Complications of Surgery for Spinal Stenosis: A Clinical Prediction Rule

描述(由申请人提供)：我们的首要目标是提高椎管狭窄手术患者的安全性。我们希望通过更好地为外科医生和患者的治疗决策提供关于手术风险的个性化数据来实现这一点。椎管狭窄是椎管变窄，导致神经根受压。这在老年人中最常见，由脊柱结构的退行性变化引起。65岁以上成年人的狭窄手术是美国增长最快的脊柱手术类型，每年有4万例手术，全国医院向医疗保险支付的账单为11.2亿美元。然而，老年人群的风险很大，并发症数据仅限于小病例系列，因此临床医生往往不确定是否建议手术以及手术的范围应该有多大。更全面的数据将帮助临床医生和患者决定是否进行这一择期手术，以及手术可以安全地进行多大范围。我们建议使用Medicare Claims和退伍军人管理局的国家外科质量改进计划(NSQIP)来研究腰椎管狭窄手术的并发症和再手术。我们的目标是(1)确定人群和显著亚组中再次脊柱手术的比率和原因；(2)确定危及生命的并发症和30天死亡率与年龄、合并症、既往手术和手术侵袭性的函数关系；(3)开发和验证主要不良事件的预测规则。手术侵袭性是一个新的和重要的研究因素，因为手术脊柱节段的数量、融合程序的使用、解剖入路和外科植入物的使用都有很大的自由裁量权。我们假设这些因素对并发症风险有重要影响。分析将利用我们经过验证的算法来识别腰椎手术患者，以及我们新的手术“侵袭性”指标。这些研究将提高外科医生评估手术风险的能力，并就脊柱手术的好处和风险向患者提供建议，从而提高患者在高风险环境下的安全性。该项目的创新方面包括：使用一种新的衡量选择性程序“侵入性”的新措施作为脊柱手术的风险因素；使用两个基于人群的数据库来增加研究结果的可靠性；展示监测手术创新的安全性、改进护理质量评估和个性化知情同意文件的新方法。公共卫生相关性：一种评估手术风险的新方法将提高患者的安全性，并有助于手术决策、知情同意、监测手术产品和改进质量评估。

DESCRIPTION (provided by applicant): Our overarching goal is to improve patient safety in surgery for spinal stenosis. We hope to achieve this by better informing surgeons' and patients' treatment decisions with individualized data on operative risks. Spinal stenosis is narrowing of the spinal canal leading to compression of nerve roots. It is most common in older adults, resulting from degenerative changes in spinal structures. Stenosis surgery in adults over age 65 is the fastest-growing type of spine surgery in the U.S., with 40,000 operations/year and a national hospital bill to Medicare of $1.12 billion. However, risks are substantial in the older population and complication data are limited to small case series, so clinicians are often uncertain whether to recommend surgery and how extensive surgery should be. More comprehensive data will assist clinicians and patients in deciding whether to undertake this elective surgery and how extensive an operation can be safely performed. We propose to study complications and reoperations of lumbar stenosis surgery using Medicare claims and the VA's National Surgical Quality Improvement Program (NSQIP). Our aims are to (1) Determine rates and reasons for repeat spine surgery in the population and salient subgroups; (2) determine rates of life-threatening complications and 30-day mortality as a function of age, comorbidity, prior surgery, and surgical invasiveness; and (3) develop and validate prediction rules for major adverse events. Surgical invasiveness is a novel and important factor for study, as there is wide discretion in the number of spinal levels operated, use of a fusion procedure, anatomical approach, and the use of surgical implants. We hypothesize that these have an important impact on complication risk. Analyses will make use of our validated algorithm for identifying patients with lumbar surgery and our new index of surgical "invasiveness." These studies will enhance surgeons' ability to estimate operative risks and advise patients about the benefits and risks of spine surgery, thus improving patient safety in a high-risk context. Innovative aspects of the project are the use of a novel measure of elective procedural "invasiveness" as a risk factor in spine surgery; use of two population-based databases to increase robustness of the findings; and demonstration of new methods for monitoring the safety of surgical innovations, improving quality of care assessments, and individualizing informed consent documents. PUBLIC HEALTH RELEVANCE: A new method for estimating surgical risk will improve patient safety and assist in surgical decision-making, informed consent, monitoring surgical products, & improving quality assessment.