Browsing by Subject "Conservative Treatment"
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Item Open Access Cost-effectiveness of adult lumbar scoliosis surgery: an as-treated analysis from the adult symptomatic scoliosis surgery trial with 5-year follow-up.(Spine deformity, 2020-12) Glassman, Steven D; Carreon, Leah Y; Shaffrey, Christopher I; Kelly, Michael P; Crawford, Charles H; Yanik, Elizabeth L; Lurie, Jon D; Bess, R Shay; Baldus, Christine R; Bridwell, Keith HStudy design
Longitudinal comparative cohort.Objective
The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for Adult Symptomatic Lumbar Scoliosis (ASLS) using the as-treated data and provide a comparison to previously reported intent-to-treat (ITT) analysis. Adult spinal deformity is a relatively prevalent condition for which surgical treatment has become increasingly common but concerns surrounding complications, revision rates and cost-effectiveness remain unresolved. Of these issues, cost-effectiveness is perhaps the most difficult to quantify as the requisite data is difficult to obtain. The purpose of this study is to report on the cost-effectiveness of surgical versus non-surgical treatment for ASLS using the as-treated data and provide a comparison to previously reported ITT analysis.Methods
Patients with at least 5-year follow-up data within the same treatment arm were included. Data collected every 3 months included use of nonoperative modalities, medications and employment status. Costs for surgeries and non-operative modalities were determined using Medicare Allowable rates. Medication costs were determined using the RedBook and indirect costs were calculated based on the reported employment status and income. Quality-Adjusted Life Years (QALY) was determined using the SF-6D.Results
Of 226 patients, 195 patients (73 Non-op, 122 Op) met inclusion criteria. At 5 years, 29 (24%) patients in the Op group had a revision surgery of whom two had two revisions and one had three revisions. The cumulative cost for the Op group was $111,451 with a cumulative QALY gain of 2.3. The cumulative cost for the Non-Op group was $29,124 with a cumulative QALY gain of 0.4. This results in an ICER of $44,033 in favor of Op treatment.Conclusion
This as-treated cost-effectiveness analysis demonstrates that surgical treatment for adult lumbar scoliosis becomes favorable at year-three, 1 year earlier than suggested by a previous intent-to-treat analysis.Level of evidence
II.Item Open Access Impact of US hospital center and interhospital transfer on spinal cord injury management: An analysis of the National Trauma Data Bank.(The journal of trauma and acute care surgery, 2021-06) Williamson, Theresa; Hodges, Sarah; Yang, Lexie Zidanyue; Lee, Hui-Jie; Gabr, Mostafa; Ugiliweneza, Beatrice; Boakye, Maxwell; Shaffrey, Christopher I; Goodwin, C Rory; Karikari, Isaac O; Lad, Shivanand; Abd-El-Barr, MuhammadBackground
Traumatic spinal cord injury (SCI) is a serious public health problem. Outcomes are determined by severity of immediate injury, mitigation of secondary downstream effects, and rehabilitation. This study aimed to understand how the center type a patient presents to and whether they are transferred influence management and outcome.Methods
The National Trauma Data Bank was used to identify patients with SCI. The primary objective was to determine association between center type, transfer, and surgical intervention. A secondary objective was to determine association between center type, transfer, and surgical timing. Multivariable logistic regression models were fit on surgical intervention and timing of the surgery as binary variables, adjusting for relevant clinical and demographic variables.Results
There were 11,744 incidents of SCI identified. A total of 2,883 patients were transferred to a Level I center and 4,766 presented directly to a level I center. Level I center refers to level I trauma center. Those who were admitted directly to level I centers had a higher odd of receiving a surgery (odds ratio, 1.703; 95% confidence interval, 1.47-1.97; p < 0.001), but there was no significant difference in terms of timing of surgery. Patients transferred into a level I center were also more likely to undergo surgery than those at a level II/III/IV center, although this was not significant (odds ratio, 1.213; 95% confidence interval, 0.099-1.48; p = 0.059).Conclusion
Patients with traumatic SCI admitted to level I trauma centers were more likely to have surgery, particularly if they were directly admitted to a level I center. This study provides insights into a large US sample and sheds light on opportunities for improving pre hospital care pathways for patients with traumatic SCI, to provide the timely and appropriate care and achieve the best possible outcomes.Level of evidence
Care management, Level IV.Item Open Access Outcomes of Operative and Nonoperative Treatment for Adult Spinal Deformity: A Prospective, Multicenter, Propensity-Matched Cohort Assessment With Minimum 2-Year Follow-up.(Neurosurgery, 2016-06) Smith, Justin S; Lafage, Virginie; Shaffrey, Christopher I; Schwab, Frank; Lafage, Renaud; Hostin, Richard; OʼBrien, Michael; Boachie-Adjei, Oheneba; Akbarnia, Behrooz A; Mundis, Gregory M; Errico, Thomas; Kim, Han Jo; Protopsaltis, Themistocles S; Hamilton, D Kojo; Scheer, Justin K; Sciubba, Daniel; Ailon, Tamir; Fu, Kai-Ming G; Kelly, Michael P; Zebala, Lukas; Line, Breton; Klineberg, Eric; Gupta, Munish; Deviren, Vedat; Hart, Robert; Burton, Doug; Bess, Shay; Ames, Christopher P; International Spine Study GroupBackground
High-quality studies that compare operative and nonoperative treatment for adult spinal deformity (ASD) are needed.Objective
To compare outcomes of operative and nonoperative treatment for ASD.Methods
This is a multicenter, prospective analysis of consecutive ASD patients opting for operative or nonoperative care. Inclusion criteria were age >18 years and ASD. Operative and nonoperative patients were propensity matched with the baseline Oswestry Disability Index, Scoliosis Research Society-22r, thoracolumbar/lumbar Cobb angle, pelvic incidence-to-lumbar lordosis mismatch (PI-LL), and leg pain score. Analyses were confined to patients with a minimum of 2 years of follow-up.Results
Two hundred eighty-six operative and 403 nonoperative patients met the criteria, with mean ages of 53 and 55 years, 2-year follow-up rates of 86% and 55%, and mean follow-up of 24.7 and 24.8 months, respectively. At baseline, operative patients had significantly worse health-related quality of life (HRQOL) based on all measures assessed (P < .001) and had worse deformity based on pelvic tilt, pelvic incidence-to-lumbar lordosis mismatch, and sagittal vertical axis (P ≤ .002). At the minimum 2-year follow-up, all HRQOL measures assessed significantly improved for operative patients (P < .001), but none improved significantly for nonoperative patients except for modest improvements in the Scoliosis Research Society-22r pain (P = .04) and satisfaction (P < .001) domains. On the basis of matched operative-nonoperative cohorts (97 in each group), operative patients had significantly better HRQOL at follow-up for all measures assessed (P < .001), except Short Form-36 mental component score (P = .06). At the minimum 2-year follow-up, 71.5% of operative patients had ≥1 complications.Conclusion
Operative treatment for ASD can provide significant improvement of HRQOL at a minimum 2-year follow-up. In contrast, nonoperative treatment on average maintains presenting levels of pain and disability.Abbreviations
ASD, adult spinal deformityHRQOL, health-related quality of lifeLL, lumbar lordosisMCID, minimal clinically important differenceNRS, numeric rating scaleODI, Oswestry Disability IndexPI, pelvic incidenceSF-36, Short Form-36SRS-22r, Scoliosis Research Society-22rSVA, sagittal vertical axis.Item Open Access Patients with spinal deformity over the age of 75: a retrospective analysis of operative versus non-operative management.(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) Sciubba, Daniel M; Scheer, Justin K; Yurter, Alp; Smith, Justin S; Lafage, Virginie; Klineberg, Eric; Gupta, Munish; Eastlack, Robert; Mundis, Gregory M; Protopsaltis, Themistocles S; Blaskiewicz, Donald; Kim, Han Jo; Koski, Tyler; Kebaish, Khaled; Shaffrey, Christopher I; Bess, Shay; Hart, Robert A; Schwab, Frank; Ames, Christopher P; International Spine Study Group (ISSG)Purpose
The goal of the present study was to compare the outcomes of operative and non-operative patients with adult spinal deformity (ASD) over 75 years of age.Methods
A retrospective review of a multicenter prospective adult spinal deformity database was conducted examining patients with ASD over the age of 75 years. Demographics, comorbidities, operation-related variables, complications, radiographs, and Health-related quality of life (HRQOL) measures collected included Oswestry Disability Index, Short Form-36, and Scoliosis Research Society-22 preoperatively, and at 1 and 2 years later. Minimum clinically important difference (MCID) was calculated and also compared.Results
27 patients (12 operative, 15 non-operative) were studied. There were no significant differences (p > 0.05) between operative and non-operative patients for age, body mass-index, and comorbidities, but operative patients had worse baseline HRQOL than non-operative patients. Operative patients had a significant improvement in radiographic parameters in 2-year HRQOL, whereas non-operative patients did not (p > 0.05). Operative patients were significantly more likely to reach MCID (range 41.7-81.8 vs. 0-33.3 %, p < 0.05). In the surgical group, 9 (75 %) patients had at least 1 complication (24 total complications).Conclusions
In the largest series to date comparing operative and non-operative management of adult spinal deformity in elderly patients greater than 75 years of age, reconstructive surgery provides significant improvements in pain and disability over a 2-year period. Furthermore, operative patients were more likely to reach MCID than non-operative patients. When counseling elderly patients with ASD, such data may be helpful in the decision-making process regarding treatment.Item Open Access 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 HStudy 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.