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European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection
BACKGROUND: Contradictory results were reported on the role of school closure/reopening on the overall SARS-CoV-2 transmission rate, as well as on which kind and level of mitigation measures implemented in schools may be effective in limiting its diffusion. Some recent studies were reassuring, showi...
Autores principales: | , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9808677/ https://www.ncbi.nlm.nih.gov/pubmed/36597074 http://dx.doi.org/10.1186/s12879-022-07947-6 |
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author | Raimondi, Sara Gandini, Sara Rubio Quintanares, Gibran Horemheb Abecasis, Ana Lopalco, Pier Luigi D’Ecclesiis, Oriana Chiocca, Susanna Tomezzoli, Elisa Cutica, Ilaria Mazzoni, Davide Amparo, Nuno Pingarilho, Marta Carmagnola, Daniela Dallavia, Claudia Zuccotti, Gianvincenzo Ronchini, Chiara Bellerba, Federica Dewald, Felix Kaiser, Rolf Incardona, Francesca |
author_facet | Raimondi, Sara Gandini, Sara Rubio Quintanares, Gibran Horemheb Abecasis, Ana Lopalco, Pier Luigi D’Ecclesiis, Oriana Chiocca, Susanna Tomezzoli, Elisa Cutica, Ilaria Mazzoni, Davide Amparo, Nuno Pingarilho, Marta Carmagnola, Daniela Dallavia, Claudia Zuccotti, Gianvincenzo Ronchini, Chiara Bellerba, Federica Dewald, Felix Kaiser, Rolf Incardona, Francesca |
author_sort | Raimondi, Sara |
collection | PubMed |
description | BACKGROUND: Contradictory results were reported on the role of school closure/reopening on the overall SARS-CoV-2 transmission rate, as well as on which kind and level of mitigation measures implemented in schools may be effective in limiting its diffusion. Some recent studies were reassuring, showing that opening did not increase the community spread, although teachers and families are worried about the high class density. On the other hand, distance learning was associated with a negative impact on learning, sociability and psychological health, especially in vulnerable children. As it becomes clear that the SARS-CoV-2 pandemic will last for a long time, there is a high need for studies and solutions to support safe schools opening based on scientific evidence of harms and benefits. The Lolli-Methode (LM) is a strategy for epidemiological surveillance and early intervention aiming at SARS-CoV-2 outbreaks’ reduction in schools, relying on polymerase chain reaction analysis of saliva samples. METHODS: In this cluster randomised trial protocol, we aim to determine whether the LM is useful to support schools opening and to reduce clusters and attack rates in schools, compared with the standard of care (SoC) surveillance by public health departments. This multicenter study will enrol 440 classes (around 8800 students, teachers and other personnel) from two countries, cluster randomised to LM or SoC. The samples from the pools will be collected and tested using PCR-based techniques. Test results will be combined with questionnaires filled in by children, parents, schoolteachers, and principals, concerning ongoing mitigation measures, their perceived psychological impact and other health and socio-economic information. An ancillary observational study will be carried out to study the prevalence of SARS-CoV-2 in schools, frequencies and size of clusters and attack rates, to compare the effectiveness of the different preventive measures adopted and to evaluate psychological issues in students and teachers in relation to the pandemic’s containment measures. DISCUSSION: By the end of this study, we will have defined and characterised the applicability of the LM for SARS-CoV-2 surveillance, as well as the impact of pandemic preventive measures on children and teachers. Trial registration International Standard Randomised Controlled Trial Number: NCT05396040, 27.05.2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-022-07947-6. |
format | Online Article Text |
id | pubmed-9808677 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-98086772023-01-04 European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection Raimondi, Sara Gandini, Sara Rubio Quintanares, Gibran Horemheb Abecasis, Ana Lopalco, Pier Luigi D’Ecclesiis, Oriana Chiocca, Susanna Tomezzoli, Elisa Cutica, Ilaria Mazzoni, Davide Amparo, Nuno Pingarilho, Marta Carmagnola, Daniela Dallavia, Claudia Zuccotti, Gianvincenzo Ronchini, Chiara Bellerba, Federica Dewald, Felix Kaiser, Rolf Incardona, Francesca BMC Infect Dis Study Protocol BACKGROUND: Contradictory results were reported on the role of school closure/reopening on the overall SARS-CoV-2 transmission rate, as well as on which kind and level of mitigation measures implemented in schools may be effective in limiting its diffusion. Some recent studies were reassuring, showing that opening did not increase the community spread, although teachers and families are worried about the high class density. On the other hand, distance learning was associated with a negative impact on learning, sociability and psychological health, especially in vulnerable children. As it becomes clear that the SARS-CoV-2 pandemic will last for a long time, there is a high need for studies and solutions to support safe schools opening based on scientific evidence of harms and benefits. The Lolli-Methode (LM) is a strategy for epidemiological surveillance and early intervention aiming at SARS-CoV-2 outbreaks’ reduction in schools, relying on polymerase chain reaction analysis of saliva samples. METHODS: In this cluster randomised trial protocol, we aim to determine whether the LM is useful to support schools opening and to reduce clusters and attack rates in schools, compared with the standard of care (SoC) surveillance by public health departments. This multicenter study will enrol 440 classes (around 8800 students, teachers and other personnel) from two countries, cluster randomised to LM or SoC. The samples from the pools will be collected and tested using PCR-based techniques. Test results will be combined with questionnaires filled in by children, parents, schoolteachers, and principals, concerning ongoing mitigation measures, their perceived psychological impact and other health and socio-economic information. An ancillary observational study will be carried out to study the prevalence of SARS-CoV-2 in schools, frequencies and size of clusters and attack rates, to compare the effectiveness of the different preventive measures adopted and to evaluate psychological issues in students and teachers in relation to the pandemic’s containment measures. DISCUSSION: By the end of this study, we will have defined and characterised the applicability of the LM for SARS-CoV-2 surveillance, as well as the impact of pandemic preventive measures on children and teachers. Trial registration International Standard Randomised Controlled Trial Number: NCT05396040, 27.05.2022. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12879-022-07947-6. BioMed Central 2023-01-03 /pmc/articles/PMC9808677/ /pubmed/36597074 http://dx.doi.org/10.1186/s12879-022-07947-6 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Study Protocol Raimondi, Sara Gandini, Sara Rubio Quintanares, Gibran Horemheb Abecasis, Ana Lopalco, Pier Luigi D’Ecclesiis, Oriana Chiocca, Susanna Tomezzoli, Elisa Cutica, Ilaria Mazzoni, Davide Amparo, Nuno Pingarilho, Marta Carmagnola, Daniela Dallavia, Claudia Zuccotti, Gianvincenzo Ronchini, Chiara Bellerba, Federica Dewald, Felix Kaiser, Rolf Incardona, Francesca European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection |
title | European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection |
title_full | European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection |
title_fullStr | European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection |
title_full_unstemmed | European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection |
title_short | European Cohorts of patients and schools to Advance Response to Epidemics (EuCARE): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and SARS-CoV-2 infection |
title_sort | european cohorts of patients and schools to advance response to epidemics (eucare): a cluster randomised interventional and observational study protocol to investigate the relationship between schools and sars-cov-2 infection |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9808677/ https://www.ncbi.nlm.nih.gov/pubmed/36597074 http://dx.doi.org/10.1186/s12879-022-07947-6 |
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