Organisation for the Review of Care and Health Apps, Daresbury, United Kingdom.
Centre for Health Technology, University of Plymouth, Plymouth, United Kingdom.
JMIR Mhealth Uhealth. 2023 Nov 22;11:e46937. doi: 10.2196/46937.
User involvement is increasingly acknowledged as a central part of health care innovation. However, meaningful user involvement during the development and testing of mobile health apps is often not fully realized.
This study aims to examine in which areas user input is most prevalent and whether there is an association between user inclusion and compliance with best practices for mobile health apps.
A secondary analysis was conducted on an assessment data set of 1595 health apps. The data set contained information on whether the apps had been developed or tested with user input and whether they followed best practices across several domains. Background information was also available regarding the apps' country of origin, targeted condition areas, subjective user ratings, download numbers, and risk (as per the National Institute for Health and Care Excellence Evidence Standards Framework [ESF]). Descriptive statistics, Mann-Whitney U tests, and Pearson chi-square analyses were applied to the data.
User involvement was reported by 8.71% (139/1595) of apps for only the development phase, by 33.67% (537/1595) of apps for only the testing phase, by 21.88% (349/1595) of apps for both phases, and by 35.74% (570/1595) of apps for neither phase. The highest percentage of health apps with reported user input during development was observed in Denmark (19/24, 79%); in the condition areas of diabetes (38/79, 48%), cardiology (15/32, 47%), pain management (20/43, 47%), and oncology (25/54, 46%); and for high app risk (ESF tier 3a; 105/263, 39.9%). The highest percentage of health apps with reported user input during testing was observed in Belgium (10/11, 91%), Sweden (29/34, 85%), and France (13/16, 81%); in the condition areas of neurodiversity (42/52, 81%), respiratory health (58/76, 76%), cardiology (23/32, 72%), and diabetes (56/79, 71%); and for high app risk (ESF tier 3a; 176/263, 66.9%). Notably, apps that reported seeking user input during testing demonstrated significantly more downloads than those that did not (P=.008), and user inclusion was associated with better compliance with best practices in clinical assurance, data privacy, risk management, and user experience.
The countries and condition areas in which the highest percentage of health apps with user involvement were observed tended to be those with higher digital maturity in health care and more funding availability, respectively. This suggests that there may be a trade-off between developers' willingness or ability to involve users and the need to meet challenges arising from infrastructure limitations and financial constraints. Moreover, the finding of a positive association between user inclusion and compliance with best practices indicates that, where no other guidance is available, users may benefit from prioritizing health apps developed with user input as the latter may be a proxy for broader app quality.
用户参与越来越被认为是医疗保健创新的核心部分。然而，在移动健康应用的开发和测试过程中，真正有意义的用户参与往往并未完全实现。
本研究旨在探讨用户投入在哪些领域最为普遍，以及用户纳入是否与移动健康应用的最佳实践合规性相关联。
对 1595 个健康应用的评估数据集进行了二次分析。该数据集包含了有关应用程序是否已开发或测试过用户输入以及它们在多个领域是否遵循最佳实践的信息。还提供了应用程序的背景信息，包括其原产国、目标病症领域、主观用户评分、下载量和风险（根据国家卫生与临床优化研究所的证据标准框架[ESF]）。应用描述性统计、Mann-Whitney U 检验和 Pearson 卡方分析对数据进行了分析。
报告在开发阶段仅涉及用户参与的应用程序占 8.71%（139/1595），在测试阶段仅涉及用户参与的应用程序占 33.67%（537/1595），在两个阶段都涉及用户参与的应用程序占 21.88%（349/1595），在两个阶段都不涉及用户参与的应用程序占 35.74%（570/1595）。在开发阶段报告有用户投入的健康应用程序中，丹麦（19/24，79%）的比例最高；在糖尿病（38/79，48%）、心脏病学（15/32，47%）、疼痛管理（20/43，47%）和肿瘤学（25/54，46%）等病症领域；以及高风险应用程序（ESF 第 3a 层；105/263，39.9%）。在测试阶段报告有用户投入的健康应用程序中，比利时（10/11，91%）、瑞典（29/34，85%）和法国（13/16，81%）的比例最高；在神经多样性（42/52，81%）、呼吸健康（58/76，76%）、心脏病学（23/32，72%）和糖尿病（56/79，71%）等病症领域；以及高风险应用程序（ESF 第 3a 层；176/263，66.9%）。值得注意的是，报告在测试阶段寻求用户投入的应用程序的下载量明显高于未报告的应用程序（P=.008），用户纳入与临床保证、数据隐私、风险管理和用户体验方面的最佳实践合规性之间存在显著关联。
观察到用户参与度最高的健康应用程序所在的国家和病症领域往往是医疗保健数字化程度较高和资金可用性较高的国家和领域。这表明，在基础设施限制和财务约束的挑战面前，开发者愿意或有能力让用户参与和满足这些挑战之间可能存在权衡。此外，用户纳入与最佳实践合规性之间存在正相关的发现表明，在没有其他指导的情况下，用户可能会受益于优先考虑具有用户投入的健康应用程序，因为后者可能是更广泛的应用程序质量的代表。
