ArticleCirculation. Cardiovascular quality and outcomes2021
Comparison of Investigator-Reported and Clinical Event Committee-Adjudicated Outcome Events in GLASSY.
Article in Circulation. Cardiovascular quality and outcomes, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03231059 (GLOBAL LEADERS Adjudication Sub-Study), which is not on this map. Cited by 8 papers, 2 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.
GLOBAL LEADERS Adjudication Sub-Study
Who cites it
8 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- P2Y12 inhibitor monotherapy or dual antiplatelet therapy after coronary revascularisation: individual patient level meta-analysis of randomised controlled trials.BMJ (Clinical research ed.) · 2021Pooled it
- Comparison of Clinical Outcomes Between Ticagrelor and Clopidogrel in Acute Coronary Syndrome: A Comprehensive Meta-Analysis.Frontiers in cardiovascular medicine · 2021Pooled it
- Comparison of Investigator-Reported vs Centrally Adjudicated Major Adverse Cardiac Events: A Secondary Analysis of the COMPASS Trial.JAMA network open · 2022Trial
- Reducing risk of bias in interventional studies during their design and conduct: a scoping review.BMC medical research methodology · 2025Article
- Influence of the Triglyceride-Glucose Index on Adverse Cardiovascular and Cerebrovascular Events in Prediabetic Patients With Acute Coronary Syndrome.Frontiers in endocrinology · 2022Article
- Predictive Value of Plasma Big Endothelin-1 in Adverse Events of Patients With Coronary Artery Restenosis and Diabetes Mellitus: Beyond Traditional and Angiographic Risk Factors.Frontiers in cardiovascular medicine · 2022Article
- Aspirin-free antiplatelet regimens after PCI: insights from the GLOBAL LEADERS trial and beyond.European heart journal. Cardiovascular pharmacotherapy · 2021Article
- GLASS(Y) Half-Full: Moving Towards Greater Pragmatism in Outcome Ascertainment for Clinical Trials.Circulation. Cardiovascular quality and outcomes · 2021Article
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Authors and funding
32 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundEvent adjudication by a clinical event committee (CEC) provides a standardized, independent outcome assessment. However, the added value of CEC to investigators reporting remains debated. GLASSY (GLOBAL LEADERS Adjudication Sub-Study) implemented, in a subset of the open-label, investigator-reported (IR) GLOBAL LEADERS trial, an independent adjudication process of reported and unreported potential outcome events (triggers). We describe metrics of GLASSY feasibility and efficiency, diagnostic accuracy of IR events, and their concordance with corresponding CEC-adjudicated events.
methodsWe report the proportion of myocardial infarction, bleeding, stroke, and stent thrombosis triggers with sufficient evidence for assessment (feasibility) that were adjudicated as outcome events (efficiency), stratified by source (IR or non-IR). Using CEC-adjudicated events as criterion standard, we describe sensitivity, specificity, positive and negative predictive value, and global diagnostic accuracy of IR events. Using Gwet AC coefficient, we examine the concordance between IR- and corresponding CEC-adjudicated triggers. There was sufficient evidence for assessment for 2592 (98.3%) of 2636 triggers.
resultsOverall, the adjudicated end point-to-trigger ratio was high and similar between IR- (88%) and non-IR-reported (87%) triggers. The global diagnostic accuracy and concordance between IR-reported and CEC-adjudicated outcome events was 0.70 (95% CI, 0.65-0.74) and 0.54 (95% CI, 0.45-0.62), respectively, for myocardial infarction; 0.77 (95% CI, 0.75-0.79) and 0.71 (95% CI, 0.68-0.74) for bleeding; 0.70 (95% CI, 0.62-0.79) and 0.59 (95% CI, 0.43-0.74) for stroke; 0.59 (95% CI, 0.52-0.66) and 0.39 (95% CI, 0.25-0.53) for stent thrombosis. For IR bleedings, the concordance with the CEC on type of events was generally weak.
conclusionsImplementing CEC adjudication in a pragmatic open-label trial with IR events is feasible and efficient. Our findings of modest global diagnostic accuracy for IR events and generally weak concordance between investigators and CEC support the role for CEC adjudication in such settings. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03231059.
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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.