Final Report: Addressing clinical equipoise for hearing devices: the qualitative COACH (q-COACH) study for stakeholder involvement in the design of a Randomised Controlled Trial (RCT)

Background and aims: Hearing loss is a common chronic problem which can be effectively managed with hearing devices. The growing prevalence of adults with moderately severe-to-profound sensorineural hearing loss (SNHL) suggests more people than at present may benefit from hearing aids (HAs) and cochlear implants (CIs) to improve hearing and sound quality and enhance quality of life. However, 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 but holding personal views on the matter), can lead to confusion over when to recommend moving from HAs to CIs and inconsistent referral processes and outcomes. 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 different patient needs. Qualitative research can improve this RCT, by gathering information on patient and provider perspectives, attitudes and values, which can inform the design, conduct, and information dissemination, either during preparatory stages, 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 pre-trial intervention examining views of patients and professionals on HAs and CIs, and views surrounding equipoise, and the impetus for an RCT of this nature. This study aimed to: (1) Disclose stakeholders’ experiences of, and insights into, hearing loss and hearing loss devices; (2) Assess how an RCT comparing hearing loss devices (CIs and HAs) should be designed, conducted and reported and for whose benefit; (3) Clarify how information about HA or CI candidacy and hearing loss devices is best disseminated, with which stakeholder groups, and how outcomes from dissemination might be sustained.
Methods and analysis: The q-COACH study involved semi-structured interviews and a demographic questionnaire. Data were collected from four participant groups: (1) General Practitioners (GPs); (2) audiologists; (3) adult HA users; and (4) adult support networks (such as family members). Data were analysed thematically and through the support of descriptive statistics. Ethical approval for the study was granted by Macquarie University Human Research Ethics Committee (approval number 5201833514848).
Data collection and analysis: 24 interviews took place. All participants were invited to take part in individual or paired interviews, and to complete a demographic questionnaire. Focus group and interview data were transcribed, and a thematic analysis of all datasets was undertaken, with extensive group work achieving a consensus of opinion over the major themes and categories arising. Data findings are planned to be reported alongside this final report, through academic publications which will include demographic data and participant characteristics.
Overview of Results: Four themes arose from this study; Theme 1: The burden of hearing loss, from the perspective of patients, support persons and healthcare professionals (HCPs) (Aim 1). Theme 2: Managing hearing loss, from the perspective of patients, support persons and healthcare professionals (HCPs) (Aim 1); Theme 3: Randomised Controlled Trial (RCT) design, conduct and dissemination, from the perspective of healthcare professionals (HCPs) (Aims 2 and 3); Theme 4: Randomised Controlled Trial (RCT) design, conduct and dissemination, from the patient and support person perspective (Aims 2 and 3). Theme 1 outlines stakeholders’ experiences of and insights into hearing loss. Theme 2 explores stakeholders’ experiences of and insights into hearing loss devices. Theme 3 assesses how an RCT comparing hearing loss devices (CIs and HAs) should be designed, conducted and reported according to HCPs. Theme 4 assesses how an RCT comparing hearing loss devices should be designed, conducted and reported according to HA users and support persons.
Recommendations: As a result of this study, twelve recommendations have been formulated for COACH RCT including: (1) Recruiting people with hearing loss who have expressed interest in CI, (2) Recruiting through targeted avenues, (3) Participants need to be well informed about CIs before they commit to the study, (4) Ensure confidentiality of participant information, (5) Clearly detail what the reimbursement will include and exclude, (6) Include support to address the emotional aspects of COACH RCT participation, (7) The study should be conducted independently to Cochlear Ltd, (8) Extend the lead-in time, (9) Consider the quality of HAs and previous use of HAs, (10) Reconsider the time, place and content of testing sessions, (11)
Dissemination avenues for COACH RCT results amongst HCPs and (12) Dissemination avenues for COACH RCT results amongst HA users.