Data on Disabilities are Underreported in Heart Disease Clinical Trials

By Rebecca Araujo - March 10, 2023

Clinical trials of patients with heart disease underreported participant disabilities and frequently used disabilities as exclusionary criteria, according to a study presented at the American College of Cardiology’s Annual Scientific Session Together With the World Congress of Cardiology.

Reporting in Cardiovascular Clinical Trials

The study, led by Roy Lan, MD, evaluated reporting and inclusion of people with disabilities in 80 cardiovascular clinical trials. The team included the 20 most recently published clinical trials across 4 areas of study: atrial fibrillation, coronary artery disease, hypertension, and diabetes. Trials included in the study had fully published data available and were conducted between 2014 and 2022. Researchers utilized published data and records from to identify trends in the reporting of participant disabilities as well as trial exclusion criteria.

Of the 80 trials assessed, 6 reported data on disabilities in participant baseline characteristics. Thirty-eight percent of trials listed at least 1 disability among their exclusion criteria. This trend was seen in 55% of hypertension trials and 15% of diabetes trials.

Disabilities as Exclusion Criteria

The US Centers for Disease Control and Prevention (CDC) defines 6 categories of disability: hearing, vision, cognition, mobility, self-care, and independent living. Despite this, the researchers found that many trials established individual definitions of disability, which could reduce the ability to compare results across studies.

Among the studies that listed a disability in their exclusion criteria, conditions due to cognition or psychiatric issues, such as Alzheimer’s disease or dementia, were the most common exclusions. One-third of trials cited cognition/psychiatric issues as exclusionary. In addition, disabilities related to mobility, vision, independent living, self-care, or healing were cited as exclusionary criteria in 3-8% of clinical trials.

“We were surprised that there was this lack of reporting for disabilities, simply because doing so is CDC guideline recommended, and it would be a valuable data point for clinicians,” Dr. Lan said about these findings. “I hope our study can jump-start an effort to increase reporting of disabilities, both in baseline patient demographics and also outcomes.”

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