Core Patient-Reported Outcome Measures for Chronic Pain Patients treated with Spinal Cord Stimulation: Findings from a Prospective, Post-Market Study

Abstract Background Spinal cord stimulation (SCS) is a highly effective therapy for treatment of chronic pain, however due to the complexity of pain, measuring a subject’s long-term response to the therapy remains difficult. Frequent measurement of patient-reported outcomes (PROs) to reflect multiple aspects of subjects’ pain is a crucial step in determining therapy outcomes. However, collecting full-length PROs is burdensome for both patients and clinicians. The objective of this work is to investigate the feasibility of using limited sets of outcomes from multiple PROs to accurately characterize subjects’ response to SCS therapy. Methods Validated PROs were used to capture pain, physical function and disability, as well as psychometric, satisfaction, and global health metrics. PROs were collected from 509 patients implanted with a neurostimulator enrolled in the post-market REALITY study. Combination of Pearson’s correlation and factor analysis was used to eliminate highly correlated questions and find the minimal meaningful set of questions within the predefined domains of each scale. Results The shortened versions of the questionnaires presented almost identical accuracy for classifying SCS therapy outcome as compared to the validated full-length versions. In addition, principal component analysis was performed on all the PROs and showed a robust clustering of pain intensity, psychological factors, physical function, and sleep across multiple PROs. A selected set of questions captured from multiple PROs can provide adequate information for measuring SCS therapy outcomes. Conclusions These shorter and more targeted PROs could result in better patient engagement, enhanced and more frequent data collection processes for digital health platforms, and ultimately increased patient satisfaction with SCS therapy. Trial registration Data for our analysis were extracted from the ongoing prospective, multicenter, international REALITY (Long-Term Real-World Outcomes Study on Patients Implanted with a Neurostimulator) study (NCT03876054).