Determinants of Zoster vaccination acceptance in people eligible for NHS shingles vaccination programme

Study type
Protocol
Date of Approval
Study reference ID
15_198
Lay Summary

Zostavax is a vaccine for people aged 50 years and over to prevent shingles and any associated complications. In September 2013, Zostavax was launched in the UK to immunise people between 70 and 79 years old. The UK is the first European country to introduce the shingles vaccine as part of its national immunisation programme.
The shingles vaccine has been routinely offered between September 2014 and September 2015 to people who are 70, 78 or 79 years old (as of 1st September 2014).

The purpose of this questionnaire based observational study is to find out how patients in the UK take their decision to have the shingles vaccination or not. This study will be conducted in the UK and will include roughly 500 patients who are 80 years old, from around 60 practices. Data will be collected using self-administered paper questionnaires completed by the patients and their General Practitioners (GP) and made anonymous.
The information from this study will help to understand the perceived benefits/barriers of shingles vaccination from patients' point of view. Apart from vaccine efficacy/effectiveness and vaccine safety, the patient acceptability is key for the success of a new vaccination program. Health Authorities are monitoring both the effectiveness/impact and safety of the UK shingles program. With this study we aim to better understand how patients in the UK decide to receive or not the shingles vaccination.

Technical Summary

The main objective of this non-interventional case-control study is to explore the determinants of the acceptance of the shingles vaccination in adults who were eligible for National Health Service (NHS) shingles vaccination programme in the United Kingdom, by comparing vaccinated patients with unvaccinated patients. We will leverage Clinical Practice Research Datalink (CPRD) general practitioners (GPs) network. This study also aims to describe the patients' population, to identify the sources of information that influenced the patient decision-making process and to assess the physician's opinion concerning the perceived barriers to Zoster vaccination.
Self-administered questionnaires will be distributed to patients aged 80 years and their GPs.
The study is based on the concept of Health Belief Model (HBM) that explains health seeking-behaviour by assessing how people perceive their susceptibility to a disease, the severity of the disease, as well as benefits or usefulness of taking a new behaviour in preventing the disease, and barriers to follow a preventive action. The underlying concept is that health behaviours are determined by personal beliefs or perceptions about a disease and the strategies available to minimise its occurrence. The model has been used in several studies to understand the differences between vaccinated and non-vaccinated people.
The patient questionnaire will collect socio-demographics, health status, as well as constructs from the health belief model.
The physician questionnaire will collect demographics, practice location, vaccine recommendations for elderly patients, communication campaign for Zoster vaccination and perceived barriers to Zoster vaccination. The patients' vaccination status, gender, year of birth, GPs' practice size and nation will be obtained from CPRD database.
The patients' and GPs' population will be described. The association between Zoster vaccination and beliefs expressed by the patients, modifying factors and cues to action will be assessed using a multivariate logistic regression model.

Collaborators

Helene Bricout - Chief Investigator - Sanofi Pasteur MSD ( closed )
Ana Wheelock - Collaborator - Imperial College London
Coralie Lecomte - Collaborator - IQVIA (Quintiles) France
Emma Boyle - Collaborator - Not from an Organisation
Laurence Torcel-Pagnon - Collaborator - Sanofi Pasteur MSD ( closed )
Nick Sevdalis - Collaborator - King's College London (KCL)
Stephane Thomas - Collaborator - Sanofi Pasteur MSD ( closed )
Xavier Cornen - Collaborator - Sanofi Pasteur MSD ( closed )