Complications of Surgery for Spinal Stenosis: A Clinical Prediction Rule

椎管狭窄手术并发症：临床预测规则

• 批准号: 7932448
• 负责人: RICHARD A DEYO
• 金额: $ 16.92万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-21 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7932448
• 关键词: Accounting; Acute myocardial infarction; Adult; Adverse event; Age; Algorithms; Attention; Back; Benefits and Risks; Case Series; Classification; Clinical; Comorbidity; Complication; Consent Forms; Data; Data Set; Databases; Decision Making; Devices; Effectiveness; Elderly; Evaluation; Event; Evolution; Failure; Fibrinogen; General Population; Goals; Heart Arrest; Hospitals; Implant; Individual; Informed Consent; Insurance Carriers; Life; Measures; Medicare; Medicare claim; Methods; Monitor; Nerve; Nerve Root Compressions; Nursing Homes; Observational Study; Older Population; Operative Surgical Procedures; Outcome; Pain in lower limb; Patients; Plant Roots; Pneumonia; Population; Printing; Probability; Procedures; Progressive Disease; Publishing; Pulmonary Embolism; Quality of Care; Randomized Controlled Clinical Trials; Repeat Surgery; Reporting; Research; Risk; Risk Factors; Safety; Sampling; Solid; Spinal; Spinal Canal; Spinal Stenosis; Stenosis; Stroke; Structure; Subgroup; Surgeon; Surgical complication; Symptoms; Time; Treatment Efficacy; Vertebral column; Welding; aged; comparative effectiveness; effectiveness research; falls; follow-up; high risk; implantable device; improved; indexing; innovation; mortality; novel; patient safety; population based; programs; public health relevance; spine bone structure

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.

描述（由申请人提供）：我们的总体目标是提高椎管狭窄手术中患者的安全性。我们希望通过更好地为外科医生和患者的治疗决策提供有关手术风险的个性化数据来实现这一目标。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变化引起。在美国，65岁以上成人的狭窄手术是增长最快的脊柱手术类型，每年有40，000例手术，国家医院的医疗保险费用为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，因此临床医生通常不确定是否建议手术以及手术的范围。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，以及如何安全地进行广泛的手术。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）来研究腰椎管狭窄症手术的并发症和再手术。我们的目的是（1）确定人群和显著亚组中再次脊柱手术的发生率和原因;（2）确定危及生命的并发症发生率和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）开发和验证主要不良事件的预测规则。手术侵入性是研究的一个新的重要因素，因为在手术的脊柱节段数量、融合术的使用、解剖入路和外科植入物的使用方面有很大的自由裁量权。我们假设这些对并发症风险有重要影响。分析将使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估计手术风险的能力，并向患者提供脊柱手术的益处和风险，从而提高患者在高风险环境中的安全性。该项目的创新方面是使用一种新的措施，选择程序的“侵入性”作为脊柱手术的风险因素;使用两个人口为基础的数据库，以增加结果的鲁棒性;和示范的新方法，监测手术创新的安全性，提高护理质量的评估，并个性化的知情同意文件。公共卫生关系：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，监测手术产品和改善质量评估。