Ginige Jeewani Anupama, Boulamatsis Christos, Heffernan Megan, San Jose Juan Carlos, Chuprov Igor, Chau Tiffany, Maeder Anthony, Valenzuela Michael, Fiatarone Singh Maria, Mavros Yorgi, Noble Yian, Radd-Vagenas Sue, Guerrero Yareni, Jain Nidhi, O'Leary Fiona, Kochan Nicole, Brodaty Henry
School of Computer, Mathematical and Data Sciences, Western Sydney University, Sydney.
Centre for Healthy Brain Ageing, School of Psychiatry, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Stud Health Technol Inform. 2020 Mar 2;268:97-112. doi: 10.3233/SHTI200009.
Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.
“维护你的大脑”（MYB）i是一项随机对照试验（RCT），涉及多种在线干预措施，旨在针对阿尔茨海默病和痴呆症的可改变风险因素。传统临床试验管理系统（CTMS）的要求包括研究管理、研究地点、受试者（参与者）、临床结果、外部和内部请求、教育、数据提取与报告、安全性和隐私等功能。除了满足这些传统要求外，MYB还有一系列特定的功能需要实现。这些特定要求包括：（i）支持一项研究中的多种干预措施；（ii）与第三方软件供应商的灵活互操作性选项；（iii）研究参与者在整个试验过程中（从筛查到随访）能够通过基于网络的界面参与在线活动；（iv）能够根据参与者的需求以算法方式个性化试验活动；（v）能够长期处理大量数据。本文概述了现有CTMS在满足这些特定要求方面的不足。所介绍的系统架构、开发方法以及在MYB数字平台实施过程中吸取的经验教训，将为未来试图为类似于MYB的试验实施CTMS的研究人员提供参考。
