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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]