Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD / Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study

Antecedentes: En España, aunque el Ministerio de Sanidad elabora el informe de posicionamiento terapéutico (IPT) y las condiciones de reembolso de los fármacos, las Comunidades Autónomas (CC. AA.) gestionan los servicios de salud y deciden sobre las condiciones de prescripción en su ámbito territorial. El objetivo del estudio EQUIDAD fue describir los condicionantes para la prescripción de los nuevos fármacos en Dermatología en las CC. AA. y sus posibles diferencias. Material y métodos: Estudio transversal realizado en abril-mayo del 2023. Dos dermatólogos con responsabilidades directivas de cada Comunidad Autónoma (C. A.) informaron sobre los condicionantes autonómicos y locales en la prescripción de los fármacos cuyo IPT para el tratamiento de enfermedades dermatológicas fue publicado en los años 2016-2022. Los datos fueron recogidos mediante un cuestionario online. Resultados: Un total de 33 investigadores de 17 CC. AA. participaron en el estudio. Se observaron inequidades entre CC. AA. para el acceso a los nuevos fármacos. Existieron condicionantes autonómicos adicionales al IPT en psoriasis en el 64,7% de las CC. AA., siendo este porcentaje menor en dermatitis atópica (35,3%) o melanoma (11,8%). El más frecuente fue el requisito de un orden de prescripción previo para el uso del fármaco. En algunas CC. AA. se detectaron además variaciones y condicionantes locales (diferencias entre centros de una misma C. A.). Conclusiones: Existe una multiplicidad de criterios tanto a nivel autonómico como local que añade restricciones adicionales a las establecidas por los IPT y que plantean una situación de inequidad entre los pacientes y los profesionales de las diferentes CC. AA. en el acceso a los nuevos fármacos. (AU)

Background: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. Material and methods: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. Results: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). Conclusions: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain. (AU)

[Translated article] Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study / Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD

Background: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. Material and methods: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. Results: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). Conclusions: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain. (AU)

Antecedentes: En España, aunque el Ministerio de Sanidad elabora el informe de posicionamiento terapéutico (IPT) y las condiciones de reembolso de los fármacos, las Comunidades Autónomas (CC. AA.) gestionan los servicios de salud y deciden sobre las condiciones de prescripción en su ámbito territorial. El objetivo del estudio EQUIDAD fue describir los condicionantes para la prescripción de los nuevos fármacos en Dermatología en las CC. AA. y sus posibles diferencias. Material y métodos: Estudio transversal realizado en abril-mayo del 2023. Dos dermatólogos con responsabilidades directivas de cada Comunidad Autónoma (C. A.) informaron sobre los condicionantes autonómicos y locales en la prescripción de los fármacos cuyo IPT para el tratamiento de enfermedades dermatológicas fue publicado en los años 2016-2022. Los datos fueron recogidos mediante un cuestionario online. Resultados: Un total de 33 investigadores de 17 CC. AA. participaron en el estudio. Se observaron inequidades entre CC. AA. para el acceso a los nuevos fármacos. Existieron condicionantes autonómicos adicionales al IPT en psoriasis en el 64,7% de las CC. AA., siendo este porcentaje menor en dermatitis atópica (35,3%) o melanoma (11,8%). El más frecuente fue el requisito de un orden de prescripción previo para el uso del fármaco. En algunas CC. AA. se detectaron además variaciones y condicionantes locales (diferencias entre centros de una misma C. A.). Conclusiones: Existe una multiplicidad de criterios tanto a nivel autonómico como local que añade restricciones adicionales a las establecidas por los IPT y que plantean una situación de inequidad entre los pacientes y los profesionales de las diferentes CC. AA. en el acceso a los nuevos fármacos. (AU)

Relationships Between Gastrointestinal Permeability, Heat Stress, And Milk Production in Lactating Dairy Cows.

Heat stress (HS) is a global issue that decreases farm profits and compromises animal welfare. To distinguish between the direct and indirect effects of HS, 16 multiparous Holstein cows approximately 100 d in milk were assigned to one of 2 treatments: pair fed to match HS cow intake, housed in thermoneutral conditions (PFTN, n = 8) or cyclical HS (n = 8). All cows were subjected to 2 experimental periods. P1 consisted of a 4 d thermoneutral period with ad libitum intake. During P2, the HS cows were housed in cyclical HS conditions with a temperature humidity index (THI) ranging from 76 to 80 and the PFTN cows were exposed to a constant THI of 64 for 4 d. DMI of the PFTN cow was intake matched to the HS cows. Milk yield, milk composition, rectal temperature, and respiration rate were recorded twice daily, blood was collected daily via a jugular catheter, and cows were fed twice daily. On d 3 of each period, Cr-EDTA and sucralose were orally administered and recovered via 24 h total urine collection to assess gastrointestinal permeability (GIP). All data were analyzed using the GLIMMIX procedure in SAS. The daily data collected in P1 was averaged and used as a covariate if deemed significant in the model. HS decreased voluntary intake by 35% and increased rectal temperature and respiration rate (38.4 vs 39.4°C and 40 vs 71 respirations/min, respectively). HS reduced dry matter intake (DMI) by 35% which accounted for 66% of the decrease in milk yield. The yield, and not concentration, of milk protein, fat, and other solids were lower in the HS cows on d 4 of P2. Milk urea nitrogen (MUN) was higher and plasma urea nitrogen (PUN) tended to be higher on d 3 and d 4 of HS. Glucose was 7% lower in the HS cows and insulin was 71% higher in the HS cows than the PFTN cows on d 4 of P2. No difference in lipopolysaccharide binding protein (LBP) was observed. HS cows produced 7 L/d more urine than PFTN cows. No differences were detected in the urine concentration or percentage of the oral dose recovered for Cr-EDTA or sucralose. In conclusion, HS was responsible for 34% of the reduction of milk yield. The elevated MUN and the tendency for elevated PUN indicate a whole-body shift in nitrogen metabolism. No differences in GIP or LBP were observed. These results indicate that, under conditions of this experiment, activation of the immune system by gut derived lipopolysaccharide was not responsible for the decreased milk yield observed during HS.

Gammagrafía de perfusión miocárdica en la evaluación del riesgo cardiovascular en el trasplante hepático de adultos / Myocardial perfusion scintigraphy in the assessment of cardiovascular risk in adult liver transplantation

Introducción El estudio diagnóstico no invasivo del riesgo cardiovascular en pacientes que van a ser llevados a trasplante hepático no es claro especialmente en asintomáticos. Respecto a la gammagrafía de perfusión miocárdica (GPM) se ha pensado que la reserva vasodilatadora deteriorada en estos pacientes puede reducir su rendimiento. El objetivo es valorar el papel de la GPM en la evaluación prequirúrgica de los pacientes que van a ser tratados mediante un trasplante hepático. Material y métodos Estudio retrospectivo, descriptivo y observacional. Se incluyó a todos los pacientes adultos llevados a trasplante hepático entre 2017 y 2021 que tuvieran GPM previa. Se describen los hallazgos de la GPM y se correlacionaron con los hallazgos de angiografía invasiva y con la aparición o no de eventos cardiovasculares peri y postrasplante. Resultados De 188 pacientes trasplantados (edad promedio: 57 años, DE: 12), 178 tenían perfusión miocárdica previa, 82 (46%) pacientes no tenían factores de riesgo cardiovascular y 5 (2,8%) tenían antecedente de enfermedad coronaria. De las GPM, 177 fueron con estrés con dipiridamol realizadas en promedio 10 meses antes del trasplante. Únicamente 17/178 (9,5%) estudios fueron anormales. El seguimiento medio fue de 38 meses (DE: 10). De los pacientes con GPM normal, solo 2 (1,2%) presentaron eventos cardiovasculares, ambos con estudios realizados más de 2años atrás. No hubo muertes de origen cardiovascular. Conclusiones La GPM es una técnica segura y confiable en la valoración cardiovascular en pacientes candidatos a trasplante hepático dada la baja tasa de falsos negativos en el seguimiento (AU)

Introduction The non-invasive diagnostic study of cardiovascular risk in patients who are going to undergo liver transplantation is not clear, especially in asymptomatic patients. Regarding myocardial perfusion scintigraphy (MPS), it has been thought that the impaired vasodilator reserve in these patients may reduce its performance. The objective is to assess the role of the MPS in the pre-surgical evaluation of patients who are going to undergo liver transplantation. Material and methods Retrospective, descriptive and observational study was designed. All adult patients undergoing liver transplantation between 2017 and 2021 who had previous MPS were included. The findings of MPS were described and correlated with the findings of invasive angiography and with the appearance or not of peri- and post-transplant cardiovascular events. Results There were a total of 188 transplanted patients (mean age: 57 years, SD: 12), 178 had previous myocardial perfusion, 82 (46%) patients had no cardiovascular risk factors, and 5 (2.8%) had a history of coronary disease. Of the MPS, 177 were with dipyridamole stress performed on average 10 months before transplantation. Only 17/178 (9.5%) studies were abnormal. The mean follow-up was 38 months (SD: 10). Of the patients with normal MPS, only 2 (1.2%) presented cardiovascular events, both with studies performed more than 2years before the procedure. There were no deaths of cardiovascular origin. Conclusions MPS is a safe and reliable technique for cardiovascular assessment of patients who are candidates for liver transplantation, given the low rate of false negatives during follow-up (AU)

Cognitive decline in adult-onset temporal lobe epilepsy: Insights from aetiology.

PURPOSE: To identify patients with adult-onset temporal lobe epilepsy (TLE) at risk of developing cognitive decline. Detecting which patients, aetiologies, or factors are most closely related with memory decline would allow us to identify patients that would eventually benefit from more specific treatment. METHODS: Single centre, retrospective analysis of a prospectively followed-up cohort study, including all patients with the diagnosis of adult-onset TLE during 2013, with a minimum follow-up of five years. Memory and cognitive decline were analysed at 5 years and at last follow-up. RESULTS: Of 89 initially selected patients, 71 were included. After 5 years, 11/71 (15.5%) patients suffered cognitive decline, of which 1/71 (4%) developed dementia. At last follow-up (range 65-596 m) a total of 34/71 (47.8%) patients were diagnosed with cognitive decline, specifically either memory decline or dementia. Cognitive decline at 5 years was related to: 1. Age at onset: 62.65 years (SD 9.04) in the group with cognitive decline vs 50.33 y. (SD 13.02 in the group without cognitive decline; p=0.004); 2. Onset as status epilepticus (3/6 in patients with memory decline vs 8/65 in patients without cognitive decline; p=0.04); 3. Immune aetiology: 42% compared with unknown (10%) and structural (10%) aetiologies; p=0.036; 4. Hippocampal sclerosis on MRI: 5/11 patients with cognitive decline vs 9/51 patients without cognitive decline; p=0.035. Cognitive decline was not related to seizure frequency, sex, or age (p=0.78; p=0.40; p=0.95, respectively). CONCLUSIONS: Older age at epilepsy onset, onset as status epilepticus, immune aetiology, and hippocampal sclerosis are risk factors for developing cognitive decline in patients with adult-onset temporal lobe epilepsy.

[Translated article] Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Towards the personalization of septic shock resuscitation: the fundamentals of ANDROMEDA-SHOCK-2 trial.

Septic shock is a highly lethal and prevalent disease. Progressive circulatory dysfunction leads to tissue hypoperfusion and hypoxia, eventually evolving to multiorgan dysfunction and death. Prompt resuscitation may revert these pathogenic mechanisms, restoring oxygen delivery and organ function. High heterogeneity exists among the determinants of circulatory dysfunction in septic shock, and current algorithms provide a stepwise and standardized approach to conduct resuscitation. This review provides the pathophysiological and clinical rationale behind ANDROMEDA-SHOCK-2, an ongoing multicenter randomized controlled trial that aims to compare a personalized resuscitation strategy based on clinical phenotyping and peripheral perfusion assessment, versus standard of care, in early septic shock resuscitation.

Myocardial perfusion scintigraphy in the assessment of cardiovascular risk in adult liver transplantation.

INTRODUCTION: The non-invasive diagnostic study of cardiovascular risk in patients who are going to undergo liver transplantation is not clear, especially in asymptomatic patients. Regarding myocardial perfusion scintigraphy (MPS), it has been thought that the impaired vasodilator reserve in these patients may reduce its performance. The objective is to assess the role of the MPS in the pre-surgical evaluation of patients who are going to undergo liver transplantation. MATERIAL AND METHODS: Retrospective, descriptive and observational study was designed. All adult patients undergoing liver transplantation between 2017 and 2021 who had previous MPS were included. The findings of MPS were described and correlated with the findings of invasive angiography and with the appearance or not of peri- and post-transplant cardiovascular events. RESULTS: There were a total of 188 transplanted patients (mean age: 57 years, SD: 12), 178 had previous myocardial perfusion, 82 (46%) patients had no cardiovascular risk factors, and 5 (2.8%) had a history of coronary disease. Of the MPS, 177 were with dipyridamole stress performed on average 10 months before transplantation. Only 17/178 (9.5%) studies were abnormal. The mean follow-up was 38 months (SD: 10). Of the patients with normal MPS, only 2 (1.2%) presented cardiovascular events, both with studies performed more than 2 years before the procedure. There were no deaths of cardiovascular origin. CONCLUSIONS: MPS is a safe and reliable technique for cardiovascular assessment of patients who are candidates for liver transplantation, given the low rate of false negatives during follow-up.

How to estimate body composition in Huntington's disease. A cross-sectional, observational study using multiple frequencies bioimpedance. / Cómo estimar la composición corporal en la enfermedad de Huntington. Estudio transversal y observacional con bioimpedancia de múltiples frecuencias.

INTRODUCTION: Huntington´s disease (HD) is a rare neurodegenerative disorder. Reliable information about nutritional status, especially body composition from individuals with HD is critical for clinical care and research. The ease of application and portability of multiple frequencies bioelectrical impedance analysis (mfBIA) make it an attractive tool for measuring body composition, but its accuracy in HD is unknown. AIM: To evaluate the accuracy of mfBIA vs. Dual X-ray absorptiometry (DEXA) in HD. PATIENTS AND METHODS: Cross-sectional, observational, and single-center study. HD severity was measured using motor subscale of the unified Huntington´s disease rating scale (m-UHDRS) and the total functional capacity (TFC). Body composition was measured in terms of fat-free mass (FFM), fat mass (FM), fat-free mass index (FFMI), and fat mass index (FMI). Using Bland-Altman plots, we analyzed reliability between DEXA and mfBIA using the Intraclass Correlation Coefficient with 95% confidence intervals (CI) and bias estimates for all. RESULTS: We included 16 patients with HD, 7 men, and 9 women, median age of 58.5 (32;68) years, TFC: 10 (3;13), and m-UHDRS: 31 (7;85). The reliability between mfBIA and DEXA were high for FFMI in men: 0.88 (95% CI 0.17-0.98), and women: 0.90 (95% CI 0.61- 0.98); for FMI, men: 0.97 (95% CI 0.83-0.99), and women: 0.91 (95% CI 0.68-0.98). Compared to DEXA, mfBIA slightly overestimated FFM, FM, FMI and FFMI in men and underestimated FFMI in women. CONCLUSIONS: mfBIA is an easy-to-use, safe, non-invasive, accurate method for measuring body composition and nutritional status in patients with mild-moderate HD.

TITLE: Cómo estimar la composición corporal en la enfermedad de Huntington. Estudio transversal y observacional con bioimpedancia de múltiples frecuencias.Introducción. La enfermedad de Huntington (EH) es un trastorno raro neurodegenerativo. La información fiable del estado nutricional, especialmente de la composición corporal, es crítica en clínica y en investigación. La facilidad de aplicación y portabilidad del análisis de la bioimpedancia de múltiples frecuencias (mfBIA) la convierten en una herramienta atractiva para medirla, pero se desconoce su precisión en la EH. Objetivo. Evaluar la precisión del mfBIA frente a la absorciometría dual de rayos X (DEXA) en la EH. Pacientes y métodos. Estudio transversal, observacional y unicéntrico. La EH se midió con la subescala motora de la escala unificada de valoración de la EH y con la capacidad funcional total. La composición corporal se valoró según la masa libre de grasa (MLG), la masa grasa (MG), el índice de masa libre de grasa (IMLG) y el índice de masa grasa (IMG). Se utilizó el coeficiente de correlación intraclase con intervalos de confianza al 95% y estimaciones de sesgo mediante gráficos de Bland-Altman. Resultados. Se incluyó a 16 pacientes, siete hombres y nueve mujeres, con edad media de 58,5 (32-68) años, capacidad funcional total de 10 (3-13) y escala unificada de valoración de la EH de 31 (7-85). La fiabilidad era alta entre el mfBIA y la DEXA para el IMLG en hombres, 0,88 (intervalo de confianza al 95%: 0,17-0,98), y mujeres, 0,9 (intervalo de confianza al 95%: 0,61-0,98); y para el IMG en hombres, 0,97 (intervalo de confianza al 95%: 0,83-0,99), y mujeres, 0,91 (intervalo de confianza al 95%: 0,68-0,98). El mfBIA sobreestimó ligeramente la MLG, la MG, el IMG y el IMLG en los hombres, pero subestimó el IMLG en las mujeres. Conclusiones. El mfBIA es un método fácil de usar, seguro, no invasivo y preciso para medir la composición corporal y el estado nutricional en pacientes con EH leve-moderada.

External urology consultation quality at a third-level public hospital in Mexico.

INTRODUCTION: Patient satisfaction is the degree of conformity with the healthcare they receive. It is real evidence and one of the most important factors in determining the effectiveness and quality of healthcare systems. OBJECTIVE: To identify the quality of care in the Urology outpatient department of a third-level hospital. MATERIALS AND METHODS: The NHS (National Health Service) 2018 quality of care questionnaire with 11 sections, 133 items, and duration of approximately 25min was randomly administered to 250 patients attending Urology outpatients at a third-level public hospital in Mexico. RESULTS: According to responses, 92% (n=230) knew the reason for the consultation. 64.8% (n=162) had a consultation with the same physician by whom they were initially seen. The longest reported hospital wait time before being seen was more than 2h in 29.6% (n=74). As for consultation time, 212 patients responded and the duration was 11-20min in 52.8% (n=112). Finally, 33.2% (n=83) considered the quality of service to be good. CONCLUSIONS: The use of the NHS 2018 survey in the Urology service at a third-level public hospital in Mexico is feasible, since we managed to obtain a significant and continuous improvement in all its indicators which is satisfactory for all.

Encuesta sobre el manejo del nevus displásico por los dermatólogos de la sección Centro de la Academia Española de Dermatología y Venereología (AEDV) / Survey on the Management of Dysplastic Nevus by Dermatologists in the Center-Spain section of the Spanish Academy of Dermatology and Venereology (AEDV)

Antecedentes y objetivos No existen guías clínicas para el manejo del nevus displásico (ND). Determinaremos el porcentaje de dermatólogos de la sección Centro de la Academia Española de Dermatología y Venereología (AEDV) que ampliarían márgenes o tendrían actitud conservadora en un ND, y si los antecedentes personales (AP) y/o familiares (AF) de melanoma modificarían la actitud tomada frente a un paciente sin antecedentes de interés. Material y métodos Se difundió la encuesta a 738 dermatólogos y se recogieron datos de forma anónima del 15 de junio de 2022 al 31 de julio de 2022. Las variables de exposición fueron el grado de displasia (bajo/alto), los márgenes (afecto/libre) y los antecedentes de melanoma (sin antecedentes/AF/AP). Las variables dependientes (actitud) incluyeron observación/márgenes de 1-4mm /márgenes 5-10mm. Resultados Se recibieron 86 respuestas. Si el patólogo informase bordes afectos en un ND de bajo grado, el 60,5% ampliarían márgenes de 1 a 4mm, mientras que si los márgenes están libres el 97,7%, tendrían una actitud conservadora. Si el patólogo informara bordes afectos en un ND de alto grado, solo el 1,2% tendrían una actitud conservadora, porcentaje que se incrementa notablemente si los márgenes están libres (68,6%). El AF o el AP de melanoma no influirían en la actitud de la mayoría. Conclusiones El manejo del ND no es uniforme entre los dermatólogos de la sección centro de la AEDV, especialmente en el caso de ND de bajo grado con bordes afectos y ND de alto grado con bordes libres. El AF o el AP de melanoma no modifican en la mayor parte de los casos la actitud clínica (AU)

Background and objectives There are no clinical guidelines on the management of dysplastic nevus (DN). The aims of this study were to determine the percentage of dermatologists in the center-Spain section of the Spanish Academy of Dermatology and Venereology (AEDV) who would manage a histologically confirmed DN with a watch-and-wait approach or with wider surgical margins and to investigate whether their attitudes would vary depending on whether or not the patient had a personal and/or family history of melanoma. Material and methods We collected data from an anonymous survey sent to 738 dermatologists between June 15 and July 31, 2022. The independent variables were degree of dysplasia (low vs. high), margin status (positive vs. negative), and a personal or family history of melanoma (yes vs. no in both cases). The dependent variables were attitude towards management (watch-and-wait vs. re-excision with a surgical margin of 1 to 4mm or re-excision with a surgical margin of 5 to 10mm). Results We obtained 86 responses to the questionnaire. When pathology indicated a low-grade DN, 60.5% of dermatologists stated they would obtain a surgical margin of 1 to 4mm if the first margins were positive, and 97.7% would watch and wait if the report described negative margins. For high-grade DNs, 1.2% of dermatologists would watch and wait to manage DN with positive margins; 68.8% would use this approach for negative margins. A family or personal history of melanoma had no influence on most of the dermatologists’ attitudes. Conclusions Management strategies for DN among dermatologists from the center-Spain section of the AEDV varied, particularly when faced with low-grade DN with positive margins and high-grade DN with negative margins. A family or personal history of melanoma did not influence clinical attitudes in most cases (AU)

[Translated article] Survey on the Management of Dysplastic Nevus by Dermatologists in the Center-Spain Section of the Spanish Academy of Dermatology and Venereology (AEDV) / Encuesta sobre el manejo del nevus displásico por los dermatólogos de la sección Centro de la Academia Española de Dermatología y Venereología (AEDV)

Background and objectives There are no clinical guidelines on the management of dysplastic nevus (DN). The aims of this study were to determine the percentage of dermatologists in the center-Spain section of the Spanish Academy of Dermatology and Venereology (AEDV) who would manage a histologically confirmed DN with a watch-and-wait approach or with wider surgical margins and to investigate whether their attitudes would vary depending on whether or not the patient had a personal and/or family history of melanoma. Material and methods We collected data from an anonymous survey sent to 738 dermatologists between June 15 and July 31, 2022. The independent variables were degree of dysplasia (low vs. high), margin status (positive vs. negative), and a personal or family history of melanoma (yes vs. no in both cases). The dependent variables were attitude towards management (watch-and-wait vs. re-excision with a surgical margin of 1 to 4mm or re-excision with a surgical margin of 5 to 10mm). Results We obtained 86 responses to the questionnaire. When pathology indicated a low-grade DN, 60.5% of dermatologists stated they would obtain a surgical margin of 1 to 4mm if the first margins were positive, and 97.7% would watch and wait if the report described negative margins. For high-grade DNs, 1.2% of dermatologists would watch and wait to manage DN with positive margins; 68.8% would use this approach for negative margins. A family or personal history of melanoma had no influence on most of the dermatologists’ attitudes. Conclusions Management strategies for DN among dermatologists from the center-Spain section of the AEDV varied, particularly when faced with low-grade DN with positive margins and high-grade DN with negative margins. A family or personal history of melanoma did not influence clinical attitudes in most cases (AU)

Antecedentes y objetivos No existen guías clínicas para el manejo del nevus displásico (ND). Determinaremos el porcentaje de dermatólogos de la sección Centro de la Academia Española de Dermatología y Venereología (AEDV) que ampliarían márgenes o tendrían actitud conservadora en un ND, y si los antecedentes personales (AP) y/o familiares (AF) de melanoma modificarían la actitud tomada frente a un paciente sin antecedentes de interés. Material y métodos Se difundió la encuesta a 738 dermatólogos y se recogieron datos de forma anónima del 15 de junio de 2022 al 31 de julio de 2022. Las variables de exposición fueron el grado de displasia (bajo/alto), los márgenes (afecto/libre) y los antecedentes de melanoma (sin antecedentes/AF/AP). Las variables dependientes (actitud) incluyeron observación/márgenes de 1-4mm /márgenes 5-10mm. Resultados Se recibieron 86 respuestas. Si el patólogo informase bordes afectos en un ND de bajo grado, el 60,5% ampliarían márgenes de 1 a 4mm, mientras que si los márgenes están libres el 97,7%, tendrían una actitud conservadora. Si el patólogo informara bordes afectos en un ND de alto grado, solo el 1,2% tendrían una actitud conservadora, porcentaje que se incrementa notablemente si los márgenes están libres (68,6%). El AF o el AP de melanoma no influirían en la actitud de la mayoría. Conclusiones El manejo del ND no es uniforme entre los dermatólogos de la sección centro de la AEDV, especialmente en el caso de ND de bajo grado con bordes afectos y ND de alto grado con bordes libres. El AF o el AP de melanoma no modifican en la mayor parte de los casos la actitud clínica (AU)

Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study. / Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Bilastine 0.6% preservative-free eye drops, an effective once-daily treatment to reduce signs and symptoms of allergic conjunctivitis: A pooled analysis of two randomized clinical trials.

BACKGROUND AND OBJECTIVE: Allergic conjunctivitis is the most common type of ocular allergy. The objective of this study was to evaluate the efficacy of a new once-daily, preservative-free, bilastine 0.6% eye drop formulation for the treatment of allergic conjunctivitis. METHODS: Two double-masked, vehicle controlled, clinical studies (a Phase 2 Dose Ranging Study and a Phase 3 Efficacy Study) were conducted to assess the efficacy of bilastine ophthalmic solution for the treatment of signs and symptoms of allergic conjunctivitis. Both studies used the Ora-CAC® Conjunctival Allergen Challenge (CAC) Model to allow observations of allergic responses under controlled conditions. Each study was analyzed separately and then combined to create an integrated dataset. RESULTS: Efficacy was achieved for the primary efficacy endpoint of ocular itching for three bilastine concentrations (0.2%, 0.4%, and 0.6%) at 15 minutes and 8 hours post-instillation and bilastine 0.6% ophthalmic solution was also efficacious at 16 hours post-instillation. Bilastine 0.6% ophthalmic solution demonstrated non-inferiority to ketotifen 0.025% at the onset of action. From the integrated data set, differences between vehicle and bilastine 0.6% were significant at all time points both at onset (15 minutes) and at a prolonged duration (16 hours) after instillation. CONCLUSION: This multi-trial assessment suggests that bilastine 0.6% ophthalmic solution is efficacious for the treatment of the signs and symptoms of allergic conjunctivitis, with a rapid and prolonged duration of action, and has a favorable safety profile. The added convenience of a once-a-day dosing regimen may contribute to patient adherence and improve their quality of life.

Milk production and anatomical udder capacity changes of udder halves subjected to increased milking frequency at two stages of lactation.

This study aimed to characterize the effects of increased milking frequency (IMF) at early and mid-lactation on milk yield and its association with changes in cistern and alveolar capacity. Fourteen multiparous Holstein cows were subjected to IMF using the unilateral frequent milking method from 3 to 24 d in milk (DIM). At mid-lactation, cows were randomly assigned to 1 of 2 treatments: control or repeated. From 150 to 170 DIM, IMF treatment was reimposed in the repeated group. During IMF, left udder halves were milked 2× and right udder halves were milked 4× daily. To separate individual milk yields of udder halves, separate buckets were used to collect samples from each udder half. Milk samples and milk yield from right and left udder halves were collected on d 150, 170, 200, 230, 260, and 290 of lactation. Alveolar and cistern capacity were measured 26 h after the last milking at 140 and 172 DIM using an oxytocin inhibitor. Cistern and alveolar capacity were measured by evaluating the milk harvested after oxytocin inhibitor and oxytocin administration, respectively. Udder half difference yields were calculated by subtracting left half yield from right half yield. At 170 DIM, the udder half difference in repeated was 2.27 kg greater than the udder half difference in control. Udder halves milked 4× produced more milk and protein than 2× udder halves in the repeated group at 170, 200, 230, and 260 DIM. Cumulative (150 to 290 DIM) and carry over (200 to 290 DIM) udder half differences in milk yield were similar between the control and repeated treatments. Alveolar volume was similar between udder halves milked 2× or 4× at 140 DIM, while cistern volume was larger for udder halves milked 4× than 2× in early lactation. There was no difference between alveolar or cistern volume proportion in udder halves milked 2× or 4× before mid-lactation IMF. After 20 d IMF for the repeated group, alveolar volume was similar between control and repeated independent of udder half milking frequency. However, repeated held 4.9 kg more cistern milk than control. Control treatment udder halves had a greater alveolar proportion than repeated treatment udder halves. As expected, the cistern proportion was smaller in control and larger in repeated after mid-lactation IMF. IMF at early and mid-lactation enhances milk and protein yield largely during differential milking frequency regimens. The lack of enhancement in milk yield after IMF might be associated with a different response to IMF in the mammary gland at early versus mid-lactation. Based on our results, we conclude that udder halves subjected to early and mid-lactation IMF had increased cistern volume capacity.

Survey on the Management of Dysplastic Nevus by Dermatologists in the Center-Spain section of the Spanish Academy of Dermatology and Venereology (AEDV). / Encuesta sobre el manejo del nevus displásico por los dermatólogos de la sección Centro de la Academia Española de Dermatología y Venereología (AEDV).

BACKGROUND AND OBJECTIVES: There are no clinical guidelines on the management of dysplastic nevus (DN). The aims of this study were to determine the percentage of dermatologists in the center-Spain section of the Spanish Academy of Dermatology and Venereology (AEDV) who would manage a histologically confirmed DN with a watch-and-wait approach or with wider surgical margins and to investigate whether their attitudes would vary depending on whether or not the patient had a personal and/or family history of melanoma. MATERIAL AND METHODS: We collected data from an anonymous survey sent to 738 dermatologists between June 15 and July 31, 2022. The independent variables were degree of dysplasia (low vs. high), margin status (positive vs. negative), and a personal or family history of melanoma (yes vs. no in both cases). The dependent variables were attitude towards management (watch-and-wait vs. re-excision with a surgical margin of 1 to 4mm or re-excision with a surgical margin of 5 to 10mm). RESULTS: We obtained 86 responses to the questionnaire. When pathology indicated a low-grade DN, 60.5% of dermatologists stated they would obtain a surgical margin of 1 to 4mm if the first margins were positive, and 97.7% would watch and wait if the report described negative margins. For high-grade DNs, 1.2% of dermatologists would watch and wait to manage DN with positive margins; 68.8% would use this approach for negative margins. A family or personal history of melanoma had no influence on most of the dermatologists' attitudes. CONCLUSIONS: Management strategies for DN among dermatologists from the center-Spain section of the AEDV varied, particularly when faced with low-grade DN with positive margins and high-grade DN with negative margins. A family or personal history of melanoma did not influence clinical attitudes in most cases.