Holistic treatment response: an international expert panel definition and criteria for a new paradigm in the assessment of clinical outcomes of spinal cord stimulation

Levy, R. M. et al. (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. Neuromodulation, 26(5), pp. 1015-1022. (doi: 10.1016/j.neurom.2022.11.011) (PMID:36604242)

Abstract

Background: Treatment 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. Aim: The 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”. Discussion: Several 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.

• Item Type: Articles
• Keywords: Spinal cord stimulation, physiologic confirmation of therapy, holistic treatment response, chronic pain, minimal clinical important difference.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Taylor, Professor Rod
• Authors: Levy, R. M., Mekhail, N., Abd-Elsayed, A., Abejón, D., Anitescu, M., Deer, T. R., Eldabe, S., Goudman, L., Kallewaard, J. W., Moens, M., Petersen, E. A., Pilitsis, J. G., Pope, J. E., Poree, L., Raslan, A. M., Russo, M., Sayed, D., Staats, P. S., Taylor, R. S., Thomson, S., Verrills, P., and Duarte, R. V.
• College/School: College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > MRC/CSO SPHSU
• Journal Name: Neuromodulation
• Publisher: Elsevier
• ISSN: 1094-7159
• ISSN (Online): 1525-1403
• Published Online: 04 January 2023
• Copyright Holders: Copyright © 2022 The Authors
• First Published: First published in Neuromodulation 26(5):1015-1022
• Publisher Policy: Reproduced under a Creative Commons License