A qualitative exploration of trial-related terminology in a study involving Deaf British Sign Language users

Abstract

BackgroundInternationally, few clinical trials have involved Deaf people who use a signed language and none have involved BSL (British Sign Language) users. Appropriate terminology in BSL for key concepts in clinical trials that are relevant to recruitment and participant information materials, to support informed consent, do not exist. Barriers to conceptual understanding of trial participation and sources of misunderstanding relevant to the Deaf community are undocumented.MethodsA qualitative, community participatory exploration of trial terminology including conceptual understanding of ‘randomisation’, ‘trial’, ‘informed choice’ and ‘consent’ was facilitated in BSL involving 19 participants in five focus groups. Data were video-recorded and analysed in source language (BSL) using a phenomenological approach.Results and discussionSix necessary conditions for developing trial information to support comprehension were identified. These included: developing appropriate expressions and terminology from a community basis, rather than testing out previously derived translations from a different language; paying attention to language-specific features which support best means of expression (in the case of BSL expectations of specificity, verb directionality, handshape); bilingual influences on comprehension; deliberate orientation of information to avoid misunderstanding not just to promote accessibility; sensitivity to barriers to discussion about intelligibility of information that are cultural and social in origin, rather than linguistic; the importance of using contemporary language-in-use, rather than jargon-free or plain language, to support meaningful understanding.ConclusionsThe study reinforces the ethical imperative to ensure trial participants who are Deaf are provided with optimum resources to understand the implications of participation and to make an informed choice. Results are relevant to the development of trial information in other signed languages as well as in spoken/written languages when participants’ language use is different from the dominant language of the country.

Evaluating the effectiveness and cost-effectiveness of British Sign Language Improving Access to Psychological Therapies: an exploratory study

“…Parts of this section have previously appeared in Young et al 34 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The text below includes minor additions and formatting changes to the original text.…”

“…41,43 It is argued that both are required for informed consent and recall of one might hide misapprehension of the other'. 34 In the case of Deaf people's understanding of key trial-related terminology, the situation is more complex. There are very low levels of awareness, even in lay terms, of such concepts as randomisation, trial and informed choice.…”

“…RCTs routinely exclude them because of the confounding factors that their participation might bring, whether these are perceived in terms of disability (hearing loss) or in terms of language use. 34,44 Deafness also impacts on general knowledge. Deaf people commonly experience highly limited access to information on a wide range of everyday subjects because it is not available in a signed language.…”

“…Objective ii in the study reported here addresses the exploration and development of trialrelated terminology in BSL. 34 The second aspect of the acceptability of randomisation concerns perceived preferences for a particular intervention. For example, as a systematic review of barriers to cancer trial participation has demonstrated, if there is a strong lay perception of one treatment being better than the other, or one not being regarded as appropriate or desirable, then this can act as a barrier to consent to randomisation and trial entry.…”

“…34 Two separate coding frameworks were developed from the same data. The first addressed the specific question of the acceptability of randomisation (objective i) and the second addressed terminology and ways of conveying key concepts associated with recruitment to RCTs (objective ii).…”