To examine the costs and cost-effectiveness of mirtazapine compared to placebo over 12-week follow-up.

Economic evaluation in a double-blind randomized controlled trial of mirtazapine vs. placebo.

Community settings and care homes in 26 UK centers.

People with probable or possible Alzheimer’s disease and agitation.

Primary outcome included incremental cost of participants’ health and social care per 6-point difference in CMAI score at 12 weeks. Secondary cost-utility analyses examined participants’ and unpaid carers’ gain in quality-adjusted life years (derived from EQ-5D-5L, DEMQOL-Proxy-U, and DEMQOL-U) from the health and social care and societal perspectives.

One hundred and two participants were allocated to each group; 81 mirtazapine and 90 placebo participants completed a 12-week assessment (87 and 95, respectively, completed a 6-week assessment). Mirtazapine and placebo groups did not differ on mean CMAI scores or health and social care costs over the study period, before or after adjustment for center and living arrangement (independent living/care home). On the primary outcome, neither mirtazapine nor placebo could be considered a cost-effective strategy with a high level of confidence. Groups did not differ in terms of participant self- or proxy-rated or carer self-rated quality of life scores, health and social care or societal costs, before or after adjustment.

On cost-effectiveness grounds, the use of mirtazapine cannot be recommended for agitated behaviors in people living with dementia. Effective and cost-effective medications for agitation in dementia remain to be identified in cases where non-pharmacological strategies for managing agitation have been unsuccessful.

Evidence on the impact of the pandemic on healthcare presentations for self-harm has accumulated rapidly. However, existing reviews do not include studies published beyond 2020.

To systematically review evidence on presentations to health services following self-harm during the COVID-19 pandemic.

A comprehensive search of databases (WHO COVID-19 database; Medline; medRxiv; Scopus; PsyRxiv; SocArXiv; bioRxiv; COVID-19 Open Research Dataset, PubMed) was conducted. Studies published from 1 January 2020 to 7 September 2021 were included. Study quality was assessed with a critical appraisal tool.

Fifty-one studies were included: 57% (29/51) were rated as ‘low’ quality, 31% (16/51) as ‘moderate’ and 12% (6/51) as ‘high-moderate’. Most evidence (84%, 43/51) was from high-income countries. A total of 47% (24/51) of studies reported reductions in presentation frequency, including all six rated as high-moderate quality, which reported reductions of 17–56%. Settings treating higher lethality self-harm were overrepresented among studies reporting increased demand. Two of the three higher-quality studies including study observation months from 2021 reported reductions in self-harm presentations. Evidence from 2021 suggests increased numbers of presentations among adolescents, particularly girls.

Sustained reductions in numbers of self-harm presentations were seen into the first half of 2021, although this evidence is based on a relatively small number of higher-quality studies. Evidence from low- and middle-income countries is lacking. Increased numbers of presentations among adolescents, particularly girls, into 2021 is concerning. Findings may reflect changes in thresholds for help-seeking, use of alternative sources of support and variable effects of the pandemic across groups.

There is evidence that the COVID-19 pandemic has negatively affected mental health, but most studies have been conducted in the general population.

To identify factors associated with mental health during the COVID-19 pandemic in individuals with pre-existing mental illness.

Participants (N = 2869, 78% women, ages 18–94 years) from a UK cohort (the National Centre for Mental Health) with a history of mental illness completed a cross-sectional online survey in June to August 2020. Mental health assessments were the GAD-7 (anxiety), PHQ-9 (depression) and WHO-5 (well-being) questionnaires, and a self-report question on whether their mental health had changed during the pandemic. Regressions examined associations between mental health outcomes and hypothesised risk factors. Secondary analyses examined associations between specific mental health diagnoses and mental health.

A total of 60% of participants reported that mental health had worsened during the pandemic. Younger age, difficulty accessing mental health services, low income, income affected by COVID-19, worry about COVID-19, reduced sleep and increased alcohol/drug use were associated with increased depression and anxiety symptoms and reduced well-being. Feeling socially supported by friends/family/services was associated with better mental health and well-being. Participants with a history of anxiety, depression, post-traumatic stress disorder or eating disorder were more likely to report that mental health had worsened during the pandemic than individuals without a history of these diagnoses.

We identified factors associated with worse mental health during the COVID-19 pandemic in individuals with pre-existing mental illness, in addition to specific groups potentially at elevated risk of poor mental health during the pandemic.

Perinatal self-harm is of concern but poorly understood.

To determine if women's risk of self-harm changes in pregnancy and the first postpartum year, and if risk varies by mental illness, age and birth outcome.

This was a retrospective cohort study of 2 666 088 women aged 15–45 years from the 1 January 1990 to 31 December 2017 linked to 1 102 040 pregnancies and their outcomes, utilising the Clinical Practice Research Datalink and Pregnancy Register. We identified self-harm events and mental illness (depression/anxiety/addiction/affective/non-affective psychosis/eating/personality disorders) from clinical records and grouped women's age into 5-year bands. They calculated the rate of self-harm during discrete non-perinatal, pregnant and postpartum periods. We used a gap-time, stratified Cox model to manage multiple self-harm events, and calculated the unadjusted and adjusted hazard ratios (adjHR) of self-harm associated with pregnancy and the postpartum compared with non-perinatal periods. Pre-planned interactions tested if risk varied by mental illness, age and birth outcome.

The analysis included 57 791 self-harm events and 14 712 319 person-years of follow-up. The risk of self-harm shrank in pregnancy (2.07 v. 4.01 events/1000 person-years, adjHR = 0.53, 95% CI 0.49–0.58) for all women except for 15- to 19-year-olds (adjHR = 0.95, 95% CI 0.84–1.07) and the risk reduced most for women with mental illness (adjHR = 0.40, 95% CI 0.36–0.44). Postpartum, self-harm risk peaked at 6–12 months (adjHR = 1.08, 95% CI 1.02–1.15), at-risk groups included young women and women with a pregnancy loss or termination.

Maternity and perinatal mental health services are valuable. Family planning services might have psychological benefit, particularly for young women.

Little is known about mental health problems of children and young people (CYP) involved with public and private law family court proceedings, and how these CYP fare compared to those not involved in these significant disruptions to family life.

This study examined records of depression/anxiety in CYP involved in public and private law proceedings using linked population-level data across Wales.

Retrospective e-cohort study. We calculated the incidence of primary-care-recorded depression/anxiety among CYP involved in these proceedings and in a comparison group, using Poisson regression. Depression/anxiety outcomes following proceedings were evaluated using pairwise Cox regression, with age- and gender-matched controls of CYP who had no involvement with the courts.

CYP in the public group had twice the risk of depression (adjusted incidence rate ratio aIRR = 2.2; 95% CI 1.9–2.6) and 20% higher risk of anxiety (aIRR = 1.2; 95% CI 1.0–1.5) relative to the comparison group. The private group had 60% higher risk of depression (aIRR = 1.6; 95% CI 1.4–1.7) and 30% higher risk of anxiety (aIRR = 1.3; 95% CI 1.2–1.4). Following private law proceedings, CYP were more likely to have depression (hazard ratio HR = 1.9; 95% CI 1.7–2.1), and anxiety (HR = 1.4; 95% CI 1.2–1.6) than the control group. Following public proceedings, CYP were more likely to have depression (HR = 2.1; 95% CI 1.7–2.5). Incidence of anxiety or depression following court proceedings was around 4%.

Findings highlight the vulnerability of CYP involved in family court proceedings and increased risk of depression and anxiety. Schools, health professionals, social and family support workers have a role to play in identifying needs and ensuring CYP receive appropriate support before, during and after proceedings.

The coronavirus disease 2019 (COVID-19) pandemic and ensuing restrictions have negatively affected the mental health and well-being of the general population, and there is increasing evidence suggesting that lockdowns have led to a disruption of health services. In March 2020, South Africa introduced a lockdown in response to the COVID-19 pandemic, entailing the suspension of all non-essential activities and a complete ban of tobacco and alcohol sales. We studied the effect of the lockdown on mental health care utilisation rates in private-sector care in South Africa.

We conducted an interrupted time-series analysis using insurance claims from 1 January 2017 to 1 June 2020 of beneficiaries 18 years or older from a large private sector medical insurance scheme. We calculated weekly outpatient consultation and hospital admission rates for organic mental disorders, substance use disorders, serious mental disorders, depression, anxiety, other mental disorders, any mental disorder and alcohol withdrawal syndrome. We calculated adjusted odds ratios (OR) for the effect of the lockdown on weekly outpatient consultation and hospital admission rates and the weekly change in rates during the lockdown until 1 June 2020.

710 367 persons were followed up for a median of 153 weeks. Hospital admission rates (OR 0.38; 95% confidence interval (CI) 0.33–0.44) and outpatient consultation rates (OR 0.74; 95% CI 0.63–0.87) for any mental disorder decreased substantially after the introduction of the lockdown and did not recover to pre-lockdown levels by 1 June 2020. Health care utilisation rates for alcohol withdrawal syndrome doubled after the introduction of the lockdown, but the statistical uncertainty around the estimates was large (OR 2.24; 95% CI 0.69–7.24).

Mental health care utilisation rates for inpatient and outpatient services decreased substantially after the introduction of the lockdown. Hospital admissions and outpatient consultations for alcohol withdrawal syndrome increased after the introduction of the lockdown, but statistical uncertainty precludes strong conclusions about a potential unintended effect of the alcohol sales ban. Governments should integrate strategies for ensuring access and continuity of essential mental health services during lockdowns in pandemic preparedness planning.

Extrapolation is often required to inform cost-effectiveness (CE) evaluations of immune-checkpoint inhibitors (ICIs) since survival data from pivotal clinical trials are seldom complete. The objectives of this study were to evaluate the accuracy of estimates of long-term overall survival (OS) predicted in French CE assessment reports of ICIs, and to identify models presenting the best fit to the observed long-term survival data.

A systematic review of French assessment reports of ICIs in the metastatic setting since inception until May 2020 was performed. A targeted literature review was conducted to collect associated extended follow-up of randomized controlled trials (RCTs) used in the CE assessment reports. Difference between projected and observed OS was calculated. A range of standard parametric and spline-based models were applied to the extended follow-up data from the RCT to determine the best-fitting survival models.

Of the 121 CE assessment reports published, 11 reports met the inclusion criteria. OS was underestimated in 73 percent of the CE assessment reports. The mean relative difference between each source was −13 percent (median: −15 percent; IQR: −0.4 to 26 percent). Models providing the best fit were those that could reflect nonmonotonic hazards.

Based on the available data at the time of submission, longer-term survival of ICIs was not fully captured by the extrapolation models used in CE assessments. Standard and flexible parametric models which can capture nonmonotonic hazard functions provided the best fit to the extended follow-up data. However, these models may still have performed poorly if fitted to survival data available at the time of submission to the French National Authority for Health.