Niall McCrae

Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial

BACKGROUND Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo. METHODS We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimers disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at Kings College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38. FINDINGS Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI -0·23 to 2·58; p=0·10) or mirtazapine (0·01, -1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, -0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39. INTERPRETATION Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimers disease should be reconsidered. FUNDING UK National Institute of Health Research HTA Programme.

Study of the use of antidepressants for depression in dementia: the HTA-SADD trial--a multicentre, randomised, double-blind, placebo-controlled trial of the clinical effectiveness and cost-effectiveness of sertraline and mirtazapine

OBJECTIVE Depression is common in dementia, causing considerable distress and other negative impacts. Treating it is a clinical priority, but the evidence base is sparse and equivocal. This trial aimed to determine clinical effectiveness of sertraline and mirtazapine in reducing depression 13 weeks post randomisation compared with placebo. DESIGN Multicentre, parallel-group, double-blind placebo-controlled randomised controlled trial of the clinical effectiveness of sertraline and mirtazapine with 13- and 39-week follow-up. SETTING Nine English old-age psychiatry services. PARTICIPANTS A pragmatic trial. Eligibility: probable or possible Alzheimers disease (AD), depression (4+ weeks) and Cornell Scale for Depression in Dementia (CSDD) score of 8+. EXCLUSIONS clinically too critical (e.g. suicide risk); contraindication to medication; taking antidepressants; in another trial; and having no carer. INTERVENTIONS (1) Sertraline; (2) mirtazapine; and (3) placebo, all with normal care. Target doses: 150 mg of sertraline or 45 mg of mirtazapine daily. MAIN OUTCOME MEASURES OUTCOME CSDD score. Randomisation: Allocated 1 : 1 : 1 through Trials Unit, independently of trial team. Stratified block randomisation by centre, with randomly varying block sizes; computer-generated randomisation. Blinding: Double blind: medication and placebo identical for each antidepressant. Referring clinicians, research workers, participants and pharmacies were blind. Statisticians blind until analyses completed. RESULTS Numbers randomised: 326 participants randomised (111 placebo, 107 sertraline and 108 mirtazapine). OUTCOME Differences in CSDD at 13 weeks from an adjusted linear-mixed model: mean difference (95% CI) placebo-sertraline 1.17 (-0.23 to 2.78; p = 0.102); placebo-mirtazapine 0.01 (-1.37 to 1.38; p = 0.991); and mirtazapine-sertraline 1.16 (-0.27 to 2.60; p = 0.112). HARMS Placebo group had fewer adverse reactions (29/111, 26%) than sertraline (46/107, 43%) or mirtazapine (44/108, 41%; p = 0.017); 39-week mortality equal, five deaths in each group. CONCLUSIONS This is a trial with negative findings but important clinical implications. The data suggest that the antidepressants tested, given with normal care, are not clinically effective (compared with placebo) for clinically significant depression in AD. This implies a need to change current practice of antidepressants being the first-line treatment of depression in AD. From the data generated we formulated the following recommendations for future work. (1) The secondary analyses presented here suggest that there would be value in carrying out a placebo-controlled trial of the clinical effectiveness and cost-effectiveness of mirtazapine in the management of Behavioural and Psychological Symptoms of Dementia. (2) A conclusion from this study is that it remains both ethical and essential for trials of new medication for depression in dementia to have a placebo arm. (3) Further research is required to evaluate the impact that treatments for depression in people with dementia can have on their carers not only in terms of any impacts on their quality of life, but also the time they spend care-giving. (4) There is a need for research into alternative biological and psychological therapies for depression in dementia. These could include evaluations of new classes of antidepressants (such as venlafaxine) or antidementia medication (e.g. cholinesterase inhibitors). (5) Research is needed to investigate the natural history of depression in dementia in the community when patients are not referred to secondary care services. (6) Further work is needed to investigate the cost modelling results in this rich data set, investigating carer burden and possible moderators to the treatment effects. (7) There is scope for reanalysis of the primary outcome in terms of carer and participant CSDD results.

Whither Nursing Models? The value of nursing theory in the context of evidence‐based practice and multidisciplinary health care

AIM This paper presents a discussion of the role of nursing models and theory in the modern clinical environment. BACKGROUND Models of nursing have had limited success in bridging the gap between theory and practice. DATA SOURCES Literature on nursing models and theory since the 1950s, from health and social care databases. DISCUSSION Arguments against nursing theory are challenged. In the current context of multidisciplinary services and the doctrine of evidence-based practice, a unique theoretical standpoint comprising the art and science of nursing is more relevant than ever. IMPLICATIONS FOR NURSING A theoretical framework should reflect the eclectic, pragmatic practice of nursing. CONCLUSION Nurse educators and practitioners should embrace theory-based practice as well as evidence-based practice.

'They're all depressed, aren't they?' - A qualitative study of social care workers and depression in older adults

Statutory and voluntary social services provide care and support for vast numbers of vulnerable older adults, yet little is known about how social care practitioners respond to depression in this high risk population. This study elicited the perceptions and conceptualizations of this condition among social care staff, and views on how the response of social care and other agencies might be improved. Qualitative interviews were conducted with 20 social care practitioners working in generic services for older adults in south London. Depression was perceived to be remarkably common among clients, a phenomenon largely attributed to the adverse circumstances of old age, particularly social isolation. A key message from participants was that social causes indicate a need for social interventions. While primary care was criticised for not taking depression seriously in older people, mental health services were generally praised. Expansion of social, recreational and psychological interventions was advocated.

‘A violent thunderstorm’: Cardiazol treatment in British mental hospitals:

In the annals of psychiatric treatment, the advent of Cardiazol therapy has been afforded merely passing mention as a stepping-stone to the development of electroconvulsive therapy. Yet in the 1930s it was the most widely used of the major somatic treatment innovations in Britains public mental hospitals, where its relative simplicity and safety gave it preference over the elaborate and hazardous insulin coma procedure. Devised on a dubious hypothesis of biological antagonism, Cardiazol armed psychiatry with an immediately effective weapon in the battle against schizophrenia, an enduring and debilitating condition responsible for over half of the mental hospital population. What made Cardiazol work – or appear to work? This account shows how evaluation of convulsive therapy was skewed by naÔve outcome measurement and diagnostic discrepancies, and how its therapeutic indication evolved from schizophrenia to affective disorders. Psychological mechanisms are considered, with the suggestion that the intense fear experienced during treatment – the major reason for abandoning Cardiazol in favour of electroshock – was therapeutically advantageous.

Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial

BACKGROUND Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes. AIMS To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia. METHOD A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods. RESULTS There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively. CONCLUSIONS In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.

An extra pair of hands? A case study of the introduction of support workers in community mental health teams for older adults.

BACKGROUND Despite the expanding deployment of support workers in mental health services, little evidence exists on what managers and professional practitioners should expect of such staff in community settings. AIMS This case study evaluated the introduction of support workers in community mental health teams for older adults. METHOD A multiple method design engaged support workers and professional colleagues in individual interviews, a focus group and a work satisfaction survey. RESULTS While the new resource boosted service provision, disparity between the intended role and the assumptions of professional practitioners caused confusion and dissatisfaction. CONCLUSIONS The study highlights the need for managers to ensure role clarity when non-professional workers are introduced into multidisciplinary community teams. IMPLICATIONS FOR NURSING MANAGEMENT Promoting diversity of skills in the mental health workforce is a progressive move in tuning services to the heterogenous needs of clients in the community. However, introducing unqualified workers into multi-disciplinary teams necessitates clear guidance to prevent their activity being confined within existing professional models. Support workers offer much potential in innovative service delivery.

Prospects for mental health social work: A qualitative study of attitudes of service managers and academic staff

Background: Increasing overlap between professional roles in integrated mental health care raises questions about the future of social work as a distinct discipline. Aims: This study explored the prospects for mental health social work in the eyes of key stakeholders. Method: Qualitative interviews were held with senior mental health service managers, and academic staff from institutions providing social work training. Results: A typology of attitudes emerged from service managers, who were categorized as traditionalists, eclecticists and genericists. Traditionalists supported a unified social work discipline, which would remain distinct from the NHS professions. Eclecticists favoured merging of roles, whilst believing that professional diversity should be retained. Genericists saw little difference between the various disciplines, and were enthusiastic towards a generic mental health practitioner. There was widespread recognition of the challenges facing social work, particularly its lack of academic status and evidence to support its interventions. Conclusions: Mental health social work has an uncertain future. To gain influence on mental health policy and its own professional future, social work must boost its credibility by developing a stronger evidence base and asserting the value of its contribution. Declaration of interest: None.

Is it really theoretical? A review of sampling in grounded theory studies in nursing journals

BACKGROUND Grounded theory is a distinct method of qualitative research, where core features are theoretical sampling and constant comparative analysis. However, inconsistent application of these activities has been observed in published studies. AIM This review assessed the use of theoretical sampling in grounded theory studies in nursing journals. DESIGN An adapted systematic review was conducted. METHOD Three leading nursing journals (2010-2014) were searched for studies stating grounded theory as the method. Sampling was assessed using a concise rating tool. RESULTS A high proportion (86%) of the 134 articles described an iterative process of data collection and analysis. However, half of the studies did not demonstrate theoretical sampling, with many studies declaring or indicating a purposive sampling approach throughout. CONCLUSION Specific reporting guidelines for grounded theory studies should be developed to ensure that study reports describe an iterative process of fieldwork and theoretical development.

Merely a stepping stone?: Professional identity and career prospects following postgraduate mental health nurse training

ACCESSIBLE SUMMARY Accelerated mental health nurse training attracts talented graduates, many with a psychology degree. Our study shows that such trainees feel incompatible with the nursing culture. Consequently, professional identification is inhibited, and on qualifying these nurses may choose to develop their careers elsewhere. Nurse educators and mentors should pay greater attention to nurturing a positive professional identity in trainees. Alongside their attainment of knowledge and skills, nursing trainees are moulded by a professional culture and inculcated to norms of beliefs and behaviour. The process of professional identification may be inhibited by accelerated nurse training and an influx of psychology graduates potentially using mental health nursing qualification as a springboard to other career opportunities. This study explored facilitators and barriers to professional identification in newly qualified nurses of accelerated postgraduate training. Qualitative interviews were conducted with 10 nurses who had recently completed a postgraduate diploma in mental health nursing at Kings College London. Participants identified more with the mental health field than with the broader profession of nursing. They defined their practice in terms of values rather than skills and found difficulty in articulating a distinct role for mental health nursing. Although participants had found experience in training and as a registered practitioner rewarding, they were concerned that nursing may not fulfil their aspirations. Professional identity is likely to be a major factor in satisfaction and retention of nurses. Training and continuing professional development should promote career advancement within clinical nursing practice.