Zhang Jing, Sun Lei, Liu Yu, Wang Hongyi, Sun Ningling, Zhang Puhong
The George Institute for Global Health at Peking University Health Science Center, Beijing, China.
Beihang University, Beijing, China.
J Med Internet Res. 2017 Mar 8;19(3):e66. doi: 10.2196/jmir.6978.
Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device-based electronic data capture (mEDC) system has not been well evaluated.
The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT).
We developed an mEDC to support an RCT called "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes.
The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study.
The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial.
电子数据采集（EDC）系统已在临床研究中广泛应用，但基于移动设备的电子数据采集（mEDC）系统尚未得到充分评估。
本研究旨在评估mEDC在一项随机对照试验（RCT）的数据收集、项目管理和远程监测中的可行性、优势及挑战。
我们开发了一个mEDC以支持一项名为“替米沙坦和氢氯噻嗪降压治疗（THAT）”的RCT研究，该研究为多中心、双盲RCT，目的是比较替米沙坦和氢氯噻嗪（HCTZ）单药治疗在高钠摄入的轻至中度高血压患者60天随访期间的疗效。在试验期间及试验后进行了半结构化访谈，以评估mEDC的可行性、优势及挑战。使用Nvivo 9.0版本（QSR国际公司）分析访谈记录，并采用主题框架法得出结果。
mEDC成功用于支持所有14家研究医院的数据收集和项目管理。在mEDC的支持下，共招募了1333名患者，其中1037名成功完成了全部4次访视。在所有访视中，每位患者回答141个问题平均所需时间为53分钟，医生和患者都能接受。所有受访者，包括24名医生、53名患者、1名临床研究协调员（CRA）、1名项目经理（PM）和1名数据管理员（DM），对创新型mEDC在随机分组、数据收集、项目管理、质量控制和实时远程监测方面的几乎所有功能都表示满意。平均满意度评分为9.2（评分范围0 - 10）。尽管在THAT研究中这不是问题，但最大的挑战来自移动或Wi-Fi信号的稳定性。
创新型mEDC有诸多优点，在支持临床试验中的数据收集和项目管理方面及时且易于接受。
