Background
Signed languages such as BSL (British Sign Language) are naturally occurring, grammatically complete languages [
1]. They are not visual versions of the dominant spoken language of the countries where they are used. For Deaf people who use their native signed language, its use is a marker of cultural identity and a gateway to a common community whose traditions and histories in each country around the world stretch back over many centuries [
2‐
4]. Yet Deaf communities around the world have experienced oppression through a failure to recognise their language and culture [
2]. BSL only gained formal recognition as an indigenous language of the UK in 2003 [
5] and only in Scotland has a law recently been passed conferring legal rights and duties towards BSL users [
6].
English predominates as the language of education for Deaf children; for example, in England 87 % of deaf children only use spoken language in the school environment [
7]. Fewer than 5 % of deaf children have one or more parent who is Deaf [
8]; therefore, it is more usual for BSL
not to be acquired from within one’s birth family. Also, Deaf culture is rarely passed inter-generationally with many young Deaf people forming their Deaf cultural identity as young adults through peers and Deaf community involvement [
9]. In previous generations, it was more usual for deaf children to attend specialist deaf schools, often residentially, where sign language and Deaf culture were absorbed at an early age, even in those which were spoken-language educational environments.
In the United Kingdom, population estimates for BSL users range from 28,000 to over 100,000 [
10] with a conservative estimate of around 70,000 being commonly cited [
11]. Culturally, Deaf people who sign are often marked in literature by the use of a capital ‘D’ to distinguish them from the much larger population of deaf people who do not sign; a convention we follow here [
12].
Although the health inequalities that Deaf people experience are increasingly recognised [
13‐
16] and the distinct needs of Deaf people in terms of access to health services and care are a focus of interest [
17], Deaf people are largely invisible in the clinical trials literature. The invisibility occurs both because Deaf sign language users are commonly excluded from trial participation because of the likely confounding variables they would introduce (see [
18], chapter 5) and because there is almost no clinical trial work on an international basis that is focused specifically on Deaf people; for a rare exception see [
19].
Using language to explore language, and in particular, terminology, has inherent challenges because language is both the subject and process of the endeavour; it is the referent and the means of reference ([
20], p.15). Furthermore, familiarity with a word (lexical item) does not always confer familiarity with its meaning. In everyday life we all have knowledge of words whose meaning eludes us or words whose meaning we are sure of, only to realise that we have misunderstood. This is further complicated in communication between researchers of different disciplines, who attach different technical meanings to the same term. Communication between researchers and non-researchers faces similar problems compounded by a wide range of lay meanings attached to concepts and words. For example, ‘efficiency’ to the economist means maximising benefit for a given budget or minimising the cost of achieving a given outcome. In lay terms, for the general population and other research disciplines, ‘efficiency’ is often used to denote simply cost-cutting with no regard to outcome.
Yet using language to talk about language and its meaning is not an impossible task. Terminology (‘jargon’) can act like a placeholder – its potential ambiguity, obscurity, lack of transparency or multiple meanings are accepted on a temporary basis whilst it is talked
about. Encyclopaedic understanding of how the words we use are defined is usually not required for us to use them in everyday life [
21]. We can choose our words on the basis of our linguistic knowledge (ibid) only, having experience of when or how terms might be used without fully understanding them.
This approach has formed the basis of many studies which have sought to understand participants’ understandings of familiar terminology in clinical trial designs and the common assumptions associated with words such as ‘randomisation’, ‘trial’, ‘consent’, ‘placebo’, ‘arm’[
22‐
24]. The findings have revealed understandings and misunderstandings of key concepts and have been used to help improve participation in trials through ensuring that the information is relevant, appropriate and accessible [
25,
26]. From an ethical perspective, supporting understanding and avoiding misunderstanding are crucial to informed consent.
In relation to Deaf participants who use BSL, three key sources of complexity in producing relevant and accessible recruitment-related information are likely to be: (1) background (general) knowledge considerations associated with Deaf people, (2) properties of a visual spatial language, and (3) bilingual considerations.
In terms of background knowledge considerations, Deaf people routinely experience considerable barriers to accessing information and the acquisition of knowledge, whether deliberately or incidentally. In part, this is because 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 [
27,
28]. Secondly, the majority of Deaf people who have been deaf since birth or early childhood, have lower than average levels of literacy in the written word in comparison with hearing people [
29]. Also, the acquisition of incidental and everyday information is hampered by limited access to the spoken word. Finally, a paucity of peers who sign in the general environment reduces further the opportunities to pick up knowledge through casual conversation. Consequently, it is recognised that many Deaf people experience what has been termed a ‘low fund of information’ [
30]. Therefore, many Deaf people, who are potential trial participants, might not be even casually familiar with the terms and concepts used in participant information sheets, informed consent forms and the verbal support available from researchers.
In relation to the properties of a visual, spatial language, there are features of a signed language that potentially raise different challenges to spoken languages, which use terminology as temporary placeholders to explore understanding. For example, ambiguity and non-specificity can be harder to convey in a language where visual specificity is integral to those signs that are iconic in nature [
31]. A phrase such as ‘kill oneself’, for example, that in English remains without any indication of means, in BSL would be more difficult to convey without an assumption of manner of death in how it is signed (see [
32] for more examples).
Signed expressions that operate as temporary placeholders to facilitate discussion are also potentially problematic within a visual language. This is because their form can influence the conceptual understanding of participants unfamiliar with the term; the shape, orientation or movement involved in a signed expression can reveal underlying assumptions associated with its meaning. For example, EXPERIMENTAL STUDY
1 might be expressed, at least initially, using signs drawn from the common lexicon, such as EXPERIMENT followed by STUDY, until the true meaning can be discussed and an appropriate signed phrase arrived at. However, the
sign for EXPERIMENT is not vague; it is usually an iconic representation of test tubes being poured. This immediately introduces the notion of laboratory science rather than an experimental study potentially involving complex interventions of people, behaviour and therapies. The temporary placeholding sign sets up unwelcome initial assumptions and implications because of
how it looks even if those involved are aware it is acting as a placeholder. Finger spelling
2 the English form of a term is a common way to get round this problem – one may spell out e-x-p-e-r-i-m-e-n-t-a-l – however, to do so introduces a bilingual aspect into an otherwise monolingual discussion and requires acts of translation.
In terms of bilingual considerations, although the first and/or preferred language of Deaf trial participants is BSL, no Deaf person in England is growing up in a monolingual environment. The written word and the spoken word are everywhere. Deaf individuals will, therefore, have differing degrees of access to, and familiarity with, English (or other spoken/written languages) that will have an influence on conceptual understanding as well as basic knowledge. There are examples where the written form of a word might influence the signed lexicon, e.g. the Isle of Wight used to commonly be signed as ISLE of WEIGHT. In other cases the phonetic properties of the surrounding spoken language can be an influence as in the case of Preston (the city), being signed as PRIEST, because the shape on the lips of Preston and Priest are similar. Also for Deaf people who, like hearing people, may be prodigiously bilingual or multi-lingual, there are just some words and expressions more familiar in one language than another and the ability to code switch between languages can be a strength.
In 2014 we were funded by the National Institute for Health Research in England to undertake the preparatory work required for a feasibility study leading to a clinical trial involving Deaf people in the context of a primary mental health intervention (
http://www.nets.nihr.ac.uk/projects/hsdr/1213679). The programme known as BSL Healthy Minds [
33] is an adaptation of the National Institute for Health and Care Excellence (NICE) approved psychological intervention: Improving Access to Psychological Therapies (IAPT) [
34]. It is delivered in BSL by Deaf trained practitioners and aimed at Deaf people experiencing common mental health disorders including depression and anxiety. In line with the Medical Research Council (MRC) framework for complex interventions [
35] a range of preparatory studies were undertaken, one of which is the focus of this paper: namely, exploring lay understanding amongst Deaf people of key terminology and concepts associated with clinical trials. This was a necessary precursor to creating linguistically and culturally appropriate recruitment, information and consent materials for the forthcoming clinical trial.
However, there were no previous randomised controlled trials (RCTs) that involved Deaf people who use BSL. This meant that we were not seeking to improve participation but rather to facilitate participation in the first place. It also meant that there was no confirmed lexicon in BSL for common terms associated with clinical trials. This was true both of the sign bilingual university research department carrying out the study and for the everyday contexts of Deaf lives and conversation. Vocabulary and relevant forms of expression in any language only emerge when a population has direct experience of a topic; think, for example, of the evolution in English of vocabulary to match the explosion in information and communication technologies. As a consequence, the focus of our work in the study reported here was not on the translation into BSL of key terminology associated with clinical trials; it was on its conceptual exploration with a linguistic community in order to identify best means of signed expression and explanation, and likely barriers to comprehension.
Specifically our aims were to:
-
Explore, in BSL, the meaning and understanding of key concepts and common lexical items associated with recruitment and consent to a clinical trial
-
Enable signs/signed expressions to emerge that are semantically accurate and support Deaf people’s informed consent in any future trial
-
Identify key points that can inform the continued development of acceptable and accessible participant information for Deaf people who use BSL and are recruited to clinical trials
We anticipated that many participants in our study might not be even casually familiar with the terms and concepts we would be exploring, and that access to information that might support understanding of unfamiliar terms would be more limited than amongst hearing lay communities.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
AY led the design of the study, contributed to the data analysis and led the writing of the manuscript; RO, and CNG led the data collection and contributed to the data analysis; CD contributed to the data analysis and drafting of the manuscript; RB contributed to process discussions around data analysis and the drafting of the manuscript; KR, KL and LD contributed to the design of the study and the drafting of the manuscript. All authors read and approved the final manuscript.
Authors RO, KR and CNG are native BSL (British Sign Language) users. Authors CD, AY and RB are second-language BSL users. Authors KL and LD are experienced triallists but new to working in the context of signed languages. AY is the chief investigator.