ArticleTrials2020
Exploring the recruitment, ethical considerations, conduct and information dissemination of an audiology trial: a pretrial qualitative study (q-COACH).
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.
- The value of qualitative research in randomized controlled trials involving drugs and medical devices: a systematic mapping review.International journal of technology assessment in health care · 2026Pooled it
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
Abstract
introductionRandomised 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.
methodsTwenty-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.
resultsFour 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.
conclusionsThis 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.