Psilocybin-assisted psychotherapy (PAP) has gained attention as a promising intervention for conditions including depression, anxiety and post-traumatic stress disorder, but understanding of its side-effects is limited. This review evaluates the quality of side-effects reporting in PAP trials, to guide treatment, policy and research.

To assess side-effects reporting quality in PAP trials for psychiatric conditions, comparing published articles and ClinicalTrials.gov records.

A PROSPERO-registered review (no. CRD42023458960) included English-language PAP trials (2005–2024) identified via Embase, CENTRAL, PubMed and reference searches. Reporting quality was assessed using the CONSORT Harms extension, categorised as either high (17–21), moderate (12–16), low (7–11) or very low (0–6). Randomised controlled trials underwent risk of bias analysis, and descriptive statistics compared side-effects across sources.

Twenty-four trials were included. Reporting quality was high in six studies, moderate in four, low in nine and very low in five. All randomised controlled trials (n = 9) showed high risk of bias for side-effects outcomes. Variability in reporting hindered comparisons between articles and ClinicalTrials.gov, underscoring the need for standardisation. Overall, there was no evidence of systematic underreporting of side-effects in published articles compared with trial registers.

Side-effects reporting in PAP trials is inconsistent but is improving over time. Existing evidence has a high risk of bias. Future trials should align with best-practice guidelines for side-effects reporting. Discussions with patients should prioritise findings from high-quality studies and emphasise the current uncertainty regarding PAP side-effects.

Children with CHD are at risk of neurodevelopmental impairment. Modifiable risk factors associated with hospitalisation that could impact neurodevelopment include being left alone for long periods of time with minimal interaction or opportunity to engage in developmentally appropriate play. Volunteers are an underutilised resource to help the medical team and families support neurodevelopment in cardiac care. Our Cardiac Inpatient Neurodevelopmental Care Optimization or CINCO team aimed to develop a volunteer programme specific to paediatric cardiac inpatient units.

CINCO volunteers were recruited from the hospital volunteer pool and, in 2022, partnered with the University of Colorado to recruit health profession-interested students from under-represented backgrounds. All underwent hospital volunteer orientation and CINCO-specific training with cardiac child life, including education and shadowing. Volunteers completed an activity log and provided qualitative feedback.

Between September 2021 and October 2024, 43 volunteers were onboarded and worked a total of 754 shifts. There were 2310 patient interactions, with an average of 3 patients seen per shift. Volunteers held patients 1231 times, played with patients 1230 times, and read to patients 780 times.

A dedicated cardiac volunteer programme is a feasible, low-cost, and low-risk way to enhance neurodevelopmental care for inpatient children with CHD. When parents or caregivers are not present, volunteers participate as therapy extenders and may offset the care burden for nurses. Furthermore, allowing parents breaks may support their mental health, and increasing neurodevelopmental stimulation through volunteer interactions may mitigate disadvantageous aspects of a hospitalisation for neurodevelopment.

Peer-supported Open Dialogue (POD) integrates peer practitioners within mental health teams, fostering a collaborative, person-centred and social network approach to care. Although peer practitioners are increasingly involved in Open Dialogue, the role of peer practitioners within such teams remains underexplored.

This study aimed to explore (a) the experiences of peer practitioners working within Open Dialogue teams in the Open Dialogue: Development and Evaluation of a Social Intervention for Severe Mental Illness trial, and (b) the perspectives of non-peer Open Dialogue practitioners regarding peer involvement. Our further objectives were to understand the nature, degree and perceived impact of peer practitioner involvement in Open Dialogue.

A qualitative study was conducted using semi-structured interviews and joint interviews with peer practitioners (n = 9). Additionally, excerpts from 11 interviews and 4 focus groups (n = 18), in which non-peer practitioners discussed peer practitioners’ contributions in Open Dialogue, were analysed. Thematic analysis was employed to identify key themes.

Three themes were developed. The first focuses on the perceived influence of peer practitioners on Open Dialogue network meetings; the second explores the opportunities and challenges of working as a peer practitioner in Open Dialogue, while the third details the perceived impact of peer practitioners on team and organisational culture.

Open Dialogue’s emphasis on a flattened hierarchy facilitates the integration of peer practitioners, enabling them to contribute meaningfully to network meetings and team culture. Despite the overall positive experiences, peers still faced common challenges faced by those in other services, such as low pay and occasional instances of a compromised, flattened hierarchy.

Household food insecurity (HFI) is a social determinant of health globally. Rates of HFI have risen in many high-income countries in recent years, particularly in households with children. The health outcomes associated with HFI for children and adolescents have not been systematically synthesised. This review was conducted to support advocacy efforts for meaningful policy action to reduce HFI in households with children.

A systematic search was conducted in Medline, Embase and PsycInfo databases. Primary studies measuring the association between physical or mental health outcomes and HFI were included. Studies were appraised and population, setting, measures and outcomes were extracted. Findings were grouped by related outcomes. Due to heterogeneity, findings were synthesised narratively. Rapid review methodology was used to accommodate resource constraints.

High-income countries.

Youth aged less than 18 years.

Thirty-six studies were included. Most were cross-sectional studies conducted in the USA. Outcomes included general health, early childhood, cardiometabolic, asthma, dental caries, mental health, sleep, diet and anaemia. Despite substantial heterogeneity in HFI measures and analysis, findings support associations between HFI and negative outcomes for general health status, asthma, dental caries and mental health. Findings for other outcomes were mixed.

This review clarifies the effects of HFI on children and adolescents. Findings highlight trends for negative physical and mental health outcomes associated with HFI during youth, particularly related to mental health, oral health, asthma and general health status. Policy-level action should address rising rates of HFI and long-term effects on these vulnerable populations.

We investigated differences in cognition between variants of progressive supranuclear palsy (PSP) including PSP-Richardson (PSP-RS) and subcortical and cortical variants using updated diagnostic criteria and comprehensive neuropsychological assessment.

We recruited 140 participants with PSP (age = 71.3 ± 6.9 years; education = 15.0 ± 2.8 years; 49.3% female) who completed neurological and neuropsychological assessment. Participants received diagnoses of PSP clinical variants at their evaluation (or retrospectively if evaluated before 2017) according to the Movement Disorder Society PSP criteria. We grouped variants as PSP-RS (62 participants), PSP-Cortical (25 with PSP-speech/language and 9 with PSP-corticobasal syndrome), and PSP-Subcortical (27 with PSP-parkinsonism, 11 with PSP-progressive gait freezing, and 6 with PSP-postural instability). Analysis of covariance adjusted for age assessed for differences in neuropsychological performance between variants across cognitive domains.

PSP-Cortical participants performed worst on measures of visual attention/working memory (Spatial Span Forward/Backward/Total), executive function (Frontal Assessment Battery), and language (Letter Fluency). PSP-RS participants performed worst on verbal memory (Camden Words). There were no significant group differences for the MoCA or indices of visuospatial function. There were no sex or education differences between PSP groups; however, there were differences in age at visit and disease duration.

In a large sample of participants with PSP, there were differences in cognition across PSP-RS, PSP-Subcortical, and PSP-Cortical variants, with PSP-Cortical and, to a lesser extent, PSP-RS, performing worse on tests of attention and executive function. These findings suggest cognitive distinctions among PSP clinical variants and highlight the value of neuropsychological assessment in differential diagnosis of PSP subtypes for more accurate and timely clinical classification.

Group cognitive stimulation therapy (CST) has been shown to improve cognition and quality of life of people with dementia in multiple trials, but there has been scant research involving people with intellectual disability and dementia. This study aimed to assess the feasibility of conducting a randomised controlled trial of group CST for this population.

To assess the feasibility of participant recruitment and retention, the appropriateness of outcome measures, and the feasibility of group CST (adherence, fidelity, acceptability), as well as the feasibility of collecting data for an economic evaluation.

Participants were recruited from six National Health Service trusts in England and randomised to group CST plus treatment as usual (TAU) or TAU only. Cognition, quality of life, depression, and use of health and social care services were measured at baseline and at 8–9 weeks. Qualitative interviews with participants, carers and facilitators were used to explore facilitators of and barriers to delivery of CST. Trial registration number: ISRCTN88614460.

We obtained consent from 46 participants, and 34 (73.9%) were randomised: 18 to CST and 16 to TAU. All randomised participants completed follow-up. Completion rates of outcome measures (including health economic measures) were adequate; 75.7% of sessions were delivered, and 56% of participants attended ten or more. Fidelity of delivery was of moderate quality. CST was acceptable to all stakeholders; barriers included travel distance, carer availability and sessions needing further adaptations. The estimated cost per participant of delivering CST was £602.

There were multiple challenges including recruitment issues, a large dropout rate before randomisation and practical issues affecting attendance. These issues would need to be addressed before conducting a larger trial.

Underrepresentation of diverse populations in medical research undermines generalizability, exacerbates health disparities, and erodes trust in research institutions. This study aimed to identify a suitable survey instrument to measure trust in medical research among Black and Latino communities in Baltimore, Maryland.

Based on a literature review, a committee selected two validated instruments for community evaluation: Perceptions of Research Trustworthiness (PoRT) and Trust in Medical Researchers (TiMRs). Both were translated into Spanish through a standardized process. Thirty-four individuals participated in four focus groups (two in English, two in Spanish). Participants reviewed and provided feedback on the instruments’ relevance and clarity. Discussions were recorded, transcribed, and analyzed thematically.

Initial reactions to the instruments were mixed. While 68% found TiMR easier to complete, 74% preferred PoRT. Key discussion themes included the relevance of the instrument for measuring trust, clarity of the questions, and concerns about reinforcing negative perceptions of research. Participants felt that PoRT better aligned with the research goal of measuring community trust in research, though TiMR was seen as easier to understand. Despite PoRT’s lower reading level, some items were found to be more confusing than TiMR items.

Community feedback highlighted the need to differentiate trust in medical research, researchers, and institutions. While PoRT and TiMR are acceptable instruments for measuring trust in medical research, refinement of both may be beneficial. Development and validation of instruments in multiple languages is needed to assess community trust in research and inform strategies to improve diverse participation in research.

The calcitonin gene-related peptide monoclonal antibodies (CGRP MABs) erenumab, fremanezumab, and galcanezumab are reimbursed in Ireland under the High Tech Arrangement, subject to a managed access protocol (MAP), for the prophylaxis of chronic migraine in adults in whom three or more prophylactic treatments have failed. This study provides an overview of submitted reimbursement applications and the utilization of CGRP MABs.

The MAP for CGRP MABs was introduced on 1 September 2021 and is operated by the Health Service Executive (HSE) Medicines Management Programme. Individual patient reimbursement applications for CGRP MABs submitted through an online reimbursement application system between 1 September 2021 and 30 April 2023 were reviewed. Utilization data from 1 September 2021 to 30 April 2023 were extracted from the HSE Primary Care Reimbursement Service national pharmacy reimbursement claims database for the High Tech Arrangement. Analysis was performed using SAS® 9.4 software.

A total of 1,517 reimbursement applications were submitted in the study period. Reimbursement was approved for 96.1 percent (n=1,458) of the applications. A total of 1,399 individual patients (mean age 45 years) were dispensed a CGRP MAB under the High Tech Arrangement between September 2021 and April 2023, the majority of whom were women (n=1,141). Almost 90 percent of patients were considered treatment adherent. In April 2023, the market share of the individual CGRP MABs on the High Tech Arrangement was 56 percent (n=599) for fremanezumab, 38.3 percent (n=409) for erenumab, and 5.7 percent (n=61) for galcanezumab.

MAPs are part of the health technology management approach to drug reimbursement in the Irish healthcare setting, ensuring that reimbursement is in line with approved subgroups of the licensed indication. Used in conjunction with health technology assessment, MAPs enable access to high-cost drug treatments for patients with the greatest unmet need, while providing budgetary oversight and certainty for the payer.

Increasingly in Ireland, there are specific criteria attached to reimbursement approval for new medicines. Health technology assessment (HTA) identifies where uncertainty is greatest in relation to clinical and cost-effectiveness evidence and budget impact estimates; our health technology management (HTM) approach uses these outputs from HTA to design protocols to manage these uncertainties in the post-reimbursement phase.

A bespoke managed access protocol (MAP) is developed for each medicine reimbursed under this approach, informed by uncertainties highlighted in the HTA, directions from the decision-maker, and relevant particulars arising from commercial negotiations. Individual patient reimbursement applications are submitted via an online application system linked directly to the national pharmacy claims system. Pharmacists review the applications and approve reimbursement support where the patient meets the reimbursement criteria. The process is adaptive, allowing expansion of the criteria to include previously excluded patient cohorts, and the addition of new indications. It can also work across differing reimbursement arrangements (hospital/primary care).

The MAP for liraglutide for weight management confines reimbursement to patients with a body mass index greater than or equal to 35 kg/m², prediabetes, and high risk for cardiovascular disease. Phase I reimbursement support lasts for six months; patients not attaining greater than or equal to five percent weight loss are deemed non-responders as per the HTA, and reimbursement support is discontinued. The MAP for dupilumab confined reimbursement support to adults with refractory moderate-to-severe atopic dermatitis, where cost-effectiveness was plausible in the HTA. The MAP for calcitonin-gene-related-peptides monoclonal antibodies confines reimbursement support to patients with chronic migraine, refractory to at least three prophylactic treatments, where cost-effectiveness was plausible in the HTA.

Across these MAPs, over 3,000 patients accessed novel treatments for chronic illnesses in September 2023. HTM provides an effective mechanism to facilitate access to high-cost medicines for targeted patient groups, while providing increased oversight and budgetary certainty. Key to acceptance is utilization of HTA outputs to implement evidence-based HTM measures targeting specific uncertainties as highlighted in the HTA report.

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.

While loss of insight into one’s cognitive impairment (anosognosia) is a feature in Alzheimer’s disease dementia, less is known about memory self-awareness in cognitively unimpaired (CU) older adults or mild cognitive impairment (MCI) or factors that may impact self-awareness. Locus of control, specifically external locus of control, has been linked to worse cognitive/health outcomes, though little work has examined locus of control as it relates to self-awareness of memory functioning or across cognitive impairment status. Therefore, we examined associations between locus of control and memory self-awareness and whether MCI status impacted these associations.

Participants from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study (mean age=73.51; 76% women; 26% Black/African American) were classified as CU (n=2177) or MCI (amnestic n=313; non-amnestic n=170) using Neuropsychological Criteria. A memory composite score measured objective memory performance and the Memory Functioning Questionnaire measured subjective memory. Memory self-awareness was defined as objective memory minus subjective memory, with positive values indicating overreporting of memory difficulties relative to actual performance (hypernosognosia) and negative values indicating underreporting (hyponosognosia). Internal (i.e., personal skills/attributes dictate life events) and external (i.e., environment/others dictate life events) locus of control scores came from the Personality in Intellectual Aging Contexts Inventory. General linear models, adjusting for age, education, sex/gender, depressive symptoms, general health, and vocabulary examined the effects of internal and external locus of control on memory self-awareness and whether MCI status moderated these associations.

Amnestic and non-amnestic MCI participants reported lower internal and higher external locus of control than CU participants. There was a main effect of MCI status on memory self-awareness such that amnestic MCI participants showed the greatest degree of hyponosognosia/underreporting, followed by non-amnestic MCI, and CU participants slightly overreported their memory difficulties. While, on average, participants were fairly accurate at reporting their degree of memory difficulty, internal locus of control was negatively associated with self-awareness such that higher internal locus of control was associated with greater underreporting (ß=-.127, 95% CI [-.164, -.089], p<.001). MCI status did not moderate this association. External locus of control was positively associated with self-awareness such that higher external locus of control was associated with greater hypernosonosia/overreporting (ß=.259, 95% CI [.218, .300], p<.001). Relative to CU, amnestic, but not non-amnestic, MCI showed a stronger association between external locus of control and memory self-awareness. Specifically, higher external locus of control was associated with less underreporting of cognitive difficulties in amnestic MCI (ß=.107, 95% CI [.006, .208], p=.038).

In CU participants, higher external locus of control was associated with greater hypernosognosia/overreporting. In amnestic MCI, the lower external locus of control associations with greater underreporting of objective cognitive difficulties suggests that perhaps reduced insight in some people with MCI may result in not realizing the need for external supports, and therefore not asking for help from others. Alternatively, in amnestic participants with greater external locus of control, perhaps the environmental cues/feedback translate to greater accuracy in their memory self-perceptions. Longitudinal analyses are needed to determine how memory self-awareness is related to future cognitive declines.

This national pre-pandemic survey compared demand and capacity of adult community eating disorder services (ACEDS) with NHS England (NHSE) commissioning guidance.

Thirteen services in England and Scotland responded (covering 10.7 million population). Between 2016–2017 and 2019–2020 mean referral rates increased by 18.8%, from 378 to 449/million population. Only 3.7% of referrals were from child and adolescent eating disorder services (CEDS-CYP), but 46% of patients were aged 18–25 and 54% were aged >25. Most ACEDS had waiting lists and rationed access. Many could not provide full medical monitoring, adapt treatment for comorbidities, offer assertive outreach or provide seamless transitions. For patient volume, the ACEDS workforce budget was 15%, compared with the NHSE workforce calculator recommendations for CEDS-CYP. Parity required £7 million investment/million population for the ACEDS.

This study highlights the severe pressure in ACEDS, which has increased since the COVID-19 pandemic. Substantial investment is required to ensure NHS ACEDS meet national guidance, offer evidence-based treatment, reduce risk and preventable deaths, and achieve parity with CEDS-CYP.