The Institute for Digital Medicine WisDM, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
The N.1 Institute for Health, National University of Singapore, Singapore, Singapore.
J Med Internet Res. 2023 Aug 1;25:e47094. doi: 10.2196/47094.
Digital therapeutics (DTx), a class of software-based clinical interventions, are promising new technologies that can potentially prevent, manage, or treat a spectrum of medical disorders and diseases as well as deliver unprecedented portability for patients and scalability for health care providers. Their adoption and implementation were accelerated by the need for remote care during the COVID-19 pandemic, and awareness about their utility has rapidly grown among providers, payers, and regulators. Despite this, relatively little is known about the capacity of DTx to provide economic value in care.
This study aimed to systematically review and summarize the published evidence regarding the cost-effectiveness of clinical-grade mobile app-based DTx and explore the factors affecting such evaluations.
A systematic review of economic evaluations of clinical-grade mobile app-based DTx was conducted following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Major electronic databases, including PubMed, Cochrane Library, and Web of Science, were searched for eligible studies published from inception to October 28, 2022. Two independent reviewers evaluated the eligibility of all the retrieved articles for inclusion in the review. Methodological quality and risk of bias were assessed for each included study.
A total of 18 studies were included in this review. Of the 18 studies, 7 (39%) were nonrandomized study-based economic evaluations, 6 (33%) were model-based evaluations, and 5 (28%) were randomized clinical trial-based evaluations. The DTx intervention subject to assessment was found to be cost-effective in 12 (67%) studies, cost saving in 5 (28%) studies, and cost-effective in 1 (6%) study in only 1 of the 3 countries where it was being deployed in the final study. Qualitative deficiencies in methodology and substantial potential for bias, including risks of performance bias and selection bias in participant recruitment, were identified in several included studies.
This systematic review supports the thesis that DTx interventions offer potential economic benefits. However, DTx economic analyses conducted to date exhibit important methodological shortcomings that must be addressed in future evaluations to reduce the uncertainty surrounding the widespread adoption of DTx interventions.
PROSPERO International Prospective Register of Systematic Reviews CRD42022358616; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022358616.
数字疗法（DTx）是一类基于软件的临床干预措施，是很有前途的新技术，有可能预防、管理或治疗一系列医学疾病和病症，并为患者提供前所未有的便携性和医疗服务提供者的可扩展性。在 COVID-19 大流行期间需要远程护理的推动下，以及提供者、支付者和监管者对其效用的认识迅速提高，它们的采用和实施得到了加速。尽管如此，关于 DTx 在护理方面提供经济价值的能力，人们知之甚少。
本研究旨在系统地回顾和总结已发表的关于临床级移动应用程序 DTx 的成本效益的证据，并探讨影响这些评估的因素。
根据 PRISMA（系统评价和荟萃分析的首选报告项目）2020 指南，对临床级移动应用程序 DTx 的经济评估进行了系统回顾。主要电子数据库，包括 PubMed、Cochrane 图书馆和 Web of Science，对从成立到 2022 年 10 月 28 日发表的合格研究进行了搜索。两名独立的审查员评估了所有检索到的文章纳入审查的资格。对每个纳入研究的方法学质量和偏倚风险进行了评估。
本综述共纳入 18 项研究。在 18 项研究中，7 项（39%）是非随机研究为基础的经济评估，6 项（33%）是基于模型的评估，5 项（28%）是基于随机临床试验的评估。在仅有的 3 个正在部署该 DTx 干预措施的国家中，只有 1 个国家发现该 DTx 干预措施具有成本效益，12 个（67%）研究发现具有成本效益，5 个（28%）研究发现具有成本节约，1 个（6%）研究发现具有成本效益。在几个纳入的研究中，定性方法存在缺陷，存在很大的偏差风险，包括参与者招募中的表现偏差和选择偏差风险。
本系统评价支持 DTx 干预措施具有潜在经济效益的论点。然而，迄今为止进行的 DTx 经济分析存在重要的方法学缺陷，在未来的评估中必须加以解决，以减少广泛采用 DTx 干预措施的不确定性。
PROSPERO 国际前瞻性系统评价注册中心 CRD42022358616；https://www.crd.york.ac.uk/prospero/display_record.php？ID=CRD42022358616。
