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1.  MODEM: A comprehensive approach to modelling outcome and costs impacts of interventions for dementia. Protocol paper 
The MODEM project (A comprehensive approach to MODelling outcome and costs impacts of interventions for DEMentia) explores how changes in arrangements for the future treatment and care of people living with dementia, and support for family and other unpaid carers, could result in better outcomes and more efficient use of resources.
MODEM starts with a systematic mapping of the literature on effective and (potentially) cost-effective interventions in dementia care. Those findings, as well as data from a cohort, will then be used to model the quality of life and cost impacts of making these evidence-based interventions more widely available in England over the period from now to 2040. Modelling will use a suite of models, combining microsimulation and macrosimulation methods, modelling the costs and outcomes of care, both for an individual over the life-course from the point of dementia diagnosis, and for individuals and England as a whole in a particular year.
Project outputs will include an online Dementia Evidence Toolkit, making evidence summaries and a literature database available free to anyone, papers in academic journals and other written outputs, and a MODEM Legacy Model, which will enable local commissioners of services to apply the model to their own populations.
Modelling the effects of evidence-based cost-effective interventions and making this information widely available has the potential to improve the health and quality of life both of people with dementia and their carers, while ensuring that resources are used efficiently.
PMCID: PMC5225619  PMID: 28077155
Dementia; Costs; Outcomes; Treatments; Social care; Carers; Microsimulation model; Economics; Cost-effectiveness
2.  Predictors of care home and hospital admissions and their costs for older people with Alzheimer's disease: findings from a large London case register 
BMJ Open  2016;6(11):e013591.
To examine links between clinical and other characteristics of people with Alzheimer's disease living in the community, likelihood of care home or hospital admission, and associated costs.
Observational data extracted from clinical records using natural language processing and Hospital Episode Statistics. Statistical analyses examined effects of cognition, physical health, mental health, sociodemographic factors and living circumstances on risk of admission to care home or hospital over 6 months and associated costs, adjusting for repeated observations.
Catchment area for South London and Maudsley National Health Service Foundation Trust, provider for 1.2 million people in Southeast London.
Every individual with diagnosis of Alzheimer's disease seen and treated by mental health services in the catchment area, with at least one rating of cognition, not resident in care home at time of assessment (n=3075).
Usual treatment.
Main outcome measures
Risk of admission to, and days spent in three settings during 6-month period following routine clinical assessment: care home, mental health inpatient care and general hospital inpatient care.
Predictors of probability of care home or hospital admission and/or associated costs over 6 months include cognition, functional problems, agitation, depression, physical illness, previous hospitalisations, age, gender, ethnicity, living alone and having a partner. Patterns of association differed considerably by destination.
Most people with dementia prefer to remain in their own homes, and funding bodies see this as cheaper than institutionalisation. Better treatment in the community that reduces health and social care needs of Alzheimer's patients would reduce admission rates. Living alone, poor living circumstances and functional problems all raise admission rates, and so major cuts in social care budgets increase the risk of high-cost admissions which older people do not want. Routinely collected data can be used to reveal local patterns of admission and costs.
PMCID: PMC5128896  PMID: 27864252
alzheimer's disease; nursing home; hospital; costs
3.  Peer support and reminiscence therapy for people with dementia and their family carers: a factorial pragmatic randomised trial 
The objective of this study was to evaluate peer support and reminiscence therapy, separately and together, in comparison with usual care for people with dementia and their family carers.
Factorial pragmatic randomised trial, analysed by treatment allocated, was used for this study.
The trial ran in Community settings in England.
People with dementia and their family carers were the participants.
Treatment as usual (TAU) plus one of the following: one-to-one peer support to family carers from experienced carers (Carer Supporter Programme; CSP), group reminiscence therapy (Remembering Yesterday, Caring Today; RYCT) for people with dementia and carers, both or neither.
Main outcome measures
Primary outcomes included health-related quality of life (SF-12) for carers and quality of life (QoL-AD) for people with dementia; secondary outcomes included quality of relationship for carers and people with dementia; both were collected by blinded assessors at baseline, 5 and 12 months (primary end point).
Of 291 pairs recruited, we randomised 145 (50%) to CSP (71% uptake) and 194 (67%) to RYCT (61% uptake). CSP and RYCT, separately or together, were not effective in improving primary outcomes or most secondary outcomes. For CSP versus ‘no CSP’, adjusted difference in means was 0.52 points on the SF-12 (95% CI −1.28 to 2.32) and −0.08 points on the QoL-AD (95% CI −1.70 to 1.56). For RYCT versus ‘no RYCT’, the difference was 0.10 points on the SF-12 (95% CI −1.72 to 1.93) and 0.51 points on the QoL-AD (95% CI −1.17 to 2.08). However, carers reported better relationships with the people with dementia (difference 1.11, 95% CI 0.00 to 2.21, p=0.05). Comparison of combined intervention with TAU, and of intervention received, suggested differential impacts for carers and persons with dementia.
There is no evidence from the trial that either peer support or reminiscence is effective in improving the quality of life.
Trial registration number
ISRCTN37956201; Results.
PMCID: PMC5099314  PMID: 27521377
4.  A randomised controlled trial of calcium channel blockade (CCB) with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT): study protocol 
Trials  2016;17:324.
Vascular dementia is the second most common cause of dementia affecting over seven million people worldwide, yet there are no licensed treatments. There is an urgent need for a clinical trial in this patient group. Subcortical ischaemic vascular dementia is the most common variant of vascular dementia. This randomised trial will investigate whether use of calcium channel blockade with amlodipine, a commonly used agent, can provide the first evidence-based pharmacological treatment for subcortical ischaemic vascular dementia.
This is a randomised controlled trial of calcium channel blockade with Amlodipine For the treatment oF subcortical ischaEmic vasCular demenTia (AFFECT) to test the hypothesis that treatment with amlodipine can improve outcomes for these patients in a phase IIb, multi-centre, double-blind, placebo-controlled randomised trial.
The primary outcome is the change from baseline to 12 months in the Vascular Dementia Assessment Scale cognitive subscale (VADAS-cog). Secondary outcomes include cognitive function, executive function, clinical global impression of change, change in blood pressure, quantitative evaluation of lesion accrual based on magnetic resonance imaging (MRI), health-related quality of life, activities of daily living, non-cognitive dementia symptoms, care-giver burden and care-giver health-related quality of life, cost-effectiveness and institutionalisation.
A total of 588 patients will be randomised in a 1:1 ratio to either amlodipine or placebo, recruited from sites across the UK and enrolled in the trial for 104 weeks.
There are no treatments licensed for vascular dementia. The most common subtype is subcortical ischaemic vascular dementia (SIVD). This study is designed to investigate whether amlodipine can produce benefits compared to placebo in established SIVD. It is estimated that the numbers of people with VaD and SIVD will increase globally in the future and the results of this study should inform important treatment decisions.
Trial registration
Current Controlled Trials ISRCTN31208535. Registered on 7 March 2014.
PMCID: PMC4950108  PMID: 27430267
Vascular dementia; Subcortical ischaemic vascular dementia; Amlodipine; Calcium channel blockade; Cognitive outcome
5.  The ‘visibility’ of unpaid care in England 
Social work practice is increasingly concerned with support not just for service users but also for unpaid carers. A key aspect of practice is the assessment of carers’ needs. The Government has recently passed legislation that will widen eligibility for carers’ assessments and remove the requirement that carers must be providing a substantial amount of care on a regular basis. This article examines which carers are currently ‘visible’ or known to councils and which are not, and uses the results to examine the likely effects of the new legislation. In order to identify the characteristics of carers known to councils, the article uses large-scale surveys, comparing the 2009/10 Personal Social Services Survey of Adult Carers in England and the 2009/10 Survey of Carers in Households in England.
Carers who are known to councils provide extremely long hours of care. Among carers providing substantial care who are known to councils, the majority care for 100 or more hours a week. The focus of councils on carers providing long hours of care is associated with a number of other carer characteristics, such as poor health.
Councils' emphasis on the most intense carers is unlikely to be attributable solely to the current legislation. Therefore, dropping the substantial and regular clauses alone will not necessarily broaden access to carers' assessments and, in order to achieve this, considerable new resources may be needed. How far these resources are available will determine the extent to which practitioners can broaden access to carers' assessments.
PMCID: PMC4847125  PMID: 27182201
Social work; adult care; assessment; carers; England; large-scale survey data; social care
6.  Comparative Performance of Adult Social Care Research, 1996–2011: A Bibliometric Assessment 
British Journal of Social Work  2015;46(5):1282-1300.
Decision makers in adult social care are increasingly interested in using evidence from research to support or shape their decisions. The scope and nature of the current landscape of adult social care research (ASCR) need to be better understood. This paper provides a bibliometric assessment of ASCR outputs from 1996 to 2011. ASCR papers were retrieved using three strategies: from key journals; using keywords and noun phrases; and from additional papers preferentially citing or being cited by other ASCR papers. Overall, 195,829 ASCR papers were identified in the bibliographic database Scopus, of which 16 per cent involved at least one author from the UK. The UK output increased 2.45-fold between 1996 and 2011. Among selected countries, those with greater research intensity in ASCR generally had higher citation impact, such as the USA, UK, Canada and the Netherlands. The top five UK institutions in terms of volume of papers in the UK accounted for 26 per cent of total output. We conclude by noting the limitations to bibliometric analysis of ASCR and examine how such analysis can support the strategic development of the field.
PMCID: PMC4985733  PMID: 27559228
Adult social care; bibliometrics; research policy; comparative analysis
7.  Perinatal depression and child development: exploring the economic consequences from a South London cohort 
Psychological medicine  2014;45(1):51-61.
Depression in mothers during pregnancy and in the postnatal period has been recognised to have wide-ranging adverse impacts on offspring. Our study examines some of the outcomes and long-term economic implications experienced by offspring who have been exposed to perinatal depression.
We analysed the effects of perinatal depression on child development outcomes of children at ages 11 and 16 years from a community-based South London Child Development Study. Economic consequences were attached to those outcomes through simple decision-analytic techniques, building on evidence from studies of epidemiology, health-related quality of life, public sector costs and employment. The economic analysis takes a life-course perspective from the viewpoints of public sector, individual and society.
Additional risks that children exposed to perinatal depression develop emotional, behavioural or cognitive problems ranged from 5% to 21%. In addition, there was a high risk (24%) that children would have special educational needs. We present results in the form of cost consequences attached to adverse child outcomes. For each child exposed to perinatal depression, public sector costs exceeded £3,030, costs due to reduced earnings were £1,400 and health-related quality of life loss was valued at £3,760.
Action to prevent or treat mothers’ depression during pregnancy and after birth is likely to reduce public sector costs, increase earnings and improve quality of life for children who were exposed to the condition.
PMCID: PMC4341975  PMID: 25066467
child development; perinatal depression; long-term; cost consequences; economic modelling
8.  Cost-Effectiveness of Financial Incentives to Promote Adherence to Depot Antipsychotic Medication: Economic Evaluation of a Cluster-Randomised Controlled Trial 
PLoS ONE  2015;10(10):e0138816.
Offering a modest financial incentive to people with psychosis can promote adherence to depot antipsychotic medication, but the cost-effectiveness of this approach has not been examined.
Economic evaluation within a pragmatic cluster-randomised controlled trial. 141 patients under the care of 73 teams (clusters) were randomised to intervention or control; 138 patients with diagnoses of schizophrenia, schizo-affective disorder or bipolar disorder participated. Intervention participants received £15 per depot injection over 12 months, additional to usual acute, mental and community primary health services. The control group received usual health services. Main outcome measures: incremental cost per 20% increase in adherence to depot antipsychotic medication; incremental cost of ‘good’ adherence (defined as taking at least 95% of the prescribed number of depot medications over the intervention period).
Economic and outcome data for baseline and 12-month follow-up were available for 117 participants. The adjusted difference in adherence between groups was 12.2% (73.4% control vs. 85.6% intervention); the adjusted costs difference was £598 (95% CI -£4 533, £5 730). The extra cost per patient to increase adherence to depot medications by 20% was £982 (95% CI -£8 020, £14 000). The extra cost per patient of achieving 'good' adherence was £2 950 (CI -£19 400, £27 800). Probability of cost-effectiveness exceeded 97.5% at willingness-to-pay values of £14 000 for a 20% increase in adherence and £27 800 for good adherence.
Offering a modest financial incentive to people with psychosis is cost-effective in promoting adherence to depot antipsychotic medication. Direct healthcare costs (including costs of the financial incentive) are unlikely to be increased by this intervention.
Trial Registration 77769281
PMCID: PMC4598185  PMID: 26448540
9.  Interventions to improve therapeutic communications between Black and minority ethnic patients and professionals in psychiatric services: systematic review 
The British Journal of Psychiatry  2015;207(2):95-103.
Communication may be an influential determinant of inequality of access to, engagement with and benefit from psychiatric services.
To review the evidence on interventions designed to improve therapeutic communications between Black and minority ethnic patients and clinicians who provide care in psychiatric services.
Systematic review and evidence synthesis (PROSPERO registration: CRD42011001661). Data sources included the published and the ‘grey’ literature. A survey of experts and a consultation with patients and carers all contributed to the evidence synthesis, interpretation and recommendations.
Twenty-one studies were included in our analysis. The trials showed benefits mainly for depressive symptoms, experiences of care, knowledge, stigma, adherence to prescribed medication, insight and alliance. The effect sizes were smaller for better-quality trials (range of d 0.18–0.75) than for moderate- or lower-quality studies (range of d 0.18–4.3). The review found only two studies offering weak economic evidence.
Culturally adapted psychotherapies, and ethnographic and motivational assessment leading to psychotherapies were effective and favoured by patients and carers. Further trials are needed from outside of the UK and USA, as are economic evaluations and studies of routine psychiatric care practices.
PMCID: PMC4523926  PMID: 26243761
10.  Cluster Randomized Controlled Trial 
Supplemental Digital Content is available in the text.
Background and Purpose—
We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke.
A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months.
Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was −0.6 points (95% confidence interval, −1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups.
This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice.
Clinical Trial Registration—
URL: Unique identifier: ISRCTN 67932305.
PMCID: PMC4512748  PMID: 26152298
cluster randomized controlled trial; community health services; cost-benefit analysis; quality-adjusted life years; rehabilitation; stroke
11.  Experiences of front-line health professionals in the delivery of telehealth: a qualitative study 
The British Journal of General Practice  2014;64(624):e401-e407.
Telehealth is an emerging field of clinical practice but current UK health policy has not taken account of the perceptions of front-line healthcare professionals expected to implement it.
To investigate telehealth care for people with long-term conditions from the perspective of the front-line health professional.
Design and setting
A qualitative study in three sites within the UK (Kent, Cornwall, and the London Borough of Newham) and embedded in the Whole Systems Demonstrator evaluation, a large cluster randomised controlled trial of telehealth and telecare for patients with long-term and complex conditions.
Semi-structured qualitative interviews with 32 front-line health professionals (13 community matrons, 10 telehealth monitoring nurses and 9 GPs) involved in the delivery of telehealth. Data were analysed using a modified grounded theory approach.
Mixed views were expressed by front-line professionals, which seem to reflect their levels of engagement. It was broadly welcomed by nursing staff as long as it supplemented rather than substituted their role in traditional patient care. GPs held mixed views; some gave a cautious welcome but most saw telehealth as increasing their work burden and potentially undermining their professional autonomy.
Health care professionals will need to develop a shared understanding of patient self-management through telehealth. This may require a renegotiation of their roles and responsibilities.
PMCID: PMC4073725  PMID: 24982492
primary care; qualitative; telehealth; Whole System Demonstrator
12.  The Effectiveness of Paid Services in Supporting Unpaid Carers’ Employment in England 
Journal of Social Policy  2015;44(3):567-590.
This paper explores the effectiveness of paid services in supporting unpaid carers’ employment in England. There is currently a new emphasis in England on ‘replacement care’, or paid services for the cared-for person, as a means of supporting working carers. The international evidence on the effectiveness of paid services as a means of supporting carers’ employment is inconclusive and does not relate specifically to England. The study reported here explores this issue using the 2009/10 Personal Social Services Survey of Adult Carers in England. The study finds a positive association between carers’ employment and receipt of paid services by the cared-for person, controlling for covariates. It therefore gives support to the hypothesis that services for the cared-for person are effective in supporting carers’ employment. Use of home care and a personal assistant are associated on their own with the employment of both men and women carers, while use of day care and meals-on-wheels are associated specifically with women's employment. Use of short-term breaks are associated with carers’ employment when combined with other services. The paper supports the emphasis in English social policy on paid services as a means of supporting working carers, but questions the use of the term ‘replacement care’ and the emphasis on ‘the market’.
PMCID: PMC4462201  PMID: 26139947
13.  Schizophrenia—Time to Commit to Policy Change 
Schizophrenia Bulletin  2014;40(Suppl 3):S165-S194.
Care and outcomes for people with schizophrenia have improved in recent years, but further progress is needed to help more individuals achieve an independent and fulfilled life. This report sets out the current need, informs policy makers and all relevant stakeholders who influence care quality, and supports their commitment to creating a better future. The authors recommend the following policy actions, based on research evidence, stakeholder consultation, and examples of best practice worldwide. (1) Provide an evidence-based, integrated care package for people with schizophrenia that addresses their mental and physical health needs. (2) Provide support for people with schizophrenia to enter and to remain in their community, and develop mechanisms to help guide them through the complex benefit and employment systems. (3) Provide concrete support, information, and educational programs to families and carers on how to enhance care for an individual living with schizophrenia in a manner that entails minimal disruption to their lives. (4) All stakeholders, including organizations that support people living with schizophrenia, should be consulted to regularly revise, update, and improve policy on the management of schizophrenia. (5) Provide support, which is proportionate to the impact of the disease, for research and development of new treatments. (6) Establish adequately funded, ongoing, and regular awareness-raising campaigns that form an integral part of routine plans of action. Implementation of the above recommendations will require engagement by every stakeholder, but with commitment from all, change can be achieved.
PMCID: PMC4002061  PMID: 24778411
schizophrenia; health policy; quality of life; antipsychotics; psychotherapy; recovery
14.  Cost-effectiveness of active monitoring versus antidepressants for major depression in primary health care: a 12-month non-randomized controlled trial (INFAP study) 
BMC Psychiatry  2015;15:63.
Clinical practice guidelines for the treatment of major depressive disorder (MDD) recommend antidepressants for patients with moderate-severe depression and active monitoring for patients with mild-moderate symptoms. The feasibility and efficiency of active monitoring has not been proven conclusively. The aim of this study is to evaluate the cost-effectiveness of active monitoring in comparison to antidepressants for primary care patients with mild-moderate MDD.
This is a 12-month follow-up multicenter observational prospective controlled trial. Patients are enrolled in 12 primary care centers in Barcelona (Spain). Eligible patients are adults (≥18 years-old) with a new episode of MDD that sign a written consent to participate. This is a naturalistic study in which general practitioners (GPs) use their professional judgment to allocate patients into active monitoring or antidepressants groups. GPs treat the patients following their clinical criteria. At baseline, GPs complete a questionnaire (sociodemographic/job characteristics, training, attitude towards depression, interest on mental health and participation in communication groups). Patients’ measurements take place at baseline and after six and 12 months. Main outcome measures include severity of depression (PHQ-9), health-related quality of life (EuroQol-5D) and use of healthcare and social care services (Client Service Receipt Inventory). Secondary outcomes include diagnosis of MDD according to DSM-IV diagnostic criteria (SCID-I), disability (WHO-DAS), anxiety (BAI), comorbidities, medication side-effects and beliefs about medicines (BMQ).
The analysis will be done according to the intention to treat analysis. Missing data will be imputed using multiple imputation by chained equations. To minimize the bias resulting from the lack of randomization, a propensity score will be used. Incremental effects and costs between groups will be modelled in each of the imputed databases using multivariate generalized linear models and then combined as per Rubin’s rules. Propensity scores will be used to adjust the models. Incremental cost-effectiveness ratios will be calculated by dividing the difference in costs between groups by the difference in effects. To deal with the uncertainty, resampling techniques with bootstrapping will be used and cost-effectiveness planes and cost-effectiveness acceptability curves will be constructed. A series of sensitivity analyses will be performed.
Given the high burden and costs generated by depressive disorder, it is important that general practitioners treat major depression efficiently. Recent evidence has suggested that antidepressants have low benefits for patients with mild to moderate major depression. For such cases of depression, active monitoring exists as a treatment option, but it is not without difficulties for implementation and its effectiveness and efficiency have not been demonstrated conclusively. The results of the study will provide information on which is the most efficient approach to treat patients with mild to moderate major depression in primary care.
Trial registration NCT02245373
PMCID: PMC4394418  PMID: 25885818
Depressive Disorder; Antidepressive Agents; Active Monitoring; Watchful Waiting; Costs and Cost Analysis; Primary Health Care
15.  The cost-effectiveness challenge: is it worth it? 
Scarcity of resources means that difficult choices have to be made about how to use them. Cost-effectiveness evidence provides a way to help decision-makers get ‘best value’ from their resources when choosing between two or more clinical or other interventions. Often it is found that one intervention has better outcomes than another, but also costs more. In these circumstances there is a need for the decision-maker to reach a view as to whether those better outcomes are ‘worth’ the higher costs, necessitating difficult trade-offs. Illustrations from the dementia field are given to illustrate how these trade-offs might be made. For strategic decisions it has often proved helpful to use a generic outcome measure such as the quality-adjusted life year. The fundamental aim of a healthcare system is not to save money, but to save and improve lives. Cost-effectiveness and similar analyses can help by showing how to get the most out of available resources.
PMCID: PMC4571137  PMID: 27391601
16.  Improving the experience of dementia and enhancing active life - living well with dementia: study protocol for the IDEAL study 
Enabling people with dementia and carers to ‘live well’ with the condition is a key United Kingdom policy objective. The aim of this project is to identify what helps people to live well or makes it difficult to live well in the context of having dementia or caring for a person with dementia, and to understand what ‘living well’ means from the perspective of people with dementia and carers.
Over a two-year period, 1500 people with early-stage dementia throughout Great Britain will be recruited to the study, together with a carer wherever possible. All the participants will be visited at home initially and again 12 months and 24 months later. This will provide information about the way in which well-being, life satisfaction and quality of life are affected by social capitals, assets and resources, the challenges posed by dementia, and the ways in which people adjust to and cope with these challenges. A smaller group will be interviewed in more depth.
The findings will lead to recommendations about what can be done by individuals, communities, health and social care practitioners, care providers and policy-makers to improve the likelihood of living well with dementia.
PMCID: PMC4260182  PMID: 25433373
Quality of life; Life satisfaction; Well-being; Person with dementia; Carer; Alzheimer’s disease; Vascular dementia; Fronto-temporal dementia; Parkinson’s disease dementia; Lewy body dementia
17.  Cost-utility of cognitive behavioral therapy versus U.S. Food and Drug Administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomized controlled trial 
Cognitive behavioral therapy (CBT) and U.S. Food and Drug Administration (FDA)-recommended pharmacologic treatments (RPTs; pregabalin, duloxetine, and milnacipran) are effective treatment options for fibromyalgia (FM) syndrome and are currently recommended by clinical guidelines. We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT (combination of pregabalin + duloxetine) and usual care (TAU) groups in the treatment of FM.
The economic evaluation was conducted alongside a 6-month, multicenter, randomized, blinded, parallel group, controlled trial. In total, 168 FM patients from 41 general practices in Zaragoza (Spain) were randomized to CBT (n = 57), RPT (n = 56), or TAU (n = 55). The main outcome measures were Quality-Adjusted Life Years (QALYs, assessed by using the EuroQoL-5D questionnaire) and improvements in health-related quality of life (HRQoL, assessed by using EuroQoL-5D visual analogue scale, EQ-VAS). The costs of healthcare use were estimated from patient self-reports (Client Service Receipt Inventory). Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves (CEACs).
On average, the total costs per patient in the CBT group (1,847€) were significantly lower than those in patients receiving RPT (3,664€) or TAU (3,124€). Patients receiving CBT reported a higher quality of life (QALYs and EQ-VAS scores); the differences between groups were significant only for EQ-VAS. From a complete case-analysis approach (base case), the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed, by using both QALYs and EQ-VAS as outcomes. These findings were confirmed by bootstrap analyses, net-benefit curves, and CEACs. Two additional sensitivity analyses (intention-to-treat analysis and per-protocol analysis) indicated that the results were robust. The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs, although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS.
Because of lower costs, CBT is the most cost-effective treatment for adult FM patients. Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT.
Trial registration
Current Controlled Trials ISRCTN10804772. Registered 29 September 2008.
Electronic supplementary material
The online version of this article (doi:10.1186/s13075-014-0451-y) contains supplementary material, which is available to authorized users.
PMCID: PMC4203881  PMID: 25270426
18.  Improving Well-being and Health for People with Dementia (WHELD): study protocol for a randomised controlled trial 
Trials  2014;15:284.
People with dementia living in care homes often have complex mental health problems, disabilities and social needs. Providing more comprehensive training for staff working in care home environments is a high national priority. It is important that this training is evidence based and delivers improvement for people with dementia residing in these environments. Well-being and Health for People with Dementia (WHELD) combines the most effective elements of existing approaches to develop a comprehensive but practical staff training intervention. This optimised intervention is based on a factorial study and qualitative evaluation, to combine: training on person-centred care, promoting person-centred activities and interactions, and providing care home staff and general practitioners with updated knowledge regarding the optimal use of psychotropic medications for persons with dementia in care homes.
The trial will be a randomised controlled two-arm cluster single blind trial that will take place for nine months across 80 care homes in the United Kingdom.
The overarching goal of this trial is to determine whether this optimised WHELD intervention is more effective in improving the quality of life and mental health than the usual care provided to people with dementia living in nursing homes. This study will be the largest and best powered randomised controlled trial (RCT) evaluating the benefits of an augmented person-centred care training intervention in care homes worldwide.
Trial registration
Current controlled trials ISRCTN62237498
Date registered: 5 September 2013
PMCID: PMC4227075  PMID: 25016303
Dementia care homes; Quality of life; Antipsychotic medication; Behavioural symptoms; Cost effectiveness; Implementation; Person-centred care; Social interaction
20.  Cost-effectiveness of telecare for people with social care needs: the Whole Systems Demonstrator cluster randomised trial 
Age and Ageing  2014;43(6):794-800.
Purpose of the study: to examine the costs and cost-effectiveness of ‘second-generation’ telecare, in addition to standard support and care that could include ‘first-generation’ forms of telecare, compared with standard support and care that could include ‘first-generation’ forms of telecare.
Design and methods: a pragmatic cluster-randomised controlled trial with nested economic evaluation. A total of 2,600 people with social care needs participated in a trial of community-based telecare in three English local authority areas. In the Whole Systems Demonstrator Telecare Questionnaire Study, 550 participants were randomised to intervention and 639 to control. Participants who were offered the telecare intervention received a package of equipment and monitoring services for 12 months, additional to their standard health and social care services. The control group received usual health and social care.
Primary outcome measure: incremental cost per quality-adjusted life year (QALY) gained. The analyses took a health and social care perspective.
Results: cost per additional QALY was £297,000. Cost-effectiveness acceptability curves indicated that the probability of cost-effectiveness at a willingness-to-pay of £30,000 per QALY gained was only 16%. Sensitivity analyses combining variations in equipment price and support cost parameters yielded a cost-effectiveness ratio of £161,000 per QALY.
Implications: while QALY gain in the intervention group was similar to that for controls, social and health services costs were higher. Second-generation telecare did not appear to be a cost-effective addition to usual care, assuming a commonly accepted willingness to pay for QALYs.
Trial registration number: ISRCTN 43002091.
PMCID: PMC4204660  PMID: 24950690
telecare; economic evaluation; social care; older people
21.  Service Use, Charge, and Access to Mental Healthcare in a Private Kenyan Inpatient Setting: The Effects of Insurance 
PLoS ONE  2014;9(3):e90297.
The gap in Kenya between need and treatment for mental disorders is wide, and private providers are increasingly offering services, funded in part by private health insurance (PHI). Chiromo, a 30-bed psychiatric hospital in Nairobi, forms part of one of the largest private psychiatric providers in East Africa.
The study evaluated the effects of insurance on service use and charge, questioning implications on access to care. Data derive from invoices for 455 sequential patients, including 12-month follow-up. Multi-linear and binary logistic regressions explored the effect of PHI on readmission, cumulative length of stay, and treatment charge.
Patients were 66.4% male with a mean age of 36.8 years. Half were employed in the formal sector. 70% were admitted involuntarily. Diagnoses were: substance use disorder 31.6%; serious mental disorder 49.5%; common mental disorder 7%; comorbid 7%; other 4.9%. In addition to daily psychiatric consultations, two-thirds received individual counselling or group therapy; half received lab tests or scans; and 16.2% received ECT. Most took a psychiatric medicine. Half of those on antipsychotics were given only brands.
Insurance paid in full for 28.8% of patients. Mean length of stay was 11.8 days and, in 12 months, 16.7 days (median 10.6). 22.2% were readmitted within 12 months. Patients with PHI stayed 36% longer than those paying out-of-pocket and had 2.5 times higher odds of readmission. Mean annual charge per patient was Int$ 4,262 (median Int$ 2,821). Insurers were charged 71% more than those paying out-of-pocket - driven by higher fees and longer stays.
Chiromo delivers acute psychiatric care each year to approximately 450 people, to quality and human rights standards higher than its public counterpart, but at considerably higher cost. With more efficient delivery and wider insurance coverage, Chiromo might expand from its occupancy of 56.6% to reach a larger population in need.
PMCID: PMC3961252  PMID: 24651115
22.  Importance of Social and Cultural Factors for Attitudes, Disclosure and Time off Work for Depression: Findings from a Seven Country European Study on Depression in the Workplace 
PLoS ONE  2014;9(3):e91053.
Depression is experienced by a large proportion of the workforce and associated with high costs to employers and employees. There is little research on how the social costs of depression vary by social and cultural context. This study investigates individual, workplace and societal factors associated with greater perceived discomfort regarding depression in the workplace, greater likelihood of employees taking time off of work as a result of depression and greater likelihood of disclosure of depression to one's employer.
Employees and managers (n = 7,065) were recruited from seven European countries to participate in the IDEA survey. Multivariable logistic regression models were used to examine associations between individual characteristics and country contextual characteristics in relation to workplace perceptions, likelihood of taking time off work and disclosing depression to an employer.
Our findings suggest that structural factors such as benefit systems and flexible working hours are important for understanding workplace perceptions and consequences for employees with depression. However, manager responses that focus on offering help to the employee with depression appear to have stronger associations with positive perceptions in the workplace, and also with openness and disclosure by employees with depression.
This study highlights the importance of individual, workplace and societal factors that may be associated with how people with depression are perceived and treated in the workplace, and, hence, factors that may be associated with openness and disclosure among employees with depression. Some responses, such as flexible working hours, may be helpful but are not necessarily sufficient, and our findings also emphasise the importance of support and openness of managers in addition to flexible working hours.
PMCID: PMC3951284  PMID: 24622046
23.  Cost effectiveness of a manual based coping strategy programme in promoting the mental health of family carers of people with dementia (the START (STrAtegies for RelaTives) study): a pragmatic randomised controlled trial 
The BMJ  2013;347:f6342.
Objective To assess whether the START (STrAtegies for RelatTives) intervention added to treatment as usual is cost effective compared with usual treatment alone.
Design Cost effectiveness analysis nested within a pragmatic randomised controlled trial.
Setting Three mental health and one neurological outpatient dementia service in London and Essex, UK.
Participants Family carers of people with dementia.
Intervention Eight session, manual based, coping intervention delivered by supervised psychology graduates to family carers of people with dementia added to usual treatment, compared with usual treatment alone.
Primary outcome measures Costs measured from a health and social care perspective were analysed alongside the Hospital Anxiety and Depression Scale total score (HADS-T) of affective symptoms and quality adjusted life years (QALYs) in cost effectiveness analyses over eight months from baseline.
Results Of the 260 participants recruited to the study, 173 were randomised to the START intervention, and 87 to usual treatment alone. Mean HADS-T scores were lower in the intervention group than the usual treatment group over the 8 month evaluation period (mean difference −1.79 (95% CI −3.32 to −0.33)), indicating better outcomes associated with the START intervention. There was a small improvement in health related quality of life as measured by QALYs (0.03 (−0.01 to 0.08)). Costs were no different between the intervention and usual treatment groups (£252 (−28 to 565) higher for START group). The cost effectiveness calculations suggested that START had a greater than 99% chance of being cost effective compared with usual treatment alone at a willingness to pay threshold of £30 000 per QALY gained, and a high probability of cost effectiveness on the HADS-T measure.
Conclusions The manual based coping intervention START, when added to treatment as usual, was cost effective compared with treatment as usual alone by reference to both outcome measures (affective symptoms for family carers, and carer based QALYs).
Trial Registration ISCTRN 70017938
PMCID: PMC3808080  PMID: 24162943
24.  Clinical effectiveness of a manual based coping strategy programme (START, STrAtegies for RelaTives) in promoting the mental health of carers of family members with dementia: pragmatic randomised controlled trial 
The BMJ  2013;347:f6276.
Objective To assess whether a manual based coping strategy compared with treatment as usual reduces depression and anxiety symptoms in carers of family members with dementia.
Design Randomised, parallel group, superiority trial.
Setting Three mental health community services and one neurological outpatient dementia service in London and Essex, UK.
Participants 260 carers of family members with dementia.
Intervention A manual based coping intervention comprising eight sessions and delivered by supervised psychology graduates to carers of family members with dementia. The programme consisted of psychoeducation about dementia, carers’ stress, and where to get emotional support; understanding behaviours of the family member being cared for, and behavioural management techniques; changing unhelpful thoughts; promoting acceptance; assertive communication; relaxation; planning for the future; increasing pleasant activities; and maintaining skills learnt. Carers practised these techniques at home, using the manual and relaxation CDs.
Main outcome measures Affective symptoms (hospital anxiety and depression total score) at four and eight months. Secondary outcomes were depression and anxiety caseness on the hospital anxiety and depression scale; quality of life of both the carer (health status questionnaire, mental health) and the recipient of care (quality of life-Alzheimer’s disease); and potentially abusive behaviour by the carer towards the recipient of care (modified conflict tactics scale).
Results 260 carers were recruited; 173 were randomised to the intervention and 87 to treatment as usual. Mean total scores on the hospital anxiety and depression scale were lower in the intervention group than in the treatment as usual group over the eight month evaluation period: adjusted difference in means −1.80 points (95% confidence interval −3.29 to −0.31; P=0.02) and absolute difference in means −2.0 points. Carers in the intervention group were less likely to have case level depression (odds ratio 0.24, 95% confidence interval 0.07 to 0.76) and there was a non-significant trend towards reduced case level anxiety (0.30, 0.08 to 1.05). Carers’ quality of life was higher in the intervention group (difference in means 4.09, 95% confidence interval 0.34 to 7.83) but not for the recipient of care (difference in means 0.59, −0.72 to 1.89). Carers in the intervention group reported less abusive behaviour towards the recipient of care compared with those in the treatment as usual group (odds ratio 0.47, 95% confidence interval 0.18 to 1.23), although this was not significant.
Conclusions A manual based coping strategy was effective in reducing affective symptoms and case level depression in carers of family members with dementia. The carers’ quality of life also improved.
Trial registration Current Controlled Trials ISCTRN70017938.
PMCID: PMC3808082  PMID: 24162942
25.  Does telecare prolong community living in dementia? A study protocol for a pragmatic, randomised controlled trial 
Trials  2013;14:349.
Assistive technology and telecare (ATT) are relatively new ways of delivering care and support to people with social care needs. It is claimed that ATT reduces the need for community care, prevents unnecessary hospital admission, and delays or prevents admission into residential or nursing care. The current economic situation in England has renewed interest in ATT instead of community care packages. However, at present, the evidence base to support claims about the impact and effectiveness of ATT is limited, despite its potential to mitigate the high financial cost of caring for people with dementia and the social and psychological cost to unpaid carers.
ATTILA (Assistive Technology and Telecare to maintain Independent Living At Home for People with Dementia) is a pragmatic, multi-centre, randomised controlled trial over 104 weeks that compares outcomes for people with dementia who receive ATT and those who receive equivalent community services but not ATT. The study hypothesis is that fewer people in the ATT group will go into institutional care over the 4-year period for which the study is funded. The study aims to recruit 500 participants, living in community settings, with dementia or significant cognitive impairment, who have recently been referred to social services.
Primary outcome measures are time in days from randomisation to institutionalisation and cost effectiveness. Secondary outcomes are caregiver burden, health-related quality of life in carers, number and severity of serious adverse events, and data on acceptability, applicability and reliability of ATT intervention packages. Assessments will be undertaken in weeks 0 (baseline), 12, 24, 52 and 104 or until institutionalisation or withdrawal of the participant from the trial.
In a time of financial austerity, CASSRs in England are increasingly turning to ATT in the belief that it will deliver good outcomes for less money. There is an absence of robust evidence for the cost-effectiveness and benefit of using assistive technology and telecare. The ATTILA trial meets a pressing need for robust, generalisable evidence to either justify continuing investment or reappraise the appropriate scale of ATT use.
Trial registration
Current Controlled Trials ISRCTN86537017
PMCID: PMC4015839  PMID: 24152600
Assistive technology; Telecare; Dementia; Randomised control trial; Independence; Community living

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