Pneumococcal disease is a lung infection causes by a wide range of microorganisms such as the bacteria Streptococcus pneumoniae. This can cause mild to severe symptoms that affect each patient differently; however, it is a highly preventable disease thanks to vaccination.
Since 2006 the first pneumococcal vaccine (PCV7) was introduced in the routine childhood immunization program in England. In April 2010, the new vaccine PCV13 covering more serotypes (sub-species of the microorganism) replaced the previous vaccine (PCV7). Currently a new vaccine that protects more serotypes is being developed to prevent some severe symptoms such as invasive pneumococcal disease, pneumonia, and acute otitis media (ear impairment).
This study will use the data collected in CPRD to determine the number of people who have invasive pneumococcal disease, pneumonia, and acute otitis media, how the number of patients has changed before and after these childhood vaccination programmes started in England, and describe their characteristics. Additionally, this study will look at how these people use healthcare services, are admitted to hospitals and the economic costs.
The results of this study will fill in the gaps in our knowledge about the number of people who suffer from pneumococcal diseases in England and will help to understand the need for a new vaccine.
The aim of this study is to examine invasive and non-invasive pneumococcal disease incidence in England in primary care and inpatient settings from 2003 to 2019, including before and after the introduction of PCV7 and PCV13 vaccines and the late post PCV13 period. The study will additionally estimate healthcare resource utilisation (HCRU) and costs associated with these episodes.
Incidence rates for invasive pneumococcal disease (IPD), pneumonia and acute otitis media (AOM) episodes will be estimated separately for each calendar year over the entire study period. Episodes will be created using information from inpatient and primary care settings.
Case fatality rates will be assessed to measure the severity of IPD and pneumonia in hospitalised children. HCRU and costs will be estimated annually for IPD, pneumonia and AOM episodes and compared across pre and post PCV time periods. HCRU will include the number of hospitalisations, average length of stay in hospital, number of GP visits, and number of antibiotic prescriptions in primary care for IPD, pneumonia and AOM episodes. The demographic characteristics and known risk factors associated with IPD, pneumonia and AOM episodes will also be described. The annual incidence of simple versus recurrent AOM will be estimated as well as the HCRU and costs associated to these episodes.
Exploratory analyses related to meningitis complications, will also describe the number of hospitalisations as well as the sequalae at discharge, the HCRU and costs during the year after the meningitis hospitalisation.
For each period between October to March, the incidence of AOM will also be calculated and then retrospectively the Respiratory Syncytial Virus (RSV) and bronchiolitis incidence during the previous 14 days.
The primary outcomes to be measured are:
- Incidence rates of IPD, pneumonia and AOM episodes
- Case Fatality Rates associated with inpatient IPD and pneumonia admissions
- HCRU associated with IPD, pneumonia and AOM episodes:
• Number of inpatient admissions
• Total inpatient length of stay
• Number of GP visits
• Number of GP antibiotic prescriptions
- Costs associated with IPD, pneumonia and AOM episodes:
• Inpatient cost
• GP visit cost
• GP prescription cost
• Total costs
The secondary outcomes to be measured are:
- Incidence of simple vs. recurrent AOM
- HCRU and costs associated with simple vs. recurrent AOM
- Proportion of meningitis hospitalizations resulting in sequelae at the time of hospital discharge
- HCRU and Costs associated with managing meningitis sequelae
- AOM incidence during UK’s RSV season with incidence of retrospective bronchiolitis or RSV diagnosis during the previous 14 days
Salini Mohanty - Chief Investigator - Merck & Co. Inc - Pennsylvania, USA
Bélène Podmore - Corresponding Applicant - OXON Epidemiology - Spain
Eric Sarpong - Collaborator - Merck & Co., Inc.
Ian Matthews - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Ignacio Mendez - Collaborator - OXON Epidemiology - Spain
Jessica Weaver - Collaborator - Merck & Co., Inc.
Julia Agúndez - Collaborator - OXON Epidemiology - Spain
Laura Spowart - Collaborator - MSD Vaccins
Lorena Baquero Portela - Collaborator - OXON Epidemiology - Spain
Nawab Qizilbash - Collaborator - OXON Epidemiology - Spain
Rebeca Gonzalez Eriksen - Collaborator - OXON Epidemiology - Spain
Sergio Eslava - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Susan Farrow - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Tianyan Hu - Collaborator - Merck & Co. Inc - Pennsylvania, USA
2011 Rural-Urban Classification at LSOA level;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation