Validation of the Brazilian Portuguese version of the Venous International Assessment Scale and proposal of revision.

OBJECTIVE: To validate the Brazilian Portuguese translation and analyze the cultural adaptation of the Venous International Assessment Scale. METHODS: Observational study by employing the Delphi technique and an equivalence evaluation by experts. The results were analyzed using item scores and by content validity index calculations of item, scale, and universal agreement. RESULTS: Three rounds of evaluation were necessary for consensus. Explanatory contents were incorporated into the original scale throughout the process, resulting in a new version: VIA Scale - Revised. This scale obtained a content validity index of 0.96 and a universal agreement of 0.78. In the cross-cultural adequacy analysis phase, a score of 0.77 was obtained. The majority (90.5%) of the participants judged the scale's decision support property as positive. CONCLUSION: The VIA Scale was validated and culturally adapted to the Brazilian Portuguese language, resulting in the VIA Scale - Revised (VIA-R).

Validation of the Brazilian Portuguese version of the Venous International Assessment Scale and proposal of revision / Validación para el portugués de Brasil de la escala Venous International Assessment y propuesta de revisión / Validação para o português do Brasil da Escala Venous International Assessment e proposta de revisão

ABSTRACT Objective: To validate the Brazilian Portuguese translation and analyze the cultural adaptation of the Venous International Assessment Scale. Methods: Observational study by employing the Delphi technique and an equivalence evaluation by experts. The results were analyzed using item scores and by content validity index calculations of item, scale, and universal agreement. Results: Three rounds of evaluation were necessary for consensus. Explanatory contents were incorporated into the original scale throughout the process, resulting in a new version: VIA Scale - Revised. This scale obtained a content validity index of 0.96 and a universal agreement of 0.78. In the cross-cultural adequacy analysis phase, a score of 0.77 was obtained. The majority (90.5%) of the participants judged the scale's decision support property as positive. Conclusion: The VIA Scale was validated and culturally adapted to the Brazilian Portuguese language, resulting in the VIA Scale - Revised (VIA-R).

RESUMEN Objetivo: Validar traducción para el portugués brasileño y analizar la adaptación cultural de la Escala Venous International Assessment. Métodos: Estudio observacional dado por la aplicación de la técnica de Delphi y evaluación de la equivalencia por especialistas. Los resultados analizados mediante la calificación por ítem y cálculos de índices de validez de contenido de ítem, escala y concordancia universal. Resultados: Fueron necesarias tres rondas de evaluación para consenso. En el curso del proceso, fueron incorporados contenidos explicativos a la escala original, proponiéndose la Escala VIA - Revised. Esta obtuvo índice de validez de contenido de 0,96 y concordancia universal de 0,78. En el análisis de la adecuación transcultural, fue obtenido índice de 0,77. La mayoría (90,5%) de los participantes juzgó positivamente la propriedad de la escala de apoyo a la decisión. Conclusión: La Escala VIA fue validada y adaptada culturalmente al portugués brasileño, generando proposición de la Escala VIA - Revised (VIA-R).

RESUMO Objetivo: Validar a tradução para língua portuguesa do Brasil e analisar a adaptação cultural da Escala Venous International Assessment. Métodos: Estudo observacional dado pela aplicação da técnica de Delphi e avaliação da equivalência por especialistas. Os resultados foram analisados mediante a pontuação por item e cálculos de índices de validade de conteúdo de item, escala e concordância universal. Resultados: Foram necessárias três rodadas de avaliação para consenso. No decorrer do processo, foram incorporados conteúdos explicativos à escala original, propondo-se a Escala VIA - Revised. Esta obteve índice de validade de conteúdo de 0,96 e concordância universal de 0,78. Na etapa de análise da adequação transcultural, foi obtido índice de 0,77. A maioria (90,5%) dos participantes julgou de modo positivo a propriedade da escala de apoio à decisão. Conclusão: A Escala VIA foi validada e adaptada culturalmente para a língua portuguesa do Brasil, gerando proposição da Escala VIA - Revised (VIA-R).

Artificial intelligence prediction of the effect of rehabilitation in whiplash associated disorder.

The active cervical range of motion (aROM) is assessed by clinicians to inform their decision-making. Even with the ability of neck motion to discriminate injured from non-injured subjects, the mechanisms to explain recovery or persistence of WAD remain unclear. There are few studies of ROM examinations with precision tools using kinematics as predictive factors of recovery rate. The present paper will evaluate the performance of an artificial neural network (ANN) using kinematic variables to predict the overall change of aROM after a period of rehabilitation in WAD patients. To achieve this goal the neck kinematics of a cohort of 1082 WAD patients (55.1% females), with mean age 37.68 (SD 12.88) years old, from across Spain were used. Prediction variables were the kinematics recorded by the EBI® 5 in routine biomechanical assessments of these patients. These include normalized ROM, speed to peak and ROM coefficient of variation. The improvement of aROM was represented by the Neck Functional Holistic Analysis Score (NFHAS). A supervised multi-layer feed-forward ANN was created to predict the change in NFHAS. The selected architecture of the ANN showed a mean squared error of 308.07-272.75 confidence interval for a 95% in the Monte Carlo cross validation. The performance of the ANN was tested with a subsample of patients not used in the training. This comparison resulted in a medium correlation with R = 0.5. The trained neural network to predict the expected difference in NFHAS between baseline and follow up showed modest results. While the overall performance is moderately correlated, the error of this prediction is still too large to use the method in clinical practice. The addition of other clinically relevant factors could further improve prediction performance.

Local and Contralateral Effects after the Application of Neuromuscular Electrostimulation in Lower Limbs.

Neuromuscular electrostimulation (NMES) has been used mainly as a method to promote muscle strength, but its effects on improving blood flow are less well known. The aim of this study is to deepen the knowledge about the local and contralateral effects of the application of symmetric biphasic square currents on skin temperature (Tsk). An experimental pilot study was developed with a single study group consisting of 45 healthy subjects. Thermographic evaluations were recorded following the application of NMES to the anterior region of the thigh. The results showed an increase in the maximal Tsk of 0.67% in the anterior region of the thigh where the NMES was applied (p < 0.001) and an increase of 0.54% (p < 0.01) due to cross-education effects, which was higher when the NMES was applied on the dominant side (0.79%; p < 0.01). The duration of the effect was 20 min in the dominant leg and 10 min in the nondominant one. The application of a symmetrical biphasic current (8 Hz and 400 µs) creates an increase in the maximal Tsk at the local level. A temperature cross-education effect is produced, which is greater when the NMES is applied on the dominant side. This could be a useful noninvasive measurement tool in NMES treatments.

Validation to Spanish of the Caring Assessment Tool (CAT-V).

OBJECTIVE: to translate and validate to Spanish the Caring Assessment Scale tool, CAT-V, by Joanne Duffy, within the framework of Jean Watson; as a secondary objective, it is proposed to evaluate its psychometric properties. There are tools designed to measure the patient's perception of provided cares, including CAT-V, the subject of our interest, in a way that it can be used in Spanish-speaking patients. METHODS: to meet the objectives, it was performed sequential translation and retro-translation of the scale to be validated, through a standardized procedure. The final version of that scale was validated in a sample of 349 patients from four public and two private hospitals in Madrid, Spain. RESULTS: The instrument was translated and validated with high internal consistency (Cronbach's alpha .953). The subsequent factor analysis revealed a three-factor structure, not coincident with the data from the US population. CONCLUSION: it is considered that the translation of CAT-V is a suitable instrument to be used in the evaluation of patient care in Ibero-american health centers whose language is Spanish.

Validation to Spanish of the Caring Assessment Tool (CAT-V) / Adaptação cultural para o espanhol e consistência interna da Ferramenta de Avaliação de Cuidados, Caring Assessment Tool (CAT-V) / Validación al Español de la Herramienta de Evaluación de los Cuidados, Caring Assessment Tool (CAT-V)

Resume Objective: to translate and validate to Spanish the Caring Assessment Scale tool, CAT-V, by Joanne Duffy, within the framework of Jean Watson; as a secondary objective, it is proposed to evaluate its psychometric properties. There are tools designed to measure the patient's perception of provided cares, including CAT-V, the subject of our interest, in a way that it can be used in Spanish-speaking patients. Methods: to meet the objectives, it was performed sequential translation and retro-translation of the scale to be validated, through a standardized procedure. The final version of that scale was validated in a sample of 349 patients from four public and two private hospitals in Madrid, Spain. Results: The instrument was translated and validated with high internal consistency (Cronbach's alpha .953). The subsequent factor analysis revealed a three-factor structure, not coincident with the data from the US population. Conclusion: it is considered that the translation of CAT-V is a suitable instrument to be used in the evaluation of patient care in Ibero-american health centers whose language is Spanish.

Resume Objetivo: traduzir para castelhano e avaliar a consistência interna da escala Caring Assessment tool, CAT-V de Joanne Duffy, no marco conceitual de Jean Watson, e como objetivo secundário avaliar as suas propriedades psicométricas. Existem ferramentas desenhadas para medir a percepção do paciente sobre os cuidados dispensados, entre as quais o CAT-V, objeto de nosso interesse com o fim de poder ser aplicado aos doentes hispano falantes. Métodos: para cumprir com os objetivos serão feitas sequencialmente a tradução e retro tradução da escala a validar através de um procedimento padronizado. A versão definitiva da escala foi validada numa amostra de 349 pacientes procedente de quatro hospitais públicos e dois privados de Madrid, Espanha. Resultados: o instrumento foi traduzido e validado com uma consistência elevada (alfa de Cronbach 0,953). Conclusão: a tradução do CAT-V considera que o mesmo pode-se consistuir um instrumento adequado para a avaliação de cuidados prestados a pacientes nos centros de saúde ibero-americanos cuja língua falada seja o castelhano.

Resumen Objetivo: traducir y validar al castellano de la escala Caring Assessment tool, CAT-V, de Joanne Duffy, dentro del marco conceptual de Jean Watson, como objetivo secundario, se plantea evaluar sus propiedades psicométricas. Existen herramientas diseñadas con el fin de medir la percepción del paciente sobre los cuidados dispensados, entre ellos el CAT-V, es objeto de nuestro interés, a fin de que pueda ser utilizado en pacientes hispanohablantes. Método: para cumplir con los objetivos, se plantea, secuencialmente, la realización de la traducción y retro-traducción de la escala a validar, a través de procedimiento normalizado. La versión definitiva de esa escala se validó en una muestra de 349 pacientes procedente de cuatro hospitales públicos y dos hospitales privados en Madrid, España. Resultados: el instrumento fue traducido y validado la con una consistencia interna elevada (alfa de Cronbach .953). El análisis factorial posterior ha puesto de manifiesto una estructura de tres factores, hallazgo no coincidente con los datos procedentes de la población norteamericana. Conclusión: se considera que la traducción del CAT-V es un instrumento adecuado para su utilización en la evaluación de los cuidados a pacientes en centros sanitarios iberoamericanos cuya lengua sea el Castellano.

Standard versus continuous administration of capecitabine in metastatic breast cancer (GEICAM/2009-05): a randomized, noninferiority phase II trial with a pharmacogenetic analysis.

BACKGROUND: The approved capecitabine regimen as monotherapy in metastatic breast cancer (MBC) is 1,250 mg/m(2) twice daily for 2 weeks on and 1 week off (Cint). Dose modifications are often required because of severe hand-foot syndrome (HFS). We tested a continuous regimen with a lower daily dose but a similar cumulative dose in an attempt to reduce the severity of adverse events (AEs) while maintaining efficacy. METHODS: We randomized 195 patients with HER-2/neu-negative MBC to capecitabine 800 mg/m(2) twice daily throughout the 21-day cycle (Ccont) or to Cint to assess noninferiority in the percentage of patients free of progression at 1 year. Secondary endpoints included efficacy and safety. Associations between polymorphisms in capecitabine metabolism-related genes and drug response were assessed. RESULTS: The percentage of patients free of progression at 1 year was 27.3% with Cint versus 25.3% with Ccont (difference of -2.0%; 95% confidence interval: -15.5% to 11.5%, exceeding the 15% deemed noninferior). Differences regarding other efficacy variables were also not found. Grade 3-4 HFS was the most frequent AE (41.1% in Cint vs. 42.3% in Ccont). Grade 3-4 neutropenia, thrombocytopenia, diarrhea, and stomatitis were more frequent with Cint. A 5' untranslated region polymorphism in the carboxylesterase 2 gene was associated with HFS. One polymorphism in cytidine deaminase and two in thymidine phosphorylase were associated with survival. CONCLUSION: Our study was unable to show noninferiority with the continuous capecitabine regimen (Ccont) compared with the approved intermittent regimen (Cint). Further investigation is required to improve HFS. Polymorphisms in several genes might contribute to interindividual differences in response to capecitabine.

Identification of genetic variants associated with capecitabine-induced hand-foot syndrome through integration of patient and cell line genomic analyses.

OBJECTIVE: A primary challenge in identifying replicable pharmacogenomic markers from clinical genomewide association study (GWAS) trials in oncology is the difficulty in performing a second large clinical trial with the same drugs and dosage regimen. We sought to overcome this challenge by incorporating GWAS results from cell-based studies using the same chemotherapy as a clinical cohort. METHODS: In this study, we test whether the overlap between genetic variants identified in a preclinical study and a clinical study on capecitabine is more than expected by chance. A GWAS of capecitabine-induced cytotoxicity was performed in 164 lymphoblastoid cell lines derived from the CEU HapMap population and compared with a GWAS of hand-foot syndrome (HFS), the most frequent capecitabine-induced adverse drug reaction, in Spanish breast and colorectal cancer patients (n=160) treated with capecitabine. RESULTS: We observed an overlap of 16 single nucleotide polymorphisms associated with capecitabine-induced cytotoxicity (P<0.001) in lymphoblastoid cell lines and HFS (P<0.05) in patients, which is a greater overlap than expected by chance (genotype-phenotype permutation empirical P=0.015). Ten tag single nucleotide polymorphisms, which cover the overlap loci, were genotyped in a second patient cohort (n=85) and one of them, rs9936750, was associated with capecitabine-induced HFS (P=0.0076). CONCLUSION: The enrichment results imply that cellular models of capecitabine-induced cytotoxicity may capture components of the underlying polygenic architecture of related toxicities in patients.

Venous International Assessment, VIA scale, validated classification procedure for the peripheral venous system.

PURPOSE: VIA scale is a dynamic performance status tool of the peripheral venous system that is divided into five different grades, composed of three parameters: number of observable puncture points; optimal catheter size for cannulation and ease of performing venipuncture and risk of extravasation. METHODS: Prospective single-center, observational, open, non-randomized study divided into two phases. In the first longitudinal phase, we studied the clinical characteristics and the changes in their peripheral venous systems during intravenous chemotherapy for 16 patients (n=16) for an average period of 24 months. In the second transverse phase, we measured the vein's diameter at the selected puncture points with a high-resolution ultrasound and paired this figure with VIA scale. We selected a group of oncology patients (n=52) and a control group (n=56). RESULTS: In the first phase, the level of agreement between the three reviewers was excellent. The second step was to assess the relationship between the measurements obtained with ultrasound and the VIA scale. The vein diameter measurements show a decrease directly related to the assessment of observers in the VIA scale. CONCLUSIONS: The VIA scale is a simple, easy and practical method for classification of the peripheral venous system in terms of vascular access. The practical application of our VIA scale significantly increases the quality of life of patients by increasing the chances of successful venipuncture and cannulation and thus reducing the risk of extravasation and material costs, allowing both an economical and a safe venous assessment tool.

Heparinización versus salinización en catéteres periféricos cortos para extracciones de sangre en ensayos clínicos / Heparinization versus salinization in short peripheral catheters for blood draws in clinical trials

Objetivo: explorar si el comportamiento dinámico del torrente venoso es adecuado, siendo la prioridad el reflujo venoso, tras realizar repetidas extracciones de sangre en el marco de un ensayo clínico, a fin de poder realizar una extracción que se considere limpia y de calidad para las determinaciones posteriores. Método: la población estuvo constituida por pacientes con cáncer de ovario, glioblastoma cerebral y cáncer de mama localmente avanzado, con tratamiento en el marco de ensayos clínicos Fase I, donde el sistema venoso periférico no está previamente tratado ni dañado. Se estudiaron 83 puntos de extracción, dentro de las primeras24 horas de la colocación del catéter, eliminando del estudio el primer punto de punción, donde no hay conservación previa. Resultados: en relación a la facilidad para el reflujo, la vía heparinizada refluye fácilmente en un 82,9% de los casos, con dificultad en un 14,6% y no refluye en un 2,4% de los casos. En las vías salinizadas, refluye fácilmente en un 39,5% de los casos, con dificultad en un 55,8% y no refluye en un 4,7%. Referente a la calidad de la muestra extraída, medida a través de la hemólisis de la misma, en las vías mantenidas con suero heparinizado, se observa que las muestras se hemolizan en un 19,5% de los casos, y en las vías mantenidas con suero salino las muestras se hemolizan en un 39,5%.Conclusiones: la heparina sódica a baja concentración (20 UI/ml) en comparación con suero salino, disminuye los problemas asociados al reflujo del catéter, incrementando el número de catéteres periféricos que refluyen sin dificultad a la vez que disminuye el grado de hemólisis de la muestra, si bien hay que tener en cuenta que las vías no permanecen en las mismas condiciones que al principio pasadas las primeras horas de su canalización aunque se mantienen un período muy corto de tiempo, máximo 24 horas (AU)

Objective: to explore whether the dynamic behavior of the venous blood stream is suitable, with the priority being the venous reflux, following repeated blood draws as part of a clinical trial, in order to perform an extraction we consider to be clean and of quality for subsequent determinations. Method: the population consisted of patients with ovarian cancer, brain glioblastoma and locally advanced breast cancer, with treatment as part of Phase I clinical trials, where the peripheral venous systemis not pre-treated or damaged. 83 extraction sites were studied, within the first 24 hours of catheter insertion, eliminating from the study the first puncture site, where there is no prior preservation. Results: regarding the ease of reflux, the heparinised route refluxed more easily in 82,9% of cases, with difficulty in 14,6% of cases, and did not reflux in 2,4% of cases. In salinized routes, it refluxed easily in 39,5% of cases, with difficulty in 55,8% of cases, and did not refluxin 4,7% of cases. Concerning the quality of the extracted sample, as measured by the hemolysis of the sample, from the routes maintained with heparinized saline solution, samples lysed in 19,5%of cases, and in routes maintained with saline solution, samples lysed in 39,5% of cases. Conclusions: at low concentrations, sodium heparin (20 IU/ml) compared with saline solution reduces the problems associated with catheter reflux, increasing the number of peripheral catheters that refluxed easily while decreasing the degree of hemolysis of the sample. However, it should be noted that the routes do not remain in the same conditions as in the beginning past the first hours of canalization although they are maintained for a very short period of time, maxi -mum 24 hours (AU)

Las grasas saturadas no incrementan el riesgo cardiovascular / The origin of low-fat diet: the fallacy of the lipidic hypothesis

Por más de 30 años comer saludablemente fue sinónimo de una dieta baja en grasas. A partir de la década de 1950, con la influencia del Dr. Ancel Keys, se responsabilizó a la grasa de la dieta, especialmente la saturada, de los altos niveles de enfermedad cardiovascular que se observan en las poblaciones con hábitos de vida occidental. La reducción en el contenido de grasa saturada en la dieta tiene su fundamento en la hipótesis lipídica, que postula que la disminución del consumo de grasas saturadas reduce los niveles de colesterol plasmático y, en consecuencia, la tasa de enfermedad coronaria. Esta hipótesis fue adoptada por muchas sociedades científicas e incluso por instituciones gubernamentales para redactar recomendaciones dietarias que estigmatizan la grasa de origen animal, especialmente la de la carne de vaca. Sin embargo, la información científica proveniente de los estudios epidemiológicos y ensayos clínicos no demostró que la grasa saturada incremente el riesgo de enfermedad vascular. Aún así, la dieta hipograsa, conocida por muchos como cardiodieta, compuesta principalmente por 50% de su valor calórico por hidratos de carbono y no más del 10% de grasas saturadas, se ha difundido extensamente y es considerada actualmente como modelo de alimentación saludable.(AU)

Las grasas saturadas no incrementan el riesgo cardiovascular / The origin of low-fat diet: the fallacy of the lipidic hypothesis

Por más de 30 años comer saludablemente fue sinónimo de una dieta baja en grasas. A partir de la década de 1950, con la influencia del Dr. Ancel Keys, se responsabilizó a la grasa de la dieta, especialmente la saturada, de los altos niveles de enfermedad cardiovascular que se observan en las poblaciones con hábitos de vida occidental. La reducción en el contenido de grasa saturada en la dieta tiene su fundamento en la hipótesis lipídica, que postula que la disminución del consumo de grasas saturadas reduce los niveles de colesterol plasmático y, en consecuencia, la tasa de enfermedad coronaria. Esta hipótesis fue adoptada por muchas sociedades científicas e incluso por instituciones gubernamentales para redactar recomendaciones dietarias que estigmatizan la grasa de origen animal, especialmente la de la carne de vaca. Sin embargo, la información científica proveniente de los estudios epidemiológicos y ensayos clínicos no demostró que la grasa saturada incremente el riesgo de enfermedad vascular. Aún así, la dieta hipograsa, conocida por muchos como cardiodieta, compuesta principalmente por 50% de su valor calórico por hidratos de carbono y no más del 10% de grasas saturadas, se ha difundido extensamente y es considerada actualmente como modelo de alimentación saludable.

Obesidad: de la plétora al fracaso / Obesity: from to plethora to the failure

La obesidad es la causa más frecuente de insulino-resistencia, siendo el exceso de tejido adiposo el factor productor tradicionalmente responsabilizado. Sin embargo, en síndromes lipodistróficos con ausencia total de tejido adiposo, se pueden desarrollar las alteraciones metabólicas características del síndrome de insulino-resistencia. Algunas cepas de ratones genéticamente obesos presentan menor número e intensidad de manifestaciones de insulino-resistencia que otros animales que carecen de tejido adiposo, sugiriendo que los mecanismos relacionados con la insulino-sensibilidad no dependen exclusiva ni absolutamente de la cantidad de grasa adiposa almacenada y que el tejido adiposo podría tener alguna función evitativa de la insulino-resistencia. Cuando la capacidad del adipocito está colmada, ulteriores aportes de energía se depositan ectópicamente como triglicéridos en tejidos como el hígado y el músculo esquelético, produciendo insulino-resistencia local. Además, la plétora adipocitaria modifica la secreción de hormonas y de metabolitos adiposos, quienes actuando local y sistémicamente afectan el metabolismo de órganos y tejidos distantes. El fracaso adipocitario ante el exceso de triglicéridos podría ser interpretado como una claudicación ante la cual se disparan desde el tejido adiposo mecanismos productores del síndrome plurimetabólico. Su elevada frecuencia y escasa sintomatología hace que los criterios para su diagnóstico deban tenerse en consideración. La descarga funcional de los adipositos, sea por adelgazamiento o por aumento de su número, suele resultar eficaz para el tratamiento del síndrome de insulino-resistencia. (AU)

Obesidad: de la plétora al fracaso / Obesity: from to plethora to the failure

La obesidad es la causa más frecuente de insulino-resistencia, siendo el exceso de tejido adiposo el factor productor tradicionalmente responsabilizado. Sin embargo, en síndromes lipodistróficos con ausencia total de tejido adiposo, se pueden desarrollar las alteraciones metabólicas características del síndrome de insulino-resistencia. Algunas cepas de ratones genéticamente obesos presentan menor número e intensidad de manifestaciones de insulino-resistencia que otros animales que carecen de tejido adiposo, sugiriendo que los mecanismos relacionados con la insulino-sensibilidad no dependen exclusiva ni absolutamente de la cantidad de grasa adiposa almacenada y que el tejido adiposo podría tener alguna función evitativa de la insulino-resistencia. Cuando la capacidad del adipocito está colmada, ulteriores aportes de energía se depositan ectópicamente como triglicéridos en tejidos como el hígado y el músculo esquelético, produciendo insulino-resistencia local. Además, la plétora adipocitaria modifica la secreción de hormonas y de metabolitos adiposos, quienes actuando local y sistémicamente afectan el metabolismo de órganos y tejidos distantes. El fracaso adipocitario ante el exceso de triglicéridos podría ser interpretado como una claudicación ante la cual se disparan desde el tejido adiposo mecanismos productores del síndrome plurimetabólico. Su elevada frecuencia y escasa sintomatología hace que los criterios para su diagnóstico deban tenerse en consideración. La descarga funcional de los adipositos, sea por adelgazamiento o por aumento de su número, suele resultar eficaz para el tratamiento del síndrome de insulino-resistencia.