TOWARD OPTIMIZING DECOMPRESSIVE LAMINECTOMY OUTCOMES: LOOKING OUTSIDE THE SPINE

描述(由申请人提供)： 这项6点前瞻性队列研究的主要目的是开发可在临床环境中使用的算法，以预测患有腰椎管狭窄症(LSS)的老年人的减压椎板切除术(DL)结果(即成功与失败)，LSS是老年患者脊柱手术的最常见适应症。开发的临床算法将主要基于LSS之外的因素，这些因素是与年龄相关的疼痛和残疾的重要预测因素(例如，髋关节骨关节炎、纤维肌痛综合征、抑郁、焦虑、恐惧回避信念、功能障碍应对)。初步数据支持这些因素中的一些因素对DL结果的影响，但没有研究包括在前瞻性队列的背景下对严格收集的数据进行全面评估。因此，LSS治疗仍然只专注于腰椎，治疗结果不佳，平均而言，疼痛减少了20%。据估计，每三名DL患者中就有一人根本没有改善。此外，LSS的解剖学证据(即，基于先进的成像)存在于许多没有疼痛或功能损害的老年患者中。250名有症状的腰椎综合征患者计划在没有融合的情况下接受DL手术，他们没有痴呆症、脊柱不稳定或以前的腰椎手术经历，将从6个参与地点(VA匹兹堡医疗系统、达勒姆VA医学中心[MC]、里士满VAMC、Ann Arbor VAMC、丹佛VAMC、圣安东尼奥VAMC)的脊柱外科实践中招募。在学习障碍前30天内(即在基线时)，参与者将接受全面和严格的疼痛和残疾产生因素的评估，包括：1)使用Brigham脊柱狭窄问卷(BSS，最特异的LSS测量工具)的SS症状；2)肌肉骨骼合并症(脊柱侧弯、脊柱后凸、髋关节骨关节炎、纤维肌痛症状、严重椎管狭窄、退行性腰椎间盘和小关节疾病)；3)情绪(抑郁[CES-D]、焦虑[GAD-7])；4)认知功能(通过计算机评估轻度认知障碍的正常与轻度认知障碍)；5)心理功能(恐惧回避信念[与恐惧回避信念问卷]、慢性疼痛自我效能[与慢性疼痛自我效能量表]、功能性疼痛应对技能[与认知策略问卷]、治疗预期、非法药物使用、酗酒、吸烟状况、创伤后应激障碍症状)；6)医学共病(包括体重指数)；7)人口统计因素(年龄、性别、种族、教育/婚姻状况)。BSS将在基线时、术后第一次访问时和为期一年的每3个月收集一次。基于BSS测量的综合因素和DL成功/失败确定的预测规则将使用多种方法创建，以最大限度地提高预测准确性，并随后在100人的单独队列中进行验证。我们将把这些规则应用于未来的比较有效性试验，这些试验测试个性化的LSS治疗方法(即，涉及将LSS以外的因素作为整体治疗方案的一部分)与单独使用DL进行比较。这项研究的一个探索性目的是评估目标达成量表(GAS)作为学习障碍结果的使用情况。这种以患者为中心的结果测量方法在康复环境中普遍使用，但以前从未在DL患者中使用。为了准备未来的比较有效性试验，我们希望开发GAS作为一种结果衡量标准，因为它可以用来跟踪手术和非手术干预的SS患者的结果，我们预计两者都将被用作个性化治疗的一部分。我们将探索(通过10-12个患者访谈)和提炼(使用改进的Delphi专家小组)SS患者的GAS目标，并在20名参与者中衡量目标实现情况。如果老年LSS患者在接受DL之前在全面的术前计划中进行治疗，会发生什么情况？与糖尿病肾病相关的长期结果是否会改善？患者的满意度会提高吗？一些患者可能避免弥漫性结肠炎吗？这些都是我们最终希望回答的问题。

DESCRIPTION (provided by applicant): The primary aim of this 6-site prospective cohort study is to develop algorithms usable in the clinical setting that predict decompressive laminectomy (DL) outcomes (i.e., success vs. failure) in older adults with lumbar spinal stenosis (LSS), the most common indication for spine surgery in older patients. The clinical algorithms developed will be based primarily on factors outside of LSS that are important aging-related predictors of pain and disability (e.g., hip osteoarthritis [OA], fibromyalgia syndrome, depression, anxiety, fear-avoidance beliefs, dysfunctional coping). Preliminary data support the impact of some of these factors on DL outcomes, but no study has included comprehensive assessment of rigorously collected data in the context of a prospective cohort. Thus LSS treatment remains focused exclusively on the lumbar spine and treatment outcomes suboptimal with, on average, < 20% reduction in pain. An estimated one in three DL patients does not improve at all. Further, anatomical evidence of LSS (i.e., based on advanced imaging) exists in many older patients without pain or functional compromise. Two hundred fifty patients with symptomatic LSS scheduled to undergo DL without fusion and who have no dementia, spinal instability, or prior lumbar surgery will be recruited from spine surgery practice at each of the 6 participating sites (VA Pittsburgh Healthcare System, Durham VA Medical Center [MC], Richmond VAMC, Ann Arbor VAMC, Denver VAMC, San Antonio VAMC). Within 30 days prior to DL (i.e., at baseline), participants will undergo comprehensive and rigorous assessment of pain and disability-generating factors including: 1) SS symptoms with the Brigham Spinal Stenosis questionnaire (BSS, the most specific available LSS measurement tool); 2) musculoskeletal comorbidities (scoliosis, kyphosis, hip osteoarthritis, fibromyalgia symptoms, severity of spinal stenosis, degenerative disc and facet disease); 3) mood (depression [with the CES-D], anxiety [with the GAD-7]); 4) cognitive function (normal vs. mild cognitive impairment with the computer-based assessment of mild cognitive impairment); 5) psychological function (fear-avoidance beliefs [with the Fear Avoidance Beliefs Questionnaire], chronic pain self-efficacy [with the Chronic Pain Self-Efficacy Scales], dysfunctional pain coping skills [with the Cognitive Strategies Questionnaire], treatment expectancy, illicit substance use, alcohol use, smoking status, PTSD symptoms); 6) medical comorbidity (including BMI); 7) demographic factors (age, gender, race, educational/marital status). The BSS will be collected at baseline, at the first postoperative visit, and every 3 months for one year. Prediction rules, based on the comprehensive set of factors measured and DL success/failure determined by the BSS, will be created using multiple methods to maximize predictive accuracy and validated subsequently in a separate cohort of 100 individuals. We will apply these rules to future comparative effectiveness trials that test personalized LSS treatment approaches (i.e., that involve targeting extra-LSS factors as part of the total treatment package) as compared with DL alone. An exploratory aim of the proposed study is to evaluate the use of Goal Attainment Scaling (GAS) as a DL outcome. This patient-centered outcomes measurement approach is used commonly in the rehabilitation setting, but never before in DL patients. To prepare for future comparative effectiveness trials, we want to develop GAS as an outcome measure because it can be used to track outcomes in SS patients across surgical and non-surgical interventions, and we anticipate that both will be employed as part of personalized treatment. We will explore (through 10-12 patient interviews) and refine (with a modified Delphi panel of experts) GAS goals in patients with SS, and measure goal achievement in a subset of 20 participants. What might happen if older adults with LSS were treated in the context of a comprehensive pre-operative program before undergoing DL? Might long-term outcomes associated with DL improve? Might patient satisfaction improve? Might some patients avoid DL? These are questions that ultimately we hope to answer.