PMID- 35088757
OWN - NLM
STAT- MEDLINE
DCOM- 20230110
LR  - 20230111
IS  - 1525-1403 (Electronic)
IS  - 1094-7159 (Linking)
VI  - 26
IP  - 1
DP  - 2023 Jan
TI  - Gradation of Clinical Holistic Response as New Composite Outcome to Evaluate 
      Success in Spinal Cord Stimulation Studies for Pain.
PG  - 139-146
LID - S1094-7159(21)06395-9 [pii]
LID - 10.1016/j.neurom.2021.10.020 [doi]
AB  - INTRODUCTION: The most prominent outcome measurement in the field of 
      neuromodulation is pain relief. Nevertheless, the number of studies that rely on 
      composite outcomes has increased. The aims of this study are twofold: (1) to 
      evaluate which measures are important to include in a composite outcome and (2) 
      to develop this new composite outcome to evaluate the degree of being a clinical 
      holistic responder with a corresponding minimal clinical important difference 
      (MCID). MATERIALS AND METHODS: Data from patients with persistent spinal pain 
      syndrome type 2 treated with High-Dose Spinal Cord Stimulation (HD-SCS) were 
      used. Pain intensity for low back and leg pain, disability, health-related 
      quality of life, medication use, and patient satisfaction were measured at 
      baseline and after 12 months of HD-SCS. Exploratory and Confirmatory Factor 
      Analyses were used to evaluate which measures should be included in the composite 
      outcome. Anchor-based and distribution-based methods were applied to determine 
      the MCID of the newly developed outcome measurement. RESULTS: A three-factor 
      model was the most appropriate for this data set, in which leg pain intensity, 
      EQ5D VAS, and disability had the largest loading on these factors. A clinical 
      holistic outcome was created with a total score ranging from 0 (=better [no pain, 
      no disability, and perfect health status]) to 300 (=worse [maximal pain, maximal 
      disability, and worst health status]). The MCID value based on an absolute change 
      score from baseline up to 12 months of HD-SCS was 87.97. When calculating with 
      percentage changes, a MCID value of 48.4% was revealed. CONCLUSIONS: This new 
      composite outcome evaluating the degree of deviation from being a holistic 
      responder is a step toward a meaningful, overall outcome assessment for patients 
      who are treated with SCS. Further studies to evaluate the psychometric properties 
      and the generalizability toward other patient populations still need to be 
      performed.
CI  - Copyright (c) 2021 International Neuromodulation Society. Published by Elsevier 
      Inc. All rights reserved.
FAU - Goudman, Lisa
AU  - Goudman L
AD  - Department of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan, 
      Brussels, Belgium; STIMULUS Research Group (reSearch and TeachIng neuroModULation 
      Uz bruSsel), Vrije Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Center 
      for Neurosciences (C4N), Vrije Universiteit Brussel, Laarbeeklaan, Brussels, 
      Belgium; Pain in Motion (PAIN) Research Group, Department of Physiotherapy, Human 
      Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije 
      Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Research 
      Foundation-Flanders (FWO), Brussels, Belgium.
FAU - Billot, Maxime
AU  - Billot M
AD  - PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and 
      Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, 
      France.
FAU - Duarte, Rui V
AU  - Duarte RV
AD  - Liverpool Reviews and Implementation Group, Department of Health Data Science, 
      University of Liverpool, Liverpool, UK.
FAU - Eldabe, Sam
AU  - Eldabe S
AD  - Pain Clinic, The James Cook University Hospital, Middlesbrough, UK.
FAU - Rigoard, Philippe
AU  - Rigoard P
AD  - PRISMATICS Lab (Predictive Research in Spine/Neuromodulation Management and 
      Thoracic Innovation/Cardiac Surgery), Poitiers University Hospital, Poitiers, 
      France; Department of Spine Surgery & Neuromodulation, Poitiers University 
      Hospital, Poitiers, France; Pprime Institute UPR 3346, CNRS, ISAE-ENSMA, 
      University of Poitiers, Chasseneuil-du-Poitou, France.
FAU - Moens, Maarten
AU  - Moens M
AD  - Department of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan, 
      Brussels, Belgium; STIMULUS Research Group (reSearch and TeachIng neuroModULation 
      Uz bruSsel), Vrije Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Center 
      for Neurosciences (C4N), Vrije Universiteit Brussel, Laarbeeklaan, Brussels, 
      Belgium; Pain in Motion (PAIN) Research Group, Department of Physiotherapy, Human 
      Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije 
      Universiteit Brussel, Laarbeeklaan, Brussels, Belgium; Department of Radiology, 
      Universitair Ziekenhuis Brussel, Laarbeeklaan, Brussels, Belgium. Electronic 
      address: maarten.moens@uzbrussel.be.
LA  - eng
PT  - Journal Article
DEP - 20211218
PL  - United States
TA  - Neuromodulation
JT  - Neuromodulation : journal of the International Neuromodulation Society
JID - 9804159
SB  - IM
MH  - Humans
MH  - Treatment Outcome
MH  - *Spinal Cord Stimulation/methods
MH  - Quality of Life
MH  - Patient Satisfaction
MH  - Outcome Assessment, Health Care
MH  - Spinal Cord
OTO - NOTNLM
OT  - Composite end points
OT  - factor analysis
OT  - failed back surgery syndrome
OT  - neuromodulation
OT  - persistent spinal pain syndrome type 2
EDAT- 2022/01/29 06:00
MHDA- 2023/01/11 06:00
CRDT- 2022/01/28 08:38
PHST- 2021/09/21 00:00 [received]
PHST- 2021/10/09 00:00 [revised]
PHST- 2021/10/12 00:00 [accepted]
PHST- 2022/01/29 06:00 [pubmed]
PHST- 2023/01/11 06:00 [medline]
PHST- 2022/01/28 08:38 [entrez]
AID - S1094-7159(21)06395-9 [pii]
AID - 10.1016/j.neurom.2021.10.020 [doi]
PST - ppublish
SO  - Neuromodulation. 2023 Jan;26(1):139-146. doi: 10.1016/j.neurom.2021.10.020. Epub 
      2021 Dec 18.