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提供手术风险个性化数据的治疗决策来实现这一目标。椎管狭窄是指椎管狭窄导致神经根受压。它最常见于老年人，由脊柱结构的退行性改变引起。65岁以上成人狭窄手术是美国增长最快的脊柱手术类型，每年有40,000例手术，国家医院医疗保险费用为11.2亿美元。然而，在老年人群中风险很大，并发症数据仅限于小病例系列，因此临床医生经常不确定是否推荐手术以及手术范围应该有多大。更全面的数据将有助于临床医生和患者决定是否进行这种选择性手术，以及多大范围的手术可以安全进行。我们建议使用医疗保险索赔和VA的国家手术质量改进计划（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)确定人群和突出亚组中重复脊柱手术的发生率和原因；(2)确定危及生命的并发症和30天死亡率与年龄、合并症、既往手术和手术侵入性的关系；(3)制定并验证重大不良事件预测规则。手术侵入性是研究的一个新颖而重要的因素，因为在手术的脊柱节段数量、融合手术的使用、解剖入路和手术植入物的使用方面存在广泛的自由裁量权。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和我们新的手术“侵入性”指数。这些研究将提高外科医生评估手术风险的能力，并向患者建议脊柱手术的利弊，从而提高高危环境下患者的安全性。该项目的创新之处在于，在脊柱外科手术中采用了一种新的可选程序“侵入性”衡量标准作为风险因素；使用两个基于人群的数据库来增加研究结果的稳健性；并展示用于监测外科创新安全性、提高护理评估质量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.