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PURPOSE: This study aimed to develop machine learning methods to estimate bone mineral density and detect osteopenia/osteoporosis from conventional lumbar MRI (T1-weighted and T2-weighted images) and planar radiography in combination with clinical data and imaging parameters of the acquisition protocol. METHODS: A database of 429 patients subjected to lumbar MRI, radiographs and dual-energy x-ray absorptiometry within 6 months was created from an institutional database. Several machine learning models were trained and tested (373 patients for training, 86 for testing) with the following objectives: (1) direct estimation of the vertebral bone mineral density; (2) classification of T-score lower than - 1 or (3) lower than - 2.5. The models took as inputs either the images or radiomics features derived from them, alone or in combination with metadata (age, sex, body size, vertebral level, parameters of the imaging protocol). RESULTS: The best-performing models achieved mean absolute errors of 0.15-0.16 g/cm2 for the direct estimation of bone mineral density, and areas under the receiver operating characteristic curve of 0.82 (MRIs) - 0.80 (radiographs) for the classification of T-scores lower than - 1, and 0.80 (MRIs) - 0.65 (radiographs) for T-scores lower than - 2.5. CONCLUSIONS: The models showed good discriminative performances in detecting cases of low bone mineral density, and more limited capabilities for the direct estimation of its value. Being based on routine imaging and readily available data, such models are promising tools to retrospectively analyse existing datasets as well as for the opportunistic investigation of bone disorders.
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PURPOSE: The aim of this study was to investigate the risks and outcomes of patients with long-term oral anticoagulation (OAC) undergoing spine surgery. METHODS: All patients on long-term OAC who underwent spine surgery between 01/2005 and 06/2015 were included. Data were prospectively collected within our in-house Spine Surgery registry and retrospectively supplemented with patient chart and administrative database information. A 1:1 propensity score-matched group of patients without OAC from the same time interval served as control. Primary outcomes were post-operative bleeding, wound complications and thromboembolic events up to 90 days post-surgery. Secondary outcomes included intraoperative blood loss, length of hospital stay, death and 3-month post-operative patient-rated outcomes. RESULTS: In comparison with the control group, patients with OAC (n = 332) had a 3.4-fold (95%CI 1.3-9.0) higher risk for post-operative bleeding, whereas the risks for wound complications and thromboembolic events were comparable between groups. The higher bleeding risk was driven by a higher rate of extraspinal haematomas (3.3% vs. 0.6%; p = 0.001), while there was no difference in epidural haematomas and haematoma evacuations. Risk factors for adverse events among patients with OAC were mechanical heart valves, posterior neck surgery, blood loss > 1000 mL, age, female sex, BMI > 30 kg/m2 and post-operative PTT levels. At 3-month follow-up, most patients reported favourable outcomes with no difference between groups. CONCLUSION: Although OAC patients have a higher risk for complications after spine surgery, the risk for major events is low and patients benefit similarly from surgery.
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Anticoagulantes , Tromboembolia , Humanos , Feminino , Anticoagulantes/efeitos adversos , Estudos de Coortes , Estudos Retrospectivos , Pontuação de Propensão , Hemorragia Pós-Operatória/tratamento farmacológico , Fatores de Risco , Administração Oral , Hematoma/induzido quimicamenteRESUMO
BACKGROUND: Clinical prediction models (CPM), such as the SCOAP-CERTAIN tool, can be utilized to enhance decision-making for lumbar spinal fusion surgery by providing quantitative estimates of outcomes, aiding surgeons in assessing potential benefits and risks for each individual patient. External validation is crucial in CPM to assess generalizability beyond the initial dataset. This ensures performance in diverse populations, reliability and real-world applicability of the results. Therefore, we externally validated the tool for predictability of improvement in oswestry disability index (ODI), back and leg pain (BP, LP). METHODS: Prospective and retrospective data from multicenter registry was obtained. As outcome measure minimum clinically important change was chosen for ODI with ≥ 15-point and ≥ 2-point reduction for numeric rating scales (NRS) for BP and LP 12 months after lumbar fusion for degenerative disease. We externally validate this tool by calculating discrimination and calibration metrics such as intercept, slope, Brier Score, expected/observed ratio, Hosmer-Lemeshow (HL), AUC, sensitivity and specificity. RESULTS: We included 1115 patients, average age 60.8 ± 12.5 years. For 12-month ODI, area-under-the-curve (AUC) was 0.70, the calibration intercept and slope were 1.01 and 0.84, respectively. For NRS BP, AUC was 0.72, with calibration intercept of 0.97 and slope of 0.87. For NRS LP, AUC was 0.70, with calibration intercept of 0.04 and slope of 0.72. Sensitivity ranged from 0.63 to 0.96, while specificity ranged from 0.15 to 0.68. Lack of fit was found for all three models based on HL testing. CONCLUSIONS: Utilizing data from a multinational registry, we externally validate the SCOAP-CERTAIN prediction tool. The model demonstrated fair discrimination and calibration of predicted probabilities, necessitating caution in applying it in clinical practice. We suggest that future CPMs focus on predicting longer-term prognosis for this patient population, emphasizing the significance of robust calibration and thorough reporting.
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PURPOSE: Patient-reported outcome measures (PROMs) are integral to the assessment of treatment success, but loss to follow-up (attrition) may lead to bias in the results reported. We sought to evaluate the extent, nature and implications of attrition in a long-established, single-centre spine registry. METHODS: The registry contained the data of 15,264 consecutive spine surgery patients. PROMs included the Core Outcome Measures Index (COMI) and a rating of the Global Treatment Outcome (GTO) and Satisfaction with Care. Baseline characteristics associated with returning a 12-month PROM (= "responder") were analysed (logistic regression). The 3-month outcomes of 12-month responders versus 12-month non-responders were compared (ANOVA and Chi-square). RESULTS: In total, 14,758/15,264 (97%) patients (60 ± 17y; 46% men) had consented to the use of their registry data for research. Preoperative, 3-month post-operative and 12-month post-operative PROMs were returned by 91, 90 and 86%, respectively. Factors associated with being a 12-month responder included: greater age, born in the country of the study, no private/semi-private insurance, better baseline status (lower COMI score), fewer previous surgeries, less comorbidity and no perioperative medical complications. 12-month non-responders had shown significantly worse outcomes in their 3-month PROMs than had 12-month responders (respectively, 66% vs 80% good GTO ("treatment helped/helped a lot"); 77% vs 88% satisfied/very satisfied; and 49% vs 63% achieved MCIC on COMI). CONCLUSION: Although attrition in this cohort was relatively low, 12-month non-responders displayed distinctive characteristics and their early outcomes were significantly worse than those of 12-month responders. If loss to follow-up is not addressed, treatment success will likely be overestimated, with erroneously optimistic results being reported.
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Satisfação do Paciente , Coluna Vertebral , Masculino , Humanos , Feminino , Seguimentos , Resultado do Tratamento , Sistema de RegistrosRESUMO
PURPOSE: The management of implant-associated surgical site infections (SSI) in patients with posterior instrumentation is challenging. Evidence regarding the most appropriate treatment and the need for removal of implants is equivocal. We sought to evaluate the management and outcome of such patients at our institution. METHODS: We searched our prospectively documented databases for eligible patients with posterior spinal instrumentation, excluding the cervical spine (January 2008-June 2018). Patient files were reviewed, demographic data and treatment details were recorded. Patient-reported outcome (PRO) was assessed with the Core Outcome Measures Index (COMI) preoperatively and postoperatively at 3 and 12 months. RESULTS: A total of 170 patients underwent 210 revisions for 176 SSIs. Two-thirds presented within four weeks (105/176, 59.7%, median 22.5d, 7d-11.1y). The most common pathogens were Staphylococcus aureus (n = 79/210, 37.6%) and Staphylococcus epidermidis (n = 56/210, 26.7%). Debridement and implant retention was performed in 135/210 (64.3%) revisions and partial replacement in 62/210 (29.5%). In 28/176 SSI (15.9%), persistent infection required multiple revisions (≤ 4). Surgery was followed by intravenous and oral antimicrobial treatment (10-12w). In 139/176 SSIs (79%) with ≥ 1y follow-up, infection was cured in 115/139 (82.7%); relapse occurred in 9 (relapse rate: 5.1%). Two patients (1.4%) died. COMI decreased significantly (8.2 ± 1.5 vs. 4.8 ± 2.9, p < 0.0001) over 12 months. 72.7% of patients were (very) satisfied with their care. CONCLUSION: Patients with SSI after posterior (thoraco-)lumbo(-sacral) instrumentation can be successfully treated in most cases with surgical and specific antibiotic treatment. An interdisciplinary approach is recommended. Loose implants should be replaced. In some cases, multiple revisions may be necessary. Patient outcomes were satisfactory.
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Fusão Vertebral , Infecções Estafilocócicas , Vértebras Cervicais , Humanos , Próteses e Implantes , Estudos Retrospectivos , Fusão Vertebral/efeitos adversos , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estafilocócicas/etiologia , Staphylococcus aureus , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/cirurgiaRESUMO
BACKGROUND: Indications and outcomes in lumbar spinal fusion for degenerative disease are notoriously heterogenous. Selected subsets of patients show remarkable benefit. However, their objective identification is often difficult. Decision-making may be improved with reliable prediction of long-term outcomes for each individual patient, improving patient selection and avoiding ineffective procedures. METHODS: Clinical prediction models for long-term functional impairment [Oswestry Disability Index (ODI) or Core Outcome Measures Index (COMI)], back pain, and leg pain after lumbar fusion for degenerative disease were developed. Achievement of the minimum clinically important difference at 12 months postoperatively was defined as a reduction from baseline of at least 15 points for ODI, 2.2 points for COMI, or 2 points for pain severity. RESULTS: Models were developed and integrated into a web-app ( https://neurosurgery.shinyapps.io/fuseml/ ) based on a multinational cohort [N = 817; 42.7% male; mean (SD) age: 61.19 (12.36) years]. At external validation [N = 298; 35.6% male; mean (SD) age: 59.73 (12.64) years], areas under the curves for functional impairment [0.67, 95% confidence interval (CI): 0.59-0.74], back pain (0.72, 95%CI: 0.64-0.79), and leg pain (0.64, 95%CI: 0.54-0.73) demonstrated moderate ability to identify patients who are likely to benefit from surgery. Models demonstrated fair calibration of the predicted probabilities. CONCLUSIONS: Outcomes after lumbar spinal fusion for degenerative disease remain difficult to predict. Although assistive clinical prediction models can help in quantifying potential benefits of surgery and the externally validated FUSE-ML tool may aid in individualized risk-benefit estimation, truly impacting clinical practice in the era of "personalized medicine" necessitates more robust tools in this patient population.
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Fusão Vertebral , Dor nas Costas/diagnóstico , Dor nas Costas/etiologia , Dor nas Costas/cirurgia , Feminino , Humanos , Vértebras Lombares/cirurgia , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Prognóstico , Fusão Vertebral/métodos , Resultado do TratamentoRESUMO
INTRODUCTION: Treatment failures in spine surgery are often attributable to poor patient selection and the application of inappropriate treatment. We used published appropriate use criteria (AUC) to evaluate the appropriateness of surgery in a large group of patients operated for lumbar degenerative spondylolisthesis (LDS) and to evaluate its association with outcome. METHODS: This was a retrospective analysis of prospectively collected outcome data from patients operated in our Spine Centre, 2005-2012. Appropriateness of surgery was judged based on the AUC. Patients had completed the multidimensional Core Outcome Measures Index (COMI) before surgery and at 3 months' and 1, 2 and 5 years' follow-up (FU). RESULTS: In total, 448 patients (69.8 ± 9.6 years; 323 (72%) women) were eligible for inclusion and the AUC could be applied in 393 (88%) of these. Surgery was considered appropriate (A) in 234 (59%) of the patients, uncertain/equivocal (U) in 90 (23%) and inappropriate (I) in 69 (18%). A/U patients had significantly (p < 0.05) greater improvements in COMI than I patients at each FU time point. The minimal clinically important change (MCIC) score for COMI was reached by 82% A, 76% U and 54% I patients at 1-year FU (p < 0.001, I vs A and U); the odds of achieving MCIC were 3-4 times greater in A/U patients than in I patients. CONCLUSIONS: The results suggest a relationship between appropriateness of surgery for LDS and the improvements in COMI score after surgery. The findings require confirmation in prospective studies that also include a control group of non-operated patients.
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Espondilolistese , Feminino , Humanos , Região Lombossacral , Avaliação de Resultados em Cuidados de Saúde , Estudos Prospectivos , Estudos RetrospectivosRESUMO
INTRODUCTION: Being able to quantify the invasiveness of a surgical procedure is important to weigh up its associated risks, since invasiveness governs the blood loss, operative time and likelihood of complications. Mirza et al. (Spine (Phila Pa 1976) 33:2651-2661, 2008) published an invasiveness index for spinal surgery. We evaluated the validity of a modified version of the Mirza invasiveness index (mMII), adapted for use with registry data. METHODS: A cross-sectional analysis was performed with data acquired from the Spine Tango registry including 21,634 patients. The mMII was calculated as the sum of six possible interventions on each vertebral level: decompression, fusion and stabilization either on anterior or posterior structures. The association between the mMII and blood loss, operative time and complications was evaluated using multiple regression, adjusting for possible confounders. RESULTS: The mean (± SD) mMII was 3.9 ± 5.0 (range 0-40). A 1-point increase in the mMII was associated with an additional blood loss of 12.8% (95% CI 12.6-13.0; p < 0.001) and an increase of operative time of 10.4 min (95% CI 10.20-10.53; p < 0.001). The R2 for the blood loss model was of 43% and for operative time, 47%. The mean mMII was significantly (p < 0.001) higher in patients with surgical complications (4.5 ± 5.6) and general medical complications (6.5 ± 7.0) compared to those without (3.8 ± 4.9). Our results were comparable to those reported in the original publication of Mirza et al. CONCLUSION: The mMII appeared to be a valid measure of surgical invasiveness in our study population. It can be used in predictor models and to adjust for surgical case-mix when comparing outcomes in different studies or different hospitals/surgeons in a registry.