Epidemiology of hospitalisations due to chickenpox and quality of life lost in community and hospital settings: protocol for a prospective cohort study across two countries.

While still a ubiquitous disease of childhood, chickenpox has been effectively controlled in many countries through the use of vaccination. Previous health economic assessment of the use of these vaccines in the UK were based on limited quality of life data and only routinely collected epidemiological outcomes. This two armed study will carry prospective surveillance of hospital admissions and recruit from community settings to measure the acute quality of life loss caused by paediatric chickenpox both in the UK and in Portugal. The quality of life effects on children and their primary and secondary caregivers will be assessed using the EuroQol EQ-5D with the Child Health Utility instrument (CHU-9) in addition for children. Results will be used to derive quality-adjusted life year loss estimates for cases of simple varicella and the secondary complications. We have received National Health Service ethical approval (REC ref: 18/ES/0040) for the inpatient arm, university ethical approval (University of Bristol ref: 60721) for the community arm and 10 sites currently are recruiting in the UK and 14 in Portugal. Informed consent is obtained from the parent(s). Results will be disseminated in peer-reviewed publications. ISRCTN15017985.

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Déclaration de conflit d'intérêts

Competing interests: FR has received honoraria for consultancy and/or lectures from GSK and MSD. RM has received investigator led grants from GSK and MSD. These are paid to his institution and he does not receive any (direct or indirect) financial benefit from them. AF is a member of the Joint Committee on Vaccination and Immunisation, the UK national immunisation technical advisory group and is the chair of the WHO European Technical Advisory Group of Experts (ETAGE) on immunisation. He is the investigator in clinical vaccine trials funded by GSK and is also co-investigator of similar studies of varicella epidemiology funded by both GSK and MSD in the UK but receives no personal remuneration for this work. MR, JO, ZJ, GA and JL-B have no conflicts of interest.