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Protocol for the Paediatric Otorrhoea Study (POSt): a multi-methods study to understand the burden of paediatric
Elliot Heward1, James Dempsey2, Judith Lunn3
1Division of Infection, Immunity and Respiratory Medicine, School of Biological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK elliotheward@doctors.org.uk.
Insights
This study investigates paediatric otorrhoea (PO) in the UK, aiming to determine its incidence and impact on children and families. Findings will inform future antibiotic treatment trials for this common childhood ear infection.
Area of Science:
- Paediatrics
- Infectious Diseases
- Epidemiology
Background:
- Paediatric otorrhoea (PO) is middle ear infection fluid leakage in children, often causing hearing loss and developmental issues.
- Current epidemiological data for PO primarily originates from low-income countries.
- Understanding PO's UK incidence and impact is crucial for effective management and research.
Purpose of the Study:
- To establish the incidence of paediatric otorrhoea (PO) in the UK.
- To explore the impact of PO on the daily lives of children and young people (CYP) and their families.
- To lay the groundwork for a randomised controlled trial on optimal antibiotic treatment for PO.
Main Methods:
- Utilising Clinical Practice Research Datalink (CPRD) data (2005-2021) to determine PO incidence and antimicrobial prescribing patterns.
- Conducting 30 semi-structured interviews with CYP and parents/carers to assess PO's impact on daily life and treatment success definitions.
- Holding three medical professional focus groups to understand current management, success metrics, and trial randomization acceptability, employing thematic analysis.
Main Results:
- The study is currently in progress, with data collection and analysis underway.
- Anticipated results will quantify PO incidence in the UK primary care setting.
- Qualitative data will illuminate the lived experiences of CYP and families affected by PO.
Conclusions:
- This research will provide essential UK-specific data on paediatric otorrhoea incidence and impact.
- Findings will inform clinical practice and guide the design of future interventional studies.
- Dissemination includes conferences, publications, social media, and a public-facing webpage.
Introduction:
Paediatric otorrhoea (PO) refers to the leakage of fluid through a perforation in the ear drum, resulting from an infection of the middle ear of a child or young person (CYP). PO frequently results in hearing loss which may lead to developmental delay, restricted communication and reduced educational attainment.Epidemiological information for PO is largely derived from low-income countries. The aim of this study will be to establish the incidence of PO within the UK and to understand the impact of PO on CYP and their families' everyday lives. It will build the foundations for a randomised controlled trial investigating the best antibiotic treatment for PO.
Methods And Analysis:
The study will consist of two work packages. (1) Data from the Clinical Practice Research Datalink (CPRD), January 2005 to July 2021, will be used to determine the incidence of patient presentations with PO to primary care in the UK. It will also explore the current antimicrobial prescribing practice for PO in primary care. (2) Thirty semi-structured interviews will be conducted from 13 July to 31 October 2023 with CYP and their parents/carers to help identify the impact of PO on everyday life, the patient journey and how service users define treatment success. Three medical professional focus groups will be used to understand the current management practice, how treatment success is measured and acceptability to randomise patients. Thematic analysis will be used.
Ethics And Dissemination:
The Health Research Authority, The Health and Social Care Research Ethics Committee (23/NI/0082) and the CPRD's research data governance panel (22_002508) reviewed this study. Results will be disseminated at medical conferences, in peer-reviewed journals and via social media. The study will cocreate a webpage on healthtalk.org, with the Dipex Charity, about PO to ensure members of the public can learn more about the condition.
Trial Registration Number:
ISRCTN46071200.
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