Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for adults with mild-severe sensorineural hearing loss

General Information

Summary:
Hearing loss affects approximately 1.33 million individuals across the world. The most common form of hearing loss is sensorineural hearing loss (SNHL). This is a long-term condition that is usually caused by irreversible damage to the inner ear, particularly the cochlear hair cells, or to the nerve pathways from the inner ear to the brain. Adult auditory rehabilitation for SNHL consists of a variety of interventions that have been designed to improve both sensory functioning and psychosocial functioning. Currently, the primary intervention for SNHL is the provision of hearing aids. Additional interventions include assistive listening devices, auditory training, and audiologic counselling. The effectiveness of these interventions is judged according to their effect on primary and secondary outcome measures. However, at present, there is no consensus regarding which outcome domains are the most relevant to assess in SNHL research. In other words, there is no accepted minimum set of outcome domains that should be reported as standard in all clinical trials in SNHL.

Our aim is to develop a core outcome set (COS) for clinical trials of adult auditory rehabilitation interventions for SNHL. The COS will focus on long-term, mild-severe SNHL. In order to achieve this aim, we will follow an established procedure that has been used by the COMiT initiative (Core Outcome Measures in Tinnitus), who are developing a core outcome set for clinical trials of interventions for tinnitus. We will use a mixed methods approach that involves a variety of stakeholders, including adults with hearing loss and hearing healthcare professionals. The first step is to establish which outcome domains have been measured and which outcome instruments have been used in SNHL clinical studies. This information will be used to inform the next step in which adults with hearing loss and clinicians will participate in a Delphi survey to refine the content of the COS. Once the core outcome domains have been agreed upon, the next step will be to identify outcome measures that can be used to measure the COS in clinical trials.

Contributors:
Eithne Heffernan, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre, Nottingham, UK

Melanie Ferguson, NIHR Nottingham Biomedical Research Centre, Nottingham, UK

Deborah Hall, NIHR Nottingham Biomedical Research Centre, Nottingham, UK

Pádraig Kitterick, NIHR Nottingham Biomedical Research Centre, Nottingham, UK

Additional contributors TBC

Further Study Information

Current Stage:
Ongoing
Date:
May 2017 - May 2020
Funding source(s):
National Institute of Health Research

Health Area

Disease Category
Ear, nose, & throat

Disease Name
Hearing loss

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Literature review
Survey

Our methodological approach has been adapted from the following publication:
Hall, D. A., Haider, H., Kikidis, D., Mielczarek, M., Mazurek, B., Szczepek, A. J., & Cederroth, C. R. (2015). Toward a global consensus on outcome measures for clinical trials in tinnitus: report from the first international meeting of the COMiT Initiative, November 14, 2014, Amsterdam, The Netherlands. Trends in hearing, 19, 2331216515580272.

(1) The first step will be to develop a comprehensive list of outcome domains relevant to adult aural rehabilitation for SNHL. The research question is “What are the current reported outcome domains in studies that focus on interventions for adults with SNHL?” The list of domains will primarily be derived by analysing the content of outcome measures identified in a systematic review as the most frequently used outcome measures in adult hearing loss research.

(2) The second step will be to analyse survey data collected from adults with SNHL and hearing healthcare professionals. The research question is: ‘“What are the outcome domains relevant to auditory rehabilitation for SNHL from the perspective of patients and clinicians?” Any new outcome domains will be added to the list devised in the first step.

(3) The information gathered in the above steps will be used to inform the third step, which involves key stakeholders (e.g. adults with hearing loss, hearing healthcare professionals) participating in an iterative consensus exercise known as a Delphi survey to refine the list of outcome domains by voting and agreeing about which domains are the most important and thus should be included in all relevant clinical trials. The Delphi survey will be followed by a consensus meeting to agree on the final list of core outcome domains for clinical trials of interventions for adults with mild-severe sensorineural hearing loss.

(4) The fourth step will involve assessing the measurement properties of existing outcome measures in order to identify valid measures of the core outcome domains. These measures could be used to assess the core outcome domains in future clinical trials of interventions for adults with mild-severe SNHL. Existing measures will be evaluated against published quality criteria for outcome measures. In addition, any core outcome domains that are not represented by an existing, validated outcome measure will be identified. In these cases, recommendations will be made as to existing outcome measures that should undergo validation or new outcome measures that should be developed in order to address this gap.


Stakeholders Involved

Charities
Clinical experts
Consumers (patients)
Device manufacturers
Journal editors
Patient/ support group representatives
Policy makers
Regulatory agency representatives
Researchers
Service commissioners

Study Type

COS for clinical trials or clinical research

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