5609968 REAL-WORLD PATIENT-REPORTED OUTCOMES AND WEARABLE METRIC CORRELATIONS: REMOTE DAILY MONITORING FOR EXPLORATION OF QUALITY OF LIFE IN SICKLE CELL DISEASE

Abstract

Background/Aims: Sickle Cell Disease (SCD) is a debilitating condition that lacks data on its natural history and quality of life (QoL) beyond limited snapshots through infrequent healthcare contacts. This lack of longitudinal targeted QoL measurement and understanding of the physiological factors that may influence it sees a need for more detail on the impacts key metrics have on patient outcomes. The core objective of this study was to generate real-world evidence tracking changes in live wearable metrics and patient QoL, to better characterise a baseline of key correlations in SCD. Methods: Data was collected from 238 patients over 16 months, using a CE and FDA-cleared wearable (Withings ScanWatch) to automatically record metrics including sleep quality, activity, and heart rate. EQ-5D-5L and pain scores (0-10) were manually entered by patients via a digital patient-reported outcomes (PRO) portal, and a daily cohort average across each metric was calculated. Statistically significant correlations were analysed both at an overall day-to-day level and split by weekday vs. weekend to explore the potential impacts of activities such as work on sleep patterns. Patients provided informed e-consent to participate and for analysis of their de-identified data. Results: Increasing daily EQ-5D-5L scores were found to correlate with increasing numbers of sleep disturbances (p=0.024) and decreasing pain scores (p<0.001). In turn, lower pain scores were associated with lower sleep heart rates (p<0.001) and wake-up durations (p<0.001), as well as lower active heart rates (p<0.001) and higher activity levels (p<0.001).While sleep quality (sleep disturbances) appeared to show a contradictory increase with higher EQ-5D scores, the significance of this correlation was lost following a split by weekdays and weekends. Statistical significance was also lost for the link between pain scores and steps during the weekend, whereas an additional correlation between pain and total sleep duration (p=0.023) was found only during weekdays, and between pain and the number of sleep disturbances (p=0.033) during the weekend. Similarly, a correlation between EQ-5D and active heart rate (p=0.022), as well as duration to wakeup (p=0.017), was seen only during the weekend. Summary-Conclusion: Analysis of putative associations between PROs and real-time metrics, as well as the potential influences of activities such as work, were shown by changes in significance both before and after split by weekdays/weekends. Notably, lower EQ-5D scores were found to correlate with higher levels of pain, in turn linking to lower daily steps. With a correlating increase in both active and sleep heart rates despite these lower activity levels, this may indicate higher detectable stress correlating with increased pain, with paralleled impacts on QoL. As such, these metrics may form points of monitoring when identifying or predicting risks of pain and related complications in SCD patients. Future work will explore potential causality, differences across patient groups, and more granular detail of the impact of specific treatments or healthcare events. Additional investigation into changes at an individual patient level will be conducted to better characterise deviations from patients’ own baselines. This will support ongoing work to improve the understanding of baselines in SCD, and what the key factors in pain and quality of life may be in order to support patient outcomes improvement.