Assessing the Clinical and Socioeconomic Burden of Respiratory Syncytial Virus in Children Aged Under 5 Years in Primary Care: Protocol for a Prospective Cohort Study in England and Report on the Adaptations of the Study to the COVID-19 Pandemic

Uy Hoang, Elizabeth Button, Miguel Armstrong, Cecilia Okusi, Joanna Ellis, Maria Zambon, Sneha Anand, Gayathri Delanerolle, F. D.Richard Hobbs, Jojanneke van Summeren, John Paget, Simon de Lusignan*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Respiratory syncytial virus (RSV) commonly causes lower respiratory tract infections and hospitalization in children. In 2019-2020, the Europe-wide RSV ComNet standardized study protocol was developed to measure the clinical and socioeconomic disease burden of RSV infections among children aged <5 years in primary care. RSV has a recognized seasonality in England. Objective: We aimed to describe (1) the adaptations of the RSV ComNet standardized study protocol for England and (2) the challenges of conducting the study during the COVID-19 pandemic. Methods: This study was conducted by the Oxford-Royal College of General Practitioners Research and Surveillance Centre-the English national primary care sentinel network. We invited all (N=248) general practices within the network that undertook virology sampling to participate in the study by recruiting eligible patients (registered population: n=3,056,583). Children aged <5 years with the following case definition of RSV infection were included in the study: those consulting a health care practitioner in primary care with symptoms meeting the World Health Organization's definition of acute respiratory illness or influenza-like illness who have laboratory-confirmed RSV infection. The parents/guardians of these cases were asked to complete 2 previously validated questionnaires (14 and 30 days postsampling). A sample size of at least 100 RSV-positive cases is required to estimate the percentage of children that consult in primary care who need hospitalization. Assuming a swab positivity rate of 20% in children aged <5 years, we estimated that 500 swabs are required. We adapted our method for the pandemic by extending sampling planned for winter 2020-2021 to a rolling data collection, allowing verbal consent and introducing home swabbing because of increased web-based consultations during the COVID-19 pandemic. Results: The preliminary results of the data collection between International Organization for Standardization (ISO) weeks 1-41 in 2021 are described. There was no RSV detected in the winter of 2020-2021 through the study. The first positive RSV swab collected through the sentinel network in England was collected in ISO week 17 and then every week since ISO week 25. In total, 16 (N=248, 6.5%) of the virology-sampling practices volunteered to participate; these were high-sampling practices collecting the majority of eligible swabs across the sentinel network-200 (43.8%) out of 457 swabs, of which 54 (N=200, 27%) were positive for RSV. Conclusions: Measures to control the COVID-19 pandemic meant there was no circulating RSV last winter; however, RSV has circulated out of season, as detected by the sentinel network. The sentinel network practices have collected 40% (200/500) of the required samples, and 27% (54/200) were RSV positive. We have demonstrated the feasibility of implementing a European-standardized RSV disease burden study protocol in England during a pandemic, and we now need to recruit to this adapted protocol.

Original languageEnglish
Article numbere38026
JournalJMIR Research Protocols
Volume11
Issue number8
DOIs
Publication statusPublished - 1 Aug 2022
Externally publishedYes

Bibliographical note

Funding Information:
This collaborative study is funded by the Netherlands Institute for Health Services Research (Nivel), Utrecht, the Netherlands, through grants provided by Sanofi and AstraZeneca (study code RSV 00027). Nivel reviewed and proposed edits to the study protocol and study documents prior to submission for ethics approval. The manuscript was also reviewed by Sanofi before submission.

Funding Information:
JP and JvS declares that the Netherlands Institute for Health Services Research has received unrestricted research grants from the World Health Organization, the European Union’s Innovative Medicines Initiative, Sanofi, and the Foundation for Influenza Epidemiology. SdL is the director of the Oxford-Royal College of General Practitioners Research and Surveillance Centre. SdL has undertaken projects unrelated to RSV funded by GSK, Takeda, and Seqirus and has been a member of Global Advisory Boards for Seqirus and Sanofi.

Publisher Copyright:
© 2022 JMIR Publications. All rights reserved.

Keywords

  • children
  • COVID-19
  • general practice
  • general practitioners
  • medical records systems, computerized
  • outcome assessment, health care
  • pandemics
  • pediatric
  • primary health care
  • respiratory
  • respiratory syncytial virus

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