• Neuromodulation · Jul 2023

    Holistic Treatment Response: An International Expert Panel Definition and Criteria for a New Paradigm in the Assessment of Clinical Outcomes of Spinal Cord Stimulation.

    • Robert M Levy, Nagy Mekhail, Alaa Abd-Elsayed, David Abejón, Magdalena Anitescu, Timothy R Deer, Sam Eldabe, Lisa Goudman, Jan W Kallewaard, Maarten Moens, Erika A Petersen, Julie G Pilitsis, Jason E Pope, Lawrence Poree, Ahmed M Raslan, Marc Russo, Dawood Sayed, Peter S Staats, Rod S Taylor, Simon Thomson, Paul Verrills, and Rui V Duarte.
    • Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA.
    • Neuromodulation. 2023 Jul 1; 26 (5): 101510221015-1022.

    BackgroundTreatment response to spinal cord stimulation (SCS) is focused on the magnitude of effects on pain intensity. However, chronic pain is a multidimensional condition that may affect individuals in different ways and as such it seems reductionist to evaluate treatment response based solely on a unidimensional measure such as pain intensity.AimThe aim of this article is to add to a framework started by IMMPACT for assessing the wider health impact of treatment with SCS for people with chronic pain, a "holistic treatment response".DiscussionSeveral aspects need consideration in the assessment of a holistic treatment response. SCS device data and how it relates to patient outcomes, is essential to improve the understanding of the different types of SCS, improve patient selection, long-term clinical outcomes, and reproducibility of findings. The outcomes to include in the evaluation of a holistic treatment response need to consider clinical relevance for patients and clinicians. Assessment of the holistic response combines two key concepts of patient assessment: (1) patients level of baseline (pre-treatment) unmet need across a range of health domains; (2) demonstration of patient-relevant improvements in these health domains with treatment. The minimal clinical important difference (MCID) is an established approach to reflect changes after a clinical intervention that are meaningful for the patient and can be used to identify treatment response to each individual domain. A holistic treatment response needs to account for MCIDs in all domains of importance for which the patient presents dysfunctional scores pre-treatment. The number of domains included in a holistic treatment response may vary and should be considered on an individual basis. Physiologic confirmation of therapy delivery and utilisation should be included as part of the evaluation of a holistic treatment response and is essential to advance the field of SCS and increase transparency and reproducibility of the findings.Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

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