Systematic evaluation of patient-reported outcomes in clinical trials of digital health in cardiovascular diseases

The integration of patient-reported outcomes (PROs) in digital health (DH) trials for cardiovascular diseases (CVDs) remains unknown. We searched ClinicalTrials.gov for randomized trials that tested DH interventions in CVDs from 2004 to 2024. The search identified 8037 trials, with 673 eligible trials included in the analysis. Among these, 321 trials (48%) incorporated PROs. The number of DH trials and the use of PROs have shown a significant upward trend. Phone-based interventions predominated (38%), mostly targeting hypertension (38%) and heart failure (27%). Behavioral interventions showed higher prevalence of PROs' usage (1.24 [1.04-1.48]), while trials for diagnostic or screening purpose (0.39 [0.20-0.77]) utilized PROs less frequently. Only 15% of trials reported results on ClinicalTrials.gov, while 58% were published in PubMed after completion. Despite DH trial expansion, PRO integration remains insufficient, especially in trials where clinical and patient perspectives are important in informing treatment decisions. Timely results dissemination is critical to improving transparency.