Speaking the Language of Inclusion: Examining English Languages Requirements in Cardiovascular Digital Health Trials

Area of Science:

• Cardiovascular Medicine
• Digital Health
• Clinical Trials

Background:

• Digital health technologies are increasingly used to decentralize cardiovascular care.
• Clinical trials for these technologies are often English-only, potentially widening health disparities.
• This study examines language criteria in digital cardiovascular health trials.

Purpose of the Study:

• To evaluate language-related inclusion and exclusion criteria in digital health trials for cardiovascular medicine.
• To determine the extent to which non-English language fluency impacts participation in these trials.

Main Methods:

• Identified digital health trials related to cardiovascular medicine on ClinicalTrials.gov.
• Utilized natural language processing to analyze inclusion and exclusion criteria for 1192 trials.
• Focused on trials conducted in the US involving adults and testing an intervention.

Main Results:

• 611 out of 1192 (51.3%) digital cardiovascular health trials excluded non-English language fluent participants.
• 39.4% listed English fluency as an inclusion criterion, and 16.4% explicitly excluded non-English speakers.
• Manual review of 50 trials corroborated these findings, with 46% requiring English fluency.

Conclusions:

• A significant portion of digital cardiovascular health trials exclude non-English language fluent individuals.
• This exclusion limits the generalizability of trial findings.
• Ensuring broader language accessibility is crucial for equitable decentralized cardiovascular care.