Core Outcome Measures in Effectiveness Trials

Towards a Consensus on Outcome Measures for Interventions that Seek to Restore Bilateral and Binaural Hearing in Adults with Unilateral Severe-to-Profound Hearing Loss: The CROSSSD (Core Rehabilitation Outcome Set for Single Sided Deafness) Study

General Information

Summary:
Single-sided deafness (SSD) is the term given 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 [1]. Good hearing in both ears helps us deal with everyday listening tasks. These include understanding speech in noisy environments and locating where sounds, such as the telephone or car traffic, are coming from [2].

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 with the help of a specialised hearing aid system that incorporates a remote microphone on the impaired ear and hearing aid on the hearing ear [3]. Alternatively, an auditory prosthesis such as a cochlear implant can deliver information about sounds directly to the auditory pathway on the side of the impaired ear, thus creating with the possibility of creating a sensation of true ‘binaural’ hearing [4].

Existing literature has highlighted inconsistencies in what benefits and risks are assessed when evaluating these interventions. The different sorts of benefits and risks are collectively called 'outcome domains'. For example, studies that evaluate these interventions have sought to assess speech perception in quiet or noisy environments and sound localisation [5] or have attempted to quantify the impact on the recipient’s quality of life [6]. These inconsistencies hinder decisions about the choice of outcome measures for trials of clinical efficacy.

Identifying appropriate outcome domains is crucial when designing clinical trials to evaluate the effects of different interventions. The selected outcomes need to be important to key stakeholders such as patients, healthcare professionals or budget holders in order to minimise bias when making decisions about healthcare.

Our methods for developing a set of minimum standards will follow the Core Outcome Measures in Effectiveness Trials (COMET) Handbook version 1.0 recommendations:
1) The published literature reporting interventions for SSD will be systematically reviewed to identify what outcome domains and what measurement instruments have been used already.
2)The patient perspective will be explored using a range of qualitative methods.
3)Key stakeholders will be invited to participate in an interactive online consensus exercise known as a Delphi Survey; aiming to identify which outcome domains are critical and important for evaluating SSD interventions.
4)A subgroup of the stakeholders will be invited to an interactive consensus meeting to discuss the recommendations arising from the Delphi survey and to agree on a minimum set of outcome domains that are relevant to all intervention options and stakeholder groups.

An agreement on a set of outcome domains of what is critical and important for deciding whether an intervention is efficacious will drive up the quality and relevance of research by ensuring that the most relevant outcomes are consistently measured and reported in every clinical trial relating to SSD. On the basis of the recommended outcome domains, further research will then be needed to identify measurement instruments that assess the outcomes domains in the minimum set.

References:
1. Vincent, C., Arndt, S., Firszt, J. B., Fraysse, B., Kitterick, P. T., Papsin, B. C., Snik, A., Van de Heyning, P., Deguine, O. and Marx, M. (2015). Identification and evaluation of cochlear implant candidates with asymmetrical hearing loss. Audiology and Neurotology, 20(Suppl. 1), 87-89.
2. Akeroyd, M. A. (2006). The psychoacoustics of binaural hearing. International Journal of Audiology, 45(sup1), 25-33.
3. Peters, J. P., Smit, A. L., Stegeman, I., & Grolman, W. (2015). Bone conduction devices and contralateral routing of sound systems in single-sided deafness. The Laryngoscope, 125(1), 218-226.
4. Arndt, S., Aschendorff, A., Laszig, R., Beck, R., Schild, C., Kroeger, S., Ihorst, G. and Wesarg, T. (2011). Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otology & Neurotology, 32(1), pp.39-47.
5. Kitterick, P. T., Smith, S. N., & Lucas, L. (2016). Hearing instruments for unilateral severe-to-profound sensorineural hearing loss in adults: a systematic review and meta-analysis. Ear and Hearing, 37(5), 495.
6. Kitterick, P. T., Lucas, L., & Smith, S. N. (2015). Improving health-related quality of life in single-sided deafness: a systematic review and meta-analysis. Audiology and Neurotology, 20(Suppl. 1), 79-86.

Contributors:
Study Management Team:
Deborah A. Hall, Professor of Hearing Sciences, Faculty of Medicine & Health Sciences, National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK.
Pádraig T. Kitterick, Associate Professor, Faculty of Medicine & Health Sciences, National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK.
Roulla Katiri, PhD Student, Faculty of Medicine & Health Sciences, National Institute for Health Research (NIHR), Nottingham Biomedical Research Centre, Nottingham, UK and Chief Audiologist, Mater Misericordiae University Hospital, Dublin, Ireland.

Steering Group:
Study Management Team: Professor Deborah A. Hall (Expertise in Core Outcome Sets), Dr Pádraig T. Kitterick (Expertise in Single Sided Deafness) and Roulla Katiri (PhD Student CROSSSD Study).
Patient and Public Involvement (PPI) Team: Dr Adele Horobin (PPI and Engagement Manager), TBC (Research Partner 1) and TBC (Research Partner 2).
Experts in Clinical Practice and Research: Professor Iain A. Bruce (Paediatric Otolaryngologist, Royal Manchester Children’s Hospital and Honorary Clinical Professor of Paediatric Otolaryngology, Manchester Academic Health Science Centre, University of Manchester, UK Representative), Professor Paul Van de Heyning (Professor and Chairman Univ Dept Otorhinolaryngology and Head and Neck Surgery, Antwerp University Hospital - University of Antwerp, Europe Representative) and Professor Jill B. Firszt (Professor in Otolaryngology, Audiology and Communication Sciences, Washington University School of Medicine in St. Louis, USA Representative).


Further Study Information

Current Stage:
Planning
Date:
October 2017 - October 2022
Funding source(s):
National Institute for Health Research (NIHR)

Health Area

Disease Category
Ear, nose, & throat

Disease Name
Single Sided Deafness (SSD)
Unilateral Hearing Loss

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Device
Other
Procedure

Method(s)

Consensus meeting
Delphi process
Focus group(s)
Interview
Literature review
Semi structured discussion
Survey
Systematic review

SSD interventions that seek to restore hearing: Contralateral Routing of Sounds (CROS) aids, Bone Conduction Hearing Aids (BAHA), Middle Ear Implants (MEI) and Cochlear Implants (CI).

Our methods for developing a set of minimum standards will follow the Core Outcome Measures in Effectiveness Trials (COMET) Handbook version 1.0 recommendations:
1)The published literature reporting interventions for SSD will be systematically reviewed to identify what outcome domains and what measurement instruments have been used already.
2)The patient perspective will be explored using a range of qualitative methods.
3)Key stakeholders will be invited to participate in an interactive online consensus exercise known as a Delphi Survey; aiming to identify which outcome domains are critical and important for evaluating SSD interventions.
4)A subgroup of the stakeholders will be invited to an interactive consensus meeting to discuss the recommendations arising from the Delphi survey and to agree on a minimum set of outcome domains that are relevant to all intervention options and stakeholder groups.
An agreement on a set of outcome domains of what is critical and important for deciding whether an intervention is efficacious will drive up the quality and relevance of research by ensuring that the most relevant outcomes are consistently measured and reported in every clinical trial relating to SSD. On the basis of the recommended outcome domains, further research will then be needed to identify measurement instruments that assess the outcomes domains in the minimum set.


Stakeholders Involved

Charities
Clinical experts
Conference participants
Consumers (patients)
Device manufacturers
Economists
Governmental agencies
Journal editors
Methodologists
Patient/ support group representatives
Researchers
Service commissioners
Service providers
Service users
Statisticians

Study Type

COS for clinical trials or clinical research
COS for practice

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