ArticleThe Annals of thoracic surgery2012
Weighting composite endpoints in clinical trials: essential evidence for the heart team.
Article in The Annals of thoracic surgery, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 5 of them syntheses that pooled it.
What it found
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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.
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, 5 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Stent versus Coronary Artery Bypass Surgery in Multi-Vessel and Left Main Coronary Artery Disease: A Meta-Analysis of Randomized Trials with Subgroups Evaluation.Arquivos brasileiros de cardiologia · 2019Pooled it
- Achieving the composite endpoint of glycated haemoglobin <7.0%, no weight gain and no hypoglycaemia in the once-weekly dulaglutide AWARD programme.Diabetes, obesity & metabolism · 2016 · on this mapPooled it
- Outcome Reporting in Cardiac Surgery Trials: Systematic Review and Critical Appraisal.Journal of the American Heart Association · 2015Pooled it
- Discrete choice experiments in health economics: a review of the literature.PharmacoEconomics · 2014Pooled it
- Risk as an attribute in discrete choice experiments: a systematic review of the literature.The patient · 2014Pooled it
- Responsiveness of Single versus Composite Measures of Pain in Knee Osteoarthritis.The Journal of rheumatology · 2018Trial
- The Application of Preference Elicitation Methods in Clinical Trial Design to Quantify Trade-Offs: A Scoping Review.The patient · 2022Article
- Percutaneous Coronary Intervention with Stenting versus Coronary Artery Bypass Grafting in Stable Coronary Artery Disease.The International journal of angiology : official publication of the International College of Angiology, Inc · 2021Review
- A patient-centered composite endpoint weighting technique for orthopaedic trauma research.BMC medical research methodology · 2019Article
- Article
- General Population vs. Patient Preferences in Anticoagulant Therapy: A Discrete Choice Experiment.The patient · 2019Article
- Are component endpoints equal? A preference study into the practice of composite endpoints in clinical trials.Health expectations : an international journal of public participation in health care and health policy · 2018Observational
- Rationale and design of study of dapagliflozin versus sitagliptin treatment efficacy on prevention of cardiovascular risk factors in type 2 diabetes patients: the DIVERSITY-CVR study.Cardiovascular diabetology · 2018Article
- Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges.Journal of veterinary internal medicine · 2017Article
- Weighted analysis of composite endpoints with simultaneous inference for flexible weight constraints.Statistics in medicine · 2017Article
- Patient Preferences in Treatment Choices for Early-Stage Lung Cancer.The Annals of thoracic surgery · 2016Article
- Statistical Approaches to Composite Endpoints.JACC. Cardiovascular interventions · 2016Article
- Rethinking composite end points in clinical trials: insights from patients and trialists.Circulation · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundCoronary revascularization trials often use a composite endpoint of major adverse cardiac and cerebrovascular events (MACCE). The usual practice in analyzing data with a composite endpoint is to assign equal weights to each of the individual MACCE elements. Noninferiority margins are used to offset effects of presumably less important components, but their magnitudes are subject to bias. This study describes the relative importance of MACCE elements from a patient perspective.
methodsA discrete choice experiment was conducted. Survey respondents were presented with a scenario that would make them eligible for the Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery (SYNTAX) trial three-vessel disease cohort. Respondents chose among pairs of procedures that differed on the 3-year probability of MACCE, potential for increased longevity, and procedure/recovery time. Conjoint analysis derived relative weights for these attributes.
resultsIn all, 224 respondents completed the survey. The attributes did not have equal weight. Risk of death was most important (relative weight 0.23), followed by stroke (0.18), potential increased longevity and recovery time (each 0.17), myocardial infarction (0.14), and risk of repeat revascularization (0.11). Applying these weights to the SYNTAX 3-year endpoints resulted in a persistent, but decreased margin of difference in MACCE favoring coronary artery bypass graft surgery compared to percutaneous coronary intervention. When labeled only as "procedure A" and "procedure B," 87% of respondents chose coronary artery bypass graft surgery over percutaneous coronary intervention. When procedures were labeled as "coronary stent" and "coronary bypass surgery," only 73% chose coronary artery bypass graft surgery. Procedural preference varied with demographics, sex, and familiarity with the procedures.
conclusionsThe MACCE elements do not carry equal weight in a composite endpoint, from a patient perspective. Using a weighted composite endpoint increases the validity of statistical analyses and trial conclusions. Patients are subject to bias by labels when considering coronary revascularization.
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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.