Addressing clinical equipoise for hearing devices: the qualitative COACH (q-COACH) study protocol for Australian stakeholder involvement in the design of a randomised controlled trial

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Abstract

Introduction: Hearing loss is a common chronic problem which can be effectively managed with hearing devices. At present, only a limited number of people with hearing loss use hearing aids (HAs) and cochlear implants (CIs) to improve hearing and sound quality and enhance quality of life. Clinical equipoise, by which we mean healthcare professional uncertainty about which treatment options are the most efficacious due to the lack of evidence-based information, can lead to inconsistent and poorly informed referral processes for hearing devices.
A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients. Qualitative research can improve this RCT, by gathering the information on patient and provider perspectives, attitudes and values, which can inform design, conduct and information dissemination, either during preparatory stages of an intervention, or as a fully integrated methodology. The Comparison of Outcomes with hearing Aids and Cochlear implants in adults with moderately severe-to-profound bilateral sensorineural Hearing loss (COACH) study is being planned as an RCT with a qualitative arm (the qualitative COACH study, q-COACH), acting as a pretrial intervention examining views of HAs, CIs, equipoise and the impetus for an RCT of this nature.
Methods and analysis: The q-COACH study involves semistructured interviews and a demographic questionnaire which will be collected from four participant cohorts: General Practitioners (GPs) and Ear, Nose and Throat Surgeons (ENTs); audiologists; adult HA users and their support networks. Data will be analysed thematically and through descriptive statistics.
Ethics and dissemination: Macquarie University Human Research Ethics Committee, Australia, granted ethical approval (no. 5201833514848). Peer-reviewed journal articles, research conferences and a final report will present study findings.
LanguageEnglish
Article numbere030100
Pages1-8
Number of pages8
JournalBMJ Open
Volume9
Issue number9
DOIs
Publication statusPublished - 8 Sep 2019

Fingerprint

Hearing Aids
Cochlear Implants
Hearing
Randomized Controlled Trials
Equipment and Supplies
Hearing Loss
Bilateral Hearing Loss
Information Dissemination
Sensorineural Hearing Loss
Qualitative Research
Research Ethics Committees
Pharynx
Nose
Ethics
General Practitioners
Uncertainty
Ear
Arm
Referral and Consultation
Quality of Life

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • audiology
  • cochlear implants
  • hearing loss
  • qualitative research
  • randomised controlled trials

Cite this

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title = "Addressing clinical equipoise for hearing devices: the qualitative COACH (q-COACH) study protocol for Australian stakeholder involvement in the design of a randomised controlled trial",
abstract = "Introduction: Hearing loss is a common chronic problem which can be effectively managed with hearing devices. At present, only a limited number of people with hearing loss use hearing aids (HAs) and cochlear implants (CIs) to improve hearing and sound quality and enhance quality of life. Clinical equipoise, by which we mean healthcare professional uncertainty about which treatment options are the most efficacious due to the lack of evidence-based information, can lead to inconsistent and poorly informed referral processes for hearing devices.A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients. Qualitative research can improve this RCT, by gathering the information on patient and provider perspectives, attitudes and values, which can inform design, conduct and information dissemination, either during preparatory stages of an intervention, or as a fully integrated methodology. The Comparison of Outcomes with hearing Aids and Cochlear implants in adults with moderately severe-to-profound bilateral sensorineural Hearing loss (COACH) study is being planned as an RCT with a qualitative arm (the qualitative COACH study, q-COACH), acting as a pretrial intervention examining views of HAs, CIs, equipoise and the impetus for an RCT of this nature.Methods and analysis: The q-COACH study involves semistructured interviews and a demographic questionnaire which will be collected from four participant cohorts: General Practitioners (GPs) and Ear, Nose and Throat Surgeons (ENTs); audiologists; adult HA users and their support networks. Data will be analysed thematically and through descriptive statistics.Ethics and dissemination: Macquarie University Human Research Ethics Committee, Australia, granted ethical approval (no. 5201833514848). Peer-reviewed journal articles, research conferences and a final report will present study findings.",
keywords = "audiology, cochlear implants, hearing loss, qualitative research, randomised controlled trials",
author = "Frances Rapport and Emilie Auton and Chris Warren and Jeffrey Braithwaite",
note = "Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",
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language = "English",
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T1 - Addressing clinical equipoise for hearing devices

T2 - BMJ Open

AU - Rapport, Frances

AU - Auton, Emilie

AU - Warren, Chris

AU - Braithwaite, Jeffrey

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N2 - Introduction: Hearing loss is a common chronic problem which can be effectively managed with hearing devices. At present, only a limited number of people with hearing loss use hearing aids (HAs) and cochlear implants (CIs) to improve hearing and sound quality and enhance quality of life. Clinical equipoise, by which we mean healthcare professional uncertainty about which treatment options are the most efficacious due to the lack of evidence-based information, can lead to inconsistent and poorly informed referral processes for hearing devices.A randomised controlled trial (RCT) that offers high-quality, generalisable information is needed to clarify which hearing device (HA or CI) is more suitable for different degrees of hearing loss and for which kinds of patients. Qualitative research can improve this RCT, by gathering the information on patient and provider perspectives, attitudes and values, which can inform design, conduct and information dissemination, either during preparatory stages of an intervention, or as a fully integrated methodology. The Comparison of Outcomes with hearing Aids and Cochlear implants in adults with moderately severe-to-profound bilateral sensorineural Hearing loss (COACH) study is being planned as an RCT with a qualitative arm (the qualitative COACH study, q-COACH), acting as a pretrial intervention examining views of HAs, CIs, equipoise and the impetus for an RCT of this nature.Methods and analysis: The q-COACH study involves semistructured interviews and a demographic questionnaire which will be collected from four participant cohorts: General Practitioners (GPs) and Ear, Nose and Throat Surgeons (ENTs); audiologists; adult HA users and their support networks. Data will be analysed thematically and through descriptive statistics.Ethics and dissemination: Macquarie University Human Research Ethics Committee, Australia, granted ethical approval (no. 5201833514848). Peer-reviewed journal articles, research conferences and a final report will present study findings.

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