Background British Sign Language (BSL) is a fully grammatical, living language, independent of spoken English. Deaf BSL users are routinely excluded from clinical trials either on grounds of language and/or assumptions of confounding factors associated with disability. Few clinical trials specifically targeted at Deaf people exist internationally. Appropriate terminology in BSL for key concepts in clinical trials is needed to support informed consent.. Barriers to conceptual (mis)understanding of trial participation and sources relevant to the Deaf community are unexplored. This study set out to:
(i) Explore, in BSL, the meaning and understanding of key concepts and common vocabulary used in recruitment and informed consent to a clinical trial
(ii) Enable signs/signed expressions to emerge that are semantically accurate and support Deaf people’s informed consent in any future trial
Methods A community participatory approach underpinned data collection. This comprised Deaf-led, qualitative, exploratory group discussions (19 self-selected participants in five groups), facilitated in BSL. Discussion was structured to explore the meaning of key terminology (such as trial, randomisation, consent) and through that exploration generate signed explanations of concepts to use in future trials. Data were video-recorded and analysed in BSL, using a phenomenological approach, built from the application of 4 themes and 8 sub-themes using NVIVO8 for visual data.
Results All participants were over 30 years old, with a self-declared ‘strong Deaf identity’; BSL was their first or preferred language. Six necessary conditions for developing optimal trial information were identified. (i) developing appropriate expressions and terminology from a community basis, rather than testing out previously derived translations from a different language; (ii) paying attention to language-specific features which support best means of expression (in the case of BSL expectations of specificity, verb directionality, handshape); (iii) accounting for bilingual influences on comprehension; (iv) deliberate orientation of information to avoid misunderstanding not just to promote accessibility; (v) sensitivity to barriers to discussion about intelligibility of information that are cultural and social in origin, rather than linguistic; (vi) the importance of using contemporary language-in-use, rather than jargon-free or plain language, to support understanding.
Conclusion These conditions need to be met to develop signed participant information for Deaf people that is: acceptable, accessible, transmitted accurately and understood as intended. They are required to address the cultural preferences and lower background knowledge of Deaf people (using signed languages) as well as in spoken/written languages when participants’ language use is different from the dominant language of the country.
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