[Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. / Satisfacción y preferencia del paciente asmático por los dispositivos de inhalación. Aplicación del FSI-10.

BACKGROUND AND OBJECTIVE: Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma, and it has been suggested that allowing patients to choose their own inhalers would resolve this problem. The FSI-10 (Feeling of Satisfaction with Inhaler) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids: Turbuhaler, Accuhaler, and Novolizer. PATIENTS AND METHODS: We performed a multicenter, prospective, observational study in 112 stable asthmatic patients (64 women; mean [SD] age, 37 [22] years) treated on a regular basis with inhaled corticosteroids. The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned. The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used. Once the protocol was completed, patients stated their preference for the different devices used. RESULTS: The FSI-10 was easily understood and rapidly completed, and it exhibited acceptable measurement properties. Factor analysis showed that the measure was unidimensional. Although acceptance of all 3 devices assessed was reasonable, the FSI-10 questionnaire detected significant differences between them: Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions. This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study. However, the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer, even though the Turbuhaler had also usually been used by those patients prior to the study. CONCLUSIONS: The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices. It is easy to understand and complete, and able to identify differences in patient satisfaction with the different inhalers.

Satisfacción y preferencia del paciente asmático por los dispositivos de inhalación. Aplicación del FSI-10 / Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 questionnaire

ANTECEDENTES Y OBJETIVO: El incumplimiento terapéutico con los corticoides inhalados (CI) es frecuente en los pacientes con asma. Se ha señalado que la elección del dispensador por el paciente facilitaría la solución del problema. El FSI-10 (Evaluación de la Satisfacción con el Inhalador) es un cuestionario autorrellenable que valora las opiniones sobre comodidad, dificultad, transportabilidad y manejabilidad de los dispositivos para CI. El objetivo de este trabajo ha sido definir las propiedades métricas del FSI-10 y comparar, mediante este inventario, la satisfacción y las preferencias de los pacientes con asma respecto a 3 dispositivos para CI: Turbuhaler® (T), Accuhaler® (A) y Novolizer® (N). PACIENTES Y MÉTODOS: Hemos realizado un estudio observacional, prospectivo y multicéntrico en 112 asmáticos (64 mujeres; edad media ± desviación estándar: 37 ± 22 años) estables y tratados regularmente con CI. Se les explicó la técnica de utilización de los dispositivos a evaluar y, aleatoriamente, se asignó el orden en que debían emplearlos. Usaron los dispositivos durante períodos de 7 días, tras los cuales cumplimentaron el FSI-10. Completado el protocolo, todos ellos expresaron el grado de preferencia por los dispositivos empleados. RESULTADOS: El FSI-10 resultó fácil de comprender y rápido de cumplimentar, y mostró propiedades métricas aceptables. El análisis factorial exploratorio muestra la unidimensionalidad de la medida. La aceptación de los 3 dispositivos evaluados fue razonable, pero el FSI-10 detectó diferencias significativas entre ellos: los sistemas T y N se valoraron mejor que A en bastantes preguntas del cuestionario. Esta preferencia responde en parte al hecho de que T era el dispositivo comúnmente utilizado con anterioridad por los pacientes. Sin embargo, para los menores de 16 años el inhalador preferido y mejor puntuado fue N, a pesar de que en este subgrupo también era el T el habitualmente manejado. CONCLUSIONES: El FSI-10 es un instrumento útil para evaluar el grado de satisfacción del paciente asmático con los dispositivos de inhalación disponibles. Es comprensible, de fácil manejo y capaz de identificar diferencias de satisfacción entre distintos inhaladores

BACKGROUND AND OBJECTIVE: Lack of adherence to inhaled corticosteroid therapy is common in patients with asthma, and it has been suggested that allowing patients to choose their own inhalers would resolve this problem. The FSI-10 (Feeling of Satisfaction with Inhaler) is a self-completed questionnaire to assess patient opinions regarding ease or difficulty of use, portability, and usability of devices for delivery of inhaled corticosteroids. The aim of this study was to define the measurement properties of the FSI-10 questionnaire and to use this inventory to compare satisfaction and preferences of patients with asthma regarding 3 different devices for delivery of inhaled corticosteroids: Turbuhaler, Accuhaler, and Novolizer. PATIENTS AND METHODS: We performed a multicenter, prospective, observational study in 112 stable asthmatic patients (64 women; mean [SD] age, 37 [22] years) treated on a regular basis with inhaled corticosteroids. The use of the devices was explained to the patients and the order in which they should be used in each case was randomly assigned. The devices were used for 7-day periods and at the end of each the FSI-10 questionnaire was completed for the device used. Once the protocol was completed, patients stated their preference for the different devices used. RESULTS: The FSI-10 was easily understood and rapidly completed, and it exhibited acceptable measurement properties. Factor analysis showed that the measure was unidimensional. Although acceptance of all 3 devices assessed was reasonable, the FSI-10 questionnaire detected significant differences between them: Turbuhaler and Novolizer scored higher than Accuhaler on a number of questions. This preference is partly explained by Turbuhaler having been the device that was commonly used by the patients prior to the study. However, the highest scoring and most often preferred inhaler in patients under 16 years of age was the Novolizer, even though the Turbuhaler had also usually been used by those patients prior to the study. CONCLUSIONS: The FSI-10 is a useful instrument for assessing the degree of satisfaction of asthmatic patients regarding available inhalation devices. It is easy to understand and complete, and able to identify differences in patient satisfaction with the different inhalers

[Variability in peak expiratory flow does not classify asthma according to severity]. / La variabilidad del flujo espiratorio máximo no clasifica el asma por niveles de gravedad.

OBJECTIVE: The aim of this study was to determine whether variability in peak expiratory flow (PEF) could be used to classify the level of severity of asthma in children. PATIENTS AND METHODS: We studied 387 boys and girls diagnosed with asthma and classified severity according to clinical criteria (Spanish Society of Pediatric Pneumology). PEF variability was determined using a portable mini-Wright peak flow meter (Clement Clarke International, London, UK; range, 50 L/min-800 L/min) over a 14-day period, with no changes in normal treatment. The following indices were used to calculate PEF variability: 1) difference between morning PEF and nighttime PEF, expressed as a percentage of the mean value of the PEF measurements taken on that day; 2) minimum PEF rate during a week, expressed as a percentage of the highest value recorded during that week; 3) difference between the highest and the lowest PEF values, expressed as a percentage of the highest value; and 4) the 10th percentile of PEF values recorded during a week, expressed as a percentage of the highest value recorded during that week. We assessed agreement between clinical classification and PEF variability using the weighted kappa coefficient. We also analyzed the sensitivity and specificity of PEF variability indices for episodic and persistent asthma. RESULTS: The analysis of levels of agreement between clinical classification of asthma and formulas 1, 2, 3, and 4 gave quadratic weighted kappa coefficients of 0.494, 0, 0.488, and 0.346, respectively. The results were similar when patients were grouped and analyzed by type of asthma (episodic or persistent asthma). CONCLUSIONS: The monitoring of PEF variability, a recommendation common in national and international guidelines on the management of asthma in children, is not valid for classifying severity of asthma in children.

La variabilidad del flujo espiratorio máximo no clasifica el asma por niveles de gravedad / Variability in peak expiratory flow does not classify asthma according to severity

Objetivo: El objetivo de este estudio ha sido estudiar si la variabilidad del flujo espiratorio máximo (FEM) permite clasificar el asma en niños por niveles de gravedad. Pacientes y métodos: Se ha estudiado a 387 niños y niñas diagnosticados de asma, cuya gravedad se clasificó atendiendo a criterios clínicos (Sociedad Española de Neumología Pediátrica). Se determinó la variabilidad del FEM con un medidor portátil (Mini Wright Peak Flow Meter Clement, Clarke International Ltd., Londres, Reino Unido; escala 50-800 l/min) en los 14 días siguientes, sin modificar los tratamientos habituales, según los índices de variabilidad del FEM: 1) diferencia entre el FEM de la mañana y el de la noche, expresado como porcentaje del valor medio de las medidas del FEM durante el día; 2) mínimo valor del FEM durante una semana, expresado como porcentaje del mejor FEM durante esa semana; 3) diferencia del mejor sobre el peor FEM, como porcentaje sobre el mejor, y 4) percentil 10 de los valores del FEM durante una semana, expresado como porcentaje del mejor FEM durante esa semana. Se analizó el grado de acuerdo entre la clasificación clínica y la variabilidad del FEM mediante el estudio de la concordancia (índice kappa ponderado). También se efectuó un análisis de sensibilidad y especificidad para el asma episódica y el asma persistente en relación con la variabilidad del FEM. Resultados: Los niveles de acuerdo entre la clasificación clínica del asma y las fórmulas 1, 2, 3 y 4 mostraron índices kappa ponderados bicuadrados de 0,494, 0, 0,488 y 0,346, respectivamente. Los resultados fueron similares cuando los pacientes se agruparon en asma episódica y asma persistente. Conclusiones: La medida de la variabilidad del FEM, recomendación común de las guías nacionales e internacionales para el manejo del asma en niños, no es válida para clasificar el asma en niños por niveles de gravedad

Objective: The aim of this study was to determine whether variability in peak expiratory flow (PEF) could be used to classify the level of severity of asthma in children. Patients and methods: We studied 387 boys and girls diagnosed with asthma and classified severity according to clinical criteria (Spanish Society of Pediatric Pneumology). PEF variability was determined using a portable mini-Wright peak flow meter (Clement Clarke International, London, UK; range, 50 L/min­800 L/min) over a 14-day period, with no changes in normal treatment. The following indices were used to calculate PEF variability: 1) difference between morning PEF and nighttime PEF, expressed as a percentage of the mean value of the PEF measurements taken on that day; 2) minimum PEF rate during a week, expressed as a percentage of the highest value recorded during that week; 3) difference between the highest and the lowest PEF values, expressed as a percentage of the highest value; and 4) the 10th percentile of PEF values recorded during a week, expressed as a percentage of the highest value recorded during that week. We assessed agreement between clinical classification and PEF variability using the weighted kappa coefficient. We also analyzed the sensitivity and specificity of PEF variability indices for episodic and persistent asthma. Results: The analysis of levels of agreement between clinical classification of asthma and formulas 1, 2, 3, and 4 gave quadratic weighted kappa coefficients of 0.494, 0, 0.488, and 0.346, respectively. The results were similar when patients were grouped and analyzed by type of asthma (episodic or persistent asthma). Conclusions: The monitoring of PEF variability, a recommendation common in national and international guidelines on the management of asthma in children, is not valid for classifying severity of asthma in children

Asma en l’infant: on som ara? / No disponible

No disponible

Parents' adherence with nebulizer treatment of their children when using an adaptive aerosol delivery (AAD) system.

The objective of this study was to analyze data on parents' adherence to their child's prescribed nebulizer treatment regimen and compliance with the demands of the nebulizer and the face mask. Data on adherence and compliance were recorded in a 24-week double-blind, randomized, parallel-group study with budesonide inhalation suspension in 125 young children with mild to moderate asthma. Budesonide was administered with an Adaptive Aerosol Delivery (AAD) system, which recorded adherence to treatment and compliance with the AAD system. A total of 35,481 treatments were recorded and analyzed. A study questionnaire regarding the parents' and children's acceptance of the AAD system has also been analyzed. The adherence to the treatment regimen was 91.3%, and the compliance with the AAD system was 90.4%. True adherence, the product of adherence and compliance, was 82.5%. Approximately 90% of the parents found the face mask easy to seal and the AAD equipment easy to use, and over 90% of the children accepted it within 1 week. In conclusion, the results indicate that the AAD system could be of real clinical advantage for treatment of asthma in young children.

[Cystic fibrosis in adults: study of 111 patients]. / Fibrosis quística del adulto: estudio de 111 pacientes.

BACKGROUND: Our goal was to establish the clinical and genetic characteristics of patients diagnosed with adult-onset cystic fibrosis (CF). PATIENTS AND METHOD: This was a retrospective observational descriptive comparative study of CF patients according to their age at the time of diagnosis. All adult patients (> 16 years old) attended in our CF Unit until November 2001 were included in the study. Those patients diagnosed of CF at their childhood (< 16 years old) were categorized as Group A patients, and those diagnosed in adulthood (>= 16 years old) were categorized as group B patients. Anthropometric parameters, respiratory and digestive clinical abnormalities, chest and abdominal radiological exams, sputum bacteriology, respiratory function and genetic tests were evaluated. Statistical analysis between groups was performed by comparing chi square test for qualitative values and the Student t test for quantitative values. RESULTS: One hundred and eleven patients (60 women, mean age 28, range 16-69 years) out of a total sample of 245 (45.3%) patients attended at the CF unit were enrolled in the study. Group A included 61 patients (32 women; mean age 23) and group B included 50 patients (28 women; mean age 32). The comparative study between both groups showed that patients in group B were older, had a higher weight and less incidence of initial digestive abnormalities, pancreatic insufficiency, malnutrition, hepatic disease, chronic bronchial colonization by Pseudomonas aeruginosa, admissions, lung transplantation and deaths due to CF. On the contrary, these patients had a higher incidence of pancreatitis, allergic bronchopulmonary aspergillosis at diagnosis and better respiratory function test parameters. The sweat test was negative in 4 patients of group B and 1 of group A. The genetic study showed 31 different CF mutations, from which only 10 were observed in group B. CONCLUSIONS: CF can also be diagnosed in adult age. Patients diagnosed in adulthood have less digestive abnormalities, better lung function and different genetic mutations. The sweat test can be negative or undetermined. These patients also display a better prognosis.

Fibrosis quística del adulto: estudio de 111 pacientes / Cystic fibrosis in adults: study of 111 patients

FUNDAMENTO: Establecer las características clínicas y genéticas de los pacientes diagnosticados de fibrosis quística (FQ) en la edad adulta. PACIENTES Y MÉTODO: Estudio retrospectivo, observacional, descriptivo y comparativo de pacientes adultos afectados de FQ según edad del diagnóstico. Se incluyó en el estudio a todos los pacientes adultos (mayores de 16 años) controlados en una unidad de fibrosis quística hasta noviembre de 2001. Los pacientes con diagnóstico de FQ en la infancia (edad < 16 años) se incluyeron en el grupo A, y los diagnosticados en la edad adulta (edad 16 años) en el grupo B. Se valoraron parámetros antropométricos, enfermedades digestivas y respiratorias, estudio radiológico de tórax y abdomen, bacteriológico de esputo, de función respiratoria y estudio genético. La comparación entre grupos se realizó mediante la prueba de la 2 para valores cualitativos y de la t de Student para los cuantitativos. Una p < 0,05 de dos colas fue considerada significativa. RESULTADOS: Se incluyó en el estudio a los 111 pacientes adultos (60 mujeres; edad media: 28 años; intervalo: 16-69 años) de los 245 (45,3 per cent) pacientes controlados en la unidad de FQ. El grupo A lo formaron 61 pacientes (32 mujeres; edad media: 23 años) y el grupo B, 50 pacientes (28 mujeres; edad media: 32 años). En la comparación entre ambos grupos se encontró que los pacientes del grupo B presentaban una edad media superior, mayor peso, menor incidencia de manifestaciones digestivas iniciales, de insuficiencia pancreática, de malnutrición, de enfermedad hepática, de colonización bronquial crónica por Pseudomonas aeruginosa, de ingresos hospitalarios, de trasplantes pulmonares y de fallecimientos por FQ. Por el contrario, presentaron mayor incidencia de pancreatitis y de aspergilosis broncopulmonar alérgica al diagnóstico y una función pulmonar más conservada. La prueba del sudor fue negativa en 4 pacientes del grupo B, frente a uno del grupo A. El estudio genético detectó 31 mutaciones genéticas diferentes, de las que 10 sólo se observaron en el grupo B. CONCLUSIONES: La FQ es una enfermedad también de diagnóstico en la edad adulta. Los pacientes diagnosticados en la edad adulta tienen una menor incidencia de afectación digestiva, mejor funcionalismo pulmonar y diferentes mutaciones genéticas; la prueba del sudor puede ser negativa o indeterminada y el pronóstico, más favorable (AU)

Validación de la versión española del Pediatric Quality of Life Questionnaire en la valoración de la calidad de vida del niño asmático / Validity of the Spanish version of the Pediatric Quality of Life Questionnaire for evaluating quality of life in asthma children

Fundamento: Analizar la utilidad clínica y validar el cuestionario de calidad de vida para niños asmáticos (PAQLQ) en situación de práctica clínica. Pacientes y método: Se incluyeron 1.012 niños entre 6 y 14 años, diagnosticados de asma leve o moderada, atendidos en 48 hospitales españoles. Además de recoger variables sociodemográficas y clínicas de los pacientes, se administraron los cuestionarios PAQLQ y EQ-5D en dos ocasiones: en la visita basal y a los 2-3 meses en pacientes con asma no controlada (grupo A), o en la visita basal y a los 15 días en pacientes con asma controlada (grupo B). Se valoró la factibilidad, la validez, la fiabilidad y la sensibilidad al cambio del PAQLQ. Resultados: El PAQLQ puede aplicarse sin dificultades en niños con asma leve o moderada a partir de los 7 años. Este cuestionario no presentó una relación estadísticamente significativa con las variables sociodemográficas ni con la mayoría de las clínicas, a excepción de la gravedad del asma, el número de exacerbaciones, los síntomas y el uso de agonistas de ß2 de corta duración a demanda. Las dimensiones más asociadas entre el PAQLQ y el EQ-5D fueron aquellas que medían aspectos similares de la calidad de vida. El coeficiente * de Cronbach de las puntuaciones del PAQLQ osciló entre 0,88 (limitación de las actividades) y 0,96 (puntuación global). El coeficiente de correlación intraclase de las puntuaciones del PAQLQ obtenido en el grupo B osciló entre 0,71 (limitación de las actividades) y 0,83 (puntuación global). La magnitud del efecto entre ambas visitas osciló entre 0,49 y 0,69. Conclusiones: La versión española del PAQLQ demostró ser factible y válida para su uso en niños con asma leve y moderada (AU)