PMID- 36604242 OWN - NLM STAT- MEDLINE DCOM- 20230710 LR - 20230718 IS - 1525-1403 (Electronic) IS - 1094-7159 (Linking) VI - 26 IP - 5 DP - 2023 Jul TI - Holistic Treatment Response: An International Expert Panel Definition and Criteria for a New Paradigm in the Assessment of Clinical Outcomes of Spinal Cord Stimulation. PG - 1015-1022 LID - S1094-7159(22)01379-4 [pii] LID - 10.1016/j.neurom.2022.11.011 [doi] AB - 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. CI - Copyright (c) 2022 The Authors. Published by Elsevier Inc. All rights reserved. FAU - Levy, Robert M AU - Levy RM AD - Neurosurgical Services, Clinical Research, Anesthesia Pain Care Consultants, Tamarac, FL, USA. FAU - Mekhail, Nagy AU - Mekhail N AD - Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA. FAU - Abd-Elsayed, Alaa AU - Abd-Elsayed A AD - Department of Anesthesiology and Pain Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA. FAU - Abejon, David AU - Abejon D AD - Multidisciplinary Pain Management Unit, Hospital Universitario Quironsalud, Madrid, Spain. FAU - Anitescu, Magdalena AU - Anitescu M AD - University of Chicago Medical Center, Chicago, IL, USA. FAU - Deer, Timothy R AU - Deer TR AD - The Spine and Nerve Center of the Virginias, Charleston, WV, USA. FAU - Eldabe, Sam AU - Eldabe S AD - Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK. FAU - Goudman, Lisa AU - Goudman L AD - Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; Center for Neurosciences (C4N), Vrije Universiteit Brussel, Brussels, Belgium; STIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium; Research Foundation-Flanders, Brussels, Belgium. FAU - Kallewaard, Jan W AU - Kallewaard JW AD - Department of Anaesthesiology and Pain Management, Rijnstate Hospital, Velp, the Netherlands; Department of Anesthesiology and Pain Medicine, Amsterdam University Medical Centre, Amsterdam, the Netherlands. FAU - Moens, Maarten AU - Moens M AD - Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; Center for Neurosciences (C4N), Vrije Universiteit Brussel, Brussels, Belgium; STIMULUS research group, Vrije Universiteit Brussel, Brussels, Belgium; Department of Radiology, Universitair Ziekenhuis Brussel, Brussels, Belgium. FAU - Petersen, Erika A AU - Petersen EA AD - Department of Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, AR, USA. FAU - Pilitsis, Julie G AU - Pilitsis JG AD - Department of Clinical Neurosciences, Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL, USA. FAU - Pope, Jason E AU - Pope JE AD - Evolve Restorative Center, Santa Rosa, CA, USA. FAU - Poree, Lawrence AU - Poree L AD - Department of Anesthesia and Perioperative Care, University of California at San Francisco, San Francisco, CA, USA. FAU - Raslan, Ahmed M AU - Raslan AM AD - Department of Neurological Surgery, Oregon Health & Science University, Portland, OR, USA. FAU - Russo, Marc AU - Russo M AD - Hunter Pain Specialists, Broadmeadow, New South Wales, Australia. FAU - Sayed, Dawood AU - Sayed D AD - The University of Kansas Medical Center, Kansas City, KS, USA. FAU - Staats, Peter S AU - Staats PS AD - National Spine and Pain Centers, Shrewsbury, NJ, USA. FAU - Taylor, Rod S AU - Taylor RS AD - College of Medicine and Health, University of Exeter, Exeter, UK; MRC/CSO Social and Public Health Sciences Unit & Robertson Centre for Biostatistics, Institute of Health and Well Being, University of Glasgow, Glasgow, UK. FAU - Thomson, Simon AU - Thomson S AD - Department of Pain Medicine and Neuromodulation, Mid & South Essex University Hospitals, Essex, UK. FAU - Verrills, Paul AU - Verrills P AD - Metro Pain Group, Melbourne, New South Wales, Australia. FAU - Duarte, Rui V AU - Duarte RV AD - Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia; Liverpool Reviews and Implementation Group, Department of Health Data Science, University of Liverpool, Liverpool, UK. Electronic address: rui.duarte@liverpool.ac.uk. LA - eng PT - Journal Article DEP - 20230104 PL - United States TA - Neuromodulation JT - Neuromodulation : journal of the International Neuromodulation Society JID - 9804159 SB - IM MH - Humans MH - *Chronic Pain/diagnosis/therapy/etiology MH - *Spinal Cord Stimulation/methods MH - Reproducibility of Results MH - Treatment Outcome MH - Spinal Cord OTO - NOTNLM OT - Chronic pain OT - holistic treatment response OT - minimal clinical important difference OT - physiologic confirmation of therapy OT - spinal cord stimulation EDAT- 2023/01/06 06:00 MHDA- 2023/07/10 06:42 CRDT- 2023/01/05 21:55 PHST- 2022/09/17 00:00 [received] PHST- 2022/11/03 00:00 [revised] PHST- 2022/11/08 00:00 [accepted] PHST- 2023/07/10 06:42 [medline] PHST- 2023/01/06 06:00 [pubmed] PHST- 2023/01/05 21:55 [entrez] AID - S1094-7159(22)01379-4 [pii] AID - 10.1016/j.neurom.2022.11.011 [doi] PST - ppublish SO - Neuromodulation. 2023 Jul;26(5):1015-1022. doi: 10.1016/j.neurom.2022.11.011. Epub 2023 Jan 4.