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

Figures

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  Fig. 1. Trial selection. The flowchart illustrates the process of identifying and screening studies, from ClinicalTrials.gov searches to the final selection of studies meeting the eligibility criteria. DH digital health, PRO patient-reported outcome.

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  Fig. 2. Yearly use of PROs and different digital health techniques in trials of digital health in cardiovascular diseases. a Bar charts for number of DH trials in CVDs using versus not using PROs as outcomes per year. The digits on the bar chart represent the percentage of trials including PROs as outcomes among all trials per year. The lower number of trials in 2024 than in 2023 is due to the search strategy being limited to 31 August, 2024. b Stacked area chart for number of trials using different DH techniques. Among the DH techniques investigated, the most commonly used were mobile app and telehealth. PROs patient-reported outcomes, DH digital health, CVDs cardiovascular diseases.

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  Fig. 3. Use of PROs in digital health trials per subcategory of cardiovascular diseases. The bar chart displays the number of DH trials using versus not using PROs as outcomes per subcategory of CVDs. The five most common subcategories of diseases were hypertension, heart failure, coronary artery disease, arrhythmias and valvular heart disease. PRO patient-reported outcome, DH digital health, CVD cardiovascular disease.

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  Fig. 4. Kaplan–Meier curves showing days to results or manuscripts submission from primary completion date for trials. a Kaplan–Meier curves for days to results or manuscripts submission by use of PROs. b Kaplan–Meier curves for days to results or manuscripts submission by type of sponsors, including federal or other governments, industry, NIH and other sponsors. PROs patient-reported outcomes.