Publications by authors named "Kevin T Foley"

83 Publications

Identifying patients at risk for nonroutine discharge after surgery for cervical myelopathy: an analysis from the Quality Outcomes Database.

J Neurosurg Spine 2021 May 7:1-9. Epub 2021 May 7.

15Department of Neurological Surgery, University of Utah, Salt Lake City, Utah.

Objective: Optimizing patient discharge after surgery has been shown to impact patient recovery and hospital/physician workflow and to reduce healthcare costs. In the current study, the authors sought to identify risk factors for nonroutine discharge after surgery for cervical myelopathy by using a national spine registry.

Methods: The Quality Outcomes Database cervical module was queried for patients who had undergone surgery for cervical myelopathy between 2016 and 2018. Nonroutine discharge was defined as discharge to postacute care (rehabilitation), nonacute care, or another acute care hospital. A multivariable logistic regression predictive model was created using an array of demographic, clinical, operative, and patient-reported outcome characteristics.

Results: Of the 1114 patients identified, 11.2% (n = 125) had a nonroutine discharge. On univariate analysis, patients with a nonroutine discharge were more likely to be older (age ≥ 65 years, 70.4% vs 35.8%, p < 0.001), African American (24.8% vs 13.9%, p = 0.007), and on Medicare (75.2% vs 35.1%, p < 0.001). Among the patients younger than 65 years of age, those who had a nonroutine discharge were more likely to be unemployed (70.3% vs 36.9%, p < 0.001). Overall, patients with a nonroutine discharge were more likely to present with a motor deficit (73.6% vs 58.7%, p = 0.001) and more likely to have nonindependent ambulation (50.4% vs 14.0%, p < 0.001) at presentation. On multivariable logistic regression, factors associated with higher odds of a nonroutine discharge included African American race (vs White, OR 2.76, 95% CI 1.38-5.51, p = 0.004), Medicare coverage (vs private insurance, OR 2.14, 95% CI 1.00-4.65, p = 0.04), nonindependent ambulation at presentation (OR 2.17, 95% CI 1.17-4.02, p = 0.01), baseline modified Japanese Orthopaedic Association severe myelopathy score (0-11 vs moderate 12-14, OR 2, 95% CI 1.07-3.73, p = 0.01), and posterior surgical approach (OR 11.6, 95% CI 2.12-48, p = 0.004). Factors associated with lower odds of a nonroutine discharge included fewer operated levels (1 vs 2-3 levels, OR 0.3, 95% CI 0.1-0.96, p = 0.009) and a higher quality of life at baseline (EQ-5D score, OR 0.43, 95% CI 0.25-0.73, p = 0.001). On predictor importance analysis, baseline quality of life (EQ-5D score) was identified as the most important predictor (Wald χ2 = 9.8, p = 0.001) of a nonroutine discharge; however, after grouping variables into distinct categories, socioeconomic and demographic characteristics (age, race, gender, insurance status, employment status) were identified as the most significant drivers of nonroutine discharge (28.4% of total predictor importance).

Conclusions: The study results indicate that socioeconomic and demographic characteristics including age, race, gender, insurance, and employment may be the most significant drivers of a nonroutine discharge after surgery for cervical myelopathy.
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http://dx.doi.org/10.3171/2020.11.SPINE201442DOI Listing
May 2021

Patient-reported outcome improvements at 24-month follow-up after fusion added to decompression for grade I degenerative lumbar spondylolisthesis: a multicenter study using the Quality Outcomes Database.

J Neurosurg Spine 2021 Apr 16:1-10. Epub 2021 Apr 16.

16Department of Neurological Surgery, University of California, San Francisco, California.

Objective: The ideal surgical management of grade I lumbar spondylolisthesis has not been determined despite extensive prior investigations. In this cohort study, the authors used data from the large, multicenter, prospectively collected Quality Outcomes Database to bridge the gap between the findings in previous randomized trials and those in a more heterogeneous population treated in a typical practice. The objective was to assess the difference in patient-reported outcomes among patients undergoing decompression alone or decompression plus fusion.

Methods: The primary outcome measure was change in 24-month Oswestry Disability Index (ODI) scores. The minimal clinically important difference (MCID) in ODI score change and 30% change in ODI score at 24 months were also evaluated. After adjusting for patient-specific and clinical factors, multivariable linear and logistic regressions were employed to evaluate the impact of fusion on outcomes. To account for differences in age, sex, body mass index, and baseline listhesis, a sensitivity analysis was performed using propensity score analysis to match patients undergoing decompression only with those undergoing decompression and fusion.

Results: In total, 608 patients who had grade I lumbar spondylolisthesis were identified (85.5% with at least 24 months of follow-up); 140 (23.0%) underwent decompression alone and 468 (77.0%) underwent decompression and fusion. The 24-month change in ODI score was significantly greater in the fusion plus decompression group than in the decompression-only group (-25.8 ± 20.0 vs -15.2 ± 19.8, p < 0.001). Fusion remained independently associated with 24-month ODI score change (B = -7.05, 95% CI -10.70 to -3.39, p ≤ 0.001) in multivariable regression analysis, as well as with achieving the MCID for the ODI score (OR 1.767, 95% CI 1.058-2.944, p = 0.029) and 30% change in ODI score (OR 2.371, 95% CI 1.286-4.371, p = 0.005). Propensity score analysis resulted in 94 patients in the decompression-only group matched 1 to 1 with 94 patients in the fusion group. The addition of fusion to decompression remained a significant predictor of 24-month change in the ODI score (B = 2.796, 95% CI 2.228-13.275, p = 0.006) and of achieving the 24-month MCID ODI score (OR 2.898, 95% CI 1.214-6.914, p = 0.016) and 24-month 30% change in ODI score (OR 2.300, 95% CI 1.014-5.216, p = 0.046).

Conclusions: These results suggest that decompression plus fusion in patients with grade I lumbar spondylolisthesis may be associated with superior outcomes at 24 months compared with decompression alone, both in reduction of disability and in achieving clinically meaningful improvement. Longer-term follow-up is warranted to assess whether this effect is sustained.
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http://dx.doi.org/10.3171/2020.9.SPINE201082DOI Listing
April 2021

Design of experiment (DOE) applied to artificial neural network architecture enables rapid bioprocess improvement.

Bioprocess Biosyst Eng 2021 Jun 27;44(6):1301-1308. Epub 2021 Feb 27.

DiscGenics Inc, Salt Lake City, Utah, USA.

Modern bioprocess development employs statistically optimized design of experiments (DOE) and regression modeling to find optimal bioprocess set points. Using modeling software, such as JMP Pro, it is possible to leverage artificial neural networks (ANNs) to improve model accuracy beyond the capabilities of regression models. Herein, we bridge the gap between a DOE skill set and a machine learning skill set by demonstrating a novel use of DOE to systematically create and evaluate ANN architecture using JMP Pro software. Additionally, we run a mammalian cell culture process at historical, one factor at a time, standard least squares regression, and ANN-derived set points. This case study demonstrates the significant differences between one factor at a time bioprocess development, DOE bioprocess development and the relative power of linear regression versus an ANN-DOE hybrid modeling approach.
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http://dx.doi.org/10.1007/s00449-021-02529-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8144078PMC
June 2021

Artificial Intelligence-enabled, Real-time Intraoperative Ultrasound Imaging of Neural Structures Within the Psoas: Validation in a Porcine Spine Model.

Spine (Phila Pa 1976) 2021 Feb;46(3):E146-E152

Semmes-Murphey Clinic & Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, TN.

Study Design: Experimental in-vivo animal study.

Objective: The aim of this study was to evaluate an Artificial Intelligence (AI)-enabled ultrasound imaging system's ability to detect, segment, classify, and display neural and other structures during trans-psoas spine surgery.

Summary Of Background Data: Current methodologies for intraoperatively localizing and visualizing neural structures within the psoas are limited and can impact the safety of lateral lumbar interbody fusion (LLIF). Ultrasound technology, enhanced with AI-derived neural detection algorithms, could prove useful for this task.

Methods: The study was conducted using an in vivo porcine model (50 subjects). Image processing and machine learning algorithms were developed to detect neural and other anatomic structures within and adjacent to the psoas muscle while using an ultrasound imaging system during lateral lumbar spine surgery (SonoVision,™ Tissue Differentiation Intelligence, USA). The imaging system's ability to detect and classify the anatomic structures was assessed with subsequent tissue dissection. Dice coefficients were calculated to quantify the performance of the image segmentation.

Results: The AI-trained ultrasound system detected, segmented, classified, and displayed nerve, psoas muscle, and vertebral body surface with high sensitivity and specificity. The mean Dice coefficient score for each tissue type was >80%, indicating that the detected region and ground truth were >80% similar to each other. The mean specificity of nerve detection was 92%; for bone and muscle, it was >95%. The accuracy of nerve detection was >95%.

Conclusion: This study demonstrates that a combination of AI-derived image processing and machine learning algorithms can be developed to enable real-time ultrasonic detection, segmentation, classification, and display of critical anatomic structures, including neural tissue, during spine surgery. AI-enhanced ultrasound imaging can provide a visual map of important anatomy in and adjacent to the psoas, thereby providing the surgeon with critical information intended to increase the safety of LLIF surgery.Level of Evidence: N/A.
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http://dx.doi.org/10.1097/BRS.0000000000003704DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7787186PMC
February 2021

"July Effect" Revisited: July Surgeries at Residency Training Programs are Associated with Equivalent Long-term Clinical Outcomes Following Lumbar Spondylolisthesis Surgery.

Spine (Phila Pa 1976) 2021 Jun;46(12):836-843

Department of Neurological Surgery, University of California, San Francisco, Ca.

Study Design: Retrospective analysis of a prospective registry.

Objective: We utilized the Quality Outcomes Database (QOD) registry to investigate the "July Effect" at QOD spondylolisthesis module sites with residency trainees.

Summary Of Background Data: There is a paucity of investigation on the long-term outcomes following surgeries involving new trainees utilizing high-quality, prospectively collected data.

Methods: This was an analysis of 608 patients who underwent single-segment surgery for grade 1 degenerative lumbar spondylolisthesis at 12 high-enrolling sites. Surgeries were classified as occurring in July or not in July (non-July). Outcomes collected included estimated blood loss, length of stay, operative time, discharge disposition, complications, reoperation and readmission rates, and patient-reported outcomes (Oswestry Disability Index [ODI], Numeric Rating Scale [NRS] Back Pain, NRS Leg Pain, EuroQol-5D [EQ-5D] and the North American Spine Society [NASS] Satisfaction Questionnaire). Propensity score-matched analyses were utilized to compare postoperative outcomes and complication rates between the July and non-July groups.

Results: Three hundred seventy-one surgeries occurred at centers with a residency training program with 21 (5.7%) taking place in July. In propensity score-matched analyses, July surgeries were associated with longer operative times ( average treatment effect = 22.4 minutes longer, 95% confidence interval 0.9-449.0, P = 0.041). Otherwise, July surgeries were not associated with significantly different outcomes for the remaining perioperative parameters (estimated blood loss, length of stay, discharge disposition, postoperative complications), overall reoperation rates, 3-month readmission rates, and 24-month ODI, NRS back pain, NRS leg pain, EQ-5D, and NASS satisfaction score (P > 0.05, all comparisons).

Conclusion: Although July surgeries were associated with longer operative times, there were no associations with other clinical outcomes compared to non-July surgeries following lumbar spondylolisthesis surgery. These findings may be due to the increased attending supervision and intraoperative education during the beginning of the academic year. There is no evidence that the influx of new trainees in July significantly affects long-term patient-centered outcomes.Level of Evidence: 3.
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http://dx.doi.org/10.1097/BRS.0000000000003903DOI Listing
June 2021

Perspectives on the Treatment of Lumbar Disc Degeneration: The Value Proposition for a Cell-Based Therapy, Immunomodulatory Properties of Discogenic Cells and the Associated Clinical Evaluation Strategy.

Front Surg 2020 16;7:554382. Epub 2020 Dec 16.

DiscGenics Inc., Salt Lake City, UT, United States.

Low back pain (LBP) is a serious medical condition that affects a large percentage of the population worldwide. One cause of LBP is disc degeneration (DD), which is characterized by progressive breakdown of the disc and an inflamed disc environment. Current treatment options for patients with symptomatic DD are limited and are often unsuccessful, so many patients turn to prescription opioids for pain management in a time when opioid usage, addiction, and drug-related deaths are at an all-time high. In this paper, we discuss the etiology of lumbar DD and currently available treatments, as well as the potential for cell therapy to offer a biologic, non-opioid alternative to patients suffering from the condition. Finally, we present an overview of an investigational cell therapy called IDCT (Injectable Discogenic Cell Therapy), which is currently under evaluation in multiple double-blind clinical trials overseen by major regulatory agencies. The active ingredient in IDCT is a novel allogeneic cell population known as Discogenic Cells. These cells, which are derived from intervertebral disc tissue, have been shown to possess both regenerative and immunomodulatory properties. Cell therapies have unique properties that may ultimately lead to decreased pain and improved function, as well as curb the numbers of patients pursuing opioids. Their efficacy is best assessed in rigorous double-blinded and placebo-controlled clinical studies.
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http://dx.doi.org/10.3389/fsurg.2020.554382DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772215PMC
December 2020

Retooling the Health Care Workforce for an Aging America: A Current Perspective.

Gerontologist 2021 Jun;61(4):487-496

Department of Family and Community Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing.

A 2008 Institute of Medicine (IoM) report outlined a vision for health care and a workforce capable of addressing health and extended care needs of our aging population. It highlighted dramatic shortages necessitating bold action and outlined recommendations aimed at building a sizable and qualified workforce. This study updates report findings and progress made on its recommendations. Through review of publicly accessible, internet-based literature and government and professional organization websites, current workforce data and recent policy changes are compared to the report's statistics and recommendations. Direct comparisons are limited by changing definitions, context, and data collection and analyses methods. Future workforce-need projections are estimated using reports from various sources. Inability to forecast medical advances, socioeconomic changes, and world events affects the accuracy of these projections. Nonetheless, clear conclusions emerge despite such limitations. Progress toward fulfilling the IoM goals is variable and insufficient. The current and projected numbers for all geriatric health providers remain inadequate compared to estimated 2030 demand. Challenges in meeting estimated needs persist essentially unchanged. The 2008 IoM framework and recommendations remain relevant and constitute an important roadmap to complete unfinished goals. Initial findings from this update provide a platform for developing practice and policy reforms.
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http://dx.doi.org/10.1093/geront/gnaa163DOI Listing
June 2021

The Part-Time Geriatrics Fellowship: Five Easy Steps for Creating an Alternative Training Option.

J Am Geriatr Soc 2020 12 5;68(12):E69-E71. Epub 2020 Oct 5.

Department of Family and Community Medicine, College of Osteopathic Medicine, Michigan State University, East Lansing, Michigan.

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http://dx.doi.org/10.1111/jgs.16849DOI Listing
December 2020

The Institute for Healthcare Improvement-NeuroPoint Alliance collaboration to decrease length of stay and readmission after lumbar spine fusion: using national registries to design quality improvement protocols.

J Neurosurg Spine 2020 Aug 21:1-10. Epub 2020 Aug 21.

4Carolina Neurosurgery & Spine Associates, Neuroscience and Musculoskeletal Institutes, Atrium Health Charlotte, North Carolina.

Objective: National databases collect large amounts of clinical information, yet application of these data can be challenging. The authors present the NeuroPoint Alliance and Institute for Healthcare Improvement (NPA-IHI) program as a novel attempt to create a quality improvement (QI) tool informed through registry data to improve the quality of care delivered. Reducing the length of stay (LOS) and readmission after elective lumbar fusion was chosen as the pilot module.

Methods: The NPA-IHI program prospectively enrolled patients undergoing elective 1- to 3-level lumbar fusions across 8 institutions. A three-pronged approach was taken that included the following phases: 1) Research Phase, 2) Development Phase, and 3) Implementation Phase. Primary outcomes were LOS and readmission. From January to June 2017, a learning system was created utilizing monthly conference calls, weekly data submission, and continuous refinement of the proposed QI tool. Nonparametric tests were used to assess the impact of the QI intervention.

Results: The novel QI tool included the following three areas of intervention: 1) preoperative discharge assessment (location, date, and instructions), 2) inpatient changes (LOS rounding checklist, daily huddle, and pain assessments), and 3) postdischarge calls (pain, primary care follow-up, and satisfaction). A total of 209 patients were enrolled, and the most common procedure was a posterior laminectomy/fusion (60.2%). Seven patients (3.3%) were readmitted during the study period. Preoperative discharge planning was completed for 129 patients (61.7%). A shorter median LOS was seen in those with a known preoperative discharge date (67 vs 80 hours, p = 0.018) and clear discharge instructions (71 vs 81 hours, p = 0.030). Patients with a known preoperative discharge plan also reported significantly increased satisfaction (8.0 vs 7.0, p = 0.028), and patients with increased discharge readiness (scale 0-10) also reported higher satisfaction (r = 0.474, p < 0.001). Those receiving postdischarge calls (76%) had a significantly shorter LOS than those without postdischarge calls (75 vs 99 hours, p = 0.020), although no significant relationship was seen between postdischarge calls and readmission (p = 0.342).

Conclusions: The NPA-IHI program showed that preoperative discharge planning and postdischarge calls have the potential to reduce LOS and improve satisfaction after elective lumbar fusion. It is our hope that neurosurgical providers can recognize how registries can be used to both develop and implement a QI tool and appreciate the importance of QI implementation as a separate process from data collection/analysis.
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http://dx.doi.org/10.3171/2020.5.SPINE20457DOI Listing
August 2020

Development and Validation of Cervical Prediction Models for Patient-Reported Outcomes at 1 Year After Cervical Spine Surgery for Radiculopathy and Myelopathy.

Spine (Phila Pa 1976) 2020 Nov;45(22):1541-1552

Department of Orthopaedic Surgery, Center for Musculoskeletal Research, Vanderbilt University School of Medicine, Nashville, Tennessee.

Study Design: Retrospective analysis of prospectively collected registry data.

Objective: To develop and validate prediction models for 12-month patient-reported outcomes of disability, pain, and myelopathy in patients undergoing elective cervical spine surgery.

Summary Of Background Data: Predictive models have the potential to be utilized preoperatively to set expectations, adjust modifiable characteristics, and provide a patient-centered model of care.

Methods: This study was conducted using data from the cervical module of the Quality Outcomes Database. The outcomes of interest were disability (Neck Disability Index:), pain (Numeric Rating Scale), and modified Japanese Orthopaedic Association score for myelopathy. Multivariable proportional odds ordinal regression models were developed for patients with cervical radiculopathy and myelopathy. Patient demographic, clinical, and surgical covariates as well as baseline patient-reported outcomes scores were included in all models. The models were internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients.

Results: Four thousand nine hundred eighty-eight patients underwent surgery for radiculopathy and 2641 patients for myelopathy. The most important predictor of poor postoperative outcomes at 12-months was the baseline Neck Disability Index score for patients with radiculopathy and modified Japanese Orthopaedic Association score for patients with myelopathy. In addition, symptom duration, workers' compensation, age, employment, and ambulatory and smoking status had a statistically significant impact on all outcomes (P < 0.001). Clinical and surgical variables contributed very little to predictive models, with posterior approach being associated with higher odds of having worse 12-month outcome scores in both the radiculopathy and myelopathy cohorts (P < 0.001). The full models overall discriminative performance ranged from 0.654 to 0.725.

Conclusions: These predictive models provide individualized risk-adjusted estimates of 12-month disability, pain, and myelopathy outcomes for patients undergoing spine surgery for degenerative cervical disease. Predictive models have the potential to be used as a shared decision-making tool for evidence-based preoperative counselling.

Level Of Evidence: 2.
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http://dx.doi.org/10.1097/BRS.0000000000003610DOI Listing
November 2020

Metrics Development for Minimal Invasive Unilateral Laminotomy for Bilateral Decompression of Lumbar Spinal Stenosis With and Without Spondylolisthesis by an International Expert Panel.

Global Spine J 2020 Apr 28;10(2 Suppl):168S-175S. Epub 2020 May 28.

Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY, USA.

Study Design: Prospective study.

Objectives: To develop, operationally define, and seek consensus from procedure experts on the metrics that best characterize a reference approach to the performance of a minimally invasive unilateral laminotomy for bilateral decompression (ULBD) for lumbar spinal stenosis.

Methods: A Metrics Group consisting of 3 experienced spine surgeons (2 neurosurgeons, 1 orthopedic surgeon), each with over 25 years of clinical practice, and an educational expert formed the Metrics Group that characterized a lumbar decompression surgery for spinal stenosis as a "reference" procedure. In a modified Delphi panel, 26 spine surgeons from 14 countries critiqued these metrics and their operational definitions before reaching consensus.

Results: Performance metrics consisting of 6 phases with 42 steps, 21 errors, and 17 sentinel errors were identified that characterize the procedure. During the peer review, these were evaluated, modified, and agreed.

Conclusions: Surgical procedures can be broken down into elemental tasks necessary for the safe and effective completion of a reference approach to a specified surgical procedure. Spinal experts from 16 countries reached consensus on performance metrics for the procedure. This metric-based characterization can be used in a training curriculum and also for assessment of training and performance in clinical practice.
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http://dx.doi.org/10.1177/2192568219893675DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263325PMC
April 2020

Impact of Dominant Symptom on 12-Month Patient-Reported Outcomes for Patients Undergoing Lumbar Spine Surgery.

Neurosurgery 2020 10;87(5):1037-1045

Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota.

Background: The impact of symptom characteristics on outcomes of spine surgery remains elusive.

Objective: To determine the impact of symptom location, severity, and duration on outcomes following lumbar spine surgery.

Methods: We queried the Quality Outcomes Database (QOD) for patients undergoing elective lumbar spine surgery for lumbar degenerative spine disease. Multivariable regression was utilized to determine the impact of preoperative symptom characteristics (location, severity, and duration) on improvement in disability, quality of life, return to work, and patient satisfaction at 1 yr. Relative predictor importance was determined using an importance metric defined as Wald χ2 penalized by degrees of freedom.

Results: A total of 22 022 subjects were analyzed. On adjusted analysis, we found patients with predominant leg pain were more likely to be satisfied (P < .0001), achieve minimum clinically important difference (MCID) in Oswestry Disability Index (ODI) (P = .002), and return to work (P = .03) at 1 yr following surgery without significant difference in Euro-QoL-5D (EQ-5D) (P = .09) [ref = predominant back pain]. Patients with equal leg and back pain were more likely to be satisfied (P < .0001), but showed no significant difference in achieving MCID (P = .22) or return to work (P = .07). Baseline numeric rating scale-leg pain and symptom duration were most important predictors of achieving MCID and change in EQ-5D. Predominant symptom was not found to be an important determinant of return to work. Worker's compensation was found to be most important determinant of satisfaction and return to work.

Conclusion: Predominant symptom location is a significant determinant of functional outcomes following spine surgery. However, pain severity and duration have higher predictive importance. Return to work is more dependent on sociodemographic features as compared to symptom characteristics.
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http://dx.doi.org/10.1093/neuros/nyaa240DOI Listing
October 2020

Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis.

Neurosurgery 2020 Jun 4. Epub 2020 Jun 4.

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated.

Objective: To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis.

Methods: A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change.

Results: The mean age was 64.2 ± 11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [-12.9 to -2.6]; P = .003), NRS back pain change (β -1.2; 95% CI [-2.1 to -0.4]; P = .004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 3.7; 95% CI [1.7-8.3]; P < .001). Increasing age was associated with superior NRS leg pain change (β -0.1; 95% CI [-0.1 to -0.01]; P = .03) and NASS satisfaction (OR = 1.05; 95% CI [1.01-1.09]; P = .02). Fusion surgeries were associated with superior ODI change (β -6.7; 95% CI [-12.7 to -0.7]; P = .03), NRS back pain change (β -1.1; 95% CI [-2.1 to -0.2]; P = .02), and NASS satisfaction (OR = 3.6; 95% CI [1.6-8.3]; P = .002).

Conclusion: Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.
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http://dx.doi.org/10.1093/neuros/nyaa206DOI Listing
June 2020

A Comparison of Minimally Invasive and Open Transforaminal Lumbar Interbody Fusion for Grade 1 Degenerative Lumbar Spondylolisthesis: An Analysis of the Prospective Quality Outcomes Database.

Neurosurgery 2020 09;87(3):555-562

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: It remains unclear if minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) is comparable to traditional, open TLIF because of the limitations of the prior small-sample-size, single-center studies reporting comparative effectiveness.

Objective: To compare MI-TLIF to traditional, open TLIF for grade 1 degenerative lumbar spondylolisthesis in the largest study to date by sample size.

Methods: We utilized the prospective Quality Outcomes Database registry and queried patients with grade 1 degenerative lumbar spondylolisthesis who underwent single-segment surgery with MI- or open TLIF methods. Outcomes were compared 24 mo postoperatively.

Results: A total of 297 patients were included: 72 (24.2%) MI-TLIF and 225 (75.8%) open TLIF. MI-TLIF surgeries had lower mean body mass indexes (29.5 ± 5.1 vs 31.3 ± 7.0, P = .0497) and more worker's compensation cases (11.1% vs 1.3%, P < .001) but were otherwise similar. MI-TLIF had less blood loss (108.8 ± 85.6 vs 299.6 ± 242.2 mL, P < .001), longer operations (228.2 ± 111.5 vs 189.6 ± 66.5 min, P < .001), and a higher return-to-work (RTW) rate (100% vs 80%, P = .02). Both cohorts improved significantly from baseline for 24-mo Oswestry Disability Index (ODI), Numeric Rating Scale back pain (NRS-BP), NRS leg pain (NRS-LP), and Euro-Qol-5 dimension (EQ-5D) (P > .001). In multivariable adjusted analyses, MI-TLIF was associated with lower ODI (β = -4.7; 95% CI = -9.3 to -0.04; P = .048), higher EQ-5D (β = 0.06; 95% CI = 0.01-0.11; P = .02), and higher satisfaction (odds ratio for North American Spine Society [NASS] 1/2 = 3.9; 95% CI = 1.4-14.3; P = .02). Though trends favoring MI-TLIF were evident for NRS-BP (P = .06), NRS-LP (P = .07), and reoperation rate (P = .13), these results did not reach statistical significance.

Conclusion: For single-level grade 1 degenerative lumbar spondylolisthesis, MI-TLIF was associated with less disability, higher quality of life, and higher patient satisfaction compared with traditional, open TLIF. MI-TLIF was associated with higher rates of RTW, less blood loss, but longer operative times. Though we utilized multivariable adjusted analyses, these findings may be susceptible to selection bias.
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http://dx.doi.org/10.1093/neuros/nyaa097DOI Listing
September 2020

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

Neurosurg Focus 2020 05;48(5):E5

17Geisinger Health, Danville, Pennsylvania.

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.
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http://dx.doi.org/10.3171/2020.2.FOCUS191022DOI Listing
May 2020

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.

Neurosurg Focus 2020 05;48(5):E2

4Department of Neurologic Surgery, Mayo Clinic, Rochester, Minnesota.

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).
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http://dx.doi.org/10.3171/2020.2.FOCUS207DOI Listing
May 2020

Regional Variance in Disability and Quality-of-Life Outcomes After Surgery for Grade I Degenerative Lumbar Spondylolisthesis: A Quality Outcomes Database Analysis.

World Neurosurg 2020 06 28;138:e336-e344. Epub 2020 Feb 28.

Department of Neurosurgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, Utah, USA. Electronic address:

Objective: Regional differences in outcomes after spine surgery are poorly understood. We assessed disability and quality-of-life outcomes by geographic region in the United States using the NeuroPoint Alliance Quality Outcomes Database.

Methods: We queried the prospective Quality Outcomes Database patient registry to identify patients who underwent elective 1- or 2-level lumbar surgery for grade I degenerative spondylolisthesis from July 2014 through June 2016. Primary outcome measures included Oswestry Disability Index (ODI) and EuroQOL-5D (EQ-5D) reported at 24 months postoperatively. Differences in EQ-5D and ODI were compared across geographic regions of the United States (Northeast, Midwest, South, West).

Results: We identified 608 patients from 12 centers who underwent surgery. Of these, 517 (85.0%) had ODI data and 492 (80.9%) had EQ-5D data at 24 months. Southern states had the largest representation (304 patients; 5 centers), followed by Northeastern (114 patients; 3 centers), Midwestern (96 patients; 2 centers), and Western (94 patients; 2 centers) states. Baseline ODI scores were significantly different among regions, with the South having the greatest baseline disability burden (Northeast: 40.9 ± 16.9, South: 51.2 ± 15.8, Midwest: 40.9 ± 17.8, West: 45.0 ± 17.1, P < 0.001). The change in ODI at 24 months postoperatively was significantly different among regions, with the South showing the greatest ODI improvement (Northeast: -21.1 ± 18.2, South: -26.5 ± 20.2, Midwest: -18.2 ± 22.9, West: -21.7 ± 19.6, P < 0.001). All regions had ≥60% achievement of the minimum clinically important difference in ODI at 24 months postoperatively. No regional differences were observed for EQ-5D.

Conclusion: Significant regional variation exists for disability outcomes, but not quality of life, at 24 months after spinal surgery for grade I degenerative spondylolisthesis.
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http://dx.doi.org/10.1016/j.wneu.2020.02.117DOI Listing
June 2020

Outcomes and Complications With Age in Spondylolisthesis: An Evaluation of the Elderly From the Quality Outcomes Database.

Spine (Phila Pa 1976) 2020 Jul;45(14):1000-1008

Department of Neurological Surgery, Clinical Neurosciences Center, University of Utah, Salt Lake City, UT.

Study Design: Prospective database analysis.

Objective: To assess the effect of age on patient-reported outcomes (PROs) and complication rates after surgical treatment for spondylolisthesis SUMMARY OF BACKGROUND DATA.: Degenerative lumbar spondylolisthesis affects 3% to 20% of the population and up to 30% of the elderly. There is not yet consensus on whether age is a contraindication for surgical treatment of elderly patients.

Methods: The Quality Outcomes Database lumbar registry was used to evaluate patients from 12 US academic and private centers who underwent surgical treatment for grade 1 lumbar spondylolisthesis between July 2014 and June 2016.

Results: A total of 608 patients who fit the inclusion criteria were categorized by age into the following groups: less than 60 (n = 239), 60 to 70 (n = 209), 71 to 80 (n = 128), and more than 80 (n = 32) years. Older patients showed lower mean body mass index (P < 0.001) and higher rates of diabetes (P = 0.007), coronary artery disease (P = 0.0001), and osteoporosis (P = 0.005). A lower likelihood for home disposition was seen with higher age (89.1% in <60-year-old vs. 75% in >80-year-old patients; P = 0.002). There were no baseline differences in PROs (Oswestry Disability Index, EuroQol health survey [EQ-5D], Numeric Rating Scale for leg pain and back pain) among age categories. A significant improvement for all PROs was seen regardless of age (P < 0.05), and most patients met minimal clinically important differences (MCIDs) for improvement in postoperative PROs. No differences in hospital readmissions or reoperations were seen among age groups (P < 0.05). Multivariate analysis demonstrated that, after controlling other variables, a higher age did not decrease the odds of achieving MCID at 12 months for the PROs.

Conclusion: Our results indicate that well-selected elderly patients undergoing surgical treatment of grade 1 spondylolisthesis can achieve meaningful outcomes. This modern, multicenter US study reflects the current use and limitations of spondylolisthesis treatment in the elderly, which may be informative to patients and providers.

Level Of Evidence: 4.
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http://dx.doi.org/10.1097/BRS.0000000000003441DOI Listing
July 2020

Cranial flap fixation in sheep using a resorbable bone adhesive.

J Neurosurg 2020 Feb 7:1-9. Epub 2020 Feb 7.

5LaunchPad Medical, Lowell, Massachusetts.

Objective: The authors' goal in this study was to investigate the use of a novel, bioresorbable, osteoconductive, wet-field mineral-organic bone adhesive composed of tetracalcium phosphate and phosphoserine (TTCP-PS) for cranial bone flap fixation and compare it with conventional low-profile titanium plates and self-drilling screws.

Methods: An ovine craniotomy surgical model was used to evaluate the safety and efficacy of TTCP-PS over 2 years. Bilateral cranial defects were created in 41 sheep and were replaced in their original position. The gaps (kerfs) were completely filled with TTCP-PS (T1 group), half-filled with TTCP-PS (T2 group), or left empty and the flaps fixated by plates and screws as a control (C group). At 12 weeks, 1 year, and 2 years following surgery, the extent of bone healing, local tissue effects, and remodeling of the TTCP-PS were analyzed using macroscopic observations and histopathological and histomorphometric analyses. Flap fixation strength was evaluated by biomechanical testing at 12 weeks and 1 year postoperatively.

Results: No adverse local tissue effects were observed in any group. At 12 weeks, the bone flap fixation strengths in test group 1 (1689 ± 574 N) and test group 2 (1611 ± 501 N) were both statistically greater (p = 0.01) than that in the control group (663 ± 385 N). From 12 weeks to 1 year, the bone flap fixation strengths increased significantly (p < 0.05) for all groups. At 1 year, the flap fixation strength in test group 1 (3240 ± 423 N) and test group 2 (3212 ± 662 N) were both statistically greater (p = 0.04 and p = 0.02, respectively) than that in the control group (2418 ± 1463 N); however, there was no statistically significant difference in the strengths when comparing the test groups at both timepoints. Test group 1 had the best overall performance based on histomorphometric evaluation and biomechanical testing. At 2 years postoperatively, the kerfs filled with TTCP-PS had histological evidence of osteoconduction and replacement of TTCP-PS by bone with nearly complete osteointegration.

Conclusions: TTCP-PS was demonstrated to be safe and effective for cranial flap fixation in an ovine model. In this study, the bioresorbable, osteoconductive bone adhesive appeared to have multiple advantages over standard plate-and-screw bone flap fixation, including biomechanical superiority, more complete and faster bony healing across the flap kerfs without fibrosis, and the minimization of bone flap and/or hardware migration and loosening. These properties of TTCP-PS may improve human cranial bone flap fixation and cranioplasty.
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http://dx.doi.org/10.3171/2019.11.JNS192806DOI Listing
February 2020

Predictors of nonroutine discharge among patients undergoing surgery for grade I spondylolisthesis: insights from the Quality Outcomes Database.

J Neurosurg Spine 2019 Dec 6:1-10. Epub 2019 Dec 6.

4Department of Neurological Surgery, University of Utah, Salt Lake City, Utah.

Objective: Discharge to an inpatient rehabilitation facility or another acute-care facility not only constitutes a postoperative challenge for patients and their care team but also contributes significantly to healthcare costs. In this era of changing dynamics of healthcare payment models in which cost overruns are being increasingly shifted to surgeons and hospitals, it is important to better understand outcomes such as discharge disposition. In the current article, the authors sought to develop a predictive model for factors associated with nonroutine discharge after surgery for grade I spondylolisthesis.

Methods: The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis who underwent a surgical intervention between July 2014 and June 2016. Only those patients enrolled in a multisite study investigating the impact of fusion on clinical and patient-reported outcomes among patients with grade I spondylolisthesis were evaluated. Nonroutine discharge was defined as those who were discharged to a postacute or nonacute-care setting in the same hospital or transferred to another acute-care facility.

Results: Of the 608 patients eligible for inclusion, 9.4% (n = 57) had a nonroutine discharge (8.7%, n = 53 discharged to inpatient postacute or nonacute care in the same hospital and 0.7%, n = 4 transferred to another acute-care facility). Compared to patients who were discharged to home, patients who had a nonroutine discharge were more likely to have diabetes (26.3%, n = 15 vs 15.7%, n = 86, p = 0.039); impaired ambulation (26.3%, n = 15 vs 10.2%, n = 56, p < 0.001); higher Oswestry Disability Index at baseline (51 [IQR 42-62.12] vs 46 [IQR 34.4-58], p = 0.014); lower EuroQol-5D scores (0.437 [IQR 0.308-0.708] vs 0.597 [IQR 0.358-0.708], p = 0.010); higher American Society of Anesthesiologists score (3 or 4: 63.2%, n = 36 vs 36.7%, n = 201, p = 0.002); and longer length of stay (4 days [IQR 3-5] vs 2 days [IQR 1-3], p < 0.001); and were more likely to suffer a complication (14%, n = 8 vs 5.6%, n = 31, p = 0.014). On multivariable logistic regression, factors found to be independently associated with higher odds of nonroutine discharge included older age (interquartile OR 9.14, 95% CI 3.79-22.1, p < 0.001), higher body mass index (interquartile OR 2.04, 95% CI 1.31-3.25, p < 0.001), presence of depression (OR 4.28, 95% CI 1.96-9.35, p < 0.001), fusion surgery compared with decompression alone (OR 1.3, 95% CI 1.1-1.6, p < 0.001), and any complication (OR 3.9, 95% CI 1.4-10.9, p < 0.001).

Conclusions: In this multisite study of a defined cohort of patients undergoing surgery for grade I spondylolisthesis, factors associated with higher odds of nonroutine discharge included older age, higher body mass index, presence of depression, and occurrence of any complication.
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http://dx.doi.org/10.3171/2019.9.SPINE19644DOI Listing
December 2019

Sexual Dysfunction: Prevalence and Prognosis in Patients Operated for Degenerative Lumbar Spondylolisthesis.

Neurosurgery 2020 08;87(2):200-210

Department of Neurological Surgery, University of California, San Francisco, San Francisco, California.

Background: There is a paucity of investigation on the impact of spondylolisthesis surgery on back pain-related sexual inactivity.

Objective: To investigate predictors of improved sex life postoperatively by utilizing the prospective Quality Outcomes Database (QOD) registry.

Methods: A total of 218 patients who underwent surgery for grade 1 degenerative lumbar spondylolisthesis were included who were sexually active. Sex life was assessed by Oswestry Disability Index item 8 at baseline and 24-mo follow-up.

Results: Mean age was 58.0 ± 11.0 yr, and 108 (49.5%) patients were women. At baseline, 178 patients (81.7%) had sex life impairment. At 24 mo, 130 patients (73.0% of the 178 impaired) had an improved sex life. Those with improved sex lives noted higher satisfaction with surgery (84.5% vs 64.6% would undergo surgery again, P = .002). In multivariate analyses, lower body mass index (BMI) was associated with improved sex life (OR = 1.14; 95% CI [1.05-1.20]; P < .001). In the younger patients (age < 57 yr), lower BMI remained the sole significant predictor of improvement (OR = 1.12; 95% CI [1.03-1.23]; P = .01). In the older patients (age ≥ 57 yr)-in addition to lower BMI (OR = 1.12; 95% CI [1.02-1.27]; P = .02)-lower American Society of Anesthesiologists (ASA) grades (1 or 2) (OR = 3.7; 95% CI [1.2-12.0]; P = .02) and ≥4 yr of college education (OR = 3.9; 95% CI [1.2-15.1]; P = .03) were predictive of improvement.

Conclusion: Over 80% of patients who present for surgery for degenerative lumbar spondylolisthesis report a negative effect of the disease on sex life. However, most patients (73%) report improvement postoperatively. Sex life improvement was associated with greater satisfaction with surgery. Lower BMI was predictive of improved sex life. In older patients-in addition to lower BMI-lower ASA grade and higher education were predictive of improvement.
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http://dx.doi.org/10.1093/neuros/nyz406DOI Listing
August 2020

Impact of occupational characteristics on return to work for employed patients after elective lumbar spine surgery.

Spine J 2019 12 20;19(12):1969-1976. Epub 2019 Aug 20.

Department of Orthopedic Surgery, Vanderbilt University School of Medicine, South Tower, Suite 4200, Nashville, TN, USA; Department of Neurological surgery, Vanderbilt University School of Medicine, South Tower, Suite 4200, Nashville, TN, USA; Orthopedics of Steamboat Springs, Steamboat Springs, CO, USA. Electronic address:

Background Context: Low back pain has an immense impact on the US economy. A significant number of patients undergo surgical management in order to regain meaningful functionality in daily life and in the workplace. Return to work (RTW) is a key metric in surgical outcomes, as it has profound implications for both individual patients and the economy at large.

Purpose: In this study, we investigated the factors associated with RTW in patients who achieved otherwise favorable outcomes after lumbar spine surgery.

Study Design/setting: This study retrospectively analyzes prospectively collected data from the lumbar module of national spine registry, the Quality Outcomes Database (QOD).

Patient Sample: The lumbar module of QOD includes patients undergoing lumbar surgery for primary stenosis, disc herniation, spondylolisthesis (Grade I) and symptomatic mechanical disc collapse or revision surgery for recurrent same-level disc herniation, pseudarthrosis, and adjacent segment disease. Exclusion criteria included age under 18 years and diagnoses of infection, tumor, or trauma as the cause of lumbar-related pain.

Outcome Measures: The outcome of interest for this study was the return to work 12-month after surgery.

Methods: The lumbar module of QOD was queried for patients who were employed at the time of surgery. Good outcomes were defined as patients who had no adverse events (readmissions/complications), had achieved 30% improvement in Oswestry disability index (ODI) and were satisfied (NASS satisfaction) at 3-month post-surgery. Distinct multivariable logistic regression models were fitted with 12-month RTW as outcome for a. overall population and b. the patients with good outcomes. The variables included in the models were age, gender, race, insurance type, education level, occupation type, currently working/on-leave status, workers' compensation, ambulatory status, smoking status, anxiety, depression, symptom duration, number of spinal levels, diabetes, motor deficit, and preoperative back-pain, leg-pain and ODI score.

Results: Of the total 12,435 patients, 10,604 (85.3%) had successful RTW at 1-year postsurgery. Among patients who achieved good surgical outcomes, 605 (7%) failed to RTW. For both the overall and subgroup analysis, older patients had lower odds of RTW. Females had lower odds of RTW compared with males and patients with higher back pain and baseline ODI had lower odds of RTW. Patients with longer duration of symptoms, more physically demanding occupations, worker's compensation claim and those who had short-term disability leave at the time of surgery had lower odds of RTW independent of their good surgical outcomes.

Conclusions: This study identifies certain risk factors for failure to RTW independent of surgical outcomes. Most of these risk factors are occupational; hence, involving the patient's employer in treatment process and setting realistic expectations may help improve the patients' work-related functionality.
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http://dx.doi.org/10.1016/j.spinee.2019.08.007DOI Listing
December 2019

In vitro and in vivo evaluation of discogenic cells, an investigational cell therapy for disc degeneration.

Spine J 2020 01 20;20(1):138-149. Epub 2019 Aug 20.

DiscGenics, Inc, 5940 W Harold Gatty Dr, Salt Lake City, UT 84116, USA; Department of Neurosurgery, University of Tennessee Health Science Center, Memphis, TN, USA; Semmes-Murphey Clinic, 6325 Humphreys Blvd, Memphis, TN, USA.

Background/context: Disc degeneration (DD) is a significant driver of low back pain and few treatments exist to treat the pain and disability associated with the disease.

Purpose: Our group has developed a method to generate therapeutic discogenic cells as a potential treatment for symptomatic DD. These cells are derived and modified from adult nucleus pulposus cells. In this study, we evaluated the characteristics, mode of action, and in vivo efficacy and safety of these cells prior to human clinical testing.

Study Design: Privately funded in vitro studies and in vivo preclinical models were used in this study.

Methods: Discogenic cells generated from different adult human donors were evaluated for surface marker expression profile, matrix deposition and tumorigenic potential. Discogenic cells were then injected subcutaneously into nude mice to assess cell survival and possible extracellular matrix production in vivo. Finally, a rabbit model of DD was used to evaluate the therapeutic potential of discogenic cells after disc injury.

Results: We found that discogenic cells have a consistent surface marker profile, are multipotent for mesenchymal lineages, and produce extracellular matrix consisting of aggrecan, collagen 1 and collagen 2. Cells did not show abnormal karyotype after culturing and did not form tumor-like aggregates in soft agar. After subcutaneous implantation in a nude mouse model, the human discogenic cells were found to have generated regions rich with extracellular matrix over the course of 4 months, with no signs of tumorigenicity. Intradiscal injection of human discogenic cells in a rabbit model of DD caused an increase in disc height and improvement of tissue architecture relative to control discs or injection of vehicle alone (no cells) with no signs of toxicity.

Conclusions: This study demonstrates that intradiscal injection of discogenic cells may be a viable treatment for human degenerative disc disease. The cells produce extracellular matrix that may rebuild the depleting tissue within degenerating discs. Also, the cells do not pose any significant safety concerns.

Clinical Significance: Human clinical testing of discogenic cells combined with a sodium hyaluronate carrier is ongoing in multiple randomized, controlled, double-blinded studies in the United States (clinicaltrials.gov identifier NCT03347708) and Japan (clinicaltrials.gov identifier NCT03955315).
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January 2020

Trajectory of Improvement in Myelopathic Symptoms From 3 to 12 Months Following Surgery for Degenerative Cervical Myelopathy.

Neurosurgery 2020 06;86(6):763-768

Department of Orthopedic Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee.

Background: Degenerative cervical myelopathy (DCM) is a progressive disease resulting from cervical cord compression. The modified Japanese Orthopaedic Association (mJOA) is commonly used to grade myelopathic symptoms, but its persistent postoperative improvement has not been previously explored.

Objective: To utilize the Quality Outcomes Database (QOD) to evaluate the trajectory of outcomes in those operatively treated for DCM.

Methods: This study is a retrospective analysis of prospectively collected data. The QOD was queried for patients undergoing elective surgery for DCM. Patients were divided into mild (≥14), moderate (9-13), or severe (<9) categories for their baseline severity of myelopathic symptoms (mJOA scores). A parsimonious multivariable logistic regression model was fitted with 2 points improvement on mJOA from 3- to 12-mo follow-up as the outcome of interest.

Results: A total of 2156 patients who underwent elective surgery for DCM and had complete 3- and 12-mo follow-up were included in our analysis. Patients improved significantly from baseline to 3-mo on their mJOA scores, regardless of their baseline mJOA severity. After adjusting for the relevant preoperative characteristics, the baseline mJOA categories had significant impact on outcome of whether a patient keeps improving in mJOA score from 3 to 12 mo postsurgery. Patient with severe mJOA score at baseline had a higher likelihood of improvement in their myelopathic symptoms, compared to patients with mild mJOA score in.

Conclusion: Most patients achieve improvement on a shorter follow-up; however, patients with severe symptoms keep on improving until after a longer follow-up. Preoperative identification of such patients helps the clinician settling realistic expectations for each follow-up timepoint.
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http://dx.doi.org/10.1093/neuros/nyz325DOI Listing
June 2020

Does Neck Disability Index Correlate With 12-Month Satisfaction After Elective Surgery for Cervical Radiculopathy? Results From a National Spine Registry.

Neurosurgery 2020 05;86(5):736-741

Department of Orthopaedic Surgery, Vanderbilt University School of Medicine, Nashville, Tennessee.

Background: Modern healthcare reforms focus on identifying and measuring the quality and value of care. Patient satisfaction is particularly important in the management of degenerative cervical radiculopathy (DCR) since it leads to significant neck pain and disability primarily affecting the patients' quality of life.

Objective: To determine the association of baseline and 12-mo Neck Disability Index (NDI) with patient satisfaction after elective surgery for DCR.

Methods: The Quality Outcomes Database cervical module was queried for patients who underwent elective surgery for DCR. A multivariable proportional odds regression model was fitted with 12-mo satisfaction as the outcome. The covariates for this model included patients' demographics, surgical characteristics, and baseline and 12-mo patient reported outcomes (PROs). Wald-statistics were calculated to determine the relative importance of each independent variable for 12-mo patient satisfaction.

Results: The analysis included 2206 patients who underwent elective surgery for DCR. In multivariable analysis, after adjusting for baseline and surgery specific variables, the 12-mo NDI score showed the highest association with 12-mo satisfaction (Waldχ2-df = 99.17, 58.1% of total χ2). The level of satisfaction increases with decrease in 12-mo NDI score regardless of the baseline NDI score.

Conclusion: Our study identifies 12-mo NDI score as a very influential driver of 12-mo patient satisfaction after surgery for DCR. In addition, there are lesser contributions from other 12-mo PROs, baseline Numeric Rating Scale for arm pain and American Society of Anesthesiologists (ASA) grade. The baseline level of disability was found to be irrelevant to patients. They seemed to only value their current level of disability, compared to baseline, in rating satisfaction with surgical outcome.
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http://dx.doi.org/10.1093/neuros/nyz231DOI Listing
May 2020

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

Neurosurg Focus 2019 05;46(5):E13

1Department of Neurological Surgery, University of California, San Francisco, California.

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 (β = -7.59, 95% CI -14.96 to -0.23; p = 0.04), NRS back pain change (β = -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.
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http://dx.doi.org/10.3171/2019.2.FOCUS18722DOI Listing
May 2019

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

Neurosurg Focus 2019 05;46(5):E12

13Atlanta Brain and Spine Care, Atlanta, Georgia; and.

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.
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May 2019

Learning to Lead: Reflections from the Tideswell-AGS-ADGAP Emerging Leaders in Aging Program Scholars.

J Am Geriatr Soc 2019 03 3;67(3):434-436. Epub 2019 Jan 3.

Division of Geriatrics, Department of Medicine, University of California, San Francisco, San Francisco, California.

The Tideswell Emerging Leaders in Aging (ELIA) Program is a 1-year leadership training program focused on developing a sustainable pipeline of leaders in aging who are poised to lead initiatives that will optimize the health of older people. The Tideswell ELIA Program is jointly administered by the American Geriatrics Society, the Association of Directors of Geriatric Academic Programs, and Tideswell at University of California, San Francisco (UCSF), a program within the Division of Geriatrics at UCSF. The ELIA Program prepares early to midcareer healthcare professionals in aging (scholars) for their transition into key leadership roles that involve one or more areas of patient care, education, and research. The program emphasizes the understanding of one's own and others' inherent work strategies and communication styles as integral to leading programs. Approximately 15 ELIA scholars are selected annually to participate in this interactive leadership development program. We conducted a qualitative analysis of program evaluations from 2015 to 2018 scholars (n = 47) to determine effectiveness and impact. All scholars (100%) completed the end-of-training survey. Scholars' satisfaction with the program is high. Scholars reported heightened leadership development and improvements in leadership skills, including communication, team building, and self-awareness. Scholars also reported enhancement of personal leadership attributes that contributed to career advancement. The Tideswell ELIA Program accelerates scholars' personal career development, positively impacts their institutions, and ultimately benefits older people. Sustaining leadership programs such as the Tideswell ELIA Program is vital to ensure a continuous pipeline of leaders skilled in both advocating for and advancing the health of older Americans. J Am Geriatr Soc 67:434-436, 2019.
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March 2019

Laminectomy alone versus fusion for grade 1 lumbar spondylolisthesis in 426 patients from the prospective Quality Outcomes Database.

J Neurosurg Spine 2018 11;30(2):234-241

1Department of Neurological Surgery, University of California, San Francisco, California.

OBJECTIVEThe AANS 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 spine surgery. Registry data offer "real-world" insights into the utility of spinal fusion and decompression surgery for lumbar spondylolisthesis. Using the QOD, the authors compared the initial 12-month outcome data for patients undergoing fusion and those undergoing laminectomy alone for grade 1 degenerative lumbar spondylolisthesis.METHODSData from 12 top enrolling sites were analyzed and 426 patients undergoing elective single-level spine surgery for degenerative grade 1 lumbar spondylolisthesis were found. Baseline, 3-month, and 12-month follow-up data were collected and compared, including baseline clinical characteristics, readmission rates, reoperation rates, and PROs. The PROs included Oswestry Disability Index (ODI), back and leg pain numeric rating scale (NRS) scores, and EuroQol-5 Dimensions health survey (EQ-5D) results.RESULTSA total of 342 (80.3%) patients underwent fusion, with the remaining 84 (19.7%) undergoing decompression alone. The fusion cohort was younger (60.7 vs 69.9 years, p < 0.001), had a higher mean body mass index (31.0 vs 28.4, p < 0.001), and had a greater proportion of patients with back pain as a major component of their initial presentation (88.0% vs 60.7%, p < 0.001). There were no differences in 12-month reoperation rate (4.4% vs 6.0%, p = 0.93) and 3-month readmission rates (3.5% vs 1.2%, p = 0.45). At 12 months, both cohorts improved significantly with regard to ODI, NRS back and leg pain, and EQ-5D (p < 0.001, all comparisons). In adjusted analysis, fusion procedures were associated with superior 12-month ODI (β -4.79, 95% CI -9.28 to -0.31; p = 0.04).CONCLUSIONSSurgery for grade 1 lumbar spondylolisthesis-regardless of treatment strategy-was associated with significant improvements in disability, back and leg pain, and quality of life at 12 months. When adjusting for covariates, fusion surgery was associated with superior ODI at 12 months. Although fusion procedures were associated with a lower rate of reoperation, there was no statistically significant difference at 12 months. Further study must be undertaken to assess the durability of either surgical strategy in longer-term follow-up.
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November 2018

Obese Patients Benefit, but do not Fare as Well as Nonobese Patients, Following Lumbar Spondylolisthesis Surgery: An Analysis of the Quality Outcomes Database.

Neurosurgery 2020 01;86(1):80-87

Department of Neurological Surgery, University of California, San Francisco, California.

Background: Given recent differing findings following 2 randomized clinical trials on degenerative lumbar spondylolisthesis (DLS) surgery, there is a need to better define how subsets of patients fare following surgery.

Objective: To investigate the impact of obesity on patient-reported outcomes (PROs) following DLS surgery.

Methods: A total of 12 high-enrolling sites were queried, and we found 797 patients undergoing surgery for grade 1 DLS. For univariate comparisons, patients were stratified by BMI ≥ 30 kg/m2 (obese) and < 30 kg/m2 (nonobese). Baseline, 3-mo, and 12-mo follow-up parameters were collected. PROs included the North American Spine Society satisfaction questionnaire, numeric rating scale (NRS) back pain, NRS leg pain, Oswestry Disability Index (ODI), and EuroQoL-5D (EQ-5D) Questionnaire.

Results: We identified 382 obese (47.9%) and 415 nonobese patients (52.1%). At baseline, obese patients had worse NRS back pain, NRS leg pain, ODI, and EQ-5D scores (P < .001, P = .01, P < .001, and P = .02, respectively). Both cohorts improved significantly for back and leg pain, ODI, and EQ-5D at 12 mo (P < .001). At 12 mo, similar proportions of obese and nonobese patients responded that surgery met their expectations (62.6% vs 67.4%, P = .24). In multivariate analyses, BMI was independently associated with worse NRS leg pain and EQ-5D at 12 mo (P = .01 and P < .01, respectively) despite adjusting for baseline differences.

Conclusion: Obesity is associated with inferior leg pain and quality of life-but similar back pain, disability, and satisfaction-12 mo postoperatively. However, obese patients achieve significant improvements in all PRO metrics at 12 mo.
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January 2020