TOWARD OPTIMIZING DECOMPRESSIVE LAMINECTOMY OUTCOMES: LOOKING OUTSIDE THE SPINE

优化减压椎板切除术结果：关注脊柱外部

• 批准号: 9000579
• 负责人: DEBRA KAYE WEINER
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-10-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9000579
• 关键词: Achievement; Age; Aging; Alcohol consumption; Alcohol or Other Drugs use; Algorithms; Anxiety; Arthritis; Back; Back Pain; Belief; Body mass index; Client satisfaction; Clinical; Cognitive; Cohort Studies; Comorbidity; Complex; Computers; Coping Skills; Data; Dementia; Demographic Factors; Disease; Education; Elderly; Expectancy; Failure; Fibromyalgia; Fright; Future; Gender; Goals; Health Personnel; Healthcare; Healthcare Systems; Hip Osteoarthritis; Hip region structure; Image; Individual; Intervention; Interview; Kyphosis deformity of spine; Laminectomy; Lead; Magnetic Resonance Imaging; Marital Status; Measurement; Measures; Medical; Medical center; Mental Depression; Methods; Moods; Multi-Institutional Clinical Trial; Musculoskeletal; Operative Surgical Procedures; Outcome; Outcome Measure; Pain; Pain Measurement; Pain in lower limb; Participant; Patient-Focused Outcomes; Patients; Post-Traumatic Stress Disorders; Postoperative Period; Process; Questionnaires; Race; Recruitment Activity; Rehabilitation therapy; Resources; Risk; Sampling; Schedule; Self Efficacy; Severities; Site; Smoking Status; Spinal; Spinal Canal; Spinal Stenosis; Spine surgery; Statistical Data Interpretation; Symptoms; Testing; Total Hip Replacement; Treatment outcome; Vertebral column; Veterans; Visit; Walking; age related; base; chronic pain; cognitive function; cohort; comorbid depression; comparative effectiveness; coping; design; disability; effectiveness trial; experience; improved; mild cognitive impairment; older patient; patient oriented; personalized medicine; programs; prospective; psychologic; public health relevance; response; scoliosis; success; tool

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.

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，预测患有腰椎管狭窄 (LSS) 的老年人的减压椎板切除术 (DL) 结果（即成功与失败），腰椎管狭窄 (LSS) 是老年患者脊柱手术最常见的适应症。开发的临床算法将主要基于 LSS 之外的因素，这些因素是与衰老相关的疼痛和残疾的重要预测因子（例如髋骨关节炎 [OA]、纤维肌痛综合征、抑郁、焦虑、回避恐惧信念、应对功能障碍）。初步数据支持其中一些因素对 DL 结果的影响，但没有研究对前瞻性队列中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，治疗效果不佳，疼痛平均减少 < 20%。据估计，三分之一的 DL 患者根本没有任何改善。此外，许多老年患者存在 LSS 的解剖学证据（即基于高级成像），且没有疼痛或功能受损。将从 6 个参与中心（VA 匹兹堡医疗系统、达勒姆 VA 医疗中心 [MC]、里士满 VAMC、安娜堡 VAMC、丹佛 VAMC、圣安东尼奥 VAMC）的脊柱手术实践中招募 250 名计划接受 DL 但不进行融合的有症状 LSS 患者，这些患者没有痴呆、脊柱不稳定或既往腰椎手术史。在 DL 前 30 天内（即基线），参与者将接受对疼痛和残疾产生因素的全面而严格的评估，包括： 1) 使用 Brigham 椎管狭窄问卷（BSS，最具体的可用 LSS 测量工具）评估 SS 症状； 2）肌肉骨骼合并症（脊柱侧凸、后凸、髋骨关节炎、纤维肌痛症状、椎管狭窄的严重程度、退行性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（正常与轻度认知障碍，基于计算机的轻度认知障碍评估）； 5) 心理功能（恐惧回避信念[使用恐惧避免信念问卷]、慢性疼痛自我效能[使用慢性疼痛自我效能量表]、功能失调的疼痛应对技能[使用认知策略问卷]、治疗预期、非法物质使用、饮酒、吸烟状况、PTSD症状）； 6) 合并症（包括BMI）； 7) 人口因素（年龄、性别、种族、教育/婚姻状况）。 BSS 将在基线、术后第一次就诊时收集，并在一年内每 3 个月收集一次。将使用多种方法创建预测规则，该规则基于测量的综合因素和 BSS 确定的 DL 成功/失败，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到未来的比较有效性试验中，以测试与单独 DL 相比的个性化 LSS 治疗方法（即，涉及将额外的 LSS 因素作为整个治疗方案的一部分）。拟议研究的探索性目的是评估目标达成量表（GAS）作为深度学习结果的使用。这种以患者为中心的结果测量方法通常用于康复环境，但以前从未用于 DL 患者。为了为未来的比较有效性试验做好准备，我们希望将 GAS 开发为一种结果衡量标准，因为它可用于跟踪 SS 患者的手术和非手术干预结果，并且我们预计两者都将用作个性化治疗的一部分。我们将探索（通过 10-12 名患者访谈）并完善（通过修改后的德尔菲专家小组）SS 患者的 GAS 目标，并衡量 20 名参与者的目标实现情况。如果患有 LSS 的老年人在接受 DL 之前接受全面的术前计划治疗，会发生什么？与深度学习相关的长期结果可能会有所改善吗？患者满意度可能会提高吗？有些患者可能会避免 DL 吗？这些都是我们最终希望回答的问题。