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Ayer — Marzo 4th 2026Tus fuentes RSS

“The system is a bit broken…” a qualitative exploration of barriers in the pathway for diagnosing Developmental Coordination Disorder

by Lucy H. Eddy, Nat K. Merrick, Cara E. Staniforth, Jade L. Jukes, Liam J. B. Hill, Mark Mon-Williams, Farid Bardid, Rebecca Murray

Background

Approximately 5% of children are affected by a neurodevelopmental disorder of their sensorimotor skills. DSM-V and ICD-10, the two most widely used diagnostic systems, define this diagnostically as ‘Developmental Coordination Disorder’ (DCD) or ‘Specific Developmental Disorder of Motor Function’ (SDDMF), respectively. A diagnosis of DCD has been found to have a detrimental impact on a range of outcomes (e.g., health and education). It is therefore crucial that these children receive timely intervention. This is reliant, however, on effective assessment and support pathways. Research has shown there is great parental dissatisfaction, but there has been limited research exploring a clinical and education perspective. This study therefore aimed to understand barriers and facilitators for clinical and education practitioners in the pathway in a diverse district in the UK (Bradford).

Methods

Semi-structured interviews were completed with stakeholders across the pathway to identify barriers and facilitators to assessing, diagnosing, and supporting children with sensorimotor skill difficulties. Theoretical thematic analysis aligned to the Capability, Opportunity, Motivation model of Behaviour change (COM-B) was used to analyse the qualitative data.

Results

Interviews revealed many barriers in the DCD pathway related to capability (confusing terminology, inconsistent knowledge, inappropriate referrals), opportunity (resource constraints, DCD being considered low priority, and disconnected services), and motivation (overlapping job roles, a desire to consider those with difficulties not eligible for a diagnosis). No facilitators were consistently identified across interviews.

Conclusion

Families face multiple barriers to obtaining a diagnosis for their child through existing clinical pathways for assessment and support. These findings are unlikely to be unique to Bradford, due to international research highlighting these issues via parental interviews. These findings therefore may reflect challenges both nationally and internationally within DCD pathways. There is an urgent need for: (i) clear communication across different services (with consistency in terminology), and (ii) a more collaborative and integrated approach to assessment, diagnosis, and support in order to help these children thrive.

Pragmatic, open-label, multicentre, randomised controlled trial to guide initial therapy for immune checkpoint inhibitor-induced inflammatory arthritis comparing standard of care (prednisolone) to adalimumab without glucocorticoids: REACT trial protocol

Por: Fisher · B. A. · Rowe · A. · Hodson · C. · Wilkhu · M. · Williams · E. · Turner · E. · Allard · A. · Blake · T. · Bombardieri · M. · Cope · A. P. · Dubey · S. · Mankia · K. · Malley · T. · Moore · O. · Payne · M. · Plummer · R. · Tilby · M. · Tillett · T. · Wong · E. · Wu · Y. · Filer · A. · Pra
Introduction

Immune checkpoint inhibitors (ICIs) have revolutionised cancer treatment through targeted disruption of the physiological pathways that maintain tissue tolerance, but which are co-opted by cancers to evade immunosurveillance. Thus, the resultant T-cell activity often causes immune-related adverse events including immune checkpoint inhibitor-induced inflammatory arthritis (ICI-IA). ICI-IA results in functional impairment that frequently persists, even after ICI discontinuation, with substantial quality-of-life impacts for cancer survivors.

A high-quality body of evidence to guide ICI-IA management remains an unmet need. Pharmacological treatment may be prolonged, typically begins with non-specific immunosuppression, including systemic steroids, and is usually only rationalised to more targeted therapy in resistant cases. Moreover, retrospective data suggest the high dose glucocorticoids sometimes used in new-onset ICI-IA may be associated with worse cancer outcomes.

Tumour necrosis factor (TNF) inhibition strategies are well established with excellent efficacy and safety profiles in ‘spontaneous’ inflammatory arthritides including rheumatoid and psoriatic arthritis. Mechanistic evidence from ex vivo and murine studies also supports the utility of anti-TNF therapy for steroid-refractory cases of ICI-IA. Although good clinical responses have been reported in this setting, the REACT trial (REmission induction of Arthritis caused by Cancer ImmunoTherapy) aims to provide randomised and robust clinical evidence for deploying targeted therapy earlier in ICI-IA management. It will test whether up-front anti-TNF therapy can more effectively and quickly control symptoms, reduce glucocorticoid exposure, prevent early ICI discontinuation and increase the frequency of drug-free ICI-IA remission.

Methods and analysis

REACT is a prospective, multicentre, open-label, superiority, two-arm, randomised controlled clinical trial to guide initial therapy for patients with ICI-IA. The trial will compare the current standard of care (initial prednisolone; Arm A) with the anti-TNF drug, adalimumab without glucocorticoids (Arm B).

The primary outcome is glucocorticoid-free arthritis remission rate at 24 weeks where remission is defined as: (i) No use of systemic or intra-articular glucocorticoids (except when used for adrenal insufficiency) within 4 weeks prior to assessment at 24 weeks; and (ii) absence of synovitis on clinical examination.

Ethics and dissemination

The protocol was approved by East Midlands—Leicester South Research Ethics Committee on 31-Oct-2024 (Ref: 24/EM/0202). Participants are required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

Trial registration number

ISRCTN18217497.

Hepatitis B virus infection and its determinants among pregnant women in Ethiopia: protocol for umbrella review of systematic review and meta-analysis 2025

Por: Bekele · M. · Oche · W. O. · Geltore · T. E. · Sileshi · E. · Hadaro · T. S. · Alano · B. A. · Abera · W.
Introduction

Among the five hepatitis viruses, the hepatitis B virus (HBV) is a major cause of serious acute and chronic liver infections worldwide. The major public health impact of HBV infection arises from chronic liver disease, including cirrhosis and hepatocellular carcinoma, which predominantly affects young and middle-aged adults of both sexes. Therefore, preventive interventions focusing on mothers and infants are critical due to vertical and early childhood transmission dynamics.

HBV prevalence largely varies among pregnant women in Ethiopia because of multiple interrelated factors. This umbrella review will consolidate all existing systematic reviews and create a more reliable picture of HBV infection and its determinants among pregnant women in Ethiopia.

Methods and analysis

This umbrella review will be conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses reporting standards. The review will focus on identifying and integrating evidence from eligible systematic reviews and meta-analyses, with methodological quality appraised using the MeaSurement Tool to Assess systematic Reviews instrument. A comprehensive literature search strategy will be developed using relevant Medical Subject Headings alongside free-text keywords. Electronic searches will be conducted in PubMed/MEDLINE, African Journals Online, Web of Science, Scopus and Google Scholar. Statistical heterogeneity among the included reviews will be quantified using the I² statistic. Data management and meta-analytic procedures will be performed using STATA version 17, and effect estimates will be presented with corresponding 95% CIs to determine statistical precision.

Ethics and dissemination

This review uses only published or publicly available data, so ethics approval is not required. Findings will be disseminated via peer-reviewed publications, conference presentations and shared with policymakers, healthcare partners, clinicians and patients to inform policy, enhance education and guide future research.

PROSPERO registration number

PROSPERO (CRD420251118982).

Fighting for care: how can we better support people with multiple long-term conditions who are accessing community mental health groups? A qualitative interview study within a UK arts therapies trial

Por: Hounsell · L. · Millard · E. · Medlicott · E. · Fry · E. · Fernandes · J. · Carr · C.
Objective

To explore the impact of multiple long-term conditions (MTLCs) and a comorbid mental health condition on decision-making processes, attendance and engagement in NHS community-based therapy groups.

Design

Qualitative in-depth interviews analysed using reflexive codebook analysis as part of a study within a trial.

Setting

Secondary community mental health teams from two UK sites.

Participants

Purposive sample of 20 participants recruited to a randomised controlled trial of group therapies (arts therapies and counselling) holding a mental health diagnosis and self-reported as having at least one additional physical health condition.

Results

Six themes were constructed: (1) MLTCs influenced arts modality choices and goals; (2) importance of planning ahead to be organised; (3) the journey loomed over participants; (4) the impact of MLTCs on group attendance and participation; (5) the group was valued and important; (6) determination and fighting to get what I need.

Decisions about arts modalities and group attendance were based on a self-perceived level of felt capability. It was important for participants to plan in advance and feel informed ahead of making commitments, enabling them to prepare and manage symptoms. Travelling to the groups was dreaded, and many participants required support with travel in order to attend. Managing symptoms during the journey and groups was challenging; however, participants had a strong determination to uphold the commitment to attend despite their difficulties, as the group was highly valued.

Conclusions

MLTCs have a large impact on people’s capacity to engage in community groups, requiring additional planning and effort. The scale of this impact is often not recognised. Despite this, the benefits of groups for people with MLTCs are especially important, including motivation to leave the house, opportunities for socialisation and a means of reaching one’s own goals. Clinicians are recommended to accommodate the needs of MLTCs when designing community group interventions and consider multiple attendees with MLTCs in the group composition to improve attendance and group engagement.

Trial registration number

ISRCTN88805048.

Effectiveness and cost-effectiveness of a 9 week multi-component cycling programme versus an existing single cycling training session: protocol for the Cycle Nation Communities randomised controlled trial

Por: Lawlor · E. R. · Gabler Trisotti · M. F. · McIntosh · E. · McConnachie · A. · Gill · J. M. R. · Gray · C. M.
Introduction

Cycling can be beneficial for health, well-being and the environment; however, cycling participation in the UK remains low. Effective and cost-effective strategies are needed to support people in the community to increase cycling. The Cycle Nation Communities randomised controlled trial (RCT) will evaluate whether a 9 week multi-component cycling programme (Cycle Nation) is more effective and cost-effective than an existing national cycle training session on cycling participation, transport use and health and well-being.

Methods and analysis

This pragmatic, single-blinded, two-arm RCT will recruit ≥268 adults who cycle infrequently. Participants will be randomised to the 9 week multi-component individual/social-level group-based Cycle Nation programme or an existing national standard single group-based cycle training session. Both arms will be delivered by community-based cycling organisations in Glasgow. Participants will complete self-reported measurements at baseline, 12 weeks and 12 months. The primary outcome is the proportion of participants cycling at least weekly at 12 months. Secondary outcomes include proportion of participants cycling at least weekly at 12 weeks; change in weekly number of rides and minutes of cycling and use of private car, taxi, public transport and walking at 12 weeks and 12 months; change in motivation, perceptions of cycling safety, confidence to cycle, self-esteem, vitality, health-related quality of life and perceived general physical health at 12 weeks and 12 months. A within-trial economic evaluation from a National Health Service/personal social service and a broader societal perspective will be undertaken. Pending within-trial results, a long-term model may be developed. An embedded process evaluation will use participant and facilitator interviews, participant acceptability questionnaires, facilitator delivery proforma and session observations.

Ethics and dissemination

Ethical approval has been obtained from the University of Glasgow Medical, Veterinary and Life Sciences Ethics Committee (11 April 25). Findings will be published in peer-reviewed journals and communicated to stakeholders and the public.

Trial registration number

NCT07005674.

Cross-sectional observational study evaluating social brain health in HIV using a research domain criteria-based approach: a protocol

Por: Vance · D. E. · Brennan-Ing · M. · Lambert · C. C. · Hellemann · G. · Zeng · X. · Lee · J.
Introduction

Some people with HIV (PWH) experience brain changes that affect neurocognition, but little is known about how HIV impacts social cognition or related brain regions. Social cognition, the ability to perceive, understand and respond to social information, is important for maintaining relationships and quality of life. This article provides the protocol for the first comprehensive study examining social brain function in PWH and people without HIV (PWoH). With three aims, this study will: (1) examine neural circuits related to social cognition; (2) examine social cognitive performance across two social cognitive domains and (3) examine the role of social cognition in everyday social functioning.

Methods and analysis

Referred to as Social Brain Health Study in HIV Study, this cross-sectional study will enrol 105 PWH and 105 demographically matched PWoH aged 18–65 years. The study administers a comprehensive assessment battery across two visits within a 2-week period. Visit 1 includes behavioural measures of social cognition (Perceiving Social Cues and Understanding Others), neurocognition and social functioning (social network size and loneliness). Visit 2 involves functional MRI procedures with three social cognitive tasks designed to activate key brain regions (ie, fusiform face area, superior temporal gyrus, temporo-parietal junction, dorsal medial prefrontal cortex).

Ethics and dissemination

This study was funded by the National Institute of Mental Health (MH139613) and approved by the Institutional Review Board of the University of Alabama at Birmingham (IRB-300013394). Data collection is ongoing. The first results are expected to be submitted for publication in 2030. Findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences as well as patient organisations such as AIDS service organisations and community talks.

Population-based study of pharmacogenetics and pharmacokinetics in Southern African patients with multidrug-resistant tuberculosis (PoPG): a protocol for the Namibian cohort

Por: Boois · L. · Ekandjo · H. · Shavuka · O. · Nepolo · E. · Ndong Sima · C. A. · Oelofse · C. · Uren · C. · Petersen · D. C. · Möller · M. · Wijk · M. · Kellermann · T. · Decloedt · E. · McIlleron · H. · Denti · P. · Claassens · M. M.
Background

Multidrug-resistant tuberculosis (MDR-TB) is an urgent public health challenge in Namibia, with profound socioeconomic consequences. The high burden of both tuberculosis and HIV complicates treatment and underscores the need for optimised drug therapies. Precision medicine, which leverages patient-specific genetic and molecular information, offers promise for improving MDR-TB outcomes. However, its effective application relies on population-specific data, particularly understanding how individuals metabolise tuberculosis drugs and how genetic diversity drives variability in treatment response. Currently, no pharmacokinetic (PK) or pharmacogenetic (PG) data on TB treatment exist for Namibian populations. This gap is particularly concerning, given the country’s genetic diversity, environmental factors and comorbidities that may uniquely influence drug metabolism. This study aims to generate PK and PG data to inform dose optimisation and support personalised treatment strategies for MDR-TB in Namibia. The findings will contribute to improved patient care and inform health system strengthening based on locally relevant evidence.

Methods

This cross-sectional study will consist of 100 Namibian participants with matched human DNA and PK data of MDR-TB cases receiving isoniazid, clofazimine, bedaquiline and the fluoroquinolones (levofloxacin or moxifloxacin). PK sampling will be divided as follows: 30 individuals will undergo intensive PK sampling, while the remaining (n=70) will undergo sparse PK sampling. DNA will be extracted at Stellenbosch University (SU), and samples will be genotyped using the H3Africa microarray. Sequences will be aligned to the human reference genome, hg38 (GRCh38p13), using the freely available Burrows-Wheeler Aligner. A subset of the samples (n=20–30) will undergo whole genome sequencing (WGS) to verify imputation results and identify novel genetic variants potentially affecting PK in this population.

Data analysis

Quality control and variant call format file generation will be performed using the Genome Analysis Toolkit best practices (V.3.5). Intensive and sparse PK data will be pooled for the development of a population PK (popPK) model using a non-linear mixed-effects modelling approach. The popPK model will characterise the relationship between TB drug dose and exposure, including quantifying covariates, including genetic variation, explaining PK variability, providing a foundation for dose optimisation and personalised treatment strategies.

Ethics and dissemination

Ethics approval was obtained from the University of Namibia Human Research Ethics Committee for Health (Ref. SOM18/2024), the Ministry of Health and Social Services (Ref. 22/4/2/3), the SU Health Research Ethics Committee (Ref. N21/11/136) and the University of Cape Town Human Research Ethics Committee (Ref. 500/2022).

Common mental health outcomes among children in conflict with the law in Africa: a systematic review protocol

Por: Maotoana · M. · Phalane · K. · Ndlovu · S. M. · Rapau · M. · Quarshie · E. N.-B. · Ntho · T. A. · Sepadi · M. D. · Oppong Asante · K. · Sodi · T. · Themane · M. J.
Introduction

Common mental health outcomes among children in conflict with the law in correctional facilities in Africa are an under-researched area with significant public health implications. This review will synthesise available and accessible evidence on the prevalence and associated factors of common mental health outcomes among children in conflict with the law in Africa.

Methods and analysis

Comprehensive electronic searches will date from 01 January 2015 to 31 December 2025 and will be conducted in PubMed, Sabinet, Scopus, EBSCOhost, Web of Science and PsycINFO. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by three independent reviewers. Discrepancies will be reviewed by a ninth reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses will be used. The Mixed Methods Appraisal Tool will assess study quality, and data will be synthesised using meta-analysis or a narrative synthesis approach, depending on heterogeneity levels.

Ethics and dissemination

This study will not require ethical approval from an institutional review board, as it does not entail the direct collection of data from children in conflict with the law, nor does it pose any risk to their privacy. Once finalised, the full review report will be submitted for publication in a peer-reviewed journal. The key findings will also be shared at both local and international conferences, highlighting common mental health outcomes among children in conflict with the law.

PROSPERO registration number

CRD420251011484.

ReFIT study (reversing frailty in transplantation): protocol for a longitudinal study to assess clinical and biomedical changes in frailty through kidney transplantation

Por: Payne · T. · Shaw · A. · Hanjani · L. S. · Homes · R. · Giddens · F. · Ravuri · H. G. · Yap · C. X. · Walsh · J. · Kumar · V. · Garton · F. C. · Rhee · H. · Huang · A. · Francis · R. S. · Reid · N. · McAdams-DeMarco · M. · Gordon · E. · Midwinter · M. · Hubbard · R.
Introduction

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

Methods and analysis

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

Ethics and dissemination

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

Beyond the doctors office: a longitudinal study mapping womens experiences of the maternal healthcare journey as a pathway to reducing maternal mortality in Nigeria

Por: Ope · B. W. · Attwood · P. · Mullins · E. · Hirst · J. E. · Norton · R. · Peden · M.
Objectives

Nigeria has one of the highest maternal mortality burdens globally. Improving maternal outcomes requires a better understanding of how women experience care across pregnancy, childbirth and the postnatal period. This study explored women’s maternal healthcare experiences across the perinatal continuum in Nigeria, with a focus on how challenges emerge and interact over time.

Design

Longitudinal qualitative study using patient journey mapping.

Setting

Public primary, secondary and tertiary healthcare facilities in Abuja, Nigeria.

Participants

12 pregnant women were purposively sampled. Each woman participated in two rounds of in-depth interviews: once in late pregnancy and again 2–6 weeks postpartum. All participants completed both interview rounds.

Methods

Data were collected through 24 semistructured in-depth interviews conducted longitudinally to capture changes in women’s experiences before and after childbirth. Interview guides were informed by existing maternal health frameworks. Transcripts were analysed using reflexive thematic analysis and organised across five stages of the maternal healthcare journey: Awareness, Consideration, Access, Treatment and Recovery.

Findings

This study introduces a five-stage framework: Awareness, Consideration, Access, Treatment and Recovery, to comprehensively explore maternal healthcare experiences. The findings reveal systemic inefficiencies at every stage of the pregnancy journey, from limited awareness of pregnancy test kits to unreliable booking systems and inadequate postpartum mental health support. This study highlights how early-stage barriers cascade into later phases, unlike traditional research that focuses only on clinical interactions. This study emphasises the importance of maternal care accessibility and recovery support, moving beyond a treatment-centric lens. 

Conclusion

This study presents a transformative framework for understanding maternal healthcare as a continuum of interconnected experiences. The research offers actionable insights to enhance maternal health outcomes through stage-specific strategies. The globally adaptable framework provides policymakers and healthcare practitioners with a roadmap to improve maternal healthcare systems in Nigeria and beyond. This holistic approach lays the foundation for reducing maternal mortality while ensuring equitable care for all.

Adapting substance use treatment for black adolescents in the US legal system: protocol for a mixed-method, exploratory, feasibility and acceptability study using the eight-step ADAPT-ITT framework

Por: Bryant · B. E. · Tolou-Shams · M. · Ezimora · I. · Zapolski · T. C. · DiClemente · R. · Jordan · A. · Becker · S. J. · Squeglia · L. M.
Introduction

This community-led research study protocol emphasises placing black youth impacted by the legal system, their families and their communities at the forefront of substance use treatment development research and decision-making. The study, the Cultural Adaptation of a Substance Use Treatment (CAST) Project, challenges traditional top-down approaches to treatment creation, advocating for a grassroots model that centres community knowledge, values and active participation.

Methods and analysis

The CAST project is a US-based mixed-methods study with an exploratory design that examines the impact of racial discrimination on substance use in black youth impacted by the legal system. The study participants are black youth impacted by the legal system (N=15), parents of black youth impacted by the legal system (N=10) and community members who serve black youth (N=10) (total N=35 study participants). Study participants from each group (youth, parents and community members) will participate in three separate focus groups, respectively, to provide feedback on the culturally responsive content needed to best support black youth impacted by the legal system around substance use and mental health. The eight-step Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing framework will be used as a guide to inform adaptations to the Motivational Enhancement Therapy and Cognitive Behavioural Therapy (MET/CBT12) for black youth impacted by the legal system. Once the cultural adaptation process has been completed, the study will conclude with an open feasibility and accessibility trial of the culturally adapted MET/CBT12 manual. The primary outcomes of this study are the feasibility and acceptability of the culturally adapted manual, measured by treatment attendance and participant feedback. Secondary outcomes include reductions in substance use and discrimination distress, and improvements in mental health symptoms.

Ethics and dissemination

This study was approved by the Institutional Review Board (IRB) at the University of California, San Francisco (IRB Protocol Number: 23-40126). All study procedures will be conducted in accordance with the ethical standards outlined by the institutional review board. The results from this study will be shared through peer-reviewed publications, academic conferences, community forums and policy briefs to support broader implementation of culturally adapted adolescent substance use interventions that address discrimination-related stress and substance use among black individuals impacted by the legal system.

Trial registration number

NCT06003725.

Harm reduction and pharmacy practice: a scoping review of services for people who use drugs provided by pharmacy staff

Por: Navarrete · J. · Berg · E. · Hughes · C. · Salokangas · E. · Taylor · M. · Kung · J. Y. · Johnson · J. A. · Hyshka · E.
Objectives

The roles of pharmacy staff have expanded to include public health functions, such as delivering harm reduction services for people who use drugs (PWUD), particularly unregulated substances and non-medical drug use, in response to an ongoing drug overdose crisis. Nonetheless, their involvement across the full spectrum of harm reduction services remains underexplored. This study mapped existing research describing or evaluating the implementation of harm reduction services for PWUD provided by pharmacy staff.

Design

Scoping review.

Data sources

MEDLINE, EMBASE, CINAHL, Web of Science, Scopus and Cochrane Library (inception to July 2025).

Study selection

Studies reporting on the description or evaluation of harm reduction services for PWUD provided by pharmacy staff.

Data extraction

Two team members screened studies for eligibility and extracted the data. The data were analysed primarily to describe harm reduction services and the role of pharmacy staff.

Results

43 articles were included. The most frequently reported harm reduction services were sexually transmitted and blood-borne infection care (33%), needle and syringe programmes (21%), naloxone distribution (19%) and medication treatment for opioid use disorder (19%). Pharmacy staff were integrated into multidisciplinary teams (79%), with their roles varying from education to medication prescribing. Included studies reported harm reduction services for PWUD delivered by pharmacy staff as effective, feasible and safe. However, implementations were not tailored to equity-deserving populations. Services primarily addressed opioid-related harms, while strategies focusing on the use of non-opioid substances were limited.

Conclusion

This scoping review highlights the diverse roles pharmacy staff play in delivering harm reduction services for PWUD. Positioned at the intersection of accessibility and healthcare delivery, pharmacy staff are ideally situated to expand access to equitable care. To fully harness this potential, future research and practice should embed harm reduction as a core philosophy, extending beyond individual interventions to support the creation of person-centred, non-judgmental and low-barrier services.

Mapping the direct and indirect costs of patient and public involvement (PPI) in stroke and aphasia research: a scoping review protocol

Por: Charalambous · M. · Kountouri · A. · Kola · E. · Claudia De Souza · A.
Introduction

Patient and public involvement (PPI) is increasingly embedded in stroke and aphasia participatory research, enhancing relevance and inclusivity. While the benefits of PPI are well-documented, the costs, both direct (eg, honoraria, travel, accessibility materials) and indirect (eg, time, administrative burden, emotional labour), remain poorly reported. This scoping review aims to (1) identify and categorise direct and indirect costs of PPI in stroke research, (2) examine how these costs are defined, reported or implied, (3) map cost-related barriers and facilitators and (4) expose evidence gaps to inform the Mapping the Economic and Social Tangible and Emotional Resources of Patient and Public Involvement (MASTER-PPI) framework.

Methods and analysis

Following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines, we will search Medline, PUBMED, Embase, CINAHL, APA PsycINFO, Scopus and Web of Science, as well as grey literature (NIHR INVOLVE, Horizon Europe, non-governmental organisation (NGO) reports). Eligible studies include those reporting or implying direct or indirect costs of PPI in stroke research. Two reviewers will independently screen and extract data, which will be synthesised descriptively and thematically. Findings will be aligned with the MASTER-PPI framework.

Ethics and dissemination

Ethical approval is not required. The findings will be disseminated through peer-reviewed journal publications, conference presentations, social media posts in lay language and policy briefs tailored for NGOs and funders.

Registration

This protocol is registered with the Open Science Framework (OSF) (https://doi.org/10.17605/OSF.IO/VM9ZU).

Wound Management and Surgery for Calcific Uremic Arteriolopathy (Calciphylaxis): A Retrospective Observational Cohort Study

ABSTRACT

Wound care in calciphylaxis remains poorly defined without evidence-based consensus on timing and technique of surgical intervention. We demonstrate that surgical debridement and subsequent wound closure are safe and effective in calciphylaxis and describe a systematic multidisciplinary approach to intervention. We retrospectively reviewed a cohort of patients with calciphylaxis at our institution. Those who underwent surgical debridement and wound closure were analysed with emphasis on wound healing, progression to amputation and mortality. Sixty-two patients with calciphylaxis underwent surgical debridement. Twenty patients had wound closure by skin grafting, five were excised with primary wound closure, and 37 were debrided and allowed to heal by secondary intention. There were excellent rates of healing in all groups, and no patients demonstrated wound progression or new lesions following operative intervention. Surgical debridement and wound closure are safe and effective in treating wounds related to calciphylaxis.

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Enhancing communication with bereaved relatives about emergency and critical care trials (ENHANCE): a mixed-methods study

Por: Doughty · H. · Deja · E. · Young · B. · Welters · I. · Shepherd · V. · Milosevic · S. · OHara · K. · Carman · J. · Sankar · V. · Thomas-Jones · E. · Euden · J. · Woolfall · K.
Objectives

Clinical research in emergency and critical care is vital, but recruitment and consent are complex. Research may be conducted without prior consent when patients are critically ill, and interventions are time critical. Some patients may die before research participation can be discussed with relatives, leaving the bereaved unaware of their involvement. This study explored potential communication strategies for informing bereaved relatives when a patient has died following enrolment into an emergency or critical care study without prior consent.

Design and setting

A mixed-methods study using a telephone survey and semi-structured interviews conducted simultaneously. The survey was conducted within a National Health Service Trust in North West England with relatives of deceased study participants. Semi-structured interviews were conducted with bereaved relatives and research and clinical staff across the UK, and medical examiner (ME)/ME officers based in England and Wales. Quantitative data were analysed descriptively, and qualitative data were analysed using reflexive thematic analysis. Data were synthesised using a constant comparison approach.

Participants

11 bereaved relatives completed the survey. 53 individuals (21 research and clinical staff, 18 relatives and 14 MEs/officers) participated in semi-structured interviews.

Results

Although many trials do not include a process for notifying bereaved relatives about research participation, most relatives valued the opportunity to learn about their family member’s participation, emphasising the importance of transparency and trust. However, some raised concerns over the potential burden of automatic disclosure by the ME service. Offering bereaved relatives the option to receive sensitively worded information about research involvement at an appropriate time, soon after death, was recommended.

Conclusion

Bereaved relatives should have the choice to be informed about research participation without prior consent. Our findings support the need for transparent and sensitive communication and will contribute to future guidance for the design and conduct of adult emergency and critical care studies.

Applications of artificial intelligence for real-world evidence generation: a protocol for a living scoping review

Por: Oikonomidi · T. · Raad · H. · Diaz-Decaro · J. · Li · H. · Y Smith · M. · Rivera · D. R. · Liu · W. · Soriano Gabarro · M. · Bennett · D. · Mack · C. D. · Teltsch · D. Y. · Gerber · J. E. · Bray · B. · Dickinson · H. · Jani · M. · Naidoo · N.
Introduction

Artificial intelligence (AI) is rapidly evolving, offering an expanding suite of capabilities that go beyond the traditional focus on prediction and classification. Generative AI (GenAI) and agentic AI could create transformative practices to support real-world evidence (RWE) generation for health research by streamlining studies, accelerating insights and improving decision-making. However, there is no published overview available describing the range of applications in RWE generation. This review aims to describe where and how genAI and agentic AI are applied across the domains of healthcare research tasks for RWE generation. Additionally, to map applications by tasks and methods across the product lifecycle continuum, and to identify emerging gaps and opportunities.

Methods and analysis

This Living Scoping Review (LSR) will include studies reporting an application and/or evaluation of genAI or agentic AI applied to one or more RWE generation research tasks. Searches will be conducted in Embase, MEDLINE and additional sources (eg, grey literature). Citations will be independently screened by two human senior reviewers for a substantive training dataset and a commercially available screening algorithm (Robot Screener) will complete screening with a human reviewer. The LSR will include reports of studies (primary or reviews) describing and/or evaluating the application of any genAI model for RWE generation in healthcare, in English, published from 1 January 2025 to the date of search. Data will be extracted from all studies included in the LSR by one independent senior reviewer using a piloted template, with 10% quality check by a second senior reviewer. Descriptive statistics will be used to summarise the applications of genAI per RWE research task, and the results of genAI evaluations. Thematic analysis will be used to describe genAI application patterns, trends, gaps and opportunities. The LSR protocol and reports will be updated annually, and findings will be published on a publicly available website (eg, ISPE—the International Society for Pharmacoepidemiology).

Ethics and dissemination

Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.

Incorporation of social medicine curriculum in academic and community health centres: a scoping review protocol

Por: Cydis · M. · Hudson · E. · Shipper · A. G. · Lane · A. · Salzman · M.
Introduction

In the field of medicine, there has been a growing understanding of the impact of social and economic inequities on patients’ health outcomes. Social medicine was established with the intention of addressing these social and economic drivers of health when caring for patients. Physicians who practise social medicine aim to take an interdisciplinary and interprofessional approach to patient care with an emphasis on the promotion of health equity and patient advocacy. As the effects of social determinants of health (SDOH) on health outcomes have become more widely appreciated, medical professional organisations and accrediting bodies have advocated for formal education on the impact of SDOH in undergraduate and graduate medical curricula. The goal of this scoping review is to examine how undergraduate and graduate medical education programmes in the USA have implemented social medicine concepts into their curricula.

Methods and analysis

The proposed scoping review will be conducted in accordance with the Joanna Briggs Institute methodology for scoping reviews. The review team worked with a medical librarian, who created a unique search for five databases (PubMed, Embase, Cochrane CENTRAL Register of Controlled Trials, ERIC and the Web of Science Core Collection). Additionally, we will conduct a grey literature search that includes medical school and residency programme websites, as well as Association of American Medical Colleges (AAMC), Council of Residency Directors in Emergency Medicine (CORD), Alliance for Academic Internal Medicine (AAIM) and Society for Academic Emergency Medicine (SAEM) conference abstracts. Two independent reviewers will assess all articles for eligibility. Data will be extracted using the Covidence data extraction tool. We will present the results of the extraction in tabular form. Themes identified during the full-text review and data extraction process will be discussed.

Ethics and dissemination

Data will be gathered from publicly accessible sources, so ethics approval is not necessary. The results will be disseminated through a peer-reviewed journal and reported at conferences related to medical education and social medicine.

Trial registration number

This protocol is registered on OSF (https://doi.org/10.17605/OSF.IO/7PZ8U).

Acceptability and adoption of a multiparameter point-of-care testing (POCT) device in primary healthcare for non-communicable diseases in resourced-limited communities in Peru

Por: Huayanay-Espinoza · C. A. · Moran · D. · Albitres-Flores · L. · Bernabe-Ortiz · A. · Cahuana-Hurtado · L. · Vetter · B. · Safary · E. · Lazo-Porras · M.
Objectives

To assess the acceptability and adoption of multiparameter point-of-care testing (POCT) devices for the diagnosis and management of non-communicable diseases (NCDs) at the primary healthcare level in a resource-limited region of Peru.

Design

Qualitative case-control process evaluation.

Setting

Eight primary healthcare facilities in northern Peru, including both urban and rural centres, where routine chronic care and laboratory services are provided.

Participants

Sixty-three participants: 36 patients, 12 laboratory technicians, 10 healthcare professionals and five facility heads. Eligible patients were ≥18 years, residing in the catchment area, with or without prior NCD diagnoses. Healthcare workers, including physicians, nurses, laboratory staff and facility managers.

Interventions

Multiparameter POCT devices were installed in four intervention facilities, accompanied by staff training and community awareness activities, while four control facilities continued with conventional laboratory diagnostics.

Primary and secondary outcome measures

Primary outcome: perceptions of patients and healthcare workers regarding the acceptability and adoption of POCT devices. Secondary outcomes: identification of facilitators and barriers to implementation, including infrastructure, supply chains and training gaps.

Results

(1) Individuals: POCT was valued for speed and comfort, but concerns over accuracy were mentioned. (2) Intervention characteristics: laboratory staff valued POCT’s practicality in emergencies, but noted limitations in handling multiple samples. (3) Outer setting: urban centres outperformed rural facilities, with more staff and longer operating hours. (4) Inner setting: calibration gaps impacted POCT and conventional test reliability, requiring quality control and training. (5) Process: clear staff communication boosted patient confidence in POCT, but inconsistent training could lead to reliability doubts.

Conclusions

Multiparameter POCT devices show promise for enhancing NCD care in resource-limited primary healthcare settings, particularly in rural areas. However, their sustainability depends on broader health system reforms, including reliable supply chains, expanded training and stronger quality assurance mechanisms. Further research should examine strategies for embedding POCT within national regulatory and policy frameworks.

Imaging the choroidal microvasculature in intensive and high dependency care unit patients: a pilot study

Por: Cooper · G. M. · Burke · J. · Hamid · C. · Godden · E. · Dhaun · N. · King · S. · MacGillivray · T. · Baillie · K. · Griffith · D. M. · MacCormick · I. J. C.
Objectives

Microcirculatory dysfunction drives the end-organ pathophysiology of circulatory shock but is not reflected within existing clinical indices of perfusion, such as blood pressure. The choroidal vasculature of the retina can be measured non-invasively and we hypothesised that this may reflect dysfunction in other organs. We tested the feasibility of measuring the choroid in intensive care and explored associations between choroidal measurements and clinical parameters.

Design

A pilot study of optical coherence tomography conducted in a sample of general intensive care unit (ICU) patients.

Setting

A tertiary mixed ICU within the UK.

Participants

15 patients were recruited. One patient was excluded following withdrawal of active treatment. 12/14 (86%) of the remaining patients had successful baseline imaging and 6 (40%) of these had follow-up imaging within intensive care. These patients had a mean age of 56.3 years, were 71% (10/14) male and mean Acute Physiology and Chronic Health Evaluation 2 (APACHE2) score on ICU admission was 20.4.

Outcome measures

Choroidal anatomy, including choroidal and suprachoroidal thickness, as well as volumetric analysis of intrachoroidal blood vessels, was assessed using automated image segmentation along with clinical, physiological and biochemical data at ICU admission and after an interval of 12–72 hours. Feasibility and safety data were assessed throughout ICU admission.

Results

Baseline choroidal vascular index and choroidal thickness were positively associated with fluid balance, and negatively with APACHE2 score, haematocrit and albumin content. A measurable suprachoroidal space was seen in nine (75%) patients (range 25.0–110.0 microns) and was inversely associated with heart rate. There was substantial intraindividual variation in choroidal measurements over time. There were no safety concerns.

Conclusions

Measuring the choroid is feasible in patients with Intensive Care Society Level 2 or Level 3 requirements. The suprachoroidal space may be markedly enlarged in these patients. Exploratory associations with systemic variables suggest that the choroid may provide information about the microvascular function of other major organs. Size and change of choroidal measurements may reflect perfusion pressure and vascular leakage.

Protocol of the RADIO-STAR trial: a phase 1 safety and dose finding study of hypofractionated radiotherapy to the stellate ganglia for the treatment of ventricular arrhythmia

Por: Bussmann · B. M. · George · B. · Robinson · M. · Grist · J. · Sukumar · P. · Chinherende · E. · Sheerin · F. · Enzhil · V. · Rider · O. · Jones · B. · Sabharwal · A. · Herring · N.
Introduction

Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.

Methods and analysis

RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.

Ethics and dissemination

This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.

Trial registration number

ISRCTN49861434.

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