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

成人脊柱侧凸生活质量的多中心前瞻性研究

• 批准号: 7914150
• 负责人: Keith Happ Bridwell
• 金额: $ 47.91万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2014-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7914150
• 关键词: Adult; Adverse event; Affect; Aftercare; Age; Age Factors; American; Analgesics; Appearance; Back Pain; Body mass index; Bone Density; Caring; Clinical; Cohort Studies; Comorbidity; Complex; Data; Decision Making; Deformity; Development; Disease; Education; Effectiveness; Elderly; Evidence based treatment; Gender; Goals; Guidelines; Health Care Costs; Healthcare; Hospital Costs; Hospitalization; Inferior; Injection of therapeutic agent; Institution; Intervention; Life; Light; Literature; Lumbar Curve; Measurement; Measures; Mental Health; Methods; Modeling; North America; Older Population; Operative Surgical Procedures; Orthopedic Surgery procedures; Orthopedics; Outcome; Outcome Study; Outcomes Research; Pain; Pain in lower limb; Pathology; Patient Care; Patient Outcomes Assessments; Patients; Peer Review; Physical therapy; Population; Population Study; Practice Management; Prevalence; Prospective Studies; Quality of life; Randomized; Randomized Controlled Trials; Research; Research Infrastructure; Research Personnel; Research Support; Resources; Review Literature; Risk; SF-12; Severities; Societies; Socioeconomic Status; Speed; Spinal; Spinal Curvatures; Target Populations; Time; Treadmill Tests; Treatment outcome; Validity of Results; Vertebral column; Walking; Work; aging population; arm; arthropathies; burden of illness; clinical practice; cohort; comparative; cost; disability; evidence base; experience; follow-up; health related quality of life; improved; indexing; innovation; instrument; member; patient oriented research; post intervention; predictive modeling; preference; prospective; public health relevance; randomized trial; scoliosis; tool

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.

描述（由申请人提供）：这项以患者为导向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与健康相关的生活质量（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、脊柱侧凸研究协会 (SRS) 领域评分 d4.0 以及基线时的 Cobb 测量值 e300。这项研究将帮助我们确定当前的治疗（无论是非手术治疗还是手术治疗）在多大程度上改善了患有这种疾病的人的生活。意义：这项重要工作的推动力是成人脊柱侧弯带来的巨大疾病负担，影响了 2.5-4% 的北美人口。原发性 ASLS 患者中症状最明显的群体是年龄在 40 岁至 80 岁之间、患有腰椎畸形的患者，这也是本研究的目标人群。鉴于我们的人口老龄化和手术治疗的高昂费用（仅住院费用就至少为 80,000 美元），这种疾病构成了一个重大问题。然而，迄今为止的研究通常是有限的、小型的、单一机构的和回顾性的。治疗对 ASLS 患者的益处程度尚不明确。初步数据：脊柱畸形研究组/成人畸形结果部门 (SDSG/ADO) 成立于 7 年前，开展了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 1) 验证了针对成人脊柱畸形的疾病特异性结果工具（SRS 患者报告结果工具）； 2) 开发并验证特定疾病的放射线照相工具； 3）分析某些干预措施的结果以进行治疗比较； 4) 收集有关治疗对患者结果影响的初步数据。方法：该研究将包括对接受当前标准护理治疗的患者进行的多中心、前瞻性、随机对照试验 (RCT) (30%) 和连续队列研究 (70%)，并将使用经我们小组验证的统一临床和放射学评估来评估这些患者。五个中心内的非手术和手术护理都将标准化。生活质量将通过 SRS-QOL、ODI、SF-12、数字评定量表 (NRS) 背痛和腿痛评分进行评估。功能测量将包括步行跑步机测试，以评估患者基线和治疗后 2 年的速度和耐力。主要目标：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：目前任何同行评审的文献中都没有结果研究来记录非手术治疗和手术治疗对原发性成人脊柱畸形的任何方面的影响。公共卫生相关性：这项重要工作的推动力是成人症状性腰椎侧凸 (ASLS) 造成的重大疾病负担。鉴于人口老龄化和手术治疗费用高昂（仅住院费用就至少需要 80,000 美元），这种疾病已成为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、改善患者护理并优化医疗资源利用。