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

描述(申请人提供)：这项以患者为中心的研究的目标是获得成人症状性腰椎侧凸(ASLS)患者治疗前和治疗后的健康相关生活质量(HRQOL)结果数据，以促进循证治疗指南的制定，改善患者护理并优化医疗资源利用。我们将ASLS定义为OSwestry残疾指数(ODI)e20，脊柱侧凸研究学会(SRS)领域得分d4.0，以及基线时Cobb测量的e300。这项研究将帮助我们确定目前的治疗方法，无论是非手术治疗还是手术治疗，都能在多大程度上改善患有这种疾病的人的生活。意义：这一关键努力的推动力是成人脊柱侧弯造成的重大疾病负担，这种疾病影响到2.5%-4%的北美人口。首发症状最严重的ASLS患者是年龄在40岁到80岁之间的腰椎畸形患者--我们这项研究的目标人群。鉴于我们的人口老龄化和手术治疗的高昂费用(仅医院费用就至少80,000美元)，这种疾病构成了一个重大问题。然而，到目前为止，研究通常是有限的、小规模的、单一的机构和回溯性的。ASLS患者在多大程度上受益于治疗尚不清楚。初步数据：成立于7年前的脊柱畸形研究组/成人畸形预后研究组(SDSG/ADO)已经发展了一个专门研究成人脊柱侧弯的多中心工作，并建立了收集一致的多中心数据的基础设施。SDSG已1)验证了成人脊柱畸形的特定疾病结果工具(SRS患者报告结果工具)；2)开发和验证了特定疾病放射学工具；3)分析了某些干预措施的结果以进行治疗比较；4)收集了有关治疗对患者结果影响的初步数据。方法：这项研究将包括一项多中心、前瞻性、随机对照试验(RCT)(30%)和连续队列研究(70%)，这些患者接受当前的护理标准治疗，并将使用我们小组验证的统一的临床和放射学评估来评估这些患者。非手术和手术护理都将在5个中心内标准化。生活质量将通过SRS-QOL、ODI、SF-12、数字评定量表(NRS)腰腿痛评分进行评估。功能测量将包括步行跑步机测试，以评估患者在基线和治疗后2年的速度和耐力。主要目的：测量ASLS患者非手术治疗和手术治疗的影响并比较其结果。创新：在任何现有的同行评议的文献中，都没有关于非手术和手术治疗对成人脊柱畸形的影响的研究结果。公共卫生相关性：这一关键努力的推动力是成人症状性腰椎侧凸(ASLS)带来的重大疾病负担。鉴于我们的人口老龄化和手术治疗的高昂费用(仅医院费用就至少80,000美元)，这种疾病构成了一个日益严重的问题。我们的研究将促进循证治疗指南的制定，改善患者护理，优化医疗资源利用。

DESCRIPTION (provided by applicant): 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 e300 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 standardized 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. PUBLIC HEALTH RELEVANCE: The impetus for this critical effort is the significant burden of disease posed by adult symptomatic lumbar scoliosis (ASLS). This disease constitutes a growing problem in light of our aging population and the high cost of surgical treatment (at least $80,000 in hospital costs alone). Our study will facilitate the development of evidence-based treatment guidelines, improve patient care, and optimize healthcare resource utilization.