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

摘要 这项以患者为中心的研究的目标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，改善患者护理和优化 医疗资源利用率。我们将ASLS定义为OSwestry残疾指数(ODI)E20，脊柱侧弯 研究协会(SRS)领域得分d4.0和基线时Cobb测量的E30？这项研究将 帮助我们确定目前的治疗，无论是非手术治疗还是手术治疗，在多大程度上改善了患者的生活 有这种病态的人。意义：这一关键努力的推动力是疾病的重大负担 由成人脊柱侧弯引起，影响北美2.5%-4%的人口。症状最严重的人群 主要表现为ASLS的患者年龄在40岁至80岁之间，患有腰椎畸形-我们的 这项研究的目标人群。鉴于我们人口老龄化，这种疾病构成了一个严重的问题。 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，迄今为止的研究表明， 通常是有限的、小规模的、单一的机构和追溯。治疗受益的程度 ASLS的患者还没有得到很好的证实。初步数据：脊柱畸形研究组/成人畸形 7年前成立的成果科(SDSG/ADO)已经发展了一个多中心的努力 专门研究成人脊柱侧弯，并建立了收集一致的多中心的基础设施 数据。SDSG已经1)验证了疾病特定结果工具(SRS患者报告的结果 用于成人脊柱畸形的仪器；2)开发和验证针对特定疾病的放射照相工具；3) 分析某些干预措施的结果以进行处理比较；以及4)收集初步数据 关于治疗对患者结局的影响。方法：本研究由多中心研究组成。 患者接受前瞻性随机对照试验(RCT)(30%)和连续队列研究(70%) 目前的护理标准治疗，并将使用统一的临床和放射学评估 经过我们小组的验证，可以评估这些患者。非手术和手术护理都将是标准的- 在5个中心内进行指导。生活质量评定采用SRS-QOL、ODI、SF-12、数字评定量表 (NRS)背痛和腿痛评分。功能措施将包括步行跑步机测试，以评估 治疗前和治疗2年后患者的速度和耐力。主要目标：衡量影响 比较ASLS患者非手术治疗与手术治疗的疗效。创新：否 结果研究存在于任何当前同行评议的文献中，以记录非手术和非手术治疗的效果 手术治疗任何方面的初发成人脊柱畸形。

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.