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This study aims to understand how osteoporosis medication acceptance varies across countries with differing guidance on treatment threshold and influence of clinical and demographic factors. A total of 79.2% accepted treatment at a fracture probability at or below the treatment threshold. Fracture history and age did not strongly impact acceptance, suggesting a need for improved fracture risk communication. PURPOSE: This part of the Improving Risk Communication in Osteoporosis (RICO) study aims to understand patients' willingness to initiate osteoporosis treatment given a hypothetical fracture probability-derived from the FRAX® Risk Assessment Tool-and how age, fracture history, and numeric literacy may influence this. METHODS: In 2022-2023, 332 postmenopausal women at risk of fracture were interviewed from nine countries to determine participants' Fracture Risk Decision Point (FRDP), the lowest probability of major osteoporotic fracture at which they would accept an osteoporosis medication. Participants' FRDP was evaluated given eight hypothetical 10-year FRAX scores. RESULTS: In countries with FRAX-based treatment thresholds, over half of the participants per country reported an FRDP that was below the threshold. Collectively, 79.2% demonstrated FRDPs at or below their respective threshold. Age and fracture history did not have a strong influence on FRDP; however, those who demonstrated higher levels of numeric literacy reported a significantly higher median FRDP (10%) compared to those who showed lower levels (5%, p < 0.001). CONCLUSIONS: Most patients were willing to accept an osteoporosis medication prescription at a hypothetical FRAX probability that was even lower than that of their nationally recommended treatment threshold. Literacy scores had a significant influence on FRDP whereas age and fracture history did not.
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This 78-week (18-month) study conducted in 479 postmenopausal women with osteoporosis evaluated the efficacy, pharmacodynamics, pharmacokinetics, safety, and immunogenicity of candidate biosimilar CT-P41 relative to US reference denosumab. CT-P41 had equivalent efficacy and pharmacodynamics to US-denosumab, with similar pharmacokinetics and comparable safety and immunogenicity profiles. PURPOSE: To demonstrate equivalence of candidate biosimilar CT-P41 and US reference denosumab (US-denosumab) in postmenopausal women with osteoporosis. METHODS: This 78-week (18-month), double-blind, randomized, active-controlled Phase 3 study (NCT04757376) comprised two treatment periods (TPs). In TPI, patients (N = 479) were randomized 1:1 to 60 mg subcutaneous CT-P41 or US-denosumab. At Week 52, those who had received CT-P41 in TPI continued to do so. Those who had received US-denosumab were randomized (1:1) to continue treatment or switch to CT-P41 in TPII. The primary efficacy endpoint was percent change from baseline in lumbar spine bone mineral density at Week 52. Efficacy equivalence was concluded if associated 95% confidence intervals (CI) for least squares (LS) mean group differences fell within ± 1.503%. The primary pharmacodynamic (PD) endpoint was area under the effect curve for serum carboxy-terminal cross-linking telopeptide of type I collagen through the first 26 weeks, with an equivalence margin of 80-125% (for 95% CIs associated with geometric LS mean ratios). RESULTS: Equivalence was demonstrated for CT-P41 and US-denosumab with respect to primary efficacy (LS mean difference [95% CI]: - 0.139 [- 0.826, 0.548] in the full analysis set and - 0.280 [- 0.973, 0.414] in the per-protocol set) and PD (geometric LS mean ratio [95% CI]: 94.94 [90.75, 99.32]) endpoints. Secondary efficacy, PD, pharmacokinetics, and safety results were comparable among all groups up to Week 78, including after transitioning to CT-P41 from US-denosumab. CONCLUSIONS: CT-P41 was equivalent to US-denosumab in women with postmenopausal osteoporosis, with respect to primary efficacy and PD endpoints.
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Biosimilares Farmacéuticos , Conservadores de la Densidad Ósea , Densidad Ósea , Denosumab , Osteoporosis Posmenopáusica , Equivalencia Terapéutica , Humanos , Femenino , Denosumab/farmacocinética , Denosumab/uso terapéutico , Denosumab/efectos adversos , Denosumab/administración & dosificación , Denosumab/farmacología , Método Doble Ciego , Biosimilares Farmacéuticos/farmacocinética , Biosimilares Farmacéuticos/uso terapéutico , Biosimilares Farmacéuticos/efectos adversos , Osteoporosis Posmenopáusica/tratamiento farmacológico , Conservadores de la Densidad Ósea/uso terapéutico , Conservadores de la Densidad Ósea/farmacocinética , Conservadores de la Densidad Ósea/efectos adversos , Conservadores de la Densidad Ósea/administración & dosificación , Conservadores de la Densidad Ósea/farmacología , Persona de Mediana Edad , Anciano , Densidad Ósea/efectos de los fármacos , Resultado del Tratamiento , Inyecciones Subcutáneas , Vértebras Lumbares/fisiopatologíaRESUMEN
The RICO study indicated that most patients would like to receive information regarding their fracture risk but that only a small majority have actually received it. Patients globally preferred a visual presentation of fracture risk and were interested in an online tool showing the risk. PURPOSE: The aim of the Risk Communication in Osteoporosis (RICO) study was to assess patients' preferences regarding fracture risk communication. METHODS: To assess patients' preferences for fracture risk communication, structured interviews with women with osteoporosis or who were at risk for fracture were conducted in 11 sites around the world, namely in Argentina, Belgium, Canada at Hamilton and with participants from the Osteoporosis Canada Canadian Osteoporosis Patient Network (COPN), Japan, Mexico, Spain, the Netherlands, the UK, and the USA in California and Washington state. The interviews used to collect data were designed on the basis of a systematic review and a qualitative pilot study involving 26 participants at risk of fracture. RESULTS: A total of 332 women (mean age 67.5 ± 8.0 years, 48% with a history of fracture) were included in the study. Although the participants considered it important to receive information about their fracture risk (mean importance of 6.2 ± 1.4 on a 7-point Likert scale), only 56% (i.e. 185/332) had already received such information. Globally, participants preferred a visual presentation with a traffic-light type of coloured graph of their FRAX® fracture risk probability, compared to a verbal or written presentation. Almost all participants considered it important to discuss their fracture risk and the consequences of fractures with their healthcare professionals in addition to receiving information in a printed format or access to an online website showing their fracture risk. CONCLUSIONS: There is a significant communication gap between healthcare professionals and patients when discussing osteoporosis fracture risk. The RICO study provides insight into preferred approaches to rectify this communication gap.
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Osteoporosis , Fracturas Osteoporóticas , Humanos , Femenino , Persona de Mediana Edad , Anciano , Prioridad del Paciente , Proyectos Piloto , Medición de Riesgo , Canadá/epidemiología , Osteoporosis/complicaciones , Fracturas Osteoporóticas/epidemiología , Fracturas Osteoporóticas/etiología , Comunicación , Factores de RiesgoRESUMEN
Task Force on 'Clinical Algorithms for Fracture Risk' commissioned by the American Society for Bone and Mineral Research (ASBMR) Professional Practice Committee has recommended that FRAX® models in the US do not include adjustment for race and ethnicity. This position paper finds that an agnostic model would unfairly discriminate against the Black, Asian and Hispanic communities and recommends the retention of ethnic and race-specific FRAX models for the US, preferably with updated data on fracture and death hazards. In contrast, the use of intervention thresholds based on a fixed bone mineral density unfairly discriminates against the Black, Asian and Hispanic communities in the US. This position of the Working Group on Epidemiology and Quality of Life of the International Osteoporosis Foundation (IOF) is endorsed both by the IOF and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO).
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Algoritmos , Densidad Ósea , Medicina Basada en la Evidencia , Fracturas Osteoporóticas , Humanos , Fracturas Osteoporóticas/prevención & control , Fracturas Osteoporóticas/etnología , Medición de Riesgo/métodos , Densidad Ósea/fisiología , Osteoporosis/etnología , Estados Unidos/epidemiología , FemeninoRESUMEN
BACKGROUND: Osteoporotic-related fractures represent an increasing burden to patients, health care systems and society. AIMS: This study estimated cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) compared to relevant alternative strategies in US men and women aged 50 to 80 years at very high fracture risk (bone mineral density T-score ≤ - 2.5 and a recent fracture). METHODS: A lifetime Markov-based microsimulation model was used to estimate healthcare costs and quality-adjusted life years (QALYs). Comparators were sequential treatment with unbranded teriparatide (TPTD)/ALN, generic ALN monotherapy, and no treatment. Analyses were conducted based on initial fracture site (hip, vertebral, or any fracture) and treatment efficacy data (derived from clinical trials or a recent network meta-analysis). RESULTS: From all analyses completed, sequential ABL/ALN demonstrated more QALYs for lower healthcare costs versus unbranded TPTD/ALN. No treatment was dominated (higher costs for less QALYs) versus ALN monotherapy. Sequential ABL/ALN resulted in favorable cost-effectiveness (at US threshold of $150,000/QALY) versus generic ALN monotherapy in men aged ≥ 50 years with any fracture type, women aged ≥ 65 years with any fracture type, and women aged ≥ 55 years having a hip or vertebral fracture. DISCUSSION: Similar cost-effectiveness of sequential ABL/ALN versus unbranded TPTD/ALN, ALN monotherapy, and no treatment was observed in both US men and women at very high fracture risk, with a moderate improvement in cost-effectiveness in men versus women and in patients with a hip or vertebral fracture. CONCLUSIONS: Sequential therapy with ABL/ALN was cost-effective in US men and women at very high risk of fractures.
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Fracturas Osteoporóticas , Fracturas de la Columna Vertebral , Femenino , Humanos , Masculino , Alendronato/uso terapéutico , Análisis Costo-Beneficio , Fracturas Osteoporóticas/prevención & control , Proteína Relacionada con la Hormona Paratiroidea , Persona de Mediana Edad , Anciano , Anciano de 80 o más AñosRESUMEN
Background There is uncertainty in the management of renal masses diagnosed as oncocytomas with image-guided percutaneous biopsy. Purpose To assess the reliability of a diagnosis of oncocytoma based on image-guided percutaneous renal mass biopsy and evaluate patient outcomes following different management strategies. Materials and Methods In this retrospective study, image-guided percutaneous biopsy pathology reports from April 2004 to April 2019 were searched for keywords "oncocytoma" and "oncocytic neoplasm" and compared with surgical pathology or repeat biopsy results. Patients with at least 12 months of clinical follow-up and known cause of death were grouped according to management strategies, and disease-specific survival and metastatic renal cell carcinoma (RCC)-free survival were compared. Mass growth rates were calculated with use of a normal linear mixed model. Results The database yielded 160 biopsy reports of 149 renal masses in 139 patients; 149 masses were categorized as oncocytoma (n = 107), likely oncocytoma (n = 12), oncocytic neoplasm (n = 28), and indeterminate with oncocytoma in differential (n = 2). Biopsied masses categorized as oncocytoma or likely oncocytoma were oncocytomas in 16 of 17 masses (94%) based on surgical pathology or repeat biopsy; four of eight masses (50%) categorized as oncocytic neoplasms were low-grade RCCs. Outcome analysis included 121 patients (mean age ± SD, 68 years ± 9.1; 82 men); 80 patients initially underwent active surveillance (11 were later treated), 33 underwent ablation, and eight underwent surgery. Disease-specific survival and metastatic-free survival were 100% after each management strategy (median follow-up, 86.6 months; range, 14.2-207.9 months). Mass growth rate (mean, 1.7 mm per year) showed no evidence of a significant difference among biopsy result categories (P = .37) or initial (P = .84) or final management strategies (P = .11). Conclusion Image-guided percutaneous biopsy diagnosis of renal oncocytoma was reliable. Although some masses diagnosed as oncocytic neoplasms were low-grade renal cell carcinomas (RCCs) at final diagnosis, no patients died of RCC, including those managed with active surveillance. © RSNA, 2023 See also the editorial by Lockhart in this issue.
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Adenoma Oxifílico , Carcinoma de Células Renales , Neoplasias Renales , Masculino , Humanos , Neoplasias Renales/diagnóstico por imagen , Neoplasias Renales/cirugía , Carcinoma de Células Renales/diagnóstico por imagen , Carcinoma de Células Renales/cirugía , Estudios Retrospectivos , Reproducibilidad de los Resultados , Biopsia , Adenoma Oxifílico/diagnóstico por imagen , Adenoma Oxifílico/cirugía , Diagnóstico Diferencial , Biopsia Guiada por ImagenRESUMEN
This narrative review summarises the recommendations of a Working Group of the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (ESCEO) for the conduct and reporting of real-world evidence studies with a focus on osteoporosis research. PURPOSE: Vast amounts of data are routinely generated at every healthcare contact and activity, and there is increasing recognition that these real-world data can be analysed to generate scientific evidence. Real-world evidence (RWE) is increasingly used to delineate the natural history of disease, assess real-life drug effectiveness, understand adverse events and in health economic analysis. The aim of this work was to understand the benefits and limitations of this type of data and outline approaches to ensure that transparent and high-quality evidence is generated. METHODS: A ESCEO Working Group was convened in December 2022 to discuss the applicability of RWE to osteoporosis research and approaches to best practice. RESULTS: This narrative review summarises the agreed recommendations for the conduct and reporting of RWE studies with a focus on osteoporosis research. CONCLUSIONS: It is imperative that research using real-world data is conducted to the highest standards with close attention to limitations and biases of these data, and with transparency at all stages of study design, data acquisition and curation, analysis and reporting to increase the trustworthiness of RWE study findings.
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Enfermedades Musculoesqueléticas , Osteoartritis , Osteoporosis , Humanos , Osteoartritis/terapia , Enfermedades Musculoesqueléticas/terapia , Sociedades MédicasRESUMEN
OBJECTIVES: To compare the incidence of persistent air leak (PAL) following cryoablation vs MWA of lung tumors when the ablation zone includes the pleura. METHODS: This bi-institutional retrospective cohort study evaluated consecutive peripheral lung tumors treated with cryoablation or MWA from 2006 to 2021. PAL was defined as an air leak for more than 24 h after chest tube placement or an enlarging postprocedural pneumothorax requiring chest tube placement. The pleural area included by the ablation zone was quantified on CT using semi-automated segmentation. PAL incidence was compared between ablation modalities and a parsimonious multivariable model was developed to assess the odds of PAL using generalized estimating equations and purposeful selection of predefined covariates. Time-to-local tumor progression (LTP) was compared between ablation modalities using Fine-Gray models, with death as a competing risk. RESULTS: In total, 260 tumors (mean diameter, 13.1 mm ± 7.4; mean distance to pleura, 3.6 mm ± 5.2) in 116 patients (mean age, 61.1 years ± 15.3; 60 women) and 173 sessions (112 cryoablations, 61 MWA) were included. PAL occurred after 25/173 (15%) sessions. The incidence was significantly lower following cryoablation compared to MWA (10 [9%] vs 15 [25%]; p = .006). The odds of PAL adjusted for the number of treated tumors per session were 67% lower following cryoablation (odds ratio = 0.33 [95% CI, 0.14-0.82]; p = .02) vs MWA. There was no significant difference in time-to-LTP between ablation modalities (p = .36). CONCLUSIONS: Cryoablation of peripheral lung tumors bears a lower risk of PAL compared to MWA when the ablation zone includes the pleura, without adversely affecting time-to-LTP. KEY POINTS: ⢠The incidence of persistent air leaks after percutaneous ablation of peripheral lung tumors was lower following cryoablation compared to microwave ablation (9% vs 25%; p = .006). ⢠The mean chest tube dwell time was 54% shorter following cryoablation compared to MWA (p = .04). ⢠Local tumor progression did not differ between lung tumors treated with percutaneous cryoablation compared to microwave ablation (p = .36).
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Ablación por Catéter , Criocirugía , Neoplasias Pulmonares , Ablación por Radiofrecuencia , Humanos , Femenino , Persona de Mediana Edad , Microondas/uso terapéutico , Estudios Retrospectivos , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Resultado del TratamientoRESUMEN
PURPOSE: To evaluate the safety and effectiveness of percutaneous image-guided thermal ablation (IGTA) for juxtacardiac lung tumors. MATERIALS AND METHODS: This bi-institutional retrospective cohort study included 23 consecutive patients (13 [57%] male; mean age, 55 years ± 18) with 30 juxtacardiac lung tumors located ≤10 mm from the pericardium treated in 28 IGTA sessions (25 sessions of cryoablation and 3 sessions of microwave ablation) between April 2008 and August 2022. The primary outcome was any adverse cardiac event within 90 days after ablation. Secondary outcomes included noncardiac adverse events, local tumor progression-free survival (LT-PFS), and the cumulative incidence of local tumor progression with death as a competing risk. Two tumors treated without curative intent or follow-up imaging were considered in the safety analysis but not in the progression analysis. RESULTS: The median imaging follow-up duration was 22 months (interquartile range [IQR], 10-53 months). Primary technical success was achieved in 25 (89%) ablations. No adverse cardiac events attributable to IGTA occurred. One patient experienced a phrenic nerve injury. The median LT-PFS duration was 59 months (IQR, 32-73 months). At 1, 3, and 5 years, LT-PFS was 90% (95% CI, 78%-100%), 74% (CI, 53%-100%), and 45% (CI, 20%-97%), respectively, and the cumulative incidence of local tumor progression was 4.3% (CI, 0.29%-19%), 11% (CI, 1.6%-30%), and 26% (CI, 3.3%-58%), respectively. CONCLUSIONS: IGTA is safe and effective for lung tumors located ≤10 mm from the pericardium. No adverse cardiac events were not observed within 90 days after ablation.
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Enfermedades Cardiovasculares , Ablación por Catéter , Criocirugía , Neoplasias Pulmonares , Ablación por Radiofrecuencia , Humanos , Masculino , Persona de Mediana Edad , Femenino , Estudios Retrospectivos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/cirugía , Criocirugía/efectos adversos , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/cirugía , Ablación por Catéter/métodos , Resultado del TratamientoRESUMEN
PURPOSE: To explore the association between risk factors established in the surgical literature and hospital length of stay (HLOS), adverse events, and hospital readmission within 30 days after percutaneous image-guided thermal ablation of lung tumors. MATERIALS AND METHODS: This bi-institutional retrospective cohort study included 131 consecutive adult patients (67 men [51%]; median age, 65 years) with 180 primary or metastatic lung tumors treated in 131 sessions (74 cryoablation and 57 microwave ablation) from 2006 to 2019. Age-adjusted Charlson Comorbidity Index, sex, performance status, smoking status, chronic obstructive pulmonary disease (COPD), primary lung cancer versus pulmonary metastases, number of tumors treated per session, maximum axial tumor diameter, ablation modality, number of pleural punctures, anesthesia type, pulmonary artery-to-aorta ratio, lung densitometry, sarcopenia, and adipopenia were evaluated. Associations between risk factors and outcomes were assessed using univariable and multivariable generalized linear models. RESULTS: In univariable analysis, HLOS was associated with current smoking (incidence rate ratio [IRR], 4.54 [1.23-16.8]; P = .02), COPD (IRR, 3.56 [1.40-9.04]; P = .01), cryoablations with ≥3 pleural punctures (IRR, 3.13 [1.07-9.14]; P = .04), general anesthesia (IRR, 10.8 [4.18-27.8]; P < .001), and sarcopenia (IRR, 2.66 [1.10-6.44]; P = .03). After multivariable adjustment, COPD (IRR, 3.56 [1.57-8.11]; P = .003) and general anesthesia (IRR, 12.1 [4.39-33.5]; P < .001) were the only risk factors associated with longer HLOS. No associations were observed between risk factors and adverse events in multivariable analysis. Tumors treated per session were associated with risk of hospital readmission (P = .03). CONCLUSIONS: Identified preprocedural risk factors from the surgical literature may aid in risk stratification for HLOS after percutaneous ablation of lung tumors, but were not associated with adverse events.
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Ablación por Catéter , Neoplasias Pulmonares , Enfermedad Pulmonar Obstructiva Crónica , Sarcopenia , Masculino , Adulto , Humanos , Anciano , Tiempo de Internación , Estudios Retrospectivos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Enfermedad Pulmonar Obstructiva Crónica/cirugía , HospitalesRESUMEN
Malignancies and other diseases may spread by multiple pathways, including direct extension, hematogenous spread, or via lymphatic vessels. A less-well-understood route is the peripheral nervous system, which is known as perineural spread (PNS). In addition to accounting for pain and other neurologic symptoms, PNS affects both disease prognosis and management. Although PNS is commonly discussed in relation to head and neck tumors, there is emerging data regarding PNS in abdominopelvic malignancies and other conditions such as endometriosis. Due to improved contrast and spatial resolution, perineural invasion, a finding heretofore diagnosed only at pathologic examination, can be detected at CT, MRI, and PET/CT. PNS most commonly manifests as abnormal soft-tissue attenuation extending along neural structures, and diagnosis of it is aided by optimizing imaging parameters, understanding pertinent anatomy, and becoming familiar with the typical neural pathways of spread that largely depend on the disease type and location. In the abdomen, the celiac plexus is a central structure that innervates the major abdominal organs and is the principal route of PNS in patients with pancreatic and biliary carcinomas. In the pelvis, the lumbosacral plexus and inferior hypogastric plexus are the central structures and principal routes of PNS in patients with pelvic malignancies. Although the imaging findings of PNS may be subtle, a radiologic diagnosis can have a substantial effect on patient care. Knowledge of anatomy and known routes of PNS and optimizing imaging parameters is of utmost importance in providing key information for prognosis and treatment planning. © RSNA, 2023 Supplemental material and the slide presentation from the RSNA Annual Meeting are available for this article. Quiz questions for this article are available through the Online Learning Center.
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Neoplasias de Cabeza y Cuello , Tomografía Computarizada por Rayos X , Femenino , Humanos , Tomografía Computarizada por Rayos X/métodos , Tomografía Computarizada por Tomografía de Emisión de Positrones , Relevancia Clínica , Radiografía , Imagen por Resonancia Magnética/métodosRESUMEN
INTRODUCTION: EQ-5D-3L preference-based value sets are predominately based on hypothetical health states and derived in cross-sectional settings. Therefore, we derived an experience-based value set from a prospective observational study. METHODS: The International Costs and Utilities Related to Osteoporotic fractures Study (ICUROS) was a multinational study on fragility fractures, prospectively collecting EQ-5D-3L and Time trade-off (TTO) within two weeks after fracture (including pre-fracture recall), and at 4, 12, and 18 months thereafter. We derived an EQ-5D-3L value set by regressing the TTO values on the ten impairment levels in the EQ-5D-3L. We explored the potential for response shift and whether preferences for domains vary systematically with prior impairment in that domain. Finally, we compared the value set to 25 other EQ-5D-3L preference-based value sets. RESULTS: TTO data were available for 12,954 EQ-5D-3L health states in 4683 patients. All coefficients in the value set had the expected sign, were statistically significant, and increased monotonically with severity of impairment. We found evidence for response shift in mobility, self-care, and usual activities. The value set had good agreement with the only other experience- and preference-based value set, but poor agreement with all hypothetical value sets. CONCLUSIONS: We present an experience- and preference-based value set with high face validity. The study indicates that response shift may be important to account for when deriving value sets. Furthermore, the study suggests that perspective (experienced versus hypothetical) is more important than country setting or demographics for valuation of EQ-5D-3L health states.
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Estado de Salud , Fracturas Osteoporóticas , Humanos , Calidad de Vida/psicología , Estudios Transversales , Encuestas y CuestionariosRESUMEN
OBJECTIVE: The Bosniak classification attempts to predict the likelihood of renal cell carcinoma (RCC) among cystic renal masses but is subject to interobserver variability and often requires multiphase imaging. Artificial intelligence may provide a more objective assessment. We applied computed tomography texture-based machine learning algorithms to differentiate benign from malignant cystic renal masses. METHODS: This is an institutional review board-approved, Health Insurance Portability and Accountability Act-compliant retrospective study of 147 patients (mean age, 62.4 years; range, 28-89 years; 94 men) with 144 cystic renal masses (93 benign, 51 RCC); 69 were pathology proven (51 RCC, 18 benign), and 75 were considered benign based on more than 4 years of stability at follow-up imaging. Using a single image from a contrast-enhanced abdominal computed tomography scan, mean, SD, mean value of positive pixels, entropy, skewness, and kurtosis radiomics features were extracted. Random forest, multivariate logistic regression, and support vector machine models were used to classify each mass as benign or malignant with 10-fold cross validation. Receiver operating characteristic curves assessed algorithm performance in the aggregated test data. RESULTS: For the detection of malignancy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve were 0.61, 0.87, 0.72, 0.80, and 0.79 for the random forest model; 0.59, 0.87, 0.71, 0.79, and 0.80 for the logistic regression model; and 0.55, 0.86, 0.68, 0.78, and 0.76 for the support vector machine model. CONCLUSION: Computed tomography texture-based machine learning algorithms show promise in differentiating benign from malignant cystic renal masses. Once validated, these may serve as an adjunct to radiologists' assessments.
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Carcinoma de Células Renales , Neoplasias Renales , Masculino , Humanos , Persona de Mediana Edad , Carcinoma de Células Renales/diagnóstico por imagen , Carcinoma de Células Renales/patología , Neoplasias Renales/diagnóstico por imagen , Neoplasias Renales/patología , Inteligencia Artificial , Estudios Retrospectivos , Estudios de Factibilidad , Tomografía Computarizada por Rayos X , Aprendizaje Automático , Algoritmos , Diagnóstico DiferencialRESUMEN
PURPOSE: We sought to understand the attitudes of individuals with abnormal breast imaging findings prompting a diagnostic breast biopsy toward donation of blood, excised tissue, or percutaneous biospecimens for research, and to understand medical oncologists' attitudes toward research biospecimen collection in this population. METHODS: We included individuals who presented to a single academic medical center for a clinically indicated, image-guided, percutaneous breast biopsy. We administered a survey prior to knowledge of biopsy results to assess willingness to consider, entirely for research purposes, donating blood or excess excised breast tissue, or having additional biospecimens (AB) obtained during a clinically indicated percutaneous biopsy. We also surveyed breast medical oncologists from National Cancer Institute-designated cancer centers to assess attitudes toward approaching patients for biospecimen research. RESULTS: Overall, 53/63 patients responded to the survey; 70% would consider donating blood, 85% would consider donating excess excised breast tissue, and 32% would consider having AB obtained during a clinically indicated biopsy. Main motivating factors for considering AB included contributing to scientific knowledge and return of study or biopsy results, whereas anxiety and the potential discomfort were the main dissuading factors. Among 191 medical oncologists, most were very comfortable (59.2%), or somewhat comfortable (32.5%) asking patients to have AB obtained during a clinically indicated breast biopsy. Medical oncologists reported hesitancy to refer a patient for AB due to potential pain/discomfort, and other procedure risks. CONCLUSIONS: Only one-third of individuals with breast imaging findings would consider consenting to AB during a diagnostic biopsy, whereas most were open to donating blood or excess excised breast tissue. Most medical oncologists would be comfortable asking patients to have AB obtained during the biopsy. Understanding patients' and oncologists' baseline attitudes may inform the design and approach to breast biospecimen-based research.
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Neoplasias de la Mama , Oncólogos , Biopsia , Mama , Neoplasias de la Mama/diagnóstico por imagen , Femenino , Humanos , Encuestas y CuestionariosRESUMEN
Active surveillance of renal masses, which includes serial imaging with the possibility of delayed treatment, has emerged as a viable alternative to immediate therapeutic intervention in selected patients. Active surveillance is supported by evidence that many benign masses are resected unnecessarily, and treatment of small cancers has not substantially reduced cancer-specific mortality. These data are a call to radiologists to improve the diagnosis of benign renal masses and differentiate cancers that are biologically aggressive (prompting treatment) from those that are indolent (allowing treatment deferral). Current evidence suggests that active surveillance results in comparable cancer-specific survival with a low risk of developing metastasis. Radiology is central in this. Imaging is used at the outset to estimate the probability of malignancy and degree of aggressiveness in malignant masses and to follow up masses for growth and morphologic change. Percutaneous biopsy is used to provide a more definitive histologic diagnosis and to guide treatment decisions, including whether active surveillance is appropriate. Emerging applications that may improve imaging assessment of renal masses include standardized assessment of cystic and solid masses and radiomic analysis. This article reviews the current and future role of radiology in the care of patients with renal masses undergoing active surveillance.
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Diagnóstico por Imagen/métodos , Neoplasias Renales/diagnóstico por imagen , Espera Vigilante/métodos , Humanos , Riñón/diagnóstico por imagenRESUMEN
Background Solid small renal masses (SRMs) (≤4 cm) represent benign and malignant tumors. Among SRMs, clear cell renal cell carcinoma (ccRCC) is frequently aggressive. When compared with invasive percutaneous biopsies, the objective of the proposed clear cell likelihood score (ccLS) is to classify ccRCC noninvasively by using multiparametric MRI, but it lacks external validation. Purpose To evaluate the performance of and interobserver agreement for ccLS to diagnose ccRCC among solid SRMs. Materials and Methods This retrospective multicenter cross-sectional study included patients with consecutive solid (≥25% approximate volume enhancement) SRMs undergoing multiparametric MRI between December 2012 and December 2019 at five academic medical centers with histologic confirmation of diagnosis. Masses with macroscopic fat were excluded. After a 1.5-hour training session, two abdominal radiologists per center independently rendered a ccLS for 50 masses. The diagnostic performance for ccRCC was calculated using random-effects logistic regression modeling. The distribution of ccRCC by ccLS was tabulated. Interobserver agreement for ccLS was evaluated with the Fleiss κ statistic. Results A total of 241 patients (mean age, 60 years ± 13 [SD]; 174 men) with 250 solid SRMs were evaluated. The mean size was 25 mm ± 8 (range, 10-39 mm). Of the 250 SRMs, 119 (48%) were ccRCC. The sensitivity, specificity, and positive predictive value for the diagnosis of ccRCC when ccLS was 4 or higher were 75% (95% CI: 68, 81), 78% (72, 84), and 76% (69, 81), respectively. The negative predictive value of a ccLS of 2 or lower was 88% (95% CI: 81, 93). The percentages of ccRCC according to the ccLS were 6% (range, 0%-18%), 38% (range, 0%-100%), 32% (range, 60%-83%), 72% (range, 40%-88%), and 81% (range, 73%-100%) for ccLSs of 1-5, respectively. The mean interobserver agreement was moderate (κ = 0.58; 95% CI: 0.42, 0.75). Conclusion The clear cell likelihood score applied to multiparametric MRI had moderate interobserver agreement and differentiated clear cell renal cell carcinoma from other solid renal masses, with a negative predictive value of 88%. © RSNA, 2022 Online supplemental material is available for this article. See also the editorial by Mileto and Potretzke in this issue.
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Carcinoma de Células Renales , Neoplasias Renales , Imágenes de Resonancia Magnética Multiparamétrica , Carcinoma de Células Renales/diagnóstico por imagen , Carcinoma de Células Renales/patología , Estudios Transversales , Humanos , Neoplasias Renales/diagnóstico por imagen , Neoplasias Renales/patología , Masculino , Persona de Mediana Edad , Estudios RetrospectivosRESUMEN
Two scoping reviews were conducted to review recommendations and guidelines for communication regarding general health risk, and to investigate communication strategies regarding risk of fracture. Healthcare professionals are invited to apply these recommendations to optimize a patient-centered approach to reducing risk of fracture. INTRODUCTION: To conduct a scoping review of the medical literature regarding recommendations and tools for effective communication between healthcare professionals and patients regarding general health risk and risk of fracture. METHODS: The scoping review was divided into two parts to search for (1) studies presenting recommendations and guidelines for communication regarding general health risk; (2) studies investigating communication regarding risk of fracture for individuals at risk for fractures. Medline was searched in April 2020 to identify relevant studies. RESULTS: The scoping review included 43 studies on communication with regard to general health risk and 25 studies about communication regarding risk of fracture. Recommendations for effective communication with regard to risk are presented. Communication of numeric data on risk should be adapted to the literacy and numeracy levels of the individual patient. Patient understanding of numerical data can be enhanced with appropriate use of visual aids (e.g., pie charts, icon arrays, bar charts, pictograms). The FRAX® tool is the most recommended and most used tool for assessing risk of fracture. Communication sent as individualized letters to patients following DXA scans has been studied, although patient understanding of their risk of fracture is often reported as low using this technique. Use of visual aids may improve patient understanding. CONCLUSION: Healthcare professionals are encouraged to apply recommendations presented in this scoping review in their clinical practice. Patient understanding of risk of fracture should be confirmed by making sure that patients feel free to ask questions and express their concerns. This will contribute to an optimal patient-centered approach. Developing online tools to convert the probability of fracture into patient-friendly visual presentations could facilitate communication between healthcare professionals and patients about risk of fracture.
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Comunicación , Fracturas Óseas , Humanos , Factores de RiesgoRESUMEN
OBJECTIVE: To compare temporal changes of ablation zones and lymph nodes following lung microwave ablation (MWA) and cryoablation. METHODS: This retrospective cohort study compared lung ablation zones and thoracic lymph nodes following MWA and cryoablation performed 2006-2020. In the ablation zone cohort, ablation zone volumes were measured on serial CT for 12 months. In the lymph node cohort, the sum of bidimensional products of lymph node diameters was measured before (baseline) and up to 6 months following ablation. Cumulative incidence curves estimated the time to 75% ablation zone reduction and linear mixed-effects regression models compared the temporal distribution of ablation zones and lymph node sizes between modalities. RESULTS: Ablation zones of 59 tumors treated in 45 sessions (16 MWA, 29 cryoablation) in 36 patients were evaluated. Differences in the time to 75% volume reduction between modalities were not detected. Following MWA, half of the ablation zones required an estimated time of 340 days to achieve a 75% volume reduction compared to 214 days following cryoablation (p = .30). Thoracic lymph node sizes after 33 sessions (13 MWA, 20 cryoablation) differed between modalities (baseline-32 days, p = .01; 32-123 days, p = .001). Following MWA, lymph nodes increased on average by 38 mm2 (95%CI, 5.0-70.7; p = .02) from baseline to 32 days, followed by an estimated decrease of 50 mm2 (32-123 days; p = .001). Following cryoablation, changes in lymph nodes were not detected (baseline-32 days, p = .33). CONCLUSION: The rate of ablation zone volume reduction did not differ between MWA and cryoablation. Thoracic lymph nodes enlarged transiently after MWA but not after cryoablation. KEY POINTS: ⢠Contrary to current belief, the rate of lung ablation zone volume reduction did not differ between microwave and cryoablation. ⢠Transient enlargement of thoracic lymph nodes after microwave ablation was not associated with regional tumor spread and decreased within six months following ablation. ⢠No significant thoracic lymph node enlargement was observed following cryoablation.
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Ablación por Catéter , Criocirugía , Neoplasias Pulmonares , Humanos , Microondas/uso terapéutico , Estudios Retrospectivos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/patología , Ganglios Linfáticos/patologíaRESUMEN
BACKGROUND. To our knowledge, outcomes between percutaneous microwave ablation (MWA) and cryoablation of sarcoma lung metastases have not been compared. OBJECTIVE. The purpose of this study was to compare technical success, complications, local tumor control, and overall survival (OS) after MWA versus cryoablation of sarcoma lung metastases. METHODS. This retrospective cohort study included 27 patients (16 women, 11 men; median age, 64 years; Eastern Cooperative Oncology Group performance score, 0-2) who, from 2009 to 2021, underwent 39 percutaneous CT-guided ablation sessions (21 MWA and 18 cryoablation sessions; one to four sessions per patient) to treat 65 sarcoma lung metastases (median number of tumors per patient, one [range, one to 12]; median tumor diameter, 11.0 mm [range, 5-33 mm]; 25% of tumors were nonperipheral). We compared complications according to ablation modality by use of generalized estimating equations. We evaluated ablation modality, tumor size, and location (peripheral vs nonperipheral) in relation to local tumor progression by use of proportional Cox hazard models, with death as the competing risk. We estimated OS using the Kaplan-Meier method. RESULTS. Primary technical success was 97% for both modalities. Median follow-up was 23 months (range, one to 102 months; interquartile range, 12-44 months). A total of seven of 61 tumors (11%) showed local progression. Estimated 1-year and 2-year local control rates were, for tumors 1 cm or smaller, 97% and 95% after MWA versus 99% and 98% after cryoablation, and for tumors larger than 1 cm, 74% and 62% after MWA versus 86% and 79% after cryoablation. Tumor size of 1 cm or smaller was associated with a decreased cumulative incidence of local progression (p = .048); ablation modality and tumor location were not associated with progression (p = .86 and p = .54, respectively). Complications (Common Terminology Criteria for Adverse Events [CTCAE] grade, ≤ 3) occurred in 17 of 39 sessions (44%), prompting chest tube placement in nine (23%). There were no CTCAE grade 4 or 5 complications. OS at 1, 2, and 3 years was 100%, 89%, and 82%, respectively. CONCLUSION. High primary technical success, local control, and OS support the use of MWA and cryoablation for treating sarcoma lung metastases. Ablation modality and tumor location did not affect local progression. The rate of local tumor progression was low, especially for small tumors. No life-threatening complications occurred. CLINICAL IMPACT. Percutaneous MWA and cryoablation are both suited for the treatment of sarcoma lung metastases, especially for tumors 1 cm or smaller, whether peripheral or nonperipheral. Complications, if they occur, are not life-threatening.
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Técnicas de Ablación/métodos , Criocirugía/métodos , Neoplasias Pulmonares/diagnóstico por imagen , Neoplasias Pulmonares/cirugía , Radiografía Intervencional/métodos , Sarcoma/diagnóstico por imagen , Sarcoma/cirugía , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Pulmón/diagnóstico por imagen , Pulmón/patología , Pulmón/cirugía , Neoplasias Pulmonares/patología , Masculino , Microondas , Persona de Mediana Edad , Estudios Retrospectivos , Sarcoma/patología , Análisis de Supervivencia , Tomografía Computarizada por Rayos X/métodos , Resultado del TratamientoRESUMEN
PURPOSE OF REVIEW: Changing attitudes about marijuana have led to an increase in use of medicinal marijuana, especially for painful chronic conditions. Patients ask rheumatologists for guidance on this topic. This review provides up-to-date information on the safety and efficacy of medicinal cannabis for rheumatic disease pain. RECENT FINDINGS: The number of publications related to rheumatic disease and cannabis has increased, but recent literature skews heavily toward reviews vs primary research. Data supporting a role for cannabinoids in rheumatic disease continue to grow. Observational and survey studies show increased use of medicinal cannabis, both by people with rheumatic disease and the general population, and suggest that patients find these treatments beneficial. Prospective studies, however, including randomized controlled clinical trials, are rare and sorely needed. As medicinal cannabis use for rheumatic diseases rises, despite lack of evidence, we review the sparse data available and provide tips for conversations about medicinal cannabis for rheumatologists.