ArticlemedRxiv : the preprint server for health sciences2025
Speaking the Language of Inclusion: Examining English Languages Requirements in Cardiovascular Digital Health Trials.
Article in medRxiv : the preprint server for health sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The trial behind it
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Authors and funding
6 authors.
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Abstract
Background: Cardiovascular medicine is rapidly evolving, as it integrates digital technologies intended to decentralize care from the clinic and/or hospital setting into patient's homes and communities. However, clinical trials of digital technologies are frequently written and communicated solely in English, potentially exacerbating existing racial and ethnic differences in cardiovascular-related health outcomes. In this work, we evaluated the language-related inclusion and exclusion criteria of digital health trials related to cardiovascular medicine registered on ClinicalTrials.gov . Methods: Planned, ongoing, and completed digital health trials were identified using the ClinicalTrials.gov website interface using terms related to digital health (see https://cardio-lang-inclusion.streamlit.app/ for detailed methods and data visualization). Only digital trials testing an intervention, conducted within the United States, and studying adults were included in analyses. The identified digital health trials were further subset to select for those related to cardiovascular medicine (i.e., prevention, weight loss and cardiometabolic disease, coronary disease, vascular disease, and arrhythmias). Natural language processing was leveraged to process the 1192 digital health trials' inclusion and exclusion criteria. Results: There were a total of 1192 digital health trials related to cardiovascular medicine were identified. Over a third (470 (39.4%)) listed English language fluency as an inclusion criteria, while 196 (16.4%) excluded non-English language fluent participants. In total, 611 (51.3%) of the analyzed digital trials in cardiovascular medicine excluded participation of non-English language fluent patients (see Conclusions: We found that there was frequent exclusion of non-English language fluent patients from digital health trials in cardiovascular medicine. This may limit the generalizability of digital health trials, which is critical as we transition to decentralized clinical practice using computers and smartphones and require an accompanying rigorous evidence base.
Identifiers
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Registered trials
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.