Journals Library

An error occurred retrieving content to display, please try again.

Page not found (404)

Sorry - the page you requested could not be found.

Please choose a page from the navigation or try a website search above to find the information you need.

{{metadata.Title}}

{{metadata.Headline}}

{{author}}{{author}}{{($index < metadata.AuthorsAndEtalArray.length-1) ? ',' : '.'}}

Iain Bruce 1, Nicola Harman 2, Paula Williamson 2,3, Stephanie Tierney 4, Peter Callery 4, Syed Mohiuddin 5, Katherine Payne 5, Elisabeth Fenwick 6, Jamie Kirkham 3, Kevin O’Brien 2,*

1 Central Manchester University Hospitals NHS Foundation Trust, Royal Manchester Children’s Hospital, Manchester, UK
2 The Healing Foundation Cleft and Craniofacial Clinical Research Centre, School of Dentistry, University of Manchester, Manchester, UK
3 Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK
4 School of Nursing, Midwifery and Social Work, University of Manchester, Manchester, UK
5 Manchester Centre for Health Economics, Institute of Population Health, University of Manchester, Manchester, UK
6 ICON Health Economics, ICON plc, Oxford, UK
* Corresponding author Email: kevin.o’brien@manchester.ac.uk

{{metadata.Journal}} Volume: {{metadata.Volume}}, Issue:{{metadata.Issue}}, Published in {{metadata.PublicationDate | date:'MMMM yyyy'}}

https://dx.doi.org/{{metadata.DOI}}

Citation: {{author}}{{ (($index < metadata.AuthorsArray.length-1) && ($index <=6)) ? ', ' : '' }}{{(metadata.AuthorsArray.length <= 6) ? '.' : '' }} {{(metadata.AuthorsArray.length > 6) ? 'et al.' : ''}} {{metadata.Title}}. {{metadata.JournalShortName}} {{metadata.PublicationDate | date:'yyyy'}};{{metadata.Volume}}({{metadata.Issue}})

You might also be interested in:
{{classification.Category.Concept}}

Report Content

The full text of this issue is available as a PDF document from the Toolkit section on this page.

The full text of this issue is available as a PDF document from the Toolkit section on this page.

Abstract

BACKGROUND

Cleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate.

OBJECTIVES

To identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies.

DESIGN

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP.

SETTING

The survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients' homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting.

PARTICIPANTS

Clinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association.

RESULTS

The clinician survey revealed that care was predominantly delivered via a 'hub-and-spoke' model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research.

CONCLUSIONS

There exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered.

FUNDING

The National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

Abstract

BACKGROUND

Cleft lip and palate are among the most common congenital malformations, with an incidence of around 1 in 700. Cleft palate (CP) results in impaired Eustachian tube function, and 90% of children with CP have otitis media with effusion (OME) histories. There are several approaches to management, including watchful waiting, the provision of hearing aids (HAs) and the insertion of ventilation tubes (VTs). However, the evidence underpinning these strategies is unclear and there is a need to determine which treatment is the most appropriate.

OBJECTIVES

To identify the optimum study design, increase understanding of the impact of OME, determine the value of future research and develop a core outcome set (COS) for use in future studies.

DESIGN

The management of Otitis Media with Effusion in children with cleft palate (mOMEnt) study had four key components: (i) a survey evaluation of current clinical practice in each cleft centre; (ii) economic modelling and value of information (VOI) analysis to determine if the extent of existing decision uncertainty justifies the cost of further research; (iii) qualitative research to capture patient and parent opinion regarding willingness to participate in a trial and important outcomes; and (iv) the development of a COS for use in future effectiveness trials of OME in children with CP.

SETTING

The survey was carried out by e-mail with cleft centres. The qualitative research interviews took place in patients' homes. The COS was developed with health professionals and parents using a web-based Delphi exercise and a consensus meeting.

PARTICIPANTS

Clinicians working in the UK cleft centres, and parents and patients affected by CP and identified through two cleft clinics in the UK, or through the Cleft Lip and Palate Association.

RESULTS

The clinician survey revealed that care was predominantly delivered via a 'hub-and-spoke' model; there was some uncertainty about treatment strategies; it is not current practice to insert VTs at the time of palate repair; centres were in a position to take part in a future study; and the response rate to the survey was not good, representing a potential concern about future co-operation. A COS reflecting the opinions of clinicians and parents was developed, which included nine core outcomes important to both health-care professionals and parents. The qualitative research suggested that a trial would have a 25% recruitment rate, and although hearing was a key outcome, this was likely to be due to its psychosocial consequences. The VOI analysis suggested that the current uncertainty justified the costs of future research.

CONCLUSIONS

There exists significant uncertainty regarding the best management strategy for persistent OME in children with clefts, reflecting a lack of high-quality evidence regarding the effectiveness of individual treatments. It is feasible, cost-effective and of significance to clinicians and parents to undertake a trial examining the effectiveness of VTs and HAs for children with CP. However, in view of concerns about recruitment rate and engagement with the clinicians, we recommend that a trial with an internal pilot is considered.

FUNDING

The National Institute for Health Research Health Technology Assessment programme. This study was part-funded by the Healing Foundation supported by the Vocational Training Charitable Trust who funded trial staff including the study co-ordinator, information systems developer, study statistician, administrator and supervisory staff.

If you would like to receive a notification when this project publishes in the NIHR Journals Library, please submit your email address below.

 

Responses to this report

 

No responses have been published.

If you would like to submit a response to this publication, please do so using the form below.

Comments submitted to the NIHR Journals Library are electronic letters to the editor. They enable our readers to debate issues raised in research reports published in the Journals Library. We aim to post within 2 working days all responses that contribute substantially to the topic investigated, as determined by the Editors.

Your name and affiliations will be published with your comment.

Once published, you will not have the right to remove or edit your response. The Editors may add, remove, or edit comments at their absolute discretion.

By submitting your response, you are stating that you agree to the terms & conditions