Comparative Effectiveness of Treatments for Degenerative Spine Disease

描述(由申请人提供)：肌肉骨骼疾病护理方面的技术创新是医疗保险支出增长的主要贡献者，这被广泛认为是不可持续的。这项拟议的研究将提供与政策相关的证据，证明新兴设备/生物制剂治疗老年人常见的背痛相关退行性脊柱疾病的临床有效性、安全性和经济价值。该项目方法是基于达特茅斯公司在基于医疗保险索赔的医疗保健流行病学方面的独特专业知识、基于模型的成本效益分析和一项主要的脊柱疾病前瞻性临床试验的数据的创新组合。提出了三个具体目标：目标1将联邦医疗保险索赔数据与脊柱患者结局研究试验(SPORT)的详细患者水平数据联系起来，以研究在联邦医疗保险人群中针对不同基础条件进行脊柱融合手术的利用率和安全性。我们假设腰椎融合手术的快速增长是在其有效性的证据仍不确定的情况下发生的，拟议的研究将提供必要的信息来评估这种护理的后果。目的2探讨腰椎融合术治疗退行性腰椎滑脱的安全性和有效性，在退行性腰椎滑脱的情况下，其他类型的融合术的安全性和价值以及使用生物制剂加强融合术的安全性和价值仍然存在争议。目标3描述了一种用于椎管狭窄的微创手术治疗的新兴设备的扩散、安全性、成本和成本效益潜力；再次将索赔数据与SPORT多中心试验的数据联系起来。通过研究护理技术的变化对退行性脊柱疾病的并发症和治疗成本的影响，并将这些发现整合到基于模型的成本效益分析中，拟议的研究将确定提高肌肉骨骼疾病护理的效率和安全性的方法。

DESCRIPTION (Provided by Applicant): Technological innovations in musculoskeletal disease care are a major contributor to Medicare spending growth, which is widely recognized as unsustainable. The proposed research will provide policy-relevant evidence on the comparative clinical effectiveness, safety, and economic value of emerging devices/biologics to treat common back-pain-related degenerative spine conditions in the elderly. The project methodology is based on an innovative combination of Dartmouth's unique expertise in Medicare claims-based health care epidemiology, model-based cost-effectiveness analysis, and data from a major prospective clinical trial in spine disease. Three specific aims are proposed: Aim 1 links Medicare claims data to detailed patient-level data from the Spine Patient Outcomes Research Trial (SPORT) to study utilization and safety of spinal fusion surgery as performed for different underlying conditions in the Medicare population. We hypothesize that the rapid growth in lumbar fusion surgery has occurred for conditions where the evidence for its effectiveness remains uncertain, and the proposed study will provide needed information to evaluate the consequences of such care. Aim 2 addresses the safety and efficiency of lumbar fusion surgery for degenerative spondylolisthesis, a condition where the safety and value of alternative types of fusion surgery and use of biologics to augment fusion remains controversial. Aim 3 characterizes diffusion, safety, costs and the cost-effectiveness potential for an emerging device for minimally invasive surgical treatment of spinal stenosis; again linking claims data with data from the SPORT multi-center trial. By examining the impact of changing care technologies on complications and costs of treatments for degenerative spinal conditions and integrating these findings into model-based cost-effectiveness analyses, the proposed research will identify ways to improve the efficiency and safety of musculoskeletal disease care.