Fully-Online, Interoperable Clinical Trial Management System for Multi-Interventional RCT: Maintain Your Brain Digital Platform.

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.

Design and Development of the Brain Training System for the Digital "Maintain Your Brain" Dementia Prevention Trial.

BACKGROUND: Dementia is the leading cause of disability worldwide, and interventions aimed at reducing the prevalence and burden of the disease are urgently needed. Maintain Your Brain (MYB) is a randomized controlled trial of a multimodal digital health intervention targeting modifiable dementia risk factors to combat cognitive decline and potentially prevent dementia. In addition to behavioral modules targeting mood, nutrition, and physical exercise, a new Brain Training System (BTS) will deliver computerized cognitive training (CCT) throughout the trial to provide systematic, challenging, and personally adaptive cognitive activity. OBJECTIVE: This paper aimed to describe the design and development of BTS. METHODS: BTS has been designed with a central focus on the end user. Raw training content is provided by our partner NeuroNation and delivered in several innovative ways. A baseline cognitive profile directs selection and sequencing of exercises within and between sessions and is updated during the 10-week 30-session module. Online trainers are available to provide supervision at different levels of engagement, including face-to-face share-screen coaching, a key implementation resource that is triaged by a "red flag" system for automatic tracking of user adherence and engagement, or through user-initiated help requests. Individualized and comparative feedback is provided to aid motivation and, for the first time, establish a social support network for the user based on their real-world circle of friends and family. RESULTS: The MYB pilot was performed from November 2017 to March 2018. We are currently analyzing data from this pilot trial (n=100), which will make up a separate research paper. The main trial was launched in June 2018. Process and implementation data from the first training module (September to November 2018) are expected to be reported in 2019 and final trial outcomes are anticipated in 2022. CONCLUSIONS: The BTS implemented in MYB is focused on maximizing adherence and engagement with CCT over the short and long term in the setting of a fully digital trial, which, if successful, could be delivered economically at scale. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000851268; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=370631&isReview=true.

Maintain Your Brain: Protocol of a 3-Year Randomized Controlled Trial of a Personalized Multi-Modal Digital Health Intervention to Prevent Cognitive Decline Among Community Dwelling 55 to 77 Year Olds.

BACKGROUND: Maintain Your Brain (MYB) is a randomized controlled trial of an online multi-modal lifestyle intervention targeting modifiable dementia risk factors with its primary aim being to reduce cognitive decline in an older age cohort. METHODS: MYB aims to recruit 8,500 non-demented community dwelling 55 to 77 year olds from the Sax Institute's 45 and Up Study in New South Wales, Australia. Participants will be screened for risk factors related to four modules that comprise the MYB intervention: physical activity, nutrition, mental health, and cognitive training. Targeting risk factors will enable interventions to be personalized so that participants receive the most appropriate modules. MYB will run for three years and up to four modules will be delivered sequentially each quarter during year one. Upon completing a module, participants will continue to receive less frequent booster activities for their eligible modules (except for the mental health module) until the end of the trial. DISCUSSION: MYB will be the largest internet-based trial to attempt to prevent cognitive decline and potentially dementia. If successful, MYB will provide a model for not just effective intervention among older adults, but an intervention that is scalable for broad use.

Representation of ICD-10-AM/ACHI Using Classification Markup Language (ClaML).

This paper outlines the Australian experience in adopting the Classification Markup Language (ClaML) to represent two clinical classification systems: ICD-10-AM (International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Australian Modification) and ACHI (Australian Classification of Health Interventions). The primary goal of this process is to share classification data efficiently with relevant parties in a consistent format. This paper outlines extensions implemented in ClaML to facilitate the representation of the above classifications, with validation of the resulting ClaML files verified through XML stylesheet transformation (XSLT) to render the data on a browser, in the same format of printed ICD-10-AM and ACHI books.

Evaluation of Visualisation Techniques for Meaningful Representation of Clinical Classification Data Sets.

In the field of clinical classifications, such as ICD-10 (International Classification of Disease, version 10), there is a transition from paper-based books towards digital systems to have an open process, powered by collaboration. Most clinical classification systems contain massive volume of terms that are hierarchically organised. There are variety of approaches to visualise hierarchical data, in digital systems. In this paper, a selected set of technologies, such as tree views, tree view diagrams, force-directed graphs are investigated to evaluate the suitability of those to accommodate a large clinical classification data sets. Our findings suggest that tree view diagram is the most appropriate technique, due to its ability to accommodate the multi-parent structure of some clinical classifications, and represent large amounts of data in a visually appealing manner.