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）：此申请解决广泛的挑战领域（09）：健康差异和特定挑战主题，09-AG-101：Medicare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，高于脊柱患者结局研究试验（Sport），这是有史以来最大的临床试验，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个高级医院，11个州的13个顶级医院，以及2700万美元的资助）。 Sport提供了1级和2级的证据，用于治疗椎间盘疝，脊柱stenos和退化性脊柱滑脱的证据；我们建议将其用作比较背部手术结果的参考标准。在运动中，患者不仅具有积极的身体发现和相关的成像发现，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的决策（“知情选择”），其中记录了他们的价值观和偏好，知情同意的标准要比传统上实行的要高得多。体育的成果已在最负盛名的医学期刊上发表，并具有> 5年的随访数据。因此，我们知道在理想条件下，与普通关节炎相关的常见背部疾病如何“安全”的背部手术。现在我们需要知道临床实践是否符合这些标准；如果不是，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受到某些类型的背部手术功效的误解，而且还可能低估了真正的风险与所需的益处。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，可靠的重复手术风险估计可能足以让患者反对该手术。背部手术利用情况的区域差异显然缺乏对适应症的共识，但对安全性方面的差异或这种变化对决策的影响知之甚少。我们知道，尽管有良好的迹象，有些患者（知情人士）会降低手术治疗。在运动中，尽管有非常适当的迹象，但仍有数百名患者的手术干预下降，并对他们的治疗决定保持满意。我们知道外科医生可能会向类似患者提供不同类型的背部手术，并且未识别或无效的手术不太可能缓解症状。反过来，持续的背部症状可能会导致其他手术。要对患者进行操作，如果了解到，那些不愿意进行操作的患者实际上是一个安全问题：这会使患者处于不必要的风险中。重复腰手术是外科医生和患者关心的不良安全结果。我们建议将基于人群的重新手术率作为研究背部手术质量差异的工具。使用运动中的重新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/或外科医生的因素与重新手术率有关，高于运动率。重复手术的高率可能表明初始手术无效（被医学研究所（IOM）在医疗保健质量方面被标记为“过度使用”）或可能避免手术并发症的并发症（由IOM标记为“滥用”）。调整患者因素和手术病例混合后，重复手术率一两个标准偏差高于运动率，可能表明手术技术性能（“滥用”）或不良手术适应症（“过度使用”）问题。国家质量论坛（NQF）已将安全性确定为国家优先事项，“旨在尽可能及地进行'零'危害”，并建议在其重点领域中进行重新手术以制定过度使用措施。我们建议使用经过验证的方法来确定行政电子健康数据中的腰手术的经过验证的方法对Medicare患者的重复手术率进行评估。我们将开发两个指标来衡量背部手术中的护理质量：（1）“滥用”我们将30天或1年重复的腰手术率高于Sport 95％置信区间的上限； （2）我们将“过度使用”定义为4年重复手术率高于Sport 95％置信区间的上限。我们将通过重新手术率对识别的单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。我们还将描述在344 Dartmouth Atlas美国医院转诊地区（HRR）和3,300医院服务区域（HSA）（HSA）中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，以允许持续的背部手术安全监视和比较有效性评估，并提供了政策和支付改革策略的必要组成部分，以使所有患者更安全。 公共卫生相关性：我们将通过查看初次手术后的30天，1年和4年需要进行第二次手术，以比较不同医院和不同外科医生背部手术的护理质量差异。脊柱患者结局研究试验是有史以来最大的背部手术研究，其中顶级外科医生和顶级医院对精心挑选的患者进行了手术，这为“安全”背部手术的标准设定了标准。我们将看到背部手术安全性的位置未达到运动基准，以及哪些医院因素和外科医生因使背部手术降低的安全性。这些知识可以帮助寻求与关节炎相关的背部和腿部症状的手术缓解的患者在哪里进行手术做出更好的选择，并且可以指导性能和激励政策，以使所有患者更安全。