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STUDY DESIGN: A systemic review and a meta-analysis. We also provided a retrospective cohort for validation in this study. OBJECTIVE: (1) Using a meta-analysis to determine the pooled discriminatory ability of The Skeletal Oncology Research Group (SORG) classical algorithm (CA) and machine learning algorithms (MLA); and (2) test the hypothesis that SORG-CA has less variability in performance than SORG-MLA in non-American validation cohorts as SORG-CA does not incorporates regional-specific variables such as body mass index as input. METHODS: After data extraction from the included studies, logit-transformation was applied for extracted AUCs for further analysis. The discriminatory abilities of both algorithms were directly compared by their logit (AUC)s. Further subgroup analysis by region (America vs non-America) was also conducted by comparing the corresponding logit (AUC). RESULTS: The pooled logit (AUC)s of 90-day SORG-CA was .82 (95% confidence interval [CI], .53-.11), 1-year SORG-CA was 1.11 (95% CI, .74-1.48), 90-day SORG-MLA was 1.36 (95% CI, 1.09-1.63), and 1-year SORG-MLA was 1.57 (95% CI, 1.17-1.98). All the algorithms performed better in United States than in Taiwan (P < .001). The performance of SORG-CA was less influenced by a non-American cohort than SORG-MLA. CONCLUSION: These observations might highlight the importance of incorporating region-specific variables into existing models to make them generalizable to racially or geographically distinct regions.
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STUDY DESIGN: Literature review with clinical recommendation. OBJECTIVE: A concise curation of the latest spine literature exploring the relationship between expectations and satisfaction for patients with metastatic spinal disease (MSD). Deliver recommendations to practicing clinicians regarding interpretation and utilisation of this evidence. METHODS: The latest spine literature in the topic of factors affecting the expectations of patients with MSD was reviewed and clinical recommendations were formulated. Recommendations are graded as strong or Conditional. RESULTS: 5 articles were selected. Article 1: risk factors for the development of dissatisfaction from a cohort of 362 MSD patients. Strong recommendation to incorporate risk factor assessment when considering treatment. Article 2: systematic review assessing the relationship between pre-operative patient expectations and subsequent satisfaction in allied disciplines. Conditional recommendation to optimize patient expectation to positively modify patient satisfaction. Article 3: qualitative study of how clinicians, from different specialties, counsel patients with MSD pre-treatment. Strong recommendation to use a multidisciplinary approach. Article 4 qualitative study of how MSD patients experience their pre-treatment counselling and how that affected their appreciation of treatment success. Conditional recommendation to furnish patients with tailored, expected outcomes in the context of systemic progression. Article 5 Design and validation of a pre-treatment questionnaire specific to MSD. A conditional recommendation to incorporate this questionnaire in clinical and research MSD practice. CONCLUSION: Patients with MSD are approaching end of life care and high levels of treatment satisfaction are crucial at this juncture. The role of expectation management and comprehensive counselling is critical.
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STUDY DESIGN: Retrospective cohort study. OBJECTIVE: In general, Multiple Myeloma (MM) patients are treated with systemic therapy including chemotherapy. Radiation therapy can have an important supportive role in the palliative management of MM-related osteolytic lesions. Our study aims to investigate the degree of radiation-induced remineralization in MM patients to gain a better understanding of its potential impact on bone mineral density and, consequently, fracture prevention. Our primary outcome measure was percent change in bone mineral density measured in Hounsfield Units (Δ% HU) between pre- and post-radiation measurements, compared to non-targeted vertebrae. METHODS: We included 119 patients with MM who underwent radiotherapy of the spine between January 2010 and June 2021 and who had a CT scan of the spine at baseline and between 3-24 months after radiation. A linear mixed effect model tested any differences in remineralization rate per month (ßdifference) between targeted and non-targeted vertebrae. RESULTS: Analyses of CT scans yielded 565 unique vertebrae (366 targeted and 199 non-targeted vertebrae). In both targeted and non-targeted vertebrae, there was an increase in bone density per month (ßoverall = .04; P = .002) with the largest effect being between 9-18 months post-radiation. Radiation did not cause a greater increase in bone density per month compared to non-targeted vertebrae (ßdifference = .67; P = .118). CONCLUSION: Our results demonstrate that following radiation, bone density increased over time for both targeted and non-targeted vertebrae. However, no conclusive evidence was found that targeted vertebrae have a higher remineralization rate than non-targeted vertebrae in patients with MM.
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Introduction: The treatment of traumatic thoracic and lumbar spine fractures remains controversial. To date no consensus exists on the correct choice of surgical approach and technique. Research question: to provide a comprehensive up-to-date overview of the available different surgical methods and their quantified outcomes. Methods: PubMed and EMBASE were searched between 2001 and 2020 using the term 'spinal fractures'. Inclusion criteria were: adults, ≥10 cases, ≥12 months follow-up, thoracic or lumbar fractures, and surgery <3 weeks of trauma. Studies were categorized per surgical technique: Posterior open (PO), posterior percutaneous (PP), stand-alone vertebral body augmentation (SA), anterior scopic (AS), anterior open (AO), posterior percutaneous and anterior open (PPAO), posterior percutaneous and anterior scopic (PPAS), posterior open and anterior open (POAO) and posterior open and anterior scopic (POAS). The PO group was used as a reference group. Results: After duplicate removal 6042 articles were identified. A total of 102 articles were Included, in which 137 separate surgical technique cohorts were described: PO (n = 75), PP, (n = 39), SA (n = 12), AO (n = 5), PPAO (n = 1), PPAS (n = 1), POAO (n = 2) and POAS (n = 2). Discussion and conclusion: For type A3/A4 burst fractures, without severe neurological deficit, posterior percutaneous (PP) technique seems the safest and most feasible option in the past two decades. If needed, PP can be combined with anterior augmentation to prevent secondary kyphosis. Furthermore, posterior open (PO) technique is feasible in almost all types of fractures. Also, this technique can provide for an additional posterior decompression or fusion. Overall, no neurologic deterioration was reported following surgical intervention.
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PURPOSE: To assess whether the intention to intraoperatively reposition pedicle screws differs when spine surgeons evaluate the same screws with 2D imaging or 3D imaging. METHODS: In this online survey study, 21 spine surgeons evaluated eight pedicle screws from patients who had undergone posterior spinal fixation. In a simulated intraoperative setting, surgeons had to decide if they would reposition a marked pedicle screw based on its position in the provided radiologic imaging. The eight assessed pedicle screws varied in radiologic position, including two screws positioned within the pedicle, two breaching the pedicle cortex < 2 mm, two breaching the pedicle cortex 2-4 mm, and two positioned completely outside the pedicle. Surgeons assessed each pedicle screw twice without knowing and in random order: once with a scrollable three-dimensional (3D) image and once with two oblique fluoroscopic two-dimensional (2D) images. RESULTS: Almost all surgeons (19/21) intended to reposition more pedicle screws based on 3D imaging than on 2D imaging, with a mean number of pedicle screws to be repositioned of, respectively, 4.1 (± 1.3) and 2.0 (± 1.3; p < 0.001). Surgeons intended to reposition two screws placed completely outside the pedicle, one breaching 2-4mm, and one breaching < 2 mm more often based on 3D imaging. CONCLUSION: When provided with 3D imaging, spine surgeons not only intend to intraoperatively reposition pedicle screws at risk of causing postoperative complications more often but also screws with acceptable positions. This study highlights the potential of intraoperative 3D imaging as well as the need for consensus on how to act on intraoperative 3D information.
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Tornillos Pediculares , Humanos , Fusión Vertebral/métodos , Columna Vertebral/cirugía , Columna Vertebral/diagnóstico por imagen , Toma de Decisiones Clínicas/métodos , Imagenología Tridimensional/métodos , Encuestas y Cuestionarios , CirujanosRESUMEN
Importance: Conventional external beam radiotherapy (cEBRT) and stereotactic body radiotherapy (SBRT) are commonly used treatment options for relieving metastatic bone pain. The effectiveness of SBRT compared with cEBRT in pain relief has been a subject of debate, and conflicting results have been reported. Objective: To compare the effectiveness associated with SBRT vs cEBRT for relieving metastatic bone pain. Data Sources: A structured search was performed in the PubMed, Embase, and Cochrane databases on June 5, 2023. Additionally, results were added from a new randomized clinical trial (RCT) and additional unpublished data from an already published RCT. Study Selection: Comparative studies reporting pain response after SBRT vs cEBRT in patients with painful bone metastases. Data Extraction and Synthesis: Two independent reviewers extracted data from eligible studies. Data were extracted for the intention-to-treat (ITT) and per-protocol (PP) populations. The study is reported following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline. Main Outcomes and Measures: Overall and complete pain response at 1, 3, and 6 months after radiotherapy, according to the study's definition. Relative risk ratios (RRs) with 95% CIs were calculated for each study. A random-effects model using a restricted maximum likelihood estimator was applied for meta-analysis. Results: There were 18 studies with 1685 patients included in the systematic review and 8 RCTs with 1090 patients were included in the meta-analysis. In 7 RCTs, overall pain response was defined according to the International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). The complete pain response was reported in 6 RCTs, all defined according to the ICPRE. The ITT meta-analyses showed that the overall pain response rates did not differ between cEBRT and SBRT at 1 (RR, 1.14; 95% CI, 0.99-1.30), 3 (RR, 1.19; 95% CI, 0.96-1.47), or 6 (RR, 1.22; 95% CI, 0.96-1.54) months. However, SBRT was associated with a higher complete pain response at 1 (RR, 1.43; 95% CI, 1.02-2.01), 3 (RR, 1.80; 95% CI, 1.16-2.78), and 6 (RR, 2.47; 95% CI, 1.24-4.91) months after radiotherapy. The PP meta-analyses showed comparable results. Conclusions and Relevance: In this systematic review and meta-analysis, patients with painful bone metastases experienced similar overall pain response after SBRT compared with cEBRT. More patients had complete pain alleviation after SBRT, suggesting that selected subgroups will benefit from SBRT.
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Neoplasias Óseas , Dolor en Cáncer , Radiocirugia , Humanos , Radiocirugia/métodos , Neoplasias Óseas/secundario , Neoplasias Óseas/radioterapia , Dolor en Cáncer/radioterapia , Dolor en Cáncer/etiología , Manejo del Dolor/métodos , Masculino , Femenino , Persona de Mediana Edad , Resultado del Tratamiento , AncianoRESUMEN
Background: Subjects with ankylosing spinal disorders, including diffuse idiopathic skeletal hyperostosis (DISH) and ankylosing spondylitis (AS) are more prone to vertebral fractures and frequently present with neurological deficit compared to the patients without an ankylosed spine. Moreover, prevalent vertebral fractures are an important predictor for subsequent fracture risk. However, the pooled fracture prevalence for DISH is unknown and less recent for AS. We aimed to systematically investigate the prevalence and risk of vertebral fractures in DISH and AS populations. Methods: Publications in Medline and EMBASE were searched from January 1980 until July 2023 for cohort studies reporting vertebral fractures in AS and DISH. Data on prevalence were pooled with random effects modeling after double arcsine transformation. Heterogeneity was assessed with I2 statistics and we performed subgroup analysis and meta-regression to explore sources of heterogeneity. Results: We included 7 studies on DISH (n = 1,193, total fractures = 231) with a pooled vertebral fracture prevalence of 22.6% (95%CI: 13.4%-33.4%). For AS, 26 studies were included (n = 2,875, total fractures = 460) with a pooled vertebral fracture prevalence of 15.2% (95%CI: 11.6%-19.1%). In general, fracture prevalence for AS remained similar for several study-level and clinically relevant characteristics, including study design, diagnostic criteria, spine level, and patient characteristics in subgroup analysis. AS publications from 2010 to 2020 showed higher fracture prevalence compared to 1990 to 2010 (18.6% vs. 11.6%). Fractures in DISH were most common at the thoracolumbar junction, whereas for AS, the most common location was the mid-thoracic spine. Conclusions: Vertebral fractures are prevalent in AS and DISH populations. Differences in fracture distribution along the spinal axis exist between the 2 disorders. Additional longitudinal studies are needed for incident fracture assessment in patients with ankylosing spinal disorders.
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BACKGROUND CONTEXT: Spinal conditions impact health-related quality of life (HRQoL). Patient education and counseling improve HRQoL, yet the effects may be limited for patients with inadequate health literacy (HL). Despite the established relationship between HRQoL and HL in other fields, research in the orthopedic spine population is lacking. PURPOSE: To investigate if limited HL results in lower HRQoL and to evaluate factors are associated with HRQoL in patients seen at an outpatient orthopedic spine center. STUDY DESIGN/SETTING: Prospective single-center cross-sectional study. PATIENT SAMPLE: Patients 18 years of age or older seen at a tertiary urban academic hospital- based multi-surgeon outpatient spine center. OUTCOME MEASURES: EQ-5D-5L health-related quality of life (HRQoL) questionnaire, and the Newest Vital Sign (NVS) HL assessment tool. METHODS: Between October 2022 and February 2023, consecutive English-speaking patients over the age of 18 and new to the outpatient spine clinic were approached for participation in this cross-sectional survey study. Patients completed a sociodemographic survey, EQ-5D-5L HRQoL questionnaire, and Newest Vital Sign (NVS) HL assessment tool. The EQ-5D-5L yields two continuous outcomes: an index score ranging from below 0 to 1 and a visual analog scale (EQ-VAS) score ranging from 0 to 100. The NVS scores were divided into limited (0-3) and adequate (4-6) HL. Multivariate linear regression with purposeful selection of variables was performed to identify independent factors associated with HRQoL. RESULTS: Out of 397 eligible patients, 348 (88%) agreed to participate and were included in statistical analysis. Limited HL was independently associated with lower EQ-5D-5L index scores (B=1.07 [95% CI 1.00-1.15], p=.049. Other factors associated with lower EQ-5D-5L index scores were being obese (BMI≥30), having housing concerns, and being an active smoker. Factors associated with lower EQ-VAS scores were being underweight (BMI<18.5), obese, having housing concerns, and higher updated Charlson comorbidity index (uCCI) scores. Being married was associated with higher EQ-VAS scores. CONCLUSIONS: Limited HL is associated with lower EQ-5D-5L index scores in spine patients, indicating lower HRQoL. To effectively apply HL-related interventions in this population, a better understanding of the complex interactions between patient characteristics, social determinants of health, and HRQoL outcomes is required. Further research should focus on interventions to improve HRQoL in patients with limited HL and how to accurately identify these patients. LEVEL OF EVIDENCE: Level II prognostic.
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Alfabetización en Salud , Calidad de Vida , Humanos , Adolescente , Adulto , Persona de Mediana Edad , Calidad de Vida/psicología , Estudios Transversales , Estudios Prospectivos , Encuestas y Cuestionarios , Obesidad , Estado de SaludRESUMEN
BACKGROUND CONTEXT: Conventional external beam radiation therapy (cEBRT) is used in multiple myeloma (MM) to treat severe pain, spinal cord compression, and disease-related bone disease. However, radiation may be associated with an increased risk of vertebral compression fractures (VCFs), which could substantially impair survival and quality of life. Additionally, the use of the Spinal Instability Neoplastic Score (SINS) in MM is debated in MM. PURPOSE: To determine the incidence of VCFs after cEBRT in patients with MM and to assess the applicability of the SINS score in the prediction of VCFs in MM. STUDY DESIGN: Retrospective multicenter cohort study. PATIENT SAMPLE: MM patients with spinal myeloma lesions who underwent cEBRT between January 2010 and December 2021. OUTCOME MEASURES: Frequency of new or progressed VCFs and subdistribution hazard ratios for potentially associated factors. METHODS: Patient and treatment characteristics were manually collected from the patients' electronic medical records. Computed tomography (CT) scans from before and up to 3 years after the start of radiation were used to score radiographic variables at baseline and at follow-up. Multivariable Fine and Gray competing risk analyses were performed to evaluate the diagnostic value of the SINS score to predict the postradiation VCF rate. RESULTS: A total of 127 patients with 427 eligible radiated vertebrae were included in this study. The mean age at radiation was 64 years, and 66.1% of them were male. At the start of radiation, 57 patients (44.9%) had at least one VCF. There were 89 preexisting VCFs (18.4% of 483 vertebrae). Overall, 39 of 127 patients (30.7%) reported new fractures (number of vertebrae (n)=12) or showed progression of existing fractures (n=36). This number represented 11.2% of all radiated vertebrae. Five of the 39 (12.8%) patients with new or worsened VCFs received an unplanned secondary treatment (augmentation [n=2] or open surgery [n=3]) within 3 years. Both the total SINS score (SHR 1.77; 95% confidence interval (CI) 1.54-2.03; p<.001) and categorical SINS score (SHR 10.83; 95% CI 4.20-27.94; p<.001) showed an independent association with higher rates of new or progressed VCFs in adjusted analyses. The use of bisphosphonates was independently associated with a lower rate of new or progressed VCFs (SHR 0.47 [95% CI 0.24-0.92; p=.027]). CONCLUSIONS: This study demonstrated that new or progressed VCFs occurred in 30.7% of patients within 3 years, in a total of 11.2% of vertebrae. The SINS score was found to be independently associated with the development or progression of VCFs and could thus be applied in MM for fracture prediction and possibly prevention.
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Fracturas por Compresión , Mieloma Múltiple , Fracturas de la Columna Vertebral , Humanos , Masculino , Femenino , Fracturas de la Columna Vertebral/diagnóstico por imagen , Fracturas de la Columna Vertebral/epidemiología , Fracturas de la Columna Vertebral/etiología , Fracturas por Compresión/diagnóstico por imagen , Fracturas por Compresión/epidemiología , Fracturas por Compresión/etiología , Mieloma Múltiple/epidemiología , Mieloma Múltiple/radioterapia , Mieloma Múltiple/complicaciones , Estudios de Cohortes , Calidad de Vida , Columna Vertebral , Estudios RetrospectivosRESUMEN
BACKGROUND: Preoperative prediction of prolonged postoperative opioid use (PPOU) after total knee arthroplasty (TKA) could identify high-risk patients for increased surveillance. The Skeletal Oncology Research Group machine learning algorithm (SORG-MLA) has been tested internally while lacking external support to assess its generalizability. The aims of this study were to externally validate this algorithm in an Asian cohort and to identify other potential independent factors for PPOU. METHODS: In a tertiary center in Taiwan, 3,495 patients receiving TKA from 2010-2018 were included. Baseline characteristics were compared between the external validation cohort and the original developmental cohorts. Discrimination (area under receiver operating characteristic curve [AUROC] and precision-recall curve [AUPRC]), calibration, overall performance (Brier score), and decision curve analysis (DCA) were applied to assess the model performance. A multivariable logistic regression was used to evaluate other potential prognostic factors. RESULTS: There were notable differences in baseline characteristics between the validation and the development cohort. Despite these variations, the SORG-MLA ( https://sorg-apps.shinyapps.io/tjaopioid/ ) remained its good discriminatory ability (AUROC, 0.75; AUPRC, 0.34) and good overall performance (Brier score, 0.029; null model Brier score, 0.032). The algorithm could bring clinical benefit in DCA while somewhat overestimating the probability of prolonged opioid use. Preoperative acetaminophen use was an independent factor to predict PPOU (odds ratio, 2.05). CONCLUSIONS: The SORG-MLA retained its discriminatory ability and good overall performance despite the different pharmaceutical regulations. The algorithm could be used to identify high-risk patients and tailor personalized prevention policy.
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Artroplastia de Reemplazo de Rodilla , Trastornos Relacionados con Opioides , Humanos , Analgésicos Opioides/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Aprendizaje Automático , Algoritmos , Prescripciones , Estudios RetrospectivosRESUMEN
STUDY DESIGN: Retrospective cohort study. OBJECTIVES: Up to 30% of Multiple Myeloma (MM) patients are expected to experience Epidural Spinal Cord Compression (ESCC) during the course of their disease. To prevent irreversible neurological damage, timely diagnosis and treatment are important. However, debate remains regarding the optimal treatment regimen. The aim of this study was to investigate the neurological outcomes and frequency of retreatments for MM patients undergoing isolated radiotherapy and surgical interventions for high-grade (grade 2-3) ESCC. METHODS: This study included patients with MM and high-grade ESCC treated with isolated radiotherapy or surgery. Pre- and post-treatment American Spinal Injury Association (ASIA) impairment scale and retreatment rate were compared between the 2 groups. Adjusted multivariable logistic regression was utilized to examine differences in neurologic compromise, pain, and retreatments. RESULTS: A total of 247 patients were included (Radiotherapy: n = 154; Surgery: n = 93). After radiotherapy, 82 patients (53%) achieved full neurologic function (ASIA E) at the end of follow-up. Of the surgically treated patients, 67 (64%) achieved full neurologic function. In adjusted analyses, patients treated with surgery were less likely to experience neurologic deterioration within 2 years (OR = .15; 95%CI .05-.44; P = .001) and had less pain (OR = .29; 95%CI .11-.74; P = .010). Surgical treatment was not associated with an increased risk of retreatments (OR = .64; 95%CI .28-1.47; P = .29) or death (HR = .62, 95%CI .28-1.38; P = .24). CONCLUSIONS: After adjusting for baseline differences, surgically treated patients with high-grade ESCC showed better neurologic outcomes compared to patients treated with radiotherapy. There were no differences in risk of retreatment or death.
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BACKGROUND AND OBJECTIVES: It has been hypothesized that a discrepancy between pretreatment expectations and perceived outcomes is a significant source of patient dissatisfaction. Currently, there is lack in understanding and tools to assess patient expectations regarding the outcomes of treatment for spinal metastases. The objective of this study was therefore to develop a patient expectations questionnaire regarding the outcomes after surgery and/or radiotherapy for spinal metastases. METHODS: A multiphase international qualitative study was conducted. Phase 1 of the study included semistructured interviews with patients and relatives to understand their expectations of the outcomes of treatment. In addition, physicians were interviewed about their communication practices with patients regarding treatment and expected outcomes. In phase 2, items were developed based on the results of the interviews in phase 1. In phase 3, patients were interviewed to validate the content and language of the questionnaire. Selection of the final items was based on feedback from patients regarding content, language, and relevance. RESULTS: In phase 1, 24 patients and 22 physicians were included. A total of 34 items were developed for the preliminary questionnaire. After phase 3, a total of 22 items were retained for the final version of the questionnaire. The questionnaire is divided into 3 sections: (1) patient expectations regarding treatment outcomes, (2) prognosis, and (3) consultation with the physician. The items cover expectations related to pain, analgesia requirements, daily and physical function, overall quality of life, life expectancy, and information provided by the physician. CONCLUSION: The new Patient Expectations in Spine Oncology questionnaire was developed to evaluate patient expectations regarding the outcomes after treatment for spinal metastases. The Patient Expectations in Spine Oncology questionnaire will allow physicians to systematically assess patient expectations of planned treatment and thus help guide patients toward realistic expectations of treatment outcome.
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Calidad de Vida , Neoplasias de la Columna Vertebral , Humanos , Neoplasias de la Columna Vertebral/cirugía , Neoplasias de la Columna Vertebral/secundario , Motivación , Columna Vertebral/cirugía , Encuestas y Cuestionarios , Satisfacción del PacienteRESUMEN
BACKGROUND: The Skeletal Oncology Research Group machine-learning algorithm (SORG-MLA) was developed to predict the survival of patients with spinal metastasis. The algorithm was successfully tested in five international institutions using 1101 patients from different continents. The incorporation of 18 prognostic factors strengthens its predictive ability but limits its clinical utility because some prognostic factors might not be clinically available when a clinician wishes to make a prediction. QUESTIONS/PURPOSES: We performed this study to (1) evaluate the SORG-MLA's performance with data and (2) develop an internet-based application to impute the missing data. METHODS: A total of 2768 patients were included in this study. The data of 617 patients who were treated surgically were intentionally erased, and the data of the other 2151 patients who were treated with radiotherapy and medical treatment were used to impute the artificially missing data. Compared with those who were treated nonsurgically, patients undergoing surgery were younger (median 59 years [IQR 51 to 67 years] versus median 62 years [IQR 53 to 71 years]) and had a higher proportion of patients with at least three spinal metastatic levels (77% [474 of 617] versus 72% [1547 of 2151]), more neurologic deficit (normal American Spinal Injury Association [E] 68% [301 of 443] versus 79% [1227 of 1561]), higher BMI (23 kg/m2 [IQR 20 to 25 kg/m2] versus 22 kg/m2 [IQR 20 to 25 kg/m2]), higher platelet count (240 × 103/µL [IQR 173 to 327 × 103/µL] versus 227 × 103/µL [IQR 165 to 302 × 103/µL], higher lymphocyte count (15 × 103/µL [IQR 9 to 21× 103/µL] versus 14 × 103/µL [IQR 8 to 21 × 103/µL]), lower serum creatinine level (0.7 mg/dL [IQR 0.6 to 0.9 mg/dL] versus 0.8 mg/dL [IQR 0.6 to 1.0 mg/dL]), less previous systemic therapy (19% [115 of 617] versus 24% [526 of 2151]), fewer Charlson comorbidities other than cancer (28% [170 of 617] versus 36% [770 of 2151]), and longer median survival. The two patient groups did not differ in other regards. These findings aligned with our institutional philosophy of selecting patients for surgical intervention based on their level of favorable prognostic factors such as BMI or lymphocyte counts and lower levels of unfavorable prognostic factors such as white blood cell counts or serum creatinine level, as well as the degree of spinal instability and severity of neurologic deficits. This approach aims to identify patients with better survival outcomes and prioritize their surgical intervention accordingly. Seven factors (serum albumin and alkaline phosphatase levels, international normalized ratio, lymphocyte and neutrophil counts, and the presence of visceral or brain metastases) were considered possible missing items based on five previous validation studies and clinical experience. Artificially missing data were imputed using the missForest imputation technique, which was previously applied and successfully tested to fit the SORG-MLA in validation studies. Discrimination, calibration, overall performance, and decision curve analysis were applied to evaluate the SORG-MLA's performance. The discrimination ability was measured with an area under the receiver operating characteristic curve. It ranges from 0.5 to 1.0, with 0.5 indicating the worst discrimination and 1.0 indicating perfect discrimination. An area under the curve of 0.7 is considered clinically acceptable discrimination. Calibration refers to the agreement between the predicted outcomes and actual outcomes. An ideal calibration model will yield predicted survival rates that are congruent with the observed survival rates. The Brier score measures the squared difference between the actual outcome and predicted probability, which captures calibration and discrimination ability simultaneously. A Brier score of 0 indicates perfect prediction, whereas a Brier score of 1 indicates the poorest prediction. A decision curve analysis was performed for the 6-week, 90-day, and 1-year prediction models to evaluate their net benefit across different threshold probabilities. Using the results from our analysis, we developed an internet-based application that facilitates real-time data imputation for clinical decision-making at the point of care. This tool allows healthcare professionals to efficiently and effectively address missing data, ensuring that patient care remains optimal at all times. RESULTS: Generally, the SORG-MLA demonstrated good discriminatory ability, with areas under the curve greater than 0.7 in most cases, and good overall performance, with up to 25% improvement in Brier scores in the presence of one to three missing items. The only exceptions were albumin level and lymphocyte count, because the SORG-MLA's performance was reduced when these two items were missing, indicating that the SORG-MLA might be unreliable without these values. The model tended to underestimate the patient survival rate. As the number of missing items increased, the model's discriminatory ability was progressively impaired, and a marked underestimation of patient survival rates was observed. Specifically, when three items were missing, the number of actual survivors was up to 1.3 times greater than the number of expected survivors, while only 10% discrepancy was observed when only one item was missing. When either two or three items were omitted, the decision curves exhibited substantial overlap, indicating a lack of consistent disparities in performance. This finding suggests that the SORG-MLA consistently generates accurate predictions, regardless of the two or three items that are omitted. We developed an internet application (https://sorg-spine-mets-missing-data-imputation.azurewebsites.net/) that allows the use of SORG-MLA with up to three missing items. CONCLUSION: The SORG-MLA generally performed well in the presence of one to three missing items, except for serum albumin level and lymphocyte count (which are essential for adequate predictions, even using our modified version of the SORG-MLA). We recommend that future studies should develop prediction models that allow for their use when there are missing data, or provide a means to impute those missing data, because some data are not available at the time a clinical decision must be made. CLINICAL RELEVANCE: The results suggested the algorithm could be helpful when a radiologic evaluation owing to a lengthy waiting period cannot be performed in time, especially in situations when an early operation could be beneficial. It could help orthopaedic surgeons to decide whether to intervene palliatively or extensively, even when the surgical indication is clear.
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BACKGROUND: Survival is an important factor to consider when clinicians make treatment decisions for patients with skeletal metastasis. Several preoperative scoring systems (PSSs) have been developed to aid in survival prediction. Although we previously validated the Skeletal Oncology Research Group Machine-learning Algorithm (SORG-MLA) in Taiwanese patients of Han Chinese descent, the performance of other existing PSSs remains largely unknown outside their respective development cohorts. We aim to determine which PSS performs best in this unique population and provide a direct comparison between these models. METHODS: We retrospectively included 356 patients undergoing surgical treatment for extremity metastasis at a tertiary center in Taiwan to validate and compare eight PSSs. Discrimination (c-index), decision curve (DCA), calibration (ratio of observed:expected survivors), and overall performance (Brier score) analyses were conducted to evaluate these models' performance in our cohort. RESULTS: The discriminatory ability of all PSSs declined in our Taiwanese cohort compared with their Western validations. SORG-MLA is the only PSS that still demonstrated excellent discrimination (c-indexes>0.8) in our patients. SORG-MLA also brought the most net benefit across a wide range of risk probabilities on DCA with its 3-month and 12-month survival predictions. CONCLUSIONS: Clinicians should consider potential ethnogeographic variations of a PSS's performance when applying it onto their specific patient populations. Further international validation studies are needed to ensure that existing PSSs are generalizable and can be integrated into the shared treatment decision-making process. As cancer treatment keeps advancing, researchers developing a new prediction model or refining an existing one could potentially improve their algorithm's performance by using data gathered from more recent patients that are reflective of the current state of cancer care.
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Algoritmos , Extremidades , Humanos , Pronóstico , Estudios Retrospectivos , Taiwán/epidemiologíaRESUMEN
Background: The use of so-called "red flags" may be beneficial in identifying patients with metastatic spinal disease. This study examined the utility and efficacy of these red flags in the referral chain of patients surgically treated for spinal metastases. Methods: The referral chains from the onset of symptoms until surgical treatment for all patients receiving surgery for spinal metastases between March 2009 and December 2020 were reconstructed. The documentation of red flags, as defined by the Dutch National Guideline on Metastatic Spinal Disease, was assessed for each healthcare provider involved. Results: A total of 389 patients were included in the study. On average, 33.3% of red flags were documented as present, 3.6% were documented as absent, and 63.1% were undocumented. A higher rate of red flags documented as present was associated with a longer time to diagnosis, but a shorter time to definitive treatment by a spine surgeon. Moreover, red flags were documented as present more often in patients who developed neurological symptoms at any point during the referral chain than those who remained neurologically intact. Conclusions: The association of red flags with developing neurological deficits highlights their significance in clinical assessment. However, the presence of red flags was not found to decrease delays prior to referral to a spine surgeon, indicating that their relevance is currently not sufficiently recognized by healthcare providers. Raising awareness of symptoms indicative of spinal metastases may expedite timely (surgical) treatment and thus improve treatment outcome.
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INTRODUCTION: There are predictive algorithms for predicting 3-month and 1-year survival in patients with spinal metastasis. However, advance in surgical technique, immunotherapy, and advanced radiation therapy has enabled shortening of postoperative recovery, which returns dividends to the overall quality-adjusted life-year. As such, the Skeletal Oncology Research Group machine learning algorithm (SORG-MLA) was proposed to predict 6-week survival in patients with spinal metastasis, whereas its utility for patients treated with nonsurgical treatment was untested externally. This study aims to validate the survival prediction of the 6-week SORG-MLA for patients with spinal metastasis and provide the measurement of model consistency (MC). METHODS: Discrimination using area under the receiver operating characteristic curve, calibration, Brier score, and decision curve analysis were conducted to assess the model's performance in the Taiwanese-based cohort. MC was also applied to detect the proportion of paradoxical predictions among 6-week, 3-month, and 1-year survival predictions. The long-term prognosis should not be better than the shorter-term prognosis in that of an individual. RESULTS: The 6-week survival rate was 84.2%. The SORG-MLA retained good discrimination with an area under the receiver operating characteristic curve of 0.78 (95% confidence interval, 0.75 to 0.80) and good prediction accuracy with a Brier score of 0.11 (null model Brier score 0.13). There is an underestimation of the 6-week survival rate when the predicted survival rate is less than 50%. Decision curve analysis showed that the model was suitable for use over all threshold probabilities. MC showed suboptimal consistency between 6-week and 90-day survival prediction (78%). CONCLUSIONS: The results of this study supported the utility of the algorithm. The online tool ( https://sorg-apps.shinyapps.io/spinemetssurvival/ ) can be used by both clinicians and patients in informative decision-making discussion before management of spinal metastasis.
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Neoplasias de la Columna Vertebral , Humanos , Pronóstico , Algoritmos , Aprendizaje Automático , Tasa de Supervivencia , Estudios RetrospectivosRESUMEN
PURPOSE: Various sustained-release formulations incorporate high bupivacaine concentrations but data on local toxicity is lacking. This study explores local toxic effects of highly concentrated (5%) bupivacaine compared to clinically used concentrations in vivo following skeletal surgery, to assess the safety of sustained-release formulations with high bupivacaine concentrations. METHODS: Sixteen rats underwent surgery, in which screws with catheters affixed were implanted in the spine or femur in a factorial experimental design, allowing single-shot or continuous 72 h local administration of 0.5%, 2.5% or 5.0% bupivacaine hydrochloride. During the 30-day follow-up, animal weight was recorded and blood samples were obtained. Implantation sites underwent histopathological scoring for muscle damage, inflammation, necrosis, periosteal reaction/thickening and osteoblast activity. Effects of bupivacaine concentration, administration mode and implantation site on local toxicity scores were analyzed. RESULTS: Chi-squared tests for score frequencies revealed a concentration-dependent decrease in osteoblast count. Moreover, spinal screw implantation led to significantly more muscle fibrosis but less bone damage than femoral screw implantation, reflecting the more invasive muscle dissection and shorter drilling times related to the spinal procedure. No differences between bupivacaine administration modes regarding histological scoring or body weight changes were observed. Weight increased, while CK levels and leukocyte counts decreased significantly during follow-up, reflecting postoperative recovery. No significant differences in weight, leukocyte count and CK were found between interventional groups. CONCLUSION: This pilot study found limited concentration-dependent local tissue effects of bupivacaine solutions concentrated up to 5.0% following musculoskeletal surgery in the rat study population.
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Background: Limited health literacy has been associated with adverse health outcomes. Undergoing orthopedic surgery often requires patients to make complex decisions and adhere to complicated instructions, suggesting that health literacy skills might have a profound impact on orthopedic surgery outcomes. Purpose: We sought to review the literature for studies investigating the level of health literacy in patients undergoing orthopedic surgery and also to assess how those studies report factors affecting health equity. Methods: We conducted a systematic search of PubMed, Embase, and Cochrane Library for all health literacy studies published in the orthopedic surgery literature up to February 8, 2022. Search terms included synonyms for health literacy and for all orthopedic surgery subspecialties. Two reviewers independently extracted study data in addition to indicators of equity reporting using the PROGRESS+ checklist (Place of Residence, Race/Ethnicity, Occupation, Gender/sex, Religion, Education, Social capital, Socioeconomic status, plus age, disability, and sexual orientation). Results: The search resulted in 616 studies; 9 studies remained after exclusion criteria were applied. Most studies were of arthroplasty (4/9; 44%) or trauma (3/9; 33%) patients. Validated health literacy assessments were used in 4 of the included studies, and only 3 studies reported the rate of limited health literacy in the patients studied, which ranged between 34% and 38.5%. At least one PROGRESS+ item was reported in 88% (8/9) of the studies. Conclusions: We found a paucity of appropriately designed studies that used validated measures of health literacy in the field of orthopedic surgery. The potential impact of health literacy on orthopedic patients and their outcomes has yet to be elucidated. Thoughtful, high-quality trials across diverse demographics and geographies are warranted.
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BACKGROUND CONTEXT: Palliative radiotherapy (RT) can lead to remineralization of osteolytic lesions thereby potentially restoring some of the weight-bearing capacity and preventing vertebral collapse. It is not clear, however, under which circumstances remineralization of osteolytic lesions occurs. PURPOSE: The aim of this study was to investigate the change in bone mineral density in spinal metastases after RT compared to a reference region, and find associated factors. STUDY DESIGN: Retrospective analysis within prospective observational cohort OUTCOME MEASURES: change in bone mineral density measured in Hounsfield Units (HU). PATIENT SAMPLE: patients treated with RT for (painful) bone metastases. METHODS: Patients with spinal metastases were included if computed tomography scans both pre- and post-RT were available. Bone density was measured in HU. A region of interest (ROI) was drawn manually in the metastatic lesion. As a reference, a measurement of bone density in adjacent, unaffected, and non-irradiated vertebrae was used. Factors tested for association were origin of the primary tumor, RT dose and fractionation scheme, and concomitant use of bisphosphonates. RESULTS: A total of 31 patients with 49 spinal metastases, originating from various primary tumors, were included. The median age on baseline was 58 years (IQR: 53-63) and median time between baseline and follow-up scan was 8.2 months (IQR: 3.0-18.4). Difference in HU in the lesion before and after treatment was 146.9 HU (95% CI 68.4-225.4; p<.01). Difference in HU in the reference vertebra between baseline and first follow-up was 19.1 HU (95% CI -47.9 to 86.0; p=.58). Difference between reference vertebrae and metastatic lesions on baseline was -194.1 HU (95% CI -276.2 to -112.0; p<.01). After RT, this difference was reduced to -50.3 HU (95% CI -199.6 to 99.0; p=.52). Patients using bisphosphonates showed a greater increase in HU, 194.1 HU versus 60.6 HU, p=.01. CONCLUSIONS: Palliative radiation of osteolytic lytic spinal metastases is positively associated with an increased bone mineral density at follow-up. The use of bisphosphonates was linked to an increased bone mineral density when used during or after RT.
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Neoplasias de la Columna Vertebral , Humanos , Preescolar , Neoplasias de la Columna Vertebral/diagnóstico por imagen , Neoplasias de la Columna Vertebral/radioterapia , Neoplasias de la Columna Vertebral/complicaciones , Estudios Retrospectivos , Densidad Ósea , Vértebras Lumbares/patologíaRESUMEN
BACKGROUND CONTEXT: Limited health literacy has previously been associated with increased health care utilization, worse general health status and self-reported health, and increased mortality. Identifying and accommodating patients with limited health literacy may offer an avenue towards mitigating adverse health outcomes and reduce unnecessary health care expenditure. Due to the challenges associated with implementation of lengthy health literacy assessments, the Brief Health Literacy Screening Instrument was developed. However, to our knowledge, there are no reports on the accuracy of this screening questionnaire, with or without the inclusion of sociodemographic characteristics, when predicting limited health literacy in orthopaedic spine patients. PURPOSE: To evaluate the reliability and predictive accuracy of self-reported health literacy screening questions with and without the inclusion of sociodemographic variables in orthopaedic spine patients. STUDY DESIGN: Cross-sectional. PATIENT SAMPLE: Patients seen at a tertiary urban academic hospital-based multi-surgeon spine center OUTCOME MEASURES: Brief Health Literacy Screening Instrument (BRIEF), and the Newest Vital Sign (NVS) health literacy assessment tool. METHODS: Between December 2021 and February 2022, consecutive English-speaking patients over the age of 18 presenting as new patients to an urban, hospital-based outpatient spine clinic were approached for participation. A sociodemographic survey, the BRIEF, and the NVS Health Literacy Assessment Tool were administered verbally. Simple and multivariable logistic regression was utilized to assess the accuracy of each BRIEF question individually, and collectively, at predicting limited health literacy as defined by the NVS. Further regression analysis included sociodemographic variables (age, body mass index, race, ethnicity, highest educational degree, employment status, marital status, annual household income, insurance status, and self-reported health. RESULTS: A total of 262 patients [mean age (years), 57 ± 17] were included in this study. One hundred thirty-four (51%) were male, 223 (85%) were White, and 151 (58%) were married. Patient BRIEF scores were as follows: 23 (9%) limited, 43 (16%) marginal, and 196 (75%) adequate. NVS scores identified 87 (33%) patients with possible limited health literacy. BRIEF items collectively demonstrated fair accuracy in the prediction of limited health literacy (area under the receiver operating characteristic curve, 0.76; 95% CI, 0.70-0.82). Individually, the fourth BRIEF item ("How confident are you in filling out medical forms by yourself?") was the best predictor of limited health literacy (area under the receiver operating characteristic curve, 0.67; 95% CI, 0.60-0.73). The predictive accuracy of the BRIEF items, both individually and collectively, increased with the inclusion of sociodemographic variables within the logistic regression. Specific characteristics independently associated with limited health literacy were self-identified Black race, retired or disabled employment status, single or divorced marital status, high school education or below, and self-reported "poor" health. CONCLUSIONS: Limited health literacy has implications for patient outcomes and health care costs. Our results show that the BRIEF questionnaire is a low-cost screening tool that demonstrates fair predictability in determining limited health literacy within a population of spine patients. Self-reported health literacy assessments may be more feasible in daily practice and easier to implement into clinical workflow.