Browsing by Subject "Retrospective Studies"
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Item Open Access A Collimator Setting Optimization Algorithm for Dual-Arc Volumetric Modulated Arc Therapy in Pancreas Stereotactic Body Radiation Therapy.(Technology in cancer research & treatment, 2019-01) Li, Xinyi; Wu, Jackie; Palta, Manisha; Zhang, You; Sheng, Yang; Zhang, Jiahan; Wang, ChunhaoPURPOSE:To optimize collimator setting to improve dosimetric quality of pancreas volumetric modulated arc therapy plan for stereotactic body radiation therapy. MATERIALS AND METHODS:Fifty-five volumetric modulated arc therapy cases in stereotactic body radiation therapy of pancreas were retrospectively included in this study with internal review board approval. Different from the routine practice of initializing collimator settings with a template, the proposed algorithm simultaneously optimizes the collimator angles and jaw positions that are customized to the patient geometry. Specifically, this algorithm includes 2 key steps: (1) an iterative optimization algorithm via simulated annealing that generates a set of potential collimator settings from 39 cases with pancreas stereotactic body radiation therapy, and (2) a multi-leaf collimator modulation scoring system that makes the final decision of the optimal collimator settings (collimator angles and jaw positions) based on organs at risk sparing criteria. For validation, the other 16 cases with pancreas stereotactic body radiation therapy were analyzed. Two plans were generated for each validation case, with one plan optimized using the proposed algorithm (Planopt) and the other plan with the template setting (Planconv). Each plan was optimized with 2 full arcs and the same set of constraints for the same case. Dosimetric results were analyzed and compared, including target dose coverage, conformity, organs at risk maximum dose, and modulation complexity score. All results were tested by Wilcoxon signed rank tests, and the statistical significance level was set to .05. RESULTS:Both plan groups had comparable target dose coverage and mean doses of all organs at risk. However, organs at risk (stomach, duodenum, large/small bowel) maximum dose sparing (D0.1 cc and D0.03 cc) was improved in Planopt compared to Planconv. Planopt also showed lower modulation complexity score, which suggests better capability of handling complex shape and sparing organs at risk . CONCLUSIONS:The proposed collimator settings optimization algorithm successfully improved dosimetric performance for dual-arc pancreas volumetric modulated arc therapy plans in stereotactic body radiation therapy of pancreas. This algorithm has the capability of immediate clinical application.Item Open Access A comparative analysis of the prevalence and characteristics of cervical malalignment in adults presenting with thoracolumbar spine deformity based on variations in treatment approach over 2 years.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2016-08) Jalai, Cyrus M; Passias, Peter G; Lafage, Virginie; Smith, Justin S; Lafage, Renaud; Poorman, Gregory W; Diebo, Bassel; Liabaud, Barthélemy; Neuman, Brian J; Scheer, Justin K; Shaffrey, Christopher I; Bess, Shay; Schwab, Frank; Ames, Christopher P; International Spine Study Group (ISSG)Purpose
Characteristics specific to cervical deformity (CD) concomitant with adult thoracolumbar deformity (TLD) remains uncertain, particularly regarding treatment. This study identifies cervical malalignment prevalence following surgical and conservative TLD treatment through 2 years.Methods
Retrospective analysis of a prospective, multicenter adult spinal deformity (ASD) database. CD was defined in operative and non-operative ASD patients according to the following criteria: T1 Slope minus Cervical Lordosis (T1S-CL) ≥20°, C2-C7 Cervical Sagittal Vertical Axis (cSVA) ≥40 mm, C2-C7 kyphosis >10°. Differences in rates, demographics, health-related quality of life (HRQoL) scores for Oswestry Disability Index (ODI) and Scoliosis Research Society Questionnaire (SRS-22r), and radiographic variables were assessed between treatment groups (Op vs. Non-Op) and follow-up periods (baseline, 1-year, 2-year).Results
Three hundred and nineteen (200 Op, 199 Non-Op) ASD patients were analyzed. Op patients' CD rates at 1 and 2 years were 78.9, and 63.0 %, respectively. Non-Op CD rates were 21.1 and 37.0 % at 1 and 2 years, respectively. T1S-CL mismatch and cSVA malalignment characterized Op CD at 1 and 2 years (p < 0.05). Op and Non-Op CD groups had similar cervical/global alignment at 1 year (p > 0.05 for all), but at 2 years, Op CD patients had worse thoracic kyphosis (TK), T1S-CL, CL, cSVA, C2-T3 SVA, and global SVA compared to Non-Ops (p < 0.05). Op CD patients had worse ODI, and SRS Activity at 1 and 2 years post-operative (p < 0.05), but had greater 2-year SRS Satisfaction scores (p = 0.019).Conclusions
In the first study to compare cervical malalignment at extended follow-up between ASD treatments, CD rates rose overall through 2 years. TLD surgery, resulting in higher CD rates characterized by T1S-CL and cSVA malalignment, produced poorer HRQoL. This information can aid in treatment method decision-making when cervical deformity is present concomitant with TLD.Item Open Access A comparison of the reliability and vulnerability of 3D sterEOS and 2D EOS when measuring the sagittal spinal alignment of patients with adolescent idiopathic scoliosis.(Spine deformity, 2022-09) Machida, Masayoshi; Rocos, Brett; Zabjek, Karl; Lebel, David EPurpose
An essential component of making the diagnosis of adolescent idiopathic scoliosis (AIS) is standing anteroposterior and lateral radiographs. Two-dimensional (2D) radiographs inevitably fail to reflect every plane of the three-dimensional (3D) deformity in scoliosis. We have tested the hypothesis that there is no difference in the assessment of the sagittal plane deformity when measured with either 2D or 3D EOS radiography.Methods
A retrospective radiographic analysis was performed on patients diagnosed with AIS, with subdivided into three groups according to the coronal angular deformity (mild group: 45°-69°, moderate group: 70°-89°, and severe group: 90° +). The sagittal parameters were compared between manual measurement with 2D sterEOS and those made using computer-aided 3D reconstruction.Results
Fifty-two patients were included in each group. The inter-study reliability when measuring the thoracic Kyphosis (TK) and lumbar lordosis (LL) between the two study modalities was excellent in mild group (ICC: 0.90, 95% CI 0.82 ~ 0.94 and ICC: 0.84, 95% CI 0.74 ~ 0.91), excellent in TK and fair in LL in moderate group (ICC: 0.76, 95% CI 0.61 ~ 0.85 and ICC: 0.70, 95% CI 0.53 ~ 0.81), and fair in TK and LL in severe group, respectively (ICC: 0.74, 95% CI 0.57 ~ 0.84 and ICC: 0.65, 95% CI 0.46 ~ 0.84). A Bland-Altman plot showed proportional bias in TK measurements in each group and LL in moderate group, which means the measured value is underestimated in 2D method when the angle is small.Conclusion
3D sterEOS is less vulnerable to the influence of coronal plane than 2D EOS in evaluating the sagittal spinal parameters of patients with a coronal deformity exceeding 70°.Level of evidence: 4
Item Open Access A Comparison of Three Different Positioning Techniques on Surgical Corrections and Postoperative Alignment in Cervical Spinal Deformity (CD) Surgery.(Spine, 2021-05) Morse, Kyle W; Lafage, Renaud; Passias, Peter; Ames, Christopher P; Hart, Robert; Shaffrey, Christopher I; Mundis, Gregory; Protopsaltis, Themistocles; Gupta, Munish; Klineberg, Eric; Burton, Doug; Lafage, Virginie; Kim, Han Jo; International Spine Study GroupStudy design
Retrospective review of a prospective multicenter cervical deformity database.Objective
To examine the differences in sagittal alignment correction between three positioning methods in cervical spinal deformity surgery (CD).Summary of background data
Surgical correction for CD is technically demanding and various techniques are utilized to achieve sagittal alignment objectives. The effect of different patient positioning techniques on sagittal alignment correction following CD remains unknown.Methods
Patients with sagittal deformity who underwent a posterior approach (with and without anterior approach) with an upper instrumented vertebra of C6 or above. Patients with Grade 5, 6, or 7 osteotomies were excluded. Positioning groups were Mayfield skull clamp, bivector traction, and halo ring. Preoperative lower surgical sagittal curve (C2-C7), C2-C7 sagittal vertical axis (cSVA), cervical scoliosis, T1 slope minus cervical lordosis (TS-CL), T1 slope (T1S), chin-brow vertebral angle (CBVA), C2-T3 curve, and C2-T3 SVA was assessed and compared with postoperative radiographs. Segmental changes were analyzed using the Fergusson method.Results
Eighty patients (58% female) with a mean age of 60.6 ± 10.5 years (range, 31-83) were included. The mean postoperative C2-C7 lordosis was 7.8° ± 14 and C2-C7 SVA was 34.1 mm ± 15. There were overall significant changes in cervical alignment across the entire cohort, with improvements in T1 slope (P < 0.001), C2-C7 (P < 0.001), TS-CL (P < 0.001), and cSVA (P = 0.006). There were no differences postoperatively of any radiographic parameter between positioning groups (P > 0.05). The majority of segmental lordotic correction was achieved at C4-5-6 (mean 6.9° ± 11). Additionally, patients who had bivector traction applied had had significantly more segmental correction at C7-T1-T2 compared with Mayfield and halo traction (4.2° vs. 0.3° vs. -1.7° respectively, P < 0.027).Conclusion
Postoperative cervical sagittal correction or alignment was not affected by patient position. The majority of segmental correction occurred at C4-5-6 across all positioning methods, while bivector traction had the largest corrective ability at the cervicothoracic junction.Level of Evidence: 4.Item Open Access A cost-effectiveness comparisons of adult spinal deformity surgery in the United States and Japan.(European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2018-03) Yagi, Mitsuru; Ames, Christopher P; Keefe, Malla; Hosogane, Naobumi; Smith, Justin S; Shaffrey, Christopher I; Schwab, Frank; Lafage, Virginie; Shay Bess, R; Matsumoto, Morio; Watanabe, Kota; International Spine Study Group (ISSG)Purpose
Information about the cost-effectiveness of surgical procedures for adult spinal deformity (ASD) is critical for providing appropriate treatments for these patients. The purposes of this study were to compare the direct cost and cost-effectiveness of surgery for ASD in the United States (US) and Japan (JP).Methods
Retrospective analysis of 76 US and 76 JP patients receiving surgery for ASD with ≥2-year follow-up was identified. Data analysis included preoperative and postoperative demographic, radiographic, health-related quality of life (HRQOL), and direct cost for surgery. An incremental cost-effectiveness ratio (ICER) was determined using cost/quality-adjusted life years (QALY). The cost/QALY was calculated from the 2-year cost and HRQOL data.Results
JP exhibited worse baseline spinopelvic alignment than the US (pelvic incidence and lumbar lordosis: 35.4° vs 22.7°, p < 0.01). The US had more three-column osteotomies (50 vs 16%), and shorter hospital stay (7.9 vs 22.7 days) (p < 0.05). The US demonstrated worse postoperative ODI (41.3 vs. 33.9%) and greater revision surgery rate (40 vs 10%) (p < 0.05). Due to the high initial cost and revision frequency, the US had greater total cost ($92,133 vs. $49,647) and cost/QALY ($511,840 vs. $225,668) at 2-year follow-up (p < 0.05).Conclusion
Retrospective analysis comparing the direct costs and cost-effectiveness of ASD surgery in the US vs JP demonstrated that the total direct costs and cost/QALY were substantially higher in the US than JP. Variations in patient cohort, healthcare costs, revision frequencies, and HRQOL improvement influenced the cost/QALY differential between these countries.Item Open Access A dimensional approach to understanding severity estimates and risk correlates of marijuana abuse and dependence in adults.(International journal of methods in psychiatric research, 2012-06) Wu, Li-Tzy; Woody, George E; Yang, Chongming; Pan, Jeng-Jong; Reeve, Bryce B; Blazer, Dan GWhile item response theory (IRT) research shows a latent severity trait underlying response patterns of substance abuse and dependence symptoms, little is known about IRT-based severity estimates in relation to clinically relevant measures. In response to increased prevalences of marijuana-related treatment admissions, an elevated level of marijuana potency, and the debate on medical marijuana use, we applied dimensional approaches to understand IRT-based severity estimates for marijuana use disorders (MUDs) and their correlates while simultaneously considering gender- and race/ethnicity-related differential item functioning (DIF). Using adult data from the 2008 National Survey on Drug Use and Health (N = 37,897), Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for MUDs among past-year marijuana users were examined by IRT, logistic regression, and multiple indicators-multiple causes (MIMIC) approaches. Among 6917 marijuana users, 15% met criteria for a MUD; another 24% exhibited subthreshold dependence. Abuse criteria were highly correlated with dependence criteria (correlation = 0.90), indicating unidimensionality; item information curves revealed redundancy in multiple criteria. MIMIC analyses showed that MUD criteria were positively associated with weekly marijuana use, early marijuana use, other substance use disorders, substance abuse treatment, and serious psychological distress. African Americans and Hispanics showed higher levels of MUDs than Whites, even after adjusting for race/ethnicity-related DIF. The redundancy in multiple criteria suggests an opportunity to improve efficiency in measuring symptom-level manifestations by removing low-informative criteria. Elevated rates of MUDs among African Americans and Hispanics require research to elucidate risk factors and improve assessments of MUDs for different racial/ethnic groups.Item Open Access A multicenter retrospective cohort study on predicting the risk for amiodarone pulmonary toxicity.(BMC pulmonary medicine, 2022-04) Kwok, Wang Chun; Ma, Ting Fung; Chan, Johnny Wai Man; Pang, Herbert H; Ho, James Chung ManBackground
Amiodarone is one of the most commonly used anti-arrhythmic agents. Amiodarone pulmonary toxicity is a potentially fatal adverse effect associated with amiodarone use. Previous studies on the epidemiology and risk factors for amiodarone pulmonary toxicity showed diverse results.Methods
A multicenter retrospective cohort study was conducted to identify clinic-epidemiologic markers associated with amiodarone pulmonary toxicity for development of a prediction rule. Patients taking amiodarone who were managed in 3 centres in Hong Kong from 2005 to 2015 were included in this study. Penalized logistic regression was used to model the outcome as it is rare.Results
A total of 34 cases with amiodarone pulmonary toxicity were identified among 1786 patients taking amiodarone for at least 90 days from 2005 to 2015. The incidence of amiodarone pulmonary toxicity was estimated to be 1.9%. The risk factors for amiodarone pulmonary toxicity included advanced age (OR 1.047, 95% CI 1.010-1.085, p = 0.013), ventricular arrhythmia (OR 2.703, 95% CI 1.053-6.935, p = 0.039), underlying lung disease (OR 2.511, 95% CI 1.146-5.501, p = 0.021) and cumulative dose of amiodarone (OR 4.762, 95% CI 1.310-17.309 p = 0.018).Conclusions
The incidence of amiodarone pulmonary toxicity in Chinese patients in Hong Kong is estimated to be 1.9% in this study. Age, underlying lung disease, ventricular arrhythmia and cumulative dose of amiodarone are associated with the development of amiodarone pulmonary toxicity. A prediction rule was developed to inform the risk of developing amiodarone pulmonary toxicity.Item Open Access A new predictive model for an improved respiratory isolation strategy in HIV-infected patients with PTB.(The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease, 2014-07) Carugati, M; Schiroli, C; Zanini, F; Vanoni, N; Galli, M; Adorni, F; Franzetti, FSetting
Luigi Sacco Hospital, Milan, Italy, 1 January 2000-31 December 2010.Objectives
To develop a predictive score for identifying human immunodeficiency virus (HIV) infected patients with pulmonary tuberculosis (PTB).Design
Retrospective study based on the medical charts of HIV-infected patients admitted consecutively on presumption of PTB. Patients with culture-positive TB were included in the TB group. Culture-negative subjects formed the non-TB group. Risk factors for PTB were identified and a predictive model was developed. The diagnostic test accuracy of the derived score and that of previously developed scores were analysed.Results
A total of 65 patients were included in the TB group and 505 subjects in the non-TB group. An eight-variable model (age, origin, alcohol use, respiratory rate, weight loss, haemoglobin, white blood cell count, typical chest X-ray) was derived. When compared with the different scores, this model showed the greatest area under the receiver operating characteristic curve (0.880). This score was the only one to present a negative likelihood ratio of <0.2, which is the threshold for giving strong diagnostic evidence against TB.Conclusions
This model may be useful in predicting PTB in HIV patients in low-endemic countries. A validation study is necessary.Item Open Access A Novel Tool for Deformity Surgery Planning: Determining the Magnitude of Lordotic Correction Required to Achieve a Desired Sagittal Vertical Axis.(World neurosurgery, 2017-08) Goldschmidt, Ezequiel; Angriman, Federico; Agarwal, Nitin; Zhou, James; Chen, Katherine; Tempel, Zachary J; Gerszten, Peter C; Kanter, Adam S; Okonkwo, David O; Passias, Peter; Scheer, Justin; Protopsaltis, Themistocles; Lafage, Virginie; Lafage, Renaud; Schwab, Frank; Bess, Shay; Ames, Christopher; Smith, Justin S; Shaffrey, Christopher I; Miller, Emily; Jain, Amit; Neuman, Brian; Sciubba, Daniel M; Burton, Douglas; Hamilton, D Kojo; International Spine Study GroupObjective
We sought to create a model capable of predicting the magnitude of pelvic incidence-lumbar lordosis (PI-LL) correction necessary to achieve a desired change in sagittal vertical axis (SVA).Methods
A retrospective review was conducted of a prospectively maintained multicenter adult spinal deformity database collected by the International Spine Study Group between 2009 and 2014. The independent variable of interest was the degree of correction achieved in the PI-LL mismatch 6 weeks after surgery. Primary outcome was the change in global sagittal alignment 6 weeks and 1 year after surgery. We used a linear mixed-effects model to determine the extent to which corrections in the PI-LL relationship affected postoperative changes in SVA.Results
A total of 1053 adult patients were identified. Of these patients, 590 were managed surgically. Eighty-seven surgically managed patients were excluded because of incomplete or missing PI-LL measurements on follow-up; the remaining 503 patients were selected for inclusion. For each degree of improvement in the PI-LL mismatch at 6 weeks, the SVA decreased by 2.18 mm (95% confidence interval, -2.56, -1.79; P < 0.01) and 1.67 mm (95% confidence interval, -2.07, -1.27; P < 0.01) at 6 weeks and 12 months, respectively. A high SVA measurement (>50 mm) 1 year after surgery was negatively associated with health-related quality of life as measured by the Scoliosis Research Society 22 outcomes assessment.Conclusions
We describe a novel model that shows how surgical correction of the PI-LL relationship affects postoperative changes in SVA. This model may enable surgeons to determine preoperatively the amount of LL necessary to achieve a desired change in SVA.Item Open Access A Novel Weave Tether Technique for Proximal Junctional Kyphosis Prevention in 71 Adult Spinal Deformity Patients: A Preliminary Case Series Assessing Early Complications and Efficacy.(Operative neurosurgery (Hagerstown, Md.), 2021-11) Rabinovich, Emily P; Buell, Thomas J; Sardi, Juan P; Lazaro, Bruno CR; Shaffrey, Christopher I; Smith, Justin SBackground
Proximal junctional kyphosis (PJK) rates may be as high as 69.4% after adult spinal deformity (ASD) surgery. PJK is one of the greatest unsolved challenges in long-segment fusions for ASD and remains a common indication for costly and impactful revision surgery. Junctional tethers may help to reduce the occurrence of PJK by attenuating adjacent-segment stress.Objective
To report our experience and assess early safety associated with a novel "weave-tether technique" (WTT) for PJK prophylaxis in a large series of patients.Methods
This single-center retrospective study evaluated consecutive patients who underwent ASD surgery including WTT between 2017 and 2018. Patient demographics, operative details, standard radiographic measurements, and complications were analyzed.Results
A total of 71 patients (mean age 66 ± 12 yr, 65% women) were identified. WTT included application to the upper-most instrumented vertebrae (UIV) + 1 and UIV + 2 in 38(53.5%) and 33(46.5%) patients, respectively. No complications directly attributed to WTT usage were identified. For patients with radiographic follow-up (96%; mean duration 14 ± 12 mo), PJK occurred in 15% (mean 1.8 ± 1.0 mo postoperatively). Proximal junctional angle increased an average 4° (10° to 14°, P = .004). Rates of symptomatic PJK and revision for PJK were 8.8% and 2.9%, respectively.Conclusion
Preliminary results support the safety of the WTT for PJK prophylaxis. Approximately 15% of patients developed radiographic PJK, no complications were directly attributed to WTT usage, and the revision rate for PJK was low. These early results warrant future research to assess longer-term efficacy of the WTT for PJK prophylaxis in ASD surgery.Item Open Access A Pilot Study on Posterior Polyethylene Tethers to Prevent Proximal Junctional Kyphosis After Multilevel Spinal Instrumentation for Adult Spinal Deformity.(Operative neurosurgery (Hagerstown, Md.), 2019-02) Buell, Thomas J; Buchholz, Avery L; Quinn, John C; Bess, Shay; Line, Breton G; Ames, Christopher P; Schwab, Frank J; Lafage, Virginie; Shaffrey, Christopher I; Smith, Justin SBACKGROUND:Proximal junctional kyphosis (PJK) is a common problem after multilevel spine instrumentation. OBJECTIVE:To determine if junctional tethers reduce PJK after multilevel instrumented surgery for adult spinal deformity (ASD). METHODS:ASD patients who underwent posterior instrumented fusion were divided into 3 groups: no tether (NT), polyethylene tether-only (TO; tied securely through the spinous processes of the uppermost instrumented vertebra [UIV] + 1 and UIV-1), and tether with crosslink (TC; passed through the spinous process of UIV+1 and tied to a crosslink between UIV-1 and UIV-2). PJK was defined as proximal junctional angle ≥ 10° and ≥ 10° greater than the corresponding preoperative measurement. RESULTS:One hundred eighty-four (96%) of 191 consecutive patients achieved minimum 3-mo follow-up (mean = 20 mo [range:3-56 mo]; mean age = 66 yr; 67.4% female). There were no significant differences between groups based on demographic, surgical, and sagittal radiographic parameters. PJK rates were 45.3% (29/64), 34.4% (22/64), and 17.9% (10/56) for NT, TO, and TC, respectively. PJK rate for all tethered patients (TO + TC; 26.7% [32/120]) was significantly lower than NT (P = .011). PJK rate for TC was significantly lower than NT (P = .001). Kaplan-Meier analysis showed significant time-dependent PJK reduction for TC vs NT (log rank test, P = .010). Older age and greater change in lumbar lordosis were independent predictors of PJK, while junctional tethers had a significant protective effect. CONCLUSION:Junctional tethers significantly reduced occurrence of PJK. This difference was progressive from NT to TO to TC, but only reached pairwise significance for NT vs TC. This suggests potential benefit of tethers to reduce PJK, and that future prospective studies are warranted.Item Open Access A Radiographic Analysis of Lumbar Fusion Status and Instrumentation Failure After Complex Adult Spinal Deformity Surgery With Spinopelvic Fixation: Two-Year Follow-up From the Scoli-Risk-1 Prospective Database.(Clinical spine surgery, 2020-12) Shimizu, Takayoshi; Lenke, Lawrence G; Cerpa, Meghan; Beauchamp, Eduardo C; Carreon, Leah Y; Shaffrey, Christopher I; Cheung, Kenneth MC; Fehlings, Michael GStudy design
A retrospective review of prospectively collected data.Objective
The objective of this study was to investigate the fusion status of the lumbar spine and lumbosacral junction at 2 years postoperatively after complex adult spinal deformity (ASD) surgery.Summary of background data
Achieving fusion is crucial for maintaining optimal alignment in ASD surgery. However, prospective data assessing fusion status using large patient populations are lacking in this patient population.Materials and methods
Postoperative radiographs of 162 patients from the Scoli-Risk-1 database, who underwent complex ASD surgery with fusion to the sacrum, were evaluated by 3 independent spine surgeons at 6-week, 6-month, and 2-year follow-up. The fusion rate of the lumbar spine segments at a 2-year follow-up was determined by using previously published radiographic grading criteria. We also assessed the prevalence of instrumentation failures.Results
The interrater reliabilities for grading the fusion status were overall fair at each level evaluated (Fleiss κ, 0.337-0.439). Overall, 70.3% (114/162) demonstrated the solid fusion of the entire lumbar spine at a 2-year follow-up. The fusion rates of each segment were L1/L2: 87.0%, L2/L3: 82.0%, L3/L4: 83.9%, L4/L5: 89.5%, and L5/S1: 89.5%. Pedicle screw loosening was the most frequent implant failure throughout the observation period (9.2%, 11.6%, and 11.0% at 6-wk, 6-mo, and 2-y follow-up, respectively). No rod breakage was observed at 6 weeks, increasing to 9.8% at 2-year follow-up. The prevalence of postoperative proximal junctional kyphosis was 5.5% at 6 weeks, showing no difference at 2 years postoperative.Conclusions
In this series of complex ASD surgeries often requiring 3-column osteotomies, 70.3% showed solid fusion of the entire lumbar spine, including the lumbosacral junction. The lumbosacral segments showed a relatively high fusion rate at a 2-year follow-up likely due to the frequent use of anterior column support and graft. The prevalence of rod breakage increased as follow-up proceeded to 9.8%, which was most commonly observed at the lumbosacral junction.Level of evidence
Level IV.Item Open Access A Risk-Benefit Analysis of Increasing Surgical Invasiveness Relative to Frailty Status in Adult Spinal Deformity Surgery.(Spine, 2021-08) Passias, Peter G; Brown, Avery E; Bortz, Cole; Pierce, Katherine; Alas, Haddy; Ahmad, Waleed; Passfall, Lara; Kummer, Nicholas; Krol, Oscar; Lafage, Renaud; Lafage, Virginie; Burton, Douglas; Hart, Robert; Anand, Neel; Mundis, Gregory; Neuman, Brian; Line, Breton; Shaffrey, Christopher; Klineberg, Eric; Smith, Justin; Ames, Christopher; Schwab, Frank J; Bess, Shay; International Spine Study GroupStudy design
Retrospective review of a prospectively enrolled multicenter Adult Spinal Deformity (ASD) database.Objective
Investigate invasiveness and outcomes of ASD surgery by frailty state.Summary of background data
The ASD Invasiveness Index incorporates deformity-specific components to assess correction magnitude. Intersections of invasiveness, surgical outcomes, and frailty state are understudied.Methods
ASD patients with baseline and 3-year (3Y) data were included. Logistic regression analyzed the relationship between increasing invasiveness and major complications or reoperations and meeting minimal clinically important differences (MCID) for health-related quality-of-life measures at 3Y. Decision tree analysis assessed invasiveness risk-benefit cutoff points, above which experiencing complications or reoperations and not reaching MCID were higher. Significance was set to P < 0.05.Results
Overall, 195 of 322 patients were included. Baseline demographics: age 59.9 ± 14.4, 75% female, BMI 27.8 ± 6.2, mean Charlson Comorbidity Index: 1.7 ± 1.7. Surgical information: 61% osteotomy, 52% decompression, 11.0 ± 4.1 levels fused. There were 98 not frail (NF), 65 frail (F), and 30 severely frail (SF) patients. Relationships were found between increasing invasiveness and experiencing a major complication or reoperation for the entire cohort and by frailty group (all P < 0.05). Defining a favorable outcome as no major complications or reoperation and meeting MCID in any health-related quality of life at 3Y established an invasiveness cutoff of 63.9. Patients below this threshold were 1.8[1.38-2.35] (P < 0.001) times more likely to achieve favorable outcome. For NF patients, the cutoff was 79.3 (2.11[1.39-3.20] (P < 0.001), 111 for F (2.62 [1.70-4.06] (P < 0.001), and 53.3 for SF (2.35[0.78-7.13] (P = 0.13).Conclusion
Increasing invasiveness is associated with increased odds of major complications and reoperations. Risk-benefit cutoffs for successful outcomes were 79.3 for NF, 111 for F, and 53.3 for SF patients. Above these, increasing invasiveness has increasing risk of major complications or reoperations and not meeting MCID at 3Y.Level of Evidence: 3.Item Open Access A Structured Approach to Detecting and Treating Depression in Primary Care: VitalSign6 Project.(Annals of family medicine, 2019-07) Jha, Manish K; Grannemann, Bruce D; Trombello, Joseph M; Clark, E Will; Eidelman, Sara Levinson; Lawson, Tiffany; Greer, Tracy L; Rush, A John; Trivedi, Madhukar HPurpose
This report describes outcomes of an ongoing quality-improvement project (VitalSign6) in a large US metropolitan area to improve recognition, treatment, and outcomes of depressed patients in 16 primary care clinics (6 charity clinics, 6 federally qualified health care centers, 2 private clinics serving low-income populations, and 2 private clinics serving patients with either Medicare or private insurance).Methods
Inclusion in this retrospective analysis was restricted to the first 25,000 patients (aged ≥12 years) screened with the 2-item Patient Health Questionnaire (PHQ-2) in the aforementioned quality-improvement project. Further evaluations with self-reports and clinician assessments were recorded for those with positive screen (PHQ-2 >2). Data collected from August 2014 though November 2016 were available at 3 levels: (1) initial PHQ-2 (n = 25,000), (2) positive screen (n = 4,325), and (3) clinician-diagnosed depressive disorder with 18 or more weeks of enrollment (n = 2,160).Results
Overall, 17.3% (4,325/25,000) of patients screened positive for depression. Of positive screens, 56.1% (2,426/4,325) had clinician-diagnosed depressive disorder. Of those enrolled for 18 or more weeks, 64.8% were started on measurement-based pharmacotherapy and 8.9% referred externally. Of the 1,400 patients started on pharmacotherapy, 45.5%, 30.2%, 12.6%, and 11.6% had 0, 1, 2, and 3 or more follow-up visits, respectively. Remission rates were 20.3% (86/423), 31.6% (56/177), and 41.7% (68/163) for those with 1, 2, and 3 or more follow-up visits, respectively. Baseline characteristics associated with higher attrition were: non-white, positive drug-abuse screen, lower depression/anxiety symptom severity, and younger age.Conclusion
Although remission rates are high in those with 3 or more follow-up visits after routine screening and treatment of depression, attrition from care is a significant issue adversely affecting outcomes.Item Open Access Adaptive stereotactic body radiation therapy planning for lung cancer.(Int J Radiat Oncol Biol Phys, 2013-09-01) Qin, Y; Zhang, F; Yoo, DS; Kelsey, CR; Yin, FF; Cai, JPURPOSE: To investigate the dosimetric effects of adaptive planning on lung stereotactic body radiation therapy (SBRT). METHODS AND MATERIALS: Forty of 66 consecutive lung SBRT patients were selected for a retrospective adaptive planning study. CBCT images acquired at each fraction were used for treatment planning. Adaptive plans were created using the same planning parameters as the original CT-based plan, with the goal to achieve comparable comformality index (CI). For each patient, 2 cumulative plans, nonadaptive plan (PNON) and adaptive plan (PADP), were generated and compared for the following organs-at-risks (OARs): cord, esophagus, chest wall, and the lungs. Dosimetric comparison was performed between PNON and PADP for all 40 patients. Correlations were evaluated between changes in dosimetric metrics induced by adaptive planning and potential impacting factors, including tumor-to-OAR distances (dT-OAR), initial internal target volume (ITV1), ITV change (ΔITV), and effective ITV diameter change (ΔdITV). RESULTS: 34 (85%) patients showed ITV decrease and 6 (15%) patients showed ITV increase throughout the course of lung SBRT. Percentage ITV change ranged from -59.6% to 13.0%, with a mean (±SD) of -21.0% (±21.4%). On average of all patients, PADP resulted in significantly (P=0 to .045) lower values for all dosimetric metrics. ΔdITV/dT-OAR was found to correlate with changes in dose to 5 cc (ΔD5cc) of esophagus (r=0.61) and dose to 30 cc (ΔD30cc) of chest wall (r=0.81). Stronger correlations between ΔdITV/dT-OAR and ΔD30cc of chest wall were discovered for peripheral (r=0.81) and central (r=0.84) tumors, respectively. CONCLUSIONS: Dosimetric effects of adaptive lung SBRT planning depend upon target volume changes and tumor-to-OAR distances. Adaptive lung SBRT can potentially reduce dose to adjacent OARs if patients present large tumor volume shrinkage during the treatment.Item Open Access Adherence to Adjuvant Endocrine Therapy in Insured Black and White Breast Cancer Survivors: Exploring Adherence Measures in Patient Data.(Journal of managed care & specialty pharmacy, 2019-05) Sheppard, Vanessa B; He, Jun; Sutton, Arnethea; Cromwell, Lee; Adunlin, Georges; Salgado, Teresa M; Tolsma, Dennis; Trout, Martha; Robinson, Brandi E; Edmonds, Megan C; Bosworth, Hayden B; Tadesse, Mahlet GBackground
Adjuvant endocrine therapy (AET) is a critical therapy in that it improves survival in women with hormone receptor-positive (HR+) breast cancer (BC), but adherence to AET is suboptimal. The purpose of this study was to fill scientific gaps about predictors of adherence to AET among black and white women diagnosed with BC.Objective
To assess AET adherence in black and white insured women using multiple measures, including one that uses an innovative statistical approach.Methods
Black and white women newly diagnosed with HR+ BC were identified from 2 health maintenance organizations. Pharmacy records captured the type of oral AET prescriptions and all fill dates. Multivariable logistic regression was used to identify predictors of adherence defined in terms of proportion of days covered (PDC; ≥ 80%) and medication gap of ≤ 10 days. A zero-inflated negative binomial (ZINB) regression model was used to identify variables associated with the total number of days of medication gaps.Results
1,925 women met inclusion criteria. 80% were PDC adherent (> 80%); 44% had a medication gap of ≤ 10 days; and 24% had no medication gap days. Race and age were significant in all multivariable models. Black women were less likely to be adherent based on PDC than white women (OR = 0.72, 95% CI = 0.57-0.90, P < 0.01), and they were less likely to have a medication gap of ≤ 10 days (OR = 0.65, 95% CI = 0.54-0.79, P < 0.001). Women aged 25-49 years were less likely to be PDC adherent than women aged 65-93 years (OR = 0.65, 95% CI = 0.48-0.87, P < 0.001). In the ZINB model, women were without their medication for an average of 37 days (SD = 50.5).Conclusions
Racial disparities in adherence to AET in the study highlight a need for interventions among insured women. Using various measures of adherence may help better understand this multidimensional concept. There might be benefits from using both more common dichotomous measures (e.g., PDC) and integrating novel statistical approaches to allow tailoring adherence to patterns within a specific sample.Disclosures
This research was funded by the National Institutes of Health (R01CA154848). It was also supported in part by the NIH-NCI Cancer Center Support Grant P30 CA016059, the Laboratory of Telomere Health P30 CA51008, and the TSA Award No. UL1TR002649 from the National Center for Advancing Translational Sciences. The contents of this study are solely the responsibility of the authors and do not necessarily represent official views of the National Center for Advancing Translational Sciences or the National Institutes of Health. Bosworth reports grants from Sanofi, Otsuka, Johnson & Johnson, and Blue Cross/Blue Shield of NC and consulting fees from Sanofi and Otsuka. The other authors have nothing to disclose. The datasets generated during and/or analyzed during the current study are not publicly available due to privacy reasons but are available from the corresponding author on reasonable request. The author does not own these data. Data use was granted to the author as part of a data use agreement between specific agencies and organizations.Item Open Access Adjuvant radiotherapy in the treatment of invasive intraductal papillary mucinous neoplasm of the pancreas: an analysis of the surveillance, epidemiology, and end results registry.(Ann Surg Oncol, 2012-04) Worni, M; Akushevich, I; Gloor, B; Scarborough, J; Chino, JP; Jacobs, DO; Hahn, SM; Clary, BM; Pietrobon, R; Shah, ABACKGROUND: Management and outcomes of patients with invasive intraductal papillary mucinous neoplasm (IPMN) of the pancreas are not well established. We investigated whether adjuvant radiotherapy (RT) improved cancer-specific survival (CSS) and overall survival (OS) among patients undergoing surgical resection for invasive IPMN. METHODS: The Surveillance, Epidemiology, and End Results (SEER) registry was used in this retrospective cohort study. All adult patients with resection of invasive IPMN from 1988 to 2007 were included. CSS and OS were analyzed using Kaplan-Meier curves. Unadjusted and propensity-score-adjusted Cox proportional-hazards modeling were used for subgroup analyses. RESULTS: 972 patients were included. Adjuvant RT was administered to 31.8% (n=309) of patients. There was no difference in overall median CSS or OS in patients who received adjuvant RT (5-year CSS: 26.5 months; 5-year OS: 23.5 months) versus those who did not (CSS: 28.5 months, P=0.17; OS: 23.5 months, P=0.23). Univariate predictors of survival were lymph node (LN) involvement, T4-classified tumors, and poorly differentiated tumor grade (all P<0.05). In the propensity-score-adjusted analysis, adjuvant RT was associated with improved 5-year CSS [hazard ratio (HR): 0.67, P=0.004] and 5-year OS (HR: 0.73, P=0.014) among all patients with LN involvement, though further analysis by T-classification demonstrated no survival differences among patients with T1/T2 disease; patients with T3/T4-classified tumors had improved CSS (HR: 0.71, P=0.022) but no difference in OS (HR: 0.76, P=0.06). CONCLUSION: On propensity-score-adjusted analysis, adjuvant RT was associated with improved survival in selected subsets of patients with invasive IPMN, particularly those with T3/T4 tumors and LN involvement.Item Open Access Adoption of direct-acting antiviral medications for hepatitis C: a retrospective observational study.(BMC health services research, 2019-07-25) Zullig, Leah L; Bhatia, Haresh L; Gellad, Ziad F; Eatherly, Mark; Henderson, Rochelle; Bosworth, Hayden BBackground
Approximately 3.5 million Americans are infected with the hepatitis C virus (HCV). Although many patients with HCV are asymptomatic, HCV is the leading cause of infection-related death in the U.S. With advances in curative medication therapy for HCV, many of these deaths are preventable. Access to innovative therapies may be unevenly distributed. Our objective was to describe medication prescribers' adoption of innovative HCV pharmacotherapy across prescriber, geographical location, and time.Methods
This is a retrospective, secondary data analysis among a national cohort of patients prescribed direct-acting antiviral HCV medications with curative intent. We assessed prescriptions by time, geographic location, and provider type.Results
The peak of the adoption rate occurred within 45 days; nearly one-sixth of all prescribers had already prescribed one of the new drugs. Geographical regions (Midwest, South, and West all p ≥ 0.05) nor gender (p = 0.455) of a prescriber impacted adoption. Similarly, patient income did not influence the likelihood of a prescriber to adopt the new drugs earlier (p = 0.175). Gastroenterologists or hepatologists were more likely earlier adopters compared to primary care physicians (p = 0.01).Conclusions
Because of the relative advantage of newer therapies, we anticipated that there would be an initial surge as early adopters prescribed the new medications and use would dwindle over time as the initial HCV cohort was cured. The data demonstrate that our hypothesis is essentially supported. There is a reduction in prescriptions at approximately 5 months post-approval and treatment is typically required for 3 months. There has been a surge in clinicians' adoption of innovative HCV treatments. As patients are cured of their infection, we anticipate a decreased need for chronic management of HCV.Trial registration
Not applicable.Item Open Access Adult Scoliosis Deformity Surgery: Comparison of Outcomes Between One Versus Two Attending Surgeons.(Spine, 2017-07) Gomez, Jaime A; Lafage, Virginie; Sciubba, Daniel M; Bess, Shay; Mundis, Gregory M; Liabaud, Barthelemy; Hanstein, Regina; Shaffrey, Christopher; Kelly, Michael; Ames, Christopher; Smith, Justin S; Passias, Peter G; Errico, Thomas; Schwab, Frank; International Spine Study GroupStudy design
Retrospective review of prospectively collected data.Objective
Assess outcomes of adult spinal deformity (ASD) surgery performed by one versus two attending surgeons.Summary of background data
ASD centers have developed two attending teams to improve efficiency; their effects on complications and outcomes have not been reported.Methods
Patients with ASD with five or more levels fused and more than 2-year follow-up were included. Estimated blood loss (EBL), length of stay (LOS), operating room (OR) time, complications, quality of life (Health Related Quality of Life), and x-rays were analyzed. Outcomes were compared between one-surgeon (1S) and two-surgeon (2S) centers. A deformity-matched cohort was analyzed.Results
A total of 188 patients in 1S and 77 in 2S group were included. 2S group patients were older and had worse deformity based on the Scoliosis Research Society-Schwab classification (P < 0.05). There were no significant differences in levels fused (P = 0.57), LOS (8.7 vs 8.9 days), OR time (445.9 vs 453.2 min), or EBL (2008 vs 1898 cm; P > 0.05). 2S patients had more three-column osteotomies (3CO; P < 0.001) and used less bone morphogenetic protein 2 (BMP-2; 79.9% vs 15.6%; P < 0.001). The 2S group had fewer intraoperative complications (1.3% vs 11.1%; P = 0.006). Postoperative (6 wk to 2 yr) complications were more frequent in the 2S group (4.8% vs 15.6%; P < 0.002). After matching for deformity, there were no differences in (9.1 vs 10.1 days), OR time (467.8 vs 508.4 min), or EBL (3045 vs 2247 cm; P = 0.217). 2S group used less BMP-2 (20.6% vs 84.8%; P < 0.001), had fewer intraoperative complications (P = 0.015) but postoperative complications due to instrumentation failure/pseudarthrosis were more frequent (P < 0.01).Conclusion
No significant differences were found in LOS, OR time, or EBL between the 1S and 2S groups, even when matching for severity of deformity. 2S group had less BMP-2 use, fewer intraoperative complications but more postoperative complications.Level of evidence
2.Item Open Access Adult Spinal Deformity Surgery Is Associated with Increased Productivity and Decreased Absenteeism From Work and School.(Spine, 2022-02) Durand, Wesley M; Babu, Jacob M; Hamilton, David K; Passias, Peter G; Kim, Han Jo; Protopsaltis, Themistocles; Lafage, Virginie; Lafage, Renaud; Smith, Justin S; Shaffrey, Christopher; Gupta, Munish; Kelly, Michael P; Klineberg, Eric O; Schwab, Frank; Gum, Jeffrey L; Mundis, Gregory; Eastlack, Robert; Kebaish, Khaled; Soroceanu, Alex; Hostin, Richard A; Burton, Doug; Bess, Shay; Ames, Christopher; Hart, Robert A; Daniels, Alan H; International Spine Study Group (ISSG)Study design
Retrospective cohort study.Objective
We hypothesized that adult spinal deformity (ASD) surgery would be associated with improved work- and school-related productivity, as well as decreased rates of absenteeism.Summary of background data
ASD patients experience markedly decreased health-related quality of life along many dimensions.Methods
Only patients eligible for 2-year follow-up were included, and those with a history of previous spinal fusion were excluded. The primary outcome measures in this study were Scoliosis Research Society-22r score (SRS-22r) questions 9 and 17. A repeated measures mixed linear regression was used to analyze responses over time among patients managed operatively (OP) versus nonoperatively (NON-OP).Results
In total, 1188 patients were analyzed. 66.6% were managed operatively. At baseline, the mean percentage of activity at work/school was 56.4% (standard deviation [SD] 35.4%), and the mean days off from work/school over the past 90 days was 1.6 (SD 1.8). Patients undergoing ASD surgery exhibited an 18.1% absolute increase in work/school productivity at 2-year follow-up versus baseline (P < 0.0001), while no significant change was observed for the nonoperative cohort (P > 0.5). Similarly, the OP cohort experienced 1.1 fewer absent days over the past 90 days at 2 years versus baseline (P < 0.0001), while the NON-OP cohort showed no such difference (P > 0.3). These differences were largely preserved after stratifying by baseline employment status, age group, sagittal vertical axis (SVA), pelvic incidence minus lumbar lordosis (PI-LL), and deformity curve type.Conclusion
ASD patients managed operatively exhibited an average increase in work/school productivity of 18.1% and decreased absenteeism of 1.1 per 90 days at 2-year follow-up, while patients managed nonoperatively did not exhibit change from baseline. Given the age distribution of patients in this study, these findings should be interpreted as pertaining primarily to obligations at work or within the home. Further study of the direct and indirect economic benefits of ASD surgery to patients is warranted.Level of Evidence: 3.