Laboratory detections of rotavirus from Public Health England Laboratory surveillance covering Merseyside residents will be included in the analysis. Other causative agents of AGE identified thing through laboratory testing including, for example, norovirus, adenovirus and astrovirus will also be extracted for analysis. Each data set will cover at least 3 years either side of vaccine introduction. All data will be pseudoanonymised to allow distinction of records but no linking
of data sets or identification of individuals will be undertaken. All data will be either geocoded from postcode to small statistical geographical community units termed Lower Super Output Areas (LSOAs) or sourced with this geography. LSOAs consist of approximately 1500 persons and denominator populations will be derived from the Office of National Statistics (ONS) mid-year population estimates by LSOA.29 Indicators of socioeconomic deprivation at LSOA level will be measured using the English Indices of Deprivation.
The UK Department for Communities and Local Government produce the English Indices of Deprivation using census and other local administrative data.28 Rotavirus vaccination uptake data will be sourced from the Child Health Information System (CHIS) which is held by community NHS health Trusts in Merseyside. Records of doses of vaccinations given as part of the UK childhood vaccine schedule are recorded in CHIS for each child. Quality control Data sources
such as HES and laboratory detections will be influenced by testing practices; for instance, testing of some organisms is more likely to occur at certain times of the year. In the hospital admission data set, it is possible that some cases of RVGE will not be coded as rotaviral enteritis (ICD10: A08.0) and may be classified as other unspecified either due to an absence of laboratory confirmation or misclassification/miscoding. In order to attempt to quantify this information bias, the investigator team will perform quality control on hospital admissions and laboratory detections at the lead NHS Trust hospital site (Alder Hey). Using a sample of cases from at least 3 years, those cases with a laboratory confirmation will be checked against clinical records and clinic coding and Brefeldin_A those coded as ICD10 A08.0 rotaviral enteritis will be cross-matched against laboratory detections. Based on the results of this assessment, it may be necessary to adjust the recorded number of hospital admissions for any ascertainment bias identified. Ethical considerations The study has been approved by NHS Research Ethics Committee, South Central-Berkshire REC Reference: 14/SC/1140. Data sharing agreement will be obtained between PHE, participating NHS Trusts and the University of Liverpool. Research governance approval will be sought form all participating NHS Trusts and Clinical Commissioning Groups.