An observational database study to estimate the burden of respiratory syncytial virus (RSV) infections using multiple databases in the United Kingdom, 2004 to 2019, by age and risk group

Study type
Protocol
Date of Approval
Study reference ID
21_000594
Lay Summary

Respiratory syncytial virus (RSV) is a highly contagious pathogen that causes multiple respiratory tract infections through life. The burden of RSV infection depends on the age of the patient or whether the patient suffered from other health conditions or diseases. This study will use data from the Clinical Research Datalink (CPRD) and Public Health England (PHE) virology data to estimate the number of GP consultations attributable to RSV for different age groups. It will also determine the burden of disease for patients that have a higher risk to develop severe complications associated with RSV. The results of this study will be published and presented at medical conferences and could be used to guide future measures for the prevention and treatment of respiratory disease caused by RSV.

Technical Summary

Respiratory syncytial virus (RSV) causes lower respiratory tract infections at all ages. As the global population ages, morbidity and mortality due to respiratory disease appear to be steadily increasing in the older adult population. Accurate estimation of the RSV burden of disease is essential to guide public health activities and policy related to RSV prevention and treatment. This study will estimate the RSV-attributable GP consultations, hospitalisations, and deaths for respiratory diseases in the total population, as well as separately by age group, risk group (defined based on chronic conditions indicating severe influenza risk as per UK recommendations for influenza vaccination), and calendar time.
The incidence proportion of weekly, seasonal, and annual events attributable to RSV will be estimated using multiple linear time series regression regressing the number of GP consultations due to respiratory diseases extracted from CPRD on the number of virological laboratory reports obtained from UKHSA (former PHE). Preliminary estimates of the RSV case fatality rate will also be obtained based on RSV attributable GP consultations, hospitalisations, and deaths. These will be calculated both as the hospitalisation case fatality ratio, and as the case fatality ratio among all patients who sought care for RSV.

Health Outcomes to be Measured

Primary outcomes: occurrence of potentially RSV-attributable GP consultations associated with respiratory outcomes.
Secondary outcomes: occurrence of potentially RSV-attributable GP consultations associated with control outcomes.

Collaborators

Jean-Yves Pirçon - Chief Investigator - GlaxoSmithKline Biologicals SA (Belgium)
Emmanuel ARIS - Corresponding Applicant - GlaxoSmithKline Biologicals SA (Belgium)
Daniel Molnar - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Desmond Curran - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Emmanuel ARIS - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Kaatje Bollaerts - Collaborator - P95
Marie-Pierre David - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Mélanie Lelubre - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Silvia Damaso - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Sophie Caterina - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Veronica Hulstrom - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Yolanda Penders - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)
Yves BRABANT - Collaborator - GlaxoSmithKline Biologicals SA (Belgium)