Abstract
INTRODUCTION: Randomised controlled trials (RCTs), while still considered the gold standard approach in medical research, can encounter impediments to their successful conduct and the dissemination of results. Pretrial qualitative research can usefully address some of these impediments, including recruitment and retention, ethical conduct, and preferred methods of dissemination. However, pretrial qualitative work is rarely undertaken in audiology. The Comparison of outcomes with hearing aids and cochlear implants in adults with moderately severe-to-profound bilateral sensorineural hearing loss (COACH) is a proposed RCT aiming to clarify when hearing aids (HAs) or cochlear implants (CIs) are the most suitable for different degrees of hearing loss and for which kinds of patients. q-COACH is a pretrial, qualitative study examining stakeholders' experiences of HAs and CIs, current clinical practices and stakeholders' perspectives of the design, conduct and dissemination plans for the proposed COACH study. METHODS: Twenty-four participants including general practitioners, audiologists, adult HA users, and adult support networks undertook either semi-structured individual or paired interviews and completed demographic questionnaires. Data were analysed thematically. RESULTS: Four key themes arose from this study: 1) rethinking sampling and recruitment strategies, 2) ethical considerations, 3) refining trial conduct, and 4) interconnected, appropriate and accessible methods of results dissemination. CONCLUSIONS: This qualitative investigation identified key considerations for the proposed RCT design, conduct and dissemination to help with successful implementation of COACH, and to indicate a plan of action at all RCT stages that would be acceptable to potential participants. By drawing on the perspectives of multiple key stakeholders and including a more general discussion of their experience and opinions of hearing loss, hearing device use and service availability, the study revealed experiential and ethical paradigms in which stakeholders operate. In so doing, q-COACH has exposed the benefits of preliminary qualitative investigations that enable detailed and rich understandings of the phenomenon at stake, forestalling problems and improving the quality of trial design, conduct and dissemination, while informing future RCT development discussions.