Condition category
Ear, Nose and Throat
Date applied
25/04/2012
Date assigned
27/04/2012
Last edited
26/06/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
The study will be run from Nottingham working with colleagues in Cambridge (study 2 above) and Exeter (study 5 above).

When is the study starting and how long is it expected to run for?
The study started in July 2012 and will run for 30 months.

Who is funding the study?
It is funded by the National Institute for Health Research, Health Technology Programme.

Who is the main contact?
Dr Heather Fortnum, an associate professor and reader in hearing research at the University of Nottingham, currently based in the NIHR Nottingham Hearing Biomedical Research Unit.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Heather Fortnum

ORCID ID

Contact details

National Biomedical Research Unit in Hearing (NBRUH)
Ropewalk House
113 The Ropewalk
Nottingham
NG1 5DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA: 10/63/03

Study information

Scientific title

The diagnostic accuracy of hearing tests and cost-effectiveness of school entry hearing screening programmes

Acronym

Study hypothesis

1. To determine and compare the diagnostic accuracy of two methods for screening for the identification of permanent hearing impairment at or around school entry i.e. pure tone sweep audiometry across 4 frequencies and 1 level, and the HearCheck pure tone screen with 2 fixed frequencies and 3 levels.
2. For a service with a routinely applied school entry hearing screen (SES) and a service with no SES, to compare the yield, referral age and route through assessment to intervention for permanent childhood hearing impairment and to measure the costs of referrals.
3. To evaluate the effectiveness and cost effectiveness of screening for hearing impairment relative to no implementation of a universal screen at school entry through an economic model
4. To explore the impact for the child and the family of a positive result from a screen (both true and false positives) resulting in referral for further assessment.
5. To determine the resource costs in implementing the two alternative screening methods in primary schools
6. To develop an existing SES economic model and synthesise the findings of studies 1-4 in order to provide robust estimates of key parameters in the economic model. In particular the yield and nature of hearing loss detected in a system with no SES; the yield, consequences and costs of screen positive individuals in an SES system; and the costs of setting up an SES system.

Ethics approval

Not provided at time of registration

Study design

Observational: case-control study (study 1), retrospective and prospective cohort studies (study 2&3), practical implementation (study 4), health economic modelling (study 5)

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Permanent sensorinerual or conductive hearing loss

Intervention

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. Given the small numbers, it would need a very long and expensive study to do this in a prospective randomised control trial. We propose therefore to conduct this part of the research as a case-control study, simply assessing the accuracy of the two tests. 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, the gold standard) and invite them to undergo two 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. Recruitment will occur in school terms from October 2012 to July 2014 and children will be invited fo rassessment in the School holidays over the same period.

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. Anonymised data will be analysed retrospectively for data collected from October 2007 to June 2012 and prospectively for data collected from July 2012 to June 2014.

Study 3 will collect the same information for all children referred over the period September 2012 to December 2013 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 literature.

In study 4 we will measure the resources used and practical implications of using the 2 screening methods in real-life situations in schools between November 2012 and June 2013.

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Study 1:
For both screening tests will be a “pass” or “refer‟ as defined by the protocol compared with the result of the gold-standard pure-tone audiogram which provides a measure of hearing level on the decibel scale.

Study 2
Age of referral

Study 3
Age at referral and the costs both to the service and the families of referral through to definitive identification of hearing loss or discharge

Study 4
The mean cost per child of implementing each of the two test technologies. Costs will include the staff type, grade and time taken in conducting the test plus the cost of the equipment. For the purposes of this study we will assume that all other things between the two tests are equal i.e. travel time of screening to visit the school, set up time to organise the children etc.

Secondary outcome measures

Study 2: The incidence of newly identified hearing loss in children, the referral route and aetiology of any hearing loss

Overall trial start date

01/07/2012

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Study 1:
1. Case children aged 4-6 years with a confirmed sensorineural or permanent conductive hearing loss either bilaterally (up to 60dB) or unilaterally (any level)
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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

570

Participant exclusion criteria

Children whose parents do not agree to the child taking part (Studies 1 and 4)

Recruitment start date

01/07/2012

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

National Biomedical Research Unit in Hearing (NBRUH)
Nottingham
NG1 5DU
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment programme - HTA (UK) ref:10/63/03

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes