Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial.

BACKGROUND: Older adults were more likely to be socially isolated during the COVID-19 pandemic, with increased risk of depression and loneliness. We aimed to investigate whether a behavioural activation intervention delivered via telephone could mitigate depression and loneliness in at-risk older people during the COVID-19 pandemic. METHODS: BASIL+ (Behavioural Activation in Social Isolation) was a pragmatic randomised controlled trial conducted among patients recruited from general practices in England and Wales, and was designed to assess the effectiveness of behavioural activation in mitigating depression and loneliness among older people during the COVID-19 pandemic. Eligible participants were aged 65 years and older, socially isolated, with a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9), and had multiple long-term conditions. Participants were allocated in a 1:1 ratio to the intervention (behavioural activation) or control groups by use of simple randomisation without stratification. Behavioural activation was delivered by telephone; participants were offered up to eight weekly sessions with trained BASIL+ Support Workers. Behavioural activation was adapted to maintain social connections and encourage socially reinforcing activities. Participants in the control group received usual care with existing COVID-19 wellbeing resources. The primary clinical outcome was self-reported depression severity, assessed by the PHQ-9, at 3 months. Outcomes were assessed masked to allocation and analysis was by treatment allocation. This trial is registered with the ISRCTN registry (ISRCTN63034289). FINDINGS: Between Feb 8, 2021, and Feb 28, 2022, 449 eligible participants were identified and 435 from 26 general practices were recruited and randomly assigned (1:1) to the behavioural activation intervention (n=218) or to the control group (usual care with signposting; n=217). The mean age of participants was 75·7 years (SD 6·7); 270 (62·1%) of 435 participants were female, and 418 (96·1%) were White. Participants in the intervention group attended an average of 5·2 (SD 2·9) of eight remote behavioural activation sessions. The adjusted mean difference in PHQ-9 scores between the control and intervention groups at 3 months was -1·65 (95% CI -2·54 to -0·75, p=0·0003). No adverse events were reported that were attributable to the behavioural activation intervention. INTERPRETATION: Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups. FUNDING: UK National Institute for Health and Care Research.

Play brick therapy to aid the social skills of children and young people with autism spectrum disorder: the I-SOCIALISE cluster RCT.

Background: Social skills interventions are commonly recommended to help children and young people with autism spectrum disorder develop social skills, but some struggle to engage in these interventions. LEGO® (LEGO System A/S, Billund, Denmark) based therapy, a group social skills intervention, aims to be more interesting and engaging. Objective: To evaluate the clinical effectiveness of LEGO® based therapy on the social and emotional skills of children and young people with autism spectrum disorder in school settings compared with usual support. Secondary objectives included evaluations of cost-effectiveness, acceptability and treatment fidelity. Design: A cluster randomised controlled trial randomly allocating participating schools to either LEGO® based therapy and usual support or usual support only. Setting: Mainstream schools in the north of England. Participants: Children and young people (aged 7-15 years) with autism spectrum disorder, their parent/guardian, an associated teacher/teaching assistant and a facilitator teacher/teaching assistant (intervention schools only). Intervention: Schools randomised to the intervention arm delivered 12 weekly sessions of LEGO® based therapy, which promotes collaborative play and encourages social problem-solving in groups of three children and young people with a facilitator (trained teacher or teaching assistant). Participants received usual support from school and community services. Participants in the control arm received usual support only. Research assistants and statisticians were blind to treatment allocation. Main outcome measure: The social skills subscale of the Social Skills Improvement System (SSIS), completed by the children and young people's unblinded teacher pre randomisation and 20 weeks post randomisation. The SSIS social skills subscale measures social skills including social communication, co-operation, empathy, assertion, responsibility and self-control. Participants completed a number of other pre- and post-randomisation measures of emotional health, quality of life, loneliness, problem behaviours, academic competence, service resource utilisation and adverse events. Results: A total of 250 children and young people from 98 schools were randomised: 127 to the intervention arm and 123 to the control arm. Intention-to-treat analysis of the main outcome measure showed a modest positive difference of 3.74 points (95% confidence interval -0.16 to 7.63 points, standardised effect size 0.18; p = 0.06) in favour of the intervention arm. Statistical significance increased in per-protocol analysis, with a modest positive difference (standardised effect size 0.21; p = 0.036). Cost-effectiveness of the intervention was found in reduced service use costs and a small increase in quality-adjusted life-years. Intervention fidelity and acceptability were positive. No intervention-related adverse events or effects were reported. Conclusions: The primary and pre-planned sensitivity analysis of the primary outcome consistently showed a positive clinical difference, with modest standardised effect sizes of between 0.15 and 0.21. There were positive health economics and qualitative findings, corroborated by the difference between arms for the majority of secondary outcomes, which were not statistically significant but favoured the intervention arm. Post hoc additional analysis was exploratory and was not used in drawing this conclusion. Given the small positive change, LEGO® based therapy for children and young people with autism spectrum disorder in schools should be considered. Limitations: The primary outcome measure was completed by an unblinded teacher (rather than by the facilitator). Future work: The study team recommends future research into LEGO® based therapy, particularly in school environments. Trial registration: This trial is registered as ISRCTN64852382. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 15/49/32) and is published in full in Public Health Research; Vol. 11, No. 12. See the NIHR Funding and Awards website for further award information.

Autism spectrum disorder is characterised by difficulties with social relationships and communication, which can make it difficult to make friends. Social skills training is commonly used to help children and young people learn different social skills, but some children and young people do not enjoy these therapies. LEGO^® (LEGO System A/S, Billund, Denmark) based therapy takes a new approach by focusing on making the process interesting and fun. This research investigated the effect of LEGO^® based therapy groups in schools on the social and emotional abilities of children and young people with autism spectrum disorder. It was a randomised controlled trial, so each school that was taking part was randomly chosen to provide either usual support (from the school or NHS services) or 12 sessions of LEGO^® based therapy with a trained school staff member as well as usual support. Children and young people played one of three roles ­ the 'engineer' (gives instructions), the 'supplier' (finds the pieces) or the 'builder' (builds the model) ­ and worked together. Questionnaires completed by children and young people, their parents/guardians and teachers were used to look at the intervention's effects. The main objective was to see if there was a change in social skills measured by a teacher-completed questionnaire. Results showed that the social skills of children and young people in the LEGO^® based therapy groups did improve a little. We found that the intervention is not very costly for schools to run. Many parents/guardians and teachers thought that the intervention was beneficial and that the children and young people enjoyed it.

I-SOCIALISE: Results from a cluster randomised controlled trial investigating the social competence and isolation of children with autism taking part in LEGO® based therapy ('Play Brick Therapy') clubs in school environments.

LAY ABSTRACT: Autism is characterised by keen interests and differences in social interactions and communication. Activities that help autistic children and young people with social skills are commonly used in UK schools. LEGO® based therapy is a new activity that provides interesting and fun social opportunities for children and young people and involves building LEGO® models together. This study looked at LEGO® based therapy for the social skills of autistic children and young people in schools. It was a randomised controlled trial, meaning each school was randomly chosen (like flipping a coin) to either run LEGO® based therapy groups in school over 12 weeks and have usual support from school or other professionals, or only have usual support from school or other professionals. The effect of the LEGO® based therapy groups was measured by asking children and young people, their parents/guardians, and a teacher at school in both arms of the study to complete some questionnaires. The main objective was to see if the teacher's questionnaire answers about the children and young people's social skills changed between their first and second completions. The social skills of participants in the LEGO® based therapy groups were found to have improved in a small way when compared to usual support only. The study also found that LEGO® based therapy was not very costly for schools to run and parents/guardians and teachers said they thought it was good for their children and young people. We suggest further research into different potential benefits of LEGO® based therapy.

One session treatment (OST) is equivalent to multi-session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT): results from a national non-inferiority randomized controlled trial.

BACKGROUND: 5%-10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP. METHODS: ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7-16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested cost-effectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months. RESULTS: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI -0.449 to 0.202 (ITT), mean difference -0.204, 95% CI -0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. CONCLUSIONS: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.

One-session treatment compared with multisession CBT in children aged 7-16 years with specific phobias: the ASPECT non-inferiority RCT.

BACKGROUND: Up to 10% of children and young people have a specific phobia that can significantly affect their mental health, development and daily functioning. Cognitive-behavioural therapy-based interventions remain the dominant treatment, but limitations to their provision warrant investigation into low-intensity alternatives. One-session treatment is one such alternative that shares cognitive-behavioural therapy principles but has a shorter treatment period. OBJECTIVE: This research investigated the non-inferiority of one-session treatment to cognitive-behavioural therapy for treating specific phobias in children and young people. The acceptability and cost-effectiveness of one-session treatment were examined. DESIGN: A pragmatic, multicentre, non-inferiority randomised controlled trial, with embedded economic and qualitative evaluations. SETTINGS: There were 26 sites, including 12 NHS trusts. PARTICIPANTS: Participants were aged 7-16 years and had a specific phobia defined in accordance with established international clinical criteria. INTERVENTIONS: Participants were randomised 1 : 1 to receive one-session treatment or usual-care cognitive-behavioural therapy, and were stratified according to age and phobia severity. Outcome assessors remained blind to treatment allocation. MAIN OUTCOME MEASURES: The primary outcome measure was the Behavioural Avoidance Task at 6 months' follow-up. Secondary outcomes included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety and Depression Scale, a goal-based outcome measure, Child Health Utility 9D, EuroQol-5 Dimensions Youth version and resource usage. Treatment fidelity was assessed using the Cognitive Behaviour Therapy Scale for Children and Young People and the One-Session Treatment Rating Scale. RESULTS: A total of 274 participants were recruited, with 268 participants randomised to one-session treatment (n = 134) or cognitive-behavioural therapy (n = 134). A total of 197 participants contributed some data, with 149 participants in the intention-to-treat analysis and 113 in the per-protocol analysis. Mean Behavioural Avoidance Task scores at 6 months were similar across treatment groups when both intention-to-treat and per-protocol analyses were applied [cognitive-behavioural therapy: 7.1 (intention to treat), 7.4 (per protocol); one-session treatment: 7.4 (intention to treat), 7.6 (per protocol); on the standardised scale adjusted mean difference for cognitive-behavioural therapy compared with one-session treatment -0.123, 95% confidence interval -0.449 to 0.202 (intention to treat), mean difference -0.204, 95% confidence interval -0.579 to 0.171 (per protocol)]. These findings were wholly below the standardised non-inferiority limit of 0.4, which suggests that one-session treatment is non-inferior to cognitive-behavioural therapy. No between-group differences in secondary outcome measures were found. The health economics evaluation suggested that, compared with cognitive-behavioural therapy, one-session treatment marginally decreased the mean service use costs and maintained similar mean quality-adjusted life-year improvement. Nested qualitative evaluation found one-session treatment to be considered acceptable by those who received it, their parents/guardians and clinicians. No adverse events occurred as a result of phobia treatment. LIMITATIONS: The COVID-19 pandemic meant that 48 children and young people could not complete the primary outcome measure. Service waiting times resulted in some participants not starting therapy before follow-up. CONCLUSIONS: One-session treatment for specific phobia in UK-based child mental health treatment centres is as clinically effective as multisession cognitive-behavioural therapy and highly likely to be cost-saving. Future work could involve improving the implementation of one-session treatment through training and commissioning of improved care pathways. TRIAL REGISTRATION: This trial is registered as ISRCTN19883421. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 42. See the NIHR Journals Library website for further project information.

A phobia is an intense, ongoing fear of an everyday object or situation. The phobia causes distress and the person with the phobia avoids that object or situation. Many children and young people have phobias that affect their daily lives. Cognitive­behavioural therapy helps by changing what people do or think when they have a phobia and is the most common treatment approach. However, cognitive­behavioural therapy is expensive, takes time and is not always easy to get. Different treatments are needed to help children and young people with specific phobias. One such therapy is one-session treatment, which works in similar ways to cognitive­behavioural therapy but takes place over one main 3-hour session. Our study, called ASPECT (Alleviating Specific Phobias Experienced by Children Trial), compared these two treatments to examine whether or not one-session treatment is as effective as cognitive­behavioural therapy. Overall, 274 children and young people aged 7­16 years from 26 sites nationally helped with our research, of whom 268 received either cognitive­behavioural therapy or one-session treatment. The results at 6 months found that one-session treatment and cognitive­behavioural therapy worked as well as each other for treating phobias in children and young people. We also found evidence that one-session treatment is cheaper than cognitive­behavioural therapy. We spoke with children and young people, their parents/guardians and the therapists of the single-session treatment, and we found one-session treatment to be acceptable for their needs. Future research could explore how to make one-session treatment more easily available for children and young people with specific phobias because it can save time and money, and works just as well as cognitive­behavioural therapy.

Cost and effectiveness of one session treatment (OST) for children and young people with specific phobias compared to multi-session cognitive behavioural therapy (CBT): results from a randomised controlled trial.

BACKGROUND: In the UK, around 93,000 (0.8%) children and young people (CYP) are experiencing specific phobias that have a substantial impact on daily life. The current gold-standard treatment-multi-session cognitive behavioural therapy (CBT) - is effective at reducing specific phobia severity; however, CBT is time consuming, requires specialist CBT therapists, and is often at great cost and limited availability. A briefer variant of CBT called one session treatment (OST) has been found to offer similar clinical effectiveness for specific phobia as multi-session CBT. The aim of this study was to assess the cost-effectiveness of OST compared to multi-session CBT for CYP with specific phobias through the Alleviating Specific Phobias Experienced by Children Trial (ASPECT), a two-arm, pragmatic, multi-centre, non-inferiority randomised controlled trial. METHODS: CYP aged seven to 16 years with specific phobias were recruited nationally via Health and Social Care pathways, remotely randomised to the intervention group (OST) or the control group (CBT-based therapies) and analysed (n = 267). Resource use based on NHS and personal social services perspective and quality adjusted life years (QALYs) measured by EQ-5D-Y were collected at baseline and at six-month follow-up. Incremental cost-effectiveness ratio (ICER) was calculated, and non-parametric bootstrapping was conducted to capture the uncertainty around the ICER estimates. The results were presented on a cost-effectiveness acceptability curve (CEAC). A set of sensitivity analyses (including taking a societal perspective) were conducted to assess the robustness of the primary findings. RESULTS: After adjustment and bootstrapping, on average CYP in the OST group incurred less costs (incremental cost was -£302.96 (95% CI -£598.86 to -£28.61)) and maintained similar improvement in QALYs (QALYs gained 0.002 (95% CI - 0.004 to 0.008)). The CEAC shows that the probability of OST being cost-effective was over 95% across all the WTP thresholds. Results of a set of sensitivity analyses were consistent with the primary outcomes. CONCLUSION: Compared to CBT, OST produced a reduction in costs and maintained similar improvement in QALYs. Results from both primary and sensitivity analyses suggested that OST was highly likely to be cost saving. TRIAL REGISTRATION: ISRCTN19883421 (30/11/2016).

Healthcare resource use and costs for people with type 2 diabetes mellitus with and without severe mental illness in England: longitudinal matched-cohort study using the Clinical Practice Research Datalink.

BACKGROUND: Approximately 60 000 people in England have coexisting type 2 diabetes mellitus (T2DM) and severe mental illness (SMI). They are more likely to have poorer health outcomes and require more complex care pathways compared with those with T2DM alone. Despite increasing prevalence, little is known about the healthcare resource use and costs for people with both conditions. AIMS: To assess the impact of SMI on healthcare resource use and service costs for adults with T2DM, and explore the predictors of healthcare costs and lifetime costs for people with both conditions. METHOD: This was a matched-cohort study using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics for 1620 people with comorbid SMI and T2DM and 4763 people with T2DM alone. Generalised linear models and the Bang and Tsiatis method were used to explore cost predictors and mean lifetime costs respectively. RESULTS: There were higher average annual costs for people with T2DM and SMI (£1930 higher) than people with T2DM alone, driven primarily by mental health and non-mental health-related hospital admissions. Key predictors of higher total costs were older age, comorbid hypertension, use of antidepressants, use of first-generation antipsychotics, and increased duration of living with both conditions. Expected lifetime costs were approximately £35 000 per person with both SMI and T2DM. Extrapolating nationally, this would generate total annual costs to the National Health Service of around £250 m per year. CONCLUSIONS: Our estimates of resource use and costs for people with both T2DM and SMI will aid policymakers and commissioners in service planning and resource allocation.

Cost-utility analysis of LEGO based therapy for school children and young people with autism spectrum disorder: results from a randomised controlled trial.

OBJECTIVES: To assess the cost-effectiveness of LEGO-based therapy compared with usual support. DESIGN: Cost-utility analysis alongside randomised control trial. SETTING: Mainstream primary and secondary schools in the UK. PARTICIPANTS: 248 children and young people (CYP) with autism spectrum disorder (ASD) aged 7-15 years. INTERVENTION: LEGO-based therapy is a group social skills intervention designed specifically for CYP with ASD. Through play, CYP learn to use the skills such as joint attention, sharing, communication and group problem-solving. CYP randomised to the intervention arm received 12 weekly sessions of LEGO-based therapy and usual support, while CYP allocated to control arm received usual support only. MAIN OUTCOME MEASURES: Average costs based on National Health Service (NHS) and personal social services perspective and quality-adjusted life years (QALYs) measured by EQ-5D-Y over time horizon of 1 year were collected during the trial. Incremental cost-effectiveness ratio (ICER) was calculated, and non-parametric bootstrapping was conducted. The uncertainty around the ICER estimates was presented using cost-effectiveness acceptability curve (CEAC). A set of sensitivity analyses were conducted to assess the robustness of the primary findings. RESULTS: After adjustment and bootstrapping, on average, CYP in LEGO-based therapy group incurred less costs (incremental cost was -£251 (95% CI -£752 to £268)) and gained marginal improvement in QALYs (QALYs gained 0.009 (95% CI -0.008 to 0.028)). The CEAC shows that the probability of LEGO-based therapy being cost-effective was 94% at the willingness-to-pay threshold of £20 000 per QALY gained. Results of sensitivity analyses were consistent with the primary outcomes. CONCLUSION: Compared with usual support, LEGO-based therapy produced marginal reduction in costs and improvement in QALYs. Results from both primary and sensitivity analyses suggested that LEGO-based therapy was likely to be cost-effective. TRIAL REGISTRATION NUMBER: ISRCTN64852382.

Public trust, information sources and vaccine willingness related to the COVID-19 pandemic in Trinidad and Tobago: an online cross-sectional survey.

BACKGROUND: The response of populations to public health measures may rely on the degree to which the population trusts sources of information and institutions. There has been little research in this area in the Caribbean. This exploratory study aimed to evaluate public trust in information sources, confidence in institutions and COVID-19 vaccine willingness in Trinidad and Tobago. METHODS: An exploratory online survey was conducted in Trinidad and Tobago from November 10th to December 7th 2020. The survey instrument was a validated questionnaire developed by the World Health Organisation (WHO) and adapted to the local setting. Descriptive statistics and regression analyses were used to analyse the data. FINDINGS: The most trusted sources of information included health workers (32.5%) and the ministry of health (23.6 %). Increasing levels of trust in the medical sector were associated with decreasing levels of believing misinformation. Overall, 62.8 % of participants said they would take the COVID-19 vaccine if available. Regression analyses showed those who agreed that everyone should adhere to the national immunization schedule and those who would take the flu vaccine, were 2.77 (95% CI 1.77-4.35) and 4.60 (95% CI 3.11-6.84) timesmore likely to take the vaccine, respectively. INTERPRETATION: Our study found increasing trust in health sources, confidence in medical sector, adherence to the national immunisation schedule and acceptance of the flu vaccine may increase COVID-19 vaccine willingness rates. Although the generalisability of the findings is limited, the results of this exploratory survey may be used to identify areas for prioritisation and improvement in future research.

Long-Term Cost-Effectiveness of Smoking Cessation Interventions in People With Mental Disorders: A Dynamic Decision Analytical Model.

OBJECTIVES: People with mental disorders are more likely to smoke than the general population. The objective of this study is to develop a decision analytical model that estimates long-term cost-effectiveness of smoking cessation interventions in this population. METHODS: A series of Markov models were constructed to estimate average lifetime smoking-attributable inpatient cost and expected quality-adjusted life-years. The model parameters were estimated using a variety of data sources. The model incorporated uncertainty through probabilistic sensitivity analysis using Monte Carlo simulations. It also generated tables presenting incremental cost-effectiveness ratios of the proposed interventions with varying incremental costs and incremental quit rates. We used data from 2 published trials to demonstrate the model's ability to make projections beyond the observational time frame. RESULTS: The average smoker's smoking-attributable inpatient cost was 3 times higher and health utility was 5% lower than ex-smokers. The intervention in the trial with a statistically insignificant difference in quit rate (19% vs 25%; P=.2) showed a 45% to 49% chance of being cost-effective compared with the control at willingness-to-pay thresholds of £20 000 to £30 000/quality-adjusted life-years. The second trial had a significant outcome (quit rate 35.9% vs 15.6%; P<.001), and the corresponding probability of the intervention being cost-effective was 65%. CONCLUSIONS: This model provides a consistent platform for clinical trials to estimate the potential lifetime cost-effectiveness of smoking cessation interventions for people with mental disorders and could help commissioners direct resources to the most cost-effective programs. However, direct comparisons of results between trials must be interpreted with caution owing to their different designs and settings.

Efficacy and cost-effectiveness of a community-based smoke-free-home intervention with or without indoor-air-quality feedback in Bangladesh (MCLASS II): a three-arm, cluster-randomised, controlled trial.

BACKGROUND: Exposure to second-hand smoke from tobacco is a major contributor to global morbidity and mortality. We aimed to evaluate the efficacy and cost-effectiveness of a community-based smoke-free-home intervention, with or without indoor-air-quality feedback, in reducing second-hand-smoke exposure in homes in Bangladesh. METHODS: We did a three-arm, cluster-randomised, controlled trial in Dhaka, Bangladesh, and randomly assigned (1:1:1) mosques and consenting households from their congregations to a smoke-free-home intervention plus indoor-air-quality feedback, smoke-free-home intervention only, or usual services. Households were eligible if they had at least one resident attending one of the participating mosques, at least one adult resident (age 18 years or older) who smoked cigarettes or other forms of smoked tobacco (eg, bidi, waterpipe) regularly (on at least 25 days per month), and at least one non-smoking resident of any age. The smoke-free-home intervention consisted of weekly health messages delivered within an Islamic discourse by religious leaders at mosques over 12 weeks. Indoor-air-quality feedback comprised providing households with feedback on their indoor air quality measured over 24 h. Households in the usual services group received no intervention. Masking of participants and mosque leaders was not possible. The primary outcome was the 24-h mean household airborne fine particulate matter (<2·5 microns in diameter [PM2·5]) concentration (a marker of second-hand smoke) at 12 months after randomisation. Cost-effectiveness was estimated using incremental cost-effectiveness ratios (ICERs). This trial is registered with ISRCTN, 49975452. FINDINGS: Between April 11 and Aug 2, 2018, we enrolled 1801 households from 45 mosques. 640 households (35·5%) were assigned to the smoke-free-home intervention plus indoor-air-quality feedback group, 560 (31·1%) to the smoke-free-home intervention only group, and 601 (33·4%) to the usual services group. At 12 months, the adjusted mean difference in household mean 24-h PM2·5 concentration was -1·0 µg/m3 (95% CI -12·8 to 10·9, p=0·88) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the usual services group, 5·0 µg/m3 (-7·9 to 18·0, p=0·45) for the smoke-free-home intervention only group versus the usual services group, and -6·0 µg/m3 (-18·3 to 6·3, p=0·34) for the smoke-free-home intervention plus indoor-air-quality feedback group versus the smoke-free-home intervention only group. The ICER for the smoke-free-home intervention plus indoor-air-quality feedback versus usual services was US$653 per quality-adjusted life-year (QALY) gained, which was more than the upper limit of the Bangladesh willingness-to-pay threshold of $427 per QALY. INTERPRETATION: The smoke-free-home intervention, with or without indoor-air-quality feedback, was neither effective nor cost-effective in reducing household second-hand-smoke exposure compared with usual services. These interventions are therefore not recommended for Bangladesh. FUNDING: Medical Research Council UK. TRANSLATION: For the Bengali translation of the abstract see Supplementary Materials section.

Impact of severe mental illness on healthcare use and health outcomes for people with type 2 diabetes: a longitudinal observational study in England.

BACKGROUND: People with severe mental illnesses (SMIs) have reduced life expectancy compared with the general population. Diabetes is a contributor to this disparity, with higher prevalence and poorer outcomes in people with SMI. AIM: To determine the impact of SMI on healthcare processes and outcomes for people with type 2 diabetes (T2DM). DESIGN AND SETTING: Retrospective, observational, matched, nested, case-control study conducted in England using patient records from the Clinical Practice Research Datalink, linked to Hospital Episode Statistics. METHOD: A range of healthcare processes (primary care consultations, physical health checks, and metabolic measurements) and outcomes (prevalence and hospitalisation for cardiovascular disease [CVD], and mortality risk) were compared for 2192 people with SMI and T2DM (cases) with 7773 people who had diabetes alone (controls). Sociodemographics, comorbidity, and medication prescription were covariates in regression models. RESULTS: When compared with results for participants with T2DM only, SMI was associated with increased risk of all-cause mortality (hazard ratio [HR] 1.919, 95% confidence interval [CI] = 1.602 to 2.300) and CVD-specific mortality (HR 2.242, 95% CI = 1.547 to 3.250), higher primary care physician consultation rates (incidence rate ratio [IRR] 1.149, 95% CI = 1.111 to 1.188), more-frequent checks of blood pressure (IRR 1.024, 95% CI = 1.003 to 1.046) and cholesterol (IRR 1.038, 95% CI = 1.019 to 1.058), lower prevalence of angina (odds ratio 0.671, 95% CI = 0.450 to 1.001), more emergency admissions for angina (IRR 1.532, 95% CI = 1.069 to 2.195), and fewer elective admissions for ischaemic heart disease (IRR 0.682, 95% CI = 0.508 to 0.915). CONCLUSION: Monitoring of metabolic measurements was comparable for people with T2DM who did, and did not, have SMI. Increased mortality rates observed in people with SMI may be attributable to underdiagnosis of CVD and delays in treatment.

A Generic Model for Follicular Lymphoma: Predicting Cost, Life Expectancy, and Quality-Adjusted-Life-Year Using UK Population-Based Observational Data.

OBJECTIVES: To use real-world data to develop a flexible generic decision model to predict cost, life expectancy, and quality-adjusted life-years (QALYs) for follicular lymphoma (FL) in the general patient population. METHODS: All patients newly diagnosed with FL in the UK's population-based Haematological Malignancy Research Network (www.hmrn.org) between 2004 and 2011 were followed until 2015 (N = 740). Treatment pathways, QALYs, and costs were incorporated into a discrete event simulation to reflect patient heterogeneity, including age and disease management. Two scenario analyses, based on the latest National Institute for Health and Clinical Excellence (NICE) guidelines (rituximab induction therapy for newly diagnosed asymptomatic patients and rituximab maintenance therapy for patients between treatments), were conducted and their economic impacts were compared to current practice. RESULTS: Incidence-based analysis revealed expected average lifetime costs ranging from £6,165 [US$7,709] to £63,864 [US$79,862] per patient, and average life expectancy from 75 days to 17.56 years. Prevalence-based analysis estimated average annual treatment costs of £60-65 million [US$75-80 million], accounting for approximately 10% of the United Kingdom's annual National Health Service budget for hematological cancers as a whole. Assuming that treatment effects reported in trials are applicable to all patient groups, scenario analyses for two recent NICE guidelines demonstrated potential annual cost savings for the United Kingdom that ranged with uptake frequency from £0.6 million to £11 million [US$0.75-2.75 million]. CONCLUSIONS: Costs, survival, and QALYs associated with FL vary markedly with patient characteristics and disease management. Allowing the production of more realistic outcomes across the patient population as a whole, our model addresses this heterogeneity and is a useful tool with which to evaluate new technologies/treatments to support healthcare decision makers.

Risk factors for poor outcomes of children with acute acalculous cholecystitis.

BACKGROUND: Acute acalculous cholecystitis (AAC) is generally considered to be a mild disease in children; however, if left untreated or treated without caution, AAC can lead to severe outcomes, such as death. The objectives of this study were to present the clinical features and identify the predictors of mortality in pediatric AAC. METHODS: Patients diagnosed with AAC between 2005 and 2012 were enrolled. AAC was defined by the presence of fever and an echo-proven thickened gallbladder wall exceeding 4 mm. A poor health outcome was defined as death. Further information related to the demographics, clinical manifestations, laboratory results, ultrasound findings, and pathogens present in the AAC patients was also collected. Predictors of mortality were identified by association analyses and confirmed by multivariate logistic regression. RESULTS: A total of 147 pediatric AAC patients (male/female = 1.01, mean age = 5.2 years) were included in this retrospective study. The most common clinical presentation was an elevated C-reactive protein level (84%) followed by hepatomegaly (80%) and anorexia (78%). AAC in children was associated with various diseases, including infectious diseases (70%), systemic diseases (13%), and malignancy (11%). Fourteen of the 147 (9.25%) patients died during the study period. The presences of thrombocytopenia, anemia, gallbladder sludge, hepatitis, and/or sepsis plus hepatitis were found to be the important predictors of AAC mortality. CONCLUSIONS: The factors associated with AAC mortality were anemia, thrombocytopenia, gallbladder sludge, hepatitis, and sepsis plus hepatitis. These predictors are likely to help clinicians identify patients who are at a high risk of poor prognoses and make appropriate clinical decisions.

Treatment cost and life expectancy of diffuse large B-cell lymphoma (DLBCL): a discrete event simulation model on a UK population-based observational cohort.

BACKGROUND: Diffuse large B-cell lymphoma (DLBCL) is the commonest non-Hodgkin lymphoma. Previous studies examining the cost of treating DLBCL have generally focused on a specific first-line therapy alone; meaning that their findings can neither be extrapolated to the general patient population nor to other points along the treatment pathway. Based on empirical data from a representative population-based patient cohort, the objective of this study was to develop a simulation model that could predict costs and life expectancy of treating DLBCL. METHODS: All patients newly diagnosed with DLBCL in the UK's population-based Haematological Malignancy Research Network ( www.hmrn.org ) in 2007 were followed until 2013 (n = 271). Mapped treatment pathways, alongside cost information derived from the National Tariff 2013/14, were incorporated into a patient-level simulation model in order to reflect the heterogeneities of patient characteristics and treatment options. The NHS and social services perspective was adopted, and all outcomes were discounted at 3.5 % per annum. RESULTS: Overall, the expected total medical costs were £22,122 for those treated with curative intent, and £2930 for those managed palliatively. For curative chemotherapy, the predicted medical costs were £14,966, £23,449 and £7376 for first-, second- and third-line treatments, respectively. The estimated annual cost for treating DLBCL across the UK was around £88-92 million. CONCLUSIONS: This is the first cost modelling study using empirical data to provide 'real world' evidence throughout the DLBCL treatment pathway. Future application of the model could include evaluation of new technologies/treatments to support healthcare decision makers, especially in the era of personalised medicine.

Long-term medical costs and life expectancy of acute myeloid leukemia: a probabilistic decision model.

BACKGROUND: Acute myeloid leukemia (AML) can be diagnosed at any age and treatment, which can be given with supportive and/or curative intent, is considered expensive compared with that for other cancers. Despite this, no long-term predictive models have been developed for AML, mainly because of the complexities associated with this disease. OBJECTIVE: The objective of the current study was to develop a model (based on a UK cohort) to predict cost and life expectancy at a population level. METHODS: The model developed in this study combined a decision tree with several Markov models to reflect the complexity of the prognostic factors and treatments of AML. The model was simulated with a cycle length of 1 month for a time period of 5 years and further simulated until age 100 years or death. Results were compared for two age groups and five different initial treatment intents and responses. Transition probabilities, life expectancies, and costs were derived from a UK population-based specialist registry-the Haematological Malignancy Research Network (www.hmrn.org). RESULTS: Overall, expected 5-year medical costs and life expectancy ranged from £8,170 to £81,636 and 3.03 to 34.74 months, respectively. The economic and health outcomes varied with initial treatment intent, age at diagnosis, trial participation, and study time horizon. The model was validated by using face, internal, and external validation methods. The results show that the model captured more than 90% of the empirical costs, and it demonstrated good fit with the empirical overall survival. CONCLUSIONS: Costs and life expectancy of AML varied with patient characteristics and initial treatment intent. The robust AML model developed in this study could be used to evaluate new diagnostic tools/treatments, as well as enable policy makers to make informed decisions.

Place of death in haematological malignancy: variations by disease sub-type and time from diagnosis to death.

BACKGROUND: The reasons patients with haematological malignancies die in hospital more often than those with other cancers is the subject of much speculation. We examined variations in place of death by disease sub-type and time from diagnosis to death, to identify groups of 'at-risk' patients. METHODS: The study is based in the United Kingdom within the infrastructure of the Haematological Malignancy Research Network (HMRN), a large on-going population-based cohort including all patients newly diagnosed with haematological malignancies in the north of England. Diagnostic, demographic, prognostic, treatment and outcome data are collected for each patient and individuals are 'flagged' for death. This study includes all adults (≥18 years) diagnosed 1st September 2004 to 31st August 2010 (n = 10,325), focussing on those who died on/before 31st August 2012 (n = 4829). RESULTS: Most deaths occurred in hospital (65.9%), followed by home (15.6%), nursing home (11%) and hospice (7.5%) and there was little variation by diagnostic sub-type overall. Differences in place of death were, however, observed by time from diagnosis to death, and this was closely related to sub-type; 87.7% of deaths within a month of diagnosis happened in hospital and these largely occurred in patients with acute myeloid leukaemia, diffuse large B-cell lymphoma and myeloma. Patients surviving longer, and particularly beyond 1 year, were less likely to die in hospital and this corresponded with an increase in the proportion of home deaths. CONCLUSIONS: Time from diagnosis to death was clearly a major determinant of place of death and many patients that died within three months of diagnosis did so in hospital. This was closely related to disease sub-type, with early deaths occurring most notable in the more aggressive diseases. This is likely to be due to a combination of factors including acute presentation, rapid disease progression without transition to a palliative approach to care and complications of treatment. Nonetheless, hospital deaths also occurred frequently in indolent diseases, suggesting that other factors were likely to contribute to the large proportion of hospital deaths overall. More evidence is needed to fully understand these complex cancers.

Costs of cervical cancer and precancerous lesions treatment in a publicly financed health care system.

PURPOSE: Although cervical cancer is the most frequent cancer for women in Taiwan, no examination of its treatment costs has yet been undertaken. This study aimed to investigate the costs of cervical cancer and precancerous lesion treatment in Taiwan. METHODS: A total of 7,398 cases of cervical intraepithelial neoplasia (CIN) lesions were identified from the Taiwan Cervical Cancer Screening Registration System in 2003. A further 1,469 cases of invasive cervical cancer (ICC) were also identified from a survey on cervical cancer staging information conducted by the Taiwan Cancer Registration Task Force. Resource usage covering the first 6 months after CIN diagnosis and the 5 years after ICC diagnosis were extracted from the National Health Insurance claims database. The duration of each visit and the transportation costs were collected by means of personal interviews with CIN/ICC patients. The mean and standard deviation of the treatment and indirect costs were estimated. RESULTS: The average total costs for CIN patients were NT$4,201 for CIN1, NT$8,623 for CIN2 and NT$14,406 for CIN3, with the indirect costs accounting for 25-33% of the total. The total costs for ICC patients were NT$210,230 for Stage 1, NT$392,387 for Stage 2, NT$433,969 for Stage 3 and NT$464,701 for Stage 4, with the indirect costs accounting for about 14-17% of the total. CONCLUSIONS: CIN and ICC treatment resulted in considerable costs to the healthcare system in Taiwan. Indirect costs associated with such treatment were also substantial and cannot be ignored.

Risk-adjusted cesarean section rates for the assessment of physician performance in Taiwan: a population-based study.

BACKGROUND: Over the past decade, about one-third of all births nationwide in Taiwan were delivered by cesarean section (CS). Previous studies in the US and Europe have documented the need for risk adjustment for fairer comparisons among providers. In this study, we set out to determine the impact that adjustment for patient-specific risk factors has on CS among different physicians in Taiwan. METHODS: There were 172,511 live births which occurred in either hospitals or obstetrics/gynecology clinics between 1 January and 31 December 2003, and for whom birth certificate data could be linked with National Health Insurance (NHI) claims data, available as the sample for this study. Physicians were divided into four equivalent groups based upon the quartile distribution of their crude (actual) CS rates. Stepwise logistic regressions were conducted to develop a predictive model and to determine the expected (risk-adjusted) CS rate and 95% confidence interval (CI) for each physician. The actual rates were then compared with the expected CS rates to see the proportion of physicians whose actual rates were below, within, or above the predicted CI in each quartile. RESULTS: The proportion of physicians whose CS rates were above the predicted CI increased as the quartile moved to the higher level. However, more than half of the physicians whose actual rates were higher than the predicted CI were not in the highest quartile. Conversely, there were some physicians (40 of 258 physicians) in the highest quartile who were actually providing obstetric care that was appropriate to the risk. When a stricter standard was applied to the assessment of physician performance by excluding physicians in quartile 4 for predicting CS rates, as many as 60% of physicians were found to have higher CS rates than the predicted CI, and indeed, the CS rates of no physicians in either quartile 3 or quartile 4 were below the predicted CI. CONCLUSION: Overall, our study found that the comparison of unadjusted CS rates might not provide a valid reflection of the quality of obstetric care delivered by physicians, and may ultimately lead to biased judgments by purchasers. Our study has also shown that when we changed the standard of quality assessment, the evaluation results also changed.