Relationship-centred dementia care Professor Bob Woods Dementia Services Development Centre Wales Bangor

Welcome back! 2011 – What can we learn from people with dementia? 2011 – What can we learn from people with dementia? 2012 – Dementia supportive communities 2012 – Dementia supportive communities 2013 – Making a difference through research 2013 – Making a difference through research 2014 – Relationship-centred care 2014 – Relationship-centred care

Aims of the DSDC To bring ‘care’ and ‘science’ together To bring ‘care’ and ‘science’ together To encourage evidence-based practice that is driven by values To encourage evidence-based practice that is driven by values To raise the quality of care for people living with dementia and raise their quality of life and that of those who support them To raise the quality of care for people living with dementia and raise their quality of life and that of those who support them

A quick recap: What is dementia? An acquired impairment An acquired impairment Global cognitive functions (memory plus) Global cognitive functions (memory plus) Self-care and day-to-day function Self-care and day-to-day function Clear consciousness Clear consciousness Usually progressive Usually progressive Behavioural and psychological symptoms may include wandering, aggression, apathy, hallucinations, loss of inhibitions, repetition etc. Behavioural and psychological symptoms may include wandering, aggression, apathy, hallucinations, loss of inhibitions, repetition etc.

Types of dementia Alzheimer’s disease - 40% Alzheimer’s disease - 40% Vascular (multi-infarct) - 20% Vascular (multi-infarct) - 20% Lewy Body dementia - 15% Lewy Body dementia - 15% Mixed Alzheimer’s & Vascular - 15% Mixed Alzheimer’s & Vascular - 15% Other (including alcohol-related, CJD, Pick’s etc) - 10% Other (including alcohol-related, CJD, Pick’s etc) - 10% Each type associated with distinct brain changes, evident at post-mortem Each type associated with distinct brain changes, evident at post-mortem

Some good news! (Lancet, July 2013) Compares prevalence in the 1990’s with 2010’s Compares prevalence in the 1990’s with 2010’s Shows reduced prevalence in the most ‘at risk’ age groups Shows reduced prevalence in the most ‘at risk’ age groups Lifestyle changes? Lifestyle changes? Remains major challenge for health and social care Remains major challenge for health and social care

An older older population

Why are relationships important in dementia care - 1 Care and support from family and friends crucial for people living with dementia Care and support from family and friends crucial for people living with dementia Varies at different points in the journey Varies at different points in the journey Different for different people, different relationships Different for different people, different relationships Family care-givers at increased risk of stress, depression, anxiety Family care-givers at increased risk of stress, depression, anxiety Spouse carers who experience care-giving as stressful have increased mortality Spouse carers who experience care-giving as stressful have increased mortality

Why are relationships important in dementia care - 2 For paid staff providing support and personal care key qualities include humanity, warmth, empathy For paid staff providing support and personal care key qualities include humanity, warmth, empathy Paid staff need to be able to ‘relate’ to the people for whom they provide support Paid staff need to be able to ‘relate’ to the people for whom they provide support

Q: How does relationship-centred care differ from person-centred care? Q: How does relationship-centred care differ from person-centred care? A: It fits well with Kitwood’s conception of person-centred care, and is a natural development of it A: It fits well with Kitwood’s conception of person-centred care, and is a natural development of it

Kitwood’s person-centred theory Person with dementia Person with dementia v. v. Person with dementia

Person-centred care: 4 main elements (Brooker, 2004)  Valuing people with dementia and those who care for them (V)  Treating people as individuals (I)  Looking at the world from the perspective of the person with dementia (P)  A positive social environment in which the person living with dementia can experience relative well-being (S)  PCC = V + I + P + S

Personhood in relationship Not about the person’s capabilities Not about the person’s capabilities Not about our ability to ‘overlook’ impairments Not about our ability to ‘overlook’ impairments “Personhood is a standing or status that is bestowed upon one human being, by others, in the context of relationship and social being.” (Kitwood, 1997) “Personhood is a standing or status that is bestowed upon one human being, by others, in the context of relationship and social being.” (Kitwood, 1997) “I-it” vs. “I-thou” relating (cf. Martin Buber) “I-it” vs. “I-thou” relating (cf. Martin Buber) Personhood product of the care-giving relationship Personhood product of the care-giving relationship

“Dr A’s rewards and compensations, even the most unexpected ones, are concerned with being alive; finding out not only how much there is in being alive, but what surprising new things there turn out to be; freedoms, and pleasures in constraint, which we would never have imagined or thought of, never even have considered possible.”

Personhood in dementia “In dementia many aspects of the psyche that had, for a long time, been individual and ‘internal’, are again made over to the interpersonal milieu. Memory may have faded, but something of the past is known; identity remains intact, because others hold it in place; thoughts may have disappeared, but there are still interpersonal processes; feelings are expressed and meet a validating response; and if there is a spirituality, it will most likely be of the kind that Buber describes, where the divine is encountered in the depth of I- thou relating.” (Kitwood, 1997 pp. 69) “In dementia many aspects of the psyche that had, for a long time, been individual and ‘internal’, are again made over to the interpersonal milieu. Memory may have faded, but something of the past is known; identity remains intact, because others hold it in place; thoughts may have disappeared, but there are still interpersonal processes; feelings are expressed and meet a validating response; and if there is a spirituality, it will most likely be of the kind that Buber describes, where the divine is encountered in the depth of I- thou relating.” (Kitwood, 1997 pp. 69)

Relationship-centred care: the dementia care triangle The person with dementia Family care-giver Paid care-giver

Quality of life and quality of relationship Long-established findings that quality of relationship, as rated by care-giver, predicts carer’s level of strain / depression (e.g. Morris et al., 1988; Williamson & Schulz, 1990) Long-established findings that quality of relationship, as rated by care-giver, predicts carer’s level of strain / depression (e.g. Morris et al., 1988; Williamson & Schulz, 1990) Most often based on caregiver report or on caregiver perspective (e.g. expressed emotion evaluated from critical comments during interview about the person with dementia) Most often based on caregiver report or on caregiver perspective (e.g. expressed emotion evaluated from critical comments during interview about the person with dementia) Could person with dementia also rate the relationship? Could person with dementia also rate the relationship? Can some aspects of relationship be observed? Can some aspects of relationship be observed?

Can people with dementia rate the quality of the relationship? 77 people with dementia and care-givers participated 77 people with dementia and care-givers participated Person with dementia average age 77.5; 57% female Person with dementia average age 77.5; 57% female Care-giver average age 68.9; 62% female Care-giver average age 68.9; 62% female 78% spouses; 90% co-resident 78% spouses; 90% co-resident Mean duration of memory problems 3.1 years (range 1-10) Mean duration of memory problems 3.1 years (range 1-10) 60% of carers inputting more than 50 hours per week 60% of carers inputting more than 50 hours per week 16% carers report significant symptoms of depression (GDS-15) 16% carers report significant symptoms of depression (GDS-15) Interactions video-taped – puzzle and meal planning minutes Interactions video-taped – puzzle and meal planning minutes

Can people with dementia rate the quality of the relationship? - 2 Several brief relationship questionnaires were tested Several brief relationship questionnaires were tested People with dementia were able to complete these consistently and reliably People with dementia were able to complete these consistently and reliably Positive Affect (PA) Index (Bengston, 1973) Positive Affect (PA) Index (Bengston, 1973) 5 items 5 items 6 point scale (visually presented) 6 point scale (visually presented) Communication quality, closeness, similarity of views on life, engaging in joint activities, overall relationship quality Communication quality, closeness, similarity of views on life, engaging in joint activities, overall relationship quality Quality of the Care-giving Relationship - QCPR (Spruytte 2002) Quality of the Care-giving Relationship - QCPR (Spruytte 2002) 14 items 14 items 5 point scale (visually presented) 5 point scale (visually presented) Two sub-scales: warmth and absence of criticism Two sub-scales: warmth and absence of criticism

Did people with dementia and carers agree in their ratings? Good agreement on warmth and positive affect Good agreement on warmth and positive affect Less agreement on criticism Less agreement on criticism Carers rate the relationship less positively Carers rate the relationship less positively

Different perspectives? What predicts difference in scores between person with dementia and carer: What predicts difference in scores between person with dementia and carer: Positive Affect Index: Relative’s Stress Scale only predictor (8% of variance) Positive Affect Index: Relative’s Stress Scale only predictor (8% of variance) QCPR: Relative’s Stress Scale only predictor (32% of variance) QCPR: Relative’s Stress Scale only predictor (32% of variance) Severity of memory impairment not related to differences! Severity of memory impairment not related to differences!

Association between relationship ratings and ratings on video-interaction tasks Person with dementia ratings predict video-interaction ratings just as well as carer ratings Person with dementia ratings predict video-interaction ratings just as well as carer ratings

Quality of life of the person with dementia (QoL-AD rated by person with dementia) QoL-AD relates to Positive Affect Scale and QCPR (warmth) as rated by person with dementia QoL-AD relates to Positive Affect Scale and QCPR (warmth) as rated by person with dementia QoL-AD does not relate to ratings of QCPR (criticism) by person with dementia QoL-AD does not relate to ratings of QCPR (criticism) by person with dementia

Quality of life of the person with dementia (QoL-AD rated by person with dementia) QCPR (warmth) rated by person with dementia is the best predictor of QoL-AD QCPR (warmth) rated by person with dementia is the best predictor of QoL-AD (accounts for 14% of variance, p=0.002) (accounts for 14% of variance, p=0.002) Age, gender, MMSE, dementia severity (CDR), depression (Cornell), anxiety (RAID), Relative’s Stress Scale and carer depression (GDS) do not significantly add to the prediction Age, gender, MMSE, dementia severity (CDR), depression (Cornell), anxiety (RAID), Relative’s Stress Scale and carer depression (GDS) do not significantly add to the prediction Previous studies (e.g. Thorgrimsen et al., 2003) suggest depression is main identifiable factor in predicting QoL-AD Previous studies (e.g. Thorgrimsen et al., 2003) suggest depression is main identifiable factor in predicting QoL-AD

Family carers’ stress and quality of relationship (Relative’s Stress Scale) Higher stress associated with lower quality of relationship: Higher stress associated with lower quality of relationship: Person with dementia Positive affect index Person with dementia Positive affect index Carer’s Positive affect index Carer’s Positive affect index Person with dementia QCPR warmth Person with dementia QCPR warmth Carer QCPR warmth subscale Carer QCPR warmth subscale Carer QCPR absence of criticism scale Carer QCPR absence of criticism scale Cause or effect? Cause or effect?

Relationships Care-giving occurs in the context of (often) a long-standing relationship Care-giving occurs in the context of (often) a long-standing relationship Many people with dementia are able to reliably and accurately rate the quality of the current relationship Many people with dementia are able to reliably and accurately rate the quality of the current relationship The quality of the relationship may be observed through observation of structured tasks The quality of the relationship may be observed through observation of structured tasks The quality of life of the person with dementia and the stress experienced by the carer are associated with the quality of the current relationship The quality of life of the person with dementia and the stress experienced by the carer are associated with the quality of the current relationship The differences in perception may be attributable in part to carer stress The differences in perception may be attributable in part to carer stress

How does ‘awareness’ influence the person’s ratings of quality of life?

Awareness and quality of life MIDAS study – 100 people with early-stage dementia living in North Wales MIDAS study – 100 people with early-stage dementia living in North Wales Interviewed three times over two years Interviewed three times over two years QoL-AD predicted by male gender, low depression, quality of relationship, strong sense of self and low irritability. QoL-AD predicted by male gender, low depression, quality of relationship, strong sense of self and low irritability. Discrepancy of person’s and carer’s ratings of functional level made a small difference to ratings Discrepancy of person’s and carer’s ratings of functional level made a small difference to ratings Not related to cognitive impairment Not related to cognitive impairment

She does it just to annoy me – she could remember if she wanted to! I tell him ‘your mother has been dead for 20 years’, but he won’t listen – he always was stubborn, always had to be right…. I get him all ready to go to the day-care centre, looking clean and smart – I turn my back for 5 minutes, and he has taken his trousers off. I despair sometimes. Negative attributions and criticism from family care-givers are associated with raised stress levels in care-givers and reduced quality of life

Cognitive-behavioural family intervention (reduce criticism) (Marriott et al, 2000)

Family counselling and peer support – the New York spouse study Mittelman et al 1995; 2004 etc.: family counselling and peer support; 406 spouse care- givers randomised controlled trial Mittelman et al 1995; 2004 etc.: family counselling and peer support; 406 spouse care- givers randomised controlled trial Initial 6 sessions of individual and family counselling followed by availability of counsellor by telephone for duration of study Initial 6 sessions of individual and family counselling followed by availability of counsellor by telephone for duration of study All participants commit to attending peer support groups All participants commit to attending peer support groups Carers in control group could also access counsellors Carers in control group could also access counsellors

Family counselling and peer support – the New York spouse study - 2 (Mittelman et al., 2006) Reduced depression in carers, reduced rates of institutionalisation Reduced depression in carers, reduced rates of institutionalisation Long-term effects – depression rates lower 3 years later Long-term effects – depression rates lower 3 years later Long-term follow-up (up to 17 years); difference in median time to placement between intervention & control groups is 557 days (Mittelman et al., 2006) Long-term follow-up (up to 17 years); difference in median time to placement between intervention & control groups is 557 days (Mittelman et al., 2006) Higher levels of satisfaction with social support network over 5 year period (Drentea et al., 2006) Higher levels of satisfaction with social support network over 5 year period (Drentea et al., 2006) Changes in attributions about difficult behaviour (Mittelman et al., 2004) Changes in attributions about difficult behaviour (Mittelman et al., 2004)

Family counselling and peer support – the New York study - 3 Increased time to placement accounted for by: Increased time to placement accounted for by: Increased satisfaction with social support Increased satisfaction with social support Reduced difficulty with behaviour problems Reduced difficulty with behaviour problems Reduced depression Reduced depression The benefits of the intervention persist in the period when the person with dementia is admitted to a nursing home; burden and depression less for carers in the intervention group following the admission, compared with carers in the control group (Gaugler et al 2007) The benefits of the intervention persist in the period when the person with dementia is admitted to a nursing home; burden and depression less for carers in the intervention group following the admission, compared with carers in the control group (Gaugler et al 2007)

Relationship-centred care: the dementia care triangle The person with dementia Family care-giver Paid care-giver

The evidence-base Literature review Literature review Study in North Wales (led by Diane Seddon) – 78 family members interviewed soon after relative admitted to a home – 29 interviewed again 10 months later Study in North Wales (led by Diane Seddon) – 78 family members interviewed soon after relative admitted to a home – 29 interviewed again 10 months later European study (Woods, Keady et al.) – 60 staff and 100 carers – focus groups, interviews, questionnaires etc. European study (Woods, Keady et al.) – 60 staff and 100 carers – focus groups, interviews, questionnaires etc.

Partners in care? Staff: Relatives are more trouble than the residents? Staff: Relatives are more trouble than the residents? Relatives: The staff are always changing and they don’t have time to talk – they never tell us what is happening. Relatives: The staff are always changing and they don’t have time to talk – they never tell us what is happening.

Stress for care-givers may continue ‘The careers of caregivers do not stop at the institution’s door, but continue in an altered and still stressful way. Caregivers do not give up their role: they shift their responsibilities.’ Zarit & Whitlatch (1993, p.35) ‘The careers of caregivers do not stop at the institution’s door, but continue in an altered and still stressful way. Caregivers do not give up their role: they shift their responsibilities.’ Zarit & Whitlatch (1993, p.35)

The extent of distress in relatives A third of relatives visiting ‘frail older person’ living in a care home report significant psychological distress (especially spouses) (Buck et al., 1997) A third of relatives visiting ‘frail older person’ living in a care home report significant psychological distress (especially spouses) (Buck et al., 1997) Survey of members of Relatives’ Association (1996) (153 respondents) Survey of members of Relatives’ Association (1996) (153 respondents) 52% anxiety level above normal range 52% anxiety level above normal range 41% depression levels above normal range 41% depression levels above normal range 81% sometimes feel have let the person down 81% sometimes feel have let the person down 73% sometimes feel trapped by the responsibility 73% sometimes feel trapped by the responsibility 67% feel guilty about placing the person in a care home 67% feel guilty about placing the person in a care home

Guilt feelings ‘I felt guilty at first, very guilty, leaving her there…It’s got worse as time’s gone by and it’s like I’m stuck in this downward spiral of guilt and self-blame’ ‘I felt guilty at first, very guilty, leaving her there…It’s got worse as time’s gone by and it’s like I’m stuck in this downward spiral of guilt and self-blame’ ‘I feel guiltier now than I did the day she went there…I’ve more time to think about it..’ ‘I feel guiltier now than I did the day she went there…I’ve more time to think about it..’ (10 months after admission; Woods, Keady & Seddon, 2007, p. 36) (10 months after admission; Woods, Keady & Seddon, 2007, p. 36)

Does the home contribute to relatives’ distress? For families ‘degree of strain could be predicted from….their interaction with the nursing home’ (Almberg et al., 2000) For families ‘degree of strain could be predicted from….their interaction with the nursing home’ (Almberg et al., 2000) Not the only factor (Whitlatch et al, 2001), but a significant one – the changing relationship with person with dementia also important Not the only factor (Whitlatch et al, 2001), but a significant one – the changing relationship with person with dementia also important Circumstances of the admission also important – crisis admissions more difficult to adjust to Circumstances of the admission also important – crisis admissions more difficult to adjust to

Relatives’ views of the home 83% generally happy with the way person is cared for (Relatives’ Association survey) 83% generally happy with the way person is cared for (Relatives’ Association survey) BUT BUT 69% feel there are insufficient activities 69% feel there are insufficient activities 26% would like to participate more in daily care 26% would like to participate more in daily care 29% feel staff don’t pay enough attention to opinions of family 29% feel staff don’t pay enough attention to opinions of family 38% feel more contact is needed with staff 38% feel more contact is needed with staff USA study - >25% family members want more involvement; 4.3% want less (Port et al., 2005) USA study - >25% family members want more involvement; 4.3% want less (Port et al., 2005)

Relationships between relatives and staff Positive relationships – mutual respect, regular communication and consultation, concern for the relative as an individual Positive relationships – mutual respect, regular communication and consultation, concern for the relative as an individual ‘Very amicable. We all get on well. It’s like going to see friends. They always want to know how I am getting on’ ‘Very amicable. We all get on well. It’s like going to see friends. They always want to know how I am getting on’ Problematic relationships – ambiguity over roles and responsibilities, poor channels of communication Problematic relationships – ambiguity over roles and responsibilities, poor channels of communication ‘When my husband first went in, I was told that I was interfering too much. We still have angry words about this.’ ‘When my husband first went in, I was told that I was interfering too much. We still have angry words about this.’ ‘They do things and I’m left reeling, thinking how nice it would’ve been if they’d asked me.’ ‘They do things and I’m left reeling, thinking how nice it would’ve been if they’d asked me.’ (Woods, Keady & Seddon, 2007, p. 39) (Woods, Keady & Seddon, 2007, p. 39)

Benefits of family involvement Relatives who help with areas such as going out and taking part in activities report retaining a closer, more intimate relationship with the person with dementia (Gaugler et al., 2004) Relatives who help with areas such as going out and taking part in activities report retaining a closer, more intimate relationship with the person with dementia (Gaugler et al., 2004) Large study in USA reported by Zimmerman et al., 2005 (Gerontologist) Large study in USA reported by Zimmerman et al., 2005 (Gerontologist) 421 residents in 45 residential care / assisted living facilities & nursing homes 421 residents in 45 residential care / assisted living facilities & nursing homes Family involvement related to Quality of Life and/or well-being of the person with dementia Family involvement related to Quality of Life and/or well-being of the person with dementia

Staff perspectives Positive perceptions: Positive perceptions: A resource for staff as well as for person with dementia A resource for staff as well as for person with dementia Can show welcome appreciation Can show welcome appreciation Important source of information, so care can be personalised Important source of information, so care can be personalised Negative perceptions Negative perceptions Disrupt routines, an added burden Disrupt routines, an added burden Over-critical, always complaining, a source of burn- out Over-critical, always complaining, a source of burn- out Some don’t visit enough Some don’t visit enough If not well, take it out on staff If not well, take it out on staff

Relationship-centred care Maintaining and supporting relationships between person with dementia and family members Maintaining and supporting relationships between person with dementia and family members Do relatives feel welcome? Do relatives feel welcome? Do they feel able to continue to include the person with dementia in family activities? Do they feel able to continue to include the person with dementia in family activities? Do they feel their visits have a meaning and a purpose? Do they feel their visits have a meaning and a purpose? Can they find support when distressed? Can they find support when distressed?

Key areas of family involvement Monitoring the care provided Monitoring the care provided Advocacy and decision making for the person with dementia Advocacy and decision making for the person with dementia Providing care, outside the home or within it, contributing to personalised care Providing care, outside the home or within it, contributing to personalised care

Intervention and training programmes Need to involve staff and families Need to involve staff and families USA – Partners in Caregiving program (Pillemer et al., 1998) – improved communication USA – Partners in Caregiving program (Pillemer et al., 1998) – improved communication Sweden / UK – Partners in Care (Jessica Kingsley, 2008 DVD + Booklet) – 4 sessions Sweden / UK – Partners in Care (Jessica Kingsley, 2008 DVD + Booklet) – 4 sessions Sharing information Sharing information Sharing the care Sharing the care Developing supportive relationships Developing supportive relationships Making it work Making it work Lundh et al. (2003) – improved communication, greater sense of partnership and community, greater clarity about roles and joint working Lundh et al. (2003) – improved communication, greater sense of partnership and community, greater clarity about roles and joint working

Not like this… ‘I would say something about how he used to like something at home, and they would contradict me. It was as if the five years of my looking after him didn’t really count…but it was as if ‘Oh, we’re the professionals, we know what we’re doing’. ‘I would say something about how he used to like something at home, and they would contradict me. It was as if the five years of my looking after him didn’t really count…but it was as if ‘Oh, we’re the professionals, we know what we’re doing’.

It’s not impossible… ‘The owner of the home my mum was in was super. If he ever saw you looking slightly upset, straight away he was always there, arm round your shoulder, and ‘come and have a cup of tea with me and a chat’…very, very good like that. And of course you get very friendly with some of the regular staff…they were very supportive.’ ‘The owner of the home my mum was in was super. If he ever saw you looking slightly upset, straight away he was always there, arm round your shoulder, and ‘come and have a cup of tea with me and a chat’…very, very good like that. And of course you get very friendly with some of the regular staff…they were very supportive.’

Improving relationship quality – intervention studies (1) REMCARE study (Woods et al., 2012) – joint reminiscence groups for people with dementia and family carers REMCARE study (Woods et al., 2012) – joint reminiscence groups for people with dementia and family carers 488 dyads took part 488 dyads took part 12 weekly group sessions and monthly sessions for 7 months 12 weekly group sessions and monthly sessions for 7 months People with dementia who attended more sessions at 10 months reported improved quality of life and improved quality of relationship (warmth) – carers reported more stress People with dementia who attended more sessions at 10 months reported improved quality of life and improved quality of relationship (warmth) – carers reported more stress

Improving relationship quality – intervention studies (2) Individual cognitive stimulation Individual cognitive stimulation Family care-givers trained to provide sessions two or three times a week for 6 months Family care-givers trained to provide sessions two or three times a week for 6 months Provided with manual, workbooks and telephone support Provided with manual, workbooks and telephone support 365 dyads took part 365 dyads took part Relationship rated by person with dementia improved? Relationship rated by person with dementia improved?

iCST manual iCST manual Published November 2014 Published November 2014 iCST trial – Orrell et al. iCST trial – Orrell et al. Funded by NIHR HTA Funded by NIHR HTA

Improving relationship quality – intervention studies (3) Life story books for people with dementia living in care homes (Subramaniam & Woods, 2014) Life story books for people with dementia living in care homes (Subramaniam & Woods, 2014) Quality of relationship rated by family member improved after person had Life Story Book for 6 weeks Quality of relationship rated by family member improved after person had Life Story Book for 6 weeks Made visiting easier, more to talk about, triggered other memories… Made visiting easier, more to talk about, triggered other memories…

Relatives’ comments after Life Story Book Quality Time - Helped me to spend good ½ hour with____. Very productive and not like before. -At least for ½ hour my brother is happy Positive feelings and Pleasure - I’m glad that I helped ____ to leave her legacy -Pleasure in seeing photos of mum’s life; obviously it covers some of my life too.

Thank Thanks to colleagues and collaborators: Thanks to colleagues and collaborators: The DSDC Wales team The DSDC Wales team The NISCHR team The NISCHR team Joan Woods, Training Officer, DSDC Joan Woods, Training Officer, DSDC Professor Linda Clare – Bangor University Professor Linda Clare – Bangor University Professor Martin Orrell – UCL Professor Martin Orrell – UCL NIHR HTA programme 'The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.' NIHR HTA programme 'The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.'