BIOBADATOP Spanish Atopic Dermatitis Registry: Description and Early Findings. / BIOBADATOP: Registro Español de Dermatitis Atópica. Descripción y primeros resultados.

BACKGROUND: In recent years, remarkable improvements in our understanding of atopic dermatitis (AD) have revolutionized treatment perspectives, but access to reliable data from clinical practice is essential. MATERIALS AND METHOD: The Spanish Atopic Dermatitis Registry, BIOBADATOP, is a prospective, multicenter database that collects information on patients of all ages with AD requiring systemic therapy with conventional or novel drugs. We analyzed the registry to describe patient characteristics, diagnoses, treatments, and adverse events (AEs). RESULTS: We studied data entries for 258 patients who had received 347 systemic treatments for AD. Treatment was discontinued in 29.4% of cases, mostly due to a lack of effectiveness (in 10.7% of cases). A total of 132 AEs were described during follow-up. Eighty-six AEs (65%) were linked to a systemic treatment, most commonly dupilumab (39AEs) and cyclosporine (38AEs). The most common AEs were conjunctivitis (11patients), headache (6), hypertrichosis (5), and nausea (4). There was 1severe AE (acute mastoiditis) associated with cyclosporine. CONCLUSIONS: Initial findings on AEs from the Spanish BIOBADATOP registry are limited by short follow-up times precluding comparisons or calculation of crude and adjusted incidence rates. At the time of our analysis, no severe AEs had been reported for novel systemic therapies. BIOBADATOP will help answer questions on the effectiveness and safety of conventional and novel systemic therapies in AD.

Adaptación transcultural del cuestionario Mastocytosis Quality of Life questionnaire (MC-QoL) del alemán al castellano / Translation and Cultural Adaptation of the German Mastocytosis Quality of Life Questionnaire (MC-QoL) into Spanish

INTRODUCCIÓN: Las mastocitosis son un grupo de proliferaciones clonales de mastocitos que pueden afectar a distintos órganos y tejidos, siendo la piel uno de los implicados con mayor frecuencia. La clínica está relacionada con la liberación de mediadores proinflamatorios. Diversos estudios han señalado la afectación en la calidad de vida de estos pacientes. El reciente desarrollo en Alemania de un cuestionario específico sobre calidad de vida en pacientes con mastocitosis (Mastocytosis Quality of Life questionnaire [MC-QoL]), con una versión en inglés, supone un paso significativo en la valoración del impacto psicosocial. OBJETIVO: Realizar la adaptación transcultural al castellano del MC-QoL, garantizando su equivalencia con la versión original. MATERIAL Y MÉTODOS: Metodología de traducción directa, entrevistas cognitivas y traducción inversa, siguiendo los principios de buena práctica de la International Society for Pharmacoeconomics and Outcomes Research. El MC-QoL incluye 27 preguntas estructuradas en 4 dominios: síntomas, emociones, funcionamiento/vida social y sintomatología cutánea. RESULTADOS: La primera versión del cuestionario en español, obtenida por traducción directa de la versión en alemán, se sometió a entrevistas cognitivas, modificándose 3 preguntas para hacerlas más comprensibles. Posteriormente, los autores originales modificaron una pregunta de la versión obtenida por retrotraducción al considerar que había perdido especificidad. Tras mínimas modificaciones en consenso con los autores originales, se obtuvo la versión definitiva en castellano. CONCLUSIÓN: Se obtiene la adaptación transcultural en castellano de un cuestionario de calidad de vida específico para pacientes con mastocitosis, que podrá ser utilizado en la práctica clínica para una valoración más completa de este grupo de pacientes

BACKGROUND: Mastocytosis encompasses a spectrum of disorders in which different organs and tissues are affected by the clonal expansion of mast cells. The skin is one of the most frequently affected organs. The clinical manifestations of mastocytosis are linked to the release of proinflammatory mediators, and the impact of this disorder on patient quality of life has been described in various studies. The Mastocytosis Quality of Life Questionnaire (MC-QoL), which was recently developed in Germany and now also exists in English, is an important tool for evaluating the psychosocial impact of this disease. OBJECTIVE: To create a Spanish version of the MC-QoL that was culturally equivalent to the original German questionnaire. MATERIAL AND METHODS: The adaptation process, which involved forward translation, cognitive interviews, and back translation, was conducted in accordance with the principles of good practice for the translation and cultural adaptation of patient-reported measures of the International Society for Pharmacoeconomics and Outcomes Research. The MC-QoL contains 27 items in 4 domains: symptoms, emotions, social life/functioning, and skin. RESULTS: The first version of the Spanish questionnaire, obtained by forward translation from German, was tested in cognitive interviews, after which 3 items were modified to make them easier to understand. The German back translation of the Spanish questionnaire was analyzed by the authors of the original MC-QoL, who modified 1 item they considered to have lost specificity in the adaptation process. The definitive Spanish MC-QoL was then produced following minor modifications agreed on with the German authors. CONCLUSIÓN: We have produced a cultural adaptation of the MC-QoL in Spanish that can be used in routine clinical practice to obtain a more complete picture of the impact of mastocytosis on patient quality of life

Translation and Cultural Adaptation of the German Mastocytosis Quality of Life Questionnaire (MC-QoL) into Spanish. / Adaptación transcultural del cuestionario Mastocytosis Quality of Life questionnaire (MC-QoL) del alemán al castellano.

BACKGROUND: Mastocytosis encompasses a spectrum of disorders in which different organs and tissues are affected by the clonal expansion of mast cells. The skin is one of the most frequently affected organs. The clinical manifestations of mastocytosis are linked to the release of proinflammatory mediators, and the impact of this disorder on patient quality of life has been described in various studies. The Mastocytosis Quality of Life Questionnaire (MC-QoL), which was recently developed in Germany and now also exists in English, is an important tool for evaluating the psychosocial impact of this disease. OBJECTIVE: To create a Spanish version of the MC-QoL that was culturally equivalent to the original German questionnaire. MATERIAL AND METHODS: The adaptation process, which involved forward translation, cognitive interviews, and back translation, was conducted in accordance with the principles of good practice for the translation and cultural adaptation of patient-reported measures of the International Society for Pharmacoeconomics and Outcomes Research. The MC-QoL contains 27 items in 4 domains: symptoms, emotions, social life/functioning, and skin. RESULTS: The first version of the Spanish questionnaire, obtained by forward translation from German, was tested in cognitive interviews, after which 3 items were modified to make them easier to understand. The German back translation of the Spanish questionnaire was analyzed by the authors of the original MC-QoL, who modified 1 item they considered to have lost specificity in the adaptation process. The definitive Spanish MC-QoL was then produced following minor modifications agreed on with the German authors. CONCLUSION: We have produced a cultural adaptation of the MC-QoL in Spanish that can be used in routine clinical practice to obtain a more complete picture of the impact of mastocytosis on patient quality of life.