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 |
| IRAS number | 320652 |
| Secondary identifying numbers | NIHR204036, IRAS 320652, CPMS 56928 |
- 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
Plain English Summary
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
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 |
| elliotheward@doctors.org.uk |
Scientific
Paediatric ENT Research Office
Royal Manchester Children's Hospital
Manchester
M13 9WL
United Kingdom
| Phone | +44 161 276 5606 |
|---|---|
| elliotheward@doctors.org.uk |
Public
Paediatric ENT Research Office
Royal Manchester Children's Hospital
Manchester
M13 9WL
United Kingdom
| Phone | +44 161 276 5606 |
|---|---|
| POstudy@mft.nhs.uk |
Study information
| Study design | Qualitative Research - Semi-structured patient interviews & medication professional focus groups |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Home, Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a 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 hypothesis | 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 |
| Condition | 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 | 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 |
| Secondary outcome measures | 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 |
| Overall study start date | 01/11/2022 |
| Overall study end 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 | Both |
| Target number of participants | 30 patients and 24 medical professionals |
| Participant 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 |
| Participant exclusion criteria | Not experienced otorrhoea in the preceding year |
| Recruitment start date | 19/06/2023 |
| Recruitment end date | 31/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Manchester
M13 9WL
United Kingdom
Sponsor information
Hospital/treatment centre
Research Office
1st Floor, Nowgen Building
29 Grafton Street
Manchester
M13 9WU
England
United Kingdom
| Phone | +44 7815987923 |
|---|---|
| research.sponsor@mft.nhs.uk | |
| Website | https://mft.nhs.uk/ |
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The research findings will be presented at medical conferences and submitted for publication in one or more peer reviewed journals. In addition, we will publish the research on social media and the sponsor’s webpage to highlight the research findings. We will work with our PAG members, public members involved in the study workshop, and the Dipex charity to formulate an engagement plan to ensure the research findings are heard by the relevant audience. We will develop online materials with the Dipex charity for their website https://healthtalk.org which includes over 100 health topics. We aim to empower PAG members to help disseminate the research outcomes via local networks and online forums. We do not believe there are any potential risks or sensitivities for research dissemination in this area. |
| 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? |
|---|---|---|---|---|---|
| Protocol article | 05/09/2023 | 06/09/2023 | Yes | No | |
| Results article | 21/10/2024 | 03/04/2025 | Yes | No |
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).
