Disabilities Reporting in Cardiac Clinical Trials: How Are We Doing?

• Type of Material: Article
• Authors: Roy H. Lan, Stanford University; Eli N. Rice, Stanford University; Julio C. Nunes, Yale University; Rushil Shah, Stanford University; Joseph-Kevin Igwe, Stanford University; Kira Clark, Stanford University; Vyjeyanthi S. Periyakoil, Stanford University; Jonathan H. Chen, Stanford University; Bryant Lin, Stanford University; Christopher Awad, Emory University; Muhammed Idris, Morehouse School of Medicine; Erin Rose Cruz, Stanford University; Eldrin F. Lewis, Stanford University; Cati Brown Johnson, Stanford University; Paul J. Wang, Stanford University
• Language: English
• Date: 2023-11-10
• Publisher: Wiley
• Publication Version: Final Published Version
• Copyright Statement: © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): https://doi.org/10.1161/JAHA.123.029726
• Title of Journal or Parent Work: Journal of the American Heart Association
• Volume: 12
• Issue: 22
• Start Page: e029726
• Grant/Funding Information: This work was supported by an award from the American Heart Association.
• Keywords: disability reporting; peer‐reviewed articles; Cardiovascular disease
• Research Categories: Health Sciences, General; Health Sciences, Public Health

Abstract

Cardiovascular disease is associated with significant morbidity and mortality, ultimately leading to both transitory as well as permanent disability. According to the Centers for Disease Control and Prevention, a disability is any condition of the body or mind (impairment) that makes it more difficult for the person with the condition to do certain activities (activity limitation) and interact with the world around them (participation restrictions). 1 The GBD (Global Burden of Disease) 2019 study reported that ischemic heart disease was the second‐leading cause of disability‐adjusted life‐years in the world. 2 , 3 Additionally, ischemic heart disease was the leading cause of disability‐adjusted life‐years for people aged ≥50 years across the world and accounted for 11.8% of disability‐adjusted life‐years in people aged 50 to 74 years and 16.2% in patients aged ≥75 years. Patients with disabilities comprise a significant and vulnerable proportion of the population; however, the extent of their participation in clinical trials has not often been studied and is not commonly disclosed or reported. We aimed to characterize the reporting of disabilities within cardiac randomized clinical trials (RCTs) within the United States. The data that support the findings of this study are available from the corresponding author upon reasonable request. We searched ClinicalTrials.gov for the 20 most recently completed interventional studies with completed results and associated peer‐reviewed articles, with enrollment limited to the United States, in which coronary artery disease, hypertension, atrial fibrillation, and diabetes were the main conditions studied. This yielded 80 RCTs, encompassing a total of 452 149 participants. We manually reviewed each RCT's published article as well as publicly available study protocols to determine the frequency of disability reporting by exclusion criteria as well as reported baseline patient characteristics. We summarize this baseline and exclusion criteria across the 6 Centers for Disease Control and Prevention defined disability categories (Cognitive/Psychiatric, Hearing, Vision, Mobility, Independent Living, and Self‐Care). 1 This analysis of publicly available data was exempted from institutional review board approval.