A Mulit-Centered Prospective Study of Quality of Life in Adult Scoliosis

摘要 这项以患者为导向的研究的目的是获得健康相关的生活质量（HRQOL）结果数据， 治疗前后出现成人症状性腰椎侧凸（ASLS）的患者， 促进循证治疗指南的制定，改善患者护理， 医疗资源利用。我们将ASLS定义为奥斯韦斯特里残疾指数（ODI）e20，脊柱侧凸 研究协会（SRS）领域评分d4.0，基线时Cobb测量值e30？。本研究将 帮助我们确定目前的治疗，无论是非手术还是手术， 有这种病的人意义：这一关键努力的动力是疾病的重大负担 成人脊柱侧凸引起的脊柱侧凸，影响2.5-4%的北美人口。症状最严重的一组 的ASLS患者主要表现为年龄在40 - 80岁之间的腰椎畸形-我们的 本研究的目标人群。鉴于我国人口老龄化，这种疾病构成了一个重大问题 以及高昂的手术治疗费用（仅住院费用就至少8万美元）。然而，迄今为止的研究， 通常是有限的、小的、单一的机构和回顾性的。治疗受益的程度 患有ASLS的患者尚未得到充分证实。初步数据：脊柱畸形研究组/成人畸形 成果科（SDSG/ADO）成立于7年前， 专门研究成人脊柱侧凸，并建立了一个基础设施，收集一致的多中心 数据SDSG已1）验证了疾病特异性结局工具（SRS患者报告结局 器械）; 2）开发和验证的疾病特异性放射学工具; 3） 分析某些干预措施的结果，以比较治疗方法; 4）收集初步数据 关于治疗对患者结果的影响。方法：本研究将包括多中心， 前瞻性随机对照试验（RCT）（30%）和连续队列研究（70%），患者接受 目前的标准治疗，并将使用统一的临床和放射学评估， 对这些患者进行评估。非手术治疗和手术治疗都将持续进行。 在5个中心内进行dardized。将通过SRS-QOL、ODI、SF-12、数字评定量表评估生活质量 (NRS)背部疼痛和腿部疼痛评分。功能测量将包括步行跑步机测试，以评估 基线和治疗后2年患者的速度和耐力。主要目标：衡量影响 并比较ASLS患者的非手术治疗和手术治疗的结果。创新：否 在任何当前同行评审文献中都存在结局研究，以记录非手术和 手术治疗原发性成人脊柱畸形的任何方面。

ABSTRACT The goal of this patient-oriented study is to obtain health-related quality of life (HRQOL) outcomes data on patients who present with adult symptomatic lumbar scoliosis (ASLS) pre- and post-treatment in order to facilitate the development of evidence-based treatment guidelines, improve patient care and optimize healthcare resource utilization. We are defining ASLS as Oswestry Disability Index (ODI) e20, Scoliosis Research Society (SRS) domain scores d4.0 and a Cobb measurement of e30¿ at baseline. This study will help us determine how much the current treatment, either nonoperative or operative, improves the lives of people with this pathology. Significance: The impetus for this critical effort is the significant burden of disease posed by adult scoliosis, which affects 2.5-4% of the North American population. The most symptomatic group of primary presentation ASLS patients are those between the ages of 40 and 80 with lumbar deformities - our target population for this study. This disease constitutes a significant problem in light of our aging population and the high cost of surgical treatment (at least $80,000 in hospital costs alone). Studies to date, however, have typically been limited, small, single institution and retrospective. The extent to which treatment benefits patients with ASLS is not well established. Preliminary data: The Spinal Deformity Study Group/Adult Deformity Outcomes section (SDSG/ADO), which was formed 7 years ago, has developed a multi-center effort specifically to study adult scoliosis and has established an infrastructure for collecting consistent multicenter data. The SDSG has 1) validated a disease-specific outcomes tool (the SRS patient-reported outcomes instrument) for adult spinal deformity; 2) developed and validated disease-specific radiographic tools; 3) analyzed outcomes for certain interventions for comparison of treatments; and 4) collected preliminary data regarding the impact of treatments on patient outcomes. Methods: The study will comprise a multicenter, prospective, randomized controlled trial (RCT) (30%) and consecutive cohort study (70%) of patients receiving current standard-of-care treatments and will use uniform clinical and radiographic assessments that have been validated by our group for assessment of these patients. Both nonoperative and operative care will be stan- dardized within the 5 centers. Quality of life will be assessed by SRS-QOL, ODI, SF-12, numerical rating scale (NRS) back pain and leg pain scores. Functional measures will include a walking treadmill test to assess speed and endurance in patients at baseline and 2 years post-treatment. Primary Aims: Measure the impacts and compare the outcomes of nonoperative and operative treatments in ASLS patients. Innovation: No outcomes study exists in any current peer-reviewed literature to document the effect of both nonoperative and operative treatment on any aspect of primary presentation adult spinal deformity.