Simulation-based interprofessional education (Sim-IPE) enables health professions students to collaborate in a realistic, safe, simulated clinical environment. Debriefing is a critical component of simulation, facilitating reflective learning and improvement in team performance. Instructor-led (IL) debriefing is considered the gold standard but is resource-intensive and may not be feasible in settings with limited faculty availability. Peer-led (PL) debriefing offers a potentially cost-effective alternative; however, its impact on debriefing quality, interprofessional competencies and professional identity in Sim-IPE remains underexplored. This study aims to compare PL and IL debriefing in terms of perceived quality and impact on interprofessional outcomes.
This manuscript reports a prospectively registered protocol for a single-centre, parallel-group, non-inferiority randomised controlled trial to be conducted at Qatar University Simulation Centre (Tamayuz). The trial consists of two arms: an IL debriefing arm (control) and a PL debriefing arm (intervention). A total of 120 students will undergo a comprehensive simulation experience, including pre-briefing and simulation, followed by random assignment to one of the debriefing arms. Outcome measures will include the Debriefing Assessment for Simulation in Healthcare Scale, Satisfaction with Simulation Experience tool, Modified McMaster Ottawa Scale for Teams and Extended Professional Identity Scale. At the time of the original submission, participant recruitment had not yet commenced.
This study was approved by the Institutional Review Board of Qatar University (QU-IRB 237/2025-EA). All participants in this study will provide informed consent prior to participation in the study. Findings of this study will be submitted to peer-reviewed journals and may be presented at conferences.
This study is prospectively registered on the International Standard Randomised Controlled Trial Number registry, a recognised clinical trial registry, prior to participant enrolment.
Breastfeeding provides essential health benefits for infants and mothers, yet initiation and continuation can be influenced by maternal medication use. Uncertainty regarding medication safety may lead to early discontinuation or avoidance of necessary treatment. We conducted a systematic review and meta-analysis to estimate the prevalence of breastfeeding initiation and continuation at 6 months post partum among women using medications.
Systematic review and meta-analysis using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.
PubMed, Web of Science, Academic Search Premier (EBSCO) and Google Scholar were searched up to 30 November 2024.
For selecting studies: We included cohort, cross-sectional and observational studies reporting breastfeeding initiation at birth and continuation at 6 months post partum among women aged ≥18 years using medications during pregnancy or post partum. Studies reporting medication type and duration of breastfeeding were prioritised.
Two independent reviewers screened, extracted and coded data using standardised methods. Risk of bias was assessed using validated tools. Pooled prevalence estimates were calculated using a random effects meta-analysis and meta-regression was performed to explore factors associated with breastfeeding outcomes. Findings were summarised in GRADE evidence profiles and synthesised qualitatively.
Of 286 retrieved articles, 29 met the inclusion criteria and 28 were included in the meta-analysis. 14 (48%) were cohort studies reporting breastfeeding prevalence while using medications. The pooled prevalence of breastfeeding initiation among women on medication during pregnancy or post partum was 75.2% (95% CI 69.8% to 80.7%; range 14–98%), with high heterogeneity (I²=99.2%, p
Breastfeeding initiation among women using medications is generally high, but continuation declines substantially, particularly among women on psychotropic, opioid or antiepileptic drugs. HIV status, medication type, healthcare support and national guidelines influence breastfeeding outcomes. Targeted interventions, including provider education, medication-specific lactation guidance and supportive workplace policies, are essential to promote sustained breastfeeding among women using medications.
To explore barriers and facilitators to midwifery practice of intermittent auscultation according to national guidance in the UK.
Multisite ethnographic study using observations of practice, semistructured interviews and informal conversations. Framework analysis using the Consolidated Framework for Implementation Research (CFIR).
11 maternity units across seven NHS maternity services in England and Wales in 2024.
Midwives and other maternity care professionals involved in fetal monitoring during labour.
‘Intermittent auscultation’ (IA), or listening to the fetal heart rate at regular intervals, to monitor fetal well-being during active labour.
Not applicable.
IA monitoring was frequently observed to be marginalised due to national and local pressures. IA is a complex skill that requires expertise and practice to develop and maintain. However, lack of a robust evidence base for IA methods is a further barrier to implementation. The study uncovered examples of facilitators that include: leadership engagement, access to knowledge and information supported in mentorship programmes and peer support models. These features created micro-environments where IA was valued, supported and integrated into care.
Our study highlights the significant impact of multilevel factors on the implementation of IA within UK maternity care. However, when organisational readiness, strong leadership engagement and supportive conditions are present, IA can be delivered in accordance with guidance. These findings underscore the need to align policy, infrastructure and organisational culture to sustain evidence-based, woman-centred practices such as IA.
Over the last decade, a growing number of health interventions (eg, medical assistance in dying and mitochondrial donation) have become legalised or decriminalised globally. Newly legalised health interventions share characteristics that are distinct from other health interventions, making their implementation more challenging. They are often highly emotive, controversial and associated with strong opinions and ethical dilemmas, with some of them being high-stake and irreversible. This study aimed to identify, systematise and map the factors that affect the implementation of health interventions that have recently been legalised.
A systematically conducted review.
PubMed, Scopus, EMBASE and CINAHL were searched to identify studies published between 2014 and 2024.
We included studies if they evaluated the implementation of health interventions that were newly legalised or newly decriminalised.
Data were extracted and synthesised through descriptive analysis. Both deductive and inductive thematic analyses were applied to map the barriers, facilitators and implementing strategies that influence the implementation of newly legalised health interventions in healthcare settings.
The search strategy yielded 1510 publications, of which 78 were included in this review. Findings showed that several newly legalised health interventions, including medical assistance in dying (n=56 studies); medical abortion (n=13); assisted human reproduction (n=3); psychedelic-assisted therapies (n=3); use of medical cannabis (n=2) and use of biosimilars (n=1) were addressed. The analysis identified a total of 880 diverse barriers, facilitators and strategies in five domains across system, organisational and individual levels: (1) patients/service users/consumers; (2) healthcare providers; (3) healthcare organisation; (4) legal processes and (5) system. These were further divided into 27 themes of barriers, 18 themes of facilitators and 17 themes of strategies.
Implementing newly legalised health interventions is complex. Our findings can support the development of an implementation plan for the spread and scaling of future health interventions, maximising the impact of interventions and making them accessible to more people and health organisations.
Metformin is the first-line treatment for type 2 diabetes mellitus (T2DM). Long-term use of metformin has been associated with vitamin B12 deficiency, which may lead to serious complications such as anaemia and neuropathy. Although international bodies have recommended screening for vitamin B12 deficiency in patients on long-term metformin, it is unclear how aware clinicians are of this adverse effect and to what extent such guidance is being followed in practice.
A scoping review was conducted using Joanna Briggs Institute (JBI) methodology. Databases searched included MEDLINE, Medical Literature Analysis and Retrieval System Online (PubMed), British Nursing Index (BNI), Google Scholar, Cochrane, Embase, Web of Science and CINAHL, Cumulative Index to Nursing and Allied Health Literature (EBSCO) alongside searching for grey literature such as EThOS (Electronic Theses Online Service), DART (Digital Access to Research Theses) European and Kings College London Research Portal. Studies published in English from 1990 onwards were included if they addressed clinician awareness or screening practices. Data were extracted and summarised using a structured tool, with themes mapped visually. The literature search was conducted between 1 August 2025 and 1 November 2025 and included studies published from January 1990 onwards.
23 sources were included in the review. 7 studies directly assessed clinician awareness of metformin-associated vitamin B12 deficiency, all conducted outside the UK. Across 15 studies reporting screening practices, routine vitamin B12 monitoring was uncommon, with annual testing rates in general below 20% of eligible patients (range 2.6%–19.8%). In a large retrospective cohort study of patients on long-term metformin, 44.9% underwent vitamin B12 testing, with a mean delay of 990 days from treatment initiation. Screening was predominantly symptom-triggered rather than preventive, and older adults and other high-risk groups were consistently less likely to be tested. Reported barriers included lack of clinical prompts, competing priorities and testing costs.
Clinician awareness of the link between long-term metformin use and vitamin B12 deficiency is present but inconsistently translated into practice. Screening practices remain suboptimal despite recent guideline updates. Interventions, such as checklists, prompts and updated training, may support improved adherence. However, no UK-based studies were identified, highlighting a gap in national evidence. Routine, risk-based screening in primary care could prevent significant morbidity associated with undiagnosed vitamin B12 deficiency in this population.
To describe healthcare professionals’ (HCPs) assessment of safety culture in adults and paediatric critical care units in governmental hospitals in Kuwait.
A cross-sectional survey study.
Adults and paediatric critical care units in Kuwait from January to April 2023.
Full-time HCPs (physicians, nurses and clinical pharmacists) who are in direct contact with patients and work in adults and paediatric critical care units.
Patient safety culture practices.
The population consisted of 945 HCPs from adult and paediatric critical care units. In general, across most dimensions, perceptions were more positive toward the patient safety culture. Adult critical care settings were mostly higher in negative responses compared with the paediatric setting. In general, all the HCPs responded positively towards ‘Teamwork Climate’, ranging from 41.5% to 85.0%, with the same pattern in the adult and paediatric settings. In both settings, ‘Safety Climate’ in general was responded to positively, ranging from 51.3% to 86.2%, and patterns between the two settings were the same. ‘Job Satisfaction’ showed positive responses between 68.2% and 88.3%.
In this study, HCPs from adult and paediatric critical care units rated patient safety culture dimensions positively. The patient safety procedures needing improvement were staff shortages, harsh workloads, poor communication and training. Providing frequent communication training and supporting personnel could further strengthen the critical care safety culture.
Disasters can have a disproportionate impact on highly vulnerable hospitalised patients. Managers preparing hospital networks for disasters play an important role in enhancing networks’ readiness by creating disaster plans and imparting that knowledge through training and simulation exercises. The objective of this research was to uncover how those working in disaster preparedness roles in Australian hospital networks perceived the challenges that they face while ensuring adequate preparation for disasters.
A qualitative study design was employed which involved purposive sampling of Australian hospital network professionals responsible for disaster preparedness. Thematic analysis of data collected through individual online interviews generated prominent challenges of disaster preparedness in Australian hospital networks.
Local hospital networks across Australia
Twenty-six disaster preparedness managers, including hospital executives, disaster managers, emergency management coordinators and business continuity managers from 23 hospital networks located in five Australian states and one territory, participated in semi-structured online interviews. Interview transcripts were coded through an iterative inductive thematic analysis process to synthesise the predominant challenges faced by these participants when preparing their hospital networks for disasters.
Participants reported four challenges: staff’s limited interest in preparedness, budgetary constraints, staffing issues and ambiguous relationships with state and national health departments. They also presented four related solutions: capitalising on interest after disasters, attracting funding with evidence from prior disasters, facilitating staff’s availability for disaster training and specifying network-government relationships for accountability.
Disasters, although infrequent, are known to occur and can be catastrophic, yet those working in hospital network disaster preparedness roles encounter limited availability of wider staff for training and low interest in disaster planning. The sudden onset of a disaster can take a heavy toll on patients if hospitals’ staff are not sufficiently trained in disaster response or are not aware of the disaster plan. By identifying the perceptions of managers to disaster preparedness, this research presents specific challenges that hospital networks can address to improve awareness and preparation.
This study aimed to explore perceptions of the Paediatric Improvement Collaborative’s (PIC’s) Clinical Practice Guidelines (CPGs) among clinicians, with a focus on awareness, frequency of use, applicability and areas for improvement.
Cross-sectional online survey and semi-structured interviews.
Clinicians working in all Australian states and territories. Recruitment was via non-probability convenience sampling. Invitations to participate in the online survey were posted on national- and state-level paediatric organisations, networks and groups. Survey participants could express interest in taking part in a follow-up online interview.
A total of 466 clinicians, including consultants/specialists (46.1%), specialists in training (residents/registrars: 20.4%), nurses (17.8%), allied health professionals (4.7%) and general practitioners (3.6%) participated in the survey. Findings indicated a high level of usage, with two-thirds of participants (63.9%) using the guidelines weekly. Most participants (91.8%) deemed the CPGs highly applicable to their practice settings, and over half (57.9%) had referred to more than 10 different PIC CPGs in the past month. Patterns of use reflected experience, seniority and scope of practice, with utilisation significantly higher among specialists in training, those working in emergency settings and those with less practising experience. Ten clinicians were interviewed to gain deeper insights, reinforcing that PIC CPGs serve multiple purposes, such as to check practice and for self-learning, for teaching more junior staff, and to reinforce treatment decisions with parents and patients. The guidelines were noted as being useful for all members of the multidisciplinary team in providing consistent language and uniform care. Key areas for improvement included enhancing accessibility in time-pressured environments, such as incorporating human factors-based navigation features and standardised layouts, and integrating additional tools and localised referral information.
PIC CPGs are viewed as a source of credible, evidence-based information that was valued across medical, nursing and allied health professionals.
Medication non-adherence in older adults with long-term conditions contributes to significant morbidity, mortality and healthcare costs. While adherence support tools exist, many interventions fail to reach those most at risk. Automated medication dispensers (AMDs) show promise in improving adherence and health outcomes, but their integration into routine community pharmacy practice remains underexplored. This study aims to assess the effectiveness of an AMD intervention with SMS reminders in enhancing medication adherence among older adults and to evaluate how this technology can be integrated into community pharmacy workflows.
This randomised controlled trial involves 144 participants recruited from eight community pharmacies who will be randomised to receive either the AMD intervention or usual care. Primary outcomes include medication adherence, measured through pharmacy records and self-report at baseline, 3 and 6 months. Secondary outcomes include Morisky Medication Adherence Scale, health-related quality of life (SF-12), and healthcare resource use. A nested mixed methods process evaluation will explore uptake, acceptability and implementation.
The study protocol has been approved by the University of Bedfordshire Institute for Health Research Ethics Committee (IHREC1039), the NHS and the local authority Research Governance and Research Ethics Committee (NHS REC reference: 25/EE/0026). The findings will be disseminated via a final report, peer-reviewed journal publications and presentations at relevant conferences.
Musculoskeletal pain is a global issue affecting millions of individuals. Healthcare provider gender bias (HCP-GB) in pain management or treatment may have implications. This study aimed to systematically (1) identify and map the scientific and grey literature as it relates to HCP-GB in the assessment, diagnosis and management of musculoskeletal pain, and (2) identify current gaps that necessitate further research.
This scoping review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR).
The following databases were searched: PubMed (National Library of Medicine), Embase (Elsevier), Scopus (Elsevier), CINAHL Complete (Ovid), Academic Search Complete (EBSCOhost), Pre-Prints Database (National Library of Medicine) and Rehabilitation Reference Center from inception to August 2022 and updated in May 2025. Relevant grey literature was identified.
All screening was performed by two reviewers during title/abstract screening and full-text screening stages. Articles published in English, Spanish and German were included if they involved participants with musculoskeletal pain and examined HCP-GB as the dependent variable.
Two reviewers independently extracted data from the bibliometric, study characteristics and pain science variables. Results were descriptively mapped, and the frequency of concepts, population and characteristics was narratively reported.
21 full-text articles were included. All articles were published in North America and Europe. A total of 3694 healthcare providers from various specialty areas were examined. A majority of studies (57.1%; n=12) measured HCP-GB using written case vignettes, 33.3% (n=7) used case vignettes plus virtual human pictures/videos, and 9.5% (n=2) used real patients. The influence of patients’ sex in HCP pain assessment was reported in 28.5% (n=6) of the articles, while 42.9% (n=9) reported gender bias regarding HCP non-pharmacological treatment recommendations. Male patients were more likely to receive exercise recommendations for back pain and laboratory testing, whereas female patients received more psychological treatment recommendations and counselling from their HCP.
While there appears to be inconsistent use of the terms sex and gender, the literature informing this review suggests an existence of gender bias in the management of patients with musculoskeletal pain. Future research should be more purposeful in the use of sex/gender-related terms and consider exploring the impact of implicit bias training to rectify potential gender biases present in HCP.
To explore the experiences of clinicians providing pastoral and mental health services to racially and ethnically minoritised students (REMS) at UK universities, aiming to understand the challenges REMS face in accessing support and to identify ways to improve service inclusivity.
Qualitative study using semi-structured interviews.
Student health and well-being services at five universities in the North East of England, a region with comparatively low racial diversity.
Ten clinicians (nine female, one male; nine White British, one other ethnic background; mean age 42.8 years) working in therapeutic roles with experience supporting REMS. Participants were recruited via opportunity sampling.
Semi-structured interviews, averaging 44 min, were video-recorded, transcribed verbatim and analysed using thematic analysis to identify key themes.
Six overarching themes were identified: (1) the chokehold of layered systemic challenges, (2) dynamics of power, (3) lack of safety for REMS, (4) "Am I really getting it?", (5) psychological therapies for white people by white people and (6) the thirst for expertise. Clinicians were enthusiastic about providing culturally responsive care but reported limited access to reflective spaces and training. Contextual factors—including racism, Brexit and the marketisation of higher education—were perceived to affect service delivery and REMS’ engagement with mental health support. Business-model approaches to service provision were sources of frustration.
Clinicians face structural and systemic challenges in providing culturally sensitive mental health support to REMS. Enhancing staff training, reflective practice and service adaptation may improve access and efficacy. Findings offer practical insights for universities aiming to strengthen equity in student mental health services, and future work could evaluate interventions to increase clinician preparedness and REMS engagement.
Pneumonia remains a leading cause of under-5 mortality in sub-Saharan Africa, accounting for approximately 14% of deaths in this age group. In Malawi, pneumonia accounts for 12% of under-5 deaths, with recent data revealing a concerning trend of over 110 000 new cases reported in 6 months. The Malawi government has made significant strides in reducing childhood mortality through the Integrated Community Case Management (iCCM) strategy, resulting in an 11% reduction in under-5 mortality over a 5-year period. However, the current iCCM strategy does not include the management of chest indrawing pneumonia in children aged 2–59 months and fast-breathing pneumonia in infants aged up to 2 months. This implementation research aims to increase pneumonia treatment coverage for under-5 year-old children in Kasungu District, Malawi, by expanding the community-based management of pneumonia by the iCCM-trained Health Surveillance Assistants (HSAs).
The current implementation research using both qualitative and quantitative data collection methods will assess the feasibility and acceptability of iCCM-trained HSAs managing chest indrawing pneumonia and fast-breathing pneumonia in children under 5 with oral amoxicillin at the community level in district Kasungu using the existing district health system. The study will employ a district health system model, leveraging existing trained iCCM HSAs to enrol and manage infants aged 7–59 days with fast-breathing pneumonia and 2–59-month-old children with chest indrawing pneumonia in the community with 7-day and 5-day oral amoxicillin, respectively. HSAs will also use pulse oximetry to identify hypoxaemic children for prompt referral to a hospital for further care. Sociodemographic features of enrolled children will be documented. Enrolled children will be followed up on treatment compliance using follow-up forms. The pneumonia treatment coverage will be assessed using baseline, midline and end-line surveys using both qualitative and quantitative data collection methods.
Ethical approval was obtained from the National Health Research Sciences Committee and the WHO Ethics Committee. The implementation research findings will be disseminated to national-level stakeholders and specifically targeted at District Health Offices, which are responsible for implementing the interventions.
Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.
This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.
The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.
Cellulitis is a common bacterial skin infection causing significant pain, swelling and impact on daily activities, frequently leading to emergency department presentations and hospital admissions. While antibiotics are the mainstay of treatment, they do not directly address inflammation, often resulting in persisting or worsening symptoms in the initial days. Corticosteroids, with their potent anti-inflammatory effects, have shown benefit in other acute infections but are not currently standard care for patients with cellulitis. This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary care settings.
This is a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial, with an internal pilot and parallel health economic evaluation. Adult patients (≥16 years) with a clinical diagnosis of cellulitis (at any body site except the orbit) presenting to urgent secondary care will be screened for eligibility. 450 participants will be randomised (1:1) to receive either two 8 mg doses of oral dexamethasone or matched placebo, administered approximately 24 hours apart, in addition to standard antibiotic therapy. The primary outcome is total pain experienced over the first 3 days postrandomisation, calculated using the standardised area under the curve from pain scores (Numerical Rating Scale 0–10) across up to seven timepoints. Secondary outcomes include health-related quality of life (EuroQol 5 Dimension 5 Level), patient global impression of improvement, analgesia and antibiotic usage, hospital (re)admissions, complications, unscheduled healthcare use, cellulitis recurrence and cost-effectiveness at 90 days. The primary estimand will apply a treatment policy approach to intercurrent events.
The trial has received ethical approval from South Central—Oxford B Research Ethics Committee (reference: 24/SC/0289) and will be conducted in compliance with Good Clinical Practice and applicable regulations. Informed consent will be obtained from all participants. A model consent form can be seen in . Findings will be disseminated through peer-reviewed publications and conference presentations, and to patient groups and relevant clinical guideline committees.
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.
Hysterectomy, a common surgical procedure, is frequently associated with moderate-to-severe postoperative pain and a high incidence of postoperative nausea and vomiting (PONV). Dexamethasone, a corticosteroid, may help alleviate these symptoms; however, existing evidence is largely drawn from mixed surgical populations and does not specifically address its efficacy and safety in hysterectomy patients. This meta-analysis provides a focused and updated synthesis of randomised controlled trials (RCTs) in this population, incorporating time-stratified pain outcomes and subgroup analyses by dose, surgical approach, timing and route of administration to evaluate the role of dexamethasone in postoperative recovery.
Systematic review and meta-analysis using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.
PubMed, Scopus, Google Scholar and The Cochrane Central Register of Controlled Trials (CENTRAL) were searched through 1 November 2024.
We included RCTs comparing dexamethasone with placebo for postoperative outcomes in hysterectomy patients.
Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Cochrane Collaboration and Evidence Project tools. Meta-analysis was conducted using random effects models. Findings were summarised in GRADE evidence profiles and synthesised qualitatively.
15 RCTs (1362 patients) were included. Dexamethasone significantly reduced PONV (risk ratio (RR): 0.53, 95% CI 0.47 to 0.61, p2: 0% high certainty) and pain scores at 24 hours (mean difference (MD): –0.20, 95% CI –0.35 to –0.05, p=0.009, I²=0%, moderate certainty), 8–12 hours (MD: –0.60, 95% CI –0.88 to –0.31, p2: 27%, moderate certainty and 4 hours (MD: –0.43, 95% CI –1.07 to 0.21, p=0.19, 93%, moderate certainty). It also decreased the use of rescue antiemetics (RR: 0.57, 95% CI 0.43 to 0.75, I2: 39%, high certainty) and postoperative opioid consumption (standardised MD: –0.48, 95% CI –0.90 to –0.05, p=0.03, I2: 74%, low certainty). The effects of rescue analgesics and hospital stay duration were nonsignificant. Subgroup analyses showed consistent antiemetic efficacy of dexamethasone across doses, timings, routes and procedures. For pain, greater analgesic effects were seen with higher doses and perineural administration, particularly at 8–12 hours. The risk of bias was low in most studies, but evidence of publication bias was observed for the pain score outcome.
Dexamethasone is an effective adjunct in hysterectomy, significantly reducing PONV and postoperative pain at 8–12 and 24 hours, particularly with 4–10 mg doses. Benefits are consistent across routes, timings and surgical approaches, with greater early analgesia after perineural use. It reduces opioid consumption but has a limited effect on rescue analgesia, supporting its role as a complementary analgesic. While generally considered safe, current safety data are limited, highlighting the need for further research. These results support its use in multimodal recovery protocols and identify priorities for future studies in high-risk and diverse surgical populations.
CRD42024608067.
This research paper presents a study protocol for an exploratory clinical trial evaluating the safety and potential efficacy of autologous peripheral blood mononuclear cell (PBMNC)-loaded injectable cell scaffold (ICS-001) for angiogenic therapy in chronic limb-threatening ischaemia (CLTI). CLTI, the advanced stage of peripheral artery disease, presents significant therapeutic challenges.
Angiogenic therapy using ICS-001 with PBMNCs—a novel approach designed to enhance local cell retention and promote neovascularisation—will be explored. The study will address the pathophysiology of CLTI, the limitations of current treatments and the rationale for cell-based therapies, alongside the clinical trial design for evaluating the safety and efficacy of ICS-001. We hypothesise that ICS-001 will improve ulcer healing and reduce ischaemic rest pain in patients with CLTI. This paper outlines the methodology, including patient selection, CD34+ cell mobilisation, scaffold preparation, injection protocols, clinical assessments, data collection and safety monitoring. The anticipated results, discussion and conclusion will offer insight into the clinical significance and potential impact of ICS-001 as a pioneering angiogenic therapy for CLTI.
The institutional review boards of all participating hospitals approved this study protocol (latest version V.6.0, 5 June 2025). Final data will be made publicly available. A report detailing the study results will be submitted for publication in an appropriate peer-reviewed journal.
Data are available on reasonable request. Technical appendix, statistical code is available by contacting the corresponding author. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) licence, which permits others to distribute, remix, adapt, build on this work non-commercially, and licence their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
jRCT2052230115, Japan Registry of Clinical Trials.
Progress at the intersection of artificial intelligence and paediatric neuroimaging necessitates large, heterogeneous datasets to generate robust and generalisable models. Retrospective analysis of clinical brain MRI scans offers a promising avenue to augment prospective research datasets, leveraging the extensive repositories of scans routinely acquired by hospital systems in the course of clinical care. Here, we present a systematic protocol for identifying ‘scans with limited imaging pathology’ through machine-assisted manual review of radiology reports.
The protocol employs a standardised grading scheme developed with expert neuroradiologists and implemented by non-clinician graders. Categorising scans based on the presence or absence of significant pathology and image quality concerns facilitates the repurposing of clinical brain MRI data for brain research. Such an approach has the potential to harness vast clinical imaging archives—exemplified by over 250 000 brain MRIs at the Children’s Hospital of Philadelphia—to address demographic biases in research participation, to increase sample size and to improve replicability in neurodevelopmental imaging research. Ultimately, this protocol aims to enable scalable, reliable identification of clinical control brain MRIs, supporting large-scale, generalisable neuroimaging studies of typical brain development and neurogenetic conditions.
Studies using datasets generated from this protocol will be disseminated in peer-reviewed journals and at academic conferences.
Adolescence is a critical period marked by rapid brain development and the onset of many mental health disorders. Brain MRI studies during adolescence, especially when paired with behavioural phenotypes and information about genetic risk factors, hold promise to advance early identification of mental health risk and spur the creation of targeted treatments to improve patient function, prognosis and quality of life. However, prospective neuroimaging is costly and time-intensive, and individuals who participate may not be reflective of the general population. These challenges are compounded when examining adolescents, as many families lack the time, energy or resources to participate in studies that use research-grade imaging. Repurposing clinical MRIs obviates many of the challenges of neuroimaging research. Here, we describe the brain-behaviour-genetics study protocol. This protocol describes procedures used to recruit participants with recent high-quality clinical brain MRIs and prospectively acquire genetic and sociobehavioural data, resulting in a highly cost-efficient design that harnesses a vast and underused neuroscientific resource.
The brain-behaviour-genetics protocol aims to recruit 1000 adolescents who have clinical brain MRIs contained in Children’s Hospital of Philadelphia’s electronic health record. One or both parents of the adolescent proband will be recruited when possible. Parents and adolescents will complete a series of self-report scales spanning the domains of mental health, trauma, risk and resilience. Saliva samples will be collected from the adolescent and at least one biological parent, using an at-home saliva collection kit. Subsequent analysis will examine associations between brain development, genetics and behavioural measures in adolescence.
Approval for the study had been obtained from the Children’s Hospital of Philadelphia’s institutional review board (IRB #23–0 20 851). Results will be published in peer-reviewed journals.
Intrapartum-related complications are a leading cause of adverse perinatal outcomes, including stillbirths, neonatal deaths and intrapartum-related neonatal encephalopathy (IP-NE). We assessed the prevalence of adverse intrapartum-related outcomes, evaluated the association between IP-NE and obstetric and fetal risk factors, and examined whether emergency referral and emergency caesarean section (CS) modified this association through interaction effects.
Cross-sectional with a nested case–control study.
Two hospitals in rural Eastern Uganda.
Women giving birth to a live or stillborn baby weighing >2000 g between June and December 2022.
We used prospectively collected perinatal e-registry data to assess the prevalence of adverse perinatal outcomes. Logistic regression with interaction with postregression margins analysis was used to determine the association between IP-NE and emergency referral and emergency CS across risk groups of hypertensive disorders, antepartum haemorrhage, prolonged/obstructed labour and birth weight.
Adverse perinatal outcomes were stillbirths, 24-hour neonatal deaths and IP-NE (defined as Apgar score
Of 6550 births, 10.2% had an adverse perinatal outcome: 3.8% stillbirths, 0.6% neonatal deaths and 5.7% IP-NE. Adverse outcomes were higher among neonates whose mothers had antepartum haemorrhage (31.3%) or prolonged/obstructed labour (27.2%) compared with those whose mothers had no complications. Emergency referral and CS did not change the association between IP-NE and obstetric risk, except in prolonged/obstructed labour. Without emergency CS, the predicted probability of IP-NE was 0.73 (95% CI 0.51 to 0.95); with CS, it decreased to 0.45 (95% CI 0.39 to 0.50).
Neonates born to mothers with obstetric complications had low healthy survival rates. Emergency referral and CS did not alter the risks of IP-NE in women with obstetric complications except for obstructed or prolonged labour, highlighting that these interventions may not be implemented with sufficient timeliness or quality, and/or that additional, more targeted strategies beyond referral and CS are needed to address IP-NE.