哮喘移动健康研究——使用ResearchKit的大型临床观察性研究

2017/07/24

   使用移动健康软件来实施观察性临床研究的可行性需要严格的验证。在此,我们将报道完全通过智能手机远程操作的哮喘移动健康研究的初步结果,包括参与者招募、知情同意以及入组情况。我们实现了调查者和来自美国的7593名参与者之间的安全双向数据传输,其中包括许多重症哮喘患者。该平台能够在6个月的研究期间从用户亚组前瞻性地收集纵向多维数据(如调查、设备、定位和空气质量)。一致的趋势以及相关变量间的关联保证了通过这种方法得到的数据的质量。我们发现受热度、花粉以及野火影响的地区哮喘症状报告增加。这项技术的可能受到包括选择偏倚、低保留率、报道偏倚以及数据安全性的影响,解决这些问题需要充分开发移动平台在研究和患者护理方面的潜力。

 
(复旦大学附属中山医院呼吸科 李蕾摘译 杨冬审校)
(Nat Biotechnol. 2017 Apr;35(4):354-362. doi: 10.1038/nbt.3826.)
 
 
The Asthma Mobile Health Study, a large-scale clinical observational study using ResearchKit.
 
Chan YY, Wang P, Rogers L, et al.
 
 
The feasibility of using mobile health applications to conduct observational
clinical studies requires rigorous validation. Here, we report initial findings from the Asthma Mobile Health Study, a research study, including recruitment,consent, and enrollment, conducted entirely remotely by smartphone. We achieved secure bidirectional data flow between investigators and 7,593 participants from across the United States, including many with severe asthma. Our platform enabled prospective collection of longitudinal, multidimensional data (e.g., surveys,devices, geolocation, and air quality) in a subset of users over the 6-month study period. Consistent trending and correlation of interrelated variables support the quality of data obtained via this method. We detected increased reporting of asthma symptoms in regions affected by heat, pollen, and wildfires.Potential challenges with this technology include selection bias, low retention rates, reporting bias, and data security. These issues require attention to realize the full potential of mobile platforms in research and patient care.
 
Nat Biotechnol. 2017 Apr;35(4):354-362. doi: 10.1038/nbt.3826.
 


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