Browsing by Author "Glassman, Steven"

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    ItemOpen Access
    Assessing the differences in characteristics of patients lost to follow-up at 2 years: results from the Quality Outcomes Database study on outcomes of surgery for grade I spondylolisthesis.
    (Journal of neurosurgery. Spine, 2020-02) Bisson, Erica F; Mummaneni, Praveen V; Knightly, John; Alvi, Mohammed Ali; Goyal, Anshit; Chan, Andrew K; Guan, Jian; Biase, Michael; Strauss, Andrea; Glassman, Steven; Foley, Kevin; Slotkin, Jonathan R; Potts, Eric; Shaffrey, Mark; Shaffrey, Christopher I; Haid, Regis W; Fu, Kai-Ming; Wang, Michael Y; Park, Paul; Asher, Anthony L; Bydon, Mohamad
    OBJECTIVE:Loss to follow-up has been shown to bias outcomes assessment among studies utilizing clinical registries. Here, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics of patients captured with those lost to follow-up at 2 years. METHODS:The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing 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 (PROs) among patients with grade I spondylolisthesis were evaluated. RESULTS:Of the 608 patients enrolled in the study undergoing 1- or 2-level decompression (23.0%, n = 140) or 1-level fusion (77.0%, n = 468), 14.5% (n = 88) were lost to follow-up at 2 years. Patients who were lost to follow-up were more likely to be younger (59.6 ± 13.5 vs 62.6 ± 11.7 years, p = 0.031), be employed (unemployment rate: 53.3% [n = 277] for successful follow-up vs 40.9% [n = 36] for those lost to follow-up, p = 0.017), have anxiety (26.1% [n = 23] vs 16.3% [n = 85], p = 0.026), have higher back pain scores (7.4 ± 2.9 vs 6.6 ± 2.8, p = 0.010), have higher leg pain scores (7.4 ± 2.5 vs 6.4 ± 2.9, p = 0.003), have higher Oswestry Disability Index scores (50.8 ± 18.7 vs 46 ± 16.8, p = 0.018), and have lower EQ-5D scores (0.481 ± 0.2 vs 0.547 ± 0.2, p = 0.012) at baseline. CONCLUSIONS:To execute future, high-quality studies, it is important to identify patients undergoing surgery for spondylolisthesis who might be lost to follow-up. In a large, prospective registry, the authors found that those lost to follow-up were more likely to be younger, be employed, have anxiety disorder, and have worse PRO scores.
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    ItemOpen Access
    Changes in radiographic and clinical outcomes with primary treatment adult spinal deformity surgeries from two years to three- to five-years follow-up.
    (Spine, 2010-09) Bridwell, Keith H; Baldus, Christine; Berven, Sigurd; Edwards, Charles; Glassman, Steven; Hamill, Christopher; Horton, William; Lenke, Lawrence G; Ondra, Stephen; Schwab, Frank; Shaffrey, Christopher; Wootten, David

    Study design

    Retrospective analysis of data entered prospectively into a multicenter database-clinical and radiographic outcomes assessment.

    Objective

    Our hypothesis is that between the 2-year and the 3- to 5-year points surgically treated adult spinal deformity patients will show significant reduction in outcomes by Scoliosis Research Society (SRS), Oswestry Disability Index (ODI), and numerical rating scale back and leg pain scores and will show increasing thoracic kyphosis, loss of lumbar lordosis, and loss of coronal and sagittal balance.

    Summary of background data

    Most analyses of primary presentation adult spinal deformity surgery assess 2-year follow-up. However, it is established that in some patients unfavorable events occur between the 2-year and 5-year points.

    Methods

    The cohort of 113 patients entered into a multicenter database with complete preoperative, 2-year, and 3- to 5-year data. All patients who had adult spinal deformity and surgical treatment represented their first reconstruction. Diagnoses were scoliosis (82.5%), kyphosis (10%), and scoliosis and kyphosis combined (7.5%). Outcome measures and basic radiographic parameters (curve size, thoracic and lumbar sagittal plane, coronal and sagittal balance) were assessed at those 3 time intervals. Complications (pseudarthrosis/implant failure, infection, and junctional deformities) were assessed at the 2-year and the 3- to 5-year (mean, 3.76 years) points. RESULTS.: The mean major curve Cobb angle (preoperative, 57°; 2-year, 29°; 3-5 year, 26°); thoracic kyphosis T5 to T12 (30°, 31°, 32°) and lumbar lordosis T12 to sacrum (48°, 49°, 51°) did not change from the 2-year to ultimate follow-up. Likewise, coronal and sagittal balance parameters were the same at 2-year and ultimate follow-up. SRS total scores and modified ODI were similar at the 2 year and final follow-up (SRS: 3.89-3.88; ODI: 19-18). Preoperative SRS total score was 3.17. Six patients demonstrated complications at the 2-year point and additional 9 patients demonstrated complications at the 3- to 5-year point. Those 9 patients with complications at ultimate follow-up demonstrated significant deterioration in their ODI and SRS scores when compared with the patients who did not have complications at ultimate follow-up.

    Conclusion

    Contrary to our hypothesis, we could not establish deterioration in mean radiographic or clinical outcomes between the 2-year and 3- to 5-year follow-up points when analyzing the group as a whole. However, for the 9 patients who experienced complications between 3- and 5-year follow-up, their outcomes were significantly worse than for the other 104 patients.One should not anticipate an overall radiographic and clinical deterioration of the outcomes of surgically treated primary presentation adult spinal deformity patients in this studied time interval. However, close to 10% of patients will experience a new complication at the 3- to 5-year point, most commonly implant failure/nonunion and/or junctional kyphosis, which will negatively effect the patient-reported outcome.
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    ItemOpen Access
    Impact of magnitude and percentage of global sagittal plane correction on health-related quality of life at 2-years follow-up.
    (Neurosurgery, 2012-08) Blondel, Benjamin; Schwab, Frank; Ungar, Benjamin; Smith, Justin; Bridwell, Keith; Glassman, Steven; Shaffrey, Christopher; Farcy, Jean-Pierre; Lafage, Virginie

    Background

    Sagittal plane malalignment has been established as the main radiographic driver of disability in adult spinal deformity (ASD).

    Objective

    To evaluate the amount of sagittal correction needed for a patient to perceive improvement (minimal clinically important difference, MCID) in health-related quality of life (HRQOL) scores.

    Methods

    This was a multicenter, retrospective analysis of prospectively consecutively enrolled ASD patients. Inclusion criterion was a sagittal vertical axis (SVA) >80 mm. Demographic, radiographic, and HRQOL preoperative and 2-year postsurgery data were collected. Surgical treatment was categorized based on SVA correction: <60 mm, 60 mm to 120 mm, and >120 mm. Changes in parameters were analyzed using paired t test, 1-way analysis of variance, and χ2 test.

    Results

    Seventy-six patients (preoperative SVA = 140 mm) were analyzed; each subgroup revealed significant HRQOL improvements following surgery. Compared with the <60 mm correction group, the likelihood of reaching MCID was significantly improved for the >120 mm group (Oswestry Disability Index) but not for the 60 mm to 120 mm group. A significantly greater likelihood of reaching MCID thresholds was observed for corrections above 66% of preoperative SVA.

    Conclusion

    Best HRQOL outcomes for ASD patients with severe sagittal plane deformity were obtained with a correction >120 mm for SVA and at least 66% of correction. Although lesser amounts of SVA correction yielded clinical improvement, the rate of MCID threshold improvement was not significantly different for mild or modest corrections. These results underline the need for complete sagittal plane deformity correction if high rates of HRQOL benefit are sought for patients with marked sagittal plane deformity.
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    ItemOpen Access
    Minimally invasive versus open fusion for Grade I degenerative lumbar spondylolisthesis: analysis of the Quality Outcomes Database.
    (Neurosurgical focus, 2017-08) Mummaneni, Praveen V; Bisson, Erica F; Kerezoudis, Panagiotis; Glassman, Steven; Foley, Kevin; Slotkin, Jonathan R; Potts, Eric; Shaffrey, Mark; Shaffrey, Christopher I; Coric, Domagoj; Knightly, John; Park, Paul; Fu, Kai-Ming; Devin, Clinton J; Chotai, Silky; Chan, Andrew K; Virk, Michael; Asher, Anthony L; Bydon, Mohamad
    OBJECTIVE Lumbar spondylolisthesis is a degenerative condition that can be surgically treated with either open or minimally invasive decompression and instrumented fusion. Minimally invasive surgery (MIS) approaches may shorten recovery, reduce blood loss, and minimize soft-tissue damage with resultant reduced postoperative pain and disability. METHODS The authors queried the national, multicenter Quality Outcomes Database (QOD) registry for patients undergoing posterior lumbar fusion between July 2014 and December 2015 for Grade I degenerative spondylolisthesis. The authors recorded baseline and 12-month patient-reported outcomes (PROs), including Oswestry Disability Index (ODI), EQ-5D, numeric rating scale (NRS)-back pain (NRS-BP), NRS-leg pain (NRS-LP), and satisfaction (North American Spine Society satisfaction questionnaire). Multivariable regression models were fitted for hospital length of stay (LOS), 12-month PROs, and 90-day return to work, after adjusting for an array of preoperative and surgical variables. RESULTS A total of 345 patients (open surgery, n = 254; MIS, n = 91) from 11 participating sites were identified in the QOD. The follow-up rate at 12 months was 84% (83.5% [open surgery]; 85% [MIS]). Overall, baseline patient demographics, comorbidities, and clinical characteristics were similarly distributed between the cohorts. Two hundred fifty seven patients underwent 1-level fusion (open surgery, n = 181; MIS, n = 76), and 88 patients underwent 2-level fusion (open surgery, n = 73; MIS, n = 15). Patients in both groups reported significant improvement in all primary outcomes (all p < 0.001). MIS was associated with a significantly lower mean intraoperative estimated blood loss and slightly longer operative times in both 1- and 2-level fusion subgroups. Although the LOS was shorter for MIS 1-level cases, this was not significantly different. No difference was detected with regard to the 12-month PROs between the 1-level MIS versus the 1-level open surgical groups. However, change in functional outcome scores for patients undergoing 2-level fusion was notably larger in the MIS cohort for ODI (-27 vs -16, p = 0.1), EQ-5D (0.27 vs 0.15, p = 0.08), and NRS-BP (-3.5 vs -2.7, p = 0.41); statistical significance was shown only for changes in NRS-LP scores (-4.9 vs -2.8, p = 0.02). On risk-adjusted analysis for 1-level fusion, open versus minimally invasive approach was not significant for 12-month PROs, LOS, and 90-day return to work. CONCLUSIONS Significant improvement was found in terms of all functional outcomes in patients undergoing open or MIS fusion for lumbar spondylolisthesis. No difference was detected between the 2 techniques for 1-level fusion in terms of patient-reported outcomes, LOS, and 90-day return to work. However, patients undergoing 2-level MIS fusion reported significantly better improvement in NRS-LP at 12 months than patients undergoing 2-level open surgery. Longer follow-up is needed to provide further insight into the comparative effectiveness of the 2 procedures.
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    ItemOpen Access
    Open versus minimally invasive decompression for low-grade spondylolisthesis: analysis from the Quality Outcomes Database.
    (Journal of neurosurgery. Spine, 2020-05) Bisson, Erica F; Mummaneni, Praveen V; Virk, Michael S; Knightly, John; Alvi, Mohammed Ali; Goyal, Anshit; Chan, Andrew K; Guan, Jian; Glassman, Steven; Foley, Kevin; Slotkin, Jonathan R; Potts, Eric A; Shaffrey, Mark E; Shaffrey, Christopher I; Haid, Regis W; Fu, Kai-Ming; Wang, Michael Y; Park, Paul; Asher, Anthony L; Bydon, Mohamad
    OBJECTIVE:Lumbar decompression without arthrodesis remains a potential treatment option for cases of low-grade spondylolisthesis (i.e., Meyerding grade I). Minimally invasive surgery (MIS) techniques have recently been increasingly used because of their touted benefits including lower operating time, blood loss, and length of stay. Herein, the authors analyzed patients enrolled in a national surgical registry and compared the baseline characteristics and postoperative clinical and patient-reported outcomes (PROs) between patients undergoing open versus MIS lumbar decompression. METHODS:The authors queried the Quality Outcomes Database for patients with grade I lumbar degenerative spondylolisthesis undergoing a surgical intervention between July 2014 and June 2016. Among more than 200 participating sites, the 12 with the highest enrollment of patients into the lumbar spine module came together to initiate a focused project to assess the impact of fusion on PROs in patients undergoing surgery for grade I lumbar spondylolisthesis. For the current study, only patients in this cohort from the 12 highest-enrolling sites who underwent a decompression alone were evaluated and classified as open or MIS (tubular decompression). Outcomes of interest included PROs at 2 years; perioperative outcomes such as blood loss and complications; and postoperative outcomes such as length of stay, discharge disposition, and reoperations. RESULTS:A total of 140 patients undergoing decompression were selected, of whom 71 (50.7%) underwent MIS and 69 (49.3%) underwent an open decompression. On univariate analysis, the authors observed no significant differences between the 2 groups in terms of PROs at 2-year follow-up, including back pain, leg pain, Oswestry Disability Index score, EQ-5D score, and patient satisfaction. On multivariable analysis, compared to MIS, open decompression was associated with higher satisfaction (OR 7.5, 95% CI 2.41-23.2, p = 0.0005). Patients undergoing MIS decompression had a significantly shorter length of stay compared to the open group (0.68 days [SD 1.18] vs 1.83 days [SD 1.618], p < 0.001). CONCLUSIONS:In this multiinstitutional prospective study, the authors found comparable PROs as well as clinical outcomes at 2 years between groups of patients undergoing open or MIS decompression for low-grade spondylolisthesis.
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    ItemOpen Access
    Patient Factors That Influence Decision Making: Randomization Versus Observational Nonoperative Versus Observational Operative Treatment for Adult Symptomatic Lumbar Scoliosis.
    (Spine, 2016-03) Neuman, Brian J; Baldus, Christine; Zebala, Lukas P; Kelly, Michael P; Shaffrey, Christopher; Edwards, Charles; Koski, Tyler; Schwab, Frank; Glassman, Steven; Parent, Stefan; Lewis, Stephen; Lenke, Lawrence G; Buchowski, Jacob M; Smith, Justin S; Crawford, Charles H; Kim, Han Jo; Lafage, Virginia; Lurie, Jon; Carreon, Leah; Bridwell, Keith H

    Study design

    A prospective study with randomized and observational cohorts.

    Objective

    The aim of this study was to determine baseline variables affecting adult symptomatic lumbar scoliosis (ASLS) decision making to participate in randomization (RAND), observational nonsurgical (OBS-NS), or observational surgical (OBS-S) cohorts.

    Summary of background data

    Multiple factors play a key role in a patient's decision to be randomized or to choose an OBS-NS or OBS-S course for ASLS. Studies evaluating these factors are limited.

    Methods

    Eligible candidates (patients with ASLS and no prior spinal fusion deformity surgery) from 9 centers participated in a RAND, OBS-NS, or OBS-S cohort study. Baseline variables (demographics, socioeconomics, patient-reported outcomes [PROs], Functional Treadmill Test, radiographs) were analyzed.

    Results

    Two hundred ninety-five patients were enrolled: 67 RAND, 115 OBS-NS, 113 OBS-S. Subanalysis of older patients (60-80 years) found 54% of OBS-NS had college degrees compared with 82% of RAND and 71% of OBS-S (P = 0.010). Patients deciding to be part of a RAND cohort have similar clinical characteristics to the OBS-S cohort. OBS-S had more symptomatic spinal stenosis (57% vs. 39%, P = 0.029) and worse scores than OBS-NS on the basis of PROs (Back Pain Numerical Rating Scale [NRS 6.3 vs. 5.5, P = 0.007]; Scoliosis Research Society [SRS] Pain [2.8 vs. 3.0, P = 0.018], Function [3.1 vs. 3.4, P = 0.019] and Self-Image [2.7 vs. 3.1, P = 0.002]; Oswestry Disability Index (ODI) [36.9 vs. 31.8, P = 0.029]; post-Treadmill back [5.8 vs. 4.4, P = 0.002] and leg [4.3 vs. 3.1, P = 0.037] pain NRS and larger lumbar coronal Cobb angles (56.5 degrees vs. 48.8 degrees, P < 0.001). RAND had more baseline motor deficits (10.4% vs. 1.7%, P = 0.036) and worse scores than OBS-NS on the basis of ODI (38.8 vs. 31.8, P = 0.006), SRS Function [3.1 vs. 3.4, P = 0.034], and Self-Image [2.7 vs. 3.1, P = 0.007].

    Conclusion

    Patients with worse PROs, more back pain, more back and leg pain with ambulation, and larger lumbar Cobb angles are more inclined to select surgical over nonsurgical management.
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    ItemOpen Access
    Patients with a depressive and/or anxiety disorder can achieve optimum Long term outcomes after surgery for grade 1 spondylolisthesis: Analysis from the quality outcomes database (QOD).
    (Clinical neurology and neurosurgery, 2020-10) Kashlan, Osama; Swong, Kevin; Alvi, Mohammed Ali; Bisson, Erica F; Mummaneni, Praveen V; Knightly, John; Chan, Andrew; Yolcu, Yagiz U; Glassman, Steven; Foley, Kevin; Slotkin, Jonathan R; Potts, Eric; Shaffrey, Mark; Shaffrey, Christopher I; Haid, Regis W; Fu, Kai-Ming; Wang, Michael Y; Asher, Anthony L; Bydon, Mohamad; Park, Paul

    Introduction

    In the current study, we sought to compare baseline demographic, clinical, and operative characteristics, as well as baseline and follow-up patient reported outcomes (PROs) of patients with any depressive and/or anxiety disorder undergoing surgery for low-grade spondylolisthesis using a national spine registry.

    Patients and methods

    The Quality Outcomes Database (QOD) was queried for patients undergoing surgery for Meyerding grade 1 lumbar spondylolisthesis undergoing 1-2 level decompression or 1 level fusion at 12 sites with the highest number of patients enrolled in QOD with 2-year follow-up data.

    Results

    Of the 608 patients identified, 25.6 % (n = 156) had any depressive and/or anxiety disorder. Patients with a depressive/anxiety disorder were less likely to be discharged home (p < 0.001). At 3=months, patients with a depressive/anxiety disorder had higher back pain (p < 0.001), lower quality of life (p < 0.001) and higher disability (p = 0.013); at 2 year patients with depression and/or anxiety had lower quality of life compared to those without (p < 0.001). On multivariable regression, depression was associated with significantly lower odds of achieving 20 % or less ODI (OR 0.44, 95 % CI 0.21-0.94,p = 0.03). Presence of an anxiety disorder was not associated with decreased odds of achieving that milestone at 3 months. The presence of depressive-disorder, anxiety-disorder or both did not have an impact on ODI at 2 years. Finally, patient satisfaction at 2-years did not differ between the two groups (79.8 % vs 82.7 %,p = 0.503).

    Conclusion

    We found that presence of a depressive-disorder may impact short-term outcomes among patients undergoing surgery for low grade spondylolisthesis but longer term outcomes are not affected by either a depressive or anxiety disorder.
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    ItemOpen Access
    Patients with Adult Spinal Deformity with Previous Fusions Have an Equal Chance of Reaching Substantial Clinical Benefit Thresholds in Health-Related Quality of Life Measures but Do Not Reach the Same Absolute Level of Improvement
    (World Neurosurgery, 2018-05) Ailon, Tamir; Smith, Justin S; Shaffrey, Christopher I; Soroceanu, Alex; Lafage, Virginie; Schwab, Frank; Burton, Douglas; Hart, Robert; Kim, Han Jo; Gum, Jeffrey; Hostin, Richard; Kelly, Michael P; Glassman, Steven; Scheer, Justin K; Bess, Shay; Ames, Christopher P; International Spine Study Group
    © 2018 Elsevier Inc. Background: Substantial clinical benefit (SCB) represents a threshold above which patients recognize substantial improvement and represents a rational target for defining clinical success. In adult spinal deformity (ASD) surgery, previous fusions may impact outcomes after deformity correction. Objective: To investigate the impact of previous spinal fusion on the likelihood of reaching SCB thresholds for 2-year health-related quality of life (HRQOL) after ASD surgery. Methods: We conducted a retrospective review comparing baseline demographic, HRQOL, and radiographic features for patients with ASD undergoing primary versus revision procedures. The primary outcome measure was reaching SCB threshold in Oswestry Disability Index (ODI), SF-36 Physical Component Summary (PCS), and back and leg pain (numeric rating scale). Secondary outcomes included absolute and change scores in ODI, PCS, and back and leg pain. Results: In total, 332 patients achieved 2-year follow-up (228 primary; 104 revision cases). Those undergoing revision surgery had similar demographic features (age 58.3/55.9, female 80.8%/82.9%) to patients undergoing primary surgery. They had worse baseline HRQOL (ODI 48.5/41.2, PCS 29.5/33.4, back 7.5/7.0, and leg pain 4.9/4.3; P < 0.001) and radiographic deformity (sagittal vertical axis 111.4/45.1, lumbopelvic mismatch 26.7/11.0, pelvic tilt 29.5/21.0; P < 0.0001). Nevertheless, the number of patients who reached SCB for ODI (38.3/36.3%), PCS (48.5/53.4%), back (53.1/60.5%), and leg pain numeric rating scale (28.6/36.9%) did not significantly differ. Revision patients had worse 2-year HRQOL for all measures. Conclusions: Patients undergoing revision surgery have worse baseline HRQOL and deformity. Although they do not achieve the same absolute level of 2-year HRQOL outcome, they have a similar likelihood of reaching SCB threshold for improvement in 2-year HRQOL.
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    Predictors of Hospital Readmission and Surgical Site Infection in the United States, Denmark, and Japan: Is Risk Stratification a Universal Language?
    (Spine, 2017-09) Glassman, Steven; Carreon, Leah Y; Andersen, Mikkel; Asher, Anthony; Eiskjær, Soren; Gehrchen, Martin; Imagama, Shiro; Ishii, Ken; Kaito, Takahashi; Matsuyama, Yukihiro; Moridaira, Hiroshi; Mummaneni, Praveen; Shaffrey, Christopher; Matsumoto, Morio

    Study design

    Retrospective review of three spine surgery databases.

    Objectives

    The purpose of the present study is to determine whether predictors of hospital readmission and surgical site infection (SSI) after lumbar fusion will be the same in United States, Denmark, and Japan.

    Summary of background data

    Because clinical decision making becomes more data driven, risk stratification will be crucial to minimize complications. Spine surgeons worldwide face this issue, leading to parallel efforts to address risk stratification. This raises the question as to whether pooled data would be valuable and whether models generated in one country would be applicable to other populations.

    Methods

    Predictors of SSI and 30-day readmission from three prospective databases (National Neurosurgery Quality and Outcomes Database [N2QOD] N = 2653, DaneSpine N = 1993, Japan Multicenter Spine Database [JAMSD] N = 3798) were determined and compared to identify common or divergent predictive risks.

    Results

    Predictive variables differed in the three databases, for both readmission and SSI. Factors predictive for hospital readmission were American Society of Anesthesiologists (ASA) grade in N2QOD (P = 0.013, odds ratio [OR] 2.08), fusion levels in DaneSpine (P = 0.005, OR 1.67), and sex in JAMSD (P = 0.001, OR = 2.81). Associated differences in demographics and procedural factors included mean ASA grade (N2QOD = 2.45, JAMSD = 1.72) and fusion levels (N2QOD = 1.39, DaneSpine = 1.52, JAMSD = 1.34). For SSI, sex (P = 0.000, OR = 3.30), diabetes (P = 0.000, OR = 2.90), and length of stay (P = 0.000, OR = 1.02) were predictive in JAMSD. No predictors were identified in N2QOD or DaneSpine.

    Conclusion

    Predictors of SSI and hospital readmission differ in the United States, Denmark, and Japan, suggesting that risk stratification models may need to be population specific or adjusted. Some differences in measured parameters exist in the three databases analyzed; however, patient and procedure selection also appear to differ and may limit the ability to directly pool data from different regions. Therefore, risk stratification models developed in one country may not be directly applicable to other countries.

    Level of evidence

    2.
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    Predictors of nonroutine discharge among patients undergoing surgery for grade I spondylolisthesis: insights from the Quality Outcomes Database.
    (Journal of neurosurgery. Spine, 2019-12-06) Mummaneni, Praveen V; Bydon, Mohamad; Knightly, John; Alvi, Mohammed Ali; Goyal, Anshit; Chan, Andrew K; Guan, Jian; Biase, Michael; Strauss, Andrea; Glassman, Steven; Foley, Kevin T; Slotkin, Jonathan R; Potts, Eric; Shaffrey, Mark; Shaffrey, Christopher I; Haid, Regis W; Fu, Kai-Ming; Wang, Michael Y; Park, Paul; Asher, Anthony L; Bisson, Erica F
    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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    Serious Adverse Events Significantly Reduce Patient-Reported Outcomes at 2-Year Follow-up: Nonoperative, Multicenter, Prospective NIH Study of 105 Patients.
    (Spine, 2018-06) Pugely, Andrew J; Kelly, Michael P; Baldus, Christine R; Gao, Yubo; Zebala, Lukas; Shaffrey, Christopher; Glassman, Steven; Boachie-Adjei, Oheneba; Parent, Stefan; Lewis, Stephen; Koski, Tyler; Edwards, Charles; Schwab, Frank; Bridwell, Keith H

    Study design

    This is an analysis of a prospective 2-year study on nonoperative patients enrolled in the Adult Symptomatic Lumbar Scoliosis (ASLS) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) trial.

    Objective

    The purpose was to evaluate the impact of serious adverse events (SAEs) on patient-reported outcomes (PROs) in nonoperative management of ASLS as measured by Scoliosis Research Society-22 (SRS-22), Oswestry Disability Index (ODI), and Short Form-12 (SF-12) at 2-year follow-up.

    Summary of background data

    Little is known about PROs in the nonoperative management of ASLS or the prevalence and impact of SAEs on PROs.

    Methods

    The ASLS trial dataset was analyzed to identify adult lumbar scoliosis patients electively choosing or randomly assigned to nonoperative treatment with minimum 2-year follow-up. Patient data were collected prospectively from 2010 to 2015 as part of NIAMS R01-AR055176-01A2 "A Multi-Centered Prospective Study of Quality of Life in Adult Scoliosis." SAEs were defined as life-threatening medical events, new significant or permanent disability, new or prolonged hospitalization, or death.

    Results

    One hundred five nonoperative patients were studied to 2-year follow-up. Twenty-seven patients (25.7%) had 42 SAEs; 15 (14.3%) had a SAE during the first year. The SAE group had higher body mass index (29.4 vs. 25.2; P = 0.008) and reported worse SRS-22 Function scores than the non-SAE group at baseline (3.3 vs. 3.6; P = 0.024). At 2-year follow-up, SAE patients experienced less improvement (change) in SRS-22 Self-Image (-0.07 vs. 0.26; P = 0.018) and Mental Health domains (-0.19 vs. 0.25; P = 0.002) than non-SAE patients and had lower SRS-22 Function, Self-Image, Subscore, and SF-12 Mental and Physical component scores (MCS/PCS). Fewer SAE patients reached minimal clinically important difference (MCID) threshold in SRS-22 Mental Health (14.8% vs. 43.6%; P = 0.01).

    Conclusion

    A high percentage (25.7%) of ASLS patients managed nonoperatively experienced SAEs. Those patients who sustained a SAE had less improvement in reported outcomes.

    Level of evidence

    2.
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    ItemOpen Access
    The comprehensive anatomical spinal osteotomy classification.
    (Neurosurgery, 2014-01) Schwab, Frank; Blondel, Benjamin; Chay, Edward; Demakakos, Jason; Lenke, Lawrence; Tropiano, Patrick; Ames, Christopher; Smith, Justin S; Shaffrey, Christopher I; Glassman, Steven; Farcy, Jean-Pierre; Lafage, Virginie

    Background

    Global sagittal malalignment is significantly correlated with health-related quality-of-life scores in the setting of spinal deformity. In order to address rigid deformity patterns, the use of spinal osteotomies has seen a substantial increase. Unfortunately, variations of established techniques and hybrid combinations of osteotomies have made comparisons of outcomes difficult.

    Objective

    To propose a classification system of anatomically-based spinal osteotomies and provide a common language among spine specialists.

    Methods

    The proposed classification system is based on 6 anatomic grades of resection (1 through 6) corresponding to the extent of bone resection and increasing degree of destabilizing potential. In addition, a surgical approach modifier is added (posterior approach or combined anterior and posterior approaches). Reliability of the classification system was evaluated by an analysis of 16 clinical cases, rated 2 times by 8 different readers, and calculation of Fleiss kappa coefficients.

    Results

    Intraobserver reliability was classified as "almost perfect"; Fleiss kappa coefficient averaged 0.96 (range, 0.92-1.0) for resection type and 0.90 (0.71-1.0) for the approach modifier. Results from the interobserver reliability for the classification were 0.96 for resection type and 0.88 for the approach modifier.

    Conclusion

    This proposed anatomically based classification system provides a consistent description of the various osteotomies performed in spinal deformity correction surgery. The reliability study confirmed that the classification is simple and consistent. Further development of its use will provide a common frame for osteotomy assessment and permit comparative analysis of different treatments.
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    ItemOpen Access
    The comprehensive anatomical spinal osteotomy classification.
    (Neurosurgery, 2015-03) Schwab, Frank; Blondel, Benjamin; Chay, Edward; Demakakos, Jason; Lenke, Lawrence; Tropiano, Patrick; Ames, Christopher; Smith, Justin S; Shaffrey, Christopher I; Glassman, Steven; Farcy, Jean-Pierre; Lafage, Virginie

    Background

    Global sagittal malalignment is significantly correlated with health-related quality-of-life scores in the setting of spinal deformity. In order to address rigid deformity patterns, the use of spinal osteotomies has seen a substantial increase. Unfortunately, variations of established techniques and hybrid combinations of osteotomies have made comparisons of outcomes difficult.

    Objective

    To propose a classification system of anatomically-based spinal osteotomies and provide a common language among spine specialists.

    Methods

    The proposed classification system is based on 6 anatomic grades of resection (1 through 6) corresponding to the extent of bone resection and increasing degree of destabilizing potential. In addition, a surgical approach modifier is added (posterior approach or combined anterior and posterior approaches). Reliability of the classification system was evaluated by an analysis of 16 clinical cases, rated 2 times by 8 different readers, and calculation of Fleiss kappa coefficients.

    Results

    Intraobserver reliability was classified as 'almost perfect'; Fleiss kappa coefficient averaged 0.96 (range, 0.92-1.0) for resection type and 0.90 (0.71-1.0) for the approach modifier. Results from the interobserver reliability for the classification were 0.96 for resection type and 0.88 for the approach modifier.

    Conclusion

    This proposed anatomically based classification system provides a consistent description of the various osteotomies performed in spinal deformity correction surgery. The reliability study confirmed that the classification is simple and consistent. Further development of its use will provide a common frame for osteotomy assessment and permit comparative analysis of different treatments.
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    ItemOpen Access
    The National Neurosurgery Quality and Outcomes Database (N2QOD): a collaborative North American outcomes registry to advance value-based spine care.
    (Spine, 2014-10) Asher, Anthony L; Speroff, Ted; Dittus, Robert S; Parker, Scott L; Davies, Jason M; Selden, Nathan; Nian, Hui; Glassman, Steven; Mummaneni, Praveen; Shaffrey, Christopher; Watridge, Clarence; Cheng, Joseph S; McGirt, Mathew J

    Study design

    National Prospective Observational Registry.

    Objective

    Describe our preliminary experience with the National Neurosurgery Quality and Outcomes Database (NQOD), a national collaborative registry of quality and outcomes reporting after low back surgery.

    Summary of background data

    All major health care stakeholders are now requiring objective data regarding the value of medical services. Surgical therapies for spinal disorders have faced particular scrutiny in recent value-based discussions, in large part due to the dramatic growth in the cost and application of these procedures. Reliable data are fundamental to understanding the value of delivered health care. Clinical registries are increasingly used to provide such data.

    Methods

    The NQOD is a prospective observational registry designed to establish risk-adjusted expected morbidity and 1-year outcomes for the most common lumbar surgical procedures performed by spine surgeons; provide practice groups and hospitals immediate infrastructure for analyzing their 30-day morbidity and mortality and 3- and 12-month quality data in real-time; generate surgeon-, practice-, and specialty-specific quality and efficacy data; and generate nationwide quality and effectiveness data on specific surgical treatments.

    Results

    In its first 2 years of operation, the NQOD has proven to be a robust data collection platform that has helped demonstrate the objective quality of surgical interventions for medically refractory disorders of the lumbar spine. Lumbar spine surgery was found to be safe and effective at the group mean level in routine practice. Subgroups of patients did not report improvement using validated outcome measures. Substantial variation in treatment response was observed among individual patients.

    Conclusion

    The NQOD is now positioned to determine the combined contribution of patient variables to specific clinical and patient-reported outcomes. These analyses will ultimately facilitate shared decision making and encourage efficient allocation of health care resources, thus significantly advancing the value paradigm in spine care.

    Level of evidence

    3.
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    ItemOpen Access
    The Scoliosis Research Society Health-Related Quality of Life (SRS-30) age-gender normative data: an analysis of 1346 adult subjects unaffected by scoliosis.
    (Spine, 2011-06) Baldus, Christine; Bridwell, Keith; Harrast, John; Shaffrey, Christopher; Ondra, Stephen; Lenke, Lawrence; Schwab, Frank; Mardjetko, Steven; Glassman, Steven; Edwards, Charles; Lowe, Thomas; Horton, William; Polly, David

    Study design

    Prospective, cross-sectional study.

    Objective

    To determine Scoliosis Research Society (SRS)-30 health-related quality of life (HRQOL) reference values by age and gender in an adult population unaffected by scoliosis thereby allowing clinicians and investigators to compare individual and/or groups of spinal deformity patients to their generational peers.

    Summary of background data

    Normative data are collected to establish means and standard deviations of health-related quality of life outcomes representative of a population. The SRS HRQOL questionnaire has become the standard for determining and comparing treatment outcomes in spinal deformity practices. With the establishment of adult SRS-30 HRQOL population values, clinicians, and investigators now have a reference for interpretation of individual scores and/or the scores of subgroups of adult patients with spinal deformities.

    Methods

    The SRS-30 HRQOL was issued prospectively to 1346 adult volunteers recruited from across the United States. Volunteers self-reported no history of scoliosis or prior spine surgery. Domain medians, means, confidence intervals, percentiles, and minimum/maximum values were calculated for six generational age-gender groups: male/female; 20-39, 40-59, and 60-80 years of age.

    Results

    Median and mean domain values ranged from 4.1 to 4.6 for all age-gender groups. The older the age-gender group, the lower (worse) the reported domain median and mean scores. The only exception was the mental health domain scores in the female groups which improved slightly. Males reported higher (better) scores than females but only the younger males were significantly higher in all domains than their female counterparts. In addition, all male groups reported higher Mental Health domain scores than their female counterparts (P=0.003).

    Conclusion

    This study reports population medians, means, standard deviations, percentiles, and confidence intervals for the domains of the SRS-30 HRQOL instrument. Clinicians must be mindful of age-gender differences when assessing deformity populations. Generational decreases noted in the older adult volunteer scores may provide a basis for future investigators to interpret observed score decreases in patient cohorts at long-term follow-up.