Patient Recruitment Characteristics for Wearable-Sensor-Based Outcome Assessment in Trauma Surgery

Background/Objectives: Using a patient's own wearable sensor to obtain objective outcome data is a growing field in trauma allowing for the assessment of the recovery trajectory back toward the pre-injury performance. The aim of this study was to analyze recruitment characteristics and reasons for declined study participation in an orthopedic trauma study that measures postoperative recovery using wearables. Methods: Data from 225 patients screened for participation in a wearable-sensor-based outcome study were assessed. The influence of age, sex and injury location on study participation was analyzed. Reasons for patients declining to participate were investigated from the screening log. Availability and type of sensor system in patients agreeing to participate were analyzed. Results: Overall, 48% of patients agreed to participate. Age was the only significantly different factor between agreeing and declining patients (p < 0.05). The main reasons to decline study participation were technical difficulties with or inability to use the wearable device, lack of availability of a wearable, and general disinterest to participate in a study. Notably, 7% declined due to data safety concerns. Conclusions: The results show that age, availability of the wearable, and technical ability to use a wearable are the main obstacles impacting objective outcome measurement using a personal wearable device. In studies including geriatric patients, a dedicated device requiring no patient handling can be a valid option to improve enrollment. Understanding the reasons for declining to participate will facilitate the development of future sensor-based studies to address concerns of technical handling through alternative means of data harvesting and increase the inclusion rate. These outcomes will guide future study designs to optimize patient inclusion.