Abstract：
Mobile Health Interventions (MHIs) have addressed a range of healthcare challenges and have been evaluated using Randomized Controlled Trials (RCTs) to establish clinical effectiveness. Using PRISMA we conducted a systematic literature review of RCTs for MHIs and identified 70 studies which were analyzed and classified using Nickerson-Varshney-Muntermann (NVM) taxonomy. From the resultant iterations of the taxonomy, we extracted insights from the categorized studies. RCTs cover a wide range of health conditions including chronic diseases, general wellness, unhealthy practices, family planning, end-of-life, and post-transplant care. The MHIs that were utilized by the RCTs were varied as well, although most studies did not find significant differences between MHIs and usual care. The challenges for MHI-based RCTs include the use of technologies, delayed outcomes, patient recruitment, patient retention, and complex regulatory requirements. These variances can lead to a higher rate of Type I/Type II errors. Further considerations are the impact of infrastructure, contextual and cultural factors, and reductions in the technological relevancy of the intervention itself. Finally, due to the delayed effect of most outcomes, RCTs of insufficient duration are unable to measure significant, lasting improvements. Using the insights from seventy identified studies, we developed a classification of existing RCTs along with guidelines for MHI-based RCTs and a research framework for future RCTs. The framework offers opportunities for (a) personalization of MHIs, (b) use of richer technologies, and (c) emerging areas for RCTs.
摘要：
移动健康干预（MHI）已经解决了一系列医疗保健挑战，并已使用随机对照试验（RCT）进行了评估，以确定临床有效性。使用PRISMA，我们对MHI的RCT进行了系统的文献综述，并确定了70项研究，这些研究使用Nickerson-Varshney-Muntermann（NVM）分类法进行了分析和分类。从分类的结果迭代中，我们从分类研究中提取了见解。RCT涵盖广泛的健康状况，包括慢性病，一般健康，不健康的做法，计划生育,生命的终结,和移植后的护理。RCT使用的MHI也各不相同，尽管大多数研究没有发现MHIs和常规治疗之间的显著差异。基于MHI的RCT的挑战包括技术的使用，延迟结果，患者招募,保留患者,和复杂的监管要求。这些差异可能导致更高的I型/II型错误率。进一步的考虑因素是基础设施的影响，背景和文化因素，以及干预本身的技术相关性降低。最后,由于大多数结果的延迟效应，持续时间不足的随机对照试验无法衡量显著，持久的改进。利用70项已确定研究的见解，我们制定了现有RCT的分类以及基于MHI的RCT的指南和未来RCT的研究框架.该框架为(A)MHIs的个性化提供了机会，(b)使用更丰富的技术，和(c)RCTs的新兴领域。
