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 ThomsonPaul Verrills, Rui V. Duarte

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1015-1022
Number of pages8
JournalNeuromodulation
Volume26
Issue number5
DOIs
StatePublished - Jul 2023

Keywords

  • Chronic pain
  • holistic treatment response
  • minimal clinical important difference
  • physiologic confirmation of therapy
  • spinal cord stimulation

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

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