A core outcome set for research on the management of otitis media with effusion in otherwise-healthy children

Introduction
A Core Outcome Set (COS) is an agreed list of outcome domains to be reported by all studies investigating a condition. A COS for Otitis Media with Effusion (OME) in children with cleft palate exists (called MOMENT), but there isn't one for otherwise-healthy children. This study investigates whether the MOMENT COS could also be applicable to otherwise-healthy children.

Methods
A long list of potential outcomes was generated (independently of MOMENT) via three methods: literature review to establish which outcomes are reported by OME studies, a review of outcomes contained in OME questionnaires, and a focus group asking parents of children with OME what matters to them. The long list drawn up using these sources identified no outcomes additional to ones in the MOMENT long list. An online questionnaire was subsequently undertaken, asking parents/guardians and professionals/researchers whether they think that the MOMENT final list outcomes would also be applicable to otherwise healthy children.

Results
A total of 134 people took part: 53 parents/guardians (recruited through UK NHS hospitals) and 81 professionals/researchers (recruited internationally). Overall, 128 (95.5%) agreed that the MOMENT outcomes can also apply to otherwise healthy children (100% parents/guardians, 92.6% professionals/researchers).

Conclusions
The outcome domains identified in the COS for OME management in children with cleft palate can also be used in otherwise-healthy children.

Contributors

Paul Zhaobo Liu a
Hasnaa Ismail-Koch b
Kate Stephenson c
Adam J.Donne d
Neil Fergie a, e
Jo Derry a
Gill Stynes a
Tawakir Kamani a
John P.Birchall a
Mat Daniel a, f

a
Nottingham University Hospital / Nottingham Children's Hospital, United Kingdom

b
Southampton Children's Hospital, United Kingdom

c
Birmingham Women's and Children's NHS Foundation Trust, United Kingdom

d
Alder Hey Children's NHS Foundation Trust, United Kingdom

e
Sherwood Forest Hospitals, United Kingdom

f
Mat Daniel Consulting, United Kingdom

Publication

Journal: International Journal of Pediatric Otorhinolaryngology
Volume: 134
Issue:
Pages: -
Year: 2020
DOI: 10.1016/j.ijporl.2020.110029

Further Study Information

Current Stage: Completed
Date: January 2015 - January 2019
Funding source(s): British Society of Audiology, Nottingham Hospitals Charity, NIHR, MRC IHR funding


Health Area

Disease Category: Child health, Ear, nose, & throat

Disease Name: Otitis media

Target Population

Age Range: 0 - 12

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Focus group(s)
- Literature review
- Survey

A long list of potential outcomes was generated (independently of MOMENT) via three methods: lit-erature review to establish which outcomes are reported by OME studies, a review of outcomes contained inOME questionnaires, and a focus group asking parents of children with OME what matters to them. The long listdrawn up using these sources identified no outcomes additional to ones in the MOMENT long list. An onlinequestionnaire was subsequently undertaken, asking parents/guardians and professionals/researchers whetherthey think that the MOMENTfinal list outcomes would also be applicable to otherwise healthy children.

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