Variation in the Safety of Back Pain-Related Surgery

描述（由申请人提供）：本申请涉及广泛的挑战领域（09）：健康差异和具体的挑战主题，09- ag -101：医疗保险使用中的地理差异。拟议的项目将描述背部手术护理质量的地理差异，并检查与重复手术率相关的医院/外科医生特征，这些手术率高于脊柱患者结果研究试验（SPORT），这是NIAMS资助的最大的临床试验（2,472名患者，53名精英外科医生，11个州的13家顶级医院，资金超过2,700万美元）。SPORT为椎间盘突出、椎管狭窄和退行性脊柱滑脱的治疗提供了1级和2级证据；我们建议将其作为比较背部手术结果的参考标准。在SPORT中，患者不仅有阳性的身体检查结果和相关的影像学检查结果，而且还有相关症状的持续时间（6-12周以上），因此手术将是一个合理的选择。此外，所有患者都经历了共同决策（“知情选择”），其中记录了他们的价值观和偏好，这比传统做法的知情同意标准高得多。SPORT的结果已发表在最负盛名的医学期刊上，并积累了50年的随访数据。因此，我们知道在理想的条件下，对于常见的与关节炎相关的背部疾病，背部手术是多么“安全”。现在我们需要知道临床实践是否符合这些标准；如果没有，为什么呢？寻求缓解严重的背部和腿部症状的患者不仅容易对某些类型的背部手术的疗效产生误解，而且他们也可能低估了真正的风险与预期的益处。选择手术是一个重要的，不可逆转的决定。对于某些类型的手术，重复手术风险的可靠估计可能足以让患者决定不进行手术。背部手术应用的地区差异明显缺乏对适应症的共识，但对安全性方面的地区差异或这种差异对决策的影响知之甚少。我们知道，尽管有良好和适当的适应症，一些患者在充分了解情况后，会拒绝手术治疗。在SPORT中，数百名患者尽管有非常合适的适应症，但拒绝手术干预，并对他们的治疗决定感到满意。我们知道，外科医生可能会为类似的患者提供不同类型的背部手术，而无指征或无效的手术不太可能缓解症状。持续的背部症状，反过来，可能导致额外的手术。事实上，给知情但不愿接受手术的病人做手术是一个安全问题：它将病人置于不必要的风险之中。重复腰椎手术是外科医生和患者关心的不良安全结果。我们建议使用基于人群的再手术率作为研究背部手术护理质量差异的工具。将SPORT中的再手术率作为背部手术的安全基准，我们将确定哪些地区、医院和/或外科医生因素与再手术率高于SPORT中观察到的发生率相关。重复手术的高比率可能意味着无效的初始手术（被医学研究所（IOM）国家卫生保健质量圆桌会议标记为“过度使用”）或潜在的可避免的手术并发症（被IOM标记为“滥用”）。在对患者因素和手术病例组合进行调整后，背部重复手术率比SPORT率高一到两个标准差，可能表明手术技术性能存在问题（“误用”）或手术适应症不佳（“过度使用”）。国家质量论坛（NQF）已将安全确定为国家的优先事项，“旨在随时随地实现‘零伤害’”，并建议将背部手术作为制定过度使用措施的重点领域之一。我们建议以人群为基础评估医疗保险患者的重复手术率，使用经过验证的方法来确定行政电子健康数据中的腰椎手术。我们将制定两个指标来衡量背部手术的护理质量：(1)“误用”我们定义为30天或1年重复腰椎手术率高于SPORT 95%置信区间上限；(2)“过度使用”定义为4年重复手术率高于SPORT 95%置信区间上限。我们将根据再手术率对未确定的个别医院和外科医生进行排名，并确定与滥用和过度使用相关的医院/外科医生特征。我们还将描述344个达特茅斯地图集美国医院转诊区（HRR）和3300个医院服务区（HSA）中背部手术过度使用的地理差异。拟议的工作将改进电子索赔研究方法，以便进行背部手术安全监测和比较有效性评估，并为政策和支付改革战略提供必要的组成部分，使所有患者的背部手术更安全。

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (09): Health Disparities and specific Challenge Topic, 09-AG-101: Geographic Disparities in Medicare Usage. The proposed project will describe geographic disparities in quality of care of back surgery and examine hospital/surgeon characteristics associated with rates of repeat surgery higher than those in the Spine Patient Outcomes Research Trial (SPORT), the largest clinical trial ever funded by NIAMS (2,472 patients, 53 elite surgeons, 13 top hospitals in 11 states, and over $27 million in funding). SPORT provides Level 1 and Level 2 evidence for treatment of disc hernia ion, spinal stenos is, and degenerative spondylolisthesis; we propose to use it as the reference standard for comparing outcomes in back surgery. In SPORT, not only did patients have positive physical findings and correlated imaging findings, they also had a duration of associated symptoms (6-12 weeks plus) such that surgery would be a reasonable option. Furthermore, all patients experienced shared decision making ("Informed Choice"), wherein their values and preferences were recorded, a much higher standard of informed consent than is traditionally practiced. Outcomes for SPORT have been published in the most prestigious medical journals, with >5-year follow-up data accruing. Thus, we know how "safe" back surgery can be for common arthritis-related back disorders under the ideal conditions. Now we need to know if clinical practice meets these standards; and if not, why not? Patients seeking relief for severe back and leg symptoms are vulnerable not only to misperceptions about efficacy of some types of back surgery, but they may also underestimate the true risks versus desired benefits. Choice of surgery is an important, irreversible decision. For some types of surgery, reliable estimate of repeat surgery risk may be enough for patients to decide against the procedure. Regional variation in utilization of back surgery makes obvious lack of consensus on indications, but little is known about regional variation in terms of safety or the impact of this variation on decision-making. We know that despite good and appropriate indications some patients, when well informed, will decline surgical treatment. In SPORT several hundred patients, despite having very appropriate indications, declined surgical intervention and remained satisfied with their treatment decisions. We know surgeons may offer different types of back surgery to similar patients, and un-indicated or ineffective surgery is unlikely to relieve symptoms. Persistent back symptoms, in turn, may lead to additional surgery. To operate on a patient who, when well informed, would not chose to be operated on is, in fact, a SAFETY issue: it puts the patient at unnecessary risk. Repeat lumbar surgery is an undesirable safety outcome that surgeons and patients care about. We propose to use population-based rates of reoperation as a tool to study disparities in quality of care for back surgery. Using reoperation rates in SPORT as safety benchmarks for back surgery, we will determine which regional, hospital and/or surgeon factors are associated with reoperation rates higher than rates observed in SPORT. High rates of repeat surgery may point to ineffective initial surgery (labeled as "overuse" by the Institute of Medicine (IOM) National Roundtable on Health Care Quality) or potentially avoidable complications of surgery (labeled by IOM as "misuse"). After adjusting for patient factors and surgical case-mix, repeat back surgery rates one or two standard deviations higher than SPORT rates may suggest problems with technical performance of surgery ("misuse") or poor surgical indications ("overuse"). The National Quality Forum (NQF) has identified safety as a national priority, "aiming for 'zero' harm wherever and whenever possible", and it has recommended back surgery among its areas of focus for developing overuse measures. We propose population-based evaluation of repeat surgery rates in Medicare patients using validated methods for ascertaining lumbar surgery in administrative electronic health data. We will develop two indicators for measuring quality of care in back surgery: (1) "Misuse" we define as the 30-day or 1-year repeat lumbar surgery rate higher than the upper limit of SPORT 95% confidence intervals; and (2) "Overuse" we define as 4-year repeat surgery rate higher than the upper limit of the SPORT 95% confidence interval. We will rank de-identified individual hospitals and surgeons by reoperation rate and identify hospital/surgeon features associated with Misuse and Overuse. We also will describe geographic variation in back surgery Overuse across the 344 Dartmouth Atlas United States Hospital Referral Regions (HRR) and 3,300 Hospital Service Areas (HSA). The proposed work will refine electronic claims research methodology to allow ongoing back surgery safety surveillance and comparative effectiveness evaluations, and provide a necessary component of policy and payment reform strategies for making back surgery safer for all patients. PUBLIC HEALTH RELEVANCE: We will compare differences in quality of care for back surgery across different hospitals and different surgeons by seeing how often a second operation is needed 30-days, 1-year, and 4-years after the initial operation as a quality indicator. The Spine Patient Outcomes Research Trial, the largest ever back surgery study in which top surgeons and top hospitals performed surgery on carefully selected patients, sets the standard for how "safe" back surgery can be. We will see where back surgery safety falls short of the SPORT benchmarks, and which hospital factors and surgeon factors are associated with making back surgery less safe. This knowledge can help patients seeking surgical relief of arthritis-related back and leg symptoms make better choices on where to have surgery, and it can guide performance and incentive policies to make spinal surgery safer for all patients.