Inadequate recruitment and retention impede clinical trial goals. Emerging decentralized clinical trials (DCTs) leveraging digital health technologies (DHTs) for remote recruitment and data collection aim to address barriers to participation in traditional trials. The ACTIV-6 trial is a DCT using DHTs, but participants’ experiences of such trials remain largely unknown. This study explored participants’ perspectives of the ACTIV-6 DCT that tested outpatient COVID-19 therapeutics.

Participants in the ACTIV-6 study were recruited via email to share their day-to-day trial experiences during 1-hour virtual focus groups. Two human factors researchers guided group discussions through a semi-structured script that probed expectations and perceptions of study activities. Qualitative data analysis was conducted using a grounded theory approach with open coding to identify key themes.

Twenty-eight ACTIV-6 study participants aged 30+ years completed a virtual focus group including 1–4 participants each. Analysis yielded three major themes: perceptions of the DCT experience, study activity engagement, and trust. Participants perceived the use of remote DCT procedures supported by DHTs as an acceptable and efficient method of organizing and tracking study activities, communicating with study personnel, and managing study medications at home. Use of social media was effective in supporting geographically dispersed participant recruitment but also raised issues with trust and study legitimacy.

While participants in this qualitative study viewed the DCT-with-DHT approach as reasonably efficient and engaging, they also identified challenges to address. Understanding facilitators and barriers to DCT participation and DHT interaction can help improve future research design.

There is a significant mortality gap between the general population and people with psychosis. Completion rates of regular physical health assessments for cardiovascular risk in this group are suboptimal. Point-of-care testing (POCT) for diabetes and hyperlipidaemia – providing an immediate result from a finger-prick – could improve these rates.

To evaluate the impact on patient–clinician encounters and on physical health check completion rates of implementing POCT for cardiovascular risk markers in early intervention in psychosis (EIP) services in South East England.

A mixed-methods, real-world evaluation study was performed, with 40 POCT machines introduced across EIP teams in all eight mental health trusts in South East England from March to May 2021. Clinician training and support was provided. Numbers of completed physical health checks, HbA1c and lipid panel blood tests completed 6 and 12 months before and 6 months after introduction of POCT were collected for individual patients. Data were compared with those from the South West region, which acted as a control. Clinician questionnaires were administered at 2 and 8 months, capturing device usability and impacts on patient interactions.

Post-POCT, South East England saw significant increases in HbA1c testing (odds ratio 2.02, 95% CI 1.17–3.49), lipid testing (odds ratio 2.38, 95% CI 1.43–3.97) and total completed health checks (odds ratio 3.61, 95% CI 1.94–7.94). These increases were not seen in the South West. Questionnaires revealed improved patient engagement, clinician empowerment and patients’ preference for POCT over traditional blood tests.

POCT is associated with improvements in the completion and quality of physical health checks, and thus could be a tool to enhance holistic care for individuals with psychosis.

There is an urgent need to understand explanatory factors of poor mental health before (pre-) and during (peri-) the COVID-19 pandemic in university students, especially those from underrepresented and minority groups.

To examine potential differences and explanatory factors for psychological distress, clinical risk and impact of problems on academic outcomes pre- and peri-pandemic in university students.

A repeated cross-sectional design was used with routine data between August 2018 and July 2022 at the registration stage from a student counselling and mental health service at a UK university. Wilcoxon signed-rank tests were used to examine pre- and peri-pandemic differences in outcomes. Unadjusted and adjusted linear regression models were conducted to assess potential explanatory factors for poor outcomes.

A total of 9517 university students had completed sociodemographic and outcome data and were included in analysis. Psychological distress and impact of problems on academic outcomes were not significantly different between pre- and peri-pandemic groups. Clinical risk was significantly higher in the pre-pandemic than peri-pandemic group. Potential explanatory factors for poorer outcomes included being younger, female or non-binary/genderqueer, sexual minority, from a minority ethnic group, having home fee status and having a disability registration.

Poor student mental health profiles and related explanatory factors may not have changed drastically between pre- and peri-pandemic. Longitudinal methods and intersectional approaches should be used in future research. Further understanding of how universities and student mental health services can most efficiently and effectively support the mental health of university students is crucially warranted.

Neurodevelopmental follow-up programmes for children with CHD help identify neurodevelopmental impairments and support the delivery of recommended interventions. The Cardiac Neurodevelopmental Outcome Collaborative, Diversity, Equity, and Inclusion Special Interest Group surveyed members to assess perceived patient barriers to neurodevelopmental follow-up, previous diversity and inclusion education, and confidence in caring for historically marginalised populations.

A link to a Redcap online survey was emailed to Cardiac Neurodevelopmental Outcome Collaborative members on 23 April 2022, with 4 weeks given to complete.

Eighty-four participants from 37 institutions in North America completed the survey. Respondents acknowledged that education on the importance of neurodevelopmental follow-up and frequent accommodations for cancellations or rescheduling clinic visits is essential. Language interpretation and written materials were available in languages other than English, but a limited number provided fully translated evaluation reports. Driving distance and the caregiver’s lack of understanding of the rationale for neurodevelopmental follow-up were the top perceived barriers to programme attendance. At the institutional level, training for cultural competency was typically provided, and most respondents felt comfortable caring for patients from diverse backgrounds. However, many agreed their programmes could do more to make evaluations accessible to historically marginalised/underserved populations.

Multiple barriers exist to cardiac neurodevelopmental follow-up, particularly for patients from under-represented minorities and for those whose primary language is not English. Surveying families will be valuable to understand how we may overcome these barriers. Further education about the importance of neurodevelopmental follow-up programmes continues to be essential.

Accurate diagnosis of bipolar disorder (BPD) is difficult in clinical practice, with an average delay between symptom onset and diagnosis of about 7 years. A depressive episode often precedes the first manic episode, making it difficult to distinguish BPD from unipolar major depressive disorder (MDD).

We use genome-wide association analyses (GWAS) to identify differential genetic factors and to develop predictors based on polygenic risk scores (PRS) that may aid early differential diagnosis.

Based on individual genotypes from case–control cohorts of BPD and MDD shared through the Psychiatric Genomics Consortium, we compile case–case–control cohorts, applying a careful quality control procedure. In a resulting cohort of 51 149 individuals (15 532 BPD patients, 12 920 MDD patients and 22 697 controls), we perform a variety of GWAS and PRS analyses.

Although our GWAS is not well powered to identify genome-wide significant loci, we find significant chip heritability and demonstrate the ability of the resulting PRS to distinguish BPD from MDD, including BPD cases with depressive onset (BPD-D). We replicate our PRS findings in an independent Danish cohort (iPSYCH 2015, N = 25 966). We observe strong genetic correlation between our case–case GWAS and that of case–control BPD.

We find that MDD and BPD, including BPD-D are genetically distinct. Our findings support that controls, MDD and BPD patients primarily lie on a continuum of genetic risk. Future studies with larger and richer samples will likely yield a better understanding of these findings and enable the development of better genetic predictors distinguishing BPD and, importantly, BPD-D from MDD.

In North America, less than 30% of children with complex CHD receive recommended follow-up for neurodevelopmental and psychosocial care. While rates of follow-up care at surgical centres have been described, little is known about similar services outside of surgical centres.

This cohort study used Maine Health Data Organization’s All Payer Claims Data from 2015 to 2019 to identify developmental and psychosocial-related encounters received by children 0–18 years of age with complex CHD. Encounters were classified as developmental, psychological, and neuropsychological testing, mental health assessment interventions, and health and behaviour assessments and interventions. We analysed the association of demographic and clinical characteristics of children and the receipt of any encounter.

Of 799 unique children with complex CHD (57% male, 56% Medicaid, and 64% rural), 185 (23%) had at least one developmental or psychosocial encounter. Only 13 children (1.6%) received such care at a surgical centre. Developmental testing took place at a mix of community clinics/private practices (39%), state-based programmes (31%), and hospital-affiliated clinics (28%) with most encounters billing Medicaid (86%). Health and behavioural assessments occurred exclusively at hospital-affiliated clinics, predominately with Medicaid claims (82%). Encounters for mental health interventions, however, occurred in mostly community clinics/private practices (80%) with the majority of encounters billing commercial insurance (64%).

Children with complex CHD in Maine access developmental and psychosocial services in locations beyond surgical centres. To better support the neurodevelopmental outcomes of their patients, CHD centres should build partnerships with these external providers.

Black and Latino individuals are underrepresented in COVID-19 treatment and vaccine clinical trials, calling for an examination of factors that may predict willingness to participate in trials.

We administered the Common Survey 2.0 developed by the Community Engagement Alliance (CEAL) Against COVID-19 Disparities to 600 Black and Latino adults in Baltimore City, Prince George’s County, Maryland, Montgomery County, Maryland, and Washington, DC, between October and December 2021. We examined the relationship between awareness of clinical trials, social determinants of health challenges, trust in COVID-19 clinical trial information sources, and willingness to participate in COVID-19 treatment and vaccine trials using multinomial regression analysis.

Approximately half of Black and Latino respondents were unwilling to participate in COVID-19 treatment or vaccine clinical trials. Results showed that increased trust in COVID-19 clinical trial information sources and trial awareness were associated with greater willingness to participate in COVID-19 treatment and vaccine trials among Black and Latino individuals. For Latino respondents, having recently experienced more challenges related to social determinants of health was associated with a decreased likelihood of willingness to participate in COVID-19 vaccine trials.

The willingness of Black and Latino adults to participate in COVID-19 treatment and vaccine clinical trials is influenced by trial awareness and trust in trial information sources. Ensuring the inclusion of these communities in clinical trials will require approaches that build greater awareness and trust.

To assess the potential contribution of large-scale food fortification (LSFF) towards meeting dietary micronutrient requirements in Tanzania.

We used household food consumption data from the National Panel Survey 2014–15 to estimate fortifiable food vehicle coverage and consumption (standardised using the adult female equivalent approach) and the prevalence at risk of inadequate apparent intake of five micronutrients included in Tanzania’s fortification legislation. We modelled four LSFF scenarios: no fortification, status quo (i.e. compliance with current fortification contents) and full fortification with and without maize flour fortification.

Tanzania.

A nationally representative sample of 3290 Tanzanian households.

The coverage of edible oils and maize and wheat flours (including products of wheat flour and oil such as bread and cakes) was high, with 91 percent, 88 percent and 53 percent of households consuming these commodities, respectively. We estimated that vitamin A-fortified oil could reduce the prevalence of inadequate apparent intake of vitamin A (retinol activity equivalent) from 92 percent without LSFF to 80 percent with LSFF at current fortification levels. Low industry LSFF compliance of flour fortification limits the contribution of other micronutrients, but a hypothetical full fortification scenario shows that LSFF of cereal flours could substantially reduce the prevalence at risk of inadequate intakes of iron, zinc, folate and vitamin B12.

The current Tanzania LSFF programme likely contributes to reducing vitamin A inadequacy. Policies that support increased compliance could improve the supply of multiple nutrients, but the prominence of small-scale maize mills restricts this theoretical benefit.

People with intellectual disability (PwID) and epilepsy have increased premature and potentially preventable mortality. This is related to a lack of equitable access to appropriate care. The Step Together guidance and toolkit, developed with patient, clinical, charity and commissioning stakeholders, allows evaluation and benchmarking of essential epilepsy service provision for PwID in eight key domains, at a care system level.

To evaluate care provisions for adult PwID and epilepsy at a system level in the 11 integrated care systems (ICSs) of the Midlands, the largest NHS England region (population: approximately 11 million), using the Step Together toolkit

Post training, each ICS undertook its benchmarking with the toolkit and submitted their scores to Epilepsy Action, a national UK epilepsy charity, who oversaw the process. The outcomes were analysed descriptively to provide results, individual and cumulative, at care domain and system levels.

The toolkit was completed fully by nine of the 11 ICSs. Across all eight domains, overall score was 44.2% (mean 44.2%, median 43.3%, range 52.4%, interquartile range 23.8–76.2%). The domains of local planning (mean 31.1%, median 27.5%) and care planning (mean 31.4%, median 35.4%) scored the lowest, and sharing information scored the highest (mean 55.2%, median 62.5%). There was significant variability across each domain between the nine ICS. The user/carer participation domain had the widest variation across ICSs (0–100%).

The results demonstrate a significant variance in service provision for PwID and epilepsy across the nine ICSs. The toolkit identifies specific areas for improvement within each ICS and region.