Minimally invasive versus open transforaminal lumbar interbody fusion for grade I lumbar spondylolisthesis: 5-year follow-up from the prospective multicenter Quality Outcomes Database registry.

OBJECTIVE: Minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) has been used to treat degenerative lumbar spondylolisthesis and is associated with expedited recovery, reduced operative blood loss, and shorter hospitalizations compared to those with traditional open TLIF. However, the impact of MI-TLIF on long-term patient-reported outcomes (PROs) is less clear. Here, the authors compare the outcomes of MI-TLIF to those of traditional open TLIF for grade I degenerative lumbar spondylolisthesis at 60 months postoperatively. METHODS: The authors utilized the prospective Quality Outcomes Database registry and queried for patients with grade I degenerative lumbar spondylolisthesis who had undergone single-segment surgery via an MI or open TLIF method. PROs were compared 60 months postoperatively. The primary outcome was the Oswestry Disability Index (ODI). The secondary outcomes included the numeric rating scale (NRS) for back pain (NRS-BP), NRS for leg pain (NRS-LP), EQ-5D, North American Spine Society (NASS) satisfaction, and cumulative reoperation rate. Multivariable models were constructed to assess the impact of MI-TLIF on PROs, adjusting for variables reaching p < 0.20 on univariable analyses and respective baseline PRO values. RESULTS: The study included 297 patients, 72 (24.2%) of whom had undergone MI-TLIF and 225 (75.8%) of whom had undergone open TLIF. The 60-month follow-up rates were similar for the two cohorts (86.1% vs 75.6%, respectively; p = 0.06). Patients did not differ significantly at baseline for ODI, NRS-BP, NRS-LP, or EQ-5D (p > 0.05 for all). Perioperatively, MI-TLIF was associated with less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 ml, p < 0.001) and longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 minutes, p < 0.001) but had similar lengths of hospitalizations (MI-TLIF 2.9 ± 1.8 vs open TLIF 3.3 ± 1.6 days, p = 0.08). Discharge disposition to home or home health was similar (MI-TLIF 93.1% vs open TLIF 91.1%, p = 0.60). Both cohorts improved significantly from baseline for the 60-month ODI, NRS-BP, NRS-LP, and EQ-5D (p < 0.001 for all comparisons). In adjusted analyses, MI-TLIF, compared to open TLIF, was associated with similar 60-month ODI, ODI change, odds of reaching ODI minimum clinically important difference, NRS-BP, NRS-BP change, NRS-LP, NRS-LP change, EQ-5D, EQ-5D change, and NASS satisfaction (adjusted p > 0.05 for all). The 60-month reoperation rates did not differ significantly (MI-TLIF 5.6% vs open TLIF 11.6%, p = 0.14). CONCLUSIONS: For symptomatic, single-level grade I degenerative lumbar spondylolisthesis, MI-TLIF was associated with decreased blood loss perioperatively, but there was no difference in 60-month outcomes for disability, back pain, leg pain, quality of life, or satisfaction between MI and open TLIF. There was no difference in cumulative reoperation rates between the two procedures. These results suggest that in appropriately selected patients, either procedure may be employed depending on patient and surgeon preferences.

Developing nonlinear k-nearest neighbors classification algorithms to identify patients at high risk of increased length of hospital stay following spine surgery.

OBJECTIVE: Spondylolisthesis is a common operative disease in the United States, but robust predictive models for patient outcomes remain limited. The development of models that accurately predict postoperative outcomes would be useful to help identify patients at risk of complicated postoperative courses and determine appropriate healthcare and resource utilization for patients. As such, the purpose of this study was to develop k-nearest neighbors (KNN) classification algorithms to identify patients at increased risk for extended hospital length of stay (LOS) following neurosurgical intervention for spondylolisthesis. METHODS: The Quality Outcomes Database (QOD) spondylolisthesis data set was queried for patients receiving either decompression alone or decompression plus fusion for degenerative spondylolisthesis. Preoperative and perioperative variables were queried, and Mann-Whitney U-tests were performed to identify which variables would be included in the machine learning models. Two KNN models were implemented (k = 25) with a standard training set of 60%, validation set of 20%, and testing set of 20%, one with arthrodesis status (model 1) and the other without (model 2). Feature scaling was implemented during the preprocessing stage to standardize the independent features. RESULTS: Of 608 enrolled patients, 544 met prespecified inclusion criteria. The mean age of all patients was 61.9 ± 12.1 years (± SD), and 309 (56.8%) patients were female. The model 1 KNN had an overall accuracy of 98.1%, sensitivity of 100%, specificity of 84.6%, positive predictive value (PPV) of 97.9%, and negative predictive value (NPV) of 100%. Additionally, a receiver operating characteristic (ROC) curve was plotted for model 1, showing an overall area under the curve (AUC) of 0.998. Model 2 had an overall accuracy of 99.1%, sensitivity of 100%, specificity of 92.3%, PPV of 99.0%, and NPV of 100%, with the same ROC AUC of 0.998. CONCLUSIONS: Overall, these findings demonstrate that nonlinear KNN machine learning models have incredibly high predictive value for LOS. Important predictor variables include diabetes, osteoporosis, socioeconomic quartile, duration of surgery, estimated blood loss during surgery, patient educational status, American Society of Anesthesiologists grade, BMI, insurance status, smoking status, sex, and age. These models may be considered for external validation by spine surgeons to aid in patient selection and management, resource utilization, and preoperative surgical planning.

Quality Outcomes Database Spine Care Project 2012-2020: milestones achieved in a collaborative North American outcomes registry to advance value-based spine care and evolution to the American Spine Registry.

The Quality Outcomes Database (QOD), formerly known as the National Neurosurgery Quality Outcomes Database (N2QOD), was established by the NeuroPoint Alliance (NPA) in collaboration with relevant national stakeholders and experts. The overarching goal of this project was to develop a centralized, nationally coordinated effort to allow individual surgeons and practice groups to collect, measure, and analyze practice patterns and neurosurgical outcomes. Specific objectives of this registry program were as follows: "1) to establish risk-adjusted national benchmarks for both the safety and effectiveness of neurosurgical procedures, 2) to allow practice groups and hospitals to analyze their individual morbidity and clinical outcomes in real time, 3) to generate both quality and efficiency data to support claims made to public and private payers and objectively demonstrate the value of care to other stakeholders, 4) to demonstrate the comparative effectiveness of neurosurgical and spine procedures, 5) to develop sophisticated 'risk models' to determine which subpopulations of patients are most likely to benefit from specific surgical interventions, and 6) to facilitate essential multicenter trials and other cooperative clinical studies." The NPA has launched several neurosurgical specialty modules in the QOD program in the 7 years since its inception including lumbar spine, cervical spine, and spinal deformity and cerebrovascular and intracranial tumor. The QOD Spine modules, which are the primary subject of this paper, have evolved into the largest North American spine registries yet created and have resulted in unprecedented cooperative activities within our specialty and among affiliated spine care practitioners. Herein, the authors discuss the experience of QOD Spine programs to date, with a brief description of their inception, some of the key achievements and milestones, as well as the recent transition of the spine modules to the American Spine Registry (ASR), a collaboration between the American Association of Neurological Surgeons and the American Academy of Orthopaedic Surgeons (AAOS).

Correlation of return to work with patient satisfaction after surgery for lumbar spondylolisthesis: an analysis of the Quality Outcomes Database.

OBJECTIVE: Return to work (RTW) and satisfaction are important outcome measures after surgery for degenerative spine disease. The authors queried the prospective Quality Outcomes Database (QOD) to determine if RTW correlated with patient satisfaction. METHODS: The QOD was queried for patients undergoing surgery for degenerative lumbar spondylolisthesis. The primary outcome of interest was correlation between RTW and patient satisfaction, as measured by the North American Spine Society patient satisfaction index (NASS). Secondarily, data on satisfied patients were analyzed to see what patient factors correlated with RTW. RESULTS: Of 608 total patients in the QOD spondylolisthesis data set, there were 292 patients for whom data were available on both satisfaction and RTW status. Of these, 249 (85.3%) were satisfied with surgery (NASS score 1-2), and 224 (76.7%) did RTW after surgery. Of the 68 patients who did not RTW after surgery, 49 (72.1%) were still satisfied with surgery. Of the 224 patients who did RTW, 24 (10.7%) were unsatisfied with surgery (NASS score 3-4). There were significantly more people who had an NASS score of 1 in the RTW group than in the non-RTW group (71.4% vs 42.6%, p < 0.05). Failure to RTW was associated with lower level of education, worse baseline back pain (measured with a numeric rating scale), and worse baseline disability (measured with the Oswestry Disability Index [ODI]). CONCLUSIONS: There are a substantial number of patients who are satisfied with surgery even though they did not RTW. Patients who were satisfied with surgery and did not RTW typically had worse preoperative back pain and ODI and typically did not have a college education. While RTW remains an important measure after surgery, physicians should be mindful that patients who do not RTW may still be satisfied with their outcome.

Predictive model for long-term patient satisfaction after surgery for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

OBJECTIVESince the enactment of the Affordable Care Act in 2010, providers and hospitals have increasingly prioritized patient-centered outcomes such as patient satisfaction in an effort to adapt the "value"-based healthcare model. In the current study, the authors queried a prospectively maintained multiinstitutional spine registry to construct a predictive model for long-term patient satisfaction among patients undergoing surgery for Meyerding grade I lumbar spondylolisthesis.METHODSThe authors queried the Quality Outcomes Database for patients undergoing surgery for grade I lumbar spondylolisthesis between July 1, 2014, and June 30, 2016. The primary outcome of interest for the current study was patient satisfaction as measured by the North American Spine Surgery patient satisfaction index, which is measured on a scale of 1-4, with 1 indicating most satisfied and 4 indicating least satisfied. In order to identify predictors of higher satisfaction, the authors fitted a multivariable proportional odds logistic regression model for ≥ 2 years of patient satisfaction after adjusting for an array of clinical and patient-specific factors. The absolute importance of each covariate in the model was computed using an importance metric defined as Wald chi-square penalized by the predictor degrees of freedom.RESULTSA total of 502 patients, out of a cohort of 608 patients (82.5%) with grade I lumbar spondylolisthesis, undergoing either 1- or 2-level decompression (22.5%, n = 113) or 1-level decompression and fusion (77.5%, n = 389), met the inclusion criteria; of these, 82.1% (n = 412) were satisfied after 2 years. On univariate analysis, satisfied patients were more likely to be employed and working (41.7%, n = 172, vs 24.4%, n = 22; overall p = 0.001), more likely to present with predominant leg pain (23.1%, n = 95, vs 11.1%, n = 10; overall p = 0.02) but more likely to present with lower Numeric Rating Scale score for leg pain (median and IQR score: 7 [5-9] vs 8 [6-9]; p = 0.05). Multivariable proportional odds logistic regression revealed that older age (OR 1.57, 95% CI 1.09-2.76; p = 0.009), preoperative active employment (OR 2.06, 95% CI 1.27-3.67; p = 0.015), and fusion surgery (OR 2.3, 95% CI 1.30-4.06; p = 0.002) were the most important predictors of achieving satisfaction with surgical outcome.CONCLUSIONSCurrent findings from a large multiinstitutional study indicate that most patients undergoing surgery for grade I lumbar spondylolisthesis achieved long-term satisfaction. Moreover, the authors found that older age, preoperative active employment, and fusion surgery are associated with higher odds of achieving satisfaction.

A comparison of minimally invasive transforaminal lumbar interbody fusion and decompression alone for degenerative lumbar spondylolisthesis.

OBJECTIVEThe optimal minimally invasive surgery (MIS) approach for grade 1 lumbar spondylolisthesis is not clearly elucidated. In this study, the authors compared the 24-month patient-reported outcomes (PROs) after MIS transforaminal lumbar interbody fusion (TLIF) and MIS decompression for degenerative lumbar spondylolisthesis.METHODSA total of 608 patients from 12 high-enrolling sites participating in the Quality Outcomes Database (QOD) lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis, of whom 143 underwent MIS (72 MIS TLIF [50.3%] and 71 MIS decompression [49.7%]). Surgeries were classified as MIS if there was utilization of percutaneous screw fixation and placement of a Wiltse plane MIS intervertebral body graft (MIS TLIF) or if there was a tubular decompression (MIS decompression). Parameters obtained at baseline through at least 24 months of follow-up were collected. PROs included the Oswestry Disability Index (ODI), numeric rating scale (NRS) for back pain, NRS for leg pain, EuroQol-5D (EQ-5D) questionnaire, and North American Spine Society (NASS) satisfaction questionnaire. Multivariate models were constructed to adjust for patient characteristics, surgical variables, and baseline PRO values.RESULTSThe mean age of the MIS cohort was 67.1 ± 11.3 years (MIS TLIF 62.1 years vs MIS decompression 72.3 years) and consisted of 79 (55.2%) women (MIS TLIF 55.6% vs MIS decompression 54.9%). The proportion in each cohort reaching the 24-month follow-up did not differ significantly between the cohorts (MIS TLIF 83.3% and MIS decompression 84.5%, p = 0.85). MIS TLIF was associated with greater blood loss (mean 108.8 vs 33.0 ml, p < 0.001), longer operative time (mean 228.2 vs 101.8 minutes, p < 0.001), and longer length of hospitalization (mean 2.9 vs 0.7 days, p < 0.001). MIS TLIF was associated with a significantly lower reoperation rate (14.1% vs 1.4%, p = 0.004). Both cohorts demonstrated significant improvements in ODI, NRS back pain, NRS leg pain, and EQ-5D at 24 months (p < 0.001, all comparisons relative to baseline). In multivariate analyses, MIS TLIF-as opposed to MIS decompression alone-was associated with superior ODI change (ß = -7.59, 95% CI -14.96 to -0.23; p = 0.04), NRS back pain change (ß = -1.54, 95% CI -2.78 to -0.30; p = 0.02), and NASS satisfaction (OR 0.32, 95% CI 0.12-0.82; p = 0.02).CONCLUSIONSFor symptomatic, single-level degenerative spondylolisthesis, MIS TLIF was associated with a lower reoperation rate and superior outcomes for disability, back pain, and patient satisfaction compared with posterior MIS decompression alone. This finding may aid surgical decision-making when considering MIS for degenerative lumbar spondylolisthesis.

Women fare best following surgery for degenerative lumbar spondylolisthesis: a comparison of the most and least satisfied patients utilizing data from the Quality Outcomes Database.

OBJECTIVE The American Association of Neurological Surgeons launched the Quality Outcomes Database (QOD), a prospective longitudinal registry that includes demographic, clinical, and patient-reported outcome (PRO) data, to measure the safety and quality of neurosurgical procedures, including spinal surgery. Differing results from recent randomized controlled trials have established a need to clarify the groups that would most benefit from surgery for degenerative lumbar spondylolisthesis. In the present study, the authors compared patients who were the most and the least satisfied following surgery for degenerative lumbar spondylolisthesis. METHODS This was a retrospective analysis of a prospective, national longitudinal registry including patients who had undergone surgery for grade 1 degenerative lumbar spondylolisthesis. The most and least satisfied patients were identified based on an answer of "1" and "4," respectively, on the North American Spine Society (NASS) Satisfaction Questionnaire 12 months postoperatively. Baseline demographics, clinical variables, surgical parameters, and outcomes were collected. Patient-reported outcome measures, including the Numeric Rating Scale (NRS) for back pain, NRS for leg pain, Oswestry Disability Index (ODI), and EQ-5D (the EuroQol health survey), were administered at baseline and 3 and 12 months after treatment. RESULTS Four hundred seventy-seven patients underwent surgery for grade 1 degenerative lumbar spondylolisthesis in the period from July 2014 through December 2015. Two hundred fifty-five patients (53.5%) were the most satisfied and 26 (5.5%) were the least satisfied. Compared with the most satisfied patients, the least satisfied ones more often had coronary artery disease (CAD; 26.9% vs 12.2%, p = 0.04) and had higher body mass indices (32.9 ± 6.5 vs 30.0 ± 6.0 kg/m2, p = 0.02). In the multivariate analysis, female sex (OR 2.9, p = 0.02) was associated with the most satisfaction. Notably, the American Society of Anesthesiologists (ASA) class, smoking, psychiatric comorbidity, and employment status were not significantly associated with satisfaction. Although there were no significant differences at baseline, the most satisfied patients had significantly lower NRS back and leg pain and ODI scores and a greater EQ-5D score at 3 and 12 months postoperatively (p < 0.001 for all). CONCLUSIONS This study revealed that some patient factors differ between those who report the most and those who report the least satisfaction after surgery for degenerative lumbar spondylolisthesis. Patients reporting the least satisfaction tended to have CAD or were obese. Female sex was associated with the most satisfaction when adjusting for potential covariates. These findings highlight several key factors that could aid in setting expectations for outcomes following surgery for degenerative lumbar spondylolisthesis.

Defining the minimum clinically important difference for grade I degenerative lumbar spondylolisthesis: insights from the Quality Outcomes Database.

OBJECTIVE Patient-reported outcomes (PROs) play a pivotal role in defining the value of surgical interventions for spinal disease. The concept of minimum clinically important difference (MCID) is considered the new standard for determining the effectiveness of a given treatment and describing patient satisfaction in response to that treatment. The purpose of this study was to determine the MCID associated with surgical treatment for degenerative lumbar spondylolisthesis. METHODS The authors queried the Quality Outcomes Database registry from July 2014 through December 2015 for patients who underwent posterior lumbar surgery for grade I degenerative spondylolisthesis. Recorded PROs included scores on the Oswestry Disability Index (ODI), EQ-5D, and numeric rating scale (NRS) for leg pain (NRS-LP) and back pain (NRS-BP). Anchor-based (using the North American Spine Society satisfaction scale) and distribution-based (half a standard deviation, small Cohen's effect size, standard error of measurement, and minimum detectable change [MDC]) methods were used to calculate the MCID for each PRO. RESULTS A total of 441 patients (80 who underwent laminectomies alone and 361 who underwent fusion procedures) from 11 participating sites were included in the analysis. The changes in functional outcome scores between baseline and the 1-year postoperative evaluation were as follows: 23.5 ± 17.4 points for ODI, 0.24 ± 0.23 for EQ-5D, 4.1 ± 3.5 for NRS-LP, and 3.7 ± 3.2 for NRS-BP. The different calculation methods generated a range of MCID values for each PRO: 3.3-26.5 points for ODI, 0.04-0.3 points for EQ-5D, 0.6-4.5 points for NRS-LP, and 0.5-4.2 points for NRS-BP. The MDC approach appeared to be the most appropriate for calculating MCID because it provided a threshold greater than the measurement error and was closest to the average change difference between the satisfied and not-satisfied patients. On subgroup analysis, the MCID thresholds for laminectomy-alone patients were comparable to those for the patients who underwent arthrodesis as well as for the entire cohort. CONCLUSIONS The MCID for PROs was highly variable depending on the calculation technique. The MDC seems to be a statistically and clinically sound method for defining the appropriate MCID value for patients with grade I degenerative lumbar spondylolisthesis. Based on this method, the MCID values are 14.3 points for ODI, 0.2 points for EQ-5D, 1.7 points for NRS-LP, and 1.6 points for NRS-BP.

Minimally invasive versus open fusion for Grade I degenerative lumbar spondylolisthesis: analysis of the Quality Outcomes Database.

OBJECTIVE Lumbar spondylolisthesis is a degenerative condition that can be surgically treated with either open or minimally invasive decompression and instrumented fusion. Minimally invasive surgery (MIS) approaches may shorten recovery, reduce blood loss, and minimize soft-tissue damage with resultant reduced postoperative pain and disability. METHODS The authors queried the national, multicenter Quality Outcomes Database (QOD) registry for patients undergoing posterior lumbar fusion between July 2014 and December 2015 for Grade I degenerative spondylolisthesis. The authors recorded baseline and 12-month patient-reported outcomes (PROs), including Oswestry Disability Index (ODI), EQ-5D, numeric rating scale (NRS)-back pain (NRS-BP), NRS-leg pain (NRS-LP), and satisfaction (North American Spine Society satisfaction questionnaire). Multivariable regression models were fitted for hospital length of stay (LOS), 12-month PROs, and 90-day return to work, after adjusting for an array of preoperative and surgical variables. RESULTS A total of 345 patients (open surgery, n = 254; MIS, n = 91) from 11 participating sites were identified in the QOD. The follow-up rate at 12 months was 84% (83.5% [open surgery]; 85% [MIS]). Overall, baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts. Two hundred fifty seven patients underwent 1-level fusion (open surgery, n = 181; MIS, n = 76), and 88 patients underwent 2-level fusion (open surgery, n = 73; MIS, n = 15). Patients in both groups reported significant improvement in all primary outcomes (all p < 0.001). MIS was associated with a significantly lower mean intraoperative estimated blood loss and slightly longer operative times in both 1- and 2-level fusion subgroups. Although the LOS was shorter for MIS 1-level cases, this was not significantly different. No difference was detected with regard to the 12-month PROs between the 1-level MIS versus the 1-level open surgical groups. However, change in functional outcome scores for patients undergoing 2-level fusion was notably larger in the MIS cohort for ODI (-27 vs -16, p = 0.1), EQ-5D (0.27 vs 0.15, p = 0.08), and NRS-BP (-3.5 vs -2.7, p = 0.41); statistical significance was shown only for changes in NRS-LP scores (-4.9 vs -2.8, p = 0.02). On risk-adjusted analysis for 1-level fusion, open versus minimally invasive approach was not significant for 12-month PROs, LOS, and 90-day return to work. CONCLUSIONS Significant improvement was found in terms of all functional outcomes in patients undergoing open or MIS fusion for lumbar spondylolisthesis. No difference was detected between the 2 techniques for 1-level fusion in terms of patient-reported outcomes, LOS, and 90-day return to work. However, patients undergoing 2-level MIS fusion reported significantly better improvement in NRS-LP at 12 months than patients undergoing 2-level open surgery. Longer follow-up is needed to provide further insight into the comparative effectiveness of the 2 procedures.

Impact of educational background on preoperative disease severity and postoperative outcomes among patients with lumbar spondylolisthesis: a Quality Outcomes Database study.

OBJECTIVE: Deficiency in patient education has been correlated with increased disease-related morbidity and decreased access to care. However, the associations between educational level, preoperative disease severity, and postoperative outcomes in patients with lumbar spondylolisthesis have yet to be explored. METHODS: The spondylolisthesis dataset of the Quality Outcomes Database (QOD)-a cohort with prospectively collected data by the SpineCORe study team of the 12 highest enrolling sites with an 81% follow-up at 5 years -was utilized and stratified for educational level. Patients were classified into three categories (high school or less, graduate, or postgraduate). Patient-reported outcome measures (PROMs) documented at baseline and follow-up included Oswestry Disability Index (ODI) score, EQ-5D in quality-adjusted life years, and numeric rating scale (NRS) scores for back and leg pain. Disease severity was measured with PROMs. Postoperatively, patients also completed the North American Spine Society assessment to measure their satisfaction with surgery. Multivariable regression analysis was used to compare education level with disease severity and postoperative outcomes. RESULTS: A total of 608 patients underwent analysis, with 260 individuals (42.8%) at an educational level of high school or less. On univariate analysis, baseline disease severity was worse among patients with lower levels of education. On multivariable regression analysis, patients with postgraduate level of education had significantly lower ODI scores (ß = -3.75, 95% CI -7.31 to -0.2, p = 0.039) compared to graduates, while the other PROMs were not associated with significant differences at baseline. Five years postoperatively, patients from various educational backgrounds exhibited similar rates of minimal clinically important differences in PROMs. Nevertheless, patients with the lowest educational level had higher ODI scores (27.1, p < 0.01), lower EQ-5D scores (0.701, p < 0.01), and higher NRS leg pain (3.0, p < 0.01) and back pain (4.0, p < 0.01) scores compared to those with graduate or postgraduate levels of education. The odds for postoperative satisfaction were also comparable between cohorts at 5 years (reference, graduate level; high school or less, OR 0.87, 95% CI 0.46-1.64, p = 0.659; postgraduate, OR 1.6, 95% CI 0.7-3.65, p = 0.262). CONCLUSIONS: Lower patient education level was associated with a greater baseline disease severity in patients with lumbar spondylolisthesis. Surgery demonstrated similar benefits irrespective of educational background; however, individuals with lower educational level reported lower outcomes overall. This emphasizes the need for enhanced health literacy to mitigate disparities for reported outcomes.

Does diabetes affect outcome or reoperation rate after lumbar decompression or arthrodesis? A matched analysis of the Quality Outcomes Database data set.

OBJECTIVE: Diabetes mellitus (DM) is a known risk factor for postsurgical and systemic complications after lumbar spinal surgery. Smaller studies have also demonstrated diminished improvements in patient-reported outcomes (PROs), with increased reoperation and readmission rates after lumbar surgery in patients with DM. The authors aimed to examine longer-term PROs in patients with DM undergoing lumbar decompression and/or arthrodesis for degenerative pathology. METHODS: The Quality Outcomes Database was queried for patients undergoing elective lumbar decompression and/or arthrodesis for degenerative pathology. Patients were grouped into DM and non-DM groups and optimally matched in a 1:1 ratio on 31 baseline variables, including the number of operated levels. Outcomes of interest were readmissions and reoperations at 30 and 90 days after surgery in addition to improvements in Oswestry Disability Index, back pain, and leg pain scores and quality-adjusted life-years at 90 days after surgery. RESULTS: The matched decompression cohort comprised 7836 patients (3236 [41.3] females) with a mean age of 63.5 ± 12.6 years, and the matched arthrodesis cohort comprised 7336 patients (3907 [53.3%] females) with a mean age of 64.8 ± 10.3 years. In patients undergoing lumbar decompression, no significant differences in nonroutine discharge, length of stay (LOS), readmissions, reoperations, and PROs were observed. In patients undergoing lumbar arthrodesis, nonroutine discharge (15.7% vs 13.4%, p < 0.01), LOS (3.2 ± 2.0 vs 3.0 ± 3.5 days, p < 0.01), 30-day (6.5% vs 4.4%, p < 0.01) and 90-day (9.1% vs 7.0%, p < 0.01) readmission rates, and the 90-day reoperation rate (4.3% vs 3.2%, p = 0.01) were all significantly higher in the DM group. For DM patients undergoing lumbar arthrodesis, subgroup analyses demonstrated a significantly higher risk of poor surgical outcomes with the open approach. CONCLUSIONS: Patients with and without DM undergoing lumbar spinal decompression alone have comparable readmission and reoperation rates, while those undergoing arthrodesis procedures have a higher risk of poor surgical outcomes up to 90 days after surgery. Surgeons should target optimal DM control preoperatively, particularly for patients undergoing elective lumbar arthrodesis.

Cervical spondylotic myelopathy and driving abilities: defining the prevalence and long-term postoperative outcomes using the Quality Outcomes Database.

OBJECTIVE: Cervical spondylotic myelopathy (CSM) can cause significant difficulty with driving and a subsequent reduction in an individual's quality of life due to neurological deterioration. The positive impact of surgery on postoperative patient-reported driving capabilities has been seldom explored. METHODS: The CSM module of the Quality Outcomes Database was utilized. Patient-reported driving ability was assessed via the driving section of the Neck Disability Index (NDI) questionnaire. This is an ordinal scale in which 0 represents the absence of symptoms while driving and 5 represents a complete inability to drive due to symptoms. Patients were considered to have an impairment in their driving ability if they reported an NDI driving score of 3 or higher (signifying impairment in driving duration due to symptoms). Multivariable logistic regression models were fitted to evaluate mediators of baseline impairment and improvement at 24 months after surgery, which was defined as an NDI driving score < 3. RESULTS: A total of 1128 patients who underwent surgical intervention for CSM were included, of whom 354 (31.4%) had baseline driving impairment due to CSM. Moderate (OR 2.3) and severe (OR 6.3) neck pain, severe arm pain (OR 1.6), mild-moderate (OR 2.1) and severe (OR 2.5) impairment in hand/arm dexterity, severe impairment in leg use/walking (OR 1.9), and severe impairment of urinary function (OR 1.8) were associated with impaired driving ability at baseline. Of the 291 patients with baseline impairment and available 24-month follow-up data, 209 (71.8%) reported postoperative improvement in their driving ability. This improvement seemed to be mediated particularly through the achievement of the minimal clinically important difference (MCID) in neck pain and improvement in leg function/walking. Patients with improved driving at 24 months noted higher postoperative satisfaction (88.5% vs 62.2%, p < 0.01) and were more likely to achieve a clinically significant improvement in their quality of life (50.7% vs 37.8%, p < 0.01). CONCLUSIONS: Nearly one-third of patients with CSM report impaired driving ability at presentation. Seventy-two percent of these patients reported improvements in their driving ability within 24 months of surgery. Surgical management of CSM can significantly improve patients' driving abilities at 24 months and hence patients' quality of life.

Comparing posterior cervical foraminotomy with anterior cervical discectomy and fusion in radiculopathic patients: an analysis from the Quality Outcomes Database.

OBJECTIVE: The objective of this study was to compare clinical and patient-reported outcomes (PROs) between posterior foraminotomy and anterior cervical discectomy and fusion (ACDF) in patients presenting with cervical radiculopathy. METHODS: The Quality Outcomes Database was queried for patients who had undergone ACDF or posterior foraminotomy for radiculopathy. To create two highly homogeneous groups, optimal individual matching was performed at a 5:1 ratio between the two groups on 29 baseline variables (including demographic characteristics, comorbidities, symptoms, patient-reported scores, underlying pathologies, and levels treated). Outcomes of interest were length of stay, reoperations, patient-reported satisfaction, increase in EQ-5D score, and decrease in Neck Disability Index (NDI) scores for arm and neck pain as long as 1 year after surgery. Noninferiority analysis of achieving patient satisfaction and minimal clinically important difference (MCID) in PROs was performed with an accepted risk difference of 5%. RESULTS: A total of 7805 eligible patients were identified: 216 of these underwent posterior foraminotomy and were matched to 1080 patients who underwent ACDF. The patients who underwent ACDF had more underlying pathologies, lower EQ-5D scores, and higher NDI and neck pain scores at baseline. Posterior foraminotomy was associated with shorter hospitalization (0.5 vs 0.9 days, p < 0.001). Reoperations within 12 months were significantly more common among the posterior foraminotomy group (4.2% vs 1.9%, p = 0.04). The two groups performed similarly in PROs, with posterior foraminotomy being noninferior to ACDF in achieving MCID in EQ-5D and neck pain scores but also having lower rates of maximal satisfaction at 12 months (North American Spine Society score of 1 achieved by 65.2% posterior foraminotomy patients vs 74.6% of ACDF patients, p = 0.02). CONCLUSIONS: The two procedures were found to be offered to different populations, with ACDF being selected for patients with more complicated pathologies and symptoms. After individual matching, posterior foraminotomy was associated with a higher reoperation risk within 1 year after surgery compared to ACDF (4.2% vs 1.9%). In terms of 12-month PROs, posterior foraminotomy was noninferior to ACDF in improving quality of life and neck pain. The two procedures also performed similarly in improving NDI scores and arm pain, but ACDF patients had higher maximal satisfaction rates.

Leveraging machine learning to ascertain the implications of preoperative body mass index on surgical outcomes for 282 patients with preoperative obesity and lumbar spondylolisthesis in the Quality Outcomes Database.

OBJECTIVE: Prior studies have revealed that a body mass index (BMI) ≥ 30 is associated with worse outcomes following surgical intervention in grade 1 lumbar spondylolisthesis. Using a machine learning approach, this study aimed to leverage the prospective Quality Outcomes Database (QOD) to identify a BMI threshold for patients undergoing surgical intervention for grade 1 lumbar spondylolisthesis and thus reliably identify optimal surgical candidates among obese patients. METHODS: Patients with grade 1 lumbar spondylolisthesis and preoperative BMI ≥ 30 from the prospectively collected QOD lumbar spondylolisthesis module were included in this study. A 12-month composite outcome was generated by performing principal components analysis and k-means clustering on four validated measures of surgical outcomes in patients with spondylolisthesis. Random forests were generated to determine the most important preoperative patient characteristics in predicting the composite outcome. Recursive partitioning was used to extract a BMI threshold associated with optimal outcomes. RESULTS: The average BMI was 35.7, with 282 (46.4%) of the 608 patients from the QOD data set having a BMI ≥ 30. Principal components analysis revealed that the first principal component accounted for 99.2% of the variance in the four outcome measures. Two clusters were identified corresponding to patients with suboptimal outcomes (severe back pain, increased disability, impaired quality of life, and low satisfaction) and to those with optimal outcomes. Recursive partitioning established a BMI threshold of 37.5 after pruning via cross-validation. CONCLUSIONS: In this multicenter study, the authors found that a BMI ≤ 37.5 was associated with improved patient outcomes following surgical intervention. These findings may help augment predictive analytics to deliver precision medicine and improve prehabilitation strategies.

Characteristics of patients who return to work after undergoing surgery for cervical spondylotic myelopathy: a Quality Outcomes Database study.

OBJECTIVE: Return to work (RTW) is an important surgical outcome for patients who are employed, yet a significant number of patients with cervical spondylotic myelopathy (CSM) who are employed undergo cervical spine surgery and fail to RTW. In this study, the authors investigated factors associated with failure to RTW in the CSM population who underwent cervical spine surgery and who were considered to have a good surgical outcome yet failed to RTW. METHODS: This study retrospectively analyzed prospectively collected data from the cervical myelopathy module of a national spine registry, the Quality Outcomes Database. The CSM data set of the Quality Outcomes Database was queried for patients who were employed at the time of surgery and planned to RTW postoperatively. Distinct multivariable logistic regression models were fitted with 3-month RTW as an outcome for the overall population to identify risk factors for failure to RTW. Good outcomes were defined as patients who had no adverse events (readmissions or complications), who had achieved 30% improvement in Neck Disability Index score, and who were satisfied (North American Spine Society satisfaction score of 1 or 2) at 3 months postsurgery. RESULTS: Of the 409 patients who underwent surgery, 80% (n = 327) did RTW at 3 months after surgery. At 3 months, 56.9% of patients met the criteria for a good surgical outcome, and patients with a good outcome were more likely to RTW (88.1% vs 69.2%, p < 0.01). Of patients with a good outcome, 11.9% failed to RTW at 3 months. Risk factors for failing to RTW despite a good outcome included preoperative short-term disability or leave status (OR 3.03 [95% CI 1.66-7.90], p = 0.02); a higher baseline Neck Disability Index score (OR 1.41 [95% CI 1.09-1.84], p < 0.01); and higher neck pain score at 3 months postoperatively (OR 0.81 [95% CI 0.66-0.99], p = 0.04). CONCLUSIONS: Most patients with CSM who undergo spine surgery reenter the workforce within 3 months from surgery, with RTW rates being higher among patients who experience good outcomes. Among patients with good outcomes who were employed, failure to RTW was associated with being on preoperative short-term disability or leave status prior to surgery as well as higher neck pain scores at baseline and at 3 months postoperatively.

Research using the Quality Outcomes Database: accomplishments and future steps toward higher-quality real-world evidence.

OBJECTIVE: The Quality Outcomes Database (QOD) was established in 2012 by the NeuroPoint Alliance, a nonprofit organization supported by the American Association of Neurological Surgeons. Currently, the QOD has launched six different modules to cover a broad spectrum of neurosurgical practice-namely lumbar spine surgery, cervical spine surgery, brain tumor, stereotactic radiosurgery (SRS), functional neurosurgery for Parkinson's disease, and cerebrovascular surgery. This investigation aims to summarize research efforts and evidence yielded through QOD research endeavors. METHODS: The authors identified all publications from January 1, 2012, to February 18, 2023, that were produced by using data collected prospectively in a QOD module without a prespecified research purpose in the context of quality surveillance and improvement. Citations were compiled and presented along with comprehensive documentation of the main study objective and take-home message. RESULTS: A total of 94 studies have been produced through QOD efforts during the past decade. QOD-derived literature has been predominantly dedicated to spinal surgical outcomes, with 59 and 22 studies focusing on lumbar and cervical spine surgery, respectively, and 6 studies focusing on both. More specifically, the QOD Study Group-a research collaborative between 16 high-enrolling sites-has yielded 24 studies on lumbar grade 1 spondylolisthesis and 13 studies on cervical spondylotic myelopathy, using two focused data sets with high data accuracy and long-term follow-up. The more recent neuro-oncological QOD efforts, i.e., the Tumor QOD and the SRS Quality Registry, have contributed 5 studies, providing insights into the real-world neuro-oncological practice and the role of patient-reported outcomes. CONCLUSIONS: Prospective quality registries are an important resource for observational research, yielding clinical evidence to guide decision-making across neurosurgical subspecialties. Future directions of the QOD efforts include the development of research efforts within the neuro-oncological registries and the American Spine Registry-which has now replaced the inactive spinal modules of the QOD-and the focused research on high-grade lumbar spondylolisthesis and cervical radiculopathy.

How closely are outcome questionnaires correlated to patient satisfaction after cervical spine surgery for myelopathy?

OBJECTIVE: Patient-reported outcomes (PROs) have become the standard means to measure surgical outcomes. Insurers and policy makers are also increasingly utilizing PROs to assess the value of care and measure different aspects of a patient's condition. For cervical myelopathy, it is currently unclear which outcome measure best reflects patient satisfaction. In this investigation, the authors evaluated patients treated for cervical myelopathy to determine which outcome questionnaires best correlate with patient satisfaction. METHODS: The Quality Outcomes Database (QOD), a prospectively collected multi-institutional database, was used to retrospectively analyze patients undergoing surgery for cervical myelopathy. The North American Spine Society (NASS) satisfaction index, Neck Disability Index (NDI), numeric rating scales for neck pain (NP-NRS) and arm pain (AP-NRS), EQ-5D, and modified Japanese Orthopaedic Association (mJOA) scale were evaluated. RESULTS: The analysis included 1141 patients diagnosed with myelopathy, of whom 1099 had an NASS satisfaction index recorded at any of the follow-up time points. Concomitant radiculopathy was an indication for surgery in 368 (33.5%) patients, and severe neck pain (NP-NRS ≥ 7) was present in 471 (42.8%) patients. At the 3-month follow-up, NASS patient satisfaction index scores were positively correlated with scores for the NP-NRS (r = 0.30), AP-NRS (r = 0.32), and NDI (r = 0.36) and negatively correlated with EQ-5D (r = -0.38) and mJOA (r = -0.29) scores (all p < 0.001). At the 12-month follow-up, scores for the NASS index were positively correlated with scores for the NP-NRS (r = 0.44), AP-NRS (r = 0.38), and NDI (r = 0.46) and negatively correlated with scores for the EQ-5D (r = -0.40) and mJOA (r = -0.36) (all p < 0.001). At the 24-month follow-up, NASS index scores were positively correlated with NP-NRS (r = 0.49), AP-NRS (r = 0.36), and NDI (r = 0.49) scores and negatively correlated with EQ-5D (r = -0.44) and mJOA (r = -0.38) scores (all p < 0.001). CONCLUSIONS: Neck pain was highly prevalent in patients with myelopathy. Notably, improvement in neck pain-associated disability rather than improvement in myelopathy was the most prominent PRO factor for patients. This finding may reflect greater patient concern for active pain symptoms than for neurological symptoms caused by myelopathy. As commercial payers begin to examine novel remuneration strategies for surgical interventions, thoughtful analysis of PRO measurements will have increasing relevance.

Sleep Disturbances in Cervical Spondylotic Myelopathy: Prevalence and Postoperative Outcomes-an Analysis From the Quality Outcomes Database.

STUDY DESIGN: Prospective observational study, level of evidence 1 for prognostic investigations. OBJECTIVES: To evaluate the prevalence of sleep impairment and predictors of improved sleep quality 24 months postoperatively in cervical spondylotic myelopathy (CSM) using the quality outcomes database. SUMMARY OF BACKGROUND DATA: Sleep disturbances are a common yet understudied symptom in CSM. MATERIALS AND METHODS: The quality outcomes database was queried for patients with CSM, and sleep quality was assessed through the neck disability index sleep component at baseline and 24 months postoperatively. Multivariable logistic regressions were performed to identify risk factors of failure to improve sleep impairment and symptoms causing lingering sleep dysfunction 24 months after surgery. RESULTS: Among 1135 patients with CSM, 904 (79.5%) had some degree of sleep dysfunction at baseline. At 24 months postoperatively, 72.8% of the patients with baseline sleep symptoms experienced improvement, with 42.5% reporting complete resolution. Patients who did not improve were more like to be smokers [adjusted odds ratio (aOR): 1.85], have osteoarthritis (aOR: 1.72), report baseline radicular paresthesia (aOR: 1.51), and have neck pain of ≥4/10 on a numeric rating scale. Patients with improved sleep noted higher satisfaction with surgery (88.8% vs 72.9%, aOR: 1.66) independent of improvement in other functional areas. In a multivariable analysis including pain scores and several myelopathy-related symptoms, lingering sleep dysfunction at 24 months was associated with neck pain (aOR: 1.47) and upper (aOR: 1.45) and lower (aOR: 1.52) extremity paresthesias. CONCLUSION: The majority of patients presenting with CSM have associated sleep disturbances. Most patients experience sustained improvement after surgery, with almost half reporting complete resolution. Smoking, osteoarthritis, radicular paresthesia, and neck pain ≥4/10 numeric rating scale score are baseline risk factors of failure to improve sleep dysfunction. Improvement in sleep symptoms is a major driver of patient-reported satisfaction. Incomplete resolution of sleep impairment is likely due to neck pain and extremity paresthesia.