• Lisa Goudman, Maxime Billot, Rui V Duarte, Sam Eldabe, Philippe Rigoard, and Maarten Moens.
• Department of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan, Brussels, Belgium; STIMULUS Research Group (reSearch and TeachIng neuroModULation Uz bruSsel), Vrije Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Center for Neurosciences (C4N), Vrije Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Pain in Motion (PAIN) Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Research Foundation-Flanders (FWO), Brussels, Belgium.
• Neuromodulation. 2023 Jan 1; 26 (1): 139146139-146.

IntroductionThe most prominent outcome measurement in the field of neuromodulation is pain relief. Nevertheless, the number of studies that rely on composite outcomes has increased. The aims of this study are twofold: (1) to evaluate which measures are important to include in a composite outcome and (2) to develop this new composite outcome to evaluate the degree of being a clinical holistic responder with a corresponding minimal clinical important difference (MCID).Materials And MethodsData from patients with persistent spinal pain syndrome type 2 treated with High-Dose Spinal Cord Stimulation (HD-SCS) were used. Pain intensity for low back and leg pain, disability, health-related quality of life, medication use, and patient satisfaction were measured at baseline and after 12 months of HD-SCS. Exploratory and Confirmatory Factor Analyses were used to evaluate which measures should be included in the composite outcome. Anchor-based and distribution-based methods were applied to determine the MCID of the newly developed outcome measurement.ResultsA three-factor model was the most appropriate for this data set, in which leg pain intensity, EQ5D VAS, and disability had the largest loading on these factors. A clinical holistic outcome was created with a total score ranging from 0 (=better [no pain, no disability, and perfect health status]) to 300 (=worse [maximal pain, maximal disability, and worst health status]). The MCID value based on an absolute change score from baseline up to 12 months of HD-SCS was 87.97. When calculating with percentage changes, a MCID value of 48.4% was revealed.ConclusionsThis new composite outcome evaluating the degree of deviation from being a holistic responder is a step toward a meaningful, overall outcome assessment for patients who are treated with SCS. Further studies to evaluate the psychometric properties and the generalizability toward other patient populations still need to be performed.Copyright © 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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