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On request of the EU Commission, EFSA carried out an Extensive Literature Review (ELR) to provide a list of vector species or reservoirs species of pathogens of crustaceans, listed in Annex II to the AHL, aiming to update the Annex of Implementing Regulation (EU) 2018/1882. In this Technical Report, the detailed review protocol of the ELR and assessment of potential vector and reservoir species is described of the crustacean pathogens listed in Annex II to the AHL: Taura syndrome virus (TSV), Yellow head virus (YHV) or White spot syndrome virus (WSSV). In total 2,530 research publications were collected for abstract screening and from these, 110 were selected for further full text analysis. In the final data collection and assessment 34 relevant research publications were used for extracting information on vector and reservoir species of the above crustacean pathogens. The results for crustacean species for which scientific evidence indicates that a role as vector species or reservoir species is likely are presented as tables in the supplementary material of this report. This publication is linked to the following EFSA Journal articles: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8172/full, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8173/full, http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8174/full This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8122/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2023.EN-8124/full [ABSTRACT FROM AUTHOR]

Background: Children are more vulnerable to adverse drug reactions (ADRs) due to complex changes in the body during the growth process and lack specific pharmacoepidemiologic studies. Causality and Avoidability assessment of ADRs are relevant to clinical guidelines development and pharmacovigilance. This study aimed to translate and transcultural adapt two new tools-Liverpool Causality Assessment Tool (LCAT) and the Liverpool Avoidability Assessment Tool (LAAT)-to Brazilian-Portuguese and evaluate the psychometric properties of these tools to analyse ADRs in Brazilian children.Methods: The validation of the cross-cultural adaptation of tools was obtained by the functional (conceptual, semantic, operational, and measurement) equivalence between the original and translated versions of each instrument. The translated version of LCAT and LAAT was applied to assessing the twenty-six case reports of suspected adverse drug reactions in a Brazilian teaching paediatric hospital. The inter-rater reliability (a pharmacist and a physician) was evaluated using Cronbach's alpha. The exact agreement percentages (%EA) and extreme disagreement (%ED) were computed. Overall Kappa index was calculated with a 95% confidence interval.Results: There was a need to modify some terms translated into Portuguese for semantic and conceptual equivalence. The Cronbach's alpha coefficient values obtained were 0.95 and 0.85, and the weighted Kappa (95% confidence interval) were 0.82 (0.67-0.97) and 0.68 (0.45-0.91) for LCAT and LAAT, respectively. The Brazilian-Portuguese versions of the LCAT and LAAT showed reliable and valid tools for the diagnosis and follow-up of ADRs in children.Conclusion: The methodological approach allowed the translation, transcultural adaptation, and validation to Brazilian-Portuguese of two easy and quick to perform tools for causality and avoidability of ADRs in children by a multidisciplinary expert specialist committee, including the authors of original tools. We believe these versions may be applied by professionals (patient safety teams) and researchers in Brazil in groups or by a single reviewer.Trial Registration: This study was evaluated and approved by the Research Ethics Committee (Instituto de Pediatria e Puericultura Martagão Gesteira - Federal University of Rio de Janeiro - Number: 3.264.238. [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life (HRQoL) assessment, encompassing the adolescents' perceptions of their mental, physical, and social health and well-being is increasingly considered an important outcome to be used to identify population health needs and to provide targeted medical care. Although validated instruments are essential for accurately assessing HRQoL outcomes, there are few cross-culturally adapted tools for use in Brazil, and none designed exclusively for use among adolescents. The Vécu et Santé Perçue de l'Adolescent (VSP-A) is a generic, multidimensional self-reported instrument originally developed and validated in France that evaluates HRQoL of ill and healthy adolescents. Purpose: To cross-culturally adapt and validate the Brazilian-Portuguese version of the VSP-A, a generic HRQoL measure for adolescents originally developed in France. Methods: The VSP-A was translated following a well-validated forward-backward process leading to the Brazilian version. The psychometric evaluation was conducted in a sample of 446 adolescents (14-18 years) attending 2 public high schools of São Gonçalo City. The adolescents self-reported the Brazilian VSP-A, the validated Psychosomatic Symptom Checklist and socio-demographic information. A retest evaluation was carried out on a sub-sample (n = 195) at a two-week interval. The internal construct validity was assessed through confirmatory factor analysis (CFA), multi-trait scaling analyses, Rasch analysis evaluating unidimensionality of each scale and Cronbach's alpha coefficients. The reproducibility was evaluated by intra-class correlation coefficients (ICC). Zumbo's ordinal logistic regression analysis was used to detect differential item functioning (DIF) between the Brazilian and the French items. External construct validity was investigated testing expected differences between groups using one-way analysis of variance (ANOVA), Mann- Whitney tests and the univariate general regression linear model. Results: CFA showed an acceptable fit (RMSEA=0.05; CFI=0.93); 94% of scaling success was found for item-internal consistency and 98% for item discriminant validity. The items showed good fit to the Rasch model except 3 items with an INFIT at the upper threshold. Cronbach's Alpha ranged from 0.60 to 0.85. Test-retest reliability was moderate to good (ICC=0.55-0.82). DIF was evidenced in 4 out of 36 items. Expected patterns of differences were confirmed with significantly lower physical, psychological well being and vitality reported by symptomatic adolescents. [ABSTRACT FROM AUTHOR]

Confinement due to the COVID-19 pandemic can influence dietary profiles, especially those of adolescents, who are highly susceptible to acquiring bad eating habits. Adolescents' poor dietary habits increase their subsequent risk of degenerative diseases such as obesity, diabetes, cardiovascular pathologies, etc. Our aim was to study nutritional modifications during COVID-19 confinement in adolescents aged 10 to 19 years, compare them with their usual diet and dietary guidelines, and identify variables that may have influenced changes. Data were collected by an anonymous online questionnaire on food intake among 820 adolescents from Spain, Italy, Brazil, Colombia, and Chile. The results show that COVID-19 confinement did influence their dietary habits. In particular, we recorded modified consumption of fried food, sweet food, legumes, vegetables, and fruits. Moreover, gender, family members at home, watching TV during mealtime, country of residence, and maternal education were diversely correlated with adequate nutrition during COVID-19 confinement. Understanding the adolescents' nutrition behavior during COVID-19 lockdown will help public health authorities reshape future policies on their nutritional recommendations, in preparation for future pandemics. [ABSTRACT FROM AUTHOR]

Background: Health-related quality of life (HRQoL) assessment, encompassing the adolescents' perceptions of their mental, physical, and social health and well-being is increasingly considered an important outcome to be used to identify population health needs and to provide targeted medical care. Although validated instruments are essential for accurately assessing HRQoL outcomes, there are few cross-culturally adapted tools for use in Brazil, and none designed exclusively for use among adolescents. The Vécu et Santé Perçue de l'Adolescent (VSP-A) is a generic, multidimensional self-reported instrument originally developed and validated in France that evaluates HRQoL of ill and healthy adolescents.Purpose: To cross-culturally adapt and validate the Brazilian-Portuguese version of the VSP-A, a generic HRQoL measure for adolescents originally developed in France.Methods: The VSP-A was translated following a well-validated forward-backward process leading to the Brazilian version. The psychometric evaluation was conducted in a sample of 446 adolescents (14-18 years) attending 2 public high schools of São Gonçalo City. The adolescents self-reported the Brazilian VSP-A, the validated Psychosomatic Symptom Checklist and socio-demographic information. A retest evaluation was carried out on a sub-sample (n = 195) at a two-week interval. The internal construct validity was assessed through confirmatory factor analysis (CFA), multi-trait scaling analyses, Rasch analysis evaluating unidimensionality of each scale and Cronbach's alpha coefficients. The reproducibility was evaluated by intra-class correlation coefficients (ICC). Zumbo's ordinal logistic regression analysis was used to detect differential item functioning (DIF) between the Brazilian and the French items. External construct validity was investigated testing expected differences between groups using one-way analysis of variance (ANOVA), Mann-Whitney tests and the univariate general regression linear model.Results: CFA showed an acceptable fit (RMSEA=0.05; CFI=0.93); 94% of scaling success was found for item-internal consistency and 98% for item discriminant validity. The items showed good fit to the Rasch model except 3 items with an INFIT at the upper threshold. Cronbach's Alpha ranged from 0.60 to 0.85. Test-retest reliability was moderate to good (ICC=0.55-0.82). DIF was evidenced in 4 out of 36 items. Expected patterns of differences were confirmed with significantly lower physical, psychological well being and vitality reported by symptomatic adolescents.Conclusions: Although DIF in few items and responsiveness must be further explored, the Brazilian version of VSP-A demonstrated an acceptable validity and reliability in adolescents attending school and might serve as a starting point for more specific clinical investigations. [ABSTRACT FROM AUTHOR]