Low Back: A Multi-Center Clinical Trial

描述(申请人提供)：腰痛被认为是美国和世界上最常见的健康问题之一。据估计，那些因下腰痛而严重残疾的人每年的成本在300亿至700亿美元之间。随着时间的推移，美国脊柱手术的比率急剧增加，这些手术的比率在地理上的差异已经被记录下来了12倍。尽管有这些趋势，但几乎没有证据表明手术治疗与非手术治疗的疗效和成本效益。拟议研究的总体目标是改善三个主要诊断组的下腰痛及其相关腿部症状的外科治疗的临床决策：椎间盘突出症(IDH)、椎管狭窄症(SPS)和退行性腰椎滑脱(DS)。脊柱患者结局研究试验(SPORT)目前已经在三个多中心随机对照试验(RCT)和相关的观察性队列中招募了2317名患有IDH、SPS和DS的患者，以比较手术和非手术治疗下腰痛。在第一个供资周期结束时(2004年11月)，完成后，这将是对接受脊柱手术的三个最常见的诊断组进行的规模最大、方法最合理的研究。SPORT II将把最初的后续行动再延长五年。主要终点将是由SF-36健康状况问卷衡量的与健康有关的生活质量的长期变化，以及由奥斯威哲残疾指数衡量的特定疾病的残疾。次要的长期终点将包括患者对治疗的满意度、用于估计质量调整寿命年(QALY)的偏好加权健康结果、资源利用和成本。SPORT II将提供对许多方法学和临床问题的见解，包括随机对照试验结果的普适性；患者偏好；种族、性别和年龄方面的差异问题；以及临床和经济结果的地理变异性。随机对照试验和观察队列将被整合，以评估手术干预与非手术干预的成本效益。SPORT II的完成将首次提供短期和长期的科学证据，证明外科手术和非手术治疗对三种最常见的腰椎疾病的相对疗效/效果。

DESCRIPTION (provided by applicant): Low back pain is considered to be one of the most widely experienced health problems in the U.S. and the world. Estimated costs to those who are severely disabled from low back pain range from $30-70 billion annually. Rates of spinal surgery in the US have increased sharply over time, and 12-fold geographic variation in rates of these surgeries has been documented. Despite these trends, there is little evidence establishing the efficacy and cost-effectiveness of surgical therapy versus non-operative management. The broad objective of the proposed research is to improve clinical decision making with respect to the surgical treatment of low back pain and associated leg symptoms in three major diagnostic groups: intervertebral disc herniation (IDH), spinal stenosis (SpS), and degenerative spondylolisthesis (DS). The Spine Patient Outcomes Research Trial (SPORT) has currently enrolled 2,317 patients with IDH, SpS and DS in three multi-center randomized controlled trials (RCTs) and associated observational cohorts to compare surgical to non-operative treatment for low back pain. By the end of the first funding cycle (November 2004), states. When completed, this will be largest and most methodologically sound study of the three most common diagnostic groups for which spine surgery is performed. SPORT II will extend the original follow-up for an additional five years. The primary endpoints will be long-term changes in health-related quality of life as measured by the SF-36 health status questionnaire and disease-specific disability as measured by the Oswestry Disability Index. Secondary long-term endpoints will include patient satisfaction with treatment, preference-weighted health outcomes to estimate quality-adjusted life years (QALYS), resource utilization and costs. SPORT II will provide insights into many methodological and clinical questions, including the generalizability of RCT results; patient preferences; disparity issues with respect to race, gender, and age; and geographic variability of clinical and economic outcomes. The RCT and observational cohorts will be integrated to estimate the cost-effectiveness of surgical vs. nonoperative interventions. Completion of SPORT II will provide, for the first time, both short and long term scientific evidence as to the relative efficacy/effectiveness of surgical versus non-surgical treatment for the three most commonly diagnosed lumbar spine conditions.