A landscape analysis of access, equity, and reporting trends in digital health randomized controlled trials

The merger of technology and healthcare has given rise to a new era of evidence-based medicine. As global regulatory efforts in digital health expand, important questions emerge about who participates in clinical trial evaluations and how findings about digital interventions are documented. To more comprehensively understand equity and access considerations, we conducted a large language model-assisted landscape review to assess technology and study population reporting across 5452 digital health technology-enabled randomized controlled trial outcomes. Between 2010 to January 2024, we observed the compound annual growth rate of digital health trials was over 17%, demonstrating explosive growth as compared to the 9% growth rate across all RCTs with results available on ClinicalTrials.gov during the same timeframe. Digital interventions were consistently described, but reporting of participant characteristics varied. Technology-related eligibility criteria appeared in half of trials, most commonly requiring internet or device access. Age and sex or gender were reported in 98% and 87% of trials, respectively, while other identity characteristics such as race or ethnicity (29%) were less frequently documented. Our findings support a need for amplified global collaboration and consensus building around common data elements toward increasingly equitable and accessible digital health.