Background: Mobile health (mHealth) apps offer a scalable option for treating sleep disturbances at a population level. However, there is a lack of clarity about the development and evaluation of evidence-based mHealth apps. Objective: The aim of this systematic review was to provide evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. Methods: A systematic search of studies published from the inception of databases through February 2020 was conducted using 5 databases (MEDLINE, Embase, Cochrane Library, PsycINFO, and CINAHL). Results: A total of 6015 papers were identified using the search strategy. After screening, 15 papers were identified that examined the design engineering and clinical implementation and evaluation of 8 different mHealth apps for sleep disturbance. Most of these apps delivered cognitive behavioral therapy for insomnia (CBT-I, n=4) or modified CBT-I (n=2). Half of the apps (n=4) identified adopting user-centered design or multidisciplinary teams in their design approach. Only 3 papers described user and data privacy. End-user acceptability and engagement were the most frequently assessed implementation metrics. Only 1 app had available evidence assessing all 4 implementation metrics (ie, acceptability, engagement, usability, and adherence). Most apps were prototype versions (n=5), with few matured apps. A total of 6 apps had supporting papers that provided a quantitative evaluation of clinical outcomes, but only 1 app had a supporting, adequately powered randomized controlled trial. Conclusions: This is the first systematic review to synthesize and examine evidence for the design engineering and clinical implementation and evaluation of mHealth apps for sleep disturbance. The minimal number of apps with published evidence for design engineering and clinical implementation and evaluation contrasts starkly with the number of commercial sleep apps available. Moreover, there appears to be no standardization and consistency in the use of best practice design approaches and implementation assessments, along with very few rigorous efficacy evaluations. To facilitate the development of successful and evidence-based apps for sleep disturbance, we developed a high-level framework to guide researchers and app developers in the end-to-end process of app development and evaluation. Trial Registration:

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中文翻译：

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睡眠障碍移动医疗应用程序的设计工程、临床实施和评估框架：系统审查


背景：移动健康 (mHealth) 应用程序为治疗人群层面的睡眠障碍提供了可扩展的选项。然而，基于证据的移动医疗应用程序的开发和评估尚不明确。目的：本次系统评价的目的是为睡眠障碍 mHealth 应用程序的设计工程、临床实施和评估提供证据。方法：使用 5 个数据库（MEDLINE、Embase、Cochrane Library、PsycINFO 和 CINAHL）对从数据库建立到 2020 年 2 月期间发表的研究进行系统检索。结果：使用检索策略共识别出 6015 篇论文。经过筛选，确定了 15 篇论文，研究了 8 种不同的睡眠障碍 mHealth 应用程序的设计工程、临床实施和评估。这些应用程序中的大多数都提供针对失眠的认知行为疗法（CBT-I，n=4）或改良的CBT-I（n=2）。一半的应用程序 (n=4) 确定在其设计方法中采用以用户为中心的设计或多学科团队。只有 3 篇论文描述了用户和数据隐私。最终用户的可接受性和参与度是最常评估的实施指标。只有 1 个应用程序拥有评估所有 4 个实施指标（即可接受性、参与度、可用性和依从性）的可用证据。大多数应用程序都是原型版本（n=5），成熟的应用程序很少。共有 6 个应用程序具有提供临床结果定量评估的支持论文，但只有 1 个应用程序具有支持性、充分有力的随机对照试验。结论：这是首次系统评价，综合并检验了针对睡眠障碍的移动医疗应用程序的设计工程、临床实施和评估的证据。 已发布设计工程、临床实施和评估证据的应用程序数量极少，与可用的商业睡眠应用程序的数量形成鲜明对比。此外，最佳实践设计方法和实施评估的使用似乎没有标准化和一致性，而且严格的功效评估也很少。为了促进成功开发基于证据的睡眠障碍应用程序，我们开发了一个高级框架来指导研究人员和应用程序开发人员进行应用程序开发和评估的端到端过程。试用注册：


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