Does type of bone graft matter? A retrospective review of the use of biological bone grafts in patients undergoing elective 1-3 level spinal interbody fusion.

OBJECTIVE: There is a lack of strong evidence for use of expensive bone substitutes. This study compares perioperative data and patient reported quality-of-life outcomes across the varied types of bone graft extenders. The study analyzes the existing Quality and Outcomes Database and evaluates patient reported outcomes for 1-3 level lumbar fusion procedures comparing across different types of biologics bone graft. METHODS: We retrospectively analyzed a prospectively collected data registry. Bone graft implant data were collected and grouped into the following categories: (1) Autograft with basic allograft (2) Enhanced, synthetic, or cellular allograft (3) Use of BMP. Preoperative and 1 year patient reported outcomes and perioperative data from the prospective collected registry were analyzed. RESULTS: There were 384 patients included in this study. There were 168 (43.8%) patients in group 1, 133 (34.6%) patients in group 2, and 83 (21.6%) in group 3. There were no group differences in baseline or 1 year back pain, leg pain, ODI, or EQ-5D. The GLM Repeated Measures results indicate a significant difference within each of the three groups between the preoperative and postoperative measures for back pain, leg pain, ODI, and EQ-5D. The change over time was not significantly different between the groups. CONCLUSIONS: Bone graft extenders are a significant contributor to the cost of lumbar fusion. This study demonstrates no difference in preoperative, and 1 year patient reported outcomes between the three groups. There was no significant difference in rate of reoperations across the three groups.

Early postoperative physical activity and function: a descriptive case series study of 53 patients after lumbar spine surgery.

BACKGROUND: The purpose of this prospective case series study was to compare changes in early postoperative physical activity and physical function between 6 weeks and 3 and 6 months after lumbar spine surgery. METHODS: Fifty-three patients (mean [95% confidence interval; CI] age = 59.2 [56.2, 62.3] years, 64% female) who underwent spine surgery for a degenerative lumbar condition were assessed at 6 weeks and 3- and 6-months after surgery. The outcomes were objectively-measured physical activity (accelerometry) and patient-reported and objective physical function. Physical activity was assessed using mean steps/day and time spent in moderate to vigorous physical activity (MVPA) over a week. Physical function measures included Oswestry Disability Index (ODI), 12-item Short Form Health Survey (SF-12), Timed Up and Go (TUG), and 10-Meter Walk (10 MW). We compared changes over time in physical activity and function using generalized estimating equations with robust estimator and first-order autoregressive covariance structure. Proportion of patients who engaged in meaningful physical activity (e.g., walked at least 4400 and 6000 steps/day or engaged in at least 150 min/week in MVPA) and achieved clinically meaningful changes in physical function were compared at 3 and 6 months. RESULTS: After surgery, 72% of patients initiated physical therapy (mean [95%CI] sessions =8.5 [6.6, 10.4]) between 6 weeks and 3 months. Compared to 6 weeks post-surgery, no change in steps/day or time in MVPA/week was observed at 3 or 6 months. From 21 to 23% and 9 to 11% of participants walked at least 4400 and 6000 steps/day at 3 and 6 months, respectively, while none of the participants spent at least 150 min/week in MVPA at these same time points. Significant improvements were observed on ODI, SF-12, TUG and 10 MW (p <  0.05), with over 43 to 68% and 62 to 87% achieving clinically meaningful improvements on these measures at 3 and 6 months, respectively. CONCLUSION: Limited improvement was observed in objectively-measured physical activity from 6 weeks to 6 months after spine surgery, despite moderate to large function gains. Early postoperative physical therapy interventions targeting physical activity may be needed.

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).

Effect of Depression on Patient-Reported Outcomes Following Cervical Epidural Steroid Injection for Degenerative Spine Disease.

Objective: To assess the effect depression has on outcomes after cervical epidural steroid injections (CESIs). Design: Retrospective review of a prospectively collected database. Setting: Single institution tertiary care center. Subjects: Fifty-seven patients with cervical spondylosis and cervical radicular pain who were deemed appropriate surgical candidates but elected to undergo CESI first were included. Methods: Twenty-one of 57 (37%) patients with depression (defined as Zung Depression Scale >33) were included. Patient-reported outcomes including Neck Disability Index (NDI), numeric rating scale (NRS) for arm pain (AP), NRS for neck pain (NP), and EuroQol-5D (EQ-5D) were collected at baseline and three-month follow-up. Minimal clinically important differences were then calculated to provide dichotomous outcome measures of success. Results: Overall, 24 and 28 patients achieved at least 50% improvement in AP and NP, respectively. In terms of disability, 25/57 (43.9%) patients achieved >13.2-point improvement on the NDI overall. In patients with depression, 4/21 (19.0%) and 5/21 (23.8%) achieved at least 50% improvement on the NRS for AP and NP, respectively, compared with 20/36 (55.5%) and 23/36 (63.8%) in patients without depression. This difference was statistically significant for both pain measures (P < 0.002 AP, P < 0.006 NP). Statistically fewer patients, 5/21 (24%), with depression achieved ≥13.2-point improvement on the NDI compared with 20/36 (55%) nondepressed patients (P < 0.01). There was no difference in outcomes between groups on the EQ-5D. Conclusions: Patients with cervical spondylosis and comorbid depression who undergo CESI are less likely to achieve successful outcomes in both pain and function compared with nondepressed patients at three months.

A predictive model and nomogram for predicting return to work at 3 months after cervical spine surgery: an analysis from the Quality Outcomes Database.

OBJECTIVEBack pain and neck pain are two of the most common causes of work loss due to disability, which poses an economic burden on society. Due to recent changes in healthcare policies, patient-centered outcomes including return to work have been increasingly prioritized by physicians and hospitals to optimize healthcare delivery. In this study, the authors used a national spine registry to identify clinical factors associated with return to work at 3 months among patients undergoing a cervical spine surgery.METHODSThe authors queried the Quality Outcomes Database registry for information collected from April 2013 through March 2017 for preoperatively employed patients undergoing cervical spine surgery for degenerative spine disease. Covariates included demographic, clinical, and operative variables, and baseline patient-reported outcomes. Multiple imputations were used for missing values and multivariable logistic regression analysis was used to identify factors associated with higher odds of returning to work. Bootstrap resampling (200 iterations) was used to assess the validity of the model. A nomogram was constructed using the results of the multivariable model.RESULTSA total of 4689 patients were analyzed, of whom 82.2% (n = 3854) returned to work at 3 months postoperatively. Among previously employed and working patients, 89.3% (n = 3443) returned to work compared to 52.3% (n = 411) among those who were employed but not working (e.g., were on a leave) at the time of surgery (p < 0.001). On multivariable logistic regression the authors found that patients who were less likely to return to work were older (age > 56-65 years: OR 0.69, 95% CI 0.57-0.85, p < 0.001; age > 65 years: OR 0.65, 95% CI 0.43-0.97, p = 0.02); were employed but not working (OR 0.24, 95% CI 0.20-0.29, p < 0.001); were employed part time (OR 0.56, 95% CI 0.42-0.76, p < 0.001); had a heavy-intensity (OR 0.42, 95% CI 0.32-0.54, p < 0.001) or medium-intensity (OR 0.59, 95% CI 0.46-0.76, p < 0.001) occupation compared to a sedentary occupation type; had workers' compensation (OR 0.38, 95% CI 0.28-0.53, p < 0.001); had a higher Neck Disability Index score at baseline (OR 0.60, 95% CI 0.51-0.70, p = 0.017); were more likely to present with myelopathy (OR 0.52, 95% CI 0.42-0.63, p < 0.001); and had more levels fused (3-5 levels: OR 0.46, 95% CI 0.35-0.61, p < 0.001). Using the multivariable analysis, the authors then constructed a nomogram to predict return to work, which was found to have an area under the curve of 0.812 and good validity.CONCLUSIONSReturn to work is a crucial outcome that is being increasingly prioritized for employed patients undergoing spine surgery. The results from this study could help surgeons identify at-risk patients so that preoperative expectations could be discussed more comprehensively.

The effect of NSAIDs on spinal fusion: a cross-disciplinary review of biochemical, animal, and human studies.

PURPOSE: Non-steroidal anti-inflammatory drugs (NSAIDs) play an important role in postoperative pain management. However, their use in the setting of spine fusion surgery setting has long been a topic of controversy. In this review we examined relevant research, including in vivo, animal, and clinical human studies, with the aim of understanding the effect of NSAIDs on spinal fusion. STUDY DESIGN/SETTING: Systematic review of study designs of all types from randomized controlled trials and meta-analyses to single-institution retrospective reviews. METHODS: A search of PubMed and Embase was conducted using the keywords: "spine," "spinal fracture," NSAIDs, anti-inflammatory non-steroidal agents, bone, bone healing, fracture, fracture healing, yielding a total of 110 studies. Other 28 studies were identified by cross-referencing, resulting in total 138 studies. RESULTS: There is no level I evidence from human studies regarding the use of NSAIDs on spinal fusion rates. The overall tone of the spine literature in the early 2000s was that NSAIDs increased the rate of non-union; however, nearly all human studies published after 2005 suggest that short-term (<2 weeks) postoperative use have no such effect. The dose dependency that is seen with a 2-week postoperative course is not present when NSAIDs are only used for 48 h after surgery. CONCLUSIONS: NSAID appear to have dose-dependent and duration-dependent effects on fusion rates. The short-term use of low-dose NSAIDs around the time of spinal fusion surgery is reasonable. Spine surgeons can consider the incorporation of NSAIDs into pain control regimens for spinal fusion patients with the goal of improving pain control and reducing the costs and complications associated with opioids.

Impact of old age on patient-report outcomes and cost utility for anterior cervical discectomy and fusion surgery for degenerative spine disease.

PURPOSE: With growing older population and increasing rates of cervical spinal surgery, it is vital to understand the value of cervical surgery in this population. We set forth to determine the cost utility following anterior cervical decompression and fusion (ACDF) for degenerative disease in older patients. METHODS: Patients undergoing ACDF for degenerative diseases were enrolled into prospective longitudinal registry. Patient-reported outcomes (PROs) were recorded at baseline, 1-year, and 2-year postoperatively. Two-year medical resource utilization, missed work, and health-state values [quality-adjusted life years (QALYs)] were assessed to compute cost per QALY gained. Patients were dichotomized based on age: <65 years (younger) and ≥65 years (older) to compare the cost utility in these age groups. RESULTS: Total 218 (87%) younger patients and 33 (13%) older patients who underwent ACDF were analyzed. Both the groups demonstrated a significant improvement in PROs 2-year following surgery. The older patients had a lower mean cumulative gain in QALYs compared to younger patients at 1 year (0.141 vs. 0.28, P = 0.05) and 2 years (0.211 vs. 0.424, P = 0.04). There was no significant difference in the mean total 2-year cost between older [$21,041 (95% CI $18,466-$23,616)] and younger [$22,669 (95% CI $$21,259-$24,079)] patients (P = 0.27). Two-year cost per QALY gained in older vs. younger patients was ($99,720/QALYs gained vs. ($53,464/QALYs gained, P = 0.68). CONCLUSION: ACDF surgery provided a significant gain in health-state utility in older patients with degenerative cervical pathology, with a mean cumulative 2-year cost per QALY gained of $99,720/QALY. While older patients have a slightly higher cost utility compared to their younger counterparts, surgery in the older cohort does provide a significant improvement in pain, disability, and quality-of-life outcomes.

Preoperative and surgical factors associated with postoperative intensive care unit admission following operative treatment for degenerative lumbar spine disease.

PURPOSE: Evaluate the factors associated with postoperative ICU admission in patients undergoing surgical management of degenerative lumbar spine disease. METHODS: Patients undergoing surgery for degenerative lumbar spine disease were enrolled into a prospective registry over a 2-year period. Preoperative variables (age, gender, ASA grade, ODI%, CAD, HTN, MI, CHF, DM, BMI, depression, anxiety) and surgical variables (instrumentation, arthrodesis, estimated blood loss, length of surgery) were collected prospectively. Postoperative ICU admission details were retrospectively determined from the electronic medical record. Student's t test (continuous variables) and Chi-square test (categorical variables) were used to determine the association of each preoperative and surgical variable with ICU admission. RESULTS: 808 Patients (273 laminectomy, 535 laminectomy and fusion) were evaluated. Forty-one (5.1%) patients were found to have postoperative ICU admissions. Reasons for admission included blood loss (12.2%), cardiac (29.3%), respiratory (19.5%), neurologic (31.7%), and other (7.3%). For preoperative variables, female gender (P < 0.001), history of CAD (P = 0.003), history of MI (P = 0.008), history of CHF (P = 0.001), age (P = 0.025), and ASA grade (P = 0.008) were significantly associated with ICU admission. For surgical variables, estimated blood loss (P < 0.001) and length of surgery (P < 0.001) were significantly associated with ICU admission. CONCLUSIONS: Age, female gender, ASA grade, cardiac comorbidities, intraoperative blood loss, and length of surgery were associated with increased risk of postoperative ICU admission. Knowledge of these factors can aid surgeons in patient selection and preoperative discussion with patients about potential need for unexpected admission to the ICU.

Can facet joint fluid on MRI and dynamic instability be a predictor of improvement in back pain following lumbar fusion for degenerative spondylolisthesis?

PURPOSE: To investigate the relationship between lumbar facet fluid and dynamic instability in degenerative spondylolisthesis (DS), as well as the relationship between facet fluid and patient-reported outcomes following a posterior lumbar fusion. METHODS: We analyzed consecutive patients with degenerative spondylolisthesis undergoing single level posterior lumbar fusion from December 2010 to January 2013 at a single academic institution. We investigated the relationship between fluid in the facet joint as measured on axial MRI and the presence of dynamic instability. We investigated the impact of facet fluid, Modic changes, and dynamic instability on patient-reported outcomes. RESULTS: There was a significant association between the amount of facet joint fluid and the presence of dynamic instability (p = 0.03); as facet fluid increases, the probability of dynamic instability also increases. For every 1 mm of facet fluid, there was a 41.6 % increase (95 % CI 1.8-97) in the odds of dynamic instability. A facet fluid amount less than 0.5 mm gave a 90 % probability that there was no dynamic instability. The presence of facet fluid and dynamic instability were associated with achieving minimal clinical important difference (MCID) in low back pain following lumbar fusion (p = 0.04 and 0.05, respectively). CONCLUSION: Facet joint fluid is associated with the presence of dynamic instability in DS. The presence of facet fluid and dynamic instability may predict increased likelihood of achieving MCID for improvement in back pain following posterior lumbar fusion.

Is obesity associated with worse patient-reported outcomes following lumbar surgery for degenerative conditions?

PURPOSE: To investigate whether obesity is associated with worse patient-reported outcomes following surgery for degenerative lumbar conditions. METHODS: We evaluated consecutive patients undergoing elective lumbar laminectomy or laminectomy with fusion for degenerative lumbar conditions. The Oswestry Disability Index (ODI), EuroQol-5D (EQ-5D), Short-Form 12 (SF-12), and NASS patient satisfaction were utilized. Chi-square tests and student t test assessed the association of obesity with PROs. Multivariate regression controlled for age, sex, smoking status, anxiety, depression, revision, preoperative narcotic use, payer status, and diabetes. RESULTS: A total of 602 patients were included. All PROs improved significantly in both groups. BMI ≥35 was associated with increased ODI at baseline (50.6 vs. 47.2 %, p = 0.012) and 12 months (30.5 vs. 25.7 %, p = 0.005). There was no difference in ODI change scores (21.2 vs. 19.4 %, p = 0.32). With multivariate analysis, BMI ≥35 was not predictive of worse ODI at 12 months (correlation coefficient 1.23, 95 % CI -0.225 to 2.676.) There was no significant difference between groups in percentage of patients achieving the minimum clinically important difference for ODI (59.6 vs. 64 %, p = 0.46) or patient satisfaction (80.5 vs. 78.9 %, p = 0.63). CONCLUSIONS: Body mass index ≥35 is associated with worse baseline and 12-month PROs, however, there was no difference in change scores across BMI groups. Controlling for important co-variables, BMI greater than 35 was not an independent predictor of worse PROs at 12 months.

The relative value of postoperative versus preoperative Karnofsky Performance Scale scores as a predictor of survival after surgical resection of glioblastoma multiforme.

The Karnofsky Performance Scale (KPS) score is a widespread metric to stratify patient prognosis and determine appropriate management in glioblastoma multiforme(GBM). Low preoperative KPS values have been associated with shorter overall survival (OS). However, surgical resection can have a dramatic effect on a patient's functional status which subsequently alters their KPS score. To determine the predictive value of preoperative verses postoperative KPS scores in terms of OS in patients with GBM. We conducted a retrospective review of 163 patients who underwent initial surgical intervention for pathologically proven GBM at our institution between 2003 and 2013. Pre and postoperative performance status, demographic, operative, and treatment variables were recorded for each patient. Multivariate regression analysis identified predictors of prolonged OS. The adequacy index was calculated to compare the predictive value of preoperative and postoperative KPS score. Median preoperative and postoperative KPS scores were 70 and 80, respectively. Overall, 92 (57 %) patients experienced an improvement in their KPS score, 40 (25 %) remained stable, and 29 (18 %) declined. Higher postoperative KPS (P = 0.0001), radiation therapy (P < 0.0001), younger age (P = 0.0443) and the absence of diabetes (P = 0.0006) were each independently associated with increased OS in a multivariate regression model. Postoperative KPS score has superior predictive value compared to pre-operative KPS score (A = 0.758 vs. 1.002). Postoperative KPS scores have superior predictive capabilities in terms of OS in GBM and should replace preoperative KPS scores when estimating prognosis in this population.

Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes.

BACKGROUND: Long-term postdiscectomy degenerative disc disease and low back pain is a well-recognized disorder; however, its patient-centered characterization and quantification are lacking. QUESTIONS/PURPOSES: We performed a systematic literature review and prospective longitudinal study to determine the frequency of recurrent back pain after discectomy and quantify its effect on patient-reported outcomes (PROs). METHODS: A MEDLINE search was performed to identify studies reporting on the frequency of recurrent back pain, same-level recurrent disc herniation, and reoperation after primary lumbar discectomy. After excluding studies that did not report the percentage of patients with persistent back or leg pain more than 6 months after discectomy or did not report the rate of same level recurrent herniation, 90 studies, which in aggregate had evaluated 21,180 patients, were included in the systematic review portion of this study. For the longitudinal study, all patients undergoing primary lumbar discectomy between October 2010 and March 2013 were enrolled into our prospective spine registry. One hundred fifteen patients were more than 12 months out from surgery, 103 (90%) of whom were available for 1-year outcomes assessment. PROs were prospectively assessed at baseline, 3 months, 1 year, and 2 years. The threshold of deterioration used to classify recurrent back pain was the minimum clinically important difference in back pain (Numeric Rating Scale Back Pain [NRS-BP]) or Disability (Oswestry Disability Index [ODI]), which were 2.5 of 10 points and 20 of 100 points, respectively. RESULTS SYSTEMATIC REVIEW: The proportion of patients reporting short-term (6-24 months) and long-term (> 24 months) recurrent back pain ranged from 3% to 34% and 5% to 36%, respectively. The 2-year incidence of recurrent disc herniation ranged from 0% to 23% and the frequency of reoperation ranged from 0% to 13%. PROSPECTIVE STUDY: At 1-year and 2-year followup, 22% and 26% patients reported worsening of low back pain (NRS: 5.3 ± 2.5 versus 2.7 ± 2.8, p < 0.001) or disability (ODI%: 32 ± 18 versus 21 ± 18, p < 0.001) compared with 3 months. CONCLUSIONS: In a systematic literature review and prospective outcomes study, the frequency of same-level disc herniation requiring reoperation was 6%. Two-year recurrent low back pain may occur in 15% to 25% of patients depending on the level of recurrent pain considered clinically important, and this leads to worse PROs at 1 and 2 years postoperatively.

Prediction model for outcome after low-back surgery: individualized likelihood of complication, hospital readmission, return to work, and 12-month improvement in functional disability.

OBJECT Lumbar spine surgery has been demonstrated to be efficacious for many degenerative spine conditions. However, there is wide variability in outcome after spine surgery at the individual patient level. All stakeholders in spine care will benefit from identification of the unique patient or disease subgroups that are least likely to benefit from surgery, are prone to costly complications, and have increased health care utilization. There remains a large demand for individual patient-level predictive analytics to guide decision support to optimize outcomes at the patient and population levels. METHODS One thousand eight hundred three consecutive patients undergoing spine surgery for various degenerative lumbar diagnoses were prospectively enrolled and followed for 1 year. A comprehensive patient interview and health assessment was performed at baseline and at 3 and 12 months after surgery. All predictive covariates were selected a priori. Eighty percent of the sample was randomly selected for model development, and 20% for model validation. Linear regression was performed with Bayesian model averaging to model 12-month ODI (Oswestry Disability Index). Logistic regression with Bayesian model averaging was used to model likelihood of complications, 30-day readmission, need for inpatient rehabilitation, and return to work. Goodness-of-fit was assessed via R(2) for 12-month ODI and via the c-statistic, area under the receiver operating characteristic curve (AUC), for the categorical endpoints. Discrimination (predictive performance) was assessed, using R(2) for the ODI model and the c-statistic for the categorical endpoint models. Calibration was assessed using a plot of predicted versus observed values for the ODI model and the Hosmer-Lemeshow test for the categorical endpoint models. RESULTS On average, all patient-reported outcomes (PROs) were improved after surgery (ODI baseline vs 12 month: 50.4 vs 29.5%, p < 0.001). Complications occurred in 121 patients (6.6%), 108 (5.9%) were readmitted within 30 days of surgery, 188 (10.3%) required discharge to inpatient rehabilitation, 1630 (88.9%) returned to work, and 449 (24.5%) experienced an unplanned outcome (no improvement in ODI, a complication, or readmission). There were 45 unique baseline variable inputs, derived from 39 clinical variables and 38 questionnaire items (ODI, SF-12, MSPQ, VAS-BP, VAS-LP, VAS-NP), included in each model. For prediction of 12-month ODI, R(2) was 0.51 for development and 0.47 for the validation study. For prediction of a complication, readmission, inpatient rehabilitation, and return to work, AUC values ranged 0.72-0.84 for development and 0.79-0.84 for validation study. CONCLUSIONS A novel prediction model utilizing both clinical data and patient interview inputs explained the majority of variation in outcome observed after lumbar spine surgery and reliably predicted 12-month improvement in physical disability, return to work, major complications, readmission, and need for inpatient rehabilitation for individual patients. Application of these models may allow clinicians to offer spine surgery specifically to those who are most likely to benefit and least likely to incur complications and excess costs.

Patient-reported outcomes 3 months after spine surgery: is it an accurate predictor of 12-month outcome in real-world registry platforms?

OBJECT The health care landscape is rapidly shifting to incentivize quality of care rather than quantity of care. Quality and outcomes registry platforms lie at the center of all emerging evidence-driven reform models and will be used to inform decision makers in health care delivery. Obtaining real-world registry outcomes data from patients 12 months after spine surgery remains a challenge. The authors set out to determine whether 3-month patient-reported outcomes accurately predict 12-month outcomes and, hence, whether 3-month measurement systems suffice to identify effective versus noneffective spine care. METHODS All patients undergoing lumbar spine surgery for degenerative disease at a single medical institution over a 2-year period were enrolled in a prospective longitudinal registry. Patient-reported outcome instruments (numeric rating scale [NRS], Oswestry Disability Index [ODI], 12-Item Short Form Health Survey [SF-12], EQ-5D, and the Zung Self-Rating Depression Scale) were recorded prospectively at baseline and at 3 months and 12 months after surgery. Linear regression was performed to determine the independent association of 3- and 12-month outcome. Receiver operating characteristic (ROC) curve analysis was performed to determine whether improvement in general health state (EQ-5D) and disability (ODI) at 3 months accurately predicted improvement and achievement of minimum clinical important difference (MCID) at 12 months. RESULTS A total of 593 patients undergoing elective lumbar surgery were included in the study. There was a significant correlation between 3-month and 12-month EQ-5D (r = 0.71; p < 0.0001) and ODI (r = 0.70; p < 0.0001); however, the authors observed a sizable discrepancy in achievement of a clinically significant improvement (MCID) threshold at 3 versus 12 months on an individual patient level. For postoperative disability (ODI), 11.5% of patients who achieved an MCID threshold at 3 months dropped below this threshold at 12 months; 10.5% of patients who did not meet the MCID threshold at 3 months continued to improve and ultimately surpassed the MCID threshold at 12 months. For ODI, achieving MCID at 3 months accurately predicted 12-month MCID with only 62.6% specificity and 86.8% sensitivity. For postoperative health utility (EQ-5D), 8.5% of patients lost an MCID threshold improvement from 3 months to 12 months, while 4.0% gained the MCID threshold between 3 and 12 months postoperatively. For EQ-5D (quality-adjusted life years), achieving MCID at 3 months accurately predicted 12-month MCID with only 87.7% specificity and 87.2% sensitivity. CONCLUSIONS In a prospective registry, patient-reported measures of treatment effectiveness obtained at 3 months correlated with 12-month measures overall in aggregate, but did not reliably predict 12-month outcome at the patient level. Many patients who do not benefit from surgery by 3 months do so by 12 months, and, conversely, many patients reporting meaningful improvement by 3 months report loss of benefit at 12 months. Prospective longitudinal spine outcomes registries need to span at least 12 months to identify effective versus noneffective patient care.

Quality analysis of anterior cervical discectomy and fusion in the outpatient versus inpatient setting: analysis of 7288 patients from the NSQIP database.

OBJECT In an era of escalating health care cost and universal pressure of improving efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and is rapidly increasing with an expanding aging population. While ASCs offer cost advantages for ACDF, there is a scarcity of evidence that ASCs allow for equivalent quality and thus superior health care value. Therefore, the authors analyzed a nationwide, prospective quality improvement registry (National Surgical Quality Improvement Program [NSQIP]) to compare the quality of ACDF surgery performed in the outpatient ASC versus the inpatient hospital setting. METHODS Patients undergoing ACDF (2005-2011) were identified from the NSQIP database based on the primary Current Procedural Terminology codes. Patients were divided into 2 cohorts (outpatient vs inpatient) based on the acute care setting documented in the NSQIP database. All 30-day surgical morbidity and mortality rates were compared between the 2 groups. Propensity score matching and multivariate logistic regression analysis were used to adjust for confounding factors and to identify the independent association of outpatient ACDF with perioperative outcomes and morbidity. RESULTS A total of 7288 ACDF cases were identified (inpatient = 6120, outpatient = 1168). Unadjusted rates of major morbidity (0.94% vs 4.5%, p < 0.001) and return to the operating room (OR) within 30 days (0.3% vs 2.0%, p < 0.001) were significantly lower in outpatient versus inpatient ACDF. After propensity matching 1442 cases (inpatient = 650, outpatient = 792) based on baseline 32 covariates, rates of major morbidity (1.4% vs 3.1%, p = 0.03), and return to the OR (0.34% vs 1.4%, p = 0.04) remained significantly lower after outpatient ACDF. Adjusted comparison using multivariate logistic regression demonstrated that ACDF performed in the outpatient setting had 58% lower odds of having a major morbidity and 80% lower odds of return to the OR within 30 days. CONCLUSIONS An analysis of a nationwide, prospective quality improvement registry representing more than 250 hospitals demonstrates that 1- to 2-level ACDF can be safely performed in the outpatient ambulatory surgery setting in patients who are appropriate candidates. In an effort to decrease cost of care, surgeons can safely consider performing ACDF in an ASC environment.

Effect of complications within 90 days on patient-reported outcomes 3 months and 12 months following elective surgery for lumbar degenerative disease.

OBJECT There is a paradigm shift toward rewarding providers for quality rather than volume. Complications appear to occur at a fairly consistent frequency in large aggregate data sets. Understanding how complications affect long-term patient-reported outcomes (PROs) following degenerative lumbar surgery is vital. The authors hypothesized that 90-day complications would adversely affect long-term PROs. METHODS Nine hundred six consecutive patients undergoing elective surgery for degenerative lumbar disease over a period of 4 years were enrolled into a prospective longitudinal registry. The following PROs were recorded at baseline and 12-month follow-up: Oswestry Disability Index (ODI) score, numeric rating scales for back and leg pain, quality of life (EQ-5D scores), general physical and mental health (SF-12 Physical Component Summary [PCS] and Mental Component Summary [MCS] scores) and responses to the North American Spine Society (NASS) satisfaction questionnaire. Previously published minimum clinically important difference (MCID) threshold were used to define meaningful improvement. Complications were divided into major (surgicalsite infection, hardware failure, new neurological deficit, pulmonary embolism, hematoma and myocardial infarction) and minor (urinary tract infection, pneumonia, and deep venous thrombosis). RESULTS Complications developed within 90 days of surgery in 13% (118) of the patients (major in 12% [108] and minor in 8% [68]). The mean improvement in ODI scores, EQ-5D scores, SF-12 PCS scores, and satisfaction at 3 months after surgery was significantly less in the patients with complications than in those who did not have major complications (ODI: 13.5 ± 21.2 vs 21.7 ± 19, < 0.0001; EQ-5D: 0.17 ± 0.25 vs 0.23 ± 0.23, p = 0.04; SF-12 PCS: 8.6 ± 13.3 vs 13.0 ± 11.9, 0.001; and satisfaction: 76% vs 90%, p = 0.002). At 12 months after surgery, the patients with major complications had higher ODI scores than those without complications (29.1 ± 17.7 vs 25.3 ± 18.3, p = 0.02). However, there was no difference in the change scores in ODI and absolute scores across all other PROs between the 2 groups. In multivariable linear regression analysis, after controlling for an array of preoperative variables, the occurrence of a major complication was not associated with worsening ODI scores 12 months after surgery. There was no difference in the percentage of patients achieving the MCID for disability (66% vs 64%), back pain (55% vs 56%), leg pain (62% vs 59%), or quality of life (19% vs 14%) or in patient satisfaction rates (82% vs 80%) between those without and with major complications. CONCLUSIONS Major complications within 90 days following lumbar spine surgery have significant impact on the short-term PROs. Patients with complications, however, do eventually achieve clinically meaningful outcomes and report satisfaction equivalent to those without major complications. This information allows a physician to counsel patients on the fact that a complication creates frustration, cost, and inconvenience; however, it does not appear to adversely affect clinically meaningful long-term outcomes and satisfaction.

The present and future of quality measures and public reporting in neurosurgery.

Quality measurement and public reporting are intended to facilitate targeted outcome improvement, practice-based learning, shared decision making, and effective resource utilization. However, regulatory implementation has created a complex network of reporting requirements for physicians and medical practices. These include Medicare's Physician Quality Reporting System, Electronic Health Records Meaningful Use, and Value-Based Payment Modifier programs. The common denominator of all these initiatives is that to avoid penalties, physicians must meet "generic" quality standards that, in the case of neurosurgery and many other specialties, are not pertinent to everyday clinical practice and hold specialists accountable for care decisions outside of their direct control. The Centers for Medicare and Medicaid Services has recently authorized alternative quality reporting mechanisms for the Physician Quality Reporting System, which allow registries to become subspecialty-reporting mechanisms under the Qualified Clinical Data Registry (QCDR) program. These programs further give subspecialties latitude to develop measures of health care quality that are relevant to the care provided. As such, these programs amplify the power of clinical registries by allowing more accurate assessment of practice patterns, patient experiences, and overall health care value. Neurosurgery has been at the forefront of these developments, leveraging the experience of the National Neurosurgery Quality and Outcomes Database to create one of the first specialty-specific QCDRs. Recent legislative reform has continued to change this landscape and has fueled optimism that registries (including QCDRs) and other specialty-driven quality measures will be a prominent feature of federal and private sector quality improvement initiatives. These physician- and patient-driven methods will allow neurosurgery to underscore the value of interventions, contribute to the development of sustainable health care solutions, and actively participate in meaningful quality initiatives for the benefit of the patients served.

The National Neurosurgery Quality and Outcomes Database Qualified Clinical Data Registry: 2015 measure specifications and rationale.

Meaningful quality measurement and public reporting have the potential to facilitate targeted outcome improvement, practice-based learning, shared decision making, and effective resource utilization. Recent developments in national quality reporting programs, such as the Centers for Medicare & Medicaid Services Qualified Clinical Data Registry (QCDR) reporting option, have enhanced the ability of specialty groups to develop relevant quality measures of the care they deliver. QCDRs will complete the collection and submission of Physician Quality Reporting System (PQRS) quality measures data on behalf of individual eligible professionals. The National Neurosurgery Quality and Outcomes Database (N(2)QOD) offers 21 non-PQRS measures, initially focused on spine procedures, which are the first specialty-specific measures for neurosurgery. Securing QCDR status for N(2)QOD is a tremendously important accomplishment for our specialty. This program will ensure that data collected through our registries and used for PQRS is meaningful for neurosurgeons, related spine care practitioners, their patients, and other stakeholders. The 2015 N(2)QOD QCDR is further evidence of neurosurgery's commitment to substantively advancing the health care quality paradigm. The following manuscript outlines the measures now approved for use in the 2015 N(2)QOD QCDR. Measure specifications (measure type and descriptions, related measures, if any, as well as relevant National Quality Strategy domain[s]) along with rationale are provided for each measure.

Minimally invasive transpsoas L2 corpectomy and percutaneous pedicle screw fixation for osteoporotic burst fracture in the elderly: a technical report.

BACKGROUND AND IMPORTANCE: Osteoporotic vertebral burst fractures are an increasingly common cause of pain and severe functional disability in the elderly. Although anterior-posterior surgical stabilization offers an efficacious and durable treatment, the associated high blood loss, long durations of surgery, and prolonged hospitalization are often not tolerable for elderly patients, who are most often medically frail with multiple comorbidities. CLINICAL PRESENTATION: We report a case of an L2 osteoporotic burst fracture in an elderly patient with significant comorbidities treated with a minimally invasive tubular direct lateral transpsoas approach for L2 vertebrectomy and anterior cage placement. The construct was supplemented by a percutaneous pedicle screw construct and adjacent level vertebroplasty. Duration of surgery was 3.5 hours with a total of 35 mL blood loss. The patient was discharged ambulating 36 hours after surgery and reported marked improvement in pain, disability, and quality of life measures at 6 weeks postoperatively. CONCLUSIONS: L2 vertebrectomy by direct lateral transpsoas tube systems supplemented by percutaneous pedicle screws can be performed safely and may allow for anterior column decompression and reconstruction in elderly or comorbid patients not otherwise able to tolerate traditional stabilization procedures.

Transforaminal lumbar interbody graft placement using an articulating delivery arm facilitates increased segmental lordosis with superior anterior and midline graft placement.

OBJECTIVE: Transforaminal lumbar interbody fusion (TLIF) is a frequently performed method of lumbar arthrodesis in patients failing medical management of back and leg pain. Accurate placement of the interbody graft and restoration of lordosis has been shown to be crucial when performing lumbar fusion procedures. We performed a single-surgeon, prospective, randomized study to determine whether a novel articulating versus traditional straight graft delivery arm system allows for superior graft placement and increased lordosis for single-level TLIF. METHODS: Thirty consecutive patients undergoing single-level TLIF were included and prospectively randomized to one of the 2 groups (articulated vs. straight delivery arm system). Three radiographic characteristics were evaluated at 6-week follow-up: (1) degree of segmental lumbar lordosis at the fused level; (2) the percent anterior location of the interbody graft in disk space; and (3) the distance (mm) off midline of the interbody graft placement. RESULTS: Randomization yielded 16 patients in the articulated delivery arm cohort and 14 in the straight delivery arm cohort. The articulating delivery arm system yielded an average of 14.7-degree segmental lordosis at fused level, 35% anterior location, and 3.6 mm off midline. The straight delivery arm system yielded an average of 10.7-degree segmental lordosis at fused level, 46% anterior location, and 7.0 mm off midline. All 3 comparisons were statistically significant (P<0.05). CONCLUSIONS: The study suggests that an articulating delivery arm system facilitates superior anterior and midline TLIF graft placement allowing for increased segmental lordosis compared with a traditional straight delivery arm system.