Identifying meaningful aspects of health and concepts of interest for assessment in systemic lupus erythematosus: implications for digital clinical measure development.

Abstract

Objectives: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease with heterogeneous clinical manifestations which significantly impacts the daily lives of patients. Herein, we aimed to (i) investigate patients' perspectives on and experience with SLE; (ii) identify meaningful aspects of health (MAHs) and concepts of interest (COIs) in SLE that could be evaluated using digital clinical measures (DCMs); and (iii) identify target DCMs for their assessment.

Methods: A mixed-methods, multistep approach was deployed for (i) exploring patients' experience with SLE through a social media listening study and focused group discussions with patients; (ii) mapping patients' experiences to define MAHs and identify COIs measurable using DCMs; (iii) selecting DCMs for the target COIs; and (iv) identifying types of wearable sensors for measuring COIs in the patients.

Results: Six MAHs related to physical behavior and sleep were identified: difficulty in ambulating, lack of energy, inability to perform activities of daily living, difficulty engaging in sustained walking, inability to perform leisure activities and exercise, and lack of restful sleep. Measurable COIs represented walking (fatigue and pain) and sleep (sleep and pain) characteristics. Five and six DCMs related to stepping behavior and sleep quality, respectively, were identified. Several wearable sensors are available to derive DCMs for physical behavior and sleep; however, patients showed a strong preference for a wrist-worn actigraphy sensor.

Conclusion: We identified DCMs for physical behavior and sleep that are relevant and meaningful to patients with SLE, measurable in a real-world environment with wearable sensors, and have the potential to aid personalized patient care.