Paediatric Otorrhoea: Understanding the burden of disease

Study type
Protocol
Date of Approval
Study reference ID
22_002508
Lay Summary

What is Otorrhoea?

Ear infections are common in children and young people. During an infection the ear drum can burst, causing infected smelly fluid to leak out of the ear. This fluid is called otorrhoea. Many will settle without treatment, but in some, the ear may continue to leak for weeks or months. It may then cause hearing loss, which might make it harder for children to develop speech and language skills. Rarely, more serious complications can occur, for example if the ear infection spreads to the bone of the skull and the brain. Despite ear infections and otorrhoea being common in children, we do not know how many children and young people in the UK have the condition, how treatment varies, or which is the best treatment.

What are the Aims of the Study?

We want to understand how many children and young people develop otorrhoea in the UK, who it affects and how it is managed. We wish to use the data from the Clinical Practice Research Datalink Aurum to achieve this.

How will this Study Benefit Patients?

The findings of this research will help stimulate and shape future research in the UK for children and young people with otorrhoea. Future studies will help determine which is the best treatment option for children and young people with otorrhoea which will reduce patient suffering, complications, and treatment side effects.

Technical Summary

Paediatric otorrhoea (PO) is discharge from a child’s ear, that usually results from an infection of the middle ear. This descriptive study will aim to determine the incidence of otorrhoea in children and young people aged 16 years and below in the UK. We will use the index of multiple deprivation, biological sex assigned at birth, age and geographical location to demonstrate in which patient populations this disease is more prevalent. We will explore the current prescribing practice for paediatric otorrhoea.

Patients within the CPRD Aurum between January 2005 to December 2022 will be included. We will examine the effect of COVID-19 on attendances and prescribing practice. We will generate these incidence estimates by counting the number of incident cases and divide them by the total person-year at risk. The incidence will be presented as per 1000 person years with its 95% confidence interval. We will assess variation in treatment practice across the UK.

Health Outcomes to be Measured

Primary Outcome Measure: Diagnosis with paediatric otorrhoea

Secondary Outcomes Measures:
• Prescriptions for PO
• Referral to secondary care

Factors Measured:
• Biological Sex at Birth
• Age
• Geographical location
• Index of Multiple Deprivation
• Otorrhoea microbiology results

Collaborators

Darren Ashcroft - Chief Investigator - University of Manchester
Elliot Heward - Corresponding Applicant - University of Manchester
Alastair Hay - Collaborator - University of Bristol
Eleni Domzaridou - Collaborator - University of Manchester
Matthew Carr - Collaborator - University of Manchester
Sean Gavan - Collaborator - University of Manchester

Linkages

Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation