Sydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, Australia.
Strategic Ventures, University of Sydney, Sydney, Australia.
JMIR Mhealth Uhealth. 2020 Aug 25;8(8):e15284. doi: 10.2196/15284.
Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes.
The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women.
We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods.
Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; P<.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; P<.001) and a higher recommendation rate for future use (95% vs 64%; P<.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable.
MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.
传统的数据收集方法,如使用纸质文件和电子邮件,正逐渐被使用手机进行数据收集所取代,尽管将手机技术作为自动化研究管理系统的一部分应用于数据收集并改善健康结果的证据有限。
本研究旨在比较基于网络的手机自动化系统(MPAS)与结合纸质文件和电子邮件数据收集的更传统的传递和数据收集系统(PEDC),在母乳喂养妇女队列中的应用。
我们在澳大利亚悉尼进行了一项随机对照试验的子研究,其中包括分娩方式简单的足月分娩并打算母乳喂养的女性。女性在分娩后 72 小时内被招募。使用 PEDC 系统对相当数量的女性进行了准随机招募,其余女性则使用 MPAS 进行招募。评估的结果包括数据收集的有效性、对研究结果的影响、应答率、可接受性以及 MPAS 和 PEDC 方法之间的成本分析。
2015 年 4 月至 2016 年 12 月期间进行了女性招募。分析纳入了 555 名女性:471 名使用 MPAS,84 名使用 PEDC。两组的临床结局无差异。在 8 周治疗阶段结束时,MPAS 组的应答率高于 PEDC 组(56%比 37%;P<.001),在 2、6 和 12 个月随访时也观察到了这一结果。在 2 个月随访时,MPAS 组参与者的自我报告治疗依从性也有所提高(70%比 56%;P<.001),对未来使用的推荐率也更高(95%比 64%;P<.001)。与 PEDC 组相比,两组间的成本分析相当。
MPAS 是一种有效且可接受的方法,可改善临床研究的整体管理、治疗依从性和方法学质量,确保研究结果的有效性和可靠性。