tetano
Editor, Senior Moderator
NIHR Open Res
. 2024 Jul 11:4:1.
doi: 10.3310/nihropenres.13517.2. eCollection 2024. Adapting COVID-19 research infrastructure to capture influenza and respiratory syncytial virus alongside SARS-CoV-2 in UK healthcare workers winter 2022/23 and beyond: protocol for a pragmatic sub-study
Jonathan Broad[SUP] #[/SUP][SUP] 1 [/SUP], Dominic Sparkes[SUP] #[/SUP][SUP] 1 [/SUP], Naomi Platt[SUP] #[/SUP][SUP] 1 [/SUP], Anna Howells[SUP] 1 [/SUP], Sarah Foulkes[SUP] 1 [/SUP], Jameel Khawam[SUP] 1 [/SUP], Michelle Cole[SUP] 1 [/SUP], Nick Andrews[SUP] 1 [/SUP], Conall Watson[SUP] 1 [/SUP], Susan Hopkins[SUP] 1 [/SUP], Victoria Hall[SUP] 1 [/SUP]; SIREN study team
Affiliations
Introduction: During the COVID-19 pandemic, extensive research was conducted on SARS-CoV-2; however, important questions about other respiratory pathogens remain unanswered. A severe influenza season in 2022-2023 with simultaneous circulation of SARS-CoV2 and respiratory syncytial virus is anticipated. This sub-study aims to determine the incidence and impact of these respiratory viruses on healthcare workers, the symptoms they experienced, the effectiveness of both COVID-19 and influenza vaccination and the burden of these infections on the National Health Service (NHS) workforce.
Methods and analysis: This is a longitudinal prospective cohort sub-study, utilising the population and infrastructure of the SARS-CoV-2 Immunity & Reinfection Evaluation (SIREN) study, which focuses on hospital staff in the UK. Participants undergo fortnightly nucleic acid amplification testing on a multiplex assay including SARS-CoV-2, influenza A and B and RSV, regardless of symptoms. Questionnaires are completed every two weeks, capturing symptoms, sick days, exposures, and vaccination records. Serum samples are collected monthly or quarterly from participants associated with a SIREN site. This sub-study commenced on 28/11/22 to align with the predicted influenza season and participants' influenza vaccine status. The SIREN Participant Involvement Panel shaped the aims and methods for the study, highlighting its acceptability. UK devolved administrations were supported to develop local protocols. Analysis plans include incidence of asymptomatic and symptomatic infection, comparisons of vaccination coverage, assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. Data are also integrated into UKHSA nosocomial modelling.
Ethics and dissemination: The protocol was approved by the Berkshire Research Ethics Committee (IRAS ID 284460, REC Reference 20SC0230) on 14/11/2022. Participants were informed in advance. As the frequency and method of sampling remained the same, implied consent processes were approved by the committee. Participants returning to the study give informed consent. Regular reports to advisory groups and peer-reviewed publications are planned to disseminate findings and inform decision making. Clinical trial registration number: ISRCTN11041050; registration date: 12 January 2021. Sub study included in protocol version: v8.0, and amended in v9.0.
Keywords: COVID-19; Influenza; Respiratory Syncytial Virus; Winter pressures.
Plain language summary
During the COVID-19 pandemic, extensive research was conducted on COVID-19; however, important questions about other lung viruses remain unanswered. Two important seasonal respiratory viruses are Influenza ‘flu’ and respiratory syncytial virus. In 2022, after two years of the pandemic and pandemic measures, there were particular concerns about how other chest viruses might reappear and interact with COVID-19 over the winter months. In 2020 we recruited a group of healthcare workers (a cohort) and followed them up over time asking them to complete regular testing and questionnaires. This is the SIREN study cohort. This protocol describes how we have adapted the study over winter 2022-2023 to investigate the burden of winter pressures on the workforce. A severe Influenza ‘flu’ season in 2022–2023 with simultaneous circulation of COVID-19 and respiratory syncytial virus was anticipated. This sub-study aims to determine the number of new cases and impact of these viruses on healthcare workers, the symptoms they experience, the effectiveness of both COVID-19 and flu vaccination and the burden of these infections on the National Health Service workforce. Between November 2022 and March 2023 participants provided fortnightly nose and throat swabs which were tested for COVID-19, Influenza and RSV, regardless of symptoms. Questionnaires were completed every two weeks, capturing symptoms, sick days, potential routes of infection (exposures), and vaccination records. Blood samples were collected monthly or quarterly from participants associated with a SIREN site. Healthcare worker participants contributed to the design of the study through a group that we have established to represent the study participants known as the Participant Involvement Panel (PIP). UK devolved administrations were supported to develop local protocols. Analysis plans include new cases of people with infection but with and without symptoms, comparisons of how many people received vaccination, assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. The protocol was reviewed and approved by an external group responsible for ensuring research is conducted in an ethical way (the Berkshire Research Ethics Committee). We ensured participants were fully informed in advance of the purpose of the research and how their data was being used and they could withdraw at any time.
. 2024 Jul 11:4:1.
doi: 10.3310/nihropenres.13517.2. eCollection 2024. Adapting COVID-19 research infrastructure to capture influenza and respiratory syncytial virus alongside SARS-CoV-2 in UK healthcare workers winter 2022/23 and beyond: protocol for a pragmatic sub-study
Jonathan Broad[SUP] #[/SUP][SUP] 1 [/SUP], Dominic Sparkes[SUP] #[/SUP][SUP] 1 [/SUP], Naomi Platt[SUP] #[/SUP][SUP] 1 [/SUP], Anna Howells[SUP] 1 [/SUP], Sarah Foulkes[SUP] 1 [/SUP], Jameel Khawam[SUP] 1 [/SUP], Michelle Cole[SUP] 1 [/SUP], Nick Andrews[SUP] 1 [/SUP], Conall Watson[SUP] 1 [/SUP], Susan Hopkins[SUP] 1 [/SUP], Victoria Hall[SUP] 1 [/SUP]; SIREN study team
Affiliations
- PMID: 39931702
- PMCID: PMC11808846
- DOI: 10.3310/nihropenres.13517.2
Introduction: During the COVID-19 pandemic, extensive research was conducted on SARS-CoV-2; however, important questions about other respiratory pathogens remain unanswered. A severe influenza season in 2022-2023 with simultaneous circulation of SARS-CoV2 and respiratory syncytial virus is anticipated. This sub-study aims to determine the incidence and impact of these respiratory viruses on healthcare workers, the symptoms they experienced, the effectiveness of both COVID-19 and influenza vaccination and the burden of these infections on the National Health Service (NHS) workforce.
Methods and analysis: This is a longitudinal prospective cohort sub-study, utilising the population and infrastructure of the SARS-CoV-2 Immunity & Reinfection Evaluation (SIREN) study, which focuses on hospital staff in the UK. Participants undergo fortnightly nucleic acid amplification testing on a multiplex assay including SARS-CoV-2, influenza A and B and RSV, regardless of symptoms. Questionnaires are completed every two weeks, capturing symptoms, sick days, exposures, and vaccination records. Serum samples are collected monthly or quarterly from participants associated with a SIREN site. This sub-study commenced on 28/11/22 to align with the predicted influenza season and participants' influenza vaccine status. The SIREN Participant Involvement Panel shaped the aims and methods for the study, highlighting its acceptability. UK devolved administrations were supported to develop local protocols. Analysis plans include incidence of asymptomatic and symptomatic infection, comparisons of vaccination coverage, assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. Data are also integrated into UKHSA nosocomial modelling.
Ethics and dissemination: The protocol was approved by the Berkshire Research Ethics Committee (IRAS ID 284460, REC Reference 20SC0230) on 14/11/2022. Participants were informed in advance. As the frequency and method of sampling remained the same, implied consent processes were approved by the committee. Participants returning to the study give informed consent. Regular reports to advisory groups and peer-reviewed publications are planned to disseminate findings and inform decision making. Clinical trial registration number: ISRCTN11041050; registration date: 12 January 2021. Sub study included in protocol version: v8.0, and amended in v9.0.
Keywords: COVID-19; Influenza; Respiratory Syncytial Virus; Winter pressures.
Plain language summary
During the COVID-19 pandemic, extensive research was conducted on COVID-19; however, important questions about other lung viruses remain unanswered. Two important seasonal respiratory viruses are Influenza ‘flu’ and respiratory syncytial virus. In 2022, after two years of the pandemic and pandemic measures, there were particular concerns about how other chest viruses might reappear and interact with COVID-19 over the winter months. In 2020 we recruited a group of healthcare workers (a cohort) and followed them up over time asking them to complete regular testing and questionnaires. This is the SIREN study cohort. This protocol describes how we have adapted the study over winter 2022-2023 to investigate the burden of winter pressures on the workforce. A severe Influenza ‘flu’ season in 2022–2023 with simultaneous circulation of COVID-19 and respiratory syncytial virus was anticipated. This sub-study aims to determine the number of new cases and impact of these viruses on healthcare workers, the symptoms they experience, the effectiveness of both COVID-19 and flu vaccination and the burden of these infections on the National Health Service workforce. Between November 2022 and March 2023 participants provided fortnightly nose and throat swabs which were tested for COVID-19, Influenza and RSV, regardless of symptoms. Questionnaires were completed every two weeks, capturing symptoms, sick days, potential routes of infection (exposures), and vaccination records. Blood samples were collected monthly or quarterly from participants associated with a SIREN site. Healthcare worker participants contributed to the design of the study through a group that we have established to represent the study participants known as the Participant Involvement Panel (PIP). UK devolved administrations were supported to develop local protocols. Analysis plans include new cases of people with infection but with and without symptoms, comparisons of how many people received vaccination, assessment of sick day burden, and effectiveness of seasonal influenza against infection and time off work. The protocol was reviewed and approved by an external group responsible for ensuring research is conducted in an ethical way (the Berkshire Research Ethics Committee). We ensured participants were fully informed in advance of the purpose of the research and how their data was being used and they could withdraw at any time.