Community support for individuals with mental health problems is a global public health issue. Poor mental health literacy and high levels of stigmatising attitudes among the general population can hinder both help-seeking behaviours and limit the capacity of community members to provide support to people experiencing mental health challenges. The Mental Health First Aid (MHFA) training course was created to educate community members to provide initial help towards a person developing a mental health problem. MHFA training has spread to high-income countries, but there is relatively little research on cultural adaptation to lower-resource settings. This study aims to fill that gap and is the first cluster randomised controlled trial (cRCT) assessing the effectiveness of MHFA training in Chile and Argentina.

The study involves a two-arm wait-list cRCT with 240 participants (120 in each country). The study will be conducted in three settings in each of Chile and Argentina (eg, universities, health services and workplaces). Two clusters per setting in each country will be paired and randomly allocated to the intervention (the MHFA training for Chile and Argentina) or the wait-list control group. Participants in the intervention arm will be asked to complete questionnaires at baseline (T1), after training completion (T2) and 6 months after completion (T3), with control arm participants completing data collection at corresponding time points. The primary outcome will be intended support towards someone experiencing a mental health problem or experiencing a mental health crisis. Secondary outcome measures will include the ability to recognise depression and psychosis in vignettes; beliefs about the helpfulness of different types of interventions and helping actions, confidence in providing MHFA and stigmatising attitudes towards a person with depression or psychosis. Findings will demonstrate whether the culturally adapted MHFA training for Chile and Argentina can effectively enhance intended support, knowledge, attitudes and supportive actions towards other individuals within the community.

Ethics approval has been granted by the Human Research Ethics Committee at the University of Melbourne (Australia), Proyecto Suma (Argentina) and the University of Chile (Chile). Dissemination will be via academic publications and conference presentations. These will also be made available to participants and other interested parties on request.

ISRCTN63724445.

To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.

Pilot cluster randomised controlled trial (c-RCT).

Community-based healthcare services across six UK sites representing primary and secondary care settings.

31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.

The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.

Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.

Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.

The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.

ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

To examine the emotional, cognitive and dispositional experience of children and adolescents undergoing Lokomat rehabilitation by integrating self-evaluation, therapist observations and physiological metrics across repeated sessions, with the aim of characterising how patient experience evolves throughout paediatric robot-assisted gait training.

Prospective observational study using a multidimensional assessment approach combining self-report, therapist ratings and physiological measures.

Inpatients undergoing robot-assisted gait training (RAGT) with the Lokomat at the Scientific Institute Eugenio Medea in Bosisio Parini (Italy).

42 children and adolescents (N=42; mean age 11.66±5.59 years) undergoing RAGT.

Robot-assisted gait therapy with the Lokomat. Participants underwent 30-minute therapy sessions as per routine rehabilitation protocols, with treatment durations ranging from 15 to 20 sessions, as prescribed by their referring clinician.

Participants completed ad-hoc questionnaires about emotional, cognitive and dispositional factors before and after therapy; therapists provided structured assessments of patient engagement and psychological states. Physiological data, such as heart rate variability (HRV) and electrodermal activity (EDA), were recorded using wearable sensors to capture physiological correlates of emotional and cognitive engagement.

The results showed that by the end of Lokomat therapy, patients displayed increased cognitive engagement and better emotional regulation, along with higher vagal activity (normalised high-frequency) and increased phasic EDA responses. According to the therapists, patients appeared more confident, calm and cooperative. Sympathetic activation observed during satisfaction ratings reflected the involvement of the autonomic nervous system in positive emotional experiences.

This study, therefore, emphasises a multidimensional approach to rehabilitation, which involves subjective patient self-assessments, therapist observations and physiological signals in an effort to capture a more comprehensive patient experience. The findings highlight the importance of personalised, patient-centred approaches and contribute new evidence on the psychological and physiological effects of RAGT in paediatric populations. Further research is warranted to confirm these results and explore their clinical implications.

NCT05767268.

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients.

To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.

This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besancon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%.

The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences.

NCT06952907.

The 2013–2016 Western African outbreak of the Ebola virus disease (EVD), the largest recorded outbreak since the discovery of Ebola virus (EBOV) in 1976, destabilised local health systems and left thousands of survivors at risk for postacute sequelae, including vision-threatening uveitis. In an EVD survivor with severe panuveitis, the detection of persistent EBOV in the aqueous humour, long after clearance of acute viremia, focused clinical and research attention on the host-EBOV interaction in the unique terrain of ocular immune privilege. Despite the recognition that uveitis is common and consequential in EVD survivors, our understanding of pathogenesis is extremely limited, including the contributions of viral persistence and ocular-specific and systemic immune responses to disease expression. In this study protocol, we outline a multifaceted approach to characterise EVD-associated intraocular inflammation, including the clinical phenotype and complications; the presence of EBOV (or EBOV RNA/antigen) in ocular fluids and tissues; and associated local ocular-specific and peripheral immune responses.

We use an observational cohort design, which includes EVD survivors and close contacts of EVD survivors (ie, no documented history of EVD), and we propose disease (clinical examination and imaging), as well as molecular, virologic and immunologic characterisation, to meet research objectives.

This study has received Institutional Review Board approval from University of Nebraska Medical Centre, Emory University and Sierra Leone Ministry of Health. Findings will be disseminated through peer-reviewed publications.

Although the health impacts of floods are well described, there is limited research on how flooding affects health systems, services and the health workforce—despite their central role in mitigating and responding to these impacts. This scoping review examines the nature and extent of existing research evidence on the impact of flooding events on Australia’s health system.

A scoping review following the Johanna Briggs Institute methodology.

MEDLINE, Embase, CINAHL, Scopus, Web of Science, ProQuest Central and PsycINFO were searched through to 22 October 2024. Reference lists of included publications were screened for additional publications.

We included studies that reported any health system or health service disruption associated with flooding in Australia. Disruptions encompassed impacts on hospitals, primary care, health information systems, infrastructure, public health and health promotion activities, and the health workforce. We included peer-reviewed publications, including original research, commentaries, perspectives, editorials, letters to the editor, modelling studies and reviews. Grey literature was excluded.

Screening of full texts and data extraction were completed by two independent reviewers. A health system disruption analytical framework was iteratively developed and was used to categorise the findings.

Our search identified 6687 publications, of which 28 were included in the final review. 13 publications were original research publications and 15 were commentaries or reviews, with the majority published in the past ten years. Of the publications included, most focused on disruptions to hospital services and transport systems, including a reduction in health workforce availability, primarily due to the latter. Less than one-third reported impacts on health services for socially vulnerable populations. Floods affect multiple levels of the health system, intersecting with impacts across three key domains: infrastructure and health information systems, access to healthcare and the health workforce.

Original research on how floods impact Australia’s health system, its services and workforce has been limited, particularly in relation to general practice, allied health and the differential impacts on socially vulnerable populations. Further research is needed to inform targeted disaster preparedness and response strategies and to understand the complex and intersecting impacts. The analytical framework developed in this review provides a way to conceptualise how floods disrupt different components of the health system and offers a foundation for future research and policy development to strengthen system resilience in the face of increasing flood risk.

To identify the key characteristics required for hypothetical diagnostic tests to be cost-effective for diagnosing giant cell arteritis (GCA).

Combined decision tree and Markov cohort state-transition models were used to evaluate the cost-utility of new diagnostic tests compared with the standard pathways of biopsy and clinical judgement, with and without ultrasound. Input parameters were derived from secondary data and expert opinions. The analysis adopted a lifetime horizon and the UK National Health Service (NHS) perspective, using a willingness-to-pay threshold of £20 000 per quality-adjusted life year (QALY). Bivariate deterministic sensitivity analyses identified the maximum test price at varying diagnostic performance levels, and probabilistic sensitivity analyses over 5000 simulations provided 95% CIs.

UK.

Patients with symptoms suggestive of GCA.

Percentage of GCA-related and glucocorticoid-related complications avoided, maximum test price and incremental QALYs at each sensitivity and specificity combination.

A biomarker test incorporated into a hypothetical diagnostic pathway with perfect accuracy (100% sensitivity and specificity) can be priced up to £7245 (95% CI £5763 to £8727) and remain cost-effective compared with a standard pathway of temporal artery biopsy and clinical judgement. Against a standard pathway including ultrasound, the biomarker test can be priced up to £8606 (£6741 to £10 471). The test’s value was more strongly influenced by improvements in specificity than in sensitivity. The maximum prices decreased with earlier starting age, lower clinician adherence, shorter time horizons and shorter durations of glucocorticoid-related effects.

The study highlights the potential for hypothetical tests to improve GCA diagnosis and reduce glucocorticoid toxicity, while demonstrating their market viability for use within the NHS. It also illustrates how early-stage economic models can provide valuable insights into potential cost-effectiveness to inform the test development process.

Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

Mental illness typically onsets during the developmental stages from adolescence to emerging adulthood (ages 15–24 years), referred to as ‘youth’. A subset of youth with mental illness may be identified as having ‘complex’ mental health needs, defined based on requiring prolonged, extensive and resource-intensive services across multiple sectors, functional impairment, and comorbid challenges or multimorbidity . Effective early intervention for youth with complex mental illness is crucial to prevent the sequelae of long-term mental health problems. Several resource-intensive outpatient models have been developed to meet the needs of youth with complex mental illness; however, to the best of our knowledge, no scoping review has synthesised the available evidence on these interventions. A comprehensive synthesis of existing intensive outpatient interventions is needed to identify, target and inform future research and clinical efforts to better serve youth with complex mental illness. As such, the proposed scoping review will address the following research questions: (1) What intensive outpatient interventions have been evaluated for youth with complex mental illness? (2) To which populations are these interventions targeted? and (3) What outcomes have been examined within the context of these models?

This review will follow the Arksey and O’Malley framework for scoping reviews, and we will report the results following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) recommendations. We will conduct a comprehensive literature search across seven academic databases to identify relevant peer-reviewed material in English from 1990 to the present. Inclusion criteria will address evaluations of outpatient models of care with intensive components targeted to youth ages 15–24 with features of complex mental illness. Studies will be screened independently for eligibility by two reviewers in Covidence using clear inclusion criteria. We will then collate, summarise and present the findings to provide a comprehensive overview of the existing evidence.

Ethical approval will not be required, as no data will be collected for the proposed project. Results will be disseminated in peer-reviewed articles, presented at conferences and shared with stakeholders to inform the development, implementation and evaluation of comprehensive transdiagnostic services targeting youth with complex mental illness.

To explore how pre-existing conditions affect the diagnostic process for potential cancer in primary care patients.

Qualitative interview study using thematic analysis underpinned by a critical realist approach.

Primary care practices recruited through four Clinical Research Networks and UK health charities across England.

Interviews were conducted with 75 patients with one or more pre-existing conditions (anxiety/depression, diabetes, obesity, chronic obstructive pulmonary disease, Parkinson’s disease or multiple long-term conditions (four or more)) and 28 primary care professionals (general practitioners and nurses).

The study identified legitimacy as a central theme influencing patient trajectories in the health system while trying to receive a diagnosis for symptoms with which they presented to primary care. Patients engaged in self-triage to determine whether symptoms were ‘legitimate’ enough to seek care. Subsequent triaging steps (by receptionists, nurses and online systems) acted as gatekeepers, with decisions influenced by effectiveness of describing the symptom and subjective impressions. During consultations, clinicians relied on a mix of symptom narrative clarity, medical history and objective ‘metrics’ (eg, blood results, family history) to determine legitimacy for further investigations. Pre-existing conditions could either lower the threshold for referrals or obscure potential cancer symptoms. The stigma associated with mental health diagnoses often undermined perceived legitimacy and contributed to delays.

Legitimacy is continuously negotiated throughout the diagnostic pathway. It is shaped by social, moral and biomedical judgements. To promote early cancer diagnosis for patients with pre-existing conditions, clinicians must make legitimacy assessments explicit, reduce stigma especially around mental health and standardise triage processes.

Most clinical practice guidelines (CPGs) for assessing and managing people’s chronic pain focus on specific pain conditions, body sites or life course stages. This creates complexity for clinicians making care choices in the absence of a diagnosis and/or where a person experiences more than one pain condition. Specific to this context is the ICD-11 classification of chronic primary pain where an experience of pain cannot be better accounted for by another condition. CPGs for chronic primary pain, agnostic to condition or body part, may support clinicians towards best pain care since many of the principles of person-centred chronic pain care are transdiagnostic. The two aims of this systematic review are to (1) identify and appraise CPGs for chronic primary pain, relevant across the life course and (2) map the CPG content against a pain care priority framework to evaluate the extent to which the CPG content aligns with the priorities of people with lived chronic pain experience.

We will systematically search nine scholarly databases, the Epistemonikos database and international and national guidelines clearinghouses. CPGs published within 2015–2025, in any language, that offer recommendations about assessment and/or management of chronic primary pain for people of any age, excluding hospitalised inpatients or institutionalised populations, will be included. Pairs of reviewers will independently screen citations for eligibility and appraise CPG quality and implementation potential using the Appraisal of Guidelines for Research and Evaluation (AGREE)-II and the AGREE-Recommendations Excellence tools, respectively. Data extraction will include the citation and scope characteristics of each CPG, methods used to develop recommendations, verbatim recommendations, guiding principles or practice information and narrative excerpts related to the GRADE Evidence-to-Decision (EtD) considerations (or equivalent). We will use the PROGRESS-PLUS framework as a checklist to identify whether determinants of health equity were considered by guideline developers. CPG recommendations will be organised according to common topics and categorised in a matrix according to strength and direction. Qualitative content analysis will be used to synthesise excerpts relating to GRADE EtD considerations (or equivalent), and we will map extracted data against an established chronic pain care priority framework to determine the extent to which the CPGs align with values and preferences of people with lived experience. Interpretation will be informed by an interdisciplinary Advisory Group, including lived experience partners.

Ethical approval is not required for this systematic review. Results will be disseminated through publication in an open-access peer-reviewed journal, through professional societies, and integrated into education curricula and public-facing resources. Reporting will be consistent with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement.

CRD420251000482.

To describe: (1) the most visible information (from individuals or organisations) on UK social media regarding hormone replacement therapy (HRT)/menopause hormone treatment for menopause; (2) claims made by these sources for HRT and testosterone outwith the indications specified by the British National Formulary (BNF) and the National Institute of Health and Care Excellence (NICE) (ie, vasomotor instability, vaginal dryness, low mood associated with the menopause and, for testosterone, low libido after treatment with HRT) and for use for the prevention of future ill health and (3) conflicts of interest of commentators.

Cross-sectional study.

Online references to HRT, for use in menopause, in UK online media, comprising Facebook, Google, Instagram, TikTok and YouTube, 30 top ranked hits between 1 January 2022 and 1 June 2023 and Twitter (X) up to 1 May 2024.

Identification of the most visible information was performed via online searching with the term ‘HRT’ using incognito searches within each modality. Statements making claims were identified and analysed as to whether they were congruent with BNF and NICE advice on indications for use. Declarations of interest were extracted from the source or searched for if not apparent using a standardised search strategy. Data were entered into an Excel spreadsheet. Summary and descriptive statistics were used to summarise the results, including description of origin and types of claims, percentage of claims in agreement with NICE/BNF indications, relationship to financial interests and readership data, where available.

180 recommendations and/or claims for HRT were examined (30 from each of six platforms), made by professional individuals (53.4%), laypeople (41.7%) and patient, media and professional organisations (4.9%) completing the total. Overall, 67.2% of claims were outside of BNF/NICE recommendations. 139 (77.2%) were associated with a conflict of interest. In 117 cases, this was a conflict either directly or indirectly related to menopause, through provision of private practice, pharmaceutical industry funding or retail products marketed at the menopause.

Social media commonly contains claims for HRT outside BNF/NICE guidance. Conflicts of interest by commentators are also common, directly or indirectly related to menopause. Less than a quarter of media contained no commercial conflict. Policymakers should consider means to ensure that non-conflicted, evidence-based information is visible to professionals, patients and the public.

Open Science Framework (https://osf.io/r7e5c/).

Children with upper limb loss or difference (ULLD) require individualised and developmentally appropriate clinical care. To guide this specialised care, outcome measures can be used to assess important constructs, such as physical function, health-related quality of life (HRQoL) and satisfaction with medical treatments and services. However, there is limited research available on which outcome measures are used to assess these constructs and whether they have been psychometrically assessed in children with ULLD who may or may not use a prosthesis. Thus, the purpose of this scoping review is (1) to determine which outcome measures are used to assess physical function, HRQoL and satisfaction in paediatric patients with ULLD and (2) to identify articles that include children with ULLD in psychometric assessments of these outcome measures. Findings of these studies will be reported. This review will inform healthcare professionals on which outcome measures assessing function, HRQoL and satisfaction have been psychometrically tested for use in children with ULLD. It will also inform future research on outcome measurement in this population.

A two-phase scoping review will be conducted in which PubMed, Web of Science and CINAHL will be searched: first, to identify which outcome measures are used to assess physical function, HRQoL and satisfaction in children with ULLD and, second, to determine whether those measures have been psychometrically assessed for use in this population. Teams of two reviewers will review articles for eligibility and extract information from eligible articles. Tie-breaking will be conducted by a third reviewer. Narrative summaries will be used to describe the findings of this scoping review.

No ethical approval is needed. The results of the review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.

The scoping review that applies this protocol has been registered on Open Science Framework (https://doi.org/10.17605/OSF.IO/7UGWB).