Variation in the Safety of Back Pain-Related Surgery

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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.