Wang Ziming, Xia Xinxin, Lu Weijia, Ye Yuguo, Xu Jin
China Center for Health Development Studies, Peking University, Xueyuan Road, Beijing, 38, China.
Hainan Institute of Health Development Studies, Xueyuan Road, 3, Haikou, China.
NPJ Digit Med. 2025 Feb 4;8(1):83. doi: 10.1038/s41746-025-01477-6.
Digital therapeutics (DTx) are software-driven solutions for prevention, treatment, and management of medical conditions. Despite a pro-DTx momentum in China, global DTx trial assessments overlooked the country. We identified 756 DTx trials in China and analyzed their characteristics and quality parameters. Over 70% were funded by governments, hospitals, and universities, with tertiary hospitals in eastern China leading most trials. 44.8% used automated DTx, with 39.2% DTx-guided. Most trials focused on management (52.5%) and treatment (38.1%), with few on prevention (9.4%). Mental, behavioral, or neurodevelopmental disorders represented the leading condition category of focus. Recent declines in median sample size, median duration, and mean number of sites were noted. Only 18% of trials were at low overall risk of bias. While recognizing the rapid development of DTx trials in China, we call for better trial design and methodological rigor, prioritization of preventive and primary care, wider condition category scope, and higher inclusivity.
数字疗法（DTx）是用于医疗状况预防、治疗和管理的软件驱动解决方案。尽管中国对数字疗法有推动势头，但全球数字疗法试验评估忽略了该国。我们在中国识别出756项数字疗法试验，并分析了它们的特征和质量参数。超过70%由政府、医院和大学资助，中国东部的三级医院主导了大多数试验。44.8%使用自动化数字疗法，39.2%为数字疗法指导。大多数试验聚焦于管理（52.5%）和治疗（38.1%），很少涉及预防（9.4%）。精神、行为或神经发育障碍是主要的关注疾病类别。注意到近期中位样本量、中位持续时间和平均试验地点数量有所下降。只有18%的试验总体偏倚风险较低。在认识到中国数字疗法试验快速发展的同时，我们呼吁进行更好的试验设计和方法严谨性，优先考虑预防和初级保健，扩大疾病类别范围，提高包容性。
