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Dana L. Cruz, Ethan W. Ayres, Matthew A. Spiegel, Louis M. Day, Robert A. Hart, Christopher P. Ames, Douglas C. Burton, Justin S. Smith, Christopher I. Shaffrey, Frank J. Schwab, Thomas J. Errico, Shay Bess, Virginie Lafage and Themistocles S. Protopsaltis

OBJECTIVE

Neck and back pain are highly prevalent conditions that account for major disability. The Neck Disability Index (NDI) and Oswestry Disability Index (ODI) are the two most common functional status measures for neck and back pain. However, no single instrument exists to evaluate patients with concurrent neck and back pain. The recently developed Total Disability Index (TDI) combines overlapping elements from the ODI and NDI with the unique items from each. This study aimed to prospectively validate the TDI in patients with spinal deformity, back pain, and/or neck pain.

METHODS

This study is a retrospective review of prospectively collected data from a single center. The 14-item TDI, derived from ODI and NDI domains, was administered to consecutive patients presenting to a spine practice. Patients were assessed using the ODI, NDI, and EQ-5D. Validation of internal consistency, test-retest reproducibility, and validity of reconstructed NDI and ODI scores derived from TDI were assessed.

RESULTS

A total of 252 patients (mean age 55 years, 56% female) completed initial assessments (back pain, n = 115; neck pain, n = 52; back and neck pain, n = 55; spinal deformity, n = 55; and no pain/deformity, n = 29). Of these patients, 155 completed retests within 14 days. Patients represented a wide range of disability (mean ODI score: 36.3 ± 21.6; NDI score: 30.8 ± 21.8; and TDI score: 34.1 ± 20.0). TDI demonstrated excellent internal consistency (Cronbach’s alpha = 0.922) and test-retest reliability (intraclass correlation coefficient = 0.96). Differences between actual and reconstructed scores were not clinically significant. Subanalyses demonstrated TDI’s ability to quantify the degree of disability due to back or neck pain in patients complaining of pain in both regions.

CONCLUSIONS

The TDI is a valid and reliable disability measure in patients with back and/or neck pain and can capture each spine region’s contribution to total disability. The TDI could be a valuable method for total spine assessment in a clinical setting, and its completion is less time consuming than that for both the ODI and NDI.

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Samantha R. Horn, Peter G. Passias, Cheongeun Oh, Virginie Lafage, Renaud Lafage, Justin S. Smith, Breton Line, Neel Anand, Frank A. Segreto, Cole A. Bortz, Justin K. Scheer, Robert K. Eastlack, Vedat Deviren, Praveen V. Mummaneni, Alan H. Daniels, Paul Park, Pierce D. Nunley, Han Jo Kim, Eric O. Klineberg, Douglas C. Burton, Robert A. Hart, Frank J. Schwab, Shay Bess, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Cervical deformity (CD) correction is clinically challenging. There is a high risk of developing complications with these highly complex procedures. The aim of this study was to use baseline demographic, clinical, and surgical factors to predict a poor outcome following CD surgery.

METHODS

The authors performed a retrospective review of a multicenter prospective CD database. CD was defined as at least one of the following: cervical kyphosis (C2–7 Cobb angle > 10°), cervical scoliosis (coronal Cobb angle > 10°), C2–7 sagittal vertical axis (cSVA) > 4 cm, or chin-brow vertical angle (CBVA) > 25°. Patients were categorized based on having an overall poor outcome or not. Health-related quality of life measures consisted of Neck Disability Index (NDI), EQ-5D, and modified Japanese Orthopaedic Association (mJOA) scale scores. A poor outcome was defined as having all 3 of the following categories met: 1) radiographic poor outcome: deterioration or severe radiographic malalignment 1 year postoperatively for cSVA or T1 slope–cervical lordosis mismatch (TS-CL); 2) clinical poor outcome: failing to meet the minimum clinically important difference (MCID) for NDI or having a severe mJOA Ames modifier; and 3) complications/reoperation poor outcome: major complication, death, or reoperation for a complication other than infection. Univariate logistic regression followed by multivariate regression models was performed, and internal validation was performed by calculating the area under the curve (AUC).

RESULTS

In total, 89 patients with CD were included (mean age 61.9 years, female sex 65.2%, BMI 29.2 kg/m2). By 1 year postoperatively, 18 (20.2%) patients were characterized as having an overall poor outcome. For radiographic poor outcomes, patients’ conditions either deteriorated or remained severe for TS-CL (73% of patients), cSVA (8%), horizontal gaze (34%), and global SVA (28%). For clinical poor outcomes, 80% and 60% of patients did not reach MCID for EQ-5D and NDI, respectively, and 24% of patients had severe symptoms (mJOA score 0–11). For the complications/reoperation poor outcome, 28 patients experienced a major complication, 11 underwent a reoperation, and 1 had a complication-related death. Of patients with a poor clinical outcome, 75% had a poor radiographic outcome; 35% of poor radiographic and 37% of poor clinical outcome patients had a major complication. A poor outcome was predicted by the following combination of factors: osteoporosis, baseline neurological status, use of a transition rod, number of posterior decompressions, baseline pelvic tilt, T2–12 kyphosis, TS-CL, C2–T3 SVA, C2–T1 pelvic angle (C2 slope), global SVA, and number of levels in maximum thoracic kyphosis. The final model predicting a poor outcome (AUC 86%) included the following: osteoporosis (OR 5.9, 95% CI 0.9–39), worse baseline neurological status (OR 11.4, 95% CI 1.8–70.8), baseline pelvic tilt > 20° (OR 0.92, 95% CI 0.85–0.98), > 9 levels in maximum thoracic kyphosis (OR 2.01, 95% CI 1.1–4.1), preoperative C2–T3 SVA > 5.4 cm (OR 1.01, 95% CI 0.9–1.1), and global SVA > 4 cm (OR 3.2, 95% CI 0.09–10.3).

CONCLUSIONS

Of all CD patients in this study, 20.2% had a poor overall outcome, defined by deterioration in radiographic and clinical outcomes, and a major complication. Additionally, 75% of patients with a poor clinical outcome also had a poor radiographic outcome. A poor overall outcome was most strongly predicted by severe baseline neurological deficit, global SVA > 4 cm, and including more of the thoracic maximal kyphosis in the construct.

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Ferran Pellisé, Miquel Serra-Burriel, Justin S. Smith, Sleiman Haddad, Michael P. Kelly, Alba Vila-Casademunt, Francisco Javier Sánchez Pérez-Grueso, Shay Bess, Jeffrey L. Gum, Douglas C. Burton, Emre Acaroğlu, Frank Kleinstück, Virginie Lafage, Ibrahim Obeid, Frank Schwab, Christopher I. Shaffrey, Ahmet Alanay, Christopher Ames, the International Spine Study Group and the European Spine Study Group

OBJECTIVE

Adult spinal deformity (ASD) surgery has a high rate of major complications (MCs). Public information about adverse outcomes is currently limited to registry average estimates. The object of this study was to assess the incidence of adverse events after ASD surgery, and to develop and validate a prognostic tool for the time-to-event risk of MC, hospital readmission (RA), and unplanned reoperation (RO).

METHODS

Two models per outcome, created with a random survival forest algorithm, were trained in an 80% random split and tested in the remaining 20%. Two independent prospective multicenter ASD databases, originating from the European continent and the United States, were queried, merged, and analyzed. ASD patients surgically treated by 57 surgeons at 23 sites in 5 countries in the period from 2008 to 2016 were included in the analysis.

RESULTS

The final sample consisted of 1612 ASD patients: mean (standard deviation) age 56.7 (17.4) years, 76.6% women, 10.4 (4.3) fused vertebral levels, 55.1% of patients with pelvic fixation, 2047.9 observation-years. Kaplan-Meier estimates showed that 12.1% of patients had at least one MC at 10 days after surgery; 21.5%, at 90 days; and 36%, at 2 years. Discrimination, measured as the concordance statistic, was up to 71.7% (95% CI 68%–75%) in the development sample for the postoperative complications model. Surgical invasiveness, age, magnitude of deformity, and frailty were the strongest predictors of MCs. Individual cumulative risk estimates at 2 years ranged from 3.9% to 74.1% for MCs, from 3.17% to 44.2% for RAs, and from 2.67% to 51.9% for ROs.

CONCLUSIONS

The creation of accurate prognostic models for the occurrence and timing of MCs, RAs, and ROs following ASD surgery is possible. The presented variability in patient risk profiles alongside the discrimination and calibration of the models highlights the potential benefits of obtaining time-to-event risk estimates for patients and clinicians.

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Michael P. Kelly, Michael A. Kallen, Christopher I. Shaffrey, Justin S. Smith, Douglas C. Burton, Christopher P. Ames, Virginie Lafage, Frank J. Schwab, Han Jo Kim, Eric O. Klineberg, Shay Bess and the International Spine Study Group

OBJECTIVE

After using PROsetta Stone crosswalk tables to calculate Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) scores, the authors sought to examine 1) correlations with Scoliosis Research Society–22r (SRS-22r) scores, 2) responsiveness to change, and 3) the relationship between baseline scores and 2-year follow-up scores in adult spinal deformity (ASD).

METHODS

PROsetta Stone crosswalk tables were used to converted SF-36 scores to PROMIS scores for pain and physical function in a cohort of ASD patients with 2-year follow-up. Spearman correlations were used to evaluate the relationship of PROMIS scores with SRS-22r scores. Effect size (ES) and adjusted standardized response mean (aSRM) were used to assess responsiveness to change. Linear regression was used to evaluate the association between baseline scores and 2-year follow-up scores.

RESULTS

In total, 425 (425/625, 68%) patients met inclusion criteria. Strong correlations (all |r| > 0.7, p < 0.001) were found between baseline and 2-year PROMIS values and corresponding SRS-22r domain scores. PROMIS-PI showed a large ES (1.09) and aSRM (0.88), indicating good responsiveness to change. PROMIS-PF showed a moderate ES (0.52) and moderate aSRM (0.69), indicating a moderate responsiveness to change. Patients with greater baseline pain complaints were associated with greater pain improvement at 2 years for both SRS-22r Pain (B = 0.39, p < 0.001) and PROMIS-PI (B = 0.45, p < 0.001). Higher functional scores at baseline were associated with greater average improvements in both SRS-22r Activity (B = 0.62, p < 0.001) and PROMIS-PF (B = 0.40, p < 0.001).

CONCLUSIONS

The authors found strong correlations between the SRS-22r Pain and Activity domains with corresponding PROMIS-PI and -PF scores. Pain measurements showed similar and strong ES and aSRM while the function measurements showed similar, moderate ES and aSRM at 2-year follow-up. These data support further exploration of the use of PROMIS–computer adaptive test instruments in ASD.

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Justin K. Scheer, Taemin Oh, Justin S. Smith, Christopher I. Shaffrey, Alan H. Daniels, Daniel M. Sciubba, D. Kojo Hamilton, Themistocles S. Protopsaltis, Peter G. Passias, Robert A. Hart, Douglas C. Burton, Shay Bess, Renaud Lafage, Virginie Lafage, Frank Schwab, Eric O. Klineberg, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Pseudarthrosis can occur following adult spinal deformity (ASD) surgery and can lead to instrumentation failure, recurrent pain, and ultimately revision surgery. In addition, it is one of the most expensive complications of ASD surgery. Risk factors contributing to pseudarthrosis in ASD have been described; however, a preoperative model predicting the development of pseudarthrosis does not exist. The goal of this study was to create a preoperative predictive model for pseudarthrosis based on demographic, radiographic, and surgical factors.

METHODS

A retrospective review of a prospectively maintained, multicenter ASD database was conducted. Study inclusion criteria consisted of adult patients (age ≥ 18 years) with spinal deformity and surgery for the ASD. From among 82 variables assessed, 21 were used for model building after applying collinearity testing, redundancy, and univariable predictor importance ≥ 0.90. Variables included demographic data along with comorbidities, modifiable surgical variables, baseline coronal and sagittal radiographic parameters, and baseline scores for health-related quality of life measures. Patients groups were determined according to their Lenke radiographic fusion type at the 2-year follow-up: bilateral or unilateral fusion (union) or pseudarthrosis (nonunion). A decision tree was constructed, and internal validation was accomplished via bootstrapped training and testing data sets. Accuracy and the area under the receiver operating characteristic curve (AUC) were calculated to evaluate the model.

RESULTS

A total of 336 patients were included in the study (nonunion: 105, union: 231). The model was 91.3% accurate with an AUC of 0.94. From 82 initial variables, the top 21 covered a wide range of areas including preoperative alignment, comorbidities, patient demographics, and surgical use of graft material.

CONCLUSIONS

A model for predicting the development of pseudarthrosis at the 2-year follow-up was successfully created. This model is the first of its kind for complex predictive analytics in the development of pseudarthrosis for patients with ASD undergoing surgical correction and can aid in clinical decision-making for potential preventative strategies.

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David B. Bumpass, Lawrence G. Lenke, Jeffrey L. Gum, Christopher I. Shaffrey, Justin S. Smith, Christopher P. Ames, Shay Bess, Brian J. Neuman, Eric Klineberg, Gregory M. Mundis Jr., Frank Schwab, Virginie Lafage, Han Jo Kim, Douglas C. Burton, Khaled M. Kebaish, Richard Hostin, Renaud Lafage, Michael P. Kelly and for the International Spine Study Group

OBJECTIVE

Adolescent spine deformity studies have shown that male patients require longer surgery and have greater estimated blood loss (EBL) and complications compared with female patients. No studies exist to support this relationship in adult spinal deformity (ASD). The purpose of this study was to investigate associations between sex and complications, deformity correction, and health-related quality of life (HRQOL) in patients with ASD. It was hypothesized that male ASD patients would have greater EBL, longer surgery, and more complications than female ASD patients.

METHODS

A multicenter ASD cohort was retrospectively queried for patients who underwent primary posterior-only instrumented fusions with a minimum of 5 levels fused. The minimum follow-up was 2 years. Primary outcomes were EBL, operative time, intra-, peri-, and postoperative complications, radiographic correction, and HRQOL outcomes (Oswestry Disability Index, SF-36, and Scoliosis Research Society-22r Questionnaire). Poisson multivariate regression was used to control for age, comorbidities, and levels fused.

RESULTS

Ninety male and 319 female patients met the inclusion criteria. Male patients had significantly greater mean EBL (2373 ml vs 1829 ml, p = 0.01). The mean operative time, transfusion requirements, and final radiographic measurements did not differ between sexes. Similarly, changes in HRQOL showed no significant differences. Finally, there were no sex differences in the incidence of complications (total, major, or minor) at any time point after controlling for age, body mass index, comorbidities, and levels fused.

CONCLUSIONS

Despite higher EBL, male ASD patients did not experience more complications or require less deformity correction at the 2-year follow-up. HRQOL scores similarly showed no sex differences. These findings differ from adolescent deformity studies, and surgeons can counsel patients that sex is unlikely to influence the outcomes and complication rates of primary all-posterior ASD surgery.

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Taemin Oh, Justin K. Scheer, Justin S. Smith, Richard Hostin, Chessie Robinson, Jeffrey L. Gum, Frank Schwab, Robert A. Hart, Virginie Lafage, Douglas C. Burton, Shay Bess, Themistocles Protopsaltis, Eric O. Klineberg, Christopher I. Shaffrey, Christopher P. Ames and the International Spine Study Group

OBJECTIVE

Patients with adult spinal deformity (ASD) experience significant quality of life improvements after surgery. Treatment, however, is expensive and complication rates are high. Predictive analytics has the potential to use many variables to make accurate predictions in large data sets. A validated minimum clinically important difference (MCID) model has the potential to assist in patient selection, thereby improving outcomes and, potentially, cost-effectiveness.

METHODS

The present study was a retrospective analysis of a multiinstitutional database of patients with ASD. Inclusion criteria were as follows: age ≥ 18 years, radiographic evidence of ASD, 2-year follow-up, and preoperative Oswestry Disability Index (ODI) > 15. Forty-six variables were used for model training: demographic data, radiographic parameters, surgical variables, and results on the health-related quality of life questionnaire. Patients were grouped as reaching a 2-year ODI MCID (+MCID) or not (−MCID). An ensemble of 5 different bootstrapped decision trees was constructed using the C5.0 algorithm. Internal validation was performed via 70:30 data split for training/testing. Model accuracy and area under the curve (AUC) were calculated. The mean quality-adjusted life years (QALYs) and QALYs gained at 2 years were calculated and discounted at 3.5% per year. The QALYs were compared between patients in the +MCID and –MCID groups.

RESULTS

A total of 234 patients met inclusion criteria (+MCID 129, −MCID 105). Sixty-nine patients (29.5%) were included for model testing. Predicted versus actual results were 50 versus 40 for +MCID and 19 versus 29 for −MCID (i.e., 10 patients were misclassified). Model accuracy was 85.5%, with 0.96 AUC. Predicted results showed that patients in the +MCID group had significantly greater 2-year mean QALYs (p = 0.0057) and QALYs gained (p = 0.0002).

CONCLUSIONS

A successful model with 85.5% accuracy and 0.96 AUC was constructed to predict which patients would reach ODI MCID. The patients in the +MCID group had significantly higher mean 2-year QALYs and QALYs gained. This study provides proof of concept for using predictive modeling techniques to optimize patient selection in complex spine surgery.

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Justin K. Scheer, Justin S. Smith, Frank Schwab, Virginie Lafage, Christopher I. Shaffrey, Shay Bess, Alan H. Daniels, Robert A. Hart, Themistocles S. Protopsaltis, Gregory M. Mundis Jr., Daniel M. Sciubba, Tamir Ailon, Douglas C. Burton, Eric Klineberg, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

The operative management of patients with adult spinal deformity (ASD) has a high complication rate and it remains unknown whether baseline patient characteristics and surgical variables can predict early complications (intraoperative and perioperative [within 6 weeks]). The development of an accurate preoperative predictive model can aid in patient counseling, shared decision making, and improved surgical planning. The purpose of this study was to develop a model based on baseline demographic, radiographic, and surgical factors that can predict if patients will sustain an intraoperative or perioperative major complication.

METHODS

This study was a retrospective analysis of a prospective, multicenter ASD database. The inclusion criteria were age ≥ 18 years and the presence of ASD. In total, 45 variables were used in the initial training of the model including demographic data, comorbidities, modifiable surgical variables, baseline health-related quality of life, and coronal and sagittal radiographic parameters. Patients were grouped as either having at least 1 major intraoperative or perioperative complication (COMP group) or not (NOCOMP group). An ensemble of decision trees was constructed utilizing the C5.0 algorithm with 5 different bootstrapped models. Internal validation was accomplished via a 70/30 data split for training and testing each model, respectively. Overall accuracy, the area under the receiver operating characteristic (AUROC) curve, and predictor importance were calculated.

RESULTS

Five hundred fifty-seven patients were included: 409 (73.4%) in the NOCOMP group, and 148 (26.6%) in the COMP group. The overall model accuracy was 87.6% correct with an AUROC curve of 0.89 indicating a very good model fit. Twenty variables were determined to be the top predictors (importance ≥ 0.90 as determined by the model) and included (in decreasing importance): age, leg pain, Oswestry Disability Index, number of decompression levels, number of interbody fusion levels, Physical Component Summary of the SF-36, Scoliosis Research Society (SRS)–Schwab coronal curve type, Charlson Comorbidity Index, SRS activity, T-1 pelvic angle, American Society of Anesthesiologists grade, presence of osteoporosis, pelvic tilt, sagittal vertical axis, primary versus revision surgery, SRS pain, SRS total, use of bone morphogenetic protein, use of iliac crest graft, and pelvic incidence–lumbar lordosis mismatch.

CONCLUSIONS

A successful model (87% accuracy, 0.89 AUROC curve) was built predicting major intraoperative or perioperative complications following ASD surgery. This model can provide the foundation toward improved education and point-of-care decision making for patients undergoing ASD surgery.

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Joshua Bakhsheshian, Justin K. Scheer, Jeffrey L. Gum, Richard Hostin, Virginie Lafage, Shay Bess, Themistocles S. Protopsaltis, Douglas C. Burton, Malla Kate Keefe, Robert A. Hart, Gregory M. Mundis Jr., Christopher I. Shaffrey, Frank Schwab, Justin S. Smith, Christopher P. Ames and The International Spine Study Group

OBJECTIVE

Mental disease burden can have a significant impact on levels of disability and health-related quality of life (HRQOL) measures. Therefore, the authors investigated the significance of mental health status in adults with spinal deformity and poor physical function.

METHODS

A retrospective analysis of a prospective multicenter database of 365 adult spinal deformity (ASD) patients who had undergone surgical treatment was performed. Health-related QOL variables were examined preoperatively and at the 2-year postoperative follow-up. Patients were grouped by their 36-Item Short Form Health Survey mental component summary (MCS) and physical component summary (PCS) scores. Both groups had PCS scores ≤ 25th percentile for matched norms; however, the low mental health (LMH) group consisted of patients with an MCS score ≤ 25th percentile, and the high mental health (HMH) group included patients with an MCS score ≥ 75th percentile.

RESULTS

Of the 264 patients (72.3%) with a 2-year follow-up, 104 (28.5%) met the inclusion criteria for LMH and 40 patients (11.0%) met those for HMH. The LMH group had a significantly higher overall rate of comorbidities, specifically leg weakness, depression, hypertension, and self-reported neurological and psychiatric disease processes, and were more likely to be unemployed as compared with the HMH group (p < 0.05 for all). The 2 groups had similar 2-year postoperative improvements in HRQOL (p > 0.05) except for the greater improvements in the MCS and the Scoliosis Research Society-22r questionnaire (SRS-22r) mental domain (p < 0.05) in the LMH group and greater improvements in PCS and SRS-22r satisfaction and back pain domains (p < 0.05) in the HMH group. The LMH group had a higher rate of reaching a minimal clinically important difference (MCID) on the SRS-22r mental domain (p < 0.01), and the HMH group had a higher rate of reaching an MCID on the PCS and SRS-22r activity domain (p < 0.05). On multivariable logistic regression, having LMH was a significant independent predictor of failure to reach an MCID on the PCS (p < 0.05). At the 2-year postoperative follow-up, 14 LMH patients (15.1%) were categorized as HMH. Two LMH patients (2.2%), and 3 HMH patients (7.7%) transitioned to a PCS score ≥ 75th percentile for age- and sex-matched US norms (p < 0.01).

CONCLUSIONS

While patients with poor mental and physical health, according to their MCS and PCS scores, have higher medical comorbidity and unemployment rates, they still demonstrate significant improvements in HRQOL measurements postoperatively. Both LMH and HMH patient groups demonstrated similar improvements in most HRQOL domains, except that the LMH patients had difficulties in obtaining improvements in the PCS domain.