Low Back Pain: A Multi-Center Clinical Trial

描述（由申请人提供）：下背部相关疼痛是一种非常普遍和昂贵的健康问题，对国家卫生政策具有重要意义。据估计，每年腰痛造成的残疾费用为300亿至700亿美元。随着时间的推移，美国的脊柱手术率急剧增加，并且这些手术率的地理差异已被记录为12倍。然而，很少有证据证明手术治疗与非手术治疗的疗效和成本效益。脊柱患者结局研究试验（SPORT）的广泛目标是改善下背痛问题手术治疗的临床决策。SPORT代表了迄今为止对三种最常见、致残和昂贵的下背部疾病-椎间盘突出症（IDH）、椎管狭窄症（SpS）和退行性脊椎前移（DS）进行的最大规模的临床研究。SPORT的三项多中心随机对照试验（RCT）和相关的观察性队列比较了手术与非手术治疗的生活质量结果。除了了解手术是这3种诊断的有效治疗方法外，SPORT还证实，许多接受非手术治疗的患者也表现良好，突出了知情选择的重要性。 在2505名参加SPORT的患者中，91人死亡，1807人（75%）正在积极随访。SPORT III将继续跟踪患者并收集长期功能健康、生活质量和成本效益数据。我们的具体目标是：1）继续对所有受试者进行至少9年的年度随访; 2）通过SF-36健康状况问卷和奥斯韦斯特里残疾指数，比较下腰痛手术与非手术治疗的结局; 3）确定通过EuroQoL EQ-5D获得的社会健康状态值衡量的长期成本效益，以及受试者报告的资源利用率和工作生产率数据。 SPORT代表了迄今为止建立的最大和最多样化的脊柱队列，并构成了一个独特的资源，具有广泛的纵向数据，完善的临床试验基础设施和高随访率。将这些患者的随访延长至至少9年，将为这些常见、衰弱和昂贵疾病的长期结局和治疗方案的成本效益提供重要见解。作为我们正在进行的传播工作的一部分，我们将继续为患者、卫生保健提供者和卫生政策制定者开发基于网络的数据资源和交互式软件，以便将SPORT的科学成果转化为更好的临床实践。相关性（参见说明）：脊柱患者结局研究试验（SPORT）的初步结果发现，对于诊断为椎间盘突出、狭窄或退行性脊椎滑脱的患者，手术治疗的结局更好;然而，非手术治疗的患者也表现良好，突出了知情选择的必要性。这些独特队列的长期随访对于评估长期结局和成本效益至关重要。

DESCRIPTION (provided by applicant): Low back related pain is a highly prevalent and costly health problem of major significance to national health policy. Estimated costs of disability from low back pain range from $30-70 billion annually. Rates of spinal surgery in the U.S. have increased sharply overtime, and 12-fold geographic variation in rates of these surgeries has been documented. However, little evidence documents the efficacy and cost-effectiveness of surgical therapy versus non-operative management. The broad objective of the Spine Patient Outcomes Research Trial (SPORT) has been to improve clinical decision making for surgical treatment of low back pain problems. SPORT represents the largest clinical investigation yet conducted of the three most common, disabling and costly low back disorders - intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). SPORT'S three multi-center randomized controlled trials (RCTs) and associated observational cohorts compare quality of life outcomes for surgical vs. non-operative treatment. In addition to learning that surgery is an effective treatment for these 3 diagnoses, SPORT confirmed that many patients receiving non-operative treatment also do well, highlighting the importance of informed choice. Among the 2505 patients enrolled in SPORT, 91 have died and 1807 (75%) are actively in follow-up. SPORT III will continue to follow patients and gather long-term functional health, quality of life, and cost- effectiveness data. Our specific aims are: 1) To continue annual follow-up of all subjects for a minimum of 9 years; 2) To compare outcomes of surgical vs. non-operative treatment for low back pain as measured by the SF-36 health status questionnaire and the Oswestry Disability Index; 3) To determine long-term cost effectiveness as measured by societal health state values obtained via EuroQoL EQ-5D, and by subject- reported resource utilization and work productivity data. SPORT represents the largest and most diverse spine cohort established to date and constitutes a unique resource with extensive longitudinal data, a well-established clinical trial infrastructure, and high rates of follow-up. Extending the follow-up in these patients through a minimum of 9 years will provide important insights into the long-term outcomes and cost-effectiveness of treatment options in these common, debilitating and expensive conditions. As part of our ongoing efforts at dissemination, we will continue to develop web-based data resources and interactive software for patients, health care providers, and health policy makers seeking to translate the scientific results from SPORT into improved clinical practice. RELEVANCE (See instructions): Initial results from the Spine Patient Outcomes Research Trial (SPORT) found that for patients diagnosed with herniated disc, stenosis or degenerative spondylolisthesis, surgery resulted in better outcomes; however, non-operatively treated patients also did well highlighting the need for informed choice. Long-term follow-up in these unique cohorts is crucial to assess long-term outcomes and cost-effectiveness.