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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.
- qualitative research
- cochlear implants
- hearing loss
- audiology
- randomised controlled trials
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Footnotes
Contributors FR led the overall conceptualisation of the study design and co-led the first and revised drafts of the manuscript. EA contributed to the study design, led the ethics approval procedure and co-led the first draft of the manuscript and revisions of the manuscript. CW contributed to the study design, and to the first and revised drafts of the manuscript. JB critically revised the manuscript for intellectual content. All authors provided final approval of the version submitted and accepted its accuracy and integrity.
Funding This study is financially support by Cochlear Ltd - Macquarie University Partnership (MQ-Cochlear).
Disclaimer It should be emphasised that Cochlear Ltd did not influence the research agenda in any way, nor will they influence participant reporting during data collection, or analysis and data interpretation stages.
Competing interests CW is an employee of Cochlear Ltd and will, therefore, not be involved in the data collection, data analysis and reporting of the study findings. Would like to assure readers that no bias has taken place within this study and all employees of Cochlear Ltd were excluded from the data collection, analysis or reporting of results. In his capacity as Clinical Studies Research Manager at Cochlear Ltd, CW contributed to the research design to ensure that its general purpose would support the development of the COACH study and that research questions (which were not proposed by Cochlear) were consistent and appropriate for the COACH RCT. Given CW’s valuable contributions to this aspect of oversight it would be unethical for the team to exclude CW as an author. As experienced qualitative researchers, FR and EA ensured that the design of this qualitative study was not driven by an industry agenda in any way. For example, both FR and EA drafted the interview questions and ensured that the final interview schedule was not leading or contained assumptions pertaining to industry. Also, during the interviews, EA made it clear to all participants that she was not an employee of Cochlear Ltd and was only concerned with understanding participants’ genuine responses to hearing loss, hearing services and the proposed COACH study. Moreover, any attempts to influence participants towards a favourable perspective of Cochlear Implants or the proposed design would be counterproductive to the purpose of the research. That is, we are not seeking complete validation of the proposed COACH study, rather we are interested in the genuine response of a variety of stakeholders to the proposed COACH study in order to determine which aspects of the study are acceptable to stakeholders and why, as well whether the proposed study will need to be altered or improved on.
Patient consent for publication Not required.
Ethics approval Ethical approval for the study has been granted by Macquarie University Human Research Ethics Committee (approval number 5201833514848).
Provenance and peer review Not commissioned; externally peer reviewed.