Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence.

The aim of this study was to generate an experts’ consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs.

An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health.

Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general.

The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.

To describe the cumulative seroprevalence of severe acute respiratory coronavirus virus 2 (SARS-CoV-2) antibodies during the coronavirus disease 2019 (COVID-19) pandemic among employees of a large pediatric healthcare system.

Prospective observational cohort study open to adult employees at the Children’s Hospital of Philadelphia, conducted April 20–December 17, 2020.

Employees were recruited starting with high-risk exposure groups, utilizing e-mails, flyers, and announcements at virtual town hall meetings. At baseline, 1 month, 2 months, and 6 months, participants reported occupational and community exposures and gave a blood sample for SARS-CoV-2 antibody measurement by enzyme-linked immunosorbent assays (ELISAs). A post hoc Cox proportional hazards regression model was performed to identify factors associated with increased risk for seropositivity.

In total, 1,740 employees were enrolled. At 6 months, the cumulative seroprevalence was 5.3%, which was below estimated community point seroprevalence. Seroprevalence was 5.8% among employees who provided direct care and was 3.4% among employees who did not perform direct patient care. Most participants who were seropositive at baseline remained positive at follow-up assessments. In a post hoc analysis, direct patient care (hazard ratio [HR], 1.95; 95% confidence interval [CI], 1.03–3.68), Black race (HR, 2.70; 95% CI, 1.24–5.87), and exposure to a confirmed case in a nonhealthcare setting (HR, 4.32; 95% CI, 2.71–6.88) were associated with statistically significant increased risk for seropositivity.

Employee SARS-CoV-2 seroprevalence rates remained below the point-prevalence rates of the surrounding community. Provision of direct patient care, Black race, and exposure to a confirmed case in a nonhealthcare setting conferred increased risk. These data can inform occupational protection measures to maximize protection of employees within the workplace during future COVID-19 waves or other epidemics.

A paradox of genetic and environmental factors are linked to schizophrenia. For example, cases may be familial or spontaneous. Extensive studies have failed to identify a single gene or small group of genes that accounts for the majority of cases. The complex inheritance pattern suggests a strong environmental component even for those who are predisposed to disease. Environmental factors linked to disease occur early in development. Our goal is to identify common biochemical pathways affected by factors linked to schizophrenia.

Our studies included DNA comparisons between monozygotic twins discordant for schizophrenia, computational evaluations of genomic positions of candidate genes using Genbank resources, and molecular genetic/epigenetic studies on dopamine metabolism in the synaptic cleft.

Twins studies linked schizophrenia to somatic DNA instability (p = <0.01). Genomic studies linked schizophrenia to interspersed fragile site regions (p = 0.001) of the genome that are hot spots for mutation and epigenetics changes. The molecular studies on dopamine metabolism linked schizophrenia to aberrant genetic and epigenetic changes.

These, and other results, point to the confluence of DNA stability (i.e. DNA replication/repair) and epigenetic modification. DNA replication/repair and epigenetic modification are linked at both the macromolecular and biochemical level, require folate, methionine, and cobalamine, and compete for intermediates important for the cellular response to oxidative stress. Mutations in these pathways are linked to schizophrenia, as have deficits in the essential nutrients. The consequences of genetic and/or environmental perturbations to these pathways are complex because many essential pathways and processes are affected.

Although immune-mediated inflammatory diseases (IMID) are associated with multiple mental health conditions, there is a paucity of literature assessing personality disorders (PDs) in these populations. We aimed to estimate and compare the incidence of any PD in IMID and matched cohorts over time, and identify sociodemographic characteristics associated with the incidence of PD.

We used population-based administrative data from Manitoba, Canada to identify persons with incident inflammatory bowel disease (IBD), multiple sclerosis (MS) and rheumatoid arthritis (RA) using validated case definitions. Unaffected controls were matched 5:1 on sex, age and region of residence. PDs were identified using hospitalisation or physician claims. We used unadjusted and covariate-adjusted negative binomial regression to compare the incidence of PDs between the IMID and matched cohorts.

We identified 19 572 incident cases of IMID (IBD n = 6,119, MS n = 3,514, RA n = 10 206) and 97 727 matches overall. After covariate adjustment, the IMID cohort had an increased incidence of PDs (incidence rate ratio [IRR] 1.72; 95%CI: 1.47–2.01) as compared to the matched cohort, which remained consistent over time. The incidence of PDs was similarly elevated in IBD (IRR 2.19; 95%CI: 1.69–2.84), MS (IRR 1.79; 95%CI: 1.29–2.50) and RA (IRR 1.61; 95%CI: 1.29–1.99). Lower socioeconomic status and urban residence were associated with an increased incidence of PDs, whereas mid to older adulthood (age 45–64) was associated with overall decreased incidence. In a restricted sample with 5 years of data before and after IMID diagnosis, the incidence of PDs was also elevated before IMID diagnosis among all IMID groups relative to matched controls.

IMID are associated with an increased incidence of PDs both before and after an IMID diagnosis. These results support the relevance of shared risk factors in the co-occurrence of PDs and IMID conditions.

After the diagnosis of immune-mediated inflammatory diseases (IMID) such as inflammatory bowel disease (IBD), multiple sclerosis (MS) and rheumatoid arthritis (RA), the incidence of psychiatric comorbidity is increased relative to the general population. We aimed to determine whether the incidence of psychiatric disorders is increased in the 5 years before the diagnosis of IMID as compared with the general population.

Using population-based administrative health data from the Canadian province of Manitoba, we identified all persons with incident IBD, MS and RA between 1989 and 2012, and cohorts from the general population matched 5 : 1 on year of birth, sex and region to each disease cohort. We identified members of these groups with at least 5 years of residency before and after the IMID diagnosis date. We applied validated algorithms for depression, anxiety disorders, bipolar disorder, schizophrenia, and any psychiatric disorder to determine the annual incidence of these conditions in the 5-year periods before and after the diagnosis year.

We identified 12 141 incident cases of IMID (3766 IBD, 2190 MS, 6350 RA) and 65 424 matched individuals. As early as 5 years before diagnosis, the incidence of depression [incidence rate ratio (IRR) 1.54; 95% CI 1.30–1.84) and anxiety disorders (IRR 1.30; 95% CI 1.12–1.51) were elevated in the IMID cohort as compared with the matched cohort. Similar results were obtained for each of the IBD, MS and RA cohorts. The incidence of bipolar disorder was elevated beginning 3 years before IMID diagnosis (IRR 1.63; 95% CI 1.10–2.40).

The incidence of psychiatric comorbidity is elevated in the IMID population as compared with a matched population as early as 5 years before diagnosis. Future studies should elucidate whether this reflects shared risk factors for psychiatric disorders and IMID, a shared final common inflammatory pathway or other aetiology.

This study investigated local perceptions of changes stemming from a long-standing Group Interpersonal Psychotherapy (IPT-G) program for the treatment of depression in rural Uganda. The study was conducted in a low-income, severely HIV/AIDS-affected area where in 2001 the prevalence of depression was estimated at 21% among adults.

Data were collected using free-listing and key informant qualitative interviews. A convenience sample of 60 free-list respondents was selected from among IPT-G participants, their families, and other community members from 10 Ugandan villages. Twenty-two key informants and six IPT-G facilitators were also interviewed.

Content analysis yielded five primary categories of change in the community related to the IPT-G program: (1) improved school attendance for children; (2) improved productivity; (3) improved sanitation in communities; (4) greater cohesion among community members; and (5) reduced conflict in families. Community members and IPT-G facilitators suggested that as depression remitted, IPT-G participants became more hopeful, motivated and productive.

Results suggest that providing treatment for depression in communities with high depression prevalence rates may lead to positive changes in a range of non-mental health outcomes.

Tuberous sclerosis complex (TSC) is associated with intellectual disability, but the risk pathways are poorly understood.

The Tuberous Sclerosis 2000 Study is a prospective longitudinal study of the natural history of TSC. One hundred and twenty-five UK children age 0–16 years with TSC and born between January 2001 and December 2006 were studied. Intelligence was assessed using standardized measures at ≥2 years of age. The age of onset of epilepsy, the type of seizure disorder, the frequency and duration of seizures, as well as the response to treatment was assessed at interview and by review of medical records. The severity of epilepsy in the early years was estimated using the E-Chess score. Genetic studies identified the mutations and the number of cortical tubers was determined from brain scans.

TSC2 mutations were associated with significantly higher cortical tuber count than TSC1 mutations. The extent of brain involvement, as indexed by cortical tuber count, was associated with an earlier age of onset and severity of epilepsy. In turn, the severity of epilepsy was strongly associated with the degree of intellectual impairment. Structural equation modelling supported a causal pathway from genetic abnormality to cortical tuber count to epilepsy severity to intellectual outcome. Infantile spasms and status epilepticus were important contributors to seizure severity.

The findings support the proposition that severe, early onset epilepsy may impair intellectual development in TSC and highlight the potential importance of early, prompt and effective treatment or prevention of epilepsy in tuberous sclerosis.

The association between physical disorders and suicide remains unclear. The aim of this study was to examine the relationship between physical disorders and suicide after accounting for the effects of mental disorders.

Individuals who died by suicide (n = 2100) between 1996 and 2009 were matched 3:1 by balancing score to general population controls (n = 6300). Multivariate conditional logistic regression compared the two groups across physician-diagnosed physical disorders [asthma, chronic obstructive pulmonary disease (COPD), ischemic heart disease, hypertension, diabetes, cancer, multiple sclerosis and inflammatory bowel disease], adjusting for mental disorders and co-morbidity. Secondary analyses examined the risk of suicide according to time since first diagnosis of each physical disorder (1–90, 91–364, ⩾ 365 days). Similar analyses also compared individuals with suicide attempts (n = 8641) to matched controls (n = 25 923).

Cancer was associated with increased risk of suicide [adjusted odds ratio (AOR) 1.40, 95% confidence interval (CI) 1.03–1.91, p < 0.05] even after adjusting for all mental disorders. The risk of suicide with cancer was particularly high in the first 90 days after initial diagnosis (AOR 4.10, 95% CI 1.71–9.82, p < 0.01) and decreased to non-significance after 1 year. Women with respiratory diseases had elevated risk of suicide whereas men did not. COPD, hypertension and diabetes were each associated with increased odds of suicide attempts in adjusted models (AORs ranged from 1.20 to 1.73).

People diagnosed with cancer are at increased risk of suicide, especially in the 3 months following initial diagnosis. Increased support and psychiatric involvement should be considered for the first year after cancer diagnosis.

FFQ are popular instruments for assessing dietary intakes in epidemiological studies but have not been validated for use in severely obese pregnancy. The aim of the present study was to compare nutrient intakes assessed by an FFQ with those obtained from a food diary among severely obese pregnant women.

Comparison of an FFQ containing 170 food items and a food diary for 4 d (three weekdays and one weekend day); absolute agreement was assessed using the paired t test and relative agreement by Pearson/Spearman correlation, cross-classification into tertiles and weighted kappa values.

Antenatal metabolic clinic for severely obese women.

Thirty-one severely obese (BMI at booking ≥40·0 kg/m2) and thirty-two lean control (BMI = 20·0–24·9 kg/m2) pregnant women.

The findings showed that nutrient intakes estimated by the FFQ were significantly higher than those from the food diary; average correlation was 0·32 in obese and 0·43 in lean women. A mean of 48·5 % of obese and 47·3 % of lean women were correctly classified, while 12·9 % (obese) and 10·0 % (lean) were grossly misclassified. Weighted κ values ranged from −0·04 to 0·79 in obese women and from 0·16 to 0·78 in lean women.

Overall, the relative agreement between the FFQ and food diary was lower in the obese group than in the lean group, but was comparable with earlier studies conducted in pregnant women. The validity assessments suggest that the FFQ is a useful tool for ranking severely obese pregnant women according to the levels of their dietary intake.