Understanding how infections which cause ear discharge affect children and young people's lives and how they would like it to be treated

ISRCTN	ISRCTN46071200
DOI	https://doi.org/10.1186/ISRCTN46071200
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	320652
Protocol serial number	NIHR204036, IRAS 320652, CPMS 56928
Sponsor	Manchester University NHS Foundation Trust
Funder	Research for Patient Benefit Programme

Submission date: 06/06/2023
Registration date: 22/08/2023
Last edited: 03/04/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Ear, Nose and Throat

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
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. If the infection is not treated, the ear may continue to leak for weeks or months. It may also 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 it affects their lives. Importantly, we also do not know how best to treat it.
1. We want to understand how otorrhoea affects children and young people and their families everyday lives
2. We want to know which treatments children and young people and their carers would prefer and why
3. We want to ask medical professionals their experiences of treating children and young people with otorrhoea

Who can participate?
Children and young people aged 16 years and under who have or have had otorrhoea in the past 1 year & medical professionals who interact with this type of patient.

What does the study involve?
We are going to perform 30 interviews with children and young people with their carers and speak to 24 medical professionals.

What are the possible benefits and risks of participating?
Patients and medical professionals will have satisfaction in knowing they are helping to better the understanding of this health condition. They will be able to have their voices and opinions heard which will help shape future research in this area. Patients will receive a £25 voucher for their time. Medical professionals will be able to cite this activity as professional development and place any publications in their portfolio where they will be acknowledged. We will offer to send participants the research findings at the end of the study.

Where is the study run from?
Manchester University NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
November 2022 to March 2024

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).

Who is the main contact?
Dr Elliot Heward, elliotheward@doctors.org.uk
James Dempsey, POstudy@mft.nhs.uk

Contact information

Mr Elliot Heward
Principal investigator

Paediatric ENT Research Office
Royal Manchester Children's Hospital
Manchester
M13 9WL
United Kingdom

ORCID ID	0000-0002-9692-646X
Phone	+44 161 276 5606
Email	elliotheward@doctors.org.uk

Mr Elliot Heward
Scientific

Paediatric ENT Research Office
Royal Manchester Children's Hospital
Manchester
M13 9WL
United Kingdom

Phone	+44 161 276 5606
Email	elliotheward@doctors.org.uk

Mr James Dempsey
Public

Paediatric ENT Research Office
Royal Manchester Children's Hospital
Manchester
M13 9WL
United Kingdom

Phone	+44 161 276 5606
Email	POstudy@mft.nhs.uk

Study information

Primary study design	Observational
Study design	Qualitative Research - Semi-structured patient interviews & medication professional focus groups
Secondary study design	Qualitative study
Study type	Participant information sheet
Scientific title	Paediatric Otorrhoea Study (POSt): Understanding the burden of disease and acceptability of non-surgical management options
Study acronym	POSt
Study objectives	The primary objective of this study is to improve the understanding of the impact of paediatric otorrhoea (PO) on children and young people (CYP) and their carers. The secondary objectives of this study are to understand how and why CYP with PO are currently treated and to assess treatment and randomisation acceptability for CYP, their parents/carers and healthcare professionals for a future RCT.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Otorrhoea
Intervention	Patients will undertake a 60 minute semi structured interview with a qualitative researcher. Medical professionals will take part in a 60 minute focus group using a semi structured format. No subsequent follow up after the interview or focus group will be organised. Participants will be offered to be informed of the study findings. Total duration of involvement in the study is 1 day.
Intervention type	Other
Primary outcome measure(s)	Patient Interview Objectives: Understand the patient and carer experience of the condition using a 60 minute semi structured interview with a qualitative researcher analysed using thematic analysis Medical Professional Focus Group Objectives: Explore the experiences of medical professionals who manage children and young people with paediatric otorrhoea using a 60 minute focus group using a semi structured format analysed using thematic analysis
Key secondary outcome measure(s)	Patient Interview Objectives: Using a 60 minute semi structured interview with a qualitative researcher analysed using thematic analysis: 1. Understand the patient and carer experience of treatment 2. Identifying in the patient and carer’s opinion how they define treatment success 3. Identifying in the patient and carer’s opinion on randomisation in a future trial 4. Identifying in the patient and carer’s opinion on taking placebo medications 5. Identifying in the patient and carer’s opinion on motivators and barriers to participating in a randomised controlled trial Medical Professional Focus Group Objectives: Using a 60 minute focus group using a semi structured format analysed using thematic analysis 1. Understand the medical professional’s normal treatment practice 2. Understand how medical professional’s define treatment success 3. Understand the medical professional’s motivations and barriers to participating in a future randomised controlled trial
Completion date	31/03/2024

Eligibility

Participant type(s)	Patient, Health professional, Service user
Age group	Child
Lower age limit	0 Years
Upper age limit	16 Years
Sex	All
Target sample size at registration	54
Key inclusion criteria	Children and young people aged 16 years and under who have or have had otorrhoea in the past 1 year & medical professionals who interact with this patient cohort
Key exclusion criteria	Not experienced otorrhoea in the preceding year
Date of first enrolment	19/06/2023
Date of final enrolment	31/10/2023

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Royal Manchester Children's Hospital (Manchester University NHS Foundation Trust)

Oxford Road
Manchester
M13 9WL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/10/2024	03/04/2025	Yes	No
Protocol article		05/09/2023	06/09/2023	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/04/2025: Publication reference added.
05/12/2023: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2023 to 31/03/2024.
2. The intention to publish date was changed from 01/04/2024 to 01/06/2024.
3. The plain English summary was updated to reflect these changes.
02/10/2023: The overall study end date has been changed from 31/10/2023 to 31/12/2023 and the plain English summary updated accordingly.
06/09/2023: Publication reference added.
05/09/2023: Internal review.
06/06/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).