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个站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，以预测腰椎脊柱stenosis（LSS）的老年人（LSS）（LSS）中最常见的老年患者的腰椎指示性手术最常见的老年人的减压层状椎体切除术（即成功与失败）。开发的临床算法将主要基于LSS之外的因素，这些因素是重要的与衰老相关的疼痛和残疾预测指标（例如，髋关节骨关节炎[OA]，纤维肌痛综合征，抑郁症，焦虑，焦虑，避免恐惧 - 避免恐惧 - 避免恐惧的信念，功能障碍性应对）。初步数据支持其中一些因素对DL结果的影响，但是在潜在队列的背景下，没有研究对严格收集的数据进行全面评估。因此，LSS治疗仅专注于腰椎和治疗结果，平均降低疼痛<20％。估计三分之一的DL患者根本没有改善。此外，许多没有疼痛或功能妥协的老年患者中存在LSS的解剖学证据（即基于晚期成像）。有250例有症状LSS的患者计划在不融合的情况下接受DL，并且将在6个参与地点的每个参与地点中的每个部位招募脊柱手术练习中没有痴呆症，脊柱不稳定性或事先的腰手术。在DL之前的30天内（即基线），参与者将对疼痛和残疾生成因素进行全面和严格的评估，包括：1）SS症状具有杨氏脊柱狭窄问卷（BSS，最特定的可用LSS测量工具）； 2）肌肉骨骼合并症（脊柱侧弯，颅脑病，髋关节骨关节炎，纤维肌痛症状，脊柱狭窄的严重程度，退行性椎间盘和刻度疾病）； 3）情绪（抑郁[与CES-D]，焦虑[与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（避免恐惧的信念[避免恐惧信念问卷调查表]，慢性疼痛自我效能感（带有慢性疼痛自我效能量表]，功能障碍疼痛应对能力[具有认知策略问卷]，治疗预期，预期预期，非法药物使用，使用，酗酒，吸烟状态，PTSD症状）； 6）医疗合并症（包括BMI）； 7）人口统计学因素（年龄，性别，种族，教育/婚姻状况）。 BSS将在基线，术后第一次访问和每3个月进行一年时收集。将使用多种方法来创建预测规则，基于由BSS确定的全面因素和DL成功/失败的全面因素，以最大程度地提高预测精度，并随后在100个个体的单独队列中验证。我们将把这些规则应用于未来的比较有效性试验中，该试验与单独的DL相比，测试个性化的LSS治疗方法（即，涉及将超级LSS因素作为总治疗方案的一部分）。拟议研究的探索目的是评估目标达到缩放（气）作为DL结果的使用。这种以患者为中心的结果测量方法通常在康复环境中使用，但在DL患者中从未使用。为了为将来的比较有效性试验做准备，我们希望开发气体作为结果措施，因为它可以用于在外科和非手术干预措施中跟踪SS患者的结果，并且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次患者访谈），并在SS患者中精炼（经过修改的Delphi专家小组）气体目标，并在20名参与者的子集中衡量目标实现。如果在进行DL之前，在全面的术前计划的背景下对患有LSS的老年人进行了处理，该怎么办？与DL相关的长期结局会改善吗？患者的满意度会提高吗？有些患者可以避免DL吗？这些是我们希望回答的问题。