初次接受脊髓刺激治疗的患者与先前标准脊髓刺激治疗失败的患者：两个不同的群体还是同一类人群？
Spinal Cord Stimulation-Naïve Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population?
作者信息
Goudman Lisa, Rigoard Philippe, Billot Maxime, De Smedt Ann, Roulaud Manuel, Consortium Discover, Moens Maarten
机构信息
Department of Neurosurgery, Universitair Ziekenhuis Brussel, Brussels, Belgium; STIMULUS consortium (reSearch and TeachIng neuroModULation Uz bruSsel), Vrije Universiteit Brussel, Brussels, Belgium; Center for Neurosciences, Vrije Universiteit Brussel, Brussels, Belgium; Pain in Motion Research Group, Department of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education and Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Research Foundation-Flanders, Brussels, Belgium.
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.
出版信息
Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
INTRODUCTION
Nowadays, the success of spinal cord stimulation (SCS) is evaluated separately in patients who have previous experiences with standard SCS and in SCS-naïve patients. Nevertheless, it is yet to be evaluated whether both patient groups are effectively distinct patient groups. Therefore, the aims of this study are twofold: 1) Are there clusters in the data to distinguish between both patient groups? 2) Can we discriminate both patient groups based on routinely collected clinical parameters?
MATERIALS AND METHODS
Baseline data from the Discover study were used, in which 263 patients with persistent spinal pain syndrome type 2 were included (185 neurostimulation-naïve patients and 78 patients with previous SCS experience). Pain intensity scores for low back and leg pain, functional disability, medication use, and health-related quality of life utility scores were used in the analysis. Model-based clustering was performed on standardized data. Discriminant analysis was performed with linear and quadratic discriminant analysis, with leave-one-out cross-validation to evaluate model performance.
RESULTS
Model-based clustering revealed two different clusters in the data. None of the clusters clearly separated SCS-naïve patients from patients with previous SCS experience. Linear discriminant analysis resulted in a leave-one-out cross-validation error rate of 30.0% to discriminate between both patient groups, based on routinely collected clinical parameters.
CONCLUSIONS
Clustering analysis did not result in clusters that separate SCS-naïve patients from patients with previous SCS experience. This may suggest that both patient groups should not be considered as two different patient groups when comparing them on routine clinical parameters, with potentially profound implications for research and clinical settings.
CLINICAL TRIAL REGISTRATION
The Clinicaltrials.gov registration number for the Discover study is NCT02787265.
引言
如今，脊髓刺激（SCS）的成功率在有标准SCS经验的患者和初次接受SCS治疗的患者中是分别评估的。然而，这两组患者是否真的是不同的有效患者群体仍有待评估。因此，本研究有两个目的：1）数据中是否存在可区分这两组患者的聚类？2）我们能否根据常规收集的临床参数区分这两组患者？
材料与方法
使用了来自Discover研究的基线数据，该研究纳入了263例2型持续性脊柱疼痛综合征患者（185例初次接受神经刺激治疗的患者和78例有SCS经验的患者）。分析中使用了腰腿痛的疼痛强度评分、功能障碍、药物使用情况以及与健康相关的生活质量效用评分。对标准化数据进行基于模型的聚类分析。采用线性和二次判别分析进行判别分析，并采用留一法交叉验证来评估模型性能。
结果
基于模型的聚类分析在数据中发现了两个不同的聚类。没有一个聚类能明确区分初次接受SCS治疗的患者和有SCS经验的患者。基于常规收集的临床参数，线性判别分析得出区分这两组患者的留一法交叉验证错误率为30.0%。
结论
聚类分析并未产生能区分初次接受SCS治疗的患者和有SCS经验的患者的聚类。这可能表明，在根据常规临床参数对这两组患者进行比较时，不应将它们视为两个不同的患者群体，这可能对研究和临床环境产生深远影响。
临床试验注册
Discover研究在Clinicaltrials.gov上的注册号为NCT02787265。
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