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Introduction: There is growing evidence that prehabilitation programmes effectively improve the physical and psychological conditions of cancer patients awaiting treatment. During the pandemic, people with cancer were classed as vulnerable. To reduce risk to this population Kent and Medway Prehabilitation service transformed into a TeleHealth format. The aim of this study is to assess the impact on health-related quality of life (HRQoL) and the costs of a digital multimodal prehabilitation programme., Methods: HRQoL was measured with the EQ-5D and quality-adjusted life years (QALYs) were calculated. Costs of the prehabilitation service and inpatient care were calculated. Comparisons were made between different levels of prehabilitation received., Results: A sample of 192 individuals was included in the study Mean HRQoL improved from 69.53 at baseline to 85.71 post-rehabilitation, a 23% increase. For each additional week of prehabilitation care in cancer patients, the model predicts that the total QALYS increase by 0.02, when baseline utility is held constant., Conclusions: Prehabilitation is associated with improved HRQoL and QALYs. Our model of a multimodal digital prehabilitation program can be beneficial for patients and reduce costs for healthcare facilities even when the patients attend only a few sessions.

Background: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited., Objectives: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive-behavioural therapy for adults with dissociative seizures., Design: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial., Setting: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive-behavioural therapy services., Participants: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017., Interventions: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive-behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care., Main Outcome Measures: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness., Results: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n  = 182; and cognitive-behavioural therapy plus standardised medical care, n  = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1-35 dissociative seizures); cognitive-behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0-20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p  = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive-behavioural therapy at a p -value < 0.05, including the following at a p -value ≤ 0.001: the longest dissociative seizure-free period in months 7-12 inclusive post randomisation (incidence rate ratio 1.64, 95% confidence interval 1.22 to 2.20; p  = 0.001); better psychosocial functioning (Work and Social Adjustment Scale, standardised treatment effect -0.39, 95% confidence interval -0.61 to -0.18; p  < 0.001); greater self-rated and clinician-rated clinical improvement (self-rated: standardised treatment effect 0.39, 95% confidence interval 0.16 to 0.62; p  = 0.001; clinician rated: standardised treatment effect 0.37, 95% confidence interval 0.17 to 0.57; p  < 0.001); and satisfaction with treatment (standardised treatment effect 0.50, 95% confidence interval 0.27 to 0.73; p  < 0.001). Rates of adverse events were similar across arms. Cognitive-behavioural therapy plus standardised medical care produced 0.0152 more quality-adjusted life-years (95% confidence interval -0.0106 to 0.0392 quality-adjusted life-years) than standardised medical care alone. The incremental cost-effectiveness ratio (cost per quality-adjusted life-year) for cognitive-behavioural therapy plus standardised medical care versus standardised medical care alone based on the EuroQol-5 Dimensions, five-level version, and imputed data was £120,658. In sensitivity analyses, incremental cost-effectiveness ratios ranged between £85,724 and £206,067. Qualitative and quantitative process evaluations highlighted useful study components, the importance of clinical experience in treating patients with dissociative seizures and potential benefits of our multidisciplinary care pathway., Limitations: Unlike outcome assessors, participants and clinicians were not blinded to the interventions., Conclusions: There was no significant additional benefit of dissociative seizure-specific cognitive-behavioural therapy in reducing dissociative seizure frequency, and cost-effectiveness over standardised medical care was low. However, this large, adequately powered, multicentre randomised controlled trial highlights benefits of adjunctive dissociative seizure-specific cognitive-behavioural therapy for several clinical outcomes, with no evidence of greater harm from dissociative seizure-specific cognitive-behavioural therapy., Future Work: Examination of moderators and mediators of outcome., Trial Registration: Current Controlled Trials ISRCTN05681227 and ClinicalTrials.gov NCT02325544., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 25, No. 43. See the NIHR Journals Library website for further project information.

Background: Cognitive behavioral therapy (CBT) is recommended in guidelines for people with refractory irritable bowel syndrome (IBS). However, the availability of CBT is limited, and poor adherence has been reported in face-to-face CBT., Objective: Nested within a randomized controlled trial of telephone- and web-delivered CBT for refractory IBS, this qualitative study aims to identify barriers to and facilitators of engagement over time with the interventions, identify social and psychological processes of change, and provide insight into trial results., Methods: A longitudinal qualitative study was nested in a randomized controlled trial. Repeated semistructured interviews were conducted at 3 (n=34) and 12 months (n=25) post baseline. Participants received telephone-based CBT (TCBT; n=17 at 3 months and n=13 at 12 months) or web-based CBT (WCBT; n=17 at 3 months and n=12 at 12 months). Inductive thematic analysis was used to analyze the data., Results: Participants viewed CBT as credible for IBS, perceived their therapists as knowledgeable and supportive, and liked the flexibility of web-based and telephone-based delivery; these factors facilitated engagement. Potential barriers to engagement in both groups (mostly overcome by our participants) included initial skepticism and concerns about the biopsychosocial nature of CBT, initial concerns about telephone-delivered talking therapy, challenges of maintaining motivation and self-discipline given already busy lives, and finding nothing new in the WCBT (WCBT group only). Participants described helpful changes in their understanding of IBS, attitudes toward IBS, ability to recognize IBS patterns, and IBS-related behaviors. Consistent with the trial results, participants described lasting positive effects on their symptoms, work, and social lives. Reasons and remedies for some attenuation of effects were identified., Conclusions: Both TCBT and WCBT for IBS were positively received and had lasting positive impacts on participants' understanding of IBS, IBS-related behaviors, symptoms, and quality of life. These forms of CBT may broaden access to CBT for IBS., (©Stephanie Hughes, Alice Sibelli, Hazel A Everitt, Rona Moss-Morris, Trudie Chalder, J Matthew Harvey, Andrea Vas Falcao, Sabine Landau, Gilly O'Reilly, Sula Windgassen, Rachel Holland, Paul Little, Paul McCrone, Kimberley Goldsmith, Nicholas Coleman, Robert Logan, Felicity L Bishop. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 20.11.2020.)

Objectives: Patient preferences are increasingly important in informing clinical and policy decisions. Health-state utility values (HSUVs) are quantitative measures of people's preferences over different health states. In schizophrenia, there is no clarity about HSUVs across the symptoms' severity spectrum. This meta-analysis aims to synthesize the literature on HSUVs in people with schizophrenia., Methods: We searched Medline, PsycInfo, Embase, EconLit, The Cochrane Library, and specialized databases. The studies reporting HSUVs in people with schizophrenia were selected and pooled in a random-effects meta-analysis. The primary outcome was the mean HSUV obtained from participants., Results: A total of 54 studies involving 87 335 participants were included. The pooled estimate using direct elicitation was a mean HSUV of 0.79 (95% CI: 0.70-0.88) for mild symptomatic states, 0.69 (95% CI: 0.54-0.85) in moderate states, and 0.34 (95% CI: 0.13-0.56) in severe states. Studies using indirect techniques resulted in a pooled mean HSUV of 0.73 (95% CI: 0.67-0.78) applying the EuroQol 5-dimension, 0.66 (95% CI: 0.62-0.71) in the Short-Form 6-dimension, and 0.59 (95% CI: 0.57-0.61) using the Quality of Well-Being scale. All the estimates resulted in considerable heterogeneity, partially reduced by meta-regression., Conclusion: Our findings suggest that the severity of psychotic symptoms has an important effect on HSUVs in schizophrenia, with values mirroring patients with disabling physical conditions such as cancer and stroke. Decision makers should be aware of these results when including people's preferences in trials, models, and policy decisions., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Introduction: There is growing evidence that computer-delivered or computer-assisted forms of cognitive behavior therapy (CCBT) are helpful, but cost-effectiveness versus standard therapies is not well established., Objective: To evaluate the cost-effectiveness of a therapist-supported method for CCBT in comparison to standard cognitive behavior therapy (CBT)., Methods: A total of 154 drug-free major depressive disorder outpatients were randomly assigned to either 16 weeks of standard CBT (up to twenty 50-min sessions) or CCBT using the Good Days Ahead program (including up to 5.5 h of therapist contact). Outcomes were assessed at baseline, weeks 8 and 16, and at 3 and 6 months post-treatment. Economic analyses took into account the costs of services received and work/social role impairment., Results: In the context of almost identical efficacy, a form of CCBT that used only about one third the amount of therapist contact as conventional CBT was highly cost-effective compared to conventional therapy and reduced the adjusted cost of treatment by USD 945 per patient., Conclusions: A method of CCBT that blended internet-delivered modules and abbreviated therapeutic contact reduced the cost of treatment substantially without adversely affecting outcomes. Results suggest that use of this approach can more than double the access to CBT. Because clinician support in CCBT can be provided by telephone, videoconference, and/or email, this highly efficient form of treatment could be a major advance in remote treatment delivery., (© 2020 S. Karger AG, Basel.)

Objective: Stratified medicine refers to the use of tests that predict treatment response to drive treatment decisions for individual patient. The pharmacoeconomic implications of this approach in schizophrenia are unknown. We aimed to assess the cost-effectiveness of a hypothetical stratified medicine algorithm (SMA) compared with treatment as usual (TAU), for patients with schizophrenia who failed a first-line antipsychotic., Methods: A decision analytic model with embedded Markov process was constructed, which simulated the health and cost outcomes for patients followed SMA or TAU over a lifetime horizon, from healthcare and social care perspective. In the base-case analysis, sensitivity and specificity of the stratifier were both set as 60%. Extensive sensitivity analyses were conducted to test the impact of uncertainty around the value of important parameters. The primary outcome was the incremental cost per quality-adjusted life year (QALY) gained., Results: When both sensitivity and specificity of the stratified test were set at 60%, SMA appeared to be the optimal strategy as it produces more QALYs and incurs lower costs than TAU. This is robust to all scenarios tested. At a willingness-to-pay threshold of £20,000 per QALY, the probability for SMA to be the optimal strategy is 82.4%., Conclusions: Our results suggest that use of any stratifier with a sensitivity and specificity over 60% is very likely to be cost-effective comparing to TAU, for psychotic patients who failed a first-line antipsychotic. This finding, however, should be interpreted with caution due to lack of evidence for clozapine as a second-line antipsychotic.

Introduction: Cost-effectiveness analyses that use quality-adjusted life-years (QALYs) allow comparing the value for money of interventions across different health problems. Health state utility values (HSUVs) are crucial to calculate QALYs. These are weights attached to a given health state reflecting preferences in health-related quality of life (HRQoL). In schizophrenia, there is extensive evidence about the consequences of this condition on HRQoL. Besides, several interventions have claimed to be cost-effective in terms of QALYs gained. Despite this evidence, a systematic review of HSUVs has not been conducted. Therefore, we aim to synthesise the evidence about HSUVs in schizophrenia., Methods and Analysis: We will conduct a systematic review of the literature about HSUVs in people with schizophrenia following the Preferred Reporting Items for Systematic review and Meta-Analysis and the International Society for Pharmacoeconomics and Outcomes Research task force recommendations. The submissions records of eight electronic peer-reviewed databases and three health technology assessment (HTA) agencies will be searched. Quantitative synthesis will be carried out in comparable studies, using random-effects meta-analysis. Heterogeneity will be explored using meta-regression if more than 10 studies per covariate are found. A narrative synthesis and methodological quality of included studies will be also reported., Discussion: This review will provide a synthesis of the HSUVs estimated for different states experienced by people with schizophrenia. This will inform analysts when calculating QALYs, using values in a more transparent and accountable manner. Finally, it will shed light on evidence gaps and limitations about this measure in mental health., Prospero Registration Number: CRD42019123582., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: To investigate the responsiveness of and correlation between the EQ-5D-5L and the QOLIE-31P in patients with epilepsy, and develop a mapping function to predict EQ-5D-5L values based on the QOLIE-31P for use in economic evaluations., Methods: The dataset was derived from two clinical trials, the ZMILE study in the Netherlands and the SMILE study in the UK. In both studies, patients' quality of life using the EQ-5D-5L and QOLIE-31P was measured at baseline and 12 months follow-up. Spearman's correlations, effect sizes (EF) and standardized response means (SRM) were calculated for both the EQ-5D-5L and QOLIE-31P domains and sub scores. Mapping functions were derived using ordinary least square (OLS) and censored least absolute deviations models., Results: A total of 509 patients were included in this study. Low to moderately strong significant correlations were found between both instruments. The EQ-5D-5L showed high ceiling effects and small EFs and SRMs, whereas the QOLIE-31P did not show ceiling effects and also showed small to moderate EFs and SRMs. Results of the different mapping functions indicate that the highest adjusted R 2 we were able to regress was 0.265 using an OLS model with squared terms, leading to a mean absolute error of 0.103., Conclusions: Results presented in this study emphasize the shortcomings of the EQ-5D-5L in epilepsy and the importance of the development of condition-specific preference-based instruments which can be used within the QALY framework. In addition, the usefulness of the constructed mapping function in economic evaluations is questionable.

Objective: Epilepsy is one of the most common neurological conditions affecting about 1% of adults. Up to 40% of people with epilepsy (PWE) report recurring seizures while on medication. And optimal functioning requires good self-management. Our objective was to evaluate a group self-management education courses for people with epilepsy and drug-resistant seizures by means of a multicenter, pragmatic, parallel group, randomized controlled trial., Methods: We recruited adults with epilepsy, having ≥2 seizures in the prior 12 months, from specialist clinics. Consenting participants were randomized 1:1 to a group course or treatment as usual. The primary outcome measure was quality of life 12 months after randomization using Quality of Life 31-P (QOLIE-31-P). Secondary outcome measures were seizure frequency and recency, psychological distress, impact and stigma of epilepsy, self-mastery, medication adherence, and adverse effects. Analysis of outcomes followed the intention-to-treat principle using mixed-effects regression models., Results: We enrolled 404 participants (intervention: n = 205, control: n = 199) with 331 (82%) completing 12-month follow-up (intervention: n = 163, control: n = 168). Mean age was 41.7 years, ranging from 16 to 85, 54% were female and 75% were white. From the intervention arm, 73.7% attended all or some of the course. At 12-month follow-up, there were no statistically significant differences between trial arms in QOLIE-31-P (intervention mean: 67.4, standard deviation [SD]: 13.5; control mean: 69.5, SD 14.8) or in secondary outcome measures., Significance: This is the first pragmatic trial of group education for people with poorly controlled epilepsy. Recruitment, course attendance, and follow-up rates were higher than expected. The results show that the primary outcome and quality of life did not differ between the trial arms after 12 months. We found a high prevalence of felt-stigma and psychological distress in this group of people with drug-resistant seizures. To address this, social and psychological interventions require evaluation, and may be necessary before or alongside self-management-education courses., (© 2018 The Authors. Epilepsia published by Wiley Periodicals, Inc. on behalf of International League Against Epilepsy.)

Background: Epilepsy is a common neurological condition resulting in recurrent seizures. Research evidence in long-term conditions suggests that patients benefit from self-management education and that this may improve quality of life (QoL). Epilepsy self-management education has yet to be tested in a UK setting., Objectives: To determine the effectiveness and cost-effectiveness of Self-Management education for people with poorly controlled epILEpsy [SMILE (UK)]., Design: A parallel pragmatic randomised controlled trial., Setting: Participants were recruited from eight hospitals in London and south-east England., Participants: Adults aged ≥ 16 years with epilepsy and two or more epileptic seizures in the past year, who were currently being prescribed antiepileptic drugs., Intervention: A 2-day group self-management course alongside treatment as usual (TAU). The control group received TAU., Main Outcome Measures: The primary outcome is QoL in people with epilepsy at 12-month follow-up using the Quality Of Life In Epilepsy 31-P (QOLIE-31-P) scale. Other outcomes were seizure control, impact of epilepsy, medication adverse effects, psychological distress, perceived stigma, self-mastery and medication adherence. Cost-effectiveness analyses and a process evaluation were undertaken., Randomisation: A 1 : 1 ratio between trial arms using fixed block sizes of two., Blinding: Participants were not blinded to their group allocation because of the nature of the study. Researchers involved in data collection and analysis remained blinded throughout., Results: The trial completed successfully. A total of 404 participants were enrolled in the study [SMILE (UK), n  = 205; TAU, n  = 199] with 331 completing the final follow-up at 12 months [SMILE (UK), n  = 163; TAU, n  = 168]. In the intervention group, 61.5% completed all sessions of the course. No adverse events were found to be related to the intervention. At baseline, participants had a mean age of 41.7 years [standard deviation (SD) 14.1 years], and had epilepsy for a median of 18 years. The mean QOLIE-31-P score for the whole group at baseline was 66.0 out of 100.0 (SD 14.2). Clinically relevant levels of anxiety symptoms were reported in 53.6% of the group and depression symptoms in 28.0%. The results following an intention-to-treat analysis showed no change in any measures at the 12-month follow-up [QOLIE-31-P: SMILE (UK) mean: 67.4, SD 13.5; TAU mean: 69.5, SD 14.8]. The cost-effectiveness study showed that SMILE (UK) was possibly cost-effective but was also associated with lower QoL. The process evaluation with 20 participants revealed that a group course increased confidence by sharing with others and improved self-management behaviours., Conclusions: For people with epilepsy and persistent seizures, a 2-day self-management education course is cost-saving, but does not improve QoL after 12-months or reduce anxiety or depression symptoms. A psychological intervention may help with anxiety and depression. Interviewed participants reported attending a group course increased their confidence and helped them improve their self-management., Future Work: More research is needed on self-management courses, with psychological components and integration with routine monitoring., Trial Registration: Current Controlled Trials ISRCTN57937389., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 22, No. 21. See the NIHR Journals Library website for further project information., Competing Interests: Leone Ridsdale secured funding from the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King’s College London. Laura H Goldstein reports that her independent research also receives support from the National Institute for Health Research (NIHR) Maudsley Biomedical Research Unit at the South London and Maudsley NHS Foundation Trust and King’s College London. She receives royalties from Goldstein LH and McNeil JE (editors) Clinical Neuropsychology. A Practical Guide to Assessment and Management for Clinicians. 2nd edn. Chichester: Wiley-Blackwell, 2013; and from Cull C and Goldstein LH (editors) The Clinical Psychologist’s Handbook of Epilepsy: Assessment and Management. Abingdon-on-Thames: Routledge; 1997. Sabine Landau reports grants from NIHR Maudsley Biomedical Research Unit at the South London and Maudsley NHS Foundation Trust and King’s College London during the conduct of the study and received a grant from NIHR Health Technology Assessment. Stephanie JC Taylor is on the Health Technology Assessment Clinical Trials Board and reports grants from the NIHR Collaboration for Leadership in Applied Health Research and Care North Thames at Barts Health NHS Trust. The authors received a contribution from Sanofi UK to enable printing of the patient workbooks.

Background: Psychological distress is prevalent in haemodialysis (HD) patients yet access to psychotherapy remains limited. This study assessed the feasibility and acceptability of online cognitive-behavioural therapy (CBT) tailored for HD patients, with or without therapist support, for managing psychological distress., Methods: This feasibility randomised controlled trial recruited patients from a UK HD centre. Following psychological distress screens, patients with mild-moderate psychological distress (Patient Health Questionnaire PHQ-9; score: 5-19 and/or Generalised Anxiety Disorder; GAD-7 score: 5-14) who met remaining inclusion criteria were approached for consent. Consenters were individually randomised (1:1) to online-CBT or online-CBT plus three therapist support calls. Outcomes included recruitment, retention, and adherence rates. Exploratory change analyses were performed for: psychological distress, quality of life (QoL), illness perceptions, and costs. The statistician was blinded to allocation., Results: 182 (44%) out of 410 patients approached completed psychological distress screens. 26% found screening unacceptable; a further 30% found it unfeasible. Psychological distress was detected in 101 (55%) patients, 60 of these met remaining inclusion criteria. The primary reason for ineligibility was poor computer literacy (N=17, 53%). Twenty-five patients were randomised to the supported (N=18) or unsupported arm (N=7); 92% were retained at follow-up. No differences in psychological distress or cost-effectiveness were observed. No trial adverse events occurred., Conclusion: Online CBT appears feasible but only for computer literate patients who identify with the label psychological distress. A definitive trial using the current methods for psychological distress screening and online care delivery is unfeasible. ClinicalTrials.gov Identifier: NCT02352870., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: The Health of the Nation Outcomes Scale (HoNOS) is recommended for use by the English National Service Framework for Mental Health and by the working group on outcome indicators for severe mental illnesses to the Department of Health. It was developed to measure the health and social functioning of people with severe mental illness. Since the development of the HoNOS many have debated its latent structure. This paper examines the latent structure of the HoNOS using current factor analysis techniques., Method: HoNOS data for 12,910 patients with ICD10 diagnoses F20 to F29 at a UK National Health Service Mental Health Trust were analysed using exploratory, confirmatory and bifactor analysis for categorical data. The fit of models was assessed using relative and absolute fit indices., Results: Exploratory followed by confirmatory factor analysis identified a four factor solution which fit the data better than existing models. The corresponding bifactor factor solution identified three robust factors and one weak factor after accounting for a general factor. The factor loadings on the general factor were not appreciably different when compared to a unidimensional factor solution indicating the existence of a common trait., Conclusion: Existing models proposed in the literature did not fit well in our data. Factor analysis identified a new four factor solution. These factors showed clinical relevance according to published literature. The bifactor model demonstrated that there is not much loss of information when the HoNOS is used as a unidimensional construct. Further studies should explore this structure in larger samples and in alternative sample populations. A bifactor approach may have implications for how the HoNOS is used in practice, since there is ongoing debate on whether HoNOS item scores should be aggregated for interpretation.

Background: Little research has been done into the effectiveness of mental health supported accommodation services. We did a national survey to investigate provision and costs of services and assess service user quality of life and outcomes across England., Methods: We randomly sampled three types of services from 14 nationally representative regions-residential care, supported housing, and floating outreach-and recruited up to ten service users per service. Service quality and costs and service users' quality of life, autonomy, and satisfaction with care were assessed in a standardised manner with validated tools and compared by multilevel modelling., Findings: 619 service users were recruited from 22 residential care, 35 supported housing, and 30 floating outreach services. Those in residential care and supported housing had more severe mental health problems than those in floating outreach. 348 (57%) were assessed as being at risk of severe self-neglect and 229 (37%) as being vulnerable to exploitation in the previous 2 years. Residential care was most expensive but provided for people with the greatest needs. The mean annual budget was £466 687 for residential care (range £276 000-777 920), compared with £365 452 for supported housing (£174 877-818 000), and £172 114 for floating outreach (£17 126-491 692). Quality of care was best in supported housing. People in supported housing and floating outreach were more socially included but experienced more crime than those in residential care. After adjustment for service quality and service user sociodemographic and clinical factors, quality of life was similar for service users in residential care and supported housing (mean difference -0·138, 95% CI -0·402 to 0·126, p=0·306) and lower for those in floating outreach than in residential care (-0·424, -0·734 to -0·114, p=0·007). However, autonomy was greater for those in supported housing than for those in residential care (0·145, 0·010 to 0·279, p=0.035). Satisfaction with care was similar across services., Interpretation: Supported housing might be cost-effective, but the benefits need to be weighed against the risks associated with increased autonomy., Funding: National Institute for Health Research., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease typically causing death within three years. Understanding the impact of disease on patients using health utility at different stages of ALS would allow meaningful cost-benefit analysis of new potential therapies. A common health-related quality of life measurement, developed and validated for the UK, is the EQ-5D. Using clinical trial data from the LiCALS study, we calculated health utility using the EQ-5D for each King's ALS clinical stage from 214 patients. We analysed whether health utility, and other health-related measures, significantly changed between each of the clinical stages. Results showed that mean health utility decreased by 0.487 (the scale runs from 1 to - 0.594) between clinical stages 2A and 4. Emotional states, measured using the Hospital Anxiety and Depression Scale (HADS), showed worsening depression and anxiety scores as ALS progressed. Age of onset, disease onset, gender and treatment group were not predictors of EQ-5D, depression or anxiety. In conclusion, increasing severity of King's ALS Clinical Stage is associated with a progressive decrease in EQ-5D health utility. This is useful for cost-benefit analysis of new therapies and validates this ALS clinical staging system.

Background: Palliative care is increasingly offered earlier in the cancer trajectory but rarely in Idiopathic Parkinson's Disease(IPD), Progressive Supranuclear Palsy(PSP) or Multiple System Atrophy(MSA). There is little longitudinal data of people with late stage disease to understand levels of need. We aimed to determine how symptoms and quality of life of these patients change over time; and what demographic and clinical factors predicted changes., Methods: We recruited 82 patients into a longitudinal study, consenting patients with a diagnosis of IPD, MSA or PSP, stages 3-5 Hoehn and Yahr(H&Y). At baseline and then on up to 3 occasions over one year, we collected self-reported demographic, clinical, symptom, palliative and quality of life data, using Parkinson's specific and generic validated scales, including the Palliative care Outcome Scale (POS). We tested for predictors using multivariable analysis, adjusting for confounders., Findings: Over two thirds of patients had severe disability, over one third being wheelchair-bound/bedridden. Symptoms were highly prevalent in all conditions - mean (SD) of 10.6(4.0) symptoms. More than 50% of the MSA and PSP patients died over the year. Over the year, half of the patients showed either an upward (worsening, 24/60) or fluctuant (8/60) trajectory for POS and symptoms. The strongest predictors of higher levels of symptoms at the end of follow-up were initial scores on POS (AOR 1.30; 95%CI:1.05-1.60) and being male (AOR 5.18; 95% CI 1.17 to 22.92), both were more predictive than initial H&Y scores., Interpretation: The findings point to profound and complex mix of non-motor and motor symptoms in patients with late stage IPD, MSA and PSP. Symptoms are not resolved and half of the patients deteriorate. Palliative problems are predictive of future symptoms, suggesting that an early palliative assessment might help screen for those in need of earlier intervention.

Health service providers increasingly need to consider not only the efficacy and safety of a therapy, but also its cost. Our hypothesis was that in our previously reported aripiprazole add-on or switching study, the improved outcomes would be associated with reduced costs. We here report data from this study, now to 52-week follow-up, with 27 total recruits (outpatients partially refractory or intolerant of their current antipsychotic regime). Serial clinical ratings included the Quality of Life Scale and Client Service Receipt Inventory, applied at baseline (N = 24), week 26 (N = 21) and 52 (N = 18). Cost data were unavailable for the drop outs. On last observation carried forward (LOCF) analysis, there was a significant increase in the Quality of Life Scale between baseline and one year (p = 0.007). There were also reductions over time in total direct and indirect costs. For study completers, the total costs at the one-year follow-up period were £ 482 less than those for the corresponding baseline period, with the Quality of Life Scale score at one year being 21.6 points (or 16.4 on LOCF analysis) higher. Therefore, in the completers, improved outcome was associated with reduced costs. Cost-effectiveness could be similarly investigated in a controlled trial.

Aim: To assess long-term mental health outcomes in people who suffer from war-related posttraumatic stress disorder (PTSD) but do not receive appropriate treatment., Methods: We interviewed 264 subjects from former Yugoslavia, who lived in Croatia, Serbia, Germany, and the United Kingdom. All of them had suffered from PTSD at some point following the war, but never received psychiatric or psychological treatment. The interviews took place on average 10.7+/-3.0 years after the war-related trauma. Outcomes were current PTSD on the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders-IV, subjective quality of life (SQOL) on the Manchester Short Assessment of Quality of Life, and care costs. Socio-demographic characteristics, the level of traumatic war-events, and aspects of the post-war situation were tested for association with outcomes., Results: Current PTSD was diagnosed in 83.7% of participants, the mean SQOL score was 4.0+/-0.9, and mean care costs in the last 3 months exceeded euro1100 in each center. Older age, more traumatic war-events, lower education, and living in post-conflict countries were associated with higher rates of current PTSD. Older age, combat experience, more traumatic war-events, being unemployed, living alone, being housed in collective accommodation, and current PTSD were independently associated with lower SQOL. Older age and living in Germany were linked to higher costs of formal care., Conclusion: People with untreated war-related PTSD have a high risk of still having PTSD a decade after the traumatic event. Their SQOL is relatively low, and they generate considerable care costs. Factors that have been reported as influencing the occurrence of PTSD also appear relevant for recovery from PTSD. Current PTSD may impair SQOL independently of social factors.

Background: Multiple sclerosis (MS) is a chronic condition that affects quality of life (QOL), leads to disability and requires ongoing care inputs. Few studies have examined the impact of QOL, disability and demographic characteristics on treatment costs., Objective: To investigate the links between service use, costs, QOL and disability for people with MS., Methods: A cross-sectional study was conducted in people with MS who were members of the Multiple Sclerosis Society of Great Britain and Northern Ireland. A questionnaire, consisting of sociodemographic questions, the Client Service Receipt Inventory, EQ-5D and Guy's Neurological Disability Scale (GNDS), was sent to 4000 members of the Society. Service and lost employment costs were calculated. Regression models were developed to identify the participant characteristics that were associated with costs, QOL and disability. All costs are presented in year 2006-7 values., Results: Questionnaires were returned by 1942 members (48.9%). The mean (SD) EQ-5D QOL score was 0.41 (0.34), whilst the GNDS disability score was 20.8 (8.9). The mean (SD) service cost over the preceding 6 months was pound8397 ( pound10,404), and most of this (71.6%) was due to informal care. Only a small amount of cost (8.1%) was due to the use of disease-modifying drugs and drugs for spasticity. Lost employment costs amounted to a mean of pound4240. Higher costs were associated with higher levels of disability and lower levels of health-related QOL., Conclusions: This study showed that MS participants had high levels of service use, and that QOL was low in comparison with other conditions. There were significant associations between costs, QOL and disability.

This study examines perceived quality of life (QOL) in a convenience sample of children (aged 7-11) with asthma and their parents from two schools in rural West Virginia. Forty-nine child-parent dyads representing 25 males and 24 females completed the study. The PedsQL™ 3.0 Asthma Module was utilized to separately measure child and parent perceptions of various dimensions of pediatric, asthma-specific, health-related QOL. Dimensions of the tool were scored separately and included symptoms, treatment, worry, and communication. The mean module dimension scores for children ranged from 63.27 to 80.47 and for parents, the range was from 61.26 to 79.79, with higher scores indicating higher QOL. Parents of male children perceived their son's QOL to be higher than that of female children in the symptoms and treatment dimensions. Strong relationships occurred between the child's worry and the other three dimensions as well as between the symptoms and the treatment dimensions. For the dyads, the only significant relationship was between the child and the adult treatment dimensions. With the well-documented burden of asthma in school-aged populations, information regarding the QOL of child and parent dyads will enhance school nurses' ability to improve health and educational outcomes in schools.

Abstract Background Two million people in the UK are living with or beyond cancer and a third of them report poor quality of life (QoL) due to problems such as fatigue, fear of cancer recurrence, and concerns about returning to work. We aimed to develop and evaluate an intervention based on acceptance and commitment therapy (ACT), suited to address the concerns of cancer survivors and in improving their QoL. We also recognise the importance of exercise and vocational activity on QoL and therefore will integrate options for physical activity and return to work/vocational support, thus ACT Plus (+). Methods We will conduct a multi-centre, pragmatic, theory driven, randomised controlled trial. We will assess whether ACT+ including usual aftercare (intervention) is more effective and cost-effective than usual aftercare alone (control). The primary outcome is QoL of participants living with or beyond cancer measured using the Functional Assessment of Cancer Therapy: General scale (FACT-G) at 52 weeks. We will recruit 344 participants identified from secondary care sites who have completed hospital-based treatment for cancer with curative intent, with low QoL (determined by the FACT-G) and randomise with an allocation ratio of 1:1 to the intervention or control. The intervention (ACT+) will be delivered by NHS Talking Therapies, specialist services, and cancer charities. The intervention consists of up to eight sessions at weekly or fortnightly intervals using different modalities of delivery to suit individual needs, i.e. face-to-face sessions, over the phone or skype. Discussion To date, there have been no robust trials reporting both clinical and cost-effectiveness of an ACT based intervention for people with low QoL after curative cancer treatment in the UK. We will provide high quality evidence of the effectiveness and cost-effectiveness of adding ACT+ to usual aftercare provided by the NHS. If shown to be effective and cost-effective then commissioners, providers and cancer charities will know how to improve QoL in cancer survivors and their families. Trial registration ISRCTN: ISRCTN67900293 . Registered on 09 December 2019. All items from the World Health Organization Trial Registration Data Set for this protocol can be found in Additional file 2 Table S1.

IntroductionWhile some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients.Methods and analysisA total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes).Ethics and disseminationEthical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts.Trial registration numberNCT02356081.

Background: Dissociative (non-epileptic) seizures are potentially treatable by psychotherapeutic interventions; however, the evidence for this is limited. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of dissociative seizure-specific cognitive–behavioural therapy for adults with dissociative seizures. Design: This was a pragmatic, multicentre, parallel-arm, mixed-methods randomised controlled trial. Setting: This took place in 27 UK-based neurology/epilepsy services, 17 liaison psychiatry/neuropsychiatry services and 18 cognitive–behavioural therapy services. Participants: Adults with dissociative seizures in the previous 8 weeks and no epileptic seizures in the previous year and meeting other eligibility criteria were recruited to a screening phase from neurology/epilepsy services between October 2014 and February 2017. After psychiatric assessment around 3 months later, eligible and interested participants were randomised between January 2015 and May 2017. Interventions: Standardised medical care consisted of input from neurologists and psychiatrists who were given guidance regarding diagnosis delivery and management; they provided patients with information booklets. The intervention consisted of 12 dissociative seizure-specific cognitive–behavioural therapy 1-hour sessions (plus one booster session) that were delivered by trained therapists, in addition to standardised medical care. Main outcome measures: The primary outcome was monthly seizure frequency at 12 months post randomisation. The secondary outcomes were aspects of seizure occurrence, quality of life, mood, anxiety, distress, symptoms, psychosocial functioning, clinical global change, satisfaction with treatment, quality-adjusted life-years, costs and cost-effectiveness. Results: In total, 698 patients were screened and 368 were randomised (standardised medical care alone, n = 182; and cognitive–behavioural therapy plus standardised medical care, n = 186). Primary outcome data were obtained for 85% of participants. An intention-to-treat analysis with multivariate imputation by chained equations revealed no significant between-group difference in dissociative seizure frequency at 12 months [standardised medical care: median of seven dissociative seizures (interquartile range 1–35 dissociative seizures); cognitive–behavioural therapy and standardised medical care: median of four dissociative seizures (interquartile range 0–20 dissociative seizures); incidence rate ratio 0.78, 95% confidence interval 0.56 to 1.09; p = 0.144]. Of the 16 secondary outcomes analysed, nine were significantly better in the arm receiving cognitive–behavioural therapy at a p-value

Background: Cognitive Behavioural Therapy (CBT) reduces distress in multiple sclerosis, and helps manage adjustment, but cost-effectiveness evidence is lacking. Methods: An economic evaluation was conducted within a multi-centre trial. 94 patients were randomised to either eight sessions of nurse-led CBT or supportive listening (SL). Costs were calculated from the health, social and indirect care perspectives, and combined with additional quality-adjusted life years (QALY) or improvement on the GHQ-12 score, to explore cost-effectiveness at 12 months. Results: CBT had higher mean health costs (£1610, 95% CI, −£187 to 3771) and slightly better QALYs (0.0053, 95% CI, −0.059 to 0.103) compared to SL but these differences were not statistically significant. This yielded £301,509 per QALY improvement, indicating that CBT is not cost-effective according to established UK NHS thresholds. The extra cost per patient improvement on the GHQ-12 scale was £821 from the same perspective. Using a £20,000, threshold, CBT in this format has a 9% probability of being cost effective. Although subgroup analysis of patients with clinical levels of distress at baseline showed an improvement in the position of CBT compared to SL, CBT was still not cost-effective. Conclusion: Nurse delivered CBT is more effective in reducing distress among MS patients compared to SL, but is highly unlikely to be cost-effective using a preference-based measure of health (EQ-5D). Results from a disease-specific measure (GHQ-12) produced comparatively lower Incremental Cost-Effectiveness Ratios, but there is currently no acceptable willingness-to-pay threshold for this measure to guide decision-making. [ABSTRACT FROM AUTHOR]

Background. Depression and anxiety are major causes of absence from work and underperformance in the workplace. Cognitive behavioural therapy (CBT) can be effective in treating such problems and online versions offer many practical advantages. The aim of the study was to investigate the effectiveness of a computerized CBT intervention (MoodGYM) in a workplace context. Method. The study was a phase III two-arm, parallel randomized controlled trial whose main outcome was total score on the Work and Social Adjustment Scale (WSAS). Depression, anxiety, psychological functioning, costs and acceptability of the online process were also measured. Most data were collected online for 637 participants at baseline, 359 at 6 weeks marking the end of the intervention and 251 participants at 12 weeks post-baseline. Results. In both experimental and control groups depression scores improved over 6 weeks but attrition was high. There was no evidence for a difference in the average treatment effect of MoodGYM on the WSAS, nor for a difference in any of the secondary outcomes. Conclusions. This study found no evidence that MoodGYM was superior to informational websites in terms of psychological outcomes or service use, although improvement to subthreshold levels of depression was seen in nearly half the patients in both groups. [ABSTRACT FROM AUTHOR]

Background and purpose Cost-of-illness studies and health-related quality of life ( HRQoL) measurements are needed to assess the effects of chronic inflammatory demyelinating polyradiculoneuropathy ( CIDP), multifocal motor neuropathy ( MMN) and paraproteinaemic demyelinating neuropathy ( PDN) on society. Methods This study was conducted in 2008 in a southeast England population of 3 557 352 people. Data on service use and treatment were collected with a client service receipt inventory and service costs were calculated by combining these data with national unit costs. The EuroQol was used to calculate utility scores, a measurement of HRQoL. Results The total annual cost-of-illness per patient was £22 085 for CIDP, £22 812 for MMN and £7566 for PDN. The annual total cost per patient was £49 430 for individuals on intravenous immunoglobulin ( IVIg) and £9046 for those not on IVIg ( P < 0.01). The mean ( SD) utility scores were 0.62 (0.23) for CIDP, 0.63 (0.22) for PDN and 0.72 (0.14) for MMN ( P = 0.52). The mean ( SD) utility score for those on IVIg was 0.65 (0.16) and those not on IVIg 0.63 (0.23) ( P = 0.77). Conclusion The use of IVIg was the most important determinant of cost in all three diseases and the higher frequency of its use in CIDP and MMN accounted for the much greater average cost per patient in these diseases. There was no significant difference in HRQoL amongst the three diseases or between those receiving or not receiving IVIg. [ABSTRACT FROM AUTHOR]