School of Public Health,University of
School of Public Health,University of Adelaide.
Int J Technol Assess Health Care. 2018 Jan;34(5):464-475. doi: 10.1017/S026646231800051X. Epub 2018 Sep 11.
To identify and appraise existing evaluation frameworks for mobile medical applications (MMA) and determine their suitability for use in health technology assessment (HTA) of these technologies.
Systematic searches were conducted of seven bibliographic databases to identify literature published between 2008 and 2016 on MMA evaluation frameworks. Frameworks were eligible if they were used to evaluate at least one of the HTA domains of effectiveness, safety, and/or cost and cost-effectiveness of an MMA. After inclusion, the frameworks were reviewed to determine the number and extent to which other elements of an HTA were addressed by the framework.
A total of forty-five frameworks were identified that assessed MMAs. All frameworks assessed whether the app was effective. Of the thirty-four frameworks that examined safety, only seven overtly evaluated potential harms from the MMA (e.g., the impact of inaccurate information). Only one framework explicitly considered a comparator. Technology specific domains were sporadically addressed.
None of the evaluation frameworks could be used, unaltered, to guide the HTA of MMAs. To use these frameworks in HTA they would need to identify relevant comparators, improve assessments of harms and consider the ongoing effect of software updates on the safety and effectiveness of MMAs. Attention should also be paid to ethical issues, such as data privacy, and technology specific characteristics.
Existing MMA evaluation frameworks are not suitable for use in HTA. Further research is needed before an MMA evaluation framework can be developed that will adequately inform policy makers.
识别和评估现有的移动医疗应用程序（MMA）评估框架，并确定其在这些技术的健康技术评估（HTA）中的适用性。
系统地检索了七个文献数据库，以确定 2008 年至 2016 年间发表的关于 MMA 评估框架的文献。如果框架用于评估 MMA 的有效性、安全性和/或成本和成本效益的 HTA 领域中的至少一个，则该框架符合条件。纳入后，审查框架以确定框架解决 HTA 其他要素的数量和程度。
共确定了 45 个评估 MMA 的框架。所有框架都评估了应用程序是否有效。在检查安全性的三十四个框架中，只有七个框架明确评估了 MMA 可能带来的潜在危害（例如，不准确信息的影响）。只有一个框架明确考虑了比较器。技术特定领域零星涉及。
没有一个评估框架可以未经修改就用于指导 MMA 的 HTA。要在 HTA 中使用这些框架，他们需要确定相关的比较器，改进对危害的评估，并考虑软件更新对 MMA 的安全性和有效性的持续影响。还应注意数据隐私等伦理问题，以及技术特定特征。
现有的 MMA 评估框架不适合用于 HTA。在开发能够为决策者提供充分信息的 MMA 评估框架之前，需要进行进一步的研究。
