Variation in the Safety of Back Pain-Related Surgery

背痛相关手术的安全性差异

• 批准号: 7938031
• 负责人: Sohail K Mirza
• 金额: $ 42.38万
• 依托单位: DARTMOUTH COLLEGE
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7938031
• 关键词: Address; Age; American Hospital Association; American Medical Association; Area; Arthritis; Atlases; Back; Back Pain; Beds; Benchmarking; Board Certification; Case Mixes; Characteristics; Client satisfaction; Clinical Trials; Comorbidity; Complex; Confidence Intervals; Consensus; Consumer Satisfaction; Controlled Clinical Trials; Data; Decision Making; Degenerative Disorder; Diagnosis; Discipline; Disease; Electronics; Evaluation; Fellowship; Frequencies; Funding; Gender; Health; Health Personnel; Hernia; Hospital Referrals; Hospital Sizes; Hospitals; Image; Incentives; Individual; Informed Consent; Institute of Medicine (U.S.); Ions; Journals; Knowledge; Label; Lead; Leg; Link; Marketing; Measures; Medical; Medicare; Medicare claim; Methods; National Institute of Arthritis and Musculoskeletal and Skin Diseases; Operative Surgical Procedures; Orthopedics; Outcome; Outcomes Research; Patient Care; Patients; Penetration; Performance; Physicians; Policies; Procedures; Provider; Publishing; Quality Indicator; Quality of Care; Records; Reference Standards; Repeat Surgery; Research Methodology; Risk; Safety; Services; Spinal; Spinal Stenosis; Spondylolisthesis; State Hospitals; Surgeon; Surveys; Symptoms; System; Training; Treatment Factor; United States; United States Centers for Medicare and Medicaid Services; Variant; Vertebral column; Work; clinical practice; comparative effectiveness; experience; falls; follow-up; geographic difference; health care quality; health disparity; high standard; hospital bed; indexing; instrument; medical specialties; meetings; neurosurgery; operation; payment; population based; preference; public health relevance; shared decision making; tool

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.

描述（由申请人提供）：本申请解决了广泛的挑战领域 (09)：健康差异和具体挑战主题，09-AG-101：医疗保险使用中的地理差异。拟议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，该特征高于脊柱患者结果研究试验 (SPORT)，该试验是 NIAMS 资助的有史以来最大的临床试验（2,472患者、53 位精英外科医生、11 个州的 13 家顶级医院以及超过 2700 万美元的资金）。 SPORT 为椎间盘突出症、椎管狭窄和退行性脊柱滑脱的治疗提供 1 级和 2 级证据；我们建议将其用作比较背部手术结果的参考标准。在 SPORT 中，患者不仅具有积极的身体检查结果和相关的影像学检查结果，而且还具有相关症状的持续时间（6-12 周以上），因此手术是一个合理的选择。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，这是比传统实践更高的知情同意标准。 SPORT 的结果已发表在最负盛名的医学期刊上，并积累了超过 5 年的随访数据。因此，我们知道在理想条件下，背部手术对于常见的关节炎相关背部疾病是如何“安全”的。现在我们需要知道临床实践是否符合这些标准；如果没有，为什么不呢？寻求缓解严重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功效产生误解，而且还可能低估真正的风险与期望的益处。手术的选择是一个重要的、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接受手术。背部手术利用的地区差异使得在适应症上明显缺乏共识，但人们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，尽管有良好且适当的适应症，但有些患者在充分了解情况后仍会拒绝手术治疗。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仍然满意。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，而未经指示或无效的手术不太可能缓解症状。持续的背部症状可能会导致额外的手术。对一个在充分知情的情况下不愿接受手术的患者进行手术实际上是一个安全问题：它使患者面临不必要的风险。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。使用 SPORT 中的再手术率作为背部手术的安全基准，我们将确定哪些区域、医院和/或外科医生因素与高于 SPORT 中观察到的再手术率相关。高重复手术率可能表明初次手术无效（被医学研究所 (IOM) 全国医疗保健质量圆桌会议标记为“过度使用”）或潜在可避免的手术并发症（被 IOM 标记为“误用”）。在调整患者因素和手术病例组合后，重复背部手术率比运动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) 将安全确定为国家优先事项，“力争随时随地实现‘零’伤害”，并建议将背部手术列为制定过度使用措施的重点领域之一。我们建议使用经过验证的方法在行政电子健康数据中确定腰椎手术，对医疗保险患者的重复手术率进行基于人群的评估。我们将制定两个衡量背部手术护理质量的指标：（1）“误用”，我们定义为30天或1年重复腰椎手术率高于SPORT 95%置信区间的上限； (2)“过度使用”我们定义为4年重复手术率高于SPORT 95%置信区间的上限。我们将根据再手术率对未识别身份的各个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域 (HRR) 和 3,300 个医院服务区 (HSA) 中背部手术过度使用的地理差异。拟议的工作将完善电子索赔研究方法，以进行持续的背部手术安全监测和比较有效性评估，并提供政策和支付改革策略的必要组成部分，使所有患者的背部手术更加安全。 公共健康相关性：我们将通过观察初次手术后 30 天、1 年和 4 年需要进行第二次手术的频率作为质量指标，比较不同医院和不同外科医生的背部手术护理质量差异。脊柱患者结果研究试验是有史以来规模最大的背部手术研究，顶级外科医生和顶级医院对精心挑选的患者进行了手术，为背部手术的“安全”程度设定了标准。我们将了解背部手术安全性在哪些方面低于 SPORT 基准，以及哪些医院因素和外科医生因素与背部手术安全性降低有关。这些知识可以帮助寻求手术缓解关节炎相关背部和腿部症状的患者更好地选择手术地点，并且可以指导绩效和激励政策，使脊柱手术对所有患者来说更安全。