title: Ecological assessment of the direct and indirect effects of routine rotavirus vaccination in Merseyside, UK using data from multiple health systems: a study protocol.
abstract: BACKGROUND
  Rotavirus is the most common cause of severe gastroenteritis in infants and young children worldwide. Currently 67 countries include rotavirus vaccine in childhood immunisation programmes, but uptake in Western Europe has been slow. In July 2013, rotavirus vaccine was introduced into the UK's routine childhood immunisation programme. Prior to vaccine introduction in the UK, rotavirus was estimated to result in 750,000 diarrhoea episodes and 80,000 general practice (GP) consultations each year, together with 45% and 20% of hospital admissions and emergency department attendances for acute gastroenteritis, in children under 5 years of age. This paper describes a protocol for an ecological study that will assess rotavirus vaccine impact in the UK, to inform rotavirus immunisation policy in the UK and in other Western European countries.
  
  
  METHODS
  In Merseyside, UK, we will conduct an ecological study using a 'before and after' approach to examine changes in gastroenteritis and rotavirus incidence following the introduction of rotavirus vaccination. Data will be collected on mortality, hospital admissions, nosocomial infection, emergency department attendances, GP consultations and community health consultations to capture all healthcare providers in the region. We will assess both the direct and indirect effects of the vaccine on the study population. Comparisons of outcome indicator rates will be made in relation to vaccine uptake and socioeconomic status.
  
  
  BACKGROUND
  The study has been approved by NHS Research Ethics Committee, South Central-Berkshire REC Reference: 14/SC/1140. Study outputs will be disseminated through scientific conferences and peer-reviewed publications. The study will demonstrate the impact of rotavirus vaccination on the burden of disease from a complete health system perspective. It will identify key areas that require improved data collection tools to maximise the usefulness of this surveillance approach and will provide a template for vaccine evaluations using ecological methods in the UK.
authors.affiliation: Department of Clinical Infection, Microbiology & Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, UK Field Epidemiology Services, Public Health England, Liverpool, UK.
authors.forename: Daniel
authors.identifier: http://orcid.org/0000-0002-9770-0163
authors.initials: D
authors.lastname: Hungerford
authors.affiliation: Field Epidemiology Services, Public Health England, Liverpool, UK.
authors.forename: Roberto
authors.initials: R
authors.lastname: Vivancos
authors.affiliation: Department of Clinical Infection, Microbiology & Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, UK Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.
authors.forename: Neil
authors.initials: N
authors.lastname: French
authors.affiliation: Department of Clinical Infection, Microbiology & Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, UK.
authors.forename: Miren
authors.initials: M
authors.lastname: Iturriza-Gomara
authors.affiliation: Department of Clinical Infection, Microbiology & Immunology, Institute of Infection and Global Health, University of Liverpool, Liverpool, UK Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
authors.forename: Nigel
authors.initials: N
authors.lastname: Cunliffe
mesh_terms: D002675:Child, Preschool; D005759:Gastroenteritis / Q000453:epidemiology* / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007223:Infant; D009313:National Health Programs; D012400:Rotavirus Infections / Q000453:epidemiology* / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D006113:United Kingdom / Q000453:epidemiology
chemical_list: D022243:Rotavirus Vaccines
keywords: IMMUNOLOGY; STATISTICS & RESEARCH METHODS