Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jan 15, 2021
Date Accepted: Apr 12, 2021
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Usability testing of a Digital Assessment Routing Tool: An Iterative Convergent Mixed Methods Study Protocol
ABSTRACT
Background:
Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and an increasing burden on healthcare utilization. Digital technologies to improve health care outcomes and efficiency are considered a priority; however, innovations are often inadequately developed and poorly adopted. Further, they are rarely tested with sufficient rigor in clinical trials, the gold standard for clinical proof of efficacy. We have developed a new musculoskeletal Digital Assessment Routing Tool (DART) that allows users to self-assess and be directed to the right care. DART requires usability testing in preparation for clinical trials.
Objective:
This study will use the iterative-convergent mixed methods design to assess and mitigate all serious usability issues to optimize user experience and adoption. This will provide justifiable confidence to progress to full-scale randomized controlled trials when DART is integrated into clinical management pathways.
Methods:
We will collect qualitative and quantitative data from between 20-30 participants aged 18 and over four months. The exact number of participants recruited will be dependent on the number of iterative cycles required to reach the study end points. Building on previous internal testing and stakeholder involvement, quantitative data collection is defined by the constructs within the ISO 9241-210-2019 Standard and the System Usability Scale (SUS), providing a benchmark usability score for DART. Guided by the participant responses to quantitative questioning, the researcher will focus the qualitative data collection on specific usability problems. These will then be graded to provide the rationale for further DART system improvements throughout the iterative cycles.
Results:
This study received approval from Queen Mary University of London Ethics of Research Committee (QMREC2018/48/048) in June 2020. At manuscript submission, the first round of individual interviews has been completed, with data collection to be completed and results published in 2021.
Conclusions:
This study will provide evidence concerning mHealth DART system usability and acceptance determining system improvements required to support user adoption and minimize sub-optimal system usability as a potential confounder within subsequent non-inferiority clinical trials. This deliberately rigorous approach to mHealth innovation could be used as a guide for other developers of similar applications. Success should produce a safe, effective system with excellent usability, facilitating quicker and easier patient access to appropriate care while reducing the burden on primary and secondary care musculoskeletal services.
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