Wang Qianying, Huo Xiqian, Cui Jianlan, Li Jie, Bai Xueke, Wu Chaoqun, Zhang Qian, Sun Dianjianyi, Zhao Jie
National Science Library, Chinese Academy of Sciences, Beijing, PR China.
National Clinical Research Center for Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, PR China.
NPJ Digit Med. 2025 May 2;8(1):238. doi: 10.1038/s41746-025-01637-8.
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.
患者报告结局（PROs）在心血管疾病（CVDs）数字健康（DH）试验中的整合情况仍不明确。我们在ClinicalTrials.gov上搜索了2004年至2024年期间测试DH干预措施对CVDs影响的随机试验。搜索共识别出8037项试验，其中673项符合条件的试验纳入分析。在这些试验中，321项（48%）纳入了PROs。DH试验的数量和PROs的使用呈显著上升趋势。基于电话的干预措施占主导（38%），主要针对高血压（38%）和心力衰竭（27%）。行为干预措施中PROs的使用率较高（1.24 [1.04 - 1.48]），而诊断或筛查目的的试验（0.39 [0.20 - 0.77]）使用PROs的频率较低。只有15%的试验在ClinicalTrials.gov上报告了结果，而58%的试验在完成后发表于PubMed。尽管DH试验有所扩展，但PROs的整合仍然不足，尤其是在临床和患者观点对治疗决策至关重要的试验中。及时传播结果对于提高透明度至关重要。
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