scholarly journals Exploring the recruitment, ethical considerations, conduct and information dissemination of an audiology trial: a pretrial qualitative study (q-COACH)

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Emilie Francis-Auton ◽  
Chris Warren ◽  
Jeffrey Braithwaite ◽  
Frances Rapport

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.

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030100 ◽  
Author(s):  
Frances Rapport ◽  
Emilie Auton ◽  
Chris Warren ◽  
Jeffrey Braithwaite

IntroductionHearing 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 analysisThe 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 disseminationMacquarie 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.


2009 ◽  
Vol 130 (3) ◽  
pp. 333-337 ◽  
Author(s):  
Hung Thai-Van ◽  
Evelyne Veuillet ◽  
Arnaud Norena ◽  
Jeanne Guiraud ◽  
Lionel Collet

Author(s):  
Juyong Chung

A number of studies have demonstrated a significant association between age-related hearing loss (ARHL) and cognitive decline. However their relationship is not clear. In this review, we focused on the etiological mechanisms between ARHL and cognitive decline to explain the nature of this relationship: 1) causal mechanisms (e.g., cognitive load hypothesis, cascade hypothesis); 2) common cause mechanisms (e.g., microvascular disease); 3) overdiagnosis or harbinger hypothesis. We conclude that no single mechanism is sufficient and hearing and cognition related to each other in several different ways. In addition, we reviewed the effectiveness of hearing intervention (e.g., hearing aids and cochlear implants) on cognition function, and the role of hearing aid use and cochlear implant depends on the relevant mechanism.


Author(s):  
Laurence Bruggeman ◽  
Julien Millasseau ◽  
Ivan Yuen ◽  
Katherine Demuth

Purpose Children with hearing loss (HL), including those with hearing aids (HAs) and cochlear implants (CIs), often have difficulties contrasting words like “ b each ” versus “ p each ” and “ do g ” versus “ do ck ” due to challenges producing systematic voicing contrasts. Even when acoustic contrasts are present, these may not be perceived as such by others. This can cause miscommunication, leading to poor self-esteem and social isolation. Acoustic evidence is therefore needed to determine if these children have established distinct voicing categories before entering school and if misperceptions are due to a lack of phonological representations or due to a still-maturing implementation system. The findings should help inform more effective early intervention. Method Participants included 14 children with HL (eight HA users, five CI users, and one bimodal) and 20 with normal hearing, all English-speaking preschoolers. In an elicited imitation task, they produced consonant–vowel–consonant minimal pair words that contrasted voicing in word-initial (onset) or word-final (coda) position at all three places of articulation (PoAs). Results Overall, children with HL showed acoustically distinct voicing categories for both onsets and codas at all three PoAs. Contrasts were less systematic for codas than for onsets, as also confirmed by adults' perceptual ratings. Conclusions Preschoolers with HL produce acoustic differences for voiced versus voiceless onsets and codas, indicating distinct phonological representations for both. Nonetheless, codas were less accurately perceived by adult raters, especially when produced by CI users. This suggests a protracted development of the phonetic implementation of codas, where CI users, in particular, may benefit from targeted intervention.


2005 ◽  
Vol 84 (1) ◽  
pp. 26-44 ◽  
Author(s):  
Seth M. Cohen ◽  
Robert F. Labadie ◽  
David S. Haynes

We report the results of a survey designed to investigate audiologic referral patterns of primary care physicians and, more specifically, their referral of patients for hearing aids and cochlear implants. Three hundred internal medicine and family medicine physicians were identified from a referral basin of a tertiary care center and chosen randomly to be faxed questionnaires concerning their views about patients with hearing loss, hearing loss screening and referral practices, and availability of local resources. Of the 260 physicians who received a questionnaire, 85 (32.7%) responded. Of their communities (60% of which had populations of fewer than 50,000), 82.4% had an otolaryngologist and 40% had access to an academic center. Although 97.6% of the responding physicians indicated that hearing loss affected patients’ quality of life, only 60% assessed patients for hearing loss. “Lack of time” and “more pressing issues” were the most common reasons given for not evaluating patients for hearing loss. Although 76 physicians (89.4%) said they were aware of cochlear implants, only 22 (25.9%) had referred patients for implant evaluation. Lack of referral most commonly resulted from uncertainties about “where to refer” and “which patients were potential candidates.” The results of this survey suggest that a large percentage of primary care physicians do not routinely test for hearing impairment in adults.


2016 ◽  
Vol 21 (Suppl. 1) ◽  
pp. 21-28 ◽  
Author(s):  
Alessandro Castiglione ◽  
Alice Benatti ◽  
Carmelita Velardita ◽  
Diego Favaro ◽  
Elisa Padoan ◽  
...  

A growing interest in cognitive effects associated with speech and hearing processes is spreading throughout the scientific community essentially guided by evidence that central and peripheral hearing loss is associated with cognitive decline. For the present research, 125 participants older than 65 years of age (105 with hearing impairment and 20 with normal hearing) were enrolled, divided into 6 groups according to their degree of hearing loss and assessed to determine the effects of the treatment applied. Patients in our research program routinely undergo an extensive audiological and cognitive evaluation protocol providing results from the Digit Span test, Stroop color-word test, Montreal Cognitive Assessment and Geriatric Depression Scale, before and after rehabilitation. Data analysis was performed for a cross-sectional and longitudinal study of the outcomes for the different treatment groups. Each group demonstrated improvement after auditory rehabilitation or training on short- and long-term memory tasks, level of depression and cognitive status scores. Auditory rehabilitation by cochlear implants or hearing aids is effective also among older adults (median age of 74 years) with different degrees of hearing loss, and enables positive improvements in terms of social isolation, depression and cognitive performance.


2017 ◽  
Vol 21 ◽  
pp. 233121651771037 ◽  
Author(s):  
Cara L. Wong ◽  
Teresa Y. C. Ching ◽  
Linda Cupples ◽  
Laura Button ◽  
Greg Leigh ◽  
...  

2015 ◽  
Vol 58 (3) ◽  
pp. 1077-1092 ◽  
Author(s):  
Susan Nittrouer ◽  
Joanna H. Lowenstein

Purpose Children must develop optimal perceptual weighting strategies for processing speech in their first language. Hearing loss can interfere with that development, especially if cochlear implants are required. The three goals of this study were to measure, for children with and without hearing loss: (a) cue weighting for a manner distinction, (b) sensitivity to those cues, and (c) real-world communication functions. Method One hundred and seven children (43 with normal hearing [NH], 17 with hearing aids [HAs], and 47 with cochlear implants [CIs]) performed several tasks: labeling of stimuli from /bɑ/-to-/wɑ/ continua varying in formant and amplitude rise time (FRT and ART), discrimination of ART, word recognition, and phonemic awareness. Results Children with hearing loss were less attentive overall to acoustic structure than children with NH. Children with CIs, but not those with HAs, weighted FRT less and ART more than children with NH. Sensitivity could not explain cue weighting. FRT cue weighting explained significant amounts of variability in word recognition and phonemic awareness; ART cue weighting did not. Conclusion Signal degradation inhibits access to spectral structure for children with CIs, but cannot explain their delayed development of optimal weighting strategies. Auditory training could strengthen the weighting of spectral cues for children with CIs, thus aiding spoken language acquisition.


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