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A green, simple and sensitive spectrofluorometric approach for determining vonoprazan fumarate in bulk and pharmaceutical dosage form by turning off the fluorescence of sodium salicylate is developed. The addition of vonoprazan fumarate reduced linearly the fluorescence intensity of 0.4 mM sodium salicylate at λem 408 nm and at λex 330 nm. The approach was found to be linear in the 50.0-3000.0 ng/mL range. The limits of detection and quantification were 10.97 and 33.23 ng/mL, respectively. The presented method proved its suitability in determination of vonoprazan fumarate in its pure and pharmaceutical dosage form. This method employs water as the exclusive solvent and utilizes safe reagents, evaluated using the Analytical Eco Scale, Green Analytical Procedure Index (GAPI), and carbon footprint. In contrast, previous methods relied on toxic reagents and required extended heating times, resulting in higher environmental impact. The novel method not only enhances analytical efficiency but also aligns with green chemistry principles, offering a sustainable solution for routine pharmaceutical analysis.
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Colorantes Fluorescentes , Tecnología Química Verde , Límite de Detección , Pirroles , Salicilato de Sodio , Espectrometría de Fluorescencia , Sulfonamidas , Sulfonamidas/análisis , Sulfonamidas/química , Espectrometría de Fluorescencia/métodos , Pirroles/química , Tecnología Química Verde/métodos , Colorantes Fluorescentes/química , Salicilato de Sodio/química , Salicilato de Sodio/análisis , Reproducibilidad de los ResultadosRESUMEN
The prevalence of chronic kidney disease (CKD) continues to rise globally, paralleled by an increase in associated morbidity and mortality, as well as significant implications for patient quality of life and national economies. Chronic kidney disease often progresses unrecognized by patients and physicians, despite diagnosis relying on two simple laboratory measures: estimated glomerular filtration rate (eGFR) and urine analysis. GFR measurement has been grounded in renal physiology, specifically the concept of clearance, with creatinine identified as a suitable endogenous marker for estimating creatinine clearance (CrCl). On this foundation, various equations have been developed to calculate CrCl or estimated GFR (eGFR) using four variables that incorporate creatinine and certain demographic information, such as sex and age. However, creatinine measurement requires standardization to minimize assay variability across laboratories. Moreover, the accuracy of these equations remains contentious in certain patient subgroups. For these reasons, additional mathematical models have been devised to enhance CrCl estimation, for example, when urine collection is impractical, in elderly or debilitated patients, and in individuals with trauma, diabetes, or obesity. Presently, eGFR in adults can be immediately measured and reported using creatinine-based equations traceable through isotope dilution mass spectrometry. In conclusion, leveraging insights from renal physiology, eGFR can be employed clinically for early diagnosis and treatment of CKD, as well as a public health tool to estimate its prevalence.
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Creatinina , Tasa de Filtración Glomerular , Insuficiencia Renal Crónica , Humanos , Creatinina/orina , Creatinina/sangre , Insuficiencia Renal Crónica/diagnóstico , Insuficiencia Renal Crónica/fisiopatología , Reproducibilidad de los Resultados , Biomarcadores/orina , AdultoRESUMEN
BACKGROUND: Walking as a treatment is recommended for people with intermittent claudication (IC), but participation tends to be poor. Walking treatment beliefs, as defined by the Theory of Planned Behaviour (TPB) are associated with walking behavior, so assessing and designing interventions targeting walking treatment beliefs are crucial. To assess walking treatment beliefs in people with IC in Gujarat, a translated, culturally adapted questionnaire that assesses the four TPB constructs (attitude, subjective normative beliefs, perceived behavioral control beliefs, and intention to walk) is required. AIM: To translate and cross-culturally assess the content validity and face validity of a Gujarati version of a TPB questionnaire that assesses walking treatment beliefs. MATERIALS AND METHODS: A forward-backward translation of the 12-item TPB questionnaire was applied using a standardized approach. The translated versions were compared with the original questionnaire, and ten experts, rated each item according to: clarity, semantic, appropriateness, and cultural relevance. Content Validity Index (CVI), item level content validity (I-CVI), Scale -content validity index (S-CVI/Ave), and universal agreement (UA) were computed to summarize the overall content validity of the questionnaire as well as a proportion of agreement with content experts. Face validity was assessed using a think-aloud approach with ten patients with IC. This cognitive interviewing approach (think-aloud approach) asked participants to describe their thoughts whilst completing the questionnaire. Responses were analyzed thematically. RESULTS: There was complete agreement between experts for 9/12 items (I-CVI=1.00), leading to an overall agreement (S-CVI/Ave) of 0.98. For face validation, at least 50% of the participants had no significant problems with any question in the questionnaire. Most problems participants encountered were straightforward, such as re-reading some questions or considering the questions carefully before answering. CONCLUSION: The Gujarati TPB questionnaire had excellent content validity and was comprehensible and answerable by the majority of our participants with IC and, therefore, had good face validity; this will enable walking treatment beliefs to be assessed in people with IC.
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Comparación Transcultural , Claudicación Intermitente , Caminata , Humanos , Claudicación Intermitente/terapia , Claudicación Intermitente/psicología , Encuestas y Cuestionarios , Masculino , Femenino , Reproducibilidad de los Resultados , Persona de Mediana Edad , India , Psicometría , Traducción , Traducciones , Conductas Relacionadas con la Salud , Anciano , Teoría del Comportamiento PlanificadoRESUMEN
Children with Type 1 diabetes (T1D) and their parent-caregivers often experience diabetes distress due to the daily demands of diabetes management. Regular screening for diabetes distress is needed to prevent the deterioration of metabolic control and the development of mental health disorders. The aim of this analysis was to examine the psychometric properties of the German versions of the Problem Areas in Diabetes Scale for Children (PAID-C) and for caregiver burden in Parents (P-PAID-C). Data were collected from 136 children aged 7-12 years (46.7% females) and 304 parents (Mage = 42.9 (SD 6.1) years; 78% mothers) by using linguistically translated questionnaires in a multicenter study. Confirmatory factor analysis and correlational analyses were conducted. Results confirmed the two-factor model for the PAID-C and the four-factor model for the P-PAID-C with a slight modification. Cronbach's αs for children and parents were 0.88 and 0.92, respectively. The PAID-C and P-PAID-C scores had small positive associations with HbA1c (rs = .220 and .139, respectively, all p < .05) and strong inverse association with the KIDSCREEN-10 index (r = -.643 and -.520, respectively, all p < .001). P-PAID-C scores increased with increasing depressive symptoms measured in nine-item Patient Health Questionnaire among parents (rs = .534, p < .001). The scores produced by the German PAID-C and P-PAID-C were reliable and valid in measuring diabetes burdens. These German versions of PAID can be utilized to assess diabetes-specific distress and to design interventions for children and their parents experiencing high levels of diabetes distress. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Diabetes Mellitus Tipo 1 , Padres , Psicometría , Humanos , Diabetes Mellitus Tipo 1/psicología , Femenino , Masculino , Niño , Padres/psicología , Adulto , Alemania , Encuestas y Cuestionarios , Reproducibilidad de los Resultados , Persona de Mediana Edad , Cuidadores/psicología , Carga del Cuidador/psicología , Estrés Psicológico/psicología , Análisis Factorial , Distrés PsicológicoRESUMEN
With the publication of the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders, a set of dimensional criteria was added as an emerging alternative model to the diagnosis of personality disorder (PD; American Psychiatric Association, 2013). Parallel to this, within the object relations conceptualization of personality pathology, a structured interview, the Structured Interview of Personality Organization (STIPO), was developed to assess pathological personality and then revised (STIPO-R). In this study, the reliability and validity of the Chinese version of the STIPO-R were tested on a sample of 236 Chinese participants, including both psychiatric patients and healthy individuals. Overall, the STIPO-R showed good internal consistency, interrater and test-retest reliability, and generally satisfactory results in structure and convergent validity. The STIPO-R also demonstrated discriminant validity (healthy individuals vs. psychiatric patients with PD vs. psychiatric patients without PD). Results are also discussed in light of cultural differences between Chinese and Western cultures. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Entrevista Psicológica , Trastornos de la Personalidad , Psicometría , Humanos , Reproducibilidad de los Resultados , Femenino , Masculino , Adulto , Trastornos de la Personalidad/diagnóstico , Adulto Joven , Persona de Mediana Edad , China , Escalas de Valoración Psiquiátrica/normas , Determinación de la Personalidad/estadística & datos numéricosRESUMEN
BACKGROUND: Paclitaxel is a promising anticancer drug for patients with ovarian, breast, lung, gastrointestinal, genitourinary, prostate, and head-and-neck cancers. Paclitaxel follows nonlinear pharmacokinetics. The major metabolite of paclitaxel is 6-alpha-hydroxy paclitaxel, mediated by CYP2C8, while metabolism to two of its minor metabolites, 3'-p-hydroxypaclitaxel and 6a, 3'- p-dihydroxypaclitaxel, is catalyzed by CYP3A4. Therapeutic drug monitoring of paclitaxel could be a promising approach to improve the efficacy and safety of paclitaxel correct personalized doses and improve the overall benefit-risk ratio. A novel and highly sensitive chromatographic method for the detection of paclitaxel and its metabolite has been proposed that allows quantification in human plasma with 100% accuracy in terms of recovery without significant intraday or interday variations. MATERIALS AND METHODS: The present study was planned following bioanalytical method validation guidance according to the U.S. Food and Drug Administration requirements. The validation of the analytical procedure was performed as per ICH Q2(R1) guidelines. It was done to assure the reliability of the results obtained for various parameters such as linearity, accuracy, precision, limit of detection (LOD), limit of quantification, robustness, stability, and system suitability. RESULTS: The specificity of the method was established by ensuring no interference with peak obtained from paclitaxel and 6-alpha-hydroxy paclitaxel. LOD was found to be 0.05 and 0.033 while the limit of quantitation was 0.14 and 0.099 for paclitaxel and 6-alpha-hydroxy paclitaxel, respectively. Median (±interquartile range) accuracy for paclitaxel and 6-alpha-hydroxy paclitaxel was found to be 102.73 (±13.581) and 100.87 (±7.573), respectively. CONCLUSION: This novel method of simultaneous detection of paclitaxel and its major metabolite 6-alpha-hydroxy paclitaxel demonstrated significant resolution and was sensitive enough for its quantification in human plasma.
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Antineoplásicos Fitogénicos , Límite de Detección , Paclitaxel , Paclitaxel/sangre , Paclitaxel/farmacocinética , Paclitaxel/análogos & derivados , Humanos , Cromatografía Líquida de Alta Presión/métodos , Reproducibilidad de los Resultados , Antineoplásicos Fitogénicos/sangre , Antineoplásicos Fitogénicos/farmacocinética , Monitoreo de Drogas/métodosRESUMEN
School psychologists have many roles and responsibilities that often lead to high stress levels. Wise (1985) authored the School Psychologists and Stress Inventory (SPSI), but it has not been updated substantially since its publication. We developed two studies to address the stressors faced by currently practicing school psychologists. Study 1 included 229 practicing school psychologists who evaluated the relevancy of the SPSI items and who listed five highly stressful events experienced considering the current context of practice. Based on these results, 13 SPSI items were removed, 21 SPSI items were revised, and 12 new items were added. The resulting measure, the School Psychologist Distress Inventory (SPDI), consists of 33 items and an additional item addressing overall stress. Study 2 examined validity evidence associated with the SPDI score structure. Using data from a sample of 350 practicing school psychologists, a sequence of exploratory factor analytic methods indicated the presence of a general factor of distress as well as four more specific factors, including Heavy Workload, Student Needs, Lack of Professional Support, and Parental and Legal Conflicts. Convergent relations and discriminant relations were evident between (a) SPDI total and subscales and (b) measures reflecting general stress level, role stressors, role overload, and job satisfaction. Examination of SPDI scores revealed they were not significantly related to age in years, educational levels, or school-psychologist-to-student ratio by state; however, lack of professional support was statistically significantly but weakly related to years of experience. Student needs were significantly more stressful across participants in the Western region of the United States than the Midwest region. Results from these two studies suggest the promise of using the SPDI to examine general and specific experiences of school psychologists' distress and they reveal that distress across school psychologists is remarkably high-especially in the area associated with having a heavy workload. Additional research with more racially and ethnically diverse samples of school psychologists would enhance confidence in using the SPDI as a measure of distress. Results suggest an urgent need to address structural influences on stress and personal coping strategies employed by school psychologists.
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Psicometría , Estrés Psicológico , Humanos , Masculino , Femenino , Estados Unidos , Estrés Psicológico/psicología , Psicología Educacional , Adulto , Instituciones Académicas , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Persona de Mediana EdadRESUMEN
BACKGROUND: The Osteoarthritis Knowledge Scale (OAKS) is a validated tool for assessing knowledge about hip and knee osteoarthritis (OA). However, to date, there has been no translation and adaptation of the OAKS for the Turkish population. OBJECTIVES: To translate and cross-culturally adapt the OAKS into Turkish and to assess its psychometric properties in the Turkish population with and without hip or knee OA. METHODS: The OAKS was translated following accepted guidelines. A validation study assessed internal consistency, test-retest reliability and measurement error. An exploratory factor analysis was conducted to assess the factor structure. RESULTS: A total of 278 participants (n = 70 with hip OA, n = 105 with knee OA, and n = 103 without OA) were included. Internal consistency was 0.72, 0.79 and 0.79 for participants with hip OA, knee OA, and no OA, respectively. The test-retest intraclass correlation coefficient was 0.72 (95% CI; 0.45-0.85), 0.89 (95% CI; 0.82-0.93) and 0.88 (95% CI; 0.79-0.93) for participants with hip OA, knee OA and no OA, respectively. It had three principal components accounting for 57.2% of the total variance. CONCLUSIONS: The Turkish version of the OAKS is a reliable and valid tool for measuring OA knowledge in the Turkish population, including those with and without hip and knee OA. Test-retest reliability was below acceptable levels in the population with hip OA only. Therefore, we recommend that the ICC be interpreted with caution when used in this population.
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Osteoartritis de la Cadera , Osteoartritis de la Rodilla , Psicometría , Traducciones , Humanos , Femenino , Masculino , Turquía , Persona de Mediana Edad , Osteoartritis de la Cadera/psicología , Anciano , Reproducibilidad de los Resultados , Conocimientos, Actitudes y Práctica en Salud , Encuestas y Cuestionarios/normas , Comparación TransculturalRESUMEN
BACKGROUND: Comparing causal effect estimates obtained using observational data to those obtained from the gold standard (i.e., randomized controlled trials [RCTs]) helps assess the validity of these estimates. However, comparisons are challenging due to differences between observational data and RCT generated data. The unknown treatment assignment mechanism in the observational data and varying sampling mechanisms between the RCT and the observational data can lead to confounding and sampling bias, respectively. AIMS: The objective of this study is to propose a two-step framework to validate causal effect estimates obtained from observational data by adjusting for both mechanisms. MATERIALS AND METHODS: An estimator of causal effects related to the two mechanisms is constructed. A two-step framework for comparing causal effect estimates is derived from the estimator. An R package RCTrep is developed to implement the framework in practice. RESULTS: A simulation study is conducted to show that using our framework observational data can produce causal effect estimates similar to those of an RCT. A real-world application of the framework to validate treatment effects of adjuvant chemotherapy obtained from registry data is demonstrated. CONCLUSION: This study constructs a framework for comparing causal effect estimates between observational data and RCT data, facilitating the assessment of the validity of causal effect estimates obtained from observational data.
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Causalidad , Estudios Observacionales como Asunto , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Estudios Observacionales como Asunto/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Simulación por Computador , Factores de Confusión Epidemiológicos , Proyectos de Investigación , Sistema de Registros/estadística & datos numéricos , Reproducibilidad de los Resultados , Sesgo , Sesgo de Selección , Interpretación Estadística de Datos , Farmacoepidemiología/métodosRESUMEN
PURPOSE: To evaluate the intrasession repeatability of wavefront aberrations obtained by a combined adaptive optics visual simulator and Hartman-Shack aberrometer in pseudophakic eyes with and without previous corneal refractive surgery. METHODS: Three consecutive measurements were performed in one eye of each individual. Total ocular aberrations were recorded up to the 5th Zernike order for a 4.5-mm pupil. Repeatability was assessed by calculating the within-subject standard deviation (Sw), the repeatability limit (R), and the intraclass correlation coefficient (ICC). Vector analysis was performed to assess astigmatism variability between scans. RESULTS: The study enrolled 32 normal individuals and 24 individuals with a history of refractive surgery. In normal and eyes that had previous refractive surgery, respectively, the Sw values were 0.155 and 0.176 diopters (D) for sphere and 0.184 and 0.265 D for cylinder. The Sw values for all 3rd order terms ranged from 0.037 to 0.047 µm in normal eyes and 0.044 to 0.063 µm in eyes that had previous refractive surgery. The Sw for primary spherical aberration was 0.020 µm in normal eyes and 0.026 µm in eyes that had previous refractive surgery. ICC values for measurements of astigmatism yielded larger variability (ICC = 0.751 and 0.879). However, both groups demonstrated excellent repeatability (ICC > 0.9) for root mean square higher order aberrations (RMS-HOA) and total RMS values. CONCLUSIONS: In pseudophakic eyes, the adaptive optics Hartmann-Shack device demonstrated acceptable repeatability for measurement of sphere and 3rd and 4th order HOAs with higher variability for astigmatism measurements, especially in eyes with a prior history of corneal refractive surgery. [J Refract Surg. 2024;40(9):e645-e653.].
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Aberrometría , Aberración de Frente de Onda Corneal , Seudofaquia , Refracción Ocular , Agudeza Visual , Humanos , Seudofaquia/fisiopatología , Aberración de Frente de Onda Corneal/fisiopatología , Reproducibilidad de los Resultados , Femenino , Persona de Mediana Edad , Masculino , Adulto , Agudeza Visual/fisiología , Refracción Ocular/fisiología , Anciano , Topografía de la Córnea , Procedimientos Quirúrgicos Refractivos , Óptica y Fotónica , Estudios Prospectivos , Córnea/fisiopatologíaRESUMEN
PURPOSE: To investigate the impact of back-to-front corneal radius ratio (B/F ratio) and posterior keratometry (PK) on the accuracy of intraocular lens power calculation formulas in eyes after myopic laser in situ keratomileusis (LASIK)/photorefractive keratectomy (PRK) surgery. METHODS: A retrospective, consecutive case series study included 101 patients (132 eyes) with cataract after myopic LASIK/PRK. Mean prediction error (PE), mean absolute PE (MAE), median absolute error (MedAE), and the percentage of eyes within ±0.25, ±0.50, and ±1.00 diopters (D) of PE were determined. RESULTS: The Barrett True K-TK formula exhibited the lowest MAE (0.59 D) and MedAE (0.48 D) and the highest percentage of eyes within ±0.50 D of PE (54.55%) in total. In eyes with a B/F ratio of 0.70 or less and PK of -5.70 D or greater, the Potvin-Hill formula displayed the lowest MAE (0.46 to 0.67 D). CONCLUSIONS: The Barrett True-TK exhibited the highest prediction accuracy in eyes after myopic LASIK/PRK overall. However, for eyes with a low B/F ratio and flat PK, the Potvin-Hill performed best. [J Refract Surg. 2024;40(9):e635-e644.].
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Biometría , Córnea , Queratomileusis por Láser In Situ , Láseres de Excímeros , Implantación de Lentes Intraoculares , Lentes Intraoculares , Miopía , Queratectomía Fotorrefractiva , Refracción Ocular , Agudeza Visual , Humanos , Miopía/cirugía , Miopía/fisiopatología , Queratomileusis por Láser In Situ/métodos , Estudios Retrospectivos , Queratectomía Fotorrefractiva/métodos , Femenino , Masculino , Córnea/patología , Córnea/cirugía , Refracción Ocular/fisiología , Adulto , Persona de Mediana Edad , Láseres de Excímeros/uso terapéutico , Agudeza Visual/fisiología , Biometría/métodos , Óptica y Fotónica , Topografía de la Córnea , Reproducibilidad de los Resultados , Adulto Joven , FacoemulsificaciónRESUMEN
Accurate measurement of astigmatism parameters is the basis for prescribing modern means of optical correction. In recent years, another direction for correcting astigmatism has emerged - implantation of toric intraocular lenses (TIOL). PURPOSE: This study evaluates the diagnostic accuracy of various methods for measuring the parameters of regular astigmatism. MATERIAL AND METHODS: The study included 83 patients (122 eyes) with regular astigmatism exceeding 1.0 D. Three groups were formed depending on the type of astigmatism. Spherical and cylindrical (power and axis) components of refraction were determined using automatic refractometry. The results were refined with subjective tests: power and axis tests with a cross-cylinder. The criterion for diagnostic accuracy was the level of corrected visual acuity. To assess the impact of cylinder position on visual acuity, discrete deviations of the axis of trial astigmatic lenses from the correct position (determined based on subjective tests) were modeled at 5, 10, and 15 degrees in both clockwise and counterclockwise directions. RESULTS: In the overall sample of observations, coincidence of results was found only in one-third of cases, with a tendency for discrepancies in data between the two methods in nearly 70% of cases. Statistical processing revealed significant differences only in the magnitude of the cylinder in the group with against-the-rule astigmatism (p<0.0005). An increase in maximum visual acuity corrected based on subjective test data was noted. With a deviation of the cylinder axis from the correct position by 10-15 degrees, regardless of the type of astigmatism, a significant tendency for a decrease in visual acuity was identified. At the same time, with a deviation of the cylinder axis within 5 degrees, a significant decrease in visual acuity was noted only in with-the-rule astigmatism and counterclockwise deviation. CONCLUSION: To achieve maximum visual acuity in the correction of regular astigmatism, objective method data must be refined with subjective tests. The results of modeling the deviation of the axis of the corrective lens from the proper position can be considered when evaluating the functional outcomes of TIOL implantation.
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Astigmatismo , Refracción Ocular , Agudeza Visual , Astigmatismo/diagnóstico , Astigmatismo/fisiopatología , Humanos , Refracción Ocular/fisiología , Masculino , Reproducibilidad de los Resultados , Femenino , Persona de Mediana Edad , Lentes Intraoculares , Adulto , Refractometría/métodos , Pruebas de Visión/métodosAsunto(s)
Inteligencia Artificial , Neoplasias de la Mama , Ultrasonografía Mamaria , Humanos , Neoplasias de la Mama/diagnóstico por imagen , Femenino , Ultrasonografía Mamaria/métodos , Interpretación de Imagen Asistida por Computador/métodos , Mama/diagnóstico por imagen , Reproducibilidad de los Resultados , RadiómicaRESUMEN
Background Contrast-enhanced US (CEUS) can be used preoperatively for evaluating muscle invasion in bladder cancer, which is important for determining appropriate treatment. However, diagnostic criteria for assessing this at CEUS have not been standardized. Purpose To develop and validate a CEUS Vesical Imaging Reporting and Data System (VI-RADS) for evaluating muscle invasion in bladder cancer. Materials and Methods This single-center prospective study consecutively enrolled patients with suspected bladder cancer. Participants underwent transabdominal or intracavity CEUS between July 2021 and May 2023. Participants were divided into a training set and a validation set at a 2:1 ratio based on the chronologic order of enrollment. The training set was used to identify major imaging features to include in CEUS VI-RADS, and the likelihood of muscle invasion per category was determined using a pathologic reference standard. The optimal VI-RADS category cutoff for muscle invasion was determined with use of the maximum Youden index. The validation set was assessed by novice and expert readers and used to validate the diagnostic performance and interreader agreement of the developed system. Results Overall, 126 participants (median age, 64 years [IQR, 57-71 years]; 107 male) and 67 participants (median age, 64 years [IQR, 56-69 years]; 49 male) were included in the training and validation set, respectively. In the training set, the optimal CEUS VI-RADS category cutoff for muscle invasion was VI-RADS 4 or higher (Youden index, 0.77). In the validation set, CEUS VI-RADS achieved good performance for both novice and expert readers (area under the receiver operating characteristic curve, 0.80 [95% CI: 0.70, 0.90] vs 0.88 [95% CI: 0.80, 0.97]; P = .09). The interreader agreement regarding the evaluation of CEUS VI-RADS category was 0.77 (95% CI: 0.65, 0.85) for novice readers, 0.87 (95% CI: 0.79, 0.92) for expert readers, and 0.78 (95% CI: 0.70, 0.84) for all readers. Conclusion The developed CEUS VI-RADS showed good performance and interreader agreement for the assessment of muscle invasion in bladder cancer. Chinese Clinical Trial Registry no. ChiCTR2100049435 © RSNA, 2024 Supplemental material is available for this article. See also the editorial by Morrell in this issue.
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Medios de Contraste , Invasividad Neoplásica , Ultrasonografía , Neoplasias de la Vejiga Urinaria , Humanos , Neoplasias de la Vejiga Urinaria/diagnóstico por imagen , Neoplasias de la Vejiga Urinaria/patología , Masculino , Femenino , Persona de Mediana Edad , Anciano , Estudios Prospectivos , Ultrasonografía/métodos , Invasividad Neoplásica/diagnóstico por imagen , Vejiga Urinaria/diagnóstico por imagen , Vejiga Urinaria/patología , Reproducibilidad de los ResultadosRESUMEN
Background US shear-wave elastography (SWE) and vibration-controlled transient elastography (VCTE) enable assessment of liver stiffness, an indicator of fibrosis severity. However, limited reproducibility data restrict their use in clinical trials. Purpose To estimate SWE and VCTE measurement variability in nonalcoholic fatty liver disease (NAFLD) within and across systems to support clinical trial diagnostic enrichment and clinical interpretation of longitudinal liver stiffness. Materials and Methods This prospective, observational, cross-sectional study (March 2021 to November 2021) enrolled adults with NAFLD, stratified according to the Fibrosis-4 (FIB-4) index (≤1.3, >1.3 and <2.67, ≥2.67), at two sites to assess SWE with five US systems and VCTE with one system. Each participant underwent 12 elastography examinations over two separate days within 1 week, with each day's examinations conducted by a different operator. VCTE and SWE measurements were reported in units of meters per second. The primary end point was the different-day, different-operator reproducibility coefficient (RDCDDDO) pooled across systems for SWE and individually for VCTE. Secondary end points included system-specific RDCDDDO, same-day, same-operator repeatability coefficient (RCSDSO), and between-system same-day, same-operator reproducibility coefficient. The planned sample provided 80% power to detect a pooled RDCDDDO of less than 35%, the prespecified performance threshold. Results A total of 40 participants (mean age, 60 years ± 10 [SD]; 24 women) with low (n = 17), intermediate (n = 15), and high (n = 8) FIB-4 scores were enrolled. RDCDDDO was 30.7% (95% upper bound, 34.4%) for SWE and 35.6% (95% upper bound, 43.9%) for VCTE. SWE system-specific RDCDDDO varied from 24.2% to 34.3%. The RCSDSO was 21.0% for SWE (range, 13.9%-35.0%) and 19.6% for VCTE. The SWE between-system same-day, same-operator reproducibility coefficient was 52.7%. Conclusion SWE met the prespecified threshold, RDCDDDO less than 35%, with VCTE having a higher RDCDDDO. SWE variability was higher between different systems. These estimates advance liver US-based noninvasive test qualification by (a) defining expected variability, (b) establishing that serial examination variability is lower when performed with the same system, and (c) informing clinical trial design. ClinicalTrials.gov Identifier NCT04828551 © RSNA, 2024 Supplemental material is available for this article.
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Diagnóstico por Imagen de Elasticidad , Enfermedad del Hígado Graso no Alcohólico , Humanos , Diagnóstico por Imagen de Elasticidad/métodos , Enfermedad del Hígado Graso no Alcohólico/diagnóstico por imagen , Femenino , Masculino , Reproducibilidad de los Resultados , Persona de Mediana Edad , Estudios Prospectivos , Estudios Transversales , Adulto , Hígado/diagnóstico por imagen , Anciano , Cirrosis Hepática/diagnóstico por imagenRESUMEN
Introduction: Process notes contain unique information concerning core elements of a psychodynamic treatment. These elements may be both conscious and unconscious for the author. One element for study is the tendency to which a therapist writes about providing either supportive or expressive interventions. This study sought to establish a method of systematically and reliably identifying the records of therapists' interventions as supportive or expressive. Methods: Three early-career clinicians were trained in the use of a process note intervention rating scale constructed specifically for this study. Quantitative statistical analyses assessed the scale's reliability and internal consistency. Results: Interrater reliability analysis determined at a p of 0.005 a Fleiss's kappa of 0.24 and an intraclass correlation coefficient of 0.264, suggesting a low but statistically significant reliability between the raters. A Cronbach's alpha of 0.67 and a McDonald's omega of 0.53 suggested questionable internal consistency. Discussion: Early-career clinicians can reliably code the manifestations of interventions in psychodynamic process notes as supportive or expressive. Future studies may improve the reliability and internal consistency of the scale, add measures of interpretation content, and evaluate these data in relation to other core elements of process notes, such as the author's emotional engagement as manifested in language measures and clinical outcome.
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Psicoterapia Psicodinámica , Humanos , Reproducibilidad de los Resultados , Adulto , Procesos Psicoterapéuticos , Relaciones Profesional-PacienteAsunto(s)
Angiografía por Tomografía Computarizada , Angiografía Coronaria , Enfermedad de la Arteria Coronaria , Vasos Coronarios , Placa Aterosclerótica , Valor Predictivo de las Pruebas , Humanos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Interpretación de Imagen Radiográfica Asistida por Computador , Reproducibilidad de los Resultados , Automatización , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: The Questionnaire of Young People's Participation (QYPP) was developed for use in children and adolescents. To track participation throughout transition from childhood to adulthood, we adapted it for young adults using focus groups. Aim of this study was to validate this measure, the QYPP-Young Adults (QYPP-YA). METHODS: We recruited young adults with cerebral palsy (CP) and a representative, same-aged sample of the general population (GP). The GP-sample was split into two equivalent subsamples, one part to identify the factor structure via exploratory factor analysis and another part to test the resulting model via confirmatory factor analysis. Reliability and different forms of validity were investigated. RESULTS: The final QYPP-YA includes 17 items assigned to six domains (Autonomy, Independency, Intimate Relationships, Interpersonal Relationships, Social Life, Online Communication). Scales show satisfying internal consistencies in the CP-sample and in the GP-sample, except for 'Online Communication'. Convergent, divergent and known-group validity were confirmed. CONCLUSIONS: The QYPP-YA instrument features promising psychometric characteristics to assess key domains of participation in healthy and disabled young adults. It provides a multidimensional, economic and sound assessment for use in population surveys and clinical trials.
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Parálisis Cerebral , Psicometría , Humanos , Masculino , Femenino , Parálisis Cerebral/psicología , Reproducibilidad de los Resultados , Adulto Joven , Encuestas y Cuestionarios/normas , Adolescente , Participación Social , Relaciones Interpersonales , Adulto , Análisis Factorial , Grupos Focales , Personas con Discapacidad/psicologíaRESUMEN
In the mirabegron (MIR) synthesis, the N-nitroso mirabegron (NNM) is obtained during synthetic process of MIR; water is being used in reaction under acidic condition. Nitrite source is from water, and secondary amine source is from MIR as it has secondary amine; NNM is generated as an impurity during the synthesis of MIR. The presence of NNM in MIR could potentially affect its effectiveness. The purpose of this study was to establish a Ultra-performance liquid chromatography-mass spectrometry/mass spectrometry (UPLC-MS/MS) methodology to identify NNM in MIR samples. The method for NNM analysis was developed on Acquity HSS T3 (100*2.1) mm 1.8 µm column with gradient elution using mobile phase consisted of 0.1% formic acid in water (mobile phase A) and 0.1% formic acid in methanol (mobile phase B). Mass spectrometer with electrospray ionization operated in the MRM mode was used in the analysis of NNM (m/ z 426.20 â 170.00). The UPLC-MS/MS methodology proposed showed a good linearity (0.02 to 0.72 ppm), good system precision (RSD = 0.57%), good method precision (RSD = 0.87%), acceptable accuracy (94.5-116.5%), low detection limit (0.006 ppm) and low quantification limit (0.02 ppm) for NNM. The UPLC-MS/MS methodology proposed can be utilized to assess the quality of MIR sample for the presence of NNM impurity.
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Acetanilidas , Espectrometría de Masas en Tándem , Tiazoles , Espectrometría de Masas en Tándem/métodos , Acetanilidas/análisis , Acetanilidas/química , Cromatografía Líquida de Alta Presión/métodos , Tiazoles/análisis , Tiazoles/química , Reproducibilidad de los Resultados , Límite de Detección , Modelos Lineales , Contaminación de Medicamentos , Compuestos Nitrosos/análisis , Compuestos Nitrosos/química , Cromatografía Líquida con Espectrometría de MasasRESUMEN
The purpose of this study was to understand the role of "dominance" definitions in the results of TDS applied to consumers. This study compared two temporal dominance of sensations (TDS) approaches - TDS-I - that attracts the most attention and TDS-II - most intense/strongest sensation - in the context of evaluating artisanal Minas cheeses from the Serra da Canastra and chocolate with different cocoa concentrations samples. TDS curves were constructed and a trajectory-based principal component analysis (PCA) was performed dominance rates at ten equally spaced time points. Additionally, difference curves, multiple factor analysis (MFA) and regression vector coefficient (RV coefficient) were performed to compare the two approaches. The findings showed that the two approaches produced similar results, suggesting that consumers interpret the terms dominant and intense in a similar way during TDS evaluations, the results were even closer at the chocolate study than at the cheese study. However, in both approaches were observed low dominance rates and differences between the sensation perception time, mainly in the evaluation of cheese flavor. This variability may be attributed to the complexity of the cheese's flavor and the varied interpretations of dominance among evaluators. Despite these differences, the approaches showed similar characterizations across the same samples, demonstrating high reproducibility and a strong ability to differentiate between samples. This study demonstrates that the choice between the terms dominant (which captures more attention) or intense (stronger) to guide consumers in performing the sensory test does not significantly influence the results. Consequently, it is possible to adopt greater freedom and flexibility in the terminology used to instruct participants in conducting the test.