Background: Dose is multidimensional. Anecdotally, trialists perceive recording and monitoring all dimensions in a clinical trial as unfeasible. Electronic platforms may provide an innovative and realistic solution to this problem.
Aims: To test the feasibility of real-time electronic data collection through the Multidimensional Dose Articulation Framework within a multidisciplinary stroke recovery trial (UPLIFT).
Methods: A customised electronic REDCap data form was created to record Framework dose dimensions: duration (weeks), days/week, sessions/day, session density (time on task:off task), and episodes (length, difficulty, intensity). The data form was implemented prospectively to collect data electronically real-time, which was validated within 48hours of entry per the trial fidelity protocol. Queries identified were promptly cross-checked with the relevant therapist to ensure accuracy. Benefits of real-time monitoring were documented.
Results: The Framework was successfully translated into an electronic interface, which was pilot-tested with 6 trialists/clinicians. Subsequently, 19 therapists (7 physiotherapists/2 occupational therapists/10 speech pathologists) were trained to collect data electronically. To date, 640hours of training (948 therapy sessions) have been entered electronically and 25 queries (2.6% of sessions) were cross-checked for accuracy. Four benefits of real-time, electronic data entry were noted: 1) removal of at least 10hours data entry/participant required to translate paper recordings into electronic records; 2) mitigation of ~230 printing pages/participant (~$16/participant), which may have additional environmental benefits; 3) establishment of monitoring feedback loops to promptly rectify data queries, which enhanced trial rigour and reduced the need for burdensome monitoring methods e.g., video recording; and 4) enriched understanding of ‘how much’ training occurred according to the multiple dose dimensions.
Conclusion: Recording and monitoring the multiple dose dimensions in real-time electronically created data collection and fidelity efficiencies, which have cost-benefits for trial conduct (e.g., staffing, consumables). This REDCap data dictionary will be made accessible to enable broader implementation in stroke recovery trials.