Presentation (CTI)

OBJECTIVES: Digital health technologies (DHTs), such as wearable devices or sensors, can be utilized to evaluate patient experiences in real world settings, often to complement self-reported data. As DHTs become accepted as primary or secondary endpoints in clinical trials, it is important to understand whether parameters assessed via DHTs reflect meaningful changes to patients. As part of a larger study, the authors piloted a vignette-based interview method to explore meaningful change in measurements of functional mobility (FM) that can be obtained via DHTs.
METHODS: Twenty-four adults participated in individual 60-minute interviews, where a series of novel vignettes were debriefed. Each vignette depicted a measurement of FM (e.g., step count, walking speed), a baseline ability level (e.g., 2000 steps per day) and three thresholds for meaningful change expressed in percentages (e.g., 25%/50%/100%) with equivalent units (e.g., 2500/3000/4000 steps). Participants were asked to select the smallest change that would be meaningful to them for each vignette, and explain why.
RESULTS: Participants did not express any difficulties completing the vignette exercise, although the pre-selected ‘baseline’ value was sometimes considered too low or too high to relate to. In these cases, participants provided their own baseline based on personal experience. Participants (n=16/23, 70%), preferred to consider meaningful changes as a change in units (e.g., number of steps) versus percentages (e.g., a 25% improvement). Consistently, 10% or 25% changes were chosen as the smallest meaningful change across most vignettes, and participants were able to relate meaningful changes in DHT outcomes to potential broader impacts on daily life.
CONCLUSIONS: This study indicates that participants can provide both qualitative and quantitative insights into meaningful change on DHT-based outcomes which may inform future measurement strategies. It is important that vignettes are comprehensible and relevant to the context of use, with baselines that can be tailored to each individual.