Nasal polyps (NP) are small growths inside the nose that can keep growing if not treated. Approximately 1-4% of adults have NP and they infrequently occur in children. NP are usually treated with saline nasal wash or steroid nasal spray. Surgery for the removal of NP is considered only when symptoms are so bad that current medications are not working. Even after surgery NPs can grow back over a period of months to years causing further discomfort to the patient. The more surgeries a patient has, the more likely it is he or she will lose sense of smell due to permanent damage and scarring inside the nose. The purpose of this study is to determine how many adults in England live with NP and how many have had surgery for the removal of NP. This study also aims to characterise patients with NP by age, gender, body mass index, smoking status, year of NP diagnosis, what other diseases they may have, what medications they are prescribed for NPs and to count the number of visits to their GP or hospital/specialist. The number of surgeries, time between surgeries, prescriptions for medications before and after surgery, and the number of visits to the doctor/specialist will also be reported. Estimating the proportion of adult patients living with NP and assessing their severity of disease by surgery number will help describe the burden of disease in England.
The intention of this study is to provide reliable data on the prevalence of nasal polyps (NP) identified in a primary care database as well as describe disease burden in England. Specifically, the primary objective is to characterise adult NP patients stratified by the number of surgeries for the removal of NP (i.e. 0, ≥1, ≥2 surgeries) with respect to their demographics, comorbidities, treatment patterns, and healthcare resource utilisation (HRU). Treatment patterns and HRU will also be assessed in the 30-days prior to surgery and 30- and 90-days post-surgery to understand the peri-surgery period. Secondary objectives include: 1) To estimate the point prevalence of diagnosed NP on 31st December, 2018 among adults in England and to determine the percentage of these patients with surgery; 2) To evaluate the rate and frequency of NP surgery, NP surgery failure and complications, and chronic rhinosinusitis (CRS) surgery among NP patients post-surgery, and to describe time between NP surgeries; and 3) To report blood eosinophil (EOS) levels among NP patients with and without NP surgery and by number of future surgeries. Patients will be stratified by the number of surgeries during follow-up and asthma status (sensitivity analysis).
Important comorbidities include CRS, asthma, NSAID-exacerbated respiratory disease (NERD), and chronic obstructive pulmonary disease (COPD). Treatments include nasal corticosteroids, systemic corticosteroids (including oral corticosteroids), and oral antibiotics. HRU includes all-cause attendances, all-cause GP attendances, all-cause inpatient attendances, and all-cause outpatient attendances.
This is a descriptive retrospective cohort study using the Clinical Practice Research Datalink (CPRD)-Aurum with Hospital Episodes Statistics (HES) linkage. HES APC data will be used to determine inpatient attendances, and HES OP data will be used to determine outpatient attendances. Statistical methods include count, percentage, mean, median, interquartile range, incidence rate, Kaplan-Meier curve, point prevalence, and proportion.
Patient demographics; clinical characteristics; selected comorbidities; NP-related prescriptions; blood eosinophil levels; HRU; CRS surgeries; NP surgery failures; surgery complications
Victoria Tribble - Chief Investigator - GlaxoSmithKline Services Unlimited (UK)
Jennifer Reed - Corresponding Applicant - GlaxoSmithKline - USA
Ana Sousa - Collaborator - GSK
Peter Howarth - Collaborator - GSK
Qinggong Fu - Collaborator - GlaxoSmithKline Research & Development Limited (UK)
Robert Chan - Collaborator - GlaxoSmithKline - UK
Shibing Yang - Collaborator - GSK
HES Admitted Patient Care;HES Outpatient