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

IF 12.4 1区医学 Q1 HEALTH CARE SCIENCES & SERVICES

NPJ Digital Medicine Pub Date : 2025-05-02 DOI:10.1038/s41746-025-01637-8

Qianying Wang, Xiqian Huo, Jianlan Cui, Jie Li, Xueke Bai, Chaoqun Wu, Qian Zhang, Dianjianyi Sun, Jie Zhao

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Abstract

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.

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心血管疾病数字健康临床试验中患者报告结果的系统评估

在心血管疾病（cvd）的数字健康（DH）试验中整合患者报告的结果（PROs）仍然未知。我们在ClinicalTrials.gov网站上检索了2004年至2024年间检测DH干预心血管疾病的随机试验。检索确定了8037项试验，其中673项符合条件的试验纳入了分析。其中321项（48%）纳入了PROs。DH试验的数量和PROs的使用都有明显的上升趋势。电话干预占主导地位（38%），主要针对高血压（38%）和心力衰竭（27%）。行为干预显示pro的使用率较高（1.24[1.04-1.48]），而用于诊断或筛查目的的试验（0.39[0.20-0.77]）使用pro的频率较低。只有15%的试验在ClinicalTrials.gov上报告结果，而58%的试验在完成后发表在PubMed上。尽管DH试验扩大，但PRO整合仍然不足，特别是在临床和患者观点对指导治疗决策很重要的试验中。及时公布结果对提高透明度至关重要。

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来源期刊

NPJ Digital Medicine Multiple-

CiteScore

25.10

自引率

3.30%

发文量

170

审稿时长

15 weeks

期刊介绍： npj Digital Medicine is an online open-access journal that focuses on publishing peer-reviewed research in the field of digital medicine. The journal covers various aspects of digital medicine, including the application and implementation of digital and mobile technologies in clinical settings, virtual healthcare, and the use of artificial intelligence and informatics. The primary goal of the journal is to support innovation and the advancement of healthcare through the integration of new digital and mobile technologies. When determining if a manuscript is suitable for publication, the journal considers four important criteria: novelty, clinical relevance, scientific rigor, and digital innovation.