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Please use this identifier to cite or link to this item: https://hdl.handle.net/11055/1262
Title: Holistic Treatment Response: An International Expert Panel Definition and Criteria for a New Paradigm in the Assessment of Clinical Outcomes of Spinal Cord Stimulation
Authors: Levy RM
Mekhail N
Abd-Elsayed A
Abejón D
Anitescu M
Deer TR
Eldabe S
Goudman L
Kallewaard JW
Moens M
Petersen EA
Pilitsis JG
Pope JE
Poree L
Raslan AM
Russo M 
Sayed D
Staats PS
Taylor RS
Thomson S
Verrills P
Duarte RV
Keywords: Chronic pain
holistic treatment response
minimal clinical important difference
physiologic confirmation of therapy
spinal cord stimulation
Issue Date: Jul-2023
Source: 26(5):1015-1022.
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.
URI: https://hdl.handle.net/11055/1262
ISSN: 1094-7159
Appears in Collections:Scholarly and Clinical

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