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      Grado de información percibida por los tutores legales en el Consentimiento Informado de pruebas de provocación en Alergia Pediátrica Translated title: Degree of information perceived by legal guardians in the Informed Consent of challenge tests in Pediatric Allergy Translated title: Grau d'informació percebuda pels tutors legals en el Consentiment Informat de proves de provocació a Al·lèrgia Pediàtric

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          Abstract

          Resumen Introducción: Existe escasa información sobre el grado de información percibida por los tutores legales en el Consentimiento informado (CI) en el ámbito pediátrico. Objetivos: Evaluar el grado de información percibida por los tutores legales en el CI de pruebas de provocación en Alergia Pediátrica. Métodos y Materiales: Estudio descriptivo, observacional y transversal de valoración de información mediante cuestionario, en el período de abril-mayo de 2021. El cuestionario fue desarrollado por el autor y su equipo, tomando como base un cuestionario disponible en la literatura. Se realizó estudio estadístico descriptivo y analítico mediante el software SPSS 15.0. Resultados: Se reclutaron 99 tutores con una edad media de 41 años, con formación universitaria 52%, profesional 27%, secundaria 17% y primaria 4%. Más del 70% de la muestra calificó positivamente el grado de información proporcionada en relación al procedimiento, su objetivo, su riesgo-beneficio y el tiempo de dedicación y de decisión. Un 50% de los tutores calificó negativamente la información proporcionada en cuanto al tratamiento alternativo, posibilidad de negar y revocar el CI. La consistencia interna del cuestionario fue muy buena, con un valor de la alfa de Cronbach de 0.88. No se encontró correlación entre el grado de percepción y diversas variables demográficas o clínicas. Conclusiones: El grado de información percibida por los tutores es en general muy bueno. Las informaciones en relación a los procedimientos alternativos, la posibilidad de rechazo y revocación del CI fueron los puntos mejorables.

          Translated abstract

          Abstract Introduction: Knowledge about the degree of information perceived by the legal guardians from the Informed Consent (IC) in pediatric setting is scarce. Objectives: To evaluate the degree of information perceived by legal guardians in the IC for challenge tests in Pediatric Allergy. Methods and Materials: It is a descriptive, observational and cross-sectional study of information assessment through a questionnaire, in the period April-May 2021. The questionnaire was developed by the author and his team on the base of a publicly available one. A descriptive and analytical statistical study was carried out using the SPSS 15.0 software. Results: Ninety-nine tutors with a mean age of 41 years were recruited, with 52% university, 27% professional, 17% secondary and 4% primary education. More than 70% of the sample positively rated the degree of information provided in relation to the procedure, its objective, its risk-benefit, and the dedication and decision time. 50% of the tutors negatively rated the information provided regarding alternative treatment, the possibility of denying and revoking the IC. The internal consistency of the questionnaire was very good, with a Cronbach's alpha value of 0.88. No correlation was found between the degree of perception and several demographic or clinical variables. Conclusions: The degree of information perceived by the tutors is very good in general. The information in relation to the alternative procedures, the possibility of rejection and revocation of the IC can be improved.

          Translated abstract

          Resum Introducció: Hi ha escassa informació sobre el grau d'informació percebuda pels tutors legals al Consentiment informat (CI) a l'àmbit pediàtric. Objectius: Avaluar el grau d'informació percebuda pels tutors legals al CI de proves de provocació a Al·lèrgia Pediàtrica. Mètodes i Materials: Estudi descriptiu, observacional i transversal de valoració d'informació mitjançant un qüestionari, en el període d'abril-maig de 2021. El qüestionari va ser desenvolupat per l'autor i el seu equip, prenent com a base un qüestionari disponible a la literatura. Es va realitzar estudi estadístic descriptiu i analític mitjançant el programari SPSS 15.0. Resultats: Es van reclutar 99 tutors amb una edat mitjana de 41 anys, amb formació universitària 52%, professional 27%, secundària 17% i primària 4%. Més del 70% de la mostra va qualificar positivament el grau d'informació proporcionada en relació amb el procediment, el seu objectiu, el risc-benefici i el temps de dedicació i de decisió. Un 50% dels tutors va qualificar negativament la informació proporcionada pel que fa al tractament alternatiu, possibilitat de negar i revocar el CI. La consistència interna del qüestionari va ser molt bona, amb un valor de l'alfa de Cronbach de 0,88. No es va trobar correlació entre el grau de percepció i diverses variables demogràfiques o clíniques. Conclusions: En general, el grau d'informació percebuda pels tutors és molt bo. Les informacions en relació amb els procediments alternatius, la possibilitat de rebuig i revocació del CI van ser els punts millorables.

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          Making sense of Cronbach's alpha

          Medical educators attempt to create reliable and valid tests and questionnaires in order to enhance the accuracy of their assessment and evaluations. Validity and reliability are two fundamental elements in the evaluation of a measurement instrument. Instruments can be conventional knowledge, skill or attitude tests, clinical simulations or survey questionnaires. Instruments can measure concepts, psychomotor skills or affective values. Validity is concerned with the extent to which an instrument measures what it is intended to measure. Reliability is concerned with the ability of an instrument to measure consistently. 1 It should be noted that the reliability of an instrument is closely associated with its validity. An instrument cannot be valid unless it is reliable. However, the reliability of an instrument does not depend on its validity. 2 It is possible to objectively measure the reliability of an instrument and in this paper we explain the meaning of Cronbach’s alpha, the most widely used objective measure of reliability. Calculating alpha has become common practice in medical education research when multiple-item measures of a concept or construct are employed. This is because it is easier to use in comparison to other estimates (e.g. test-retest reliability estimates) 3 as it only requires one test administration. However, in spite of the widespread use of alpha in the literature the meaning, proper use and interpretation of alpha is not clearly understood. 2 , 4 , 5 We feel it is important, therefore, to further explain the underlying assumptions behind alpha in order to promote its more effective use. It should be emphasised that the purpose of this brief overview is just to focus on Cronbach’s alpha as an index of reliability. Alternative methods of measuring reliability based on other psychometric methods, such as generalisability theory or item-response theory, can be used for monitoring and improving the quality of OSCE examinations 6 - 10 , but will not be discussed here. What is Cronbach alpha? Alpha was developed by Lee Cronbach in 1951 11 to provide a measure of the internal consistency of a test or scale; it is expressed as a number between 0 and 1. Internal consistency describes the extent to which all the items in a test measure the same concept or construct and hence it is connected to the inter-relatedness of the items within the test. Internal consistency should be determined before a test can be employed for research or examination purposes to ensure validity. In addition, reliability estimates show the amount of measurement error in a test. Put simply, this interpretation of reliability is the correlation of test with itself. Squaring this correlation and subtracting from 1.00 produces the index of measurement error. For example, if a test has a reliability of 0.80, there is 0.36 error variance (random error) in the scores (0.80×0.80 = 0.64; 1.00 – 0.64 = 0.36). 12 As the estimate of reliability increases, the fraction of a test score that is attributable to error will decrease. 2 It is of note that the reliability of a test reveals the effect of measurement error on the observed score of a student cohort rather than on an individual student. To calculate the effect of measurement error on the observed score of an individual student, the standard error of measurement must be calculated (SEM). 13 If the items in a test are correlated to each other, the value of alpha is increased. However, a high coefficient alpha does not always mean a high degree of internal consistency. This is because alpha is also affected by the length of the test. If the test length is too short, the value of alpha is reduced. 2 , 14 Thus, to increase alpha, more related items testing the same concept should be added to the test. It is also important to note that alpha is a property of the scores on a test from a specific sample of testees. Therefore investigators should not rely on published alpha estimates and should measure alpha each time the test is administered. 14 Use of Cronbach’s alpha Improper use of alpha can lead to situations in which either a test or scale is wrongly discarded or the test is criticised for not generating trustworthy results. To avoid this situation an understanding of the associated concepts of internal consistency, homogeneity or unidimensionality can help to improve the use of alpha. Internal consistency is concerned with the interrelatedness of a sample of test items, whereas homogeneity refers to unidimensionality. A measure is said to be unidimensional if its items measure a single latent trait or construct. Internal consistency is a necessary but not sufficient condition for measuring homogeneity or unidimensionality in a sample of test items. 5 , 15 Fundamentally, the concept of reliability assumes that unidimensionality exists in a sample of test items 16 and if this assumption is violated it does cause a major underestimate of reliability. It has been well documented that a multidimensional test does not necessary have a lower alpha than a unidimensional test. Thus a more rigorous view of alpha is that it cannot simply be interpreted as an index for the internal consistency of a test. 5 , 15 , 17 Factor Analysis can be used to identify the dimensions of a test. 18 Other reliable techniques have been used and we encourage the reader to consult the paper “Applied Dimensionality and Test Structure Assessment with the START-M Mathematics Test” and to compare methods for assessing the dimensionality and underlying structure of a test. 19 Alpha, therefore, does not simply measure the unidimensionality of a set of items, but can be used to confirm whether or not a sample of items is actually unidimensional. 5 On the other hand if a test has more than one concept or construct, it may not make sense to report alpha for the test as a whole as the larger number of questions will inevitable inflate the value of alpha. In principle therefore, alpha should be calculated for each of the concepts rather than for the entire test or scale. 2 , 3 The implication for a summative examination containing heterogeneous, case-based questions is that alpha should be calculated for each case. More importantly, alpha is grounded in the ‘tau equivalent model’ which assumes that each test item measures the same latent trait on the same scale. Therefore, if multiple factors/traits underlie the items on a scale, as revealed by Factor Analysis, this assumption is violated and alpha underestimates the reliability of the test. 17 If the number of test items is too small it will also violate the assumption of tau-equivalence and will underestimate reliability. 20 When test items meet the assumptions of the tau-equivalent model, alpha approaches a better estimate of reliability. In practice, Cronbach’s alpha is a lower-bound estimate of reliability because heterogeneous test items would violate the assumptions of the tau-equivalent model. 5 If the calculation of “standardised item alpha” in SPSS is higher than “Cronbach’s alpha”, a further examination of the tau-equivalent measurement in the data may be essential. Numerical values of alpha As pointed out earlier, the number of test items, item inter-relatedness and dimensionality affect the value of alpha. 5 There are different reports about the acceptable values of alpha, ranging from 0.70 to 0.95. 2 , 21 , 22 A low value of alpha could be due to a low number of questions, poor inter-relatedness between items or heterogeneous constructs. For example if a low alpha is due to poor correlation between items then some should be revised or discarded. The easiest method to find them is to compute the correlation of each test item with the total score test; items with low correlations (approaching zero) are deleted. If alpha is too high it may suggest that some items are redundant as they are testing the same question but in a different guise. A maximum alpha value of 0.90 has been recommended. 14 Summary High quality tests are important to evaluate the reliability of data supplied in an examination or a research study. Alpha is a commonly employed index of test reliability. Alpha is affected by the test length and dimensionality. Alpha as an index of reliability should follow the assumptions of the essentially tau-equivalent approach. A low alpha appears if these assumptions are not meet. Alpha does not simply measure test homogeneity or unidimensionality as test reliability is a function of test length. A longer test increases the reliability of a test regardless of whether the test is homogenous or not. A high value of alpha (> 0.90) may suggest redundancies and show that the test length should be shortened. Conclusions Alpha is an important concept in the evaluation of assessments and questionnaires. It is mandatory that assessors and researchers should estimate this quantity to add validity and accuracy to the interpretation of their data. Nevertheless alpha has frequently been reported in an uncritical way and without adequate understanding and interpretation. In this editorial we have attempted to explain the assumptions underlying the calculation of alpha, the factors influencing its magnitude and the ways in which its value can be interpreted. We hope that investigators in future will be more critical when reporting values of alpha in their studies.
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            The epidemiology of food allergy in Europe: a systematic review and meta-analysis.

            Food allergy (FA) is an important atopic disease although its precise burden is unclear. This systematic review aimed to provide recent, up-to-date data on the incidence, prevalence, time trends, and risk and prognostic factors for FA in Europe. We searched four electronic databases, covering studies published from 1 January 2000 to 30 September 2012. Two independent reviewers appraised the studies and qualified the risk of bias using the Critical Appraisal Skills Programme tool. Seventy-five eligible articles (comprising 56 primary studies) were included in a narrative synthesis, and 30 studies in a random-effects meta-analysis. Most of the studies were graded as at moderate risk of bias. The pooled lifetime and point prevalence of self-reported FA were 17.3% (95% CI: 17.0-17.6) and 5.9% (95% CI: 5.7-6.1), respectively. The point prevalence of sensitization to ≥1 food as assessed by specific IgE was 10.1% (95% CI: 9.4-10.8) and skin prick test 2.7% (95% CI: 2.4-3.0), food challenge positivity 0.9% (95% CI: 0.8-1.1). While the incidence of FA appeared stable over time, there was some evidence that the prevalence may be increasing. There were no consistent risk or prognostic factors for the development or resolution of FA identified, but sex, age, country of residence, familial atopic history, and the presence of other allergic diseases seem to be important. Food allergy is a significant clinical problem in Europe. The evidence base in this area would benefit from additional studies using standardized, rigorous methodology; data are particularly required from Eastern and Southern Europe. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
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              Allergen immunotherapy for IgE-mediated food allergy: a systematic review and meta-analysis.

              The European Academy of Allergy and Clinical Immunology (EAACI) is developing Guidelines for Allergen Immunotherapy (AIT) for IgE-mediated Food Allergy. To inform the development of clinical recommendations, we sought to critically assess evidence on the effectiveness, safety and cost-effectiveness of AIT in the management of food allergy.
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                Author and article information

                Journal
                bioetica
                Revista de Bioética y Derecho
                Rev. Bioética y Derecho
                Observatori de Bioètica i Dret - Cátedra UNESCO de Bioética (Barcelona, Barcelona, Spain )
                1886-5887
                2022
                : 54
                : 139-166
                Affiliations
                [3] orgnameUniversidad Internacional de Valencia España
                [1] Valencia orgnameInstituto de Investigación Sanitaria La Fe España
                [2] orgnameHospital General Universitario de Valencia España
                [4] Valencia orgnameHospital Universitario y Politécnico La Fe España
                Article
                S1886-58872022000100139 S1886-5887(22)00005400139
                10.1344/rbd2021.54.36768
                255c5627-2f25-4992-bf2e-b21f8c75b880

                This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

                History
                : 13 October 2021
                : 28 January 2022
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 23, Pages: 28
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                SciELO Spain

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                validación,pediatría,alergia,tutor,autonomía,consentimiento informado,validació,pediatria,al·lèrgia,autonomia,consentiment informa,validation,pediatrics,allergy,autonomy,Informed consent

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