Estimating Respiratory Syncytial Virus (RSV) burden in adults +50 years in the UK using Real-World Data: a database and time-series modelling study

Study type
Protocol
Date of Approval
Study reference ID
23_003140
Lay Summary

Respiratory syncytial virus (RSV) is a common virus that causes acute infections of the lungs and respiratory tract, leading to a substantial burden on healthcare systems worldwide. It affects both young children and older adults, especially those with chronic diseases or weakened immune systems. However, we don’t have a clear picture of the impact of RSV on adults aged 60 or older.
An RSV vaccine candidate (Arexvy) to protect adults aged ≥60 years from severe RSV infections was approved for use in Europe in June 2023. To make informed decisions on vaccines and preventative measures, we need to better understand how RSV affects older adults and how it impacts healthcare resources.
Therefore, this study explores data collected on RSV in older adults (aged ≥50 years) over an 8-year study period (2012 to 2020) in the UK in both primary and secondary care. The study population of adults aged 50 years or older aligns with the potential for future label extension of the vaccine. The study will estimate hospital admissions, primary care visits, and deaths due to respiratory infections, respiratory tract infection (RTI) and flu, and describe healthcare resource usage and costs related to respiratory infections, RSV and flu.
By analysing this data, we can make better decisions about how to prevent RSV infections in older adults, improving public health in the future.

Technical Summary

We aim to conduct a retrospective cohort study using primary care records (Clinical Practice Research Datalink (CPRD)) linked with secondary care data (Hospital Episode Statistics (HES)) in England for adults 50 years and older with an RTI-related hospital admission or primary care consultation. The study period will be from 01 July 2012 to 30 September 2020.
The study describes patients’ demographics and clinical characteristics and estimates the number and rate of RTI-associated hospital admissions and mortality, healthcare resource use (HCRU) and associated costs, the patient pathway and the number and rate of RTI-associated primary care consultations and mortality.
Patient characteristics of interest are age, gender, socioeconomic status based on Index of Multiple Deprivation (IMD), vaccination status for influenza, COVID-19 diagnosis, type of RTI (upper [URTI]/lower [LRTI]), comorbidities (chronic respiratory conditions, cardiac disorders, chronic kidney disease, chronic liver disease, diabetes, stroke, immunocompromised diseases) and high-risk status. Mortality variables of interest will include all mortality, in hospital mortality and primary care mortality. HCRU variables of interest are inpatient hospitalisations, length of hospital stay, intensive care unit (ICU) admissions, ventilation support, re-admissions, A&E visits, outpatient consultations and primary care consultations. Associated HCRU costs will be calculated for inpatient hospitalisations, ICU admission, A&E visits and outpatient consultations, using NHS reference tariffs. The admissions or consultations attributable to each pathogen of interest (RSV, influenza or COVID-19) will be estimated using time-series modelling where the weekly number of hospital admissions/primary care consultations for an RTI are regressed on the weekly number of hospital admissions/primary care consultations specified as being caused by the pathogen of interest.
This study will provide a deeper understanding of the burden of RSV in older adults to help generate awareness and inform decision-making on preventative measures, including use in cost-effectiveness modelling of RSV vaccines.

Health Outcomes to be Measured

Age at index date; gender at index date; Index of Multiple Deprivation (IMD) at index date; vaccination status for influenza in the 12 months prior to index date; type of RTI; diagnosis of COVID-19 at index date; comorbidities; High-risk status;

RTI-associated hospital admissions; RTI-associated inpatient hospitalisations; RTI-associated mortality (including all mortality and in hospital mortality);

Length of hospital stay; ICU admission; ventilation support; RTI-related re-admissions; all cause re-admissions; respiratory A&E visits; respiratory outpatient consultations; costs of inpatient hospitalisations; costs of ICU admissions; costs of outpatient consultations; costs of A&E visits; total HCRU costs;

RTI-associated primary care consultation within 30 days of RTI-associated hospital admission; RTI-associated hospital admission within 30 days of RTI-associated primary care consultation;

RTI-associated primary care consultations; RTI-associated mortality – primary care;

Cardiorespiratory-associated hospital admission; cardiorespiratory-associated deaths (cardiorespiratory-associated mortality); cardiorespiratory-associated deaths (cardiorespiratory-associated in hospital mortality); cardiorespiratory-associated primary care consultations; cardiorespiratory-associated mortality – primary care;

Collaborators

Catrina Richards - Chief Investigator - IQVIA Ltd ( UK )
Sonya Patel - Corresponding Applicant - IQVIA Ltd ( UK )
Briana Coles - Collaborator - IQVIA Ltd ( UK )
Fiona Hill - Collaborator - IQVIA Ltd ( UK )
GIANLUCA LUCREZI - Collaborator - IQVIA Solutions Italy S.r.l
Jessica Lundbom - Collaborator - IQVIA Ltd ( UK )
Lorena Cirneanu - Collaborator - IQVIA Ltd ( UK )
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
Quratul Ann - Collaborator - IQVIA Ltd ( UK )
Saskia Hagenaars - Collaborator - IQVIA Ltd ( UK )

Former Collaborators

Fiona Ingleby - Collaborator - IQVIA Ltd ( UK )
GIANLUCA LUCREZI - Collaborator - IQVIA Solutions Italy S.r.l
Louise Raiteri - Collaborator - IQVIA Ltd ( UK )
Quratul Ann - Collaborator - IQVIA Ltd ( UK )
Quratul Ann - Collaborator - IQVIA

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation