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

Study 1: qualitative exploration of the acceptability of individual randomisation and development of trial-related terminology in British Sign Language (see Chapter 3)

Study 2: secondary data analysis of patient numbers and outcomes data (see Chapter 4)

Study 3: mixed-methods modelling of BSL-IAPT and standard Improving Access to Psychological Therapies as accessed by Deaf people (see Chapter 5)

Study 4: translation and validation of the EQ-5D-5L version in British Sign Language and exploratory analysis of appropriate utility weights (see Chapter 6)

Study 5: exploratory economic evaluation (see Chapter 7)

Design

The qualitative study was underpinned by a phenomenological approach, with data being collected by means of focus groups. Phenomenology55 suited the focus of this study, which was on both how key concepts are understood and the assumptions that might underpin the meaning participants bring and attribute to such issues as randomisation. 56 Focus groups were used because of their appropriateness in cultural terms as well as the exploratory nature of the research objectives. It has been remarked that Deaf culture is a particularly collective, rather than individualistic, culture,7,57 and Deaf people often prefer group discussion over individual interviews to explore new ideas or information because this is more culturally coherent,45 a trait observed in other cultural communities internationally such as Maori and First Nation peoples. 58

Inclusion criteria

A purposive sample was sought of Deaf people aged 18 years or over, who used BSL as their first or preferred language. Anyone currently receiving support through the IAPT programme was excluded because additional ethical permissions would be required for participants who were current patients of the National Health Service in England.

Young et al. 34

Recruitment

An explanation of the study in BSL was posted on the research group website and advertisements to participate in the focus groups were placed on a signed Facebook [Facebook, Inc., Menlo Park, CA, USA] site accessed by the Deaf community and through email, shared networks and word of mouth/word of hand.

Young et al. 34

Ethics

The study was approved by the University of Manchester Research Ethics Committee (Ref: 14183). Informed consent was obtained from all participants. Participant information sheets were made available in advance of the focus groups in BSL on a website as well as in plain English. Prior to the focus groups, the researchers clarified the information in BSL again, face to face, and participants had the opportunity to ask questions. All participants were provided with a pre-written, postage paid withdrawal form to facilitate easily withdrawal of consent for their data to be used subsequent to the focus groups.

Young et al. 34

Data collection

The focus groups were facilitated by two Deaf native BSL users who were part of the research team: one had a higher degree in research and was very experienced in focus group facilitation; the other was new to research but had worked for many years in the Deaf community in various social and support roles. Both facilitators were known to Deaf participants insofar as the Deaf community is small and it is not unusual to know or know of other Deaf people; however, neither had a personal or close professional relationship with any of the participants. Deaf facilitators ensured that data could be collected directly, without the more usual circumstance of an interpreter being required to facilitate discussion and, because Deaf participants and facilitators shared a common cultural background and identity, it was assumed that this would aid open and relaxed discussion. However, some participants remarked in the course of the focus groups that they perceived the facilitators to be ‘clever Deaf people’ and therefore different from themselves because the facilitators were more familiar with the kinds of issues that were being addressed in the groups.

At times, this meant that facilitators had to resist requests from participants to explain clearly what randomisation meant and why there might be an issue about acceptability. The notion of another Deaf person standing back and facilitating discussion that explored ideas rather than conveying face-to-face reliable information was difficult for some of the participants as it transgressed their expectations of Deaf people’s obligations to each other to support information access and understanding. As previous studies have documented,59 Deaf people experience a strong sense of collective obligation to each other to convey new information and knowledge when acquired in BSL because of the usual barriers that Deaf people experience to the acquisition of information that is mostly disseminated in English/spoken language.

The group sessions were in two parts, each lasting between 1.5 and 2 hours, with refreshments provided. In part 1, participants were introduced to the purpose of the study and clinical trials in general. They were introduced to the concept of randomisation and why researchers might want to do that. They were then invited to explore together what the implications of randomisation might be for someone who participated in a study about BSL-IAPT compared with standard IAPT, with adjustments for Deaf people’s access. In part 2, discussion focused more specifically on how to provide good information in BSL to support recruitment and informed consent. The specific terms that the group were asked to discuss were ‘randomisation’, ‘feasibility’, ‘informed choice’, ‘trial’, ‘consent’ and ‘experimental study’.

Three cameras were used to capture the discussions. These were time-coded enabling the later simultaneous display of all interactions and communication for purposes of analysis. PowerPoint [Microsoft Corporation, Redmond, W A, USA] was initially used as a prompt to different sections of the discussion. In some instances the prompts were visual diagrams, e.g. showing two arms of a trial and how it relates to initial recruitment of a sample; in others the prompts were specific words written in English that could be referred back to as prompts during the discussion.

Young et al. 34

Data analysis

All data were kept in their source language for purposes of analysis. The video files were uploaded to NVivo 10 [QSR International, Warrington, UK] which has the facility to tag and segment video data, in this case visual language data, for purposes of thematic coding without the need to transcribe data. This was important because if the data were transcribed this would equal translation in the case of BSL data, as BSL has no written form. This contrasts with many spoken languages where to transcribe data is only to change its modality (from spoken to written) and not to translate. 60–63

Young et al. 34

‘All data were watched and re-watched independently by two researchers (CD and CNG) with the aim of creating an initial coding framework’ (p. 5). 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). The coding frameworks for each, including the themes and subthemes, are shown in Tables 1 and 2. Although the intention had been to code for each objective separately, inevitably when watching the same material, there was some overlap in tagging data segments for different purposes.

The two researchers carrying out the analysis brought different personal and professional biographies to the task: one is a native Deaf sign language user from a Deaf family who has worked for over 10 years in research roles; the other is a hearing researcher who learned BSL as an adult and who has been a qualified and registered sign language interpreter for 11 years, in addition to her research role. Their initial coding frameworks were compared and discussed with a third researcher (AY) who was overseeing the analysis (a hearing, late learner signer who has worked in the Deaf studies field for 25 years). Many of the same themes had been identified arising from specific examples in the data but were not clustered in exactly the same way in how they had been organised by the two researchers. Further discussion led to a framework consisting of the following four areas under which there were additional layers/sub-themes.

Young et al. 34

Introduction

Through the two-part focus group structure, participants had the opportunity first to gain an understanding of what a RCT would mean in practice; the underlying rationale for it, including the key concept of equipoise; whether or not participants were permitted to change their mind or drop out of a trial; and the crucial importance of informed consent. Therefore, the subsequent guided discussions about the acceptability of randomisation and participants’ views of participation in a RCT were based on this new knowledge and group reflections on it. The purpose of the study was not to reveal ignorance but, rather, having supplied information directly in participants’ preferred language and given them the opportunity to assimilate this through Deaf-led facilitated discussion, to see what views were revealed and what might underpin those. The main themes to emerge are discussed in turn.

Participation in research

Rather than addressing participation within a RCT directly, many group members addressed participation in research in general, seeing randomisation within one particular kind of research as a subset of the general issue about Deaf participation in research studies. Participation in research that was about Deaf people was seen overall as something that was very positive, primarily because it had the potential to improve services for Deaf people or make Deaf lives ‘easier’. In this respect, several participants discussed what they perceived as the general ignorance of service providers about their needs and the perceived lack of priority given to quality health and social care services for Deaf people. Therefore, if participation in any form of research might assist with improving services or lobbying for new support to address Deaf people’s needs, group members argued that it was to be welcomed.

Research and the evidence it might produce, therefore, was seen as form of leverage. To some extent, participation by Deaf people was perceived and talked about as a political act. However, it was also perceived as an altruistic act in that participation was about benefiting the needs of all Deaf people without necessarily accruing benefit for the individual who participates. This motivation was linked, by those group members who discussed it, with a sense of collective responsibility to assist in improving the lives of all Deaf people today, and for future generations.

From a cultural perspective, this response should be understood in terms of many Deaf people holding a strong sense of the value of what other Deaf people in prior generations did to enable a better future for the Deaf community. Examples often cited include the respect for elders who are seen as having kept BSL alive when it was disallowed or unrecognised within public, educational and political structures. 64 In addition, the cultural value given to heritage and the continuation of Deaf culture through social bonds and structures over hundreds of years65–67 is seen as part of the multigenerational legacy to which Deaf people today also contribute. This orientation towards the collective good is of particular importance where culture is not predominantly transmitted through family structures, as most Deaf people have hearing, non-signing families.

In terms of the acceptability of randomisation, this view of the value of research participation in terms of the whole community, not just the individual, prompted the response among some participants of ‘why not give it a go?’, ‘let’s just do it’ and ‘what is there to lose?’. This was particularly the case in two of the focus groups where there was a greater tendency to whole group agreement and the adoption of group views, rather than differences between individuals within the groups. A small minority of group members had a more specific response, which was, if such a research design had the potential to be definitive about what was the most effective means of delivering therapy for Deaf people then, on that basis, they would want to participate in the research. However, participation was still framed in terms of the collective good even though it was an individual decision.

In summary: The question of the acceptability of randomisation is subsumed under a perception of the value of research in general for future generations of Deaf people. The details of what randomisation might imply are of less importance than a perceived cultural obligation to participate if to do so will benefit Deaf people.

Choice

There was a great deal of discussion in all of the focus groups about choice. With respect to randomisation, the abstract idea that participants would be allocated to a group through a process of randomisation was more informally understood to imply that someone would choose into which group an individual might be put. Even though the facilitators explained what randomisation meant, using a range of metaphors and examples, it still prompted many questions about ‘who’ does the choosing rather than the method by which allocation might be done. For example, the commonly used explanation about randomisation being like tossing a coin with a chance of heads or tails still prompted the question ‘but who tosses the coin?’. The explanation of a computer being used for allocation still promoted enquiries about who controlled that computerised process. Some group members found it hard to get past the notion that even if random meant by chance, someone must still, somewhere along the process, exercise some choice about what the possibilities are for any given individual.

One potential explanation for this response is related to the cultural resonance for Deaf people that choices are usually made ‘for’ them, or denied to them, by hearing people who are not cultural kin. Therefore, what is perceived as an outcome over which they have no control (to which group they are allocated in a RCT), is easily equated with many examples in Deaf life of disempowerment where the choices available are restricted or controlled by others. 68 To some extent this attitude is historical in that the history of social welfare, particularly with respect to Deaf people, is one of dependency creation by hearing people who largely controlled the flow of information and the structures of Deaf people’s lives, including who Deaf people might marry, which jobs they might have and how and where they might meet. 69,70 Even as late as the 1980s, and before the establishment of sign language interpreting as a regulated and qualified profession, Deaf people had to be clients of social services to access any form of interpreting. 71 Today, some rules within public offices and structures still disallow fundamental expectations and rights of citizenship such as jury service. 72,73

The question of the acceptability of randomisation is influenced by experiences of restriction of choice and disempowerment that have a strong historical resonance for Deaf people today.

Perceptions of service delivery models

Of the total number of 19 people who participated in the focus groups, two had personal experience of having used standard IAPT, BSL-IAPT or both, and a further two had experience of both Deaf counsellors and hearing counsellors with an interpreter. The others had no similar experiences, but were well aware that there was a BSL-IAPT service that was delivered by Deaf, trained PWPs directly in BSL without an interpreter. It was clearly explained that ethically a RCT could not be undertaken unless there was no clear evidence that one treatment is more effective than another. Groups were invited to discuss their views on that position and whether or not they agreed that that a trial could be undertaken on that basis. As this was a new concept, there was a great deal of clarification required and checking of understanding prior to moving on to discussion of opinions about it. Nonetheless, all of the groups became far more engaged in discussing issues of preference for one approach to therapy or another and the relative merits of each rather than whether or not it was reasonable to proceed on the basis of no strong evidence of one being more effective than the other. The perceptions of service delivery models shared are enlightening for a range of issues that might influence a person’s willingness to be randomised in a trial comparing standard IAPT with adjustment for Deaf people with BSL-IAPT.

Preference-related issues included communication and language concerns. On the one hand, some group members expressed dissatisfaction with the prospect of engaging with an IAPT therapist through an interpreter. This was because the experience of indirect communication would, in their view, result in a less satisfactory relationship because it would be harder to express sensitive issues, make emotional responses clear, and participate in therapeutic discussion if the therapist were not directly engaged with them. In addition, a few participants expressed concerns about the interpreters, namely whether or not they would be familiar with the range of therapeutic concepts and vocabulary or whether or not, as a Deaf client, they would in fact also become a language resource for the interpreter, teaching the interpreter the appropriate terminology? The problem with this was the time it would take away from addressing their own problems and needs within the therapeutic session.

That said, not everyone who expressed concerns about an interpreted IAPT experience saw it as an absolute reason not to engage in a process of randomisation that might mean that they were randomised into standard IAPT. One group in particular spent time thinking about potential solutions. These included the possibility of any future trial ensuring that the interpreters likely to be used within the standard IAPT arm are given additional training prior to the trial starting, so that participants could be assured of a good experience if randomised into that arm. Part of that good experience was linked with taking away any potential stress or anxiety that might be caused by concerns about who the interpreter might be and if they were going to be experienced enough in this particular domain of work. Thus, from group members’ perspectives, trusting the skills and experience of the interpreter had the potential to render randomisation into a standard IAPT service acceptable. However, there was no perception that by implementing such measures one would actually be changing the ‘usual service’, which might be the comparator arm in any future trial design.

From a different perspective, a minority of group members were anxious about language and communication for an alternative reason. For them, the main concern would be that any future research would too easily assume that if an individual used BSL then she/he would automatically prefer BSL-IAPT because it would be a directly delivered therapeutic service from a Deaf professional. One group member in particular felt strongly that such an assumption was itself discriminatory and, in their experience, using spoken language directly with a therapist and lip-reading that therapist, or using an interpreter for receptive communication from a therapist but speaking for themselves within the session, was more satisfactory. For this person, as well as for many others in the groups, the issue of individual preference and individual comfort, whatever that might be, would trump all other considerations.

There were a range of other factors associated with preference that were not directly related to language/communication but more related to cultural perspectives and the nature of the Deaf community. For example, the Deaf PWPs who may be encountered in BSL-IAPT were by definition members of the Deaf community like the clients they served. They were therefore likely to be well known and also to have been encountered by clients in other social or professional settings. This phenomenon is not unusual for Deaf people, and the situational and individual ethical issues it may provoke have been written about previously in terms of small communities of practice. 58 Consequently, some participants expressed concerns about whether or not their confidentiality would be kept if they had a Deaf PWP. The point here was not so much that they did not trust the Deaf PWP, but rather that it would be a nagging consideration in the back of their mind, and for someone struggling with anxiety this could be an added burden. On the other hand, the idea of a hearing person with little or no understanding of Deaf culture or Deaf people being the therapist was also a concern. The main problems were perceived to be the need to explain about Deaf people and the Deaf way of life as they went along rather than trusting the therapist would just ‘get it’. In effect, clients would have to become their own cultural broker too, and group members were concerned that this could be potentially detrimental to the well-being of someone experiencing depression and/or anxiety, despite being part of an intervention designed to help them. A similar concern has been recorded in a small interview study of Deaf people with experience of BSL-IAPT. 74

Some group members also worried about the qualifications and skills of a Deaf person working as a PWP. Although, from a communication perspective, a hearing therapist with an interpreter was not ideal, the hearing professional in their view was likely to be more experienced and to understand more about the work they did than the Deaf professional. There were two roots to this point of view. The first was that Deaf PWPs were very new and there is not a long history of Deaf professionals’ involvement in mental health as therapists in the community; therefore, the range of experience they were likely to have built up was seen as less than the wider pool of hearing therapists. The other was an expression of a common perception, particularly among older Deaf people, that hearing people are likely to know best and be better qualified because they have more access to information, have a greater possibility of gaining professional experiences, and work in the mainstream of general society. This point of view has previously been analysed as one of internalised oppression akin to that recorded among cultural groups which have experienced colonisation. 7,75

The possibility of randomisation represented a threat to the expression of an individual’s linguistic and cultural preferences which were considered a key priority in engagement with therapeutic services. These preferences varied and it was not a foregone conclusion that everyone would prefer a Deaf, BSL-using PWP. The possibility of not having linguistic preferences and cultural needs met was seen as detrimental to mental well-being and therefore randomisation could be seen as detrimental to well-being for some people.

Evidence

In the course of facilitating the focus groups, the two Deaf researchers ensured that they too modelled equipoise. Throughout, they repeated and maintained a stance that there was currently no evidence that one service delivery model (BSL-IAPT or standard IAPT with reasonable adjustments such as an interpreter) was more or less effective than the other. However, in all of the groups, there were challenges to this position from group members, cast in terms of cultural collusion. For example, some group members suggested that the researchers ‘had to say’ that they believed that, but as Deaf people of course they could not. In another group, members said they would ‘go along’ with the assumption for sake of the discussion but everyone of course knew that the two service delivery models could not be ‘equivalent’. What was interesting about dialogue such as this was the lack of attention to the notion of objective research evidence, in terms of outcomes and recovery, and the greater priority given to shared cultural knowledge, experience and understanding. Group members were appealing to facilitators, who were Deaf like them, to acknowledge that Deaf people’s understanding about the superiority of an intervention delivered in one’s own language was self-evident, a view that they thought was bound to be shared.

Although other literature concerning lay understanding of randomisation has recorded the appeal to common-sense notions of what must be better or preferable,41,76 the discussions in this study were a little different. They were stressing the importance of cultural, collective understanding. This has more recently been debated in the literature in terms of Deaf epistemologies in acknowledgement of diversity within a cultural group. 77–80 It is argued that knowledge generated, owned and expressed by Deaf people, which is formed from within a Deaf world view and Deaf ontological experience of life, should not only be regarded as legitimate, but as having priority setting or directive worth. 81,82

This approach highlights a different form of evidence. It is one that is increasingly important in trial design, particularly in the feasibility and modelling phases of the Medical Research Council’s Framework for Complex Interventions,83,84 but one that generates a different standard of evidence than that for which RCTs are intended. Group members, however, appealed to it, in suggesting that perhaps any future research might be designed to give patients experience of both approaches to IAPT delivery and ask them which they preferred and why. Although it was acknowledged as helpful for researchers to be Deaf people, as in this project, the importance of lay Deaf people was also emphasised, as not all Deaf knowledge is the same because of the roles and positions Deaf people find themselves in. The researchers were identified as ‘clever Deaf’ people, for example, and were contrasted by group members with the alternative lives of many ordinary Deaf people who struggle with education, employment and literacy.

There is a strong appeal to cultural common sense that access to a service in one’s own language and that is culturally matched is preferable. Randomisation may be resisted for its failure to acknowledge Deaf epistemological positioning.

Conclusion

Evidence from this study highlights a confluence of factors affecting the acceptability of randomisation that are deeply embedded in Deaf people’s historical and contemporary experiences of society, as well as shared cultural characteristics. Although individual preferences, along with perceptions and misperceptions of what randomisation implies, have some influence, the culturally contextual nature of Deaf people’s thinking predominates. This does not mean, however, that a service delivered by a Deaf person in BSL is automatically to be preferred or perceived as more appropriate. The four main influences on Deaf people’s attitudes and conclusions about the acceptability of randomisation were:

1. Research involving randomisation is a subset of research in general, which, if it benefits Deaf people today and in the future, is perceived as acceptable.

2. Randomisation can be perceived as an example of forced choice without personal power, which is a common experience for Deaf people, and on that basis may be unacceptable.

3. If randomisation implies not having personal linguistic preferences and cultural needs met, then it is of itself a threat to personal well-being.

4. Randomisation may be resisted on grounds of its perceived denial of the value of Deaf people’s common sense, knowledge and belief in what is best for them, which happens often in Deaf people’s lives.

There was, therefore, no clear picture about the acceptability of randomisation and, in fact, some helpful suggestions arose in the course of discussion about how to allay fears and concerns that may be a barrier to participation in RCTs. There was not an absolute rejection of the possibility of participation in research involving randomisation. Instead there was a strong appeal to see its implications from a cultural not just a linguistic access or service model perspective.

The nature of the sample and small scale of the exploratory work is a limitation to these findings because the generalisability of these views across the diversity of the Deaf community is untested. Results tentatively suggest that there are grounds for moving towards a feasibility study as randomisation has not been rejected outright, provided that the implications of the culturally embedded perspectives expressed here are incorporated into how recruitment might be undertaken in the future. The second element of effective recruitment would involve language, terminology and the provision of information, which we address in the trial-related terminology in BSL study reported below.

Results and implications

The principal results and conclusions (reproduced from the abstract of the original article) were:

Six 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.

Young et al. 34

Additionally, the study identified six necessary conditions that need to be met when developing signed participant information for Deaf people so that it is acceptable, accessible, transmitted accurately and understood as intended. The authors conclude that these are relevant to all signed languages, not just BSL, and potentially apply to further development of written and spoken information for hearing participants for whom the majority language (English) is not their first or preferred language. The conditions identified were:

1. A community-participatory, exploratory approach to arriving at appropriate clinical trial terminology is highly effective in instances where languages, in this case BSL, have not yet had the contact with a topic that would mean a common vocabulary/preferred means of expression has developed.

2. Languages have properties associated with their form and grammar that naturally enable some approaches to explanation to support comprehension that others may not. In this case, verb directionality, expectations of specificity and simultaneous contextual, semantic layering within expressions enabled features of the underpinning trial design to be clarified and remain consistent.

3. It is important to take into consideration bilingual influences on comprehension even when information is presented monolingually; this is a decoding strategy for unfamiliar terms and concepts that is available to those who are bilingual and multi-lingual and can be a source of both strength and misunderstanding.

4. Orientation of information to avoid misunderstanding is an important axis to consider when creating new information for a cultural-linguistic group unfamiliar with the topic. It is subtly different from an orientation designed to support comprehension and may, as in the case of the sample in this study, be a preferred orientation.

5. The researcher should understand cultural, contextual or social barriers that participants might face in engaging in open, constructive discussions of the information materials and consent procedures, over and above those that might be created by language per se. In the case of Deaf people, these barriers might derive from negative historical experiences of the education system, and class differentials.

6. Clarity of expression, in the sense of plain language or avoidance of jargon, is not sufficient to promote comprehension. Attention to language-in-use in contemporary discussion is an important means of expression to effectively communicate complex concepts because it reflects common cultural usage.

Young et al. 34

The study reinforces the ethical imperative to ensure that trial participants who are Deaf are provided with optimum resources to understand the implications of participation and to make an informed choice. We include, as one of the products of this study, a glossary of terms and their alternatives in BSL for key concepts associated with trial participation and the production of recruitment and information materials in BSL (see Appendices 1 and 2).

Methods

Results

The results of the study to establish the clinical cut-off points for the PHQ-9 BSL and GAD-7 BSL are reported in Belk et al. 85

The main findings, derived from the abstract of the article, are as follows:

The clinical cut-offs for PHQ-9 BSL and GAD-7 BSL are 8 and 6 respectively. This compares with the original English version cut-offs in the hearing population of 10 and 8 respectively. The three different statistical choices for calculating clinical cut-offs all showed a lower clinical cut-off for the Deaf population with respect to the PHQ-9 BSL and GAD-7 BSL with the exception of the Maximising criteria when used with the PHQ-9 BSL. Applying the new clinical cut-offs, the percentage of Deaf BSL-IAPT service users showing reliable recovery is 54.0% compared to 63.7% using the cut-offs scores used for English speaking hearing people. These compare favourably with national IAPT data for the general population.

Belk et al. 85

Further conclusions and implications of this work are:

Appropriate clinical cut-offs for these instruments are now established for Deaf BSL users. Assessment of the clinical effectiveness of BSL-IAPT, both for clinical practice and to allow accurate comparison with mainstream IAPT services, can now be made. Comparison is important in the national [English] monitoring of IAPT services through the mandatory data that flows upwards to the HSCIC.

Belk et al. 85

Methods

Results

Participants

BSL-IAPT data set

The BSL-IAPT data set contained data from a total of 502 clients. The participant flow diagram is shown in Figure 1. A total of 429 clients with first PHQ-9 score and/or first GAD-7 score were included in the secondary data analysis.

FIGURE 1.

Participant flow diagram for BSL-IAPT cohort (using BSL clinical cut-off points for caseness). Spec = Sens, specificity and sensitivity are equalised. Reproduced from Belk et al. 85 This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited (http://creativecommons.org/licenses/by/4.0/).

Standard Improving Access to Psychological Therapies data set

Initially, 22 NHS trusts and three non-NHS service providers granted approval and agreed to provide data from Deaf BSL users who had used their IAPT services (approvals covered 74 individual IAPT services in total, as some trusts covered several IAPT services). These approvals generated 24 separate data extractions. Some trusts provided separate extractions for each service under their authority; others provided a single extraction covering all services under their authority. Therefore, we are unable to say with any confidence exactly how many individual services are represented in our sample. Four NHS trusts and one non-NHS service provider were not included in the final analysis, as either the data they provided were not useable or contained no appointments data, or subsequent to approval they found themselves no longer able to meet the data extraction deadline. There were issues relating to how the data were recorded (or not recorded), despite the services being provided with the code key for each variable for the data transfer. Examples of the issues that some services expressed about the task of extracting data on Deaf BSL users included the following: the task proved too time-consuming for them; their recording system did not contain the information requested; there were difficulties in identifying the correct person to do the data extraction; and digital records did not cover the whole period requested.

Despite the issues with data extraction, service providers were able to identify which clients were Deaf and which were BSL users in different ways, including through mention of BSL in the client’s notes, through their interpreter booking system and through a service’s own bespoke label, which stated that a client was a BSL user. One standard IAPT service was able to identify which clients were Deaf BSL users because they had been working with a therapist who was Deaf and a BSL user. Another service provided data where clients were externally identified as Deaf BSL users via interpreter agency booking records. As shown in the participant flow diagram in Figure 2, data from a total of 116 Deaf BSL clients from standard IAPT services were included in the secondary data analysis.

FIGURE 2.

Participant flow diagram for standard IAPT cohort (using English cut-off points for caseness).

Depression and/or anxiety

Table 14 shows the numbers of clients who were initially identified as having depression and/or anxiety based on English cut-off points for the standard IAPT clients and on BSL cut-off points for BSL-IAPT clients. Most clients in both groups had depression and anxiety (75.9% for standard IAPT, 81.6% for BSL-IAPT). Ten standard IAPT clients (6.9%) did not meet caseness, compared with 18 BSL-IAPT clients (4.2%). Depressive scores above the cut-off points were similar in the two groups (standard IAPT clients 84.5%, BSL-IAPT 86.4%) but more in the BSL-IAPT group had higher anxiety scores (standard IAPT clients 82.8%, BSL-IAPT 91.1%). The difference between the two IAPT groups marginally failed to be statistically significant [χ²(3) = 7.05; p = 0.070]. Had the standard IAPT clients been assessed on the lower BSL cut-off points of 8 and 6 for the PHQ-9 and GAD-7, respectively, the numbers and percentages would have changed slightly in favour of caseness: 94 (81.0%) with both depression and anxiety, seven (6.0%) with depression, eight (6.9%) with anxiety and seven (6.0%) not meeting caseness.

TABLE 14 - Prevalence of depression and/or anxiety from first PHQ-9/GAD-7 scores, by IAPT group

Diagnosis	IAPT group, n (%)
	Standard (N = 116)	BSL (N = 428)
Depression and anxiety	88 (75.9)	350 (81.6)
Depression	10 (8.6)	20 (4.7)
Anxiety	8 (6.9)	40 (9.3)
Did not meet caseness	10 (8.6)	18 (4.2)

Recovery, reliable improvement and reliable recovery

For the calculations of recovery, reliable improvement and reliable recovery, the IAPT guidelines are followed (IAPT 2014). 103 According to these, ‘caseness’ pertains to entry into the service: an individual is defined as having reached ‘caseness’ if their score on the PHQ-9 and/or GAD-7 at assessment is equal to or higher than the cut-off value. ‘Recovery’ is said to have been reached when a client’s PHQ-9 and GAD-7 scores both fall below the clinical cut-off point and they were at ‘caseness’ at intake. ‘Reliable recovery’ is defined as the combination of ‘recovery’ and ‘reliable improvement’. ‘Reliable improvement’ is calculated using the ‘reliable change index’. The reliable change index enables the quantification of ‘reliable improvement’ and ‘reliable deterioration’ (i.e. a score change larger than the reliable change index signals a clinically significant change). This measure, when combined with ‘recovery’, enables the identification of those individuals who have ‘reliably recovered’ (i.e. shown both ‘recovery’ and ‘reliable improvement’, and who have completed therapy). Unfortunately, data on completion of therapy were not consistently recorded by standard IAPT providers, so we could not reproduce the calculations of recovery, reliable improvement and reliable recovery in Belk et al. 85 for standard IAPT clients. For the analyses here, the IAPT definition of ‘completed therapy’ was followed, which is defined as having attended a minimum of two treatment appointments104 (Table 15).

TABLE 15 - Caseness and having at least two appointments, by IAPT group

Criterion	IAPT group, n (%)
	Standard (under English cut-off points) (N = 116)	BSL (under BSL cut-off points) (N = 429)
Meeting caseness	106 (91.4)	411 (95.8)
Had at least two appointments	99 (85.3)	371 (86.5)
Meeting caseness and had at least two appointments	89 (76.7)	356 (83.0)

The numbers of clients showing recovery, reliable improvement and reliable recovery are shown in Table 16.

TABLE 16 - Recovery, reliable improvement and reliable recovery, by IAPT group

N/A, not applicable.

Note

Recovery, reliable improvement and reliable recovery here are based on ‘completed therapy’ being defined as having attended a minimum of two treatment appointments.

Measurement of recovery	IAPT group, n (%)
	Standard (English cut-off points) (N = 89)	BSL (BSL cut-off points) (N = 349)
Recovery
Recovered	35 (41.2)	150 (43.0)
Did not recover	50 (58.8)	199 (57.0)
N/A: no follow-up data	4	7
Reliable improvement
Reliably improved	54 (63.5)	233 (66.8)
No reliable change	28 (32.9)	95 (27.2)
Reliably deteriorated	3 (3.5)	21 (6.0)
N/A: no follow-up data	4	7
Reliable recovery
Reliably recovered	34 (40.0)	141 (40.4)
Did not reliably recover	51 (60.0)	208 (59.6)
N/A: no follow-up data	4	7

The association between the type of IAPT service (standard or BSL) and the recovery outcome was not significant [χ²(1) = 0.09, 95% CI for difference between percentage recovered –13.0% to 10.0%; p = 0.763]. Non-significant results were also found for the association between the type of IAPT service and reliable improvement [χ²_trend(1) = 0.01, 95% CI for difference between percentage reliably improved –14.9% to 7.5%; p = 0.917], and between the type of IAPT service and reliable recovery [χ²(1) = 0.01, 95% CI for difference between percentage reliably recovered –11.5% to 11.4%; p = 0.946]. Although the three CIs contained 0 (consistent with the non-significant test results), they were all relatively wide.

Figures 3 and 4 show rates for reliable improvement and reliable recovery, respectively, for the standard IAPT services compared with the BSL-IAPT service. The numbers of clients with caseness and at least two therapeutic appointments for each service are shown. For most standard IAPT services, this was three or fewer, so a number of the rates are either 0% or 100%. For standard IAPT services with five or more clients in the analysis, the reliable improvement rate was similar to that of the BSL-IAPT service as a whole, whereas the reliable recovery rate for these standard IAPT services showed more variation than the BSL-IAPT service rate.

FIGURE 3.

Reliable improvement for standard IAPT providers compared with BSL-IAPT data.

FIGURE 4.

Reliable recovery for standard IAPT providers compared with BSL-IAPT data.

Waiting times

Waiting times were calculated in number of days from date of referral to first appointment. The waiting times for standard IAPT ranged from 0 to 382 days (six clients had missing data, 11 had a waiting time of 0 days) and for BSL-IAPT the waiting times ranged from 3 to 306 days; both groups showed a positively skewed distribution (Table 17 and Figures 5 and 6). The median waiting time in the standard IAPT group was shorter than that for the BSL-IAPT group (21.5 days vs. 27.0 days) and the difference in distribution between groups was significant (Mann–Whitney U-test = 19439.5, z = –2.85; p = 0.004). It is not clear whether or not the 11 zeros for standard IAPT clients were observed values, which seems unlikely in a busy service. When the analysis was repeated without these clients, the median waiting times were not significantly different (26.0 days vs. 27.0 days, Mann–Whitney U-test = 19439.5, z = –1.31; p = 0.189).

TABLE 17 - Waiting time (days), by IAPT group

Measure	IAPT group
	Standard (n = 110)	BSL (n = 429)
Mean (SD)	32.35 (45.27)	36.91 (33.70)
Median	21.50	27.00
Range	0–382	3–306
Mode	0	14

FIGURE 5.

Waiting time (days) for standard IAPT group.

FIGURE 6.

Waiting time (days) for BSL-IAPT group.

The IAPT guide states the goal that ‘. . . by March 2016, 75% of people referred to the IAPT programme begin treatment within 6 weeks of referral, and 95% begin treatment within 18 weeks of referral’ (p. 5). 103 Six weeks is equivalent to 42 days, and 18 weeks to 126 days. Both standard IAPT and BSL-IAPT met these targets (Table 18).

TABLE 18 - The percentage of clients of each type of IAPT service who achieved the 6-week and 18-week target

Criterion	IAPT group, n (%)
	Standard (N = 110)	BSL (N = 429)
Within 6 weeks of referral	86 (78.2%)	328 (76.5%)
Within 18 weeks of referral	107 (97.3%)	414 (96.5%)

It was not possible to report difference in waiting time against quarter-years for standard IAPT because it was not possible to extract the information needed from the number of days between first referral and date of first appointment alone. However, the comparison for the waiting time for each quarter-year has been examined for the BSL-IAPT data set (Figures 7 and 8). It was found that the mean for waiting time started high (mean = 61 days for first quarter in 2011), which is probably accounted for by the set-up time and BSL-IAPT service lead-in (including the incremental training of Deaf people as PWPs), and then dropped to 25–30 days as the service bedded in. The marked rise in waiting times in 2014 onwards could be a consequence of changes from PCT local commissioning to CCG commissioning arrangements from April 2013, which affected the number and location of BSL-IAPT outlets and saw a change in funding arrangements from largely block commissioning arrangements to greater use of individual funding requests (IFRs) (see Chapter 5).

FIGURE 7.

The mean waiting time (days) for BSL-IAPT for each quarter from 2011 to 2015. Q, quarter.

FIGURE 8.

Waiting times (days) for BSL-IAPT per quarter. Q, quarter.

Discussion

The numbers of Deaf service users of standard IAPT on which these analyses have been run are not representative of the complete national picture. Data are drawn from only 19 trusts and two private providers, across no more than 74 services. We opened discussions with 30 other standard IAPT services that reported having seen at least one Deaf client but that were unable to arrange approval and complete the data extraction required in the time permitted. There are at least 255 IAPT services in England as a whole, and within these there may be many more Deaf clients of whom we remain unaware. Therefore, it is unknown how representative the data on Deaf clients in standard IAPT services are in comparison with the national picture. That said, it has not been possible previously to identify any Deaf users of standard IAPT or to explore their characteristics and outcomes. This is the first study that has done so.

Our concern that Deaf users of standard IAPT may have different demographic, educational and employment characteristics from the population of users of BSL-IAPT was not upheld, based on the available data. The two populations are largely comparable. With regard to patterns of service delivery and adherence, the numbers of appointments booked and attended by clients, whether standard IAPT or BSL-IAPT, were also comparable. Calculations using the available data showed that the median waiting time was shorter for clients of standard IAPT services than for clients of BSL-IAPT services (21.5 days vs. 27.0 days; p = 0.004).

Clinical characteristics at point of entry into therapy were difficult to compare by IAPT group because of differences in recording and missing data. A provisional diagnosis was not available for well over one-third of standard IAPT clients, compared with 1 in 20 BSL-IAPT clients. Interestingly, among those for whom a provisional diagnosis was present, there was a marked difference between the IAPT groups. More than half of standard IAPT clients had been given a provisional diagnosis of a depressive episode, whereas one-quarter had been provisionally diagnosed as having a mixed anxiety and depressive disorder. More than half of BSL-IAPT clients had been given a provisional diagnosis of mixed anxiety and depressive disorder, whereas one in five were provisionally diagnosed as having a depressive episode. Long-term conditions, on the other hand, were similar in the two groups.

In terms of clinical outcomes, the prevalence of depression and/or anxiety in the two IAPT groups from initial PHQ-9/GAD-7 scores marginally failed to show a significant difference (p = 0.070). Slightly more clients attending BSL-IAPT services had GAD-7 scores indicating anxiety (91.1% vs. 82.2%), whereas the two groups had similar percentages with PHQ-9 scores indicating depression. The significant difference found when comparing the final PHQ-9 score between the two IAPT groups is that Deaf clients from the standard IAPT service were more likely to be depressed than the Deaf clients from the BSL-IAPT service. That is to say that, at the start of the treatment, there are no differences in the depression score, as measured by PHQ-9, between the two IAPT groups, but on comparing the final PHQ-9 scores available from Deaf clients, the scores are significantly different. Completion of treatment was not consistently recorded across standard IAPT providers, so we had to use a definition based on attending two appointments. Using this definition, rates for recovery, reliable improvement and reliable recovery were very similar in the two IAPT groups.

The recent methodological announcement by the HSCIC105 clarifies that, from July 2016, calculation of rates of reliable recovery and reliable improvement should be based on those who have ‘finished the course of treatment’, as defined by a valid endcode in the client data upload, rather than those who have ‘completed’ treatment, defined in the IAPT KPIs as having had a minimum of two therapeutic appointments. 104 In our original calculations of reliable recovery (and reliable improvement) based on the BSL-IAPT data set, we were able to use this strict definition of ‘finished the course of therapy’ as endcodes were available for 226 clients. 85 The broader definition of ‘completed’ was available for 349 clients, and was used in our comparative analyses of Deaf users of standard IAPT and of BSL-IAPT, as endcodes were not consistently available in the standard IAPT data transfer we had received.

Given these caveats, we found no significant difference between Deaf clients of standard IAPT and BSL-IAPT in reliable improvement (63.5% vs. 66.8%; p = 0.917) and no significant difference in reliable recovery (40.0% vs. 40.4%; p = 0.946), based on attending a minimum of two therapeutic appointments as the definition of completing treatment. However, given the very small numbers of Deaf clients seen by most of the standard IAPT services in comparison with the large numbers seen by the BSL-IAPT service, comparative data on the outcomes of Deaf clients seen in standard IAPT services and those in the BSL-IAPT service should be treated with caution. It seems unlikely that those standard IAPT services who have achieved high rates of reliable recovery and reliable improvement based on, in some cases, one or two clients only, would maintain these given a larger and potentially more diverse pool of Deaf clients. It should be noted that, compared with the standard IAPT services, the BSL-IAPT service has seen a larger number, and possibly more clinically diverse population, of Deaf clients and their consistency in achieving reliable recovery and reliable improvement rates has been tested with greater experience and larger numbers, leading to more precise estimates.

Belk et al. ,85 using the tighter definition of completed therapy for 226 patients receiving BSL-IAPT, found that 76.5% of Deaf clients attending BSL-IAPT services achieved reliable improvement, whereas only 54.0% achieved reliable recovery. Gyani et al. 106 reported that, across all IAPT services (general population) between October 2008 and September 2009, 63.7% of service users achieved reliable improvement and 40.3% reliable recovery. Based on data collected in March 2015, the HSCIC107 reported a reliable improvement rate of 61.5% and a reliable recovery rate of 43.1%. All of these figures were based on a recorded endcode indicating that treatment had been finished. BSL-IAPT outcomes are better than those recorded for the general population.

The comparative analyses carried out also reveal concerns about the consistency of data recording and the reliability of some of the data. This was true both for basic demographic characteristics and for more complex issues, such as waiting time. For example, for 11 standard IAPT clients, the number of days between first referral and first appointment is recorded as zero. This may be because these individuals were seen immediately, but that is unlikely in busy services; or it may be because the client was discharged as the waiting time exceeded IAPT minimum standards but was then re-referred to be seen immediately to avoid the service having to report failure to meet minimum targets. Alternatively, it may simply be an error of recording. It is not possible to be sure, but if the 11 zeros are excluded from the analysis, there is no difference in waiting times between the IAPT groups (26.0 days vs. 27.0 days; p = 0.189).

Method

Although language preference is not a required field in the minimum data set upload from IAPT services to the HSCIC, it is an optional code on the two most common data management systems in use by IAPT services at the time of data collection: iaptus and Patient Case Management Information System. Using this route, it would therefore be possible to gain a national picture of the number of BSL users accessing standard IAPT services within a given time frame. We first established with the operating managers of the two data management systems whether or not, in theory, it would be possible to run a data extraction from the records they held on behalf of IAPT services, which would identify how many BSL users had been seen by how many IAPT services. This was feasible. Furthermore, it would be possible to compare the numbers of Deaf BSL users seen against the total number of all clients seen by service. Establishing a common time frame for these client figures would be more difficult, as different IAPT services had started using the two data management systems at different times and some had stopped using them; therefore, it would be possible to obtain aggregate figures by service only up to a common cut-off date (e.g. 31 May 2015); to go beyond this date would require considerably more investment of time by the data management system providers. BSL-IAPT data reported earlier as data set 1 (n = 502)85 were used to calculate numbers of first appointments per quarter between 1 December 2011 and 31 March 2015.

Potential numbers of users of the BSL-IAPT service in the 10 regions where it was originally established were estimated by SignHealth, the provider of BSL-IAPT. Their figures are based on the prevalence of depression in the Deaf population, assuming that 50% of the Deaf population will access mental health services and, of these, 15% should access IAPT services based on the DH’s own target for IAPT uptake.

Ethics

This process of identifying numbers of clients overall and numbers of clients who were BSL users did not require any individualised client records being transferred to the research team, nor any client attributes or clinical information other than whether or not the client was a BSL user. Nonetheless, the NRES committee from which we had gained original approval for the study overall advised that we could not acquire these aggregated data unless each individual standard IAPT service gave permission for inclusion in the data extraction that the two data management systems would run. Every IAPT service in England was written to on an individual basis and a simple online consent form enabling ‘opt in’ was set up.

Results

Permissions requested and consents obtained are shown in Figure 9.

FIGURE 9.

Permissions to obtain numbers of BSL clients from data management systems. PCMIS, Patient Case Management Information System.

Results from iaptus

Having excluded the data from the BSL-IAPT service, the 23 iaptus services that gave permission are 24.5% of the total number (n = 94) of standard IAPT services where data management system records were available. In the 23 services who had seen Deaf clients who were BSL users (n = 14), they accounted for 0.02% (n = 109) of the total number of clients seen (n = 636,150) and 0.01% (n = 109) of the total number of clients (n = 811,229) of all services that gave permission for their data to be included. Of those services that had seen Deaf clients who were BSL users, the mean number of clients was 7.8 (range 1–24 clients, median = 4 and mode = 2).

Results from the Patient Case Management Information System

Forty-one services that used the Patient Case Management Information System consented for their data to be included. Of those 41 services, the data management system recorded that 11 services had seen BSL users, which accounts for 0.01% (n = 22) of the total number of clients seen in those 11 services (n = 161,899). When the total number of clients of all 41 services are included (n = 358,938), BSL clients accounts for 0.006%. Of those services that had seen Deaf clients who were BSL users, the mean number of clients was 2 (range 1–4 clients, median = 2 and mode = 2).

It is not possible to be sure why Deaf BSL clients as a percentage of the total clients seen in one data management system is almost double that in another. It may be that the iaptus system makes it easier to record this client characteristic or it may simply be an artefact of which services use which system and the number of Deaf clients they attract for reasons unconnected with the data management system. Finally, as not all users of both systems gave permission for their data to be included, it is not possible to comment on how representative these figures are of the total number of BSL users who are seen by standard IAPT services.

Results from BSL-IAPT

Five hundred and two clients who met the study inclusion/exclusion criteria were seen with a first appointment between 1 December 2011 and 31 March 2015. These were mapped by quarter-years to show patterns of likely throughput for estimating patterns of potential recruitment to any future study. The mean number of clients per quarter was 35.8, but there were wide variations (range 3–82), which reflected the initial start-up period and embedding of the service and changes in capacity experienced by BSL-IAPT over the study period as new funding arrangements were put in place following the transition from PCTs to CCGs (Figure 10). The number of clients who met the study eligibility criteria and were seen by the service was 119 in 2012, 158 in 2013 and 194 in 2014. Figures are not available in this study for 2015 and 2016, but discussions with the service provider suggest that they are less than previously reported, although this is not necessarily a reflection of reduced demand; it is also influenced by capacity to provide a service and funding arrangements (see Chapter 5).

FIGURE 10.

First appointment date for BSL-IAPT numbered by quarter. Q, quarter.

BSL-IAPT’s own predictions of the true numbers of potential clients requiring their service by region are presented in Table 19. These estimates are based on whole population figures per region, not on time periods of access to the service.

Discussion

Despite the considerable challenges in acquiring data on Deaf users of standard IAPT services and the limited numbers of services that gave permission for the secondary analysis of data uploaded to the data management systems, these are the first available data on numbers of Deaf users of standard IAPT services. It is reasonable to assume that Deaf BSL users are likely to make up < 1% of clients that standard IAPT providers will see. However, as the modelling work reported in Chapter 5 illustrates, Deaf people face considerable barriers to accessing a standard IAPT service and being able to use it effectively; some of these barriers derive from the lack of awareness and training of staff within those services. Therefore, this estimate of Deaf users of a standard IAPT service should be placed in the context of less than optimal service access from a client’s point of view and, therefore, is probably a considerable underestimate of potential users given the heightened prevalence of depression/anxiety in the Deaf population (see Chapter 1). The estimated figures from SignHealth, the BSL-IAPT provider, are based on population estimates of Deaf people in each region that are not verified.

The BSL-IAPT service was originally offered in an area covered by two PCTs, which increased to five, followed by a reduction to three CCGs during the life of the data collection. Therefore, estimates of probable users of the service are strongly influenced by its availability geographically but also by funding arrangements. Consequently, extrapolations of probable numbers of service users in the future cannot be made other than to say it attracts high numbers of clients for a service that is commissioned currently in only three areas; access otherwise is subject to individual funding arrangements.

Background

Analysis of available data suggests an annual throughput of Deaf clients in BSL-IAPT of < 200 per year, but estimates of potential service uptake of considerably more. Limited figures drawn from a small sample of all standard IAPT providers suggests that Deaf people make up 0.01% or less of all clients seen. However, these figures are likely to be a considerable underestimate of potential demand because of service delivery factors affecting how services respond to Deaf people in terms of access and availability; this is discussed in depth in Chapter 5. In addition, the small number of standard IAPT services that participated, and incomplete and inconsistent service data recording, all raise concerns about the validity of any estimates of total numbers of Deaf people accessing IAPT nationally. Consequently, the effect size calculations and estimates of recruitment numbers for any future large-scale study, outlined in Method, are based on weak evidence. Two potential target recruitment scenarios are modelled assuming (1) a fully powered individual RCT and (2) a prospective observational study of factors associated with reliable improvement and reliable recovery in Deaf clients.

Method

In both potential study designs, the measures to be used as the primary outcomes will be reliable improvement and reliable recovery, as these take into account measurement error103,106 and are the IAPT methodological standard for outcome reporting. 105

Results

Discussion

There is a lack of evidence on which to calculate potential sample sizes required for any future study, whether a RCT or another design, and estimates of effect size remain uncertain. This is because the comparative analyses of clinical outcome data undertaken are based on a small number of participants, which in the case of standard IAPT services are a small proportion of all standard IAPT services, being those that self-selected to participate. Statistical uncertainty arises from a comparison of clinical outcomes from a single-service provider with those from multiple providers, many of whom have seen only one or two Deaf clients. The total number of Deaf users of IAPT cannot currently be ascertained, nor can the potential numbers of clients in this population be reliably extrapolated from secondary data. The study has also revealed deficits in accurate recording of clinical data. Therefore, although potential sample sizes for two different study designs have been estimated, it is not possible to judge how realistic recruitment to them might be without further research to enable greater precision.

Design

A sequential mixed-methods study design111 was used, consisting first of a survey of IAPT practitioners with closed and open questions in order to capture a broad range of views and experiences. This was followed by semistructured individual interviews of a subgroup of IAPT practitioners to explore in greater depth those topics identified from the survey responses that warranted further enquiry.

Survey inclusion criteria

All current practitioners delivering therapy at steps 2 and 3 under the IAPT umbrella to adults in England were eligible to take part. The definition of practitioner is not confined to PWPs, as other mental health professionals are also IAPT practitioners. Practitioners may be directly employed by the NHS, or may be subcontracted to provide IAPT treatments under an ‘any qualified provider’ arrangement, which operates in some areas. They may also be employed by private providers to the NHS. The IAPT workforce survey 2014112 reports that IAPT employs a 6307-strong whole-time equivalent workforce (including trainees) across IAPT in England; however, this includes non-IAPT-qualified counsellors and therapists as well as supervisors who do not treat clients, and employment support workers.

Interview inclusion criteria

For practitioners working in any service other than that provided by BSL Healthy Minds, the inclusion criteria were:

• are currently working as an IAPT practitioner

• AND have completed an initial survey

• AND have indicated that they are willing to be contacted for a follow-up semistructured interview

• OR have contacted the research team directly to indicate willingness to be interviewed regardless of having completed a survey.

For practitioners working in the BSL Healthy Minds service (the main provider of BSL-IAPT intervention), the inclusion criterion was:

• all practitioners and other staff currently involved in the development and maintenance of the specialist service.

Ethics approval

Ethics approval for the study was granted through the University of Manchester REC (reference ethics/150715). For NHS provider services, R&D approval was also required from each individual trust prior to directly inviting individual participation; this included participation in the initial survey.

Recruitment to the survey

Recruitment to the interview

A theoretical sampling approach was taken to deciding who to invite for interview based on the widest diversity of representation possible according to the criteria: (a) experience, including those who had direct experience of IAPT with a Deaf person and those who did not; (b) service context (NHS, contracted provider, private); (c) professional background of IAPT practitioner (PWP, psychologist, counsellor, etc.); and (d) a role in an IAPT service provider (e.g. service manager, individual practitioner, specialist practitioner).

Additionally, all staff involved in the delivery of the BSL Healthy Minds service, which had been the originator of a BSL-IAPT service, were invited to participate in a semistructured interview, regardless of whether or not they had completed a survey. This was because they had crucial knowledge about and experience of the operation and rationale behind a specialist IAPT provision for Deaf people, which was central to being able to model the intervention.

Data collection

The survey was hosted online using the software SelectSurvey.NET™ (version 4; ClassApps.com, Kansas City, MO, USA) and contained open and closed questions (see Appendix 6). A paper-based version was available instead on request. It invited practitioners to respond to questions outlining a range of variables associated with the delivery of IAPT to Deaf people. Practitioners were asked either to respond according to their own experience, if they had had a client who was Deaf, or to respond according to what they would do within their service if a client who was Deaf was referred to them. The survey also established basic information about the practitioners’ professional background and experience as well as the context and structure of the service in which they worked.

The semistructured interview was generated, in part, from findings from the survey responses that required further investigation about the range of adaptations and variations in the delivery of standard IAPT for Deaf people and pre-existing questions associated with modelling the BSL-IAPT intervention and potential axes of variation in its delivery (see Appendix 7).

Analysis

Survey data were analysed using descriptive statistics supported by IBM^® SPSS Statistics^® version 22 (IBM Corporation, Armonk, NY, USA). The approach to analysis of the qualitative data from both standard IAPT practitioners and BSL-IAPT practitioners was informed by realist synthesis113 and the practices of realist evaluation. 114 Realist evaluation is underpinned by a philosophical orientation that acknowledges the material reality of the social world and its structures, but also acknowledges that how it is known results from individual or collective interpretation filtered through language, culture and historical experience. Different individuals in varied social, linguistic and cultural settings will respond differently to the same set of circumstances, experiences, events, actions and available resources. 114 Consequently, realist evaluation is fundamentally concerned with a context-embedded approach to understanding outcomes that seeks to identify the mechanisms that may lead to particular outcomes for individuals in given circumstances. This is conventionally summarised as investigating what works, for whom, in which circumstances and why. 115 We employed this orientation to understand the data that practitioners had shared about access to and the practice of IAPT, to identify key variables in adaptations that may or may not be made and their consequences for Deaf people using standard IAPT.

In the case of interviews with practitioners drawn from standard IAPT, data were transcribed into written English by a registered research transcribing service and then read and reread by two researchers who independently identified thematic areas of interest. When consensus was reached on what these themes should be, the data were reread and under each theme area, the variations in practice and their interpretation by participants were mapped against a grid divided into three:

1. context (defined as the action or event or practice that occurred in the given context of the individual’s knowledge/experience, e.g. self-referral, therapeutic alliance)

2. mechanism (defined both as means of effect and resource that might underpin or be required for the effect, e.g. assessments in BSL, the provision of an interpreter, an IAPT practitioner experienced in the given problem)

3. outcome (the consequences and their variation of the context plus mechanism, e.g. ease with which Deaf people can access the service, level of satisfaction with the therapy).

Scrutiny of the table then led to the generation of context, mechanism, outcome propositions, which were tested out for their validity and variation by rereading the transcripts of the interview data as a whole, to judge the credibility of the propositions generated – did they explain the variations noted in how standard IAPT may be adapted for Deaf people and the probable results of those adaptations? These form the structure of the presentation of the interview findings.

In the case of the BSL-IAPT interview data, the same procedure was followed with the addition of the BSL interviews being translated into English by a qualified and registered BSL interpreter prior to transcription.

Survey respondents

Given the means of distribution of the survey, it is not possible to know the total number of potential respondents. Of the 118 useable responses, none was from a Deaf BSL user, and none was from someone who worked for the BSL Healthy Minds service. Therefore, the views expressed are exclusively from hearing practitioners operating within service structures we refer to as standard IAPT (i.e. not exclusively set up as a specialist IAPT service provider). That said, 61 respondents (51.7%) stated that their service had Deaf BSL users as clients and 35 respondents (29.7%) had personally provided therapy to Deaf clients who were BSL users. In addition, 11 respondents (9.3%) reported that there was at least one Deaf BSL user working as a therapist within their service, although this does not necessarily equate to 11 services with Deaf therapists because multiple respondents may be drawn from the same service.

Given the small number of services and respondents who took part in comparison with the IAPT workforce overall, these figures suggest that there is a response bias in the survey to those services and practitioners with some experience of Deaf people. Indeed, 21 respondents (17.8%) reported some BSL skills, ranging from basic communication to Level 3 (five people), which corresponds to a reasonable proficiency but below full fluency. Nonetheless, four people said that they had provided therapy to a Deaf person one to one in BSL without an interpreter. From a cultural awareness and cultural competency perspective, of the 21 who said that they had some degree of BSL skills, only four reported frequent involvement in the Deaf community. Sixteen said that they had been on training specifically about how to work with Deaf clients.

The sample was biased towards highly experienced IAPT practitioners, with 56 respondents (47.5%) having over 4 years’ IAPT experience and only 15 (8.7%) having less than 1 year’s experience. The majority of respondents were female (n = 99, 83.9%). The sample was heavily biased towards white British respondents (n = 92, 78%).

Of the 117 participants who supplied information about their role/job title, 28 had senior status (e.g. service manager, service lead PWP, senior psychologist) and six were trainees (e.g. assistant psychologist, PWP trainees). The rest were therapists, either PWPs or other professionals trained as IAPT practitioners, 13 of whom were high-intensity therapists, with a further three being high-intensity therapy trainees.

Interview participants

A total of 32 individual IAPT practitioners who completed the survey indicated that they would be willing to participate in a follow-up interview; of these, 20 were contacted and 14 took part. Two additional interviews were conducted with Deaf practitioners working within standard IAPT settings, who contacted us directly to indicate that they would be willing to be interviewed, but who chose not to complete the survey. Sixteen people were interviewed in total from standard IAPT services, 13 of whom were women. Twelve participants had over 3 years’ experience working in IAPT, nine of whom had over 4 years’ experience. All but one worked in a direct clinical role seeing clients.

Flexibility in the delivery of services

Overall, service providers described a range of axes of flexibility in the delivery of services including:

• location (e.g. in prison, community centres, libraries, GP surgeries)

• services for designated groups only (e.g. women, veterans)

• practitioners who specialised in particular conditions (e.g. trauma, long-term physical health conditions, sexual assault survivors, older adults)

• partnership working with other organisations, including the possibility of referral to any qualified provider.

The general rationale for such flexibility included familiarity of location; increasing access and comfort in provision; meeting specialist needs when required; shorter waiting lists; and supporting patient choice. However, these characteristics of structure and components of advantage did not operate in the same way for Deaf clients.

For example, flexibility in location of services (e.g. in the community) did not generally take into consideration the fact that, for reasons of cultural familiarity, Deaf people’s community, and the spaces associated with it, may not be same as those of a hearing person. Therefore, the rationale of increasing comfort and access may not operate in the same way and, furthermore, may not be recognised as operating differently. Where there was a specialist service for Deaf people operating within a mainstream service, there tended to be only one practitioner – thus reducing the possibility of choice of therapist for the client. The categories of ‘Deaf’ and ‘BSL user’ could funnel a client to a single Deaf specialist practitioner rather than to a specialist in their particular problem (e.g. trauma, coping with a long-term health condition). On the other hand, if a Deaf client was seen by a practitioner with a specialism within a specific condition/symptom cluster, that person may have little or no previous experience of working with a Deaf person.

The survey asked respondents to consider their service’s capacity in meeting Deaf clients’ preferences with regard to a therapist of the same sex, hearing status and direct versus interpreted therapy. Although sex posed few difficulties, and delivery of therapy to Deaf people through an interpreter was relatively easily met, direct therapeutic encounters without mediation were clearly problematic in terms of meeting client preference (Figure 11).

FIGURE 11.

Meeting Deaf clients’ preferences for therapist. Would Deaf BSL users be given the opportunity to choose any of the following options with regard to their allocated worker?

Results are presented below and throughout this chapter differentiated by those respondents who said that they had delivered an IAPT service to Deaf clients themselves (whether with or without an interpreter), which we term ‘personal experience’, and those who had no personal experience of service delivery to a Deaf client.

Some solutions regarding more limited flexibility of provision for Deaf people were offered as possibilities, for example referral to a qualified provider in a location/service that Deaf people may be familiar with (e.g. a Deaf women’s health project); being prepared to wait to be seen in order to be able to access a Deaf specialist therapist; or referral by a local IAPT service to a specialist practitioner/provider outside its immediate area of operation dependent on money, availability and arrangements in place.

These adaptations and special arrangements had compromises and potential risks too. For example, the Deaf person may have to choose between seeing someone who is experienced in their particular area of concern or seeing someone who is Deaf/Deaf experienced. Referral on may mean that the Deaf person waits longer to be seen and thus that their difficulties have escalated. Where no consideration is given to the cultural and linguistic suitability of a model of provision for a Deaf client, this may result in an unsatisfactory or less effective experience. It raises the question of who might be a ‘qualified provider’ in the case of a Deaf client. These variations can be represented diagrammatically (Figure 12).

FIGURE 12.

Impact of service structure flexibility on Deaf clients.

Pathways for Deaf clients within standard Improving Access to Psychological Therapies structures

Some mainstream IAPT services had invested in specialist provision or a specialist pathway for Deaf clients. They were in the minority. Of 17 practitioners interviewed, six described their own specialist provision or their specialist pathway drawn from four services. The majority had never thought about it before, but many appreciated our contact with them because it prompted them to do so. Several remained in touch with the project and requested that we send them information and resources as they became available.

We consider in detail what the components and characteristics might be of a specialist BSL-IAPT service within a standard IAPT provider when considering BSL-IAPT later in this chapter (see Results: interviews with BSL-IAPT practitioners). At this point, we address only the issues raised by standard IAPT services with respect to pathways to provision for Deaf people. Broadly speaking, there were three main approaches.

Pathway model 3: the same pathway as for any client, with the addition of an interpreter

This pathway consists of the same arrangements that would be made for any referred client to standard IAPT, but with the addition of sign language interpreters. Of the 35 survey respondents who said that they had personal experience of providing therapy to a Deaf client, 27 had achieved this with a sign language interpreter. In most cases, the therapist did not have experience of Deaf clients, but was chosen for their knowledge and relevant experience of other aspects of the client’s presentation (e.g. chronic obstructive pulmonary disease). In some instances, the therapist was chosen not because of their knowledge/experience of Deaf clients or of the client’s specific condition, but simply because they were available and willing to work with an interpreter. Although what makes this a specialist pathway may seem minimal at first glance, we have included it as a specialist pathway within standard IAPT structures because some services had thought about it and had deliberately executed this option; in comparison, the vast majority, who were yet to encounter a Deaf client, remained unaware of the alternatives and had not considered other possibilities in any depth. The additional issues associated with interpreted therapeutic provision are considered in a later section (see The therapeutic encounter).

These variations in pathway are represented diagrammatically in Figure 13.

FIGURE 13.

Pathways diagram (standard IAPT services).

Promotion, advertising and awareness raising about Improving Access to Psychological Therapies services

Many of the services we spoke with and that replied to the survey actively undertook promotion, outreach, advertising and awareness-raising activity about IAPT in their local communities. Views on the accessibility for Deaf people of information about their service were mixed with no strong tendency to assume that information was inaccessible (Figure 14).

FIGURE 14.

Views on the accessibility of information for Deaf BSL users.

Improving Access to Psychological Therapies services readily accept self-referrals as well as referrals from health or social care agencies; therefore, promoting the service to potential service users was considered important. In addition, some services said that they undertook active monitoring of ‘under-represented’ groups. A list of activities undertaken was generated from the responses received, but not all of those services that engaged in the study appreciated the problematic nature of some of these activities from the perspective of Deaf clients; our interpretation reflects our knowledge of the barriers these might pose rather than necessarily the services’ own knowledge (Table 23).

TABLE 23 - Standard IAPT approaches to advertising their service to Deaf clients and potential implications and consequences

Strategy/action	Implications	Consequences
IAPT providers seek to promote their services and raise awareness by producing information about the service in a variety of spoken languages and in some cases easy-read versions (but not in a signed language)	Assumes Deaf people could read information even if it was not in BSL and fully understand it. But this is not the case for many Deaf people, who struggle with literacy in the written word	Harder for Deaf people to be aware that the service exists
	Ignores the issue of language preference and language rights to have accessible information in own language	Unaware services make the false assumption that there are no barriers to Deaf clients’ awareness of the service and their potential self-referral
	Does not consider the duty imposed by the NHS Accessible Information Standard 2015 with respect to Deaf people and others with specific communication requirements
Service is advertised on the radio because it is a cheap approach that has been shown to be effective	Inaccessible for Deaf people	Although not all means of advertising and promotion necessarily have to be accessible to all groups, there was minimal consideration given to how this approach might be exclusionary
‘Word of mouth’ is a useful means of raising awareness of the service and encouraging self-referral	Deaf people’s communities and social groups are different and so word of mouth does not operate in the same way in terms of creating communities of informal knowledge. Where Deaf people have contact with other groups/settings/contexts where word of mouth about IAPT may be operating they will face barriers to accessing that conversation in the first place	Levels of awareness among Deaf people as to who might benefit from an IAPT service in a given locality remain low
	Word of mouth could operate well from Deaf person to Deaf person, but without initial experience of IAPT in a local provision this is unlikely
IAPT reporting mechanisms, as well as locally imposed standards in some cases, will monitor under-represented groups	Reporting would only be effective in highlighting the under-representation of Deaf people in the service if Deaf BSL users were a monitored category. Although locally some services did record Deaf BSL users, it is not a minimum data set requirement for formal reporting purposes. In the usual standard IAPT reporting requirements Deaf people are not distinguished by language category (e.g. BSL), only by disability (hearing) which would not identify BSL users	Deaf BSL users are a hidden group
		Scale of potential need remains unknown
		Not clear whether or not they are under-represented in any given service
		Service will not target their awareness raising and promotion to an under-represented group if the group is not identified in the first place
In services with stretched resources, targeting awareness raising at specific under-represented groups may be a luxury that cannot be afforded	Awareness-raising strategies are generic	Resource constraints further compound the invisibility of the under-represented group by not being identified as being in need of greater concentration of awareness raising
Services run community drop-in sessions to raise awareness in particular communities and groups of people	Does not recognise that ‘community’ may be differently understood by Deaf people; therefore, their community locations are not likely to be the same as those targeted by IAPT services	IAPT services do not encounter Deaf people in their outreach activities and therefore erroneously assume that there is a lack of need for information and knowledge

The impacts for Deaf people on reaching the service in the first place with respect to promotion, advertising and awareness raising can be represented diagrammatically (Figure 15).

FIGURE 15.

Impact of ineffective service promotion and awareness raising.

Six practitioners (from four services) participated in detailed interviews and described a specialist treatment pathway within a standard IAPT structure and the associated awareness-raising and information concerns. They were very aware of the difficulties associated with service promotion and information, discussed previously, which could pose barriers to Deaf people being aware of and accessing a local IAPT service. Three of the standard IAPT services from which participants were drawn had a specialist practitioner available and reported that she/he also had a remit to raise awareness and promote the service to Deaf communities in their area. However, as this usually fell to one individual, the activity was fragile and at greater risk of being reduced or lost due to internal and external pressures (e.g. worker diverted to other service priorities; choosing to undertake study, thereby reducing hours; maternity/sick leave; promotion or relocation). One respondent reported a high proportion of self-referrals, which they attributed to Deaf people locally being aware of their specialist provision. Another described in detail the fact that they deliberately target Deaf people through community-relevant means, thus creating a ‘word of hand’. Examples included posting information on online sites in BSL that Deaf people access; sharing information with local Deaf charities or sensory services; attending in person Deaf community interest groups to talk about the service; establishing well-being groups locally within the Deaf community run by the therapist; and linking up with local ‘Deaf Health Champions’, a time-limited initiative in some regions to campaign for better access to health information and raise Deaf people’s awareness of health issues. 117 These examples demonstrate that it is possible for standard IAPT provision successfully to reach Deaf people’s awareness and influence their knowledge given enough cultural competence and understanding of the Deaf community.

Pathways of self-referral to Improving Access to Psychological Therapies

The survey asked respondents to consider how common it was for Deaf people to self-refer; one respondent said that their service did not accept self-referrals, but 66 out of the 107 who replied (62%) said they did not know, five that it had never happened and a further five that it happened on only one occasion. Self-referral therefore was not usual. Nonetheless, respondents were asked to consider how easy it might be for Deaf clients to self-refer into their service. The results presented in Figure 16 are differentiated by those who had personal experience of having delivered a service to at least one Deaf person and those who had no personal experience.

FIGURE 16.

Assumed ease of self-referral. How easy is it for Deaf people to self-refer?

Overall, the picture is optimistic about ease of self-referral; however, analysis of the interview data reveals some complex, hidden or unacknowledged considerations that might mean that in reality the picture is less positive. In some instances, it was not appreciated how apparently inclusive practices might nonetheless create barriers for Deaf people. In others, the adjustments offered or made to usual practices had indirect consequences that were undesirable. Both perspectives could result in insufficient change to promote equality of access, in this case with respect to self-referral. To illustrate these issues we draw out some of the most common myths and assumptions, multiple examples of which were provided in the individual interviews and through the survey, and set them in the context of their potential effects for a Deaf client.

Changing the medium of contact does not necessarily make contact accessible

The survey asked respondents about how Deaf people would contact their service if they wished to self-refer and also how the service would respond. The picture is clearly one of written contact, whether by text, e-mail or letter rather than in BSL or through the medium of an interpreter (Table 24). This is highly problematic, given the low levels of literacy among Deaf people previously discussed (see Chapter 1). In addition, from a language rights perspective, it does not involve any adjustment to meet the language requirements of a potential client at the point of first contact. It is akin to a user of a spoken language other than English (e.g. Gujarati) being required to make initial contact and be responded to in English only. The potential barriers that this might create are more apparent for spoken language users. However, for Deaf users of a signed language, it is a common assumption that, by changing the medium (written rather than spoken), one can make contact accessible because it does not rely on hearing. The deafness rather than the language use is recognised and predominates.

TABLE 24 - How Deaf people would contact the service and the medium of response

NGT, new generation text; SMS, short message service.

Survey question	‘Yes’ response	n (%)
A Deaf BSL user would make a self-referral to your service via:	We do not accept self-referrals	1 (0.8)
	By SMS/text message	13 (11)
	By NGT service (Text Relay, TextDirect or Typetalk)	8 (6.8)
	By letter	70 (59.3)
	Online (e.g. e-mail, message through webpage)	83 (70.3)
	By video call [e.g. Skype, FaceTime (Apple Inc., Cupertino, CA, USA), Glide (www.glide.me)]	2 (1.7)
A self-referral from a Deaf BSL user would be responded to via:	We do not accept self-referrals	1 (0.8)
	By SMS/text message	28 (23.7)
	By NGT service (Text Relay, TextDirect or Typetalk)	7 (5.9)
	By letter	89 (75.4)
	Online (e.g. e-mail, message through webpage)	67 (56.8)
	By video call (e.g. Skype, FaceTime, Glide)	2 (1.7)

These issues were elaborated further in the interview data. Several services had means of initial contact and self-referral that were online via an electronic referral form, or by direct e-mail, or by letter. In some cases, online contact and online forms were the only means of initial contact or self-referral. This initial contact could include requesting clients to complete initial assessments online such as the PHQ-9 and GAD-7 in English as a form of triage. Some services viewed this standard online accessibility as helpful for Deaf clients because it does not require the use of a telephone and does not rely on spoken language. The possibility that standard assessments in English as a form of triage for service access might be unreliable for Deaf people was not considered because of lack of awareness that it was, in effect, a test of Deaf people’s literacy rather than a reliable psychological screening instrument for clients whose first language is not English. First contact in written English might also pose a psychological or emotional barrier for Deaf people, many of whom have school experiences of being taught in a language other than a signed language and for whom completing forms in a written language that is not their own evokes distressing memories. Changing the medium of contact to avoid sound and hearing does not necessarily address the issue of language preference and access.

Reasonable adjustments may not be that reasonable

Some services were aware of text telephones, text relay and next-generation text services118 and advertised that they could be contacted this way. However, this advertised adjustment assumed that Deaf people have text telephones or are happy to use TextDirect. This is not the case for some Deaf people, who prefer not to use English-based communication. For this adjustment to contact to work, it also requires that those within the service know what a call via text telephone is or to be experienced with text relay and able to use it. A workable system requires adjustment by both parties, and this was not always true for service providers, even those who promoted this form of access.

In contrast, in one service that provided a specialist pathway for Deaf people, the introduction of a short message service (SMS) self-referral process had proved very successful, but the key was the agile responsiveness of the service itself to that initial contact to progress a referral forward. This, in turn, increased clients’ confidence that the service understood their needs and would meet them. Text-based contact, however, still relies on a degree of literacy in English, although it has become a culturally acceptable form of quick contact among Deaf BSL users for convenience.

Universal gateways do not have universal effects

Where initial contact and self-referral was either exclusively by telephone or via online completion of forms, the onus lay with the potential client to find a means of accessing the universal gateway offered by the service. One service pointed out that it did not discriminate or change its practices according to the client group, but applied universal standards. It did not consider that these common standards might have differential effects for different clients. In the case of Deaf clients, the main problem lies in the lack of autonomy in contacting a service that this might pose. For example, to access by telephone would require an interpreter or even a family member or friend to make the call or interpret the conversation on their behalf. Some practitioners suggested this as a logical solution to not being able to use a telephone, and said their services would be happy to accept referrals in this way. Others explained that they would not accept such a referral because it was not the client themselves who was giving the information but a third party; this was particularly the case when the client was required to opt in to therapy (regardless of the fact that client may not be able to use the telephone anyway). One respondent described it might be problematic by saying, ‘we have to have explicit permission, and that could be a bit difficult if somebody’s language was completely absent’. In another example, a paper-based form was available only on request by telephone; therefore, even if the Deaf client could independently complete the self-referral form they would need to involve a third party in order to request that form in the first place.

Completion of a form that is in English could again mean that a client had to work with a translator/interpreter or a friend or family member to assist them. Given the probable nature of the self-referrals involved, all of these options that might require third party involvement disallow autonomous action by the individual, may involve a lack of confidentiality (if a qualified interpreter bound by their code of ethics is not used) or just be too sensitive or distressing for the Deaf person to contemplate. This imposed lack of autonomy, given the conditions of access available, could itself pose an additional barrier, albeit indirectly, to self-referral.

The barriers to self-referral are summarised in Figure 17.

FIGURE 17.

Summary of barriers to self-referral despite assumptions of adjustments having been made.

Referral via a general practitioner or other professional

Although IAPT services permit and in some instances actively promote self-referral, it is also common for GPs or other health or social care professionals to make referrals. Although the standard IAPT services with a specialist pathway appreciated the potential difficulties that this could pose for Deaf clients, the majority of services had not considered before that there might be additional barriers created in comparison with hearing people’s access via GP/professional referral routes.

A key problem is Deaf people’s engagement with health and social care services in the first place. When this is ineffective, the potential pathway to referral to IAPT via this route is also ineffective. Previous research in the UK has demonstrated that Deaf people wait longer than average before going to see their GP, meaning that a condition might have escalated before treatment is sought. 52 Primary care services do not consistently meet Deaf people’s communication and language requirements for a consultation, and, therefore, subsequent treatment is often not optimally effective. 119 Confidence that communication with a GP will be smooth and that the professional understands the influence of linguistic and cultural identity on a Deaf person’s presentation of symptoms and engagement with treatment is crucial. 120 The new NHS England Accessible Information Standard: Specification51 and the draft Principles for High Quality Interpreting and Translation Services in Primary Care121 are both designed to address these concerns and raise standards of care for Deaf people (as well as other language-using groups). However, the effectiveness of this guidance remains untested.

Additionally, primary care referral routes via GPs are constrained by the local arrangements for funding and service provision. In the majority of cases referral to standard IAPT services is the usual response with few standard IAPT services having special arrangements in place for Deaf people. In a minority of cases there is a block commissioning arrangement in place for Deaf people to be referred to a specialist IAPT provider. Where this is not the case, and the standard IAPT service is not considered appropriate for a Deaf client, then an IFR could be made through the GP, but this is dependent on the GP recognising that the standard service available does not meet a client’s needs. It also takes time and competes for priority in comparison with other demands on available funds.

Consequently, primary care referral routes into IAPT may:

• not be effective for Deaf people who do not use them to access help in the first place

• fail to meet Deaf people’s linguistic requirements during consultation

• not be aware of Deaf people’s specialist needs in terms of psychological support and treatment

• not be aware that specialist IAPT services for Deaf people are available

• take additional time in cases where an IFR is made and block commissioning arrangements are not in place.

These influences are summarised in Figure 18.

FIGURE 18.

Influences on referral into IAPT via GP.

The therapeutic encounter

Within standard IAPT, a Deaf client may be allocated to a Deaf therapist, a hearing therapist who is a fluent sign language user, a therapist who might know a little bit of sign language and/or have met a Deaf patient before, or a therapist who has never encountered a Deaf person and has no fluency in sign language at all. Given this diversity, participants identified a number of key issues that may require consideration when working with Deaf people within IAPT. There was varied awareness of their implications or potential significance among practitioners, largely dependent on whether or not the service or individual therapists had experience of working with Deaf clients. Where this experience and specialist knowledge was lacking, these issues tended not to be recognised. However, even if these factors were understood, constraints on service delivery associated with time and cost could militate against their significance being taken into consideration in the course of service delivery.

Deaf clients may not be used to therapeutic practice

For the standard IAPT services that had a specialist practitioner within them (usually a Deaf or hearing fluent signer), it was commented that, in the practitioner’s experience, many Deaf people were unaware of and unused to what a therapeutic relationship entailed. They therefore generally allocated an additional introductory session to cover such issues as boundaries, confidentiality and expectations of communication in therapy. Some also delivered information sessions within community settings to raise general awareness of therapy, mental health and well-being. These actions were especially important when the therapist was part of the cultural Deaf community themselves and, therefore, the client might encounter them in other roles and contexts. It was seen as a vital part of trust building, transparency and also empowerment for the client, who could, armed with new knowledge, seek a different route to support if they wished. This good practice was, however, very rare and services unused to Deaf people or without a specialist practitioner did not comment on the provision of such requirements.

Therapists may not be used to Deaf people

A Deaf client may be a therapist’s first encounter with a culturally Deaf person, with sign language or with a sign language interpreter. Consequently, there is also much for the therapist to adjust to in this therapeutic relationship. Some commented on how the Deaf client had educated them and made them more aware, which they valued. However, the implications for the Deaf person of having to do this, which is a common life experience for Deaf people in many contexts, were not always considered. For example, could this experience of always having to explain oneself and educate the hearing world to Deaf cultural norms actually have been a factor in some Deaf people’s experience of anxiety or depression? If so, a therapeutic relationship that also involved this dynamic may have been unhelpful, a view we return to later when considering models of BSL-IAPT.

More time is needed

Some therapists who used an interpreter always allocated additional time for the session in recognition of the fact that communication was indirect and could take longer than direct communication. However, explicit permission was usually required from a senior clinician and it might be withheld for resource reasons (time, client load, cost in interpreter payments or therapist time). The decision to request additional time for clients was not entirely a therapeutic one, with some therapists reluctant to request it because of how particular services operated or what they anticipated would be a negative response. Other participants in the study did not recognise that additional time might be an issue at all. Our analysis of average duration of therapy for Deaf clients using standard IAPT services demonstrates the longer time required in therapy, an analysis of which the respondents were unaware at the time of the interview (see Chapter 4). Some participants did indeed comment on the longer time that might be required for Deaf client within their service in comparison with a hearing client. They felt that this might be because the Deaf person came to the service at a later stage in the progression of their problems in comparison with the average hearing client. However, those making this observation did not always appreciate the barriers to self-referral or referral through primary care.

Using interpreters

The survey asked respondents to consider ease of booking a sign language interpreter for sessions with clients. The majority of those with prior personal experience of working with a Deaf client and those without thought it easy or quite easy to book an interpreter. However, those without personal experience were more likely to see it as difficult and a third without personal experience simply did not know (Figure 19).

FIGURE 19.

Views on ease of booking a BSL/English interpreter.

Some participants in the interviews who had personal experience of delivering therapy to a Deaf client through an interpreter had no prior experience of delivering therapy through an interpreter (whether spoken or signed language interpreter) and had received no training or support to do so. Others who were experienced in working with spoken language interpreters did not necessarily consider that there might be any differences in working with a sign language interpreter. These were often those staff who were allocated Deaf clients because of assumed insight into the differences involved in indirect therapeutic communication. Some therapists who were new to using a sign language interpreter had nonetheless also learned some basic BSL themselves such as ‘hello’, ‘how are you’ and ‘thank you’, as they felt it built trust with the Deaf client.

We also came across examples of it being decided that an interpreter was not necessary, but it was unclear on what basis such a decision had been reached and whether or not the therapist and client were able to adequately communicate with each other in reaching that decision. Examples included using spoken language on the assumption that the Deaf client had lip-reading skills, and writing things down on paper during therapy to enable dialogue. In the survey data, of the 35 therapists who responded and said they had personal experience of providing therapy to a Deaf client who was a BSL user, eight had done so on the basis of the client lip-reading the therapist and four on the basis of using pen and paper within one-to-one sessions. However, the ability of a therapist who was unused to communicating with Deaf people to monitor the quality and effectiveness of such communication has to be questioned. These questions remain valid even when a client may deliberately seek a therapist with no connection with the Deaf community and/or deliberately choose not have an interpreter because of their concerns about confidentiality or trust within their own cultural community.

In those standard IAPT services that included a specialist pathway for Deaf people but whose specialist practitioner was not a fluent signer, there was a strong awareness that was it was important not only to book an interpreter but also that the choice of interpreter was often important. It was important in terms of trust, particularly with respect to confidentiality and when there might be conflict of interest if the interpreter worked with the Deaf person in a different role in their life. Preference was also important to the Deaf person in terms of confidence that the interpreter would represent them well in the therapeutic encounter. Consistency of interpreter was also highly valued (e.g. the same interpreter being booked for each of the sessions). However, therapists also reflected that these ideal conditions might not always be met because of practical issues of timing and booking.

The survey asked respondents to consider the likelihood of using the same sign language interpreter throughout the course of the sessions with the same client. Only 60% of those with personal experience of delivering therapy to a Deaf person said that this always occurred despite best intentions to do so, indicating that it was problematic even when recognised as important (Figure 20).

FIGURE 20.

Likelihood of the use of the same sign language interpreter throughout the course of the sessions.

From the interview data it was clear that when the therapist or the service was less Deaf aware, the identity of interpreter, client choice and consistency were not thought about and/or not given priority.

It is also the case that therapists had encountered some Deaf people who were unused to using interpreters and were not sure how best to work with them within a therapeutic encounter. This was especially problematic if the therapist too was inexperienced in working with sign language interpreters. Finally, there were examples of the Deaf client teaching the therapist how to use an interpreter, best practice and how best to facilitate the indirect interpreted encounter. This is added pressure on clients, who are seeking a service from a professional and should not be expected to have to educate that professional in order to receive the service. Given that many clients who use IAPT are experiencing anxiety, this additional role could also be unhelpful in building trust with their therapist.

Assessment, monitoring and outcome measures

The survey asked respondents about their confidence in identifying mental health problems among Deaf people and identifying when Deaf people might have problems in managing their anxiety or depression (Figures 21 and 22). Those with personal experience of having delivered therapy to a Deaf person (even if it were only one Deaf person), expressed greater confidence with respect to both questions, but only 40% were very confident/quite confident about identifying mental health problems and only 37.1% were very confident/quite confident of spotting difficulties in coping. Among the group with no personal experience, the degree of confidence overall was much less. These figures suggest that there are training needs for therapists in standard IAPT about how mental health problems such as depression and or anxiety might be manifest in BSL users, regardless of whether or not the therapist has any prior personal experience of working with a Deaf client.

FIGURE 21.

Confidence in identifying mental health problems in Deaf BSL users.

FIGURE 22.

Confidence in identifying Deaf BSL users’ difficulties with coping with depression and/or anxiety.

The survey asked respondents about how they have used or would use the IAPT standard assessments (GAD-7, PHQ-9, WSAS) with Deaf people who used BSL (Figure 23). Although some had sought to ensure that the assessments were carried out in BSL rather than in English, only a minority had used the reliability tested BSL versions, rather than ad hoc interpretation or fixed translated versions, the reliability of which was untested. Most said they had used or would use the English version with a Deaf person who was a BSL user, either in written, online or spoken form. This approach ignores the common difficulties most Deaf people have with literacy in English and assumes a high level of lip-reading and/or auditory skills. This is despite the fact that over half of lip-reading skills are attributable to guesswork through experience122 and the highly heterogeneous nature of speech recognition ability among Deaf people.

FIGURE 23.

The use of PHQ-9, GAD-7 or WSAS with Deaf BSL users.

In our interview sample, only one participant used the BSL versions of the IAPT assessment and monitoring tools (GAD-7 BSL, PHQ-9 BSL and WSAS BSL). There was very low awareness that these even existed, but two interviewees who participated in this study subsequently requested copies of them. Several services used the paper versions in English of the standard tools with an interpreter translating them ‘live’ to the client. However, there was no way to know if they were being interpreted in the same way each time, particularly if interpreters varied between sessions. In addition, the validity of the interpretation could not be assured as, unlike in the validated versions, the interpreter may not have the knowledge of the original intent in the English version to produce the most accurate translation. Therapists varied in how comfortable they were with this practice. Some who did not have experience of working with a Deaf client had not considered the implications of using a ‘live’ interpreted assessment each time.

The English versions of the assessment tools were also being used without interpreters for Deaf people on the false assumption that a Deaf person did not require hearing to understand the written word and, therefore, that they were accessible. Only a small minority of participants were aware that standard assessments would need to be not only correctly translated/validated, but also normed against specific populations to establish the correct clinical cut-off points for their use in their translated versions. Assessment and monitoring practices, therefore, which are associated with patient recovery in the case of Deaf people, were highly variable, raising questions about their accuracy even within accepted margins of error for the use of such measures.

Services with a specialist pathway for Deaf clients did attempt to seek feedback from Deaf clients in order to improve their services. In the vast majority of cases there were no arrangements to ensure that standard means of feedback from clients for service improvement would be Deaf-accessible.

The various axes of variability identified in the therapeutic encounter are summarised in Figure 24.

FIGURE 24.

Axes of variability in the therapeutic encounter.

Participants

In exploring the parameters and characteristics of a BSL-IAPT service, we draw exclusively on interviews with personnel from the single originating service provider (BSL Healthy Minds). Of the 14 potential participants, 12 agreed to be interviewed. Seven were Deaf staff who declared either that they grew up using BSL as native first language or that they use BSL as their main and preferred language. The five hearing people interviewed also all signed; the two with advanced qualifications in BSL had managerial and lead roles in the delivery of the service. Of the seven Deaf staff interviewed, six were clinical practitioners or senior practitioners and only one hearing staff member interviewed worked in a direct clinical role with Deaf clients. Of the 12 interviewees, 11 had worked for the service for at least 3 years, five of whom had worked for the service for over 4 years.

Small communities of practice

Pathways into the service

BSL-IAPT service-specific adaptations

Other value-added features of the BSL-IAPT service delivery structure

Participants drew attention to the benefits deriving from the structure of the service, which supports service quality and therefore indirectly has a positive impact on clients. These were possible only because of the larger numbers of Deaf therapists and hearing people who signed well within a single-service provider. For example, there was a peer group of Deaf therapists who could be drawn on by individual therapists for support and to reduce isolation. Group supervision enabled the sharing of ideas, information and resources as well as best practices in adapting to the range of Deaf client needs. There was a shared understanding of the requirements and challenges of Deaf clients without having to explain these to people who might be linguistically and culturally unaware. Remote supervision in BSL without the requirement of an interpreter was also possible. All of these features were felt to add to the safety of therapists as well as acting as quality assurance mechanisms in the delivery of the service.

Conclusion

The key elements of the BSL-IAPT service and their perceived advantages and limitations can be summarised diagrammatically (Figure 25).

FIGURE 25.

Perceived advantages and limitations of the BSL-IAPT service.

Translating EQ-5D-5L version into British Sign Language

The technique used in the translation and reliability testing of standard instruments builds on our previous work [see Rogers et al. 33 for PHQ-9 BSL, GAD-7 BSL and WSAS BSL; and Rogers et al. 134 for Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) BSL]. The translation procedure for the EQ-5D-5L BSL followed international standards, as required by the EuroQol group; this consisted of five stages (Figure 26). As BSL is a visual, non-written language, additional amendments were required; these amendments were approved by EuroQol. Additional amendments were necessary in order to ensure an operationally equivalent version was achieved; this is not a written/print version. The aim of this procedure is to ensure that the BSL version will be as semantically equivalent as possible to the English version.

FIGURE 26.

Flow chart illustrating translation of the EQ-5D-5L into BSL.

Two translation teams were established for this translation procedure: the forward translation team [two experienced translators who are Deaf native BSL users, fluent in written English (one is a registered interpreter)]; and the back translation team (one Deaf and one hearing, both registered interpreters, who are bilingual in BSL and English).

In detail:

Forward translation: The two forward translators independently translated the EQ-5D-5L into BSL (first draft). A key problem identified concerned the repetition of the level descriptors; in the English version, these are distinguished by slight changes in the adjective used in each sentence e.g. ‘I have no problems in walking about; I have slight problems in walking about; I have moderate problems in walking about, etc.’. In a written language, this format works because someone reading the questionnaire is able to scan between the level descriptors, which are all on the same page, make comparisons and reach a decision; there is simultaneous presentation of available choices. In a visual language, where the ‘text’ of the questionnaire is presented on screen via an online interface, repeating the level descriptors one after another is a sequential experience for the ‘viewer’. To compare the different options would require flicking between five different videos, separately presented on screen, which is not an equivalent cognitive task to seeing a written version where there is simultaneous access to the range of responses from which to choose. After discussion with the forward translators and the representatives from the EuroQol Group, a change in the format of presentation of the potential responses was permitted. The five level descriptors are, for each domain, presented by a single signed phrase in the form of: ‘the health domain (e.g. mobility difficulties) followed by none; slight; moderate; severe; unable/can’t’. The grammar of BSL permits intensity to be marked in increasing degrees, having established the core subject first, through inflecting facial expression, handshape, movement and, in some instances, location of signing. 87 The viewer is able to see all possible choices of response simultaneously (as a reader of written text might) and come to their decision. Those taking the assessment give their response by clicking on one of the available choices represented on screen by corresponding English words and a BSL reference translation is given at the start and is available to be seen again throughout if required.

Back translation: The two back translators independently translated the BSL version (second draft) back into English, compared the back translations with the original version and produced a report on the back translation process to the project manager. This resulted in the third draft.

Respondent testing: the third draft was tested using a sample of eight lay Deaf respondents (five men, three women), aged between 33 to 58, with varying educational backgrounds. They included both healthy people and patients, as outlined by the EuroQol group. The ‘patients’ were those who reported that they were currently experiencing health difficulties in response to general descriptive questions about their health and any current treatment. They were asked to complete the EQ-5D-5L BSL, not having had previous access to or experience of the assessment in English, and then they took part in a structured interview. Additionally, they completed a rating exercise (on a scale of 0–100) to establish their response for each health dimension, which confirmed that the severity descriptors for each dimension were appropriate. Feedback resulted in some additional changes to the translation, including clarification of the acronym EQ-5D, a clearer distinction between pain and/or discomfort and a greater emphasis on ‘today’ to be conveyed for each dimension as it was signed.

Testing with bilingual Deaf people: To explore agreement between the English and BSL versions of EQ-5D, 11 bilingual Deaf people completed both versions. Cohen’s kappa (k) statistic was used to assess the level of agreement between the English and BSL versions. Although the sample was small, it was found that the level of agreement between the two versions was very high. Statistical agreement (Cohen’s kappa) between the BSL and English versions of each dimension of EQ-5D-5L was high: mobility, k = 1 (p < 0.001); usual activities, k = 1 (p < 0.001); pain/discomfort, k = 0.81 (p < 0.001); anxiety/depression, k = 1 (p < 0.001). For self-care, all respondents used only one category of the five levels for the English and BSL versions; thus it was not possible to estimate Cohen’s kappa. The analyses above demonstrate that the content of each item in the BSL version of EQ-5D-5L was equivalent to the English items in the original version.

Fourth draft: This took into account comments from the respondent testing and the EuroQol translation review team and was the version then used for reliability testing. Examples of the amendments made include: (i) Emphasising more strongly that the question is asking about the severity of problems for today only; (ii) making it clearer that the mobility domain refers to the ability to walk rather than barriers to mobility including communication barriers; and (iii) making the distinction between pain and discomfort clearer.

Rogers et al. 130

Although the findings from the respondent testing stage resulted in further changes to the EQ-5D-5L BSL, how Deaf people conceptualised the key words varied across the group. For example, in the case of ‘mobility’, some thought that it related simply to the use of the legs (i.e. being able to walk), whereas others also associated it with the use of arms (e.g. being able to pick up glasses). A couple of people also thought that it related to getting to places, and that because of communication barriers, it would be difficult to use a taxi or bus. This is related to how Deaf people view the world and how everyday life experiences influence how they conceptualise.

Testing the reliability and validation of the EQ-5D-5L version British Sign Language

Calculating utility values

Utility values were calculated from the EQ-5D-5L BSL for all participants who completed the measure in the translation and validation study, at the first time point, using the published crosswalk system. The crosswalk system directly maps between the three- and five-level versions of the EQ-5D. It has been used since 2012 to calculate utility values from EQ-5D-5L data. 135

More recently, Devlin et al. 136 published a new value set for the EQ-5D-5L which, over time, is intended to replace the crosswalk system. This new value set was collected at a different time and on a different sample to the value set used for the EuroQol-5 Dimensions, three-level version (EQ-5D-3L). This means that there may be differences in utility estimates and QALYs estimated using the crosswalk system and the new value set that reflect differences resulting from design rather than underlying preferences and/or changes in preferences over time. Compared with the crosswalk method of calculating utility values, the new value set has fewer states ‘worse than death’ and the minimum utility value is higher (–0.281 vs. –0.594). This means that overall utilities may be higher using the new value set than those from the crosswalk system for the EQ-5D-5L or the original EQ-5D-3L.

Thus, we used the crosswalk method to generate our utility values for most analyses to facilitate comparison between utility values estimated using the older three-level version of the EQ-5D and the more recent five-level version. The new value set published by Devlin et al. 136 was compared with the crosswalk system in the analysis to address research question 4.

To compare the EQ-5D utility values to those derived from the CORE-6D BSL data derived from study 4, we used the methods reported in a published paper. 137 This included collapsing the five-level CORE-6D BSL data down into three levels and using a regression model to calculate utilities. 137

Analysis

Descriptive statistics were used to summarise the responses of Deaf people to the population norms for the EQ-5D domains (per cent reporting no problems) and EQ-5D utility weights (mean, SD), and to compare these with population norms. Deaf participants’ EQ-5D-5L scores and utility values were compared with published norms from the hearing population, identified via the EuroQoL website.

Linear regression was used to determine if participants’ sociodemographic characteristics were associated with Deaf participants’ health and EQ-5D-5L utility weights. The analysis was also used, with descriptive statistics, to assess whether or not utility values differed between people with and without depression. In line with clinical cut-off points from the hearing population, a CORE-10 score of ≥ 13 was used to identify participants with depression (note that cut-off values specific to the Deaf population are not available). 138 The CORE-6D utility values were included in this analysis to assess whether or not the CORE-6D, which is based on a subset of the CORE items, differed between the groups. Moreover, the comparison provides additional information with which to descriptively assess the differences in EQ-5D utility values between people with and without depression.

The data were analysed using Stata version 13.1 (StataCorp LP, College Station, TX, USA).

Approach

The economic evaluation aimed to explore whether or not BSL-IAPT is cost-effective compared with standard IAPT services for the treatment of depression and/or anxiety in the Deaf BSL population in the UK. The overall perspective or decision-maker viewpoint used to determine the range of costs is that of health and social care providers. However, data constraints limited the perspective for the initial 6-month time horizon, when people are receiving IAPT treatment, to the providers of IAPT services. The costs of other health care and social care are not included. However, the costs of relapse/recurrence and recovery after the first 6 months do include a broader range of costs.

In the absence of a head-to-head trial of standard IAPT and BSL-IAPT for Deaf BSL users, it was recognised that a decision-analytic model to combine or synthesise available data was needed. The economic model focuses on Deaf BSL adults who are referred to IAPT for a low- (defined by NICE as step 2)142 or high-intensity (defined by NICE as step 3)142 intervention for the treatment of depression and/or anxiety. The key intervention is the BSL-IAPT specialist service, as provided by BSL Healthy Minds. This service was designed to meet the cultural and linguistic needs of the Deaf BSL population. IAPT interventions are delivered by health-care workers fluent in BSL, the majority of whom are Deaf. This is compared with the standard IAPT service, which the Deaf BSL population may access, usually through a sign language interpreter. Standard IAPT represents routine care for most Deaf BSL users.

The economic model estimates the costs and QALYs for 1 year after a person’s first contact with the service (i.e. the time horizon is 1 year), for the main or primary analysis. Depression and anxiety are long-term conditions, so the economic model also explored the costs and QALYs over longer time periods. However, these longer-term analyses are likely to be more uncertain, as the many of the data available for the model were collected over the short term.

The costs and outcomes for the long-term time horizons are discounted at a 3.5% rate per year, in line with UK recommendations. Discounting takes account of the fact that we prefer to take benefits now and delay costs to the future. Discounting is not needed for analyses using time frames of ≤ 1 year. 133 The price year is 2015 and costs are presented in UK pounds sterling (£).

The population, intervention, control, outcome and time frame statement

• The target population for the economic model was Deaf BSL users with depression and/or anxiety. Although service users may have only one of these conditions, it is common to suffer from both. 143–146 This was demonstrated in the IAPT data sets, in which 75.9% (standard IAPT) and 81.6% (BSL-IAPT) of participants had mixed depression and anxiety at the point of entry into the IAPT service (see Table 14).

• The intervention was the BSL-IAPT service, a specialist version of the IAPT service, with fluent BSL users delivering IAPT interventions.

• The comparator was standard IAPT. In situations in which a Deaf BSL user is referred to a standard IAPT service, they are most likely to receive this intervention through the use of an interpreter.

• The primary outcome of the economic analysis was the incremental cost-effectiveness ratio (ICER). This was estimated as the net cost of the intervention divided by the net health benefit. The measure of health benefit for the primary analysis was the QALY.

• The primary time horizon for primary analysis was 1 year from entry into the decision model.

Model structure

The economic model structure includes two distinct parts: a decision tree and a Markov model.

The decision tree used the IAPT pathway18 and the stepped care pathway recommended by NICE142 to model the treatment events for depression and/or anxiety within the IAPT service. A diagram of the decision tree is shown in Figure 28. The decision tree illustrates the pathway of events that a person could experience during treatment. A number of events may happen at the same time in the decision tree; the pathway reflects the combination of events that a person could experience, but not necessarily the sequence they occur in.

FIGURE 28.

Decision tree.

The decision tree begins with a Deaf BSL user referred (or who self-refers) to an IAPT service and models the events that may occur in the first 6 months from referral. This is represented in Figure 28 by a square node. Standard IAPT and BSL-IAPT pathways follow the same decision tree structure, although the probabilities, costs and benefits of different events may vary between the two interventions.

It is possible that people will exit the pathway before treatment. This may be for various reasons (e.g. their symptoms changed during the wait, which means that they are now no longer suitable for IAPT treatment, or they received another intervention during the wait and now no longer need the IAPT service). For people starting treatment, there are two possible options: low- or high-intensity treatment (step 2 and step 3 in the NICE guidelines). 142 The decision to refer to low- or high-intensity treatment will depend on patient characteristics/symptoms and treatment availability. Low- and high-intensity referrals have the same model structure in the decision tree, but have different probabilities and costs.

The model recognises that the intensity level may or may not be appropriate for the user’s needs. Service users may remain on the same treatment intensity throughout their IAPT therapy course (if appropriate), or they may need to change from low- to high-intensity or from high- to low-intensity services during treatment if the initial treatment is not appropriate. It is plausible that the BSL-IAPT service may be more able to appropriately refer users to low- or high-intensity intervention if it can assess symptoms more accurately (e.g. through more fluent and direct communication or using the BSL versions of the PHQ-9 and GAD-7 or more appropriate clinical cut-off points). Alternatively, services may be similar in terms of whether or not patients are appropriately referred, but BSL-IAPT may be better at identifying when a patient needs to change the intensity of treatment. Increasing the service’s ability to identify appropriate changes in treatment intensity effectively gives another chance of having a treatment benefit in the model. For the 6 months covered by the decision tree it is assumed that users will have multiple IAPT interventions only if the intensity of treatment is changed.

Service users may complete treatment or disengage and drop out, with these groups having different chances of benefiting from treatment. The benefit of treatment includes two potential outcomes: full recovery or partial recovery. It is assumed that those people who do not recover following treatment are either referred to other services or have no further treatment. The treatment pathways following a course of IAPT therapy are variable and complex and so further treatments are not explicitly included in the decision tree. However, they are included in the costs and outcomes of events in the Markov section of the economic model.

The Markov section of the model was used to capture longer time horizons and that depression and anxiety can be cyclical with recovery followed by relapse (return of symptoms before full recovery) or recurrence (recurrence of depression/anxiety symptoms following full recovery). It includes three possible states: partial or full recovery from depression/anxiety, relapse/recurrence and death. The Markov model is presented in Figure 29. Which health state people enter the Markov section of the model in is determined by the end points of the decision tree. For the decision tree pathways that end in recovery, the Markov model starts with a state of recovery (which is split into two substates for full recovery and partial recovery). Users can only move into the partial response state during the decision tree (i.e. following the modelled treatment). In the Markov model these users will either remain in this state or move out of it (into the recovery substate of full recovery, relapse or death). For the decision tree pathways that end in no recovery, the Markov model starts with a state of active depression/anxiety symptoms, which is termed as relapse/recurrence for subsequent cycles of the model. The Markov model allows transitions to occur between 3-month cycles, a half-cycle correction was applied.

FIGURE 29.

Markov model. a, Recovery consists of two substates: full and partial recovery. Users can only move into the partial recovery substate on entry to the Markov model, in the Markov they can remain or transition (move) to another state. There are no data available to model users moving into this state following the decision tree. b, Relapse is defined as the return of symptoms before full recovery and recurrence is defined as the recurrence of depression/anxiety symptoms following full recovery.

The economic model was constructed in Microsoft Excel^® 2010 (Microsoft Corporation, Redmond, WA, USA).

Users can move between health states (depicted by the arrows moving between states) and can remain in those states over a number of cycles (shown by the arrow looping back into the health state. Death is an absorbing state; people will remain in this state (shown by the single arrow looping back into ‘dead’).

Overview

The data for the model included the following categories: probabilities of events, outcomes, utilities, resource use and costs. Tables of the data estimates and sources used in the model are presented in Appendix 9.

The economic model synthesised data from a number of studies across the programme of work, as well as data from the wider literature. Data on outcomes and resource use (number of appointments and treatment intensity/step level) were estimated from the IAPT data sets analysed in study 2 (see Chapter 4). These data sets allowed us to make a comparison between the service options in terms of treatment effectiveness and the resource use and costs associated with IAPT intervention. The translation and validation of the BSL EQ-5D-5L (study 5; see Chapter 6), provided a sample of data to estimate utility values for Deaf BSL users.

These data were supplemented with data from the literature to estimate the probabilities, costs and outcomes over the longer term. This included the long-term rates of relapse/recurrence and recovery, costs of depression and/or anxiety, and mortality rates. Literature was identified through targeted searches of The Cochrane Library, NHS Evidence and MEDLINE database. Owing to a lack of evidence, which was specific to the Deaf population, data from the wider population had to be used to estimate some model parameters; this is discussed in Limitations. The choice of inputs in these cases was based on the availability of the best-quality (according to the hierarchy of evidence) and most relevant data. Given the probable mixed depression/anxiety diagnosis, the model used data relevant to the mixed diagnosis when possible. When these were not available, data that were either relevant to depression or anxiety were used, prioritising the best-quality sources of data.

Primary analysis

The primary analysis addressed the question of whether or not BSL-IAPT was potentially cost-effective compared with standard IAPT when service-specific PHQ-9 and GAD-7 tools and cut-off points were used to identify people with depression/anxiety and measure recovery. The model estimated the net costs and QALYs of BSL-IAPT compared with standard IAPT. Monte Carlo simulation was used to take account of the fact that there is uncertainty and variation in the data used in the model. To do this, all the data inputs were assigned distributions. The Monte Carlo simulation samples from the distribution of possible values for each data input in the decision model. Probabilities and utilities were assigned beta distributions, and costs were assigned triangular distributions. Odds ratios and resource use were assigned normal distributions. Estimates of the mean and SD were used. This meant that mean costs and QALYs, as well as measures of variance (SD and 95% CI), could be estimated to assess the level of uncertainty in the results due to the data inputs.

The Monte Carlo simulation produced 10,000 pairs of net cost and net outcomes. These were then used to generate cost-effectiveness acceptability curves and the probability that the BSL-IAPT service is cost-effective compared with standard IAPT for Deaf BSL users, as recommended by NICE for health technology appraisals. 133 This approach revalues benefits (e.g. QALYs gained) in monetary terms. However, there is no universally agreed monetary value to attach to QALYs. Therefore, the simulated net QALYs were revalued using a range of willingness-to-pay values that a decision-maker may be willing to pay to gain 1 QALY, ranging from £0 to £30,000. This was based on the range of willingness-to-pay values historically used in NICE decisions. 159,160 This approach takes into account uncertainty about the amount that decision would be willing to pay to gain 1 additional QALY from BSL-IAPT.

Sensitivity analysis

Sensitivity analyses were conducted to assess whether or not variations in the model structure, time horizons, cost, utilities or outcome probabilities would alter the conclusions of the primary analysis. The costs, effects, ICERs and probability of cost-effectiveness at each threshold were re-estimated for each sensitivity analysis. An overview of the sensitivity analysis (assumptions tested) is provided in Appendix 11.

Primary analysis

The results of the primary analysis are shown in Table 29, when BSL-IAPT is compared with standard IAPT using the service-/language-specific PHQ-9 and GAD-7 scales and cut-off points for depression/anxiety. This indicates that BSL-IAPT is associated with a net saving of £240 per patient (SD £832 per patient; 95th percentiles –£2303 to £935).

However, the 95th percentiles cross zero, indicating uncertainty about whether BSL-IAPT is associated with a net saving or net cost. The model predicts that BSL IAPT services are associated with a very small gain of 0.001 QALYs. Again, the 95th percentiles cross zero, indicating uncertainty about whether BSL-IAPT is associated with a QALY gain or loss. The cost-effectiveness plane in Figure 30 illustrates this uncertainty. Each dot represents a net cost–QALY pair from the Monte Carlo simulation. The figure shows that most of the points lie below zero, suggesting a net saving and that more of the points are towards the right, suggesting a net gain in QALYs.

FIGURE 30.

Cost-effectiveness plane: distribution of net costs and QALY pairs. WTPT, willingness-to-pay threshold.

The incremental cost-effectiveness acceptability analysis suggests that there is a 57% probability that BSL-IAPT is cost-effective if decision-makers are willing to pay £20,000 to gain 1 QALY; this increases slightly to 58% if decision-makers are willing to pay £30,000 per QALY gain. The cost-effectiveness acceptability curve in Figure 31 demonstrates that the probability that BSL-IAPT is cost-effective changes as the amount that decision-makers are willing to pay to gain 1 QALY changes.

FIGURE 31.

Cost-effectiveness acceptability plane. WTPT, willingness-to-pay threshold.

Sensitivity analysis

The full results of the sensitivity analyses are reported in Appendix 12, Table 39. Most of the sensitivity analyses indicated that BSL-IAPT was likely to be cost-effective even if decision-makers were not willing to pay anything to gain 1 additional QALY (probability of being cost-effective was > 50%). There were some exceptions to this. First, if the costs of an interpreter were excluded from the costs of the standard IAPT service, there was a net cost associated with BSL-IAPT of £307 (95th percentiles –£751 to £1155). The net gain in QALYs remained the same as for the primary analysis. The net cost per QALY gained was £256,224, with a 22–26% likelihood that BSL-IAPT could be cost-effective.

Second, the BSL-IAPT service was constrained to providing primarily low-intensity services, whereas standard IAPT services had more capacity to provide high- and low-intensity service. We performed a sensitivity analysis to explore the extent to which the cost-effectiveness of BSL-IAPT may change if it was possible to offer low-intensity services to more people. This increases the costs of BSL-IAPT and reduces the probability that BSL-IAPT is cost-effective to < 50%. It is important to note that this is a very exploratory analysis. What both of the sensitivity analyses demonstrate is that the costs of interpreters for standard IAPT and whether or not BSL-IAPT is able to provide high-intensity care are potentially important factors to consider in future service development and research.

Summary of findings

The primary analysis indicated that BSL-IAPT may be more cost-effective than standard IAPT. However, there is uncertainty within the estimates and so this result is not conclusive. As noted in the previous section, limited data and reliance on the IAPT data also mean that the robustness of the results is uncertain. Even if decision-makers are not willing to pay an additional cost to gain 1 QALY, BSL is > 50% likely to be cost-effective. This is when the BSL version of the PHQ-9 and GAD-7 and BSL cut-off points are applied to the BSL-IAPT service to define whether or not a person has depression, reliable recovery and reliable improvement, and the English versions are applied to the standard IAPT service. The sensitivity analysis indicated that applying the same language and cut-off points for these measures to each service did not substantially change the conclusion.

Most of the sensitivity analyses indicated that BSL-IAPT was likely to be cost-effective even if decision-makers were not willing to pay anything to gain 1 additional QALY, with a probability of being cost-effective of > 50%. There were some exceptions to this. First, if the costs of an interpreter were excluded from the costs of the standard IAPT service, the net cost per QALY gained by BSL-IAPT was £256,224, with a 22–26% likelihood that BSL-IAPT could be cost-effective. Second, if the BSL-IAPT was able to offer high-intensity services to more people, the costs of BSL-IAPT increase, reducing the probability that BSL-IAPT is cost-effective to < 50%.

Nevertheless, there were limited data available with which to estimate the different variables in the model, so that there is a high level of variance and uncertainty in the estimates of the costs and QALYs associated with the two services. In addition, although in principle a 50% probability of cost-effectiveness may be interpreted as BSL-IAPT being cost-effective, or similar to standard IAPT, the uncertainty in the data means that the results are best treated as equivocal.

Limitations

What this study adds to the evidence base

This is the first study to use an economic model to synthesise data from different sources and explore the potential cost-effectiveness of a service that has been specifically adapted to meet the cultural and linguistic needs of the Deaf BSL population in the UK. Although there are several limitations to the structure of the economic model used and the available data, the analysis provides an initial indication of the costs and QALYs of BSL and standard IAPT. The primary analysis indicates that BSL-IAPT may be more cost-effective than standard IAPT. Much of the sensitivity analysis to explore the impact of assumptions and data limitations appears to support this conclusion. The sensitivity analyses identified two key variables that affected the costs of each service and probable cost-effectiveness of BSL-IAPT. The first was the costs of interpreter services to facilitate access to standard IAPT care for Deaf BSL users. The second factor was the intensity of services provided by BSL-IAPT. If BSL-IAPT services are not constrained to providing primarily low-intensity services, in the future this could increase the costs of treatment and may improve the recovery rates above what was found in this study.

Key findings

• A new cost-effectiveness model, evaluating the potential cost-effectiveness of BSL-IAPT in comparison with standard IAPT for Deaf BSL users, has been developed.

• The costs of BSL-IAPT over 1 year were estimated to be £2977 compared with £3218 for standard IAPT. This indicated a net saving for BSL-IAPT of £240 (95th percentiles –£2303 to £935). However, the 95th percentiles cross zero, suggesting that the difference in costs may have occurred by chance.

• The QALYs associated with BSL and standard IAPT were very similar, at 0.719 and 0.717, respectively. Again, the 95th percentiles overlapped, indicating that this small difference may have occurred by chance. The simulation and cost-effectiveness acceptability analysis indicated that, overall, there was a > 50% chance that BSL was cost-effective. Key factors that could change the cost-effectiveness of BSL-IAPT are the costs of interpreter services for standard IAPT and the range of services provided by BSL-IAPT.

• The model structure and variable estimates were limited by the range and quality of data available. This means that the results are preliminary and uncertain.

EQ-5D-5L version British Sign Language

This study has produced the first validated translation into a signed language of any of the suite of EQ-5D assessments. Its psychometric properties were demonstrated to be good, indicating that it can be used to measure the health status of Deaf individuals in the UK who use BSL. Its test–retest reliability for each dimension of health was in the range of moderate to good, and was, therefore, acceptable. This, with the previously validated BSL version of the CORE-OM,134 provide new validated tools to assess the overall and mental health status of Deaf individuals, whether from a clinical or research perspective. Both measures provide preference weights that can be used to estimate QALYs and compare the costs and health benefits of intervention within specific conditions and across conditions. 133

The EQ-5D-5L BSL opens up the possibility of a new era of research, testing out the effectiveness of health and lifestyle interventions, whether targeted specifically at Deaf BSL users or through the inclusion of this population in general health research. Previously, Deaf people were excluded from health research because of the lack of availability of a common assessment tool that is validated for this population. This is a significant step forward for a population who are known to experience poorer physical and mental health than the general population and where research effort to remedy this situation has been hampered by a lack of means of reliable measurement of health status and change.

The EQ-5D-5L BSL has been accepted by EuroQol, which will be made available for future use without restriction. It has also opened up the possibility of other countries seeking a validated and reliability tested version of the instrument in their own sign language and therefore is of international significance in the field. The protocol for translation of the instrument into a signed language and the results of the investigation into the psychometric properties of the EQ-5D-5L BSL are published. 130

The results of this study indicate that health status and associated utility values published for the general population may not be generalisable to the Deaf population. The mean utility in this group was nearly 10% lower than the general population published norms. In addition, depression and anxiety are shown to be more prevalent in this group. Statistical analysis indicated that, as may be expected, utility values for people with depression may be lower than for people without.

Our results provide EQ-5D-5L utility values relevant to a Deaf population, which have previously been unavailable. However, there are some limitations. In particular, the study sample (n = 92) is too small to draw strong conclusions. The sample of bilingual Deaf people who assessed agreement between the English and BSL versions of the EQ-5D-5L was small (n = 11). However, the 11 participants’ responses agreed perfectly on four of the five domains of the EQ-5D-5L. The only domain that showed any disagreement was the pain/discomfort scale, where one participant reported no pain or discomfort when using the BSL version, but slight pain or discomfort using the English version. Nevertheless, it is possible that a larger sample would show less agreement between the versions. The estimated weighted kappa scores used to assess test–retest reliability of the BSL EQ-5D-5L version were between 0.47 and 0.61. The kappa scores were in the moderate range (0.41–0.60) for three of the five domains and in the good range (0.61–0.80) for the other two. However, the 95% CIs for the scores were wide and the lower limits of the 95% CIs extended well into the fair and poor ranges for anxiety/depression and self-care respectively. This suggests some uncertainty about the test–retest reliability of the BSL EQ-5D-5L.

Added to these factors, the sample of participants were recruited online, which may limit how representative this sample is of the wider Deaf population. Nearly 9% of Deaf participants in this study stated they did not know if they had health difficulties. The limited interview data from this study indicate that Deaf people’s responses to the EQ-5D-5L may be mediated by their experiences of communication barriers and their experiences of accessibility of services in BSL rather than only the severity of symptoms. Combined with the small sample of Deaf participants, this indicates that further work is needed to establish norms for the EQ-5D and associated utility weights for the Deaf population. These issues also indicate the need for further work before we can assess and compare the impact of mental and physical health conditions on health and utility.

Calculating the clinical cut-off points for the PHQ-9 item British Sign Language and GAD-7 British Sign Language

Our previous studies33,88 produced the validated and reliability tested BSL versions of the PHQ-9 and GAD-7 that were adopted by IAPT for use with Deaf BSL users. A short guide on the availability of the BSL assessments and how they might be used in clinical practice has been produced by the current study as a new resource (see Appendix 9). Extending our work, we have now also established the appropriate clinical cut-off points for these instruments for use with the Deaf population in the UK. This has increased the validity of their use in clinical practice, which is an ongoing legacy of the study. It has also enhanced their validity for research purposes in ensuring the more accurate identification of caseness and evaluation of clinical outcomes.

We have demonstrated that clinical cut-off points for PHQ-9 BSL and GAD-7 BSL are 8 and 6, respectively. This compares with the original English version cut-off points in the hearing population of 10 and 8, respectively. The three different statistical choices for calculating clinical cut-off points (equalising, maximising and prioritising false-negative to false-positive ratio ≈1 : 2) all showed a lower clinical cut-off point for the Deaf population with respect to the PHQ-9 BSL and GAD-7 BSL, with the exception of the maximising criteria, when used with the PHQ-9 BSL. 85

Whether Deaf people are treated by a BSL-IAPT service or by a standard IAPT service, establishing the correct clinical cut-off points for the BSL instruments will ensure first the appropriate identification of caseness. This is important because of the long-standing history of Deaf people in mental health services being subject to both under- and overdiagnosis because of the complexity of assessment in signed languages and/or the absence of such assessment in the patient’s first language. The lower cut-off scores will avoid Deaf people in need of support being turned away from treatment, notwithstanding the fact that entry into treatment is in part a clinical judgement, not just a result of score alone. The correct cut-off scores will also contribute to more accurate assessment of recovery and/or requirement for further treatment, thus preventing the early discharge of Deaf people when further treatment is necessary. Finally, the application of the appropriate clinical cut-off scores will enhance the reliability of the mandatory data flow from IAPT services to the HSCIC, with respect to Deaf people in terms of meeting caseness, reliable recovery, reliable improvement and deterioration.

The primary limitation of this study was that the cut-off scores were not able to be verified through psychiatric interviews, which is the gold standard for this kind of clinical research. Instead, the methodology used discrimination between a group defined as having a mental health problem and a group who self-reported as not having a mental health problem. Although we consider that the choice of methodology was robust, it is different from that used by the originators of PHQ-9 and GAD-7. The inclusion of a clinical interview would be required in order to validate further the clinical cut-off points for PHQ-9 BSL and GAD-7 BSL. In addition, the well group comparator was derived from an anonymous data set of a pre-existing study. This meant that further information about the sample could not be collected with which to judge their comparability with the clinical data set sample.

Acceptability of randomisation

Deaf people have few opportunities to access a health service available directly, without the requirement for a sign language interpreter, that is, delivered by Deaf practitioners and culturally matched to client needs. The gold standard of single study designs to evaluate effectiveness, safety and cost-effectiveness is the well-designed randomised clinical trial. A key component of the decision whether or not a RCT is feasible and acceptable is if randomisation is acceptable to Deaf people. In the published literature, there was no prior study of the acceptability of randomisation among Deaf people. Furthermore, Deaf people have historically been routinely excluded from RCTs. This means that there was little pre-existing knowledge or understanding among Deaf people about the meaning of randomisation, its implications, the potential benefits of participation in such studies and the basis on which informed choices about participation might be made. Our study with a small sample of people drawn from the Deaf community first equipped participants with knowledge and understanding about RCTs and key terminology and its meaning before exploring participants’ views, considerations and conclusions about the acceptability of randomisation.

The study demonstrated the strong influence of culturally rooted considerations from a whole community (rather than individual) perspective on the acceptability of randomisation. The four main influences on Deaf people’s attitudes and conclusions about the acceptability of randomisation were:

1. Research involving randomisation is perceived as a subset of research in general, which, provided it benefits Deaf people both currently and in the future, is considered acceptable.

2. Randomisation can be perceived as an example of forced choice without the individual exercise of agency, which is a common experience for Deaf people and on that basis may be unacceptable.

3. If randomisation implies not having personal linguistic preferences and cultural needs met, then it is of itself seen as a potential threat to personal well-being.

4. Randomisation may be resisted on grounds of its perceived denial of the value of Deaf people’s common sense, knowledge and belief of what is best for them, which happens often in Deaf people’s lives.

These results do not rule out the possibility that randomisation would be acceptable in future trials. They do highlight the need to attune future research to those aspects of culture, value and experience that would be important to take into consideration when deciding how potential Deaf participants should be informed about such a study. However, before this can happen, the findings of this first, small, study need to be further investigated with a larger sample of Deaf community members to ascertain the extent to which they are recognised as valid. This would help lay the groundwork required to develop appropriate participant information and recruitment strategies for specific trials. 167

In itself, this study adds to the small body of pre-existing work that has considered cultural influences on attitudes to randomisation. It highlights the importance of considering the influence of previous experiences of lack of control in decision-making that are rooted in power imbalances between populations of different social status. They include the historical denial of the legitimacy or primacy of cultural identity. In this case our findings bridge the concerns of post-colonial perspectives on the Deaf community7 and acceptability of randomisation and the work conducted by others to understand recruitment challenges in the hearing population,167 in a novel way. The principal limitation of the study was the small number of participants, who may not have been representative of the full diversity of Deaf people.

Trial-related terminology

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. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. When paragraphs are repeated here verbatim, they have been displayed as quotations with reference to the original paper.

A key barrier to Deaf people’s participation in any future study based on a trial design has been the lack of appropriate terminology, means of expression and general understanding of key concepts used in study information and recruitment materials. Although the general literature is replete with studies of a range of aspects of (in)accessible information and its consequences for participant recruitment, there has been no similar study undertaken with respect to a signed language in general, or BSL in particular. Our study explored the strengths and capacities of a signed language to aid understanding and prevent misunderstanding about key concepts such as ‘trial’, ‘informed choice’, ‘randomisation’ and ‘consent’. The focus was not on the translation of key terms. Rather it was on how to support understanding to permit informed choice about participation in randomised trials. Key to this were the characteristics of the particular language concerned – BSL – and the low levels of background knowledge among many Deaf people on which they might draw in reaching a personal decision whether or not to participate in a clinical trial. This study has been published in Trials34 and provides an evidence-based means of refining study recruitment materials in research involving Deaf people. It lays the groundwork for confident production of recruitment materials in any future study we may undertake about the effectiveness and cost-effectiveness of BSL-IAPT. Additionally, we have produced an online glossary and resource in BSL (and English) for other researchers considering undertaking work in this field. This is being made freely available as an additional output of this study.

The six principles we developed for accessible, acceptable, accurate, culturally attuned information production for recruitment are not just of specific relevance to studies involving signed languages other than BSL. They also apply to the further development of written and spoken information for hearing participants for whom the majority language (English) is not their first or preferred language. They are reproduced verbatim:34

1. A community-participatory, exploratory approach to arriving at appropriate clinical trial terminology is highly effective in instances where languages, in this case BSL, have not yet had the contact with a topic that would mean a common vocabulary/preferred means of expression has developed

2. Languages have properties associated with their form and grammar that naturally enable some approaches to explanation to support comprehension that others may not. In this case, verb directionality, expectations of specificity and simultaneous contextual, semantic layering within expressions enabled features of the underpinning trial design to be clarified and remain consistent

3. It is important to take into consideration bilingual influences on comprehension even when information is presented monolingually; this is a decoding strategy for unfamiliar terms and concepts that is available to those who are bilingual and multi-lingual and can be a source of both strength and misunderstanding

4. Orientation of information to avoid misunderstanding is an important axis to consider when creating new information for a cultural linguistic group unfamiliar with the topic. It is subtly different from an orientation designed to support comprehension and may, as in the case of the sample in this study, be a preferred orientation

5. The researcher should understand cultural, contextual or social barriers that participants might face in engaging in open, constructive discussions of the information materials and consent procedures, over and above those that might be created by language per se. In the case of Deaf people, these barriers might derive from negative historical experiences of the education system, and class differentials

6. Clarity of expression, in the sense of plain language or avoidance of jargon, is not sufficient to promote comprehension. Attention to language-in-use in contemporary discussion is an important means of expression to effectively communicate complex concepts because it reflects common cultural usage. Simple, straightforward language may still seem alien if it not recognisable as something shared and used within a given community.

Young et al. 34

The principal limitations of this study are that those who participated are not necessarily representative of the diversity of people in the Deaf community. They engaged with data collection on only two occasions, and with more time and exposure to the new ideas presented they may have made a greater and more diverse contribution.

Service delivery

During the course of this study, the initial demarcation of BSL-IAPT (delivered by a sole specialist provider) from standard IAPT (that Deaf people might access) became increasingly untenable. This was because a few standard IAPT services had started to gain experience and chosen to invest in provision for Deaf people. Models of service and provider identity were no longer entirely synonymous with respect to BSL-IAPT. Therefore, we undertook a study, underpinned by a realist inquiry method, to model the components and key variations in delivery of both BSL-IAPT and standard IAPT accessed by Deaf people.

It is commonly acknowledged that there is a wide variation in how different IAPT programmes nationally deliver services while adhering to a common set of requirements specified by IAPT. This can be regarded as a strength because it enables a degree of flexibility in service delivery to be responsive to conditions of specific geographical, client or service context. Therefore, with respect to standard IAPT, we expected to see a range of approaches to meeting the requirements of Deaf clients. Our sample of participating services and IAPT practitioners was skewed to those who had some experience of Deaf people as clients and largely consisted of services that were already interested in this client group. It was not nationally representative. Two of the practitioners who responded worked in standard IAPT services which had set up a specialist pathway for Deaf clients which employed therapists who were either Deaf or good sign language users. However, with regard to the rest, the overall picture that emerged of poor, and to some extent discriminatory, practice was even more remarkable given the positive bias of the sample to those with interest and experience.

Key issues we identified include the following.

• Awareness of the implications of using written forms of communication and information for the accessibility of the service for Deaf people in terms of initial (self-) referral, ongoing engagement, assessment and self-guided support is highly limited.

• Understanding of the relationship between ineffective means of service promotion to Deaf people and limited numbers of Deaf clients using the service is poor; consequently, the service has to make few adaptations to meet their needs.

• The choice of therapist for Deaf clients is very limited.

• Therapists have little experience and understanding of how to use an interpreter and the implications of interpreter use for therapeutic work.

• Poor or non-existent understanding of the additional barriers faced by Deaf people that may arise as indirect consequences of structural practices insisted on by services (e.g. referral through a GP, completion of an English-based written form at first triage, only direct communication by client rather than through a third party if self-referring).

• Lack of understanding of the inaccuracies inherent in using the English forms of clinical assessment (whether or not with an interpreter) for accurate assessment of illness and recovery of Deaf clients.

• Services display poor background understanding of the knowledge needs, rather than simply the linguistic needs, of Deaf people using an IAPT service arising from life-long deficits in information access and little prior experience of mental health services. Consequently, adaptations to the therapeutic experience other than interpreter provision are rare.

• Service providers show very limited cultural competence, combined with a limited awareness that this might be missing in their approach to working with Deaf people because connections are not readily made between deafness and cultural identity, rather than disability.

• No robust systems of equality impact assessment within routine monitoring of service delivery.

That said, engagement with the project itself served as a catalyst for some services to reflect on their current practices. Overall, there was an enthusiasm and willingness to provide the best service possible for Deaf clients, but services struggled to do this in the face of a lack of guidance, training and resources.

With regard to BSL-IAPT, in this case defined in terms of the original sole provider, three key components of the specialist practice and service were identified: (1) direct communication between therapist and client in a shared language (BSL) with no interpreter; (2) cultural insider positioning and cultural competence; and (3) service-related structures and practices. Each had advantages and limitations. Advantages included scope to tailor an intervention based on an in-depth understanding of clients’ background knowledge requirements, linguistic range/variation and cultural preferences. These were central to the ease of the therapeutic encounter, empathy and trust building. However, shared experiences, whether historical or contemporary, and the consequences for being known in multiple roles within small communities of practice could be disadvantageous to both client and therapist. Although specialist structures of service delivery ensured that therapists had a Deaf peer group, that ready specialist supervision was available and that there was understanding of how to ensure the service at point of referral could be accessible, the disadvantages included limited capacity and funding, a concentration of services at low-intensity therapy and a perception of long waiting times.

The principal limitations to this study consist of the small number of services and individual therapists who participated from standard IAPT and their bias towards positive interest in Deaf people, which meant that the sample was not representative. The focus on BSL-IAPT defined as one specialist service provider also had its limitations in the definition of service model components because of a lack of comparison with other BSL-IAPT services. Although through the modelling work we have undertaken we are in a position to produce a replicable description of standard IAPT for Deaf people and BSL-IAPT that could be operationalised in any future large-scale comparative intervention study, we acknowledge that this would need to be undertaken with care with appropriate fidelity checks. The boundary between these two apparently different interventions cannot be demarcated by specialist versus non-specialist service provider alone. Characteristics of the two approaches to psychological therapies for Deaf people under IAPT would have to be both defined and controlled, independent of service provider context, for a meaningful effectiveness study to be carried out.

Comparative clinical outcome data

Secondary analysis of available client outcome data demonstrated no significant difference between Deaf clients of standard IAPT and BSL-IAPT in terms of reliable improvement (63.5% vs. 66.8%; p = 0.917) and no difference in terms of reliable recovery (40.0% vs. 40.4%; p = 0.946). This analysis was based on defining completed treatment as attending a minimum of two therapeutic appointments. This is in line with the IAPT KPI definition of completion. 104 This excludes those people who needed only one appointment. It includes, as completed therapy, people whose treatment is ongoing. Using the tighter definition of completed therapy and using a verified endcode to identify patients whose treatment had finished, we found that reliable improvement was achieved in 76.5% of the 226 Deaf clients attending BSL-IAPT services while reliable recovery was achieved in 54.0%. That endcode was not included in the standard IAPT data we received for Deaf patients. Based on data collected across all IAPT services (general population) between October 2008 and September 2009,106 reliable improvement was reported in 64% of service users and reliable recovery in 40%. For data collected in March 2015, the HSCIC reported reliable improvement as 61.5% and reliable recovery as 43.1%. These figures were based on a recorded endcode that treatment had been finished. Rates of reliable improvement and reliable recovery from both sets of data based on a less rigorous definition of completion are comparable to those recorded for the general population of users of standard IAPT services based on early and current IAPT outcome data. However, these results should be treated with considerable caution.

First, although we are confident that the sample of Deaf clients from standard IAPT is Deaf people who use BSL, rather than the broader definition of deaf people/hearing impaired who use spoken language, it is drawn from a very small proportion of standard IAPT services nationally: 19 trusts and two private providers. Furthermore, this was a self-selecting sample of service providers. Therefore, the extent to which the sample is representative of the national picture is unknown, in terms of numbers of clients or clinical outcomes.

Second, the mean number of Deaf clients seen by standard IAPT services is two. Therefore, the combined reliable recovery and reliable improvement calculations for standard IAPT services are based on services with very little experience of Deaf clients in terms of number or clinical diversity. Consequently, the extent to which reliable recovery and reliable improvement rates would be maintained when faced with larger numbers and increased diversity of clients is untested. By contrast, the rates of reliable recovery and reliable improvement reported by BSL-IAPT are based on an experience by a single service of 349 clients.

Third, it was not possible with the data available to comprehensively look at deterioration and whether or not this differed between services. Adequate data on those clients who dropped out of therapy or who were referred out of the service were not available. Chapter 4 indicates that 3.5% of Deaf people in standard IAPT had reliable deterioration, compared with 6% in BSL-IAPT. This raises the question of whether this is a result of differences in samples and sample sizes, differences in types of service provided (e.g. only low-intensity services are mostly available in BSL-IAPT), or something else. Further investigation is required.

For a more robust comparison of clinical outcome data for Deaf users of standard IAPT and those of BSL-IAPT, an increase in both the quantity and the quality of the available data would be required. We calculate, for example, that if we are expecting a reliable recovery rate of 40%, we need at least 369 Deaf clients of standard IAPT in total, 40% of whom reliably recovered, to have a 95% CI of ± 5%. For a reliable improvement rate of 64%, we need at least 355 Deaf clients of standard IAPT. Our sample of Deaf clients of standard IAPT used for recovery calculations (n = 89) fell far short of this number. Furthermore, in the comparative analyses it should be noted that BSL-IAPT is a single-service provider with the same personnel (regardless of delivery location), whereas standard IAPT is made up of a number of different services with variable degrees of experience of Deaf people ranging from 1 client to 24 clients. This, combined with growing evidence about therapist effects on participant engagement and negative outcomes,162,168 increases uncertainty about the robustness and transferability of our comparisons of outcomes. To reduce uncertainty in the comparative analyses of clinical outcomes, a far greater number of Deaf clients would be required per standard IAPT service, whether a single service or a combined standard IAPT service.

The BSL-IAPT service was constrained to provide primarily low-intensity (step 2) care, with 93% assigned to low-intensity treatments, compared with 38% in the standard IAPT services. The figure for BSL-IAPT is nearly twice the rate of referral to low-intensity care found in the evaluation of the IAPT demonstration sites (48%). 168 This may indicate that some clients were not treated appropriately, but the available data make this difficult to assess. These differences in the intensity of care received by participants with similar clinical characteristics reduce the comparability of reliable improvement and reliable recovery outcomes.

Defining the intervention

We now understand the axes of variability in how standard IAPT approaches work with Deaf clients. In addition, we have demonstrated how BSL-IAPT may be defined by elements, which, in theory, could be reproduced in other contexts, including among standard IAPT providers. In saying this, we are not suggesting that the effects would necessarily be the same (that is, unknown), only that the elements that define BSL-IAPT are not necessarily confined to a single specialist provider. Therefore, although any future study may still be cast in terms of a comparison of BSL-IAPT with standard IAPT accessed by Deaf people, these would be closely defined in terms of elements of the intervention, rather than of the setting or provider. Fidelity to BSL-IAPT as a model of intervention that has been carefully defined (in its standards and practices) would be a key factor to control in any prospective study. Given the scale and diversity of contexts in which IAPT operates, such control and fidelity checks may prove challenging to operationalise.

Developing the context

Poor access to secondary data about Deaf users of IAPT has severely hampered this study, as have inconsistent clinical recording practices. This is in addition to the challenges in using secondary data sources that were typically not designed to address the research question of interest. Literature from which extrapolations can be made of population characteristics in general is also sparse. There is poor epidemiological evidence. Moving forward, therefore, we suggest the need for a well-executed mental health clinical observatory with respect to Deaf people to be established. This would:

• draw down clinical data from a variety of sources on a national scale and maintain a database of information sources relevant to Deaf people with mental/physical health problems

• review and summarise available evidence with a particular focus on Deaf people’s health profiles and unmet needs, inequalities and need for reasonable adjustments

• identify key NHS and social care data gaps and gaps in the evidence base to inform future research priorities.

The observatory would support the design and implementation of health studies with this underserved population, who in legislative terms are a population with ‘protected characteristics’. Better baseline data, whether of health and social care needs, what is provided and what is known to be (cost-)effective, as well as central accumulation of current clinical data, would improve all studies undertaken in this field.

Determinants of recovery, service use and quality-adjusted life-years

Our studies thus far have revealed the scale of variability in service delivery and its effects on access and availability of service, as well as elements of good clinical practice. However, which elements make a difference, in terms of service model, therapeutic practice and/or client characteristics, is unknown. We therefore propose that there is value in a well-controlled prospective observational study from which it will be able to examine the relative influence of a range of participant demographic, socioeconomic and clinical characteristics, as well as service and therapist factors. We can then compare this with current knowledge of determinants of reliable recovery, reliable improvement and reliable deterioration in the general population of IAPT users. The results would enable better targeting of resources to specific elements of IAPT practice with and for the Deaf community.

The study would allow prospective measurement of service use and health status data to help address the data limitations faced in developing and analysing economic models of the cost-effectiveness of health-care interventions for Deaf people. In making this suggestion we are aware of the considerable challenges faced in this current study in accessing, transferring and verifying clinical and service data. However, the strategies and mechanisms established will support a scaled-up study.

Service user involvement

Service users have contributed significantly to the success of the study reported here. In terms of research participation, their consistent reminders of the significance of cultural meaning, not just linguistic accessibility, in decision-making, preference and attitude to elements of future research designs has been invaluable. However, missing from the work thus far has been any extensive exploration with Deaf users of IAPT of their experiences, perspectives, preferences and expectations. Such qualitative work would enhance the proposed study of determinants of recovery as well as the definition of interventions in future work. It would support the co-design of relevant and appropriate recruitment methods and participant materials. The PPI work undertaken alongside the current study has made its own distinct contribution to what counts as effective involvement in health research by Deaf BSL users and how to ensure this. It is an aspect of user-led contribution that could be developed much further because Deaf people’s involvement is often alongside that of other (hearing) stakeholders and this study has shown the benefit of Deaf-led and Deaf-only user involvement too.

Further instrumentation design and testing

Our results provide EQ-5D-5L utility values relevant to a Deaf population, which have previously been unavailable. However, the study sample (n = 92) is too small to draw strong conclusions. A larger prospective cohort study is needed to confirm our initial results and identify which sociodemographic and clinical characteristics (presence of physical and mental health conditions) are key influencers of health status and utility. Such a study should include BSL versions of depression and anxiety measures (CORE-OM BSL, PHQ-9-BSL and GAD-7-BSL) to accurately identify people with these conditions. This would allow an assessment of differences in health status and utility between Deaf people with and without depression/anxiety. Including hearing participants would support comparisons of health status and utility to assess the extent to which the health status and utility of Deaf participants differs to that of hearing participants and establish appropriate norms.

Further work is ongoing to identify a larger range of published utility values for the population with depression, via a systematic review, which will be compared with our sampled Deaf population data in more detail. This will help inform the design of the larger prospective study.

Economic evaluation considerations

Little is known about the long-term impact of IAPT on service users’ health status and use of health and social care services, in the Deaf or hearing populations.

Pathways for care and possible outcomes in depression and anxiety are complex and inter-related. A more complex modelling methodology such as a discrete event simulation may be able to more accurately model pathways for depression and anxiety, as more data become available.

Analysis of linked secondary data sources over longer time horizons (e.g. 12 months and 5 years) could be used to assess the range and intensity of services used. This could also help to fill in the gaps about health and social care services used at the same time as IAPT. Current data sets available include, via NHS Digital (HHSCIC), ONS mortality data; Hospital Episode Statistics; the Mental Health Minimum Data Set, which includes data on specialist secondary mental health service use; and the IAPT data set. Other sources include linked data via the Clinical Practice Research Datalink. This requires that Deaf BSL users can be identified in at least one of the secondary data sets to be linked. Currently not all HSCIC records/minimum data set requirements include language. It is important to note that data linkage and secondary analysis of these data is, however, complex and time-consuming.

Under the NHS Accessible Information Standard, NHS services in England should ask Deaf people if they have information or communication needs and find out how to meet their needs. 51,154 This may include offering an interpreter or advocate. QALYs measure preferences for different levels of health; however, they do not measure preferences for different types of care. Stated preference techniques would allow researchers to quantitatively assess Deaf BSL users’ preferences for different aspects of health care (e.g. the assistance of an interpreter or a specially designed BSL service), and to see how they trade these off against other health (e.g. recovery, health status) and process characteristics (e.g. waiting time, distance to travel).