Estimating the burden of vaccine-preventable lower respiratory tract disease in UK primary care: protocol for a prospective surveillance study (AvonCAP GP2).
Polly Duncan, Ruth Mears, Elizabeth Begier, Sanaz Rouhbakhsh Halvaei, Jo Southern, Siân Bodfel Porter, Robin Hubler, Glenda Oben, George Qian, Maria Lahuerta, Tim Davis, James Campling, Shoba Dawson, Hannah Christensen, Jennifer Oliver, Begonia Morales-Aza, Kaijie Pan, Sharon Gray, Catherine Hyams, Leon Danon, Bradford D Gessner, Adam Finn, Alastair D Hay, AvonCAP GP2 research group
Author Information
Polly Duncan: Centre for Academic Primary Care, University of Bristol, Bristol, UK polly.duncan@bristol.ac.uk. ORCID
Ruth Mears: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
Elizabeth Begier: Global Respiratory Vaccines, Medical & Scientific Affairs, Pfizer Inc, Collegeville, PA, US.
Sanaz Rouhbakhsh Halvaei: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Jo Southern: Evidence Generation, Pfizer Inc, Collegeville, PA, US.
Siân Bodfel Porter: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Robin Hubler: Evidence Generation, Pfizer Inc, Collegeville, PA, US.
Glenda Oben: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
George Qian: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Maria Lahuerta: Global Respiratory Vaccines, Medical & Scientific Affairs, Pfizer Inc, Collegeville, PA, US.
Tim Davis: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
James Campling: Vaccines Medical Affairs, Pfizer Ltd, Tadworth, UK.
Shoba Dawson: Centre for Academic Primary Care, University of Bristol, Bristol, UK.
Hannah Christensen: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Jennifer Oliver: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Begonia Morales-Aza: Bristol Vaccine Centre, Schools of Population Health Science and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
Kaijie Pan: EvGen Statistics, Pfizer Research and Development, Pfizer Inc, Collegeville, PA, US.
BACKGROUND: The true burden of acute lower respiratory tract disease (aLRTD; includes acute lower respiratory tract infection [aLRTI] and presumed non-infective exacerbations of chronic lung disease and heart failure) among adults presenting to primary care, and the proportion that are potentially vaccine preventable is unknown. AIM: To describe aLRTD incidence in adults presenting to primary care; estimate proportions caused by respiratory syncytial virus (RSV), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and Streptococcus pneumoniae (SP); and investigate disease burden from patient and NHS perspectives. DESIGN & SETTING: Primary care prospective cohort study conducted in six representative general practices (total ∼86 000 registered adults) in Bristol, UK. METHOD: Adults (aged ≥18 years) registered at participating general practices and presenting to primary care (in-hours or out-of-hours) or emergency department (if not admitted) with aLRTD will be eligible. They will be identified by real-time primary care record searches. Researchers will screen electronic GP records, including free text, contact patients to assess eligibility, and offer enrolment in a surveillance study and an enhanced diagnostic study (urine, saliva, and respiratory samples; physical examination; and symptom diaries). Data will be collected for all aLRTD episodes, with patients assigned to one of three arms: surveillance; embedded diagnostic; and descriptive dataset. Outcome measures will include clinical and pathogen-defined aLRTD incidence rates, symptom severity and duration, NHS contacts and costs, health-related quality-of-life changes, and mortality (≤30 days post-identification). CONCLUSION: This comprehensive surveillance study of adults presenting to primary care with aLRTD, with embedded detailed data and sample collection, will provide an accurate assessment of aLRTD burden due to vaccine-preventable infections.
