The clinical and economic burden of antibiotic use among paediatric patients with Varicella infection: a retrospective cohort analysis of real-world data in the UK

Study type
Protocol
Date of Approval
Study reference ID
21_000372
Lay Summary

Varicella (more commonly known as chicken-pox) is a common, infectious disease that usually presents in childhood. Varicella causes an itchy, red rash across large portions of the body, along with headaches, tiredness and general feelings of illness. Although the majority of varicella cases resolve on their own, some patients can develop complications requiring treatment and in the most severe cases, hospitalisation.

Treatment of varicella, and its associated complications, depends on the severity of symptoms, age of the patient, and if the patient has other health conditions. Majority of cases are self-treated at home with creams to soothe the rash and paracetamol to reduce fever and pain. Patients who experience complications however, such as skin infections, may be prescribed antibiotics.

Antibiotic use is on the rise globally and is propagated by the prescription of antibiotics to patients with unconfirmed bacterial diagnoses. The health and cost related impact of antibiotic use in varicella in the UK is not well known. Implementation of varicella vaccination programs may reduce antibiotic use. This study aims to describe children with Varicella and their disease characteristics, including the type and frequency of complications they may experience. We will also describe the range of different treatments patients receive to treat varicella and its complications, as well as reporting the use and costs associated with the healthcare provided to them, with a specific focus on antibiotics prescribed throughout the varicella disease course.

Technical Summary

Aim: To assess and characterize the use of antibiotics for the treatment and management of varicella and its associated complications in the paediatric population in the UK.

Objectives: i) to describe the demographics and clinical characteristics of paediatric patients diagnosed with varicella within a primary or secondary care setting ii) to describe the type and frequency of varicella-related complications iii) to examine treatment patterns with anti-infective (antibiotic and antiviral) usage iv) to estimate the direct medical costs of antibiotic use for the treatment of varicella infection and associated complications v) to describe for primary and secondary care related to varicella and associated complications, the all cause and varicella-related health care resource utilization (HCRU) and associated direct medical costs.

Primary exposures: physician diagnosis of varicella.

Outcomes: varicella-related complications, anti-infective treatment patterns, HCRU and costs

Methods: A retrospective cohort study of paediatric varicella patients between July 2014 and June 2019 (indexing period), using linked primary and secondary care administrative data. The index date will be defined as the date of the first diagnosis of varicella occurring in primary or secondary care during the indexing period. A minimum of 28 days baseline and 3-months follow-up data post (and including) the index date will be required for inclusion into the study, during which baseline sociodemographic characteristics, clinical characteristics including complications, treatment use patterns and HCRU/ costs will be described.

Data analysis: Counts, means, medians, standard deviation, 25th and 75th percentile values will be reported for numeric variables and relative frequencies, proportions/ percentages for nominal variables. Where applicable, all estimates will be described with accompanying 95% confidence intervals. HCRU and costs will be derived by observing consultations and medications in primary care, and Healthcare Resource Group (HRG) for secondary care.

Health Outcomes to be Measured

Type and frequency of varicella-related complications; anti-infective and supportive care (emollients, pain medication) treatment patterns including type, dosage and duration; all-cause and varicella-related HCRU; all-cause and varicella related direct medical costs

Collaborators

Stephanie Kujawski - Chief Investigator - Merck & Co., Inc.
Victoria Banks - Corresponding Applicant - Adelphi Real World
Amisha Patel - Collaborator - Adelphi Real World
Caroline Casey - Collaborator - Adelphi Real World
Christina Diomatari - Collaborator - Adelphi Real World
M.Nabi Kanibir - Collaborator - Merck & Co., Inc.
Manjiri Pawaskar - Collaborator - Merck & Co. Inc - Pennsylvania, USA
Olivia Massey - Collaborator - Adelphi Real World
Tim Holbrook - Collaborator - Adelphi Real World

Linkages

HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;Patient Level Index of Multiple Deprivation