Clinical effectiveness of the psychological therapy Mental Health Intervention for Children with Epilepsy in addition to usual care compared with assessment-enhanced usual care alone: a multicentre, randomised controlled clinical trial in the UK.

BACKGROUND: Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties. METHODS: We conducted a parallel group, multicentre, open-label, randomised controlled trial of participants aged 3-18 years, attending epilepsy clinics across England and Northern Ireland who met diagnostic criteria for a common mental health disorder. Participants were randomised (1:1; using an independent web-based system) to receive the Mental Health Intervention for Children with Epilepsy (MICE) in addition to usual care, or assessment-enhanced usual care alone (control). Children and young people in both groups received a full diagnostic mental health assessment. MICE was a modular psychological intervention designed to treat common mental health conditions in children and young people using evidence-based approaches such as cognitive behaviour therapy and behavioural parenting strategies. Usual care for mental health disorders varied by site but typically included referral to appropriate services. Participants, along with their caregivers, and clinicians were not masked to treatment allocation but statisticians were masked until the point of analysis. The primary outcome, analysed by modified intention-to-treat, was the parent-report Strengths and Difficulties Questionnaire (SDQ) at 6 months post-randomisation. The study is complete and registered with ISRCTN (57823197). FINDINGS: 1401 young people were potentially deemed eligible for study inclusion. Following the exclusion of 531 young people, 870 participants were assessed for eligibility and completed the SDQ, and 480 caregivers provided consent for study inclusion between May 20, 2019, and Jan 31, 2022. Between Aug 28, 2019, and Feb 21, 2022, 334 participants (mean ages 10·5 years [SD 3·6] in the MICE group vs 10·3 [4·0] in control group at baseline) were randomly assigned to an intervention using minimisation balanced by age, primary mental health disorder, diagnosis of intellectual disability, and autistic spectrum disorder at baseline. 168 (50%) of the participants were female and 166 (50%) were male. 166 participants were randomly assigned to the MICE group and 168 were randomly assigned to the control group. At 6 months, the mean SDQ difficulties for the 148 participants in the MICE group was 17·6 (SD 6·3) and 19·6 (6·1) for the 148 participants in the control group. The adjusted effect of MICE was -1·7 (95% CI -2·8 to -0·5; p=0·0040; Cohen's d, 0·3). 14 (8%) patients in the MICE group experienced at least one serious adverse event compared with 24 (14%) in the control group. 68% percent of serious adverse events (50 events) were admission due to seizures. INTERPRETATION: MICE was superior to assessment-enhanced usual care in improving symptoms of emotional and behavioural difficulties in young people with epilepsy and common mental health disorders. The trial therefore shows that mental health comorbidities can be effectively and safely treated by a variety of clinicians, utilising an integrated intervention across ages and in the context of intellectual disability and autism. The evidence from this trial suggests that such a model should be fully embedded in epilepsy services and serves as a model for other chronic health conditions in young people. FUNDING: UK National Institute for Health Research Programme Grants for Applied Research programme and Epilepsy Research UK Endeavour Project Grant.

Estimating the Lifetime Costs and Benefits of the Incredible Years Teacher Classroom Management Intervention Using Data From 30 Months Follow-Up of the Supporting Teachers and childRen in Schools Trial.

OBJECTIVES: The Incredible Years Teacher® Classroom Management (IY-TCM) intervention is associated with short-term improvements in mental health difficulties in young people. The aim was to estimate the long-term impact and cost-effectiveness of the IY-TCM intervention compared with no intervention. METHODS: An existing health economic model (LifeSim 1.0) was used to translate short-term changes in the Strength and Difficulties Questionnaire (SDQ), based on the Supporting Teachers and childRen in Schools cluster randomized controlled trial of the IY-TCM intervention in schools, into estimated medium- and long-term effects using multiple longitudinal data sets. LifeSim 1.0 was adapted to incorporate teacher-reported SDQ and account for individual heterogeneity. Cost-effectiveness analyses were conducted using the trial-based intervention cost with subgroup analyses on deprivation, conduct scores and parental depression in the simulated baseline population. RESULTS: Regression analyses show significant predictor variables for intervention effectiveness, including deprivation and baseline SDQ. LifeSim results indicate small gains in long-term outcomes, and cost-effective analyses estimated that the IY-TCM intervention could be cost-effective, but there was a large amount of uncertainty (net monetary benefit = £10, Estimated CI = -£134, £156). Benefits and certainty of cost-effectiveness were greater for some subgroups, such as those with high conduct scores at baseline (net monetary benefit = £206, Estimated CI = £26, £318). CONCLUSIONS: IY-TCM could be cost-effective, but there was a large amount of uncertainty around costs and benefits. Greater benefits for pupils with difficulties at baseline suggest that the intervention may be more cost-effective for schools in more deprived areas with high levels of conduct problems.

Is well-becoming important for children and young people? Evidence from in-depth interviews with children and young people and their parents.

PURPOSE: This study explores how important well-becoming factors appear to be to children during childhood. We define well-becoming as the indicators which predict children and young people's future wellbeing and opportunities. The priority for this work was to explore whether well-becoming might be an important factor to include in outcome measures for children and young people. The inclusion of well-becoming indicators could ensure that opportunities to invest in promoting wellbeing in children's futures are not missed. METHODS: In-depth, qualitative interviews (N = 70) were undertaken with children and young people aged 6-15 years and their parents. Analysis used constant comparison and framework methods to investigate whether well-becoming factors were considered important by informants to children and young people's current wellbeing. RESULTS: The findings of the interviews suggested that children and young people and their parents are concerned with future well-becoming now, as factors such as future achievement, financial security, health, independence, identity, and relationships were identified as key to future quality of life. Informants suggested that they considered it important during childhood to aspire towards positive outcomes in children and young people's futures. CONCLUSION: The study findings, taken alongside relevant literature, have generated evidence to support the notion that future well-becoming is important to current wellbeing. We have drawn on our own work in capability wellbeing measure development to demonstrate how we have incorporated a well-becoming attribute into our measures. The inclusion of well-becoming indicators in measures could aid investment in interventions which more directly improve well-becoming outcomes for children and young people.

An exploration of service use pattern changes and cost analysis following implementation of community perinatal mental health teams in pregnant women with a history of specialist mental healthcare in England: a national population-based cohort study.

BACKGROUND: The National Health Service in England pledged >£365 million to improve access to mental healthcare services via Community Perinatal Mental Health Teams (CPMHTs) and reduce the rate of perinatal relapse in women with severe mental illness. This study aimed to explore changes in service use patterns following the implementation of CPMHTs in pregnant women with a history of specialist mental healthcare in England, and conduct a cost-analysis on these changes. METHODS: This study used a longitudinal cohort design based on existing routine administrative data. The study population was all women residing in England with an onset of pregnancy on or after 1st April 2016 and who gave birth on or before 31st March 2018 with pre-existing mental illness (N = 70,323). Resource use and costs were compared before and after the implementation of CPMHTs. The economic perspective was limited to secondary mental health services, and the time horizon was the perinatal period (from the start of pregnancy to 1-year post-birth, ~ 21 months). RESULTS: The percentage of women using community mental healthcare services over the perinatal period was higher for areas with CPMHTs (30.96%, n=9,653) compared to areas without CPMHTs (24.72%, n=9,615). The overall percentage of women using acute care services (inpatient and crisis resolution teams) over the perinatal period was lower for areas with CPMHTs (4.94%, n=1,540 vs. 5.58%, n=2,171), comprising reduced crisis resolution team contacts (4.41%, n=1,375 vs. 5.23%, n=2,035) but increased psychiatric admissions (1.43%, n=445 vs. 1.13%, n=441). Total mental healthcare costs over the perinatal period were significantly higher for areas with CPMHTs (fully adjusted incremental cost £111, 95% CI £29 to £192, p-value 0.008). CONCLUSIONS: Following implementation of CPMHTs, the percentage of women using acute care decreased while the percentage of women using community care increased. However, the greater use of inpatient admissions alongside greater use of community care resulted in a significantly higher mean cost of secondary mental health service use for women in the CPMHT group compared with no CPMHT. Increased costs must be considered with caution as no data was available on relevant outcomes such as quality of life or satisfaction with services.

Olanzapine for young PEople with aNorexia nervosa (OPEN): A protocol for an open-label feasibility study.

INTRODUCTION: Antipsychotics are routinely prescribed off-label for anorexia nervosa (AN) despite limited evidence. This article presents a protocol of a study aiming to assess the feasibility of a future definitive trial on olanzapine in young people with AN. METHODS AND ANALYSIS: In an open-label, one-armed feasibility study, 55 patients with AN or atypical AN, aged 12-24, receiving outpatient, inpatient or day-care treatment who are considered for olanzapine treatment will be recruited from NHS sites based in England. Assessments will be conducted at screening, baseline and at 8-, 16 weeks, 6- and 12 months. Primary feasibility parameters will be proportions of patients who agree to take olanzapine and who adhere to treatment and complete study assessments. Qualitative methods will be used to explore acceptability of the intervention and study design. Secondary feasibility parameters will be changes in body mass index, psychopathology, side effects, health-related quality of life, carer burden and proportion of participants who would enrol in a future randomised controlled trial. The study is funded by the National Institute for Health Research via Health Technology Assessment programme. DISCUSSION: Olanzapine for young PEople with aNorexia nervosa will inform a future randomised controlled trial on the efficacy and safety of prescribing olanzapine in young people with AN.

Autopsy of a failed trial part 2: Outcomes, challenges, and lessons learnt from the DAISIES trial.

OBJECTIVE: The relative merits of inpatient or day-treatment for adults with anorexia nervosa (AN) are unknown. The DAISIES trial aimed to establish the non-inferiority of a stepped-care day patient treatment (DPT) approach versus inpatient treatment as usual (IP-TAU) for improving body mass index (BMI) at 12 months in adults with AN. The trial was terminated due to poor recruitment. This paper presents outcomes and investigates the reasons behind the trial's failure. METHOD: Fifteen patients with AN (of 53 approached) participated and were followed-up to 6 or 12 months. Summary statistics were calculated due to low sample size, and qualitative data concerning treatment experiences were analysed using thematic analysis. RESULTS: At baseline, participants in both trial arms rated stepped-care DPT as more acceptable. At 12 months, participants' BMIs had increased in both trial arms. Qualitative analysis highlighted valued and challenging aspects of care across settings. Only 6/12 sites opened for recruitment. Among patients approached, the most common reason for declining participation was their treatment preference (n = 12/38). CONCLUSIONS: No conclusions can be drawn concerning the effectiveness of IP-TAU and stepped-care DPT, but the latter was perceived more positively. Patient-related, service-related and systemic factors (COVID-19) contributed to the trial's failure. Lessons learnt can inform future studies.

The Cost-Effectiveness of Financial Incentives to Achieve Heroin Abstinence in Individuals With Heroin Use Disorder Starting New Treatment Episodes: A Cluster Randomized Trial-Based Economic Evaluation.

OBJECTIVES: Cost-effectiveness analysis of two 12-week contingency management (CM) schedules targeting heroin abstinence or attendance at weekly keyworker appointments for opioid agonist treatment compared with treatment as usual (TAU). METHODS: A cost-effectiveness analysis was conducted alongside a cluster randomized trial of 552 patients from 34 clusters (drug treatment clinics) randomly allocated 1:1:1 to opioid agonist treatment plus weekly keyworker appointments with (1) CM targeted at heroin abstinence (CM abstinence), (2) CM targeted at on-time attendance at weekly appointments (CM attendance), or (3) no CM (TAU). The primary cost-effectiveness analysis at 24 weeks after randomization took a societal cost perspective with effects measured in heroin-negative urine samples. RESULTS: At 24 weeks, mean differences in weekly heroin-negative urine results compared with TAU were 0.252 (95% confidence interval [CI] -0.397 to 0.901) for CM abstinence and 0.089 (95% CI -0.223 to 0.402) for CM attendance. Mean differences in costs were £2562 (95% CI £32-£5092) for CM abstinence and £317 (95% CI -£882 to £1518) for CM attendance. Incremental cost-effectiveness ratios were £10 167 per additional heroin-free urine for CM abstinence and £3562 for CM attendance with low probabilities of cost-effectiveness of 3.5% and 36%, respectively. Results were sensitive to timing of follow-up for CM attendance, which dominated TAU (better outcomes, lower costs) at 12 weeks, with an 88.4% probability of being cost-effective. Probability of cost-effectiveness remained low for CM abstinence (8.6%). CONCLUSIONS: Financial incentives targeted toward heroin abstinence and treatment attendance were not cost-effective over the 24-week follow-up. Nevertheless, CM attendance was cost-effective over the treatment period (12 weeks), when participants were receiving keyworker appointments and incentives.

Management of fraudulent participants in online research: Practical recommendations from a randomized controlled feasibility trial.

OBJECTIVE: Fraudulent participation is an escalating concern for online clinical trials and research studies and can have a significant negative impact on findings. We aim to shed light on the risk and to provide practical recommendations for detecting and managing such instances. METHODS: The FREED-Mobile (FREED-M) study is an online, randomized controlled feasibility trial to assess a digital early intervention for young people (aged 16-25) in England or Wales with eating problems. The trial involved baseline (week 0), post-intervention (week 4), and follow-up (week 12) surveys, alongside weekly modules provided over 4 weeks on the study website. Study completers were compensated with £20 shopping vouchers. Despite the complexity of the trial design, two instances of fraudulent sign-ups occurred in January and March 2023. To counter this, we developed a "fraudulent participants protocol" following internal investigations and discussions with collaborators. RESULTS: The implementation of prevention measures such as reCAPTCHA updates, IP address review, and changes in reimbursement effectively halted further fraudulent sign-ups. Our protocol facilitated the systematic identification and withdrawal of suspected or clear fraudsters and was demonstrably robust at distinguishing between fraudsters and genuine responders. DISCUSSION: All remote, online trials or studies are at risk of fraudulent participation. Drawing from our experience and existing literature, we offer practical recommendations for researchers considering online recruitment and data collection. Vigilance and the integration of deterrents, and data quality checks into the study design from the outset are advised to safeguard research integrity. PUBLIC SIGNIFICANCE: Fraudulent participation in digital research can have asignificant impact on research findings, potentially leading to biased resultsand misinformed decisions. We developed an effective protocol for theprevention, identification, and management of fraudulent participants. Bysharing our insights and recommendations, we hope to raise awareness of thisissue and provide other researchers with the knowledge and strategies necessaryto safeguard research integrity moving forward.

Protocol for an economic evaluation of scalable strategies to improve mental health among perinatal women: non-specialist care delivered via telemedicine vs. specialist care delivered in-person.

BACKGROUND: Perinatal depression affects an estimated 1 in 5 women in North America during the perinatal period, with annualized lifetime costs estimated at $20.6 billion CAD in Canada and over $45.9 billion USD in the US. Access to psychological treatments remains limited for most perinatal women suffering from depression and anxiety. Some barriers to effective care can be addressed through task-sharing to non-specialist providers and through telemedicine platforms. The cost-effectiveness of these strategies compared to traditional specialist and in-person models remains unknown. This protocol describes an economic evaluation of non-specialist providers and telemedicine, in comparison to specialist providers and in-person sessions within the ongoing Scaling Up Maternal Mental healthcare by Increasing access to Treatment (SUMMIT) trial. METHODS: The economic evaluation will be undertaken alongside the SUMMIT trial. SUMMIT is a pragmatic, randomized, non-inferiority trial across five North American study sites (N = 1,226) of the comparable effectiveness of two types of providers (specialist vs. non-specialist) and delivery modes (telemedicine vs. in-person) of a behavioural activation treatment for perinatal depressive and anxiety symptoms. The primary economic evaluation will be a cost-utility analysis. The outcome will be the incremental cost-effectiveness ratio, which will be expressed as the additional cost required to achieve an additional quality-adjusted life-year, as assessed by the EuroQol 5-Dimension 5-Level instrument. A secondary cost-effectiveness analysis will use participants' depressive symptom scores. A micro-costing analysis will be conducted to estimate the resources/costs required to implement and sustain the interventions; healthcare resource utilization will be captured via self-report. Data will be pooled and analysed using uniform price and utility weights to determine cost-utility across all trial sites. Secondary country-specific cost-utility and cost-effectiveness analyses will also be completed. Sensitivity analyses will be conducted, and cost-effectiveness acceptability-curves will be generated, in all instances. DISCUSSION: Results of this study are expected to inform key decisions related to dissemination and scale up of evidence-based psychological interventions in Canada, the US, and possibly worldwide. There is potential impact on real-world practice by informing decision makers of the long-term savings to the larger healthcare setting in services to support perinatal women with common mental health conditions.

The Effectiveness and Cost-Effectiveness of a Universal Digital Parenting Intervention Designed and Implemented During the COVID-19 Pandemic: Evidence From a Rapid-Implementation Randomized Controlled Trial Within a Cohort.

BACKGROUND: Children's conduct and emotional problems increased during the COVID-19 pandemic. OBJECTIVE: We tested whether a smartphone parenting support app, Parent Positive, developed specifically for this purpose, reversed these effects in a cost-effective way. Parent Positive includes 3 zones. Parenting Boosters (zone 1) provided content adapted from standard face-to-face parent training programs to tackle 8 specific challenges identified by parents and parenting experts as particularly relevant for parents during the pandemic. The Parenting Exchange (zone 2) was a parent-to-parent and parent-to-expert communication forum. Parenting Resources (zone 3) provided access to existing high-quality web-based resources on a range of additional topics of value to parents (eg, neurodevelopmental problems, diet, and sleep). METHODS: Supporting Parents And Kids Through Lockdown Experiences (SPARKLE), a randomized controlled trial, was embedded in the UK-wide COVID-19: Supporting Parents, Adolescents and Children during Epidemics (Co-SPACE) longitudinal study on families' mental health during the pandemic. Parents of children aged 4 to 10 years were randomized 1:1 to Parent Positive or follow-up as usual (FAU) between May 19, 2021, and July 26, 2021. Parent Positive provided advice on common parenting challenges and evidence-based web-based resources and facilitated parent-to-parent and expert-to-parent support. Child conduct and emotional problems and family well-being were measured before randomization (T1) and at 1 (T2) and 2 (T3) months after randomization. Service use, costs, and adverse events were measured, along with app use and satisfaction. The primary outcome was T2 parent-reported child conduct problems, which were analyzed using linear mixed regression models. RESULTS: A total of 320 participants were randomized to Parent Positive, and 326 were randomized to FAU. The primary outcome analysis included 79.3% (512/646) of the participants (dropout: 84/320, 26% on Parent Positive and 50/326, 15% on FAU). There were no statistically significant intervention effects on conduct problems at either T2 (standardized effect=-0.01) or T3 (secondary outcome; standardized effect=-0.09) and no moderation by baseline conduct problems. Significant intervention-related reductions in emotional problems were observed at T2 and T3 (secondary outcomes; standardized effect=-0.13 in both cases). Parent Positive, relative to FAU, was associated with more parental worries at T3 (standardized effect=0.14). Few intervention-attributable adverse events were reported. Parent Positive was cost-effective once 4 outliers with extremely high health care costs were excluded. CONCLUSIONS: Parent Positive reduced child emotional problems and was cost-effective compared with FAU once outliers were removed. Although small when considered against targeted therapeutic interventions, the size of these effects was in line with trials of nontargeted universal mental health interventions. This highlights the public health potential of Parent Positive if implemented at the community level. Nevertheless, caution is required before making such an interpretation, and the findings need to be replicated in large-scale, whole-community studies. TRIAL REGISTRATION: ClinicalTrials.gov NCT04786080; https://clinicaltrials.gov/ct2/show/NCT04786080.

Autopsy of a failed trial part 1: A qualitative investigation of clinician's views on and experiences of the implementation of the DAISIES trial in UK-based intensive eating disorder services.

OBJECTIVE: The DAISIES trial, comparing inpatient and stepped-care day patient treatment for adults with severe anorexia nervosa was prematurely terminated in March 2022 due to poor recruitment. This qualitative study seeks to understand the difficulties faced during the trial by investigating stakeholders' views on and experiences of its implementation. METHOD: Semi-structured interview and focus group transcripts, and trial management and oversight group meeting minutes from May 2020-June 2022 were analysed using thematic analysis. Participants were 47 clinicians and co-investigators involved with the DAISIES trial. The Non-Adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework was applied to the interpretive themes to classify barriers and facilitators to implementation. RESULTS: Five themes were identified: incompatible participation interests; changing standard practice; concerns around clinical management; systemic capacity and capability issues; and Covid-19 disrupting implementation. Applying the NASSS framework indicated the greatest implementation challenges to arise with the adopters (e.g. patients, clinicians), the organisational systems (e.g. service capacity), and the wider socio-political context (e.g. Covid-19 closing services). CONCLUSIONS: Our findings emphasise the top-down impact of systemic-level research implementation challenges. The impact of the Covid-19 pandemic accentuated pre-existing organisational barriers to trial implementation within intensive eating disorder services, further limiting the capacity for research.

Effectiveness and cost-effectiveness of psychiatric mother and baby units: quasi-experimental study.

BACKGROUND: Psychiatric mother and baby units (MBUs) are recommended for severe perinatal mental illness, but effectiveness compared with other forms of acute care remains unknown. AIMS: We hypothesised that women admitted to MBUs would be less likely to be readmitted to acute care in the 12 months following discharge, compared with women admitted to non-MBU acute care (generic psychiatric wards or crisis resolution teams (CRTs)). METHOD: Quasi-experimental cohort study of women accessing acute psychiatric care up to 1 year postpartum in 42 healthcare organisations across England and Wales. Primary outcome was readmission within 12 months post-discharge. Propensity scores were used to account for systematic differences between MBU and non-MBU participants. Secondary outcomes included assessment of cost-effectiveness, experience of services, unmet needs, perceived bonding, observed mother-infant interaction quality and safeguarding outcome. RESULTS: Of 279 women, 108 (39%) received MBU care, 62 (22%) generic ward care and 109 (39%) CRT care only. The MBU group (n = 105) had similar readmission rates to the non-MBU group (n = 158) (aOR = 0.95, 95% CI 0.86-1.04, P = 0.29; an absolute difference of -5%, 95% CI -14 to 4%). Service satisfaction was significantly higher among women accessing MBUs compared with non-MBUs; no significant differences were observed for any other secondary outcomes. CONCLUSIONS: We found no significant differences in rates of readmission, but MBU advantage might have been masked by residual confounders; readmission will also depend on quality of care after discharge and type of illness. Future studies should attempt to identify the effective ingredients of specialist perinatal in-patient and community care to improve outcomes.

The impact of COVID-19 pandemic on hospital admissions for nine diseases in Iran: insight from an interrupted time series analysis.

BACKGROUND: Associations between the COVID-19 pandemic and hospitalizations have not been studied Iran. This study aimed to examine the impact of the COVID-19 pandemic on hospital admissions for nine categories of disease in seven public hospitals in Kermsnahah city, the capital of Kermsnahah province, in the west of Iran. METHODS: Data on monthly hospitalization rates (number of hospitalizations per 100,000 population) were collected for nine categories of disease for a period of 40 months (23 months before and 17 months after the COVID-19 outbreak in Iran) from the health information systems of all seven public hospitals in Kermanshah city. Categories of disease included those related to pregnancy, childbirth and the puerperium period, neoplasms, diseases of the digestive, respiratory, circulatory, genitourinary and nervous systems, mental and behavioural disorders, and infectious and parasitic diseases. Population data were extracted from the Statistics Centre of Iran. An interrupted time series analysis with segmented regression was used to examine the impact of COVID-19 on hospital admissions. FINDINGS: Average monthly hospitalization rates fell for all nine categories of disease included in the study after the onset of the pandemic, with overall rates of 85.5 per 100,000 population in the period before the COVID-19 outbreak and 50.4 per 100,000 population after the outbreak began. The relative reduction in hospitalizations for the nine diseases was 56.4%. Regression analysis of monthly data indicated a sharp decrease in hospitalisations during the first month after the COVID-19 outbreak, which was statistically significant for all diseases (p < 0.001). After the initial reduction following onset of the pandemic, significant increases were observed for some diseases, including neoplasms (increase of 3.17 per 100,000 population; p < 0.001), diseases of the digestive system (increase of 1.17 per 100,000 population; p < 0.001) and diseases related to pregnancy, childbirth and the puerperium period (increase of 1.73 per 100,000 population). For other categories of disease, rates significantly declined, including infectious and parasitic diseases (decrease of 2.46 per 100,000 population; p < 0.001). Hospitalization rates did not increase to pre-pandemic levels for any disease, with the exception of those related to pregnancy, childbirth and the puerperium period. CONCLUSIONS: Our study indicated that the COVID-19 pandemic had a significantly negative effect on hospitalizations in Iran. Although use of hospital care has gradually increased post-outbreak, it has yet to return to normal levels.

Mental health service use among pregnant and early postpartum women.

PURPOSE: To explore the proportion and characteristics of women with a mental disorder who have contact with mental health services during pregnancy and the postnatal period in a maternity service in London. METHODS: Data from the WEll-being in pregNancy stuDY (WENDY), a prospective cohort study, were used. Women were recruited at their first appointment for antenatal care and assessed for mental disorders using the Structured Clinical Interview DSM-IV Axis I/II Disorders for Research. Clinical, sociodemographic and psychosocial characteristics were collected. Mental health service use data were collected for the period from study entry to 3 months postpartum. RESULTS: Two hundred women met diagnostic criteria for a mental disorder. Fifty-five (34%) of these had at least one contact with mental health services. Moderate depression (OR 7.44, CI 2.03-27.28, p < 0.01), severe depression (OR 10.5, CI 2.68-41.12, p < 0.01), past psychiatric hospital admission (OR 3.76, CI 1.05-13.44, p < 0.05), symptoms of anxiety (OR 3.95, CI 1.86-8.37, p < 0.001) and perceived low levels of social support (OR 0.43, CI 0.18-1.01, p = 0.05) were associated with an increased likelihood of contact with mental health services in univariate analyses. However, only moderate (OR 5.92, CI 1.31-26.78, p = 0.02) and severe depression (OR 6.04, CI 1.08-33.72, p = 0.04) remained significant in the multivariate regressions analyses. CONCLUSION: Only a third of women with a diagnosable mental disorder at their first antenatal appointment had any contact with mental health services during pregnancy or up to 3 months postpartum. Further research is warranted to elicit perinatal women's views about the potential barriers to accessing professional mental health care.

Contributing factors to healthcare costs in individuals with autism spectrum disorder: a systematic review.

BACKGROUND: Individuals with autism spectrum disorder (ASD) are more likely to use healthcare than their counterparts without disabilities, which imposes high medical costs to families and health systems. This study aimed to investigate healthcare costs and its determinants among individuals with ASD. METHODS: In this systematic review, we searched online databases (Web of Science, Medline through PubMed and Scopus) for observational and experimental studies that included data on service use and costs associated with ASD and published between January 2000 and May 2021. Exclusion criteria included non-English language articles, duplicates, abstracts, qualitative studies, gray literature, and non-original papers (e.g., letters to editors, editorials, reviews, etc.). RESULTS: Our searches yielded 4015 articles screened according to PRISMA guidelines. Of 4015 studies identified, 37 articles from 10 countries were eligible for final inclusion. Therapeutic interventions, outpatient visits and medications constituted the largest proportion of direct medical expenditure on individuals with ASD. Included studies suggest lack of health insurance, having associated morbidities, more severe symptoms, younger age groups and lower socioeconomic status (SES) are associated with higher medical expenditure in individuals with ASD. CONCLUSIONS: This systematic review identified a range of factors, including lower SES and lack of health insurance, which are associated with higher healthcare costs in people with ASD. Our study supports the formulation of policy options to reduce financial risks in families of individuals with ASD in countries which do not have a tax-based or universal health coverage system.

Cost-effectiveness of screening tools for identifying depression in early pregnancy: a decision tree model.

BACKGROUND: Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. METHODS: A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. RESULTS: In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000-30,000 per QALY compared to around 20% for the no screen option. CONCLUSIONS: All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. CLINICAL TRIALS REGISTRATION: N/A.

Universal Mindfulness Training in Schools for Adolescents: a Scoping Review and Conceptual Model of Moderators, Mediators, and Implementation Factors.

There is evidence that universal school-based mindfulness training (SBMT) can have positive effects for young people. However, it is unknown who benefits most from such training, how training exerts effects, and how implementation impacts effects. This study aimed to provide an overview of the evidence on the mediators, moderators, and implementation factors of SBMT, and propose a conceptual model that can be used both to summarize the evidence and provide a framework for future research. A scoping review was performed, and six databases and grey literature were searched. Inclusion and exclusion criteria were applied to select relevant material. Quantitative and qualitative information was extracted from eligible articles and reported in accordance with PRISMA-ScR guidelines. The search produced 5479 articles, of which 31 were eligible and included in the review. Eleven studies assessed moderators of SBMT on pupil outcomes, with mixed findings for all variables tested. Five studies examined the mediating effect of specific variables on pupil outcomes, with evidence that increases in mindfulness skills and decreases in cognitive reactivity and self-criticism post-intervention are related to better pupil outcomes at follow-up. Twenty-five studies assessed implementation factors. We discuss key methodological shortcomings of included studies and integrate our findings with existing implementation frameworks to propose a conceptual model. Widespread interest in universal SBMT has led to increased research over recent years, exploring who SBMT works for and how it might work, but the current evidence is limited. We make recommendations for future research and provide a conceptual model to guide theory-led developments.

Autistic characteristics in eating disorders: Treatment adaptations and impact on clinical outcomes.

OBJECTIVE: Autistic people with eating disorders (EDs) may have special needs that are not met in standard ED treatment, raising the need for treatment adaptations to accommodate co-existing autism spectrum condition (ASC). Little is currently known about the nature of existing treatment options or adaptations for this population. We conducted a pre-registered systematic review to: (1) identify research articles describing existing interventions for patients with ED and comorbid ASC, and to critically review evidence of their clinical effectiveness and cost-effectiveness (Review 1); (2) review the impact of ASC comorbidity on ED clinical outcomes (Review 2). METHOD: Peer-reviewed studies published until the end of December 2020 were identified through a systematic search of the electronic databases: Medline, Embase, PsycINFO, Web of Science, CINAHL, Scopus and Cochrane Library. RESULTS: Only one clinical pathway of treatment adaptations (the 'PEACE' pathway) was identified in Review 1 with early evidence of cost-savings and favourable treatment outcomes. ASC characteristics were shown in Review 2 to have no direct impact on physical outcomes or ED symptoms, but could be associated with higher rates of comorbidities and greater use of intensive ED treatment. Additionally, patients with ASC characteristics may benefit more from individual sessions, rather than group sessions. CONCLUSIONS: Any new treatments or treatment adaptations may not directly impact on ED symptoms, but may be better able to support the complex needs of the ASC population, thus reducing subsequent need for intensive treatment. Future research is warranted to explore evidence of clinical and cost-effectiveness of interventions for this population.

Out of pocket expenses in obsessive compulsive disorder.

BACKGROUND: Despite anecdotal evidence that the out of pocket costs of OCD can be substantial in some cases, there is no evidence on how many people they affect, or the magnitude of these costs. AIMS: This paper explores the type and quantity of out of pocket expenses reported by a large sample of adults with OCD. METHODS: Data on out of pocket expenses were collected from participants taking part in the OCTET multi-centre randomised controlled trial. Participants were aged 18+, meeting DSM-IV criteria for OCD, and scoring 16+ on the Yale Brown Obsessive Compulsive Scale. Individual-level resource use data including a description and estimated cost of out of pocket expenses were measured using an adapted version of the Adult Service Use Schedule (AD-SUS): a questionnaire used to collect data on resource use. RESULTS: Forty-five percent (208/465) reported out of pocket expenses due to their OCD. The mean cost of out of pocket expenses was £19.19 per week (SD £27.56 SD), range £0.06-£224.00. CONCLUSIONS: Future economic evaluations involving participants with OCD should include out of pocket expenses, but careful consideration of alternative approaches to the collection and costing of this data is needed.

Cost and health impacts of adherence to the National Institute for Health and Care Excellence schizophrenia guideline recommendations.

BACKGROUND: Discrepancies between the National Institute for Health and Care Excellence (NICE) schizophrenia guideline recommendations and current clinical practice in the UK have been reported. AIMS: We aim to assess whether it is cost-effective to improve adherence to the NICE schizophrenia guideline recommendations, compared with current practice. METHOD: A previously developed whole-disease model for schizophrenia, using the discrete event simulation method, was adapted to assess the cost and health impacts of adherence to the NICE recommendations. Three scenarios to improve adherence to the clinical guidelines were modelled: universal provision of cognitive-behavioural therapy for patients at clinical high risk of psychosis, universal provision of family intervention for patients with first-episode psychosis and prompt provision of clozapine for patients with treatment-resistant schizophrenia. The primary outcomes were lifetime costs and quality-adjusted life-years gained. RESULTS: The results suggest full adherence to the guideline recommendations would decrease cost and improve quality-adjusted life-years. Based on the NICE willingness-to-pay threshold of £20 000-£30 000 per quality-adjusted life-year gained, prompt provision of clozapine for patients with treatment-resistant schizophrenia results in the greatest net monetary benefit, followed by universal provision of cognitive-behavioural therapy for patients at clinical high risk of psychosis, and universal provision of family intervention for patients with first-episode psychosis. CONCLUSIONS: Our results suggest that adherence to guideline recommendations would decrease cost and improve quality-adjusted life-years. Greater investment is needed to improve guideline adherence and therefore improve patient quality of life and realise potential cost savings.