Cost-effectiveness of screening for permanent hearing loss in children at school entry

Plain English Summary

Background and study aims
This study asks questions about the screening programme to identify permanent hearing loss in children when they start primary school; is it necessary, is the cost of such a screen appropriate for the outcomes achieved i.e. the number of children identified by this method compared with a system with no screen; and if it is to be done, which of two different ways of doing the screen is better?
These questions are very relevant as previous research has shown that the number of children identified by this screen around age 5 is low, perhaps only 1 child in every 3000 children tested. This is because all newborn babies are offered hearing screening at birth and there is a good system in place to respond to professional and parental concerns at any age so children who have a hearing impairment are very likely to be identified before they reach school age.
The aims of this project are evaluation of the diagnostic accuracy of hearing screening tests and the cost-effectiveness of screening for hearing impairment at school entry. We propose a series of five related studies.

Who can participate?
Study 1:
1. Case children aged 4-6 years with a confirmed permanent hearing loss
2. Control children aged 4-6 years with no identified hearing loss
Study 2:
All children aged 4 years or older referred to the 2nd tier audiology service in Cambridgeshire from October 2007 to June 2014
Study 3:
All children referred to the Nottingham Audiology Service as a result of failing the school entry hearing screen, and their parents
Study 4:
All children in the reception classes of participating schools in Nottinghamshire

What does the study involve?
Study 1 will look at which of two different ways of doing the screen is more accurate in correctly identifying children with and without a hearing loss. We will recruit 80 children in the East Midlands, aged 4-6 years, who have a known permanent hearing loss, assessed and documented by pure tone audiometry (PTA) and invite them to undergo 2 screening tests either at home or in research facilities in Nottingham. A second group of children aged 4-6 with no identified hearing loss will be recruited from local schools and invited to attend the research facilities to have their hearing assessed by 2 screening methods and by PTA.
Study 2 will ask whether having a screen is more effective than not having one. There has been no routine school entry screen since 1997 in parts of Cambridgeshire. We will collect data on age, level and probable cause of hearing loss, referral route and number and type of assessments and interventions for all children 4 years old and above who have been referred to the audiology service since October 2007.
Study 3 will collect the same information for all children referred over one year to the Nottingham Audiology service as a result of “failing” the routine school screen. To look at what it means for children and families referred by the screen and subsequently confirmed to have a hearing loss (true positives) or not (false positives), we will ask families to complete questionnaires. Another important issue is the impact of a child passing the screen but later being found to have a hearing loss. We will address this by reviewing the existing records.
In study 4 we will measure the resources used and practical implications of using the 2 screening methods in real-life situations in schools.
Study 5 will use the data collected and information from previous research to look at the cost-effectiveness of all aspects of the screening programme and make recommendations for its future use.
The research team includes both NHS staff contributing clinical knowledge and university staff contributing research and methodological expertise.

What are the possible benefits and risks of participating?
If any child in study 1 is found to have a previously unknown hearing loss they will be offered a referral for a full assessment of their hearing. All children taking part in studies 3 and 4 will receive the routine care they would normally receive.
There are no risks to any of the children or their families taking part in these studies.

Where is the study run from?
Study 1: Hearing-impaired children are recruited from 14 hosptials in England and non-hearing-impaired children recruited from 51 schools in Nottingham and Nottinghamshire (UK)
Study 2 and 3: Cambridge (UK)
Study 4: Seven schools in Nottingham (UK)

When is the study starting and how long is it expected to run for?
July 2012 to February 2016

Who is funding the study?
National Institute for Health Research, Health Technology Assessment Programme (UK)

Who is the main contact?
Dr Mara Ozolins

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

University of Nottingham (UK)
University/education

c/o Mr Paul Cartledge
Research Operations
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom

"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

23/03/2017: The following changes have been made to the record:
1. Ethics approval information has been added
2. The overall trial end date has been updated from 31/12/2014 to 28/02/2015
3. The recruitment dates have been updated from 01/07/2012 - 31/12/2014 to 19/02/2013 - 14/08/2014 (study 1). Study 4 recruitment dates fell within these dates; studies 2 and 3 collected anonymous data.
4. The trial participating centres have been added
5. IPD Sharing plan has been added
6. The study contact has been updated from Heather Fortnum to Mara Ozolins
06/01/2017: Publication reference added.