Quality Standards for Allergen Immunotherapy Clinics in Spain: Consensus Document.

BACKGROUND AND OBJECTIVE: Allergen immunotherapy clinics (AITCs) in Spain differ widely in terms of structure, organization, resources, and portfolio of services. Therefore, it is essential to unify treatment criteria and define quality standards for the most complex AITCs. Objective: To establish a series of recommendations that make it possible to guarantee quality and safety in the administration of immunotherapy and define quality standards for the most complex AITCs. METHODS: This project began with an online survey of 65 allergy departments/units throughout Spain in 2013. Next, a 2-phase consensus process was carried out. In the first phase, 10 experts defined and agreed on the standards using the RAND/UCLA Appropriateness method; in the second, the agreements were validated by means of a 2-round Delphi consultation with 84 experts. RESULTS: Consensus was reached on minimum safety and quality criteria in the administration of allergen immunotherapy, and 2 levels of highly complex AITCs were defined: accredited AITCs and accredited AITCs with excellence. Consensus was also reached on quality standards and accreditation criteria for both levels. CONCLUSIONS: This project is pioneering in terms of its purpose (the definition of quality standards for AITCs) and of the use of structured participation techniques (combination of the RAND/UCLA and Delphi methods). It enabled the design of minimum standards for quality and safety in administering AIT, as well as quality criteria for accreditation of AITCs supported by a broad panel of experts from the Spanish Society of Allergology and Clinical Immunology.

Delphi project in bronchial asthma. Two stages.

From the paediatric point of view, we have undertaken two Delphi studies into bronchial asthma. The first is related to the consensus known as the consensus document of the five associations. The second is more recent and has been undertaken with GEMA (the Spanish Guidelines on the Management of Asthma). The aim of this paper is to carry out a descriptive study comparing the 2 Delphi processes and to objectively assess if in some way behaviour over the past two years has changed as far as expert opinion is concerned. In the consensus document those points giving rise to most controversy were the treatment of children under three years of age and treatment with immunotherapy in allergic asthma. It is also necessary to highlight how important it was at that particular point in time to define the phenotypes of wheezing and the predictive index of asthma in children of less than 3 years of age. Of the 52 questions in the questionnaire, in 13.6% the panel of experts reached no consensus in their positions. Following GEMA the Delphi methodology, 56 questions were asked in the first round of the questionnaire, and consensus was reached in 87.5%. As regards the paediatric part relating to diagnosis and treatment in children, agreement was reached on all the questions in the first round. Agreement was reached in 8.92% questions in the second round. Clinical guidelines and consensus documents can modify behaviour towards an illness, both in the diagnosis and treatment.

[Validation of a Spanish version of the Childhood Asthma Control Test (Sc-ACT) for use in Spain]. / Validación de la versión en español de la prueba de control del asma infantil (ACT) para su uso en España.

OBJECTIVE: The Childhood Asthma Control Test (c-ACT) is a validated tool for determining pediatric asthma control. However, it is not validated in the Spanish language in Spain. We evaluated the psychometric properties of the Spanish version of the Childhood Asthma Control Test (Sc-ACT) for assessing asthma control in children ages 4 to11. METHODS: This national, multicentre, prospective study was conducted in Spain with asthmatic children and their caregivers. Patients were assessed at 3 visits (Baseline, 2 Weeks, and 4 Months). Clinical variables included: symptoms, exacerbations, FEV1, asthma classification, PAQLQ and PACQLQ questionnaire scores, and asthma control as perceived by physicians, patients and caregivers. The Sc-ACT feasibility, validity, reliability, and sensitivity to change were assessed. RESULTS: A total of 394 children were included; mean (SD) time to complete the Sc-ACT was 5.3 (4.4) minutes. Sc-ACT score was correlated with asthma control as perceived by physician (-0.52), patient (-0.53), and caregiver (-0.51) and with the PAQLQ (0.56) and PACQLQ (0.55) scores. Sc-ACT was found to be significantly related to intensity and frequency of asthma symptoms. Cronbach alpha coefficient α was 0.81 and intraclass correlation coefficient was ≥0.85 for all of the items. The global effect size of Sc-ACT was 0.55. The cutoff point scores of 21 or higher indicated a good asthma control and their MCID was 4 points. CONCLUSION: The Spanish version of the c-ACT was found to be a reliable and valid questionnaire for evaluating asthma control in Spanish-speaking children ages 4 to 11 in Spain.

Quality standards for allergen immunotherapy clinics in Spain: consensus document

BACKGROUND: Allergen immunotherapy clinics (AITCs) in Spain differ widely in terms of structure, organization, resources, and portfolio of services. Therefore, it is essential to unify treatment criteria and define quality standards for the most complex AITCs. OBJECTIVE: To establish a series of recommendations that make it possible to guarantee quality and safety in the administration of immunotherapy and define quality standards for the most complex AITCs. METHODS: This project began with an online survey of 65 allergy departments/units throughout Spain in 2013. Next, a 2-phase consensus process was carried out. In the first phase, 10 experts defined and agreed on the standards using the RAND/UCLA Appropriateness method; in the second, the agreements were validated by means of a 2-round Delphi consultation with 84 experts. RESULTS: Consensus was reached on minimum safety and quality criteria in the administration of allergen immunotherapy, and 2 levels of highly complex AITCs were defined: accredited AITCs and accredited AITCs with excellence. Consensus was also reached on quality standards and accreditation criteria for both levels. CONCLUSIONS: This project is pioneering in terms of its purpose (the definition of quality standards for AITCs) and of the use of structured participation techniques (combination of the RAND/UCLA and Delphi methods). It enabled the design of minimum standards for quality and safety in administering AIT, as well as quality criteria for accreditation of AITCs supported by a broad panel of experts from the Spanish Society of Allergology and Clinical Immunology

ANTECEDENTES: Las unidades de inmunoterapia (UIT) en España son muy diferentes en cuanto a estructura, organización, recursos y cartera de servicios. Por ello, resulta esencial homogeneizar criterios de actuación y definir estándares de calidad para las UIT de mayor complejidad. OBJETIVO: Establecer recomendaciones que permitan garantizar la calidad y seguridad en la administración de la inmunoterapia y definir estándares de calidad para las UIT de mayor complejidad. MÉTODOS: Proyecto iniciado (año 2013) con una encuesta on-line a 65 servicios o unidades de alergología de toda España. Posteriormente, se desarrolló un proceso de consenso en dos fases. En la primera, diez expertos definieron y consensuaron los estándares mediante el método RAND/UCLA; en la segunda, los acuerdos se validaron mediante una consulta Delphi a dos rondas con 84 expertos. RESULTADOS: Se consensuaron criterios mínimos de seguridad y calidad en la administración de inmunoterapia con alérgenos (ITA) y se definieron dos niveles de UIT de mayor complejidad: las UIT acreditadas (UITA) y las UIT acreditadas con excelencia (UITAE), consensuándose también los estándares de calidad y criterios de acreditación para ambos niveles. CONCLUSIONES: Proyecto pionero en su objetivo - definición de estándares de calidad de UIT- y en el empleo de técnicas de participación estructuradas -combinación de los métodos RAND/UCLA y Delphi-. El resultado es la definición de unos mínimos de calidad y seguridad para administrar ITA, y un conjunto de criterios de calidad para la acreditación de las UIT que cuenta con el respaldo de un amplio panel de expertos de la SEAIC

Validación de la versión en español de la prueba de control del asma infantil (ACT) para su uso en España / Validation of a Spanish version of the childhood asthma control test (Sc-ACT) for use in Spain

OBJETIVO: El cuestionario asthma control test (ACT) pediátrico es una herramienta validada para determinar el grado de control del asma. Sin embargo, no está valida en español para España, motivo de evaluar las propiedades psicométricas de la versión en español del cuestionario ACT pediátrico (c-ACT), dirigido a conocer el grado de control del asma en niños de 4 a 11 años de edad. MÉTODOS: Estudio nacional, prospectivo, multicéntrico, desarrollado en España en niños asmáticos y en sus padres. Los pacientes fueron evaluados en 3 visitas (basal, a las 2 semanas y a los 4 meses). Variables clínicas relacionadas: síntomas, exacerbaciones, FEV1, clasificación del asma, escalas de los cuestionarios PAQLQ y PACQLQ y control del asma percibido por el paciente, sus padres y por su médico. Se evaluaron la factibilidad, la validez, la fiabilidad y la sensibilidad del cuestionario ACT. RESULTADOS: Cohorte constituida por 394 niños. La duración media ± desviación estándar (DE) para completar el cuestionario fue 5,3 (4,4) min. La puntuación se correlacionó con el grado de control del asma percibido por su médico (-0,52), por el niño (-0,53) y por sus padres (-0,51), y con las puntuaciones de los cuestionarios PAQLQ (0,56) y PACQLQ (0,55). Se ha observado una estrecha asociación de la puntuación del cuestionario con la intensidad y la frecuencia de los síntomas relacionados con asma. Para todos los ítems, coeficiente alfa de Cronbach 0,81 y coeficiente de correlación intraclase ≥ 0,85. El punto de corte de 21 o más indican un muy buen control del asma y su MCID fue de 4 puntos. CONCLUSIÓN: La versión en español del cuestionario ACP pediátrico es fidedigno y válido para evaluar en control del asma en España, en niños de 4 a 11 años de edad

OBJECTIVE: The Childhood Asthma Control Test (c-ACT) is a validated tool for determining pediatric asthma control. However, it is not validated in the Spanish language in Spain. We evaluated the psychometric properties of the Spanish version of the Childhood Asthma Control Test (Sc-ACT) for assessing asthma control in children ages 4 to11. METHODS: This national, multicentre, prospective study was conducted in Spain with asthmatic children and their caregivers. Patients were assessed at 3 visits (Baseline, 2 Weeks, and 4 Months). Clinical variables included: symptoms, exacerbations, FEV1, asthma classification, PAQLQ and PACQLQ questionnaire scores, and asthma control as perceived by physicians, patients and caregivers. The Sc-ACT feasibility, validity, reliability, and sensitivity to change were assessed. RESULTS: A total of 394 children were included; mean (SD) time to complete the Sc-ACT was 5.3 (4.4) minutes. Sc-ACT score was correlated with asthma control as perceived by physician (-0.52), patient (-0.53), and caregiver (-0.51) and with the PAQLQ (0.56) and PACQLQ (0.55) scores. Sc-ACT was found to be significantly related to intensity and frequency of asthma symptoms. Cronbach alpha coefficient α was 0.81 and intraclass correlation coefficient was ≥0.85 for all of the items. The global effect size of Sc-ACT was 0.55. The cutoff point scores of 21 or higher indicated a good asthma control and their MCID was 4 points. CONCLUSION: The Spanish version of the c-ACT was found to be a reliable and valid questionnaire for evaluating asthma control in Spanish-speaking children ages 4 to 11 in Spain

How pediatricians in Spain manage the first acute wheezing episode in an atopic infant. Results from the TRAP study.

BACKGROUND: Although the treatment of asthma has been addressed in several guidelines, the management of the first acute wheezing episode in infants has not often been evaluated. We surveyed practicing pediatricians in Spain about the treatment they would provide in a simulated case. MATERIAL AND METHODS: A random sample of 3000 pediatricians and physicians who normally treated children was surveyed. The questionnaire inquired about how they would treat a first mild-to-moderate wheezing attack in a 5-month-old boy with a personal and family history of allergy. Pediatricians were asked about their professional background. RESULTS: A total of 2347 questionnaires were returned with useful data (78.2%). Most (90.4%) of the pediatricians would use a short-acting beta2 agonist (SABA) via a metered-dose inhaler with a spacer and a face mask or nebulizer. However, only 34.5% chose a SABA alone: 31.3% added an oral steroid and 27.6% added an inhaled corticosteroid (ICS). The factors associated with the use of ICS in the acute attack were: (1) lack of specific training in pediatrics (OR 1.45; 1.12-1.85) and (2) primary care health center setting (OR 1.31; 1.01-1.69) or rural setting (OR 1.28; 1.01-1.66). Forty-four percent did not recommend any follow-up treatment while 20.7% prescribed ICS as maintenance therapy. The factors related to this decision were the same as those described above. CONCLUSIONS: The management of a first wheezing episode seems to meet published guidelines among Spanish pediatricians with formal training in pediatrics and in those who work in a hospital setting or in urban areas.

[Round Table: Severe asthma in pediatrics: diagnosis and prognosis]. / Mesa Redonda: Asma grave en Pediatría: Diagnóstico y pronóstico.

UNLABELLED: Prevalence of asthma in children is calculated around 5-10%. In spite of this, severe asthma is not frequent in children (about 1% of asthmatic children), but its prognosis is very worrying as 90% of children with severe asthma continue with asthma in adulthood. The key question is if doctors dedicated to treatment of asthmatic children are able or not able to do something in order to modify this prognosis. OBJECTIVES: to evaluate the role of prevention measures in the evolution of severe asthma in children. METHODS: in 1995 a prospective study was begun with the aim of evaluating the evolution of a group of children who had been diagnosed as moderate or severe persistent asthma (group A; 18 patients) and comparing it with a control group of children with infrequent episodic asthma (group B, 25 patients). On the first visit we carried out anamnesis, physical exploration, skin tests, a lung function study and we trained the patient in the use of the daily diary card documenting peak expiratory flow (PEF) and asthma symptoms. Three (G-A) or six (G-B) month controls were programmed adjusting the medication dosage. Individual immunotherapy was administered, when indicated. RESULTS: both groups have evolved favourably. All of the patients with severe or moderate asthma, who had done the correct prevention measures and/or immunotherapy, have been able to stop the initial treatment with inhaled glucocorticosteroids (CGS) without lung function or clinical state deterioration. On the other hand the patients with poor compliance of prevention measures continued needing inhaled CGS. CONCLUSIONS: adequate prevention measures and/or immunotherapy can influence prognosis of asthmatic children. All of this, in the long run, could avoid or delay the remodelling process and the negative factors of an intensive pharmacotherapy.

[Antileukotrienes. Their use in pediatrics]. / Antileucotrienos. Su uso en pediatría.

The leukotriene antagonists have represented the first novelty in the treatment of asthma over the last 20 years. Their easy oral administration that favours a suitable completion of the treatment, especially on children, together with the proven efficiency and their apparent safety, gave rise to the fact in 1999 the asthma committee of the Spanish Society of Clinical Immunology and Paediatric Allergology (SSCIPA) in the bronchial asthma treatment guide that was presented a year ago during the XXIII National Congress of our Society, considered the antileukotrienes, together with the chromones, as important medicines for stage 2 asthma (frequent episodes) and as useful medicines to reduce the need to take corticoides in cases of persistent asthma. A year later, in our study we proposed to value too suitability or non suitability of this positioning, in the light of the new investigations published and from our own experience. We believe that the bibliography available to date shows that the agonist cysteinyl-leukotrienes are anti-inflammatory medicines, that have an efficiency similar to that of low doses of inhaled corticoids, equally efficient in controlling bronchospasm-induced exercise and they have a good safety profile. We present two studies that are the result of our own experience, one carried out on children with persistent asthma and the other on children with frequent episodic asthma, from which we can apparently deduce that both nedocromil (2 inhalations every 8 hours) and montelukast (5 mg every 24 hours) are medicines that have similar efficacy in the control of asthma. We conclude that the antileukotrienes, together with the chromones, should be seen as important medicines when treating infant asthma.

Delphi project in bronchial asthma. Two stages

From the paediatric point of view, we have undertaken two Delphi studies into bronchial asthma. The first is related to the consensus known as the consensus document of the five associations. The second is more recent and has been undertaken with GEMA (the Spanish Guidelines on the Management of Asthma).The aim of this paper is to carry out a descriptive study comparing the 2 Delphi processes and to objectively assess if in some way behaviour over the past two years has changed as far as expert opinion is concerned.In the consensus document those points giving rise to most controversy were the treatment of children under three years of age and treatment with immunotherapy in allergic asthma. It is also necessary to highlight how important it was at that particular point in time to define the phenotypes of wheezing and the predictive index of asthma in children of less than 3 years of age. Of the 52 questions in the questionnaire, in 13.6% the panel of experts reached no consensus in their positions.Following GEMA the Delphi methodology, 56 questions were asked in the first round of the questionnaire, and consensus was reached in 87.5%. As regards the paediatric part relating to diagnosis and treatment in children, agreement was reached on all the questions in the first round. Agreement was reached in 8.92% questions in the second round.Clinical guidelines and consensus documents can modify behaviour towards an illness, both in the diagnosis and treatment

Alimentación con fórmulas hidrolizadas para la prevención primaria de las alergias: ¿estamos seguros del beneficio? / Feeding with hydrolysed formulas for the primary prevention of allergies: are we sure of the benefits?

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Consensus Statement on the Management of Paediatric Asthma. Update 2007

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Consenso sobre tratamiento del asma en Pediatría / Consensus on the treatment of asthma in pediatrics

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