Core Rehabilitation Outcome Set for Single Sided Deafness, Ver 1.0
Research type
Research Study
Full title
CROSSSD Study: Identifying what is critical and important to measure when evaluating hearing interventions for adults with Single Sided Deafness.
IRAS ID
239750
Contact name
Pádraig T. Kitterick
Contact email
Sponsor organisation
Research and Innovation, University of Nottingham
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
Research Summary
Single Sided Deafness (SSD) refers to the condition where there is normal or near-normal hearing in one ear and a severe-to-profound hearing impairment in the other ear.
Good hearing in both ears is important for everyday listening tasks such as understanding speech in noisy environments, locating where sounds are, and identifying threats such as oncoming traffic. There is approximately 9000 new cases of SSD diagnosed in adults in the UK annually.
The most commonly used treatments for SSD restore two-sided (bilateral) access to sounds by re-routing sounds from the impaired ear to the hearing ear. Alternatively, a device such as a cochlear implant can deliver information about sounds directly to the impaired ear, thus restoring the ability to hear through both ears, and creating a sensation of true ‘binaural’ hearing.
Researchers don’t yet agree on what benefits and harms (known as ‘outcomes’) should always be measured when evaluating whether or not an intervention for SSD is effective. For example, studies that evaluate these interventions have measured speech perception in quiet or noisy environments and sound localisation or have attempted to measure the impact on tinnitus or on the recipient’s quality of life. These inconsistencies hinder progress to find the most effective intervention.
This study aims to gather the opinions of people diagnosed with SSD, healthcare practitioners, researchers and those who fund SSD research to work towards an agreement on what is important to measure when deciding if an SSD treatment works. The opinions collected from this research will inform the development of a “Core Domain Set”, a list of what to measure. This set will make it easier to compare findings from different studies, and easier to find out which treatments work best and why. These changes will help people to make better choices regarding their treatment.
Summary of Results
Research into treatments for single-sided deafness (SSD) has increased a lot in the recent years, which is great news! However, clinical researchers have been adopting a plethora of different outcomes and measures to assess if interventions, like a contralateral routing of signals (CROS) system, a bone anchored hearing aid (BAHA), or restoring interventions like cochlear implants work or not.
A recent systematic review identified 520 unique measures that have been utilised in 96 SSD studies evaluating the therapeutic benefits and harms of SSD interventions. Furthermore, the chosen outcomes to measure are not always considered important or meaningful to our patients.
The Core Rehabilitation Outcome Set for Single Sided Deafness (CROSSSD) study group at the University of Nottingham, alongside patient and public involvement collaborators and an international steering group have set out to address the inconsistency of adopted measures, by developing a ‘core outcome set’ for SSD interventions.
By involving healthcare users with experience in SSD treatments, audiologists, ENT surgeons, clinical researchers, and industry representatives; the CROSSSD study gathered international opinions via Delphi surveys and a web-based consensus meeting and found agreement on three measures that should always be reported on in SSD intervention studies. The core outcomes are (1) Spatial orientation, (2) Group conversations in noisy social situations, and (3) Impact on social situations. Further research will determine how these core outcomes should best be measured.
If all future SSD intervention studies measure these core outcomes as a minimum, we can more easily compare results, improve research quality, and enhance clinical decision-making.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
19/EM/0222
Date of REC Opinion
6 Aug 2019
REC opinion
Further Information Favourable Opinion