Composite endpoints can encode multiple pieces of information and are increasingly adopted in clinical trials. Advocacy for using composite endpoints began decades ago in cardiovascular trials, leading to incorporation of patient-oriented outcomes and consideration of a hierarchical ranking system. The use of composite endpoints in coronavirus disease (COVID-19) trials has evolved similarly. We conducted a literature review to investigate the use of composite endpoints in acute heart failure and COVID-19 clinical trials. The results showed more frequent use of patient-oriented outcomes and ordinal composite endpoints in COVID-19 trials, which might be driven by global consensus on a set of common outcome measures.
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http://dx.doi.org/10.1017/cts.2024.492 | DOI Listing |
J Med Internet Res
January 2025
Department of Nephrology, Hunan Key Laboratory of Kidney Disease and Blood Purification, The Second Xiangya Hospital of Central South University, Changsha, China.
Background: Acute kidney injury (AKI) is a common complication in hospitalized older patients, associated with increased morbidity, mortality, and health care costs. Major adverse kidney events within 30 days (MAKE30), a composite of death, new renal replacement therapy, or persistent renal dysfunction, has been recommended as a patient-centered endpoint for clinical trials involving AKI.
Objective: This study aimed to develop and validate a machine learning-based model to predict MAKE30 in hospitalized older patients with AKI.
Background: Changes in the structure and use of language are well established clinical characteristics of Alzheimer's disease. In recent years, there has been a concerted effort to objectively quantify these changes using the latest advances in Natural Language Processing (NLP) tools. Much academic research has been conducted to evaluate how these speech characteristics change with the course of illness, but they have yet to be elevated beyond exploratory endpoints in trials.
View Article and Find Full Text PDFAlzheimers Dement
December 2024
Centre for Healthy Ageing, Murdoch University, Murdoch, Perth, Western Australia, Australia.
Background: In cognitively unimpaired (CU) individuals, the PACC is widely used as a cognitive outcome measure and endpoint in observational studies and clinical trials. However, it has drawn criticism for being heavily weighted towards memory. Increasing evidence indicates a decline spanning multiple cognitive domains in CU individuals.
View Article and Find Full Text PDFEur Heart J Acute Cardiovasc Care
January 2025
Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, South Korea.
Background: The long-term effects of early left ventricular unloading after venoarterial extracorporeal membrane oxygenation (VA-ECMO) remain unclear.
Methods: The EARLY-UNLOAD trial was a single-center, investigator-initiated, open-label, randomized clinical trial involving 116 patients with cardiogenic shock (CS) undergoing VA-ECMO. The patients were randomly assigned to undergo either early routine left ventricular unloading by transseptal left atrial cannulation within 12 hours after randomization or the conventional approach, which permitted rescue transseptal cannulation in case of an increased left ventricular afterload.
Clin Trials
January 2025
Department of Biostatistics, Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Background: In randomized clinical trials, multiple-testing procedures, composite endpoints, and prioritized outcome approaches are increasingly used to analyze multiple binary outcomes. Previous studies have shown that correlations between outcomes influence their sample size requirements. Although sample size is an important factor affecting the choice of statistical methods, the power and required sample sizes of methods for analyzing multiple binary outcomes have yet to be compared under the influence of outcome correlations.
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