Patient-Reported Outcomes Following Surgery for Lumbar Disc Herniation: Comparison of a Universal and Multitier Health Care System.

STUDY DESIGN: Ambispective cohort study. OBJECTIVE: Canada has a government-funded universal health care system. The United States utilizes a multitier public and private system. The objective is to investigate differences in clinical outcomes between those surgically treated for lumbar disc herniation in a universal health care and multitier health system. METHODS: Surgical lumbar disc herniation patients enrolled in the Canadian Spine Outcome Research Network (CSORN) were compared with the surgical cohort enrolled in the Spine Patients Outcome Research Trial (SPORT) study. Baseline demographics and spine-related patient-reported outcomes (PROs) were compared at 3 months and 1 year post-operatively. RESULTS: The CSORN cohort consisted of 443 patients; the SPORT cohort had 763 patients. Patients in the CSORN cohort were older (46.4 ± 13.5 vs 41.0 ± 10.8, P < .001) and were more likely to be employed (69.5% vs 60.3%, P = .003). The CSORN cohort demonstrated significantly greater rates of satisfaction after surgery at 3 months (87.2% vs 64.8%, P < .0001) and 1 year (85.6% vs 69.6%, P < .0001). Improvements in back and leg pain followed similar trajectories in the two cohorts, but there was less improvement on ODI in the CSORN cohort (P < .01). On multivariable logistic regression, the CSORN cohort was a significant independent predictor of patient satisfaction at 1-year follow-up (P < .001). CONCLUSIONS: Despite less improvement on ODI, patients enrolled in CSORN, as part of a universal health care system, reported higher rates of satisfaction at 3 months and 1 year post-operatively compared to patients enrolled within a multitier health system.

Surgical outcomes of patients who fail to reach minimal clinically important differences: comparison of minimally invasive versus open transforaminal lumbar interbody fusion.

OBJECTIVE: Treatment of degenerative lumbar diseases has been shown to be clinically effective with open transforaminal lumbar interbody fusion (O-TLIF) or minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF). Despite this, a substantial proportion of patients do not meet minimal clinically important differences (MCIDs) in patient-reported outcomes (PROs). The objectives of this study were to compare the proportions of patients who did not meet MCIDs after O-TLIF and MIS-TLIF and to determine potential clinical factors associated with failure to achieve MCID. METHODS: The authors performed a retrospective analysis of consecutive patients who underwent O-TLIF or MIS-TLIF for lumbar degenerative disorders and had been prospectively enrolled in the Canadian Spine Outcomes and Research Network. The authors analyzed the Oswestry Disability Index (ODI) scores, physical and mental component summary scores of SF-12, numeric rating scale (NRS) scores for leg and back pain, and EQ-5D scores of the patients in each group who did not meet the MCID of ODI at 2 years postoperatively. RESULTS: In this study, 38.8% (137 of 353) of patients in the O-TLIF cohort and 41.8% (51 of 122) of patients in the MIS-TLIF cohort did not meet the MCID of ODI at 2 years postoperatively (p = 0.59). Demographic variables and baseline PROs were similar between groups. There were improvements across the PROs of both groups through 2 years, and there were no differences in any PROs between the O-TLIF and MIS-TLIF cohorts. Multivariable logistic regression analysis demonstrated that higher baseline leg pain score (p = 0.017) and a diagnosis of spondylolisthesis (p = 0.0053) or degenerative disc disease (p = 0.022) were associated with achieving the MCID at 2 years after O-TLIF, whereas higher baseline leg pain score was associated with reaching the MCID after MIS-TLIF (p = 0.038). CONCLUSIONS: Similar proportions of patients failed to reach the MCID of ODI at 2 years after O-TLIF or MIS-TLIF. Higher baseline leg pain score was predictive of achieving the MCID in both cohorts, whereas a diagnosis of spondylolisthesis or degenerative disc disease was predictive of reaching the MCID after O-TLIF. These data provide novel insights for patient counseling and suggest that either MIS-TLIF or O-TLIF does not overcome specific patient factors to mitigate clinical success or failure in terms of the intermediate-term PROs associated with 1- to 2-level lumbar fusion surgical procedures for degenerative pathologies.

Back Dominant Pain Has Equal Outcomes to Radicular Dominant Pain Following Posterior Lumbar Fusion in Adult Isthmic Spondylolisthesis: A CSORN Study.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: This study aimed to determine how the surgeon-determined and patient-rated location of predominant pain influences patient-rated outcomes at 1-year after posterior lumbar fusion in adult isthmic spondylolisthesis. METHODS: We retrospectively reviewed consecutive patients prospectively enrolled in the Canadian Spine Outcomes and Research Network national registry between 2009 and 2017 that underwent posterior lumbar fusion for isthmic spondylolisthesis. Using longitudinal mixed-model repeated-measures analysis the change from baseline in patient-reported outcome measures (PROMs) at 1 year after surgery was compared between surgeon-determined groups (back vs. radicular) and between patient-rated pain groups (back, leg, and equal) derived from preoperative pain scores on the numerical rating scale (NRS). RESULTS: 83/252 (33%) patients had a surgeon-determined chief complaint of back pain, while 103 (41%) patients rated their back pain as the predominant pain location, and 78 (31%) rated their back and leg pain to be equal. At baseline patients in the surgeon-determined radicular group had worse NRS-leg pain than those in the back-pain group but equal NRS-back pain. At baseline patients in the patient-rated equal pain group had similar back pain compared to the patient-rated back pain group and similar leg pain compared to the patient-rated leg pain group. All PROMs improved post-operatively and were not different between the 2 groups at 1 year. CONCLUSIONS: Our study found no difference in outcome, irrespective of whether a surgeon determines the patient's primary pain complaint back or radicular dominant, or the patient rates pain in one location greater than another.

National adverse event profile after lumbar spine surgery for lumbar degenerative disorders and comparison of complication rates between hospitals: a CSORN registry study.

OBJECTIVE: Previous works investigating rates of adverse events (AEs) in spine surgery have been retrospective, with data collection from administrative databases, and often from single centers. To date, there have been no prospective reports capturing AEs in spine surgery on a national level, with comparison among centers. METHODS: The Spine Adverse Events Severity system was used to define the incidence and severity of AEs after spine surgery by using data from the Canadian Spine Outcomes and Research Network (CSORN) prospective registry. Patient data were collected prospectively and during hospital admission for those undergoing elective spine surgery for degenerative conditions. The Spine Adverse Events Severity system defined minor and major AEs as grades 1-2 and 3-6, respectively. RESULTS: There were 3533 patients enrolled in this cohort. There were 85 (2.4%) individual patients with at least one major AE and 680 (19.2%) individual patients with at least one minor AE. There were 25 individual patients with 28 major intraoperative AEs and 260 patients with 275 minor intraoperative AEs. Postoperatively there were 61 patients with a total of 80 major AEs. Of the 487 patients with minor AEs postoperatively there were 698 total AEs. The average enrollment was 321 patients (range 47-1237 patients) per site. The rate of major AEs was consistent among sites (mean 2.9% ± 2.4%, range 0%-9.1%). However, the rate of minor AEs varied widely among sites-from 7.9% to 42.5%, with a mean of 18.8% ± 9.7%. The rate of minor AEs varied depending on how they were reported, with surgeon reporting associated with the lowest rates (p < 0.01). CONCLUSIONS: The rate of major AEs after lumbar spine surgery is consistent among different sites but the rate of minor AEs appears to vary substantially. The method by which AEs are reported impacts the rate of minor AEs. These data have implications for the detection and reporting of AEs and the design of strategies aimed at mitigating complications.

Clinical predictors of achieving the minimal clinically important difference after surgery for cervical spondylotic myelopathy: an external validation study from the Canadian Spine Outcomes and Research Network.

OBJECTIVE: Recently identified prognostic variables among patients undergoing surgery for cervical spondylotic myelopathy (CSM) are limited to two large international data sets. To optimally inform shared clinical decision-making, the authors evaluated which preoperative clinical factors are significantly associated with improvement on the modified Japanese Orthopaedic Association (mJOA) scale by at least the minimum clinically important difference (MCID) 12 months after surgery, among patients from the Canadian Spine Outcomes and Research Network (CSORN). METHODS: The authors performed an observational cohort study with data that were prospectively collected from CSM patients at 7 centers between 2015 and 2017. Candidate variables were tested using univariable and multiple binomial logistic regression, and multiple sensitivity analyses were performed to test assumptions about the nature of the statistical models. Validated mJOA MCIDs were implemented that varied according to baseline CSM severity. RESULTS: Among 205 patients with CSM, there were 64 (31%) classified as mild, 86 (42%) as moderate, and 55 (27%) as severe. Overall, 52% of patients achieved MCID and the mean change in mJOA score at 12 months after surgery was 1.7 ± 2.6 points (p < 0.01), but the subgroup of patients with mild CSM did not significantly improve (mean change 0.1 ± 1.9 points, p = 0.8). Univariate analyses failed to identify significant associations between achieving MCID and sex, BMI, living status, education, smoking, disability claims, or number of comorbidities. After adjustment for potential confounders, the odds of achieving MCID were significantly reduced with older age (OR 0.7 per decade, 95% CI 0.5-0.9, p < 0.01) and higher baseline mJOA score (OR 0.8 per point, 95% CI 0.7-0.9, p < 0.01). The effects of symptom duration (OR 1.0 per additional month, 95% CI 0.9-1.0, p = 0.2) and smoking (OR 0.4, 95% CI 0.2-1.0, p = 0.06) were not statistically significant. CONCLUSIONS: Surgery is effective at halting the progression of functional decline with CSM, and approximately half of all patients achieve the MCID. Data from the CSORN confirmed that older age is independently associated with poorer outcomes, but novel findings include that patients with milder CSM did not experience meaningful improvement, and that symptom duration and smoking were not important. These findings support a nuanced approach to shared decision-making that acknowledges some prognostic uncertainty when weighing the various risks, benefits, and alternatives to surgical treatment.

Predictive Factors for Discharge Destination Following Posterior Lumbar Spinal Fusion: A Canadian Spine Outcome and Research Network (CSORN) Study.

STUDY DESIGN: Ambispective cohort study. OBJECTIVE: Patients spend on average 3 to 7 days in hospital after lumbar fusion surgery. Patients who are unable to be discharged home may require a prolonged hospital stay while awaiting a bed at a rehabilitation facility, adding cost and imposing a considerable burden on the health care system. Our objective is to identify patient or procedure related predictors of discharge destination for patients undergoing posterior lumbar fusion. METHODS: Analysis of data from the Canadian Spine Outcomes and Research Network. Patients who underwent lumbar fusion for degenerative pathology between 2008 and 2015 were identified. Multivariable logistic regression analysis was used to identify independent predictors of the discharge destination. RESULTS: A total of 643 patients were identified from the database, 87.1% of the patients (N = 560) were discharged home while 12.9% (N = 83) required discharge to nonhome facilities. Using multivariate logistic regression analysis, the predictors for discharge to a facility rather than home were identified including: increasing age (odds ratio [OR] 1.045, 95% confidence interval [CI] 1.017 -1.075, P < .002), increasing body mass index (BMI) (OR 1.069, 95% CI 1.021 -1.118, P < .004), increasing disability score (OR 1.025, 95% CI 1.004 -1.046, P < .02), living alone preoperatively (OR 1.916, 95% CI 1.004-3.654, P < .05), increasing operating time (OR 1.005, 95% CI 1.003 -1.008, P < .0001), need for blood transfusion (OR 3.32, 95% CI 1.687-6.528, P < .001), and multilevel fusion surgery (OR 1.142, 95% CI 1.007 -1.297, P < .04). CONCLUSIONS: Older age, high BMI, living alone, high disability score, extended surgical time, blood transfusion, and multilevel fusion are significant factors that increase the odds of being discharged to facilities other than home. LEVEL OF EVIDENCE: Level 3.

Patient-reported outcomes following surgery for degenerative spondylolitshtesis: comparison of a universal and multitier health care system.

STUDY DESIGN: Retrospective review of results from a prospectively collected Canadian cohort in comparison to published literature. OBJECTIVES: (1) To investigate whether patients in a universal health care system have different outcomes than those in a multitier health care system in surgical management of degenerative spondylolisthesis (DS). (2) To identify independent factors predictive of outcome in surgical DS patients. SUMMARY OF BACKGROUND DATA: Canada has a national health insurance program with unique properties. It is a single-payer system, coverage is universal, and access to specialist care requires referral by the primary care physician. The United States on the other hand is a multitier public/private payer system with more rapid access for insured patients to specialist care. METHODS: Surgical DS patients treated between 2013 and 2016 in Canada were identified through the Canadian Spine Outcome Research Network (CSORN) database, a national registry that prospectively enrolls consecutive patients with spinal pathology from 16 tertiary care academic hospitals. This population was compared with the surgical DS arm of patients treated in the Spine Patients Outcome Research Trial (SPORT) study. We compared baseline demographics, spine-related, and health-related quality of life (HRQOL) outcomes at 3 months and 1 year. Multivariate analysis was used to identify factors predictive of outcome in surgical DS patients. RESULTS: The CSORN cohort of 213 patients was compared with the SPORT cohort of 248 patients. Patients in the CSORN cohort were younger (mean age 60.1 vs. 65.2; p<.001), comprised fewer females (60.1% vs. 67.7%; p=.09), and had a higher proportion of smokers (23.3% vs. 8.9%; p<.001). The SPORT cohort had more patients receiving compensation (14.6% vs. 7.7%; p<.001). The CSORN cohort consisted of patients with slightly greater baseline disability (Oswestry disability index scores: 47.7 vs. 44.0; p=.008) and had more patients with symptom duration of greater than 6 months (93.7% vs. 62.1%; p<.001). The CSORN cohort showed greater satisfaction with surgical results at 3 months (91.1% vs. 66.1% somewhat or very satisfied; p<.01) and 1 year (88.2% vs. 71.0%, p<.01). Improvements in back and leg pain were similar comparing the two cohorts. On multivariate analysis, duration of symptoms, treatment group (CSORN vs. SPORT) or insurance type (public/Medicare/Medicaid vs. Private/Employer) predicted higher level of postoperative satisfaction. Baseline depression was also associated with worse Oswestry disability index at 1-year postoperative follow-up in both cohorts. CONCLUSIONS: Surgical DS patients treated in Canada (CSORN cohort) reported higher levels of satisfaction than those treated in the United States (SPORT cohort) despite similar to slightly worse baseline HRQOL measures. Symptom duration and insurance type appeared to impact satisfaction levels. Improvements in other patient-reported health-related quality of life measures were similar between the cohorts.

Clinical outcomes research in spine surgery: what are appropriate follow-up times?

In BriefThe time course required for the patient-reported outcomes of pain, physical function, and mental health to reach a recovery plateau after elective lumbar spine surgery was assessed utilizing a prospectively maintained multicenter registry. The work is important as it demonstrates that specific health dimensions follow different recovery plateaus and it provides evidence that a 2-year postoperative follow-up is not required to accurately assess the treatment effect of established surgeries for lumbar spinal pathologies.