Russell Colleen, Ammour Nadir, Wells Toby, Bonnet Nicolas, Kruse Matthias, Tardat Agnes, Erales Christel, Shook Thomas, Kirkesseli Stephane, Hovsepian Lionel, Pretorius Sy
PAREXEL International, Waltham, Massachusetts, USA.
Sanofi-Aventis Recherche & Développement, Chilly-Mazarin, France.
Digit Biomark. 2018 Nov 7;2(3):126-138. doi: 10.1159/000493883. eCollection 2018 Sep-Dec.
The use of mobile technologies for data capture and transmission has the potential to streamline clinical trials, but researchers lack methods for collecting, processing, and interpreting data from these tools.
To assess the performance of a technical platform for collecting and transmitting data from six mobile technologies in the clinic and at home, to apply methods for comparing them to clinical standard devices, and to measure their usability, including how willing subjects were to use them on a regular basis.
In part 1 of the study, conducted over 3 weeks in the clinic, we tested two device pairs (mobile vs. clinical standard blood pressure monitor and mobile vs. clinical standard spirometer) on 25 healthy volunteers. In part 2 of the study, conducted over 3 days both in the clinic and at home, we tested the same two device pairs as in part 1, plus four additional pairs (mobile vs. clinical standard pulse oximeter, glucose meter, weight scale, and activity monitor), on 22 healthy volunteers.
Data collection reliability was 98.1% in part 1 of the study and 95.8% in part 2 (the percentages exclude the wearable activity monitor, which collects data continuously). In part 1, 20 of 1,049 overall expected measurements were missing (1.9%), and in part 2, 45 of 1,083 were missing (4.2%). The most common reason for missing data was a single malfunctioning spirometer (13 of 20 total missed readings) in part 1, and that the subject did not take the measurement (22 of 45 total missed readings) in part 2. Also in part 2, a higher proportion of at-home measurements than in-clinic readings were missing (12.6 vs. 2.7%). The data from this experimental study were unable to establish repeatability or agreement for every mobile technology; only the pulse oximeter demonstrated repeatability, and only the weight scale demonstrated agreement with the clinical standard device. Most mobile technologies received high "willingness to use" ratings from the patients on the questionnaires.
This study demonstrated that the wireless data transmission and processing platform was dependable. It also identified three critical areas of study for advancing the use of mobile technologies in clinical research: (1) if a mobile technology captures more than one type of endpoint (such as blood pressure and pulse), repeatability and agreement may need to be established for each endpoint to be included in a clinical trial; (2) researchers need to develop criteria for excluding invalid device readings (to be identified by algorithms in real time) for the population studied using ranges based on accumulated subject data and established norms; and (3) careful examination of a mobile technology's performance (reliability, repeatability, and agreement with accepted reference devices) during pilot testing is essential, even for medical devices approved by regulators.
使用移动技术进行数据采集和传输有潜力简化临床试验，但研究人员缺乏从这些工具收集、处理和解释数据的方法。
评估一个技术平台在诊所和家庭中从六种移动技术收集和传输数据的性能，应用将这些技术与临床标准设备进行比较的方法，并衡量它们的可用性，包括受试者定期使用它们的意愿。
在研究的第1部分，在诊所进行了3周，我们在25名健康志愿者身上测试了两对设备（移动设备与临床标准血压监测仪以及移动设备与临床标准肺活量计）。在研究的第2部分，在诊所和家庭中都进行了3天，我们在22名健康志愿者身上测试了与第1部分相同的两对设备，另外还有四对（移动设备与临床标准脉搏血氧仪、血糖仪、体重秤和活动监测仪）。
在研究的第1部分，数据收集可靠性为98.1%，在第2部分为95.8%（这些百分比不包括持续收集数据的可穿戴活动监测仪）。在第1部分，1049个总体预期测量值中有20个缺失（1.9%），在第2部分，1083个中有45个缺失（4.2%）。数据缺失的最常见原因在第1部分是一个肺活量计故障（20个总缺失读数中的13个），在第2部分是受试者未进行测量（45个总缺失读数中的22个）。同样在第2部分，家庭测量中缺失的比例高于诊所读数（分别为12.6%和2.7%）。这项实验研究的数据无法为每种移动技术确立重复性或一致性；只有脉搏血氧仪显示出重复性，只有体重秤显示出与临床标准设备的一致性。大多数移动技术在问卷中获得了患者较高的“使用意愿”评分。
本研究表明无线数据传输和处理平台是可靠的。它还确定了在临床研究中推进移动技术使用的三个关键研究领域：（1）如果一种移动技术捕获多种类型的终点（如血压和脉搏），可能需要为临床试验中要纳入的每个终点确立重复性和一致性；（2）研究人员需要制定排除无效设备读数的标准（通过算法实时识别），该标准基于积累的受试者数据和既定规范的范围针对所研究的人群；（3）即使对于监管机构批准的医疗设备，在试点测试期间仔细检查移动技术的性能（可靠性、重复性以及与公认参考设备的一致性）也至关重要。
