascularization (ratio, 0.48 and 0.20, respectively) and hospitalization (ratio, 0.28 and 0.13, respectively) as substantially less severe than death. Differences between patient and trialist end point weights persisted after adjustment for demographic and clinical characteristics (P<0.001 for all comparisons).
conclusionsPatients and clinical trialists did not weigh individual components of a composite end point equally. Whereas trialists are most concerned about avoiding death, patients place equal or greater importance on reducing myocardial infarction or stroke. Both groups considered revascularization and hospitalization as substantially less severe. These findings suggest that equal weights in a composite clinical end point do not accurately reflect the preferences of either patients or trialists.
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