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
Authors: Broad Jonathan , Sparkes Dominic , Platt Naomi , Howells Anna , Foulkes Sarah , Khawam Jameel , Cole Michelle , Andrews Nick , Watson Conall , Hopkins Susan , Hall Victoria ,   the SIREN study team
Published: September 2023

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 (RSV) is anticipated. This sub-study aims to determine the incidence and impact of these respiratory viruses on healthcare workers (HCW), 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 SIREN, which focuses on hospital staff in the UK. Participants undergo fortnightly Nucleic Acid Amplification Testing (NAAT) on a multiplex assay including SARS-CoV-2, Influenza A&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 (PIP) 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.Trial registration number:ISRCTN11041050.

Strengths and limitations of this study

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The positioning of this sub-study, led by public health agencies in collaboration with a network of NHS sites, facilitates horizon scanning enabling rapid adaptation of the study protocol and deployment to conduct relevant scientific research in a cohort of healthcare workers

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To achieve target recruitment, deployment of a new postal pathway is underway, allowing for more direct communication between the central research team and participants

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The multi-disciplinary partnerships including a network of academic centres established and embedded by SIREN can now be leveraged and extended to explore ‘Flu and RSV

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Decentralised study delivery, with testing at a network of NHS sites has both strengths and limitations. This includes enabling more in-depth relationships and communications between participants and their local research teams, however, introduce additional communication, governance, and data sharing requirements.

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Some demographics are over-represented such as female staff, nurses and doctors, and some are under-represented such as staff from ethnic minorities, porters and estates. This is partly the consequence of a rapid recruitment drive at the beginning of the COVID-19 pandemic.