Sports-related concussion (SRC) is an established research topic in the context of sport professionals suffering from mild traumatic brain injury (mTBI), but there is scant investigation of SRC arising in school-aged athletes. Effective management of SRC in adolescents is especially dependent on obtaining an understanding of its pathophysiology and the multifaceted nature of recovery. In this planned observational study, we shall investigate the associations among multimodal data comprising blood-based and saliva-based biomarkers, diffusion tensor imaging (DTI), quantified susceptibility imaging (QSM), resting state functional connectivity MRI (rsfMRI) and cognitive testing in school rugby players with a conventional diagnosis of concussion. Our objective is to map out a natural history of the post-concussion injury and recovery process as measured by diverse biomarkers.
This prospective cohort study will enrol 450 male adolescents who participate in sports (including rugby, basketball and swimming). We shall quantify blood biomarker levels (total tau, neurofilament light, glial fibrillar acidic protein and ubiquitin C-terminal hydrolase-L1), white matter integrity on DTI, cerebral venous oxygen saturation on QSM, connectivity metrics on rsfMRI and cognitive performance after SRC. We conduct measurements at pre-injury baseline measure and post-SRC at four to five pivotal times: day 1 (day of injury), 3, 6, 13 and 21 (if symptoms persist) post-concussion. Using mixed-effects and trajectory modelling, we shall assess biomarker trajectories.
We have secured ethical approval for this study from The University of Queensland’s Human Research Ethics Committee, Queensland. We shall inform participants and/or their guardians verbally and in writing of the study’s scope and procedures as a condition for informed consent. The dissemination of findings shall entail peer-reviewed publications and presentations at national and international conferences and via research and clinical networks. Completion of this study should provide a clearer understanding of anatomic and functional outcomes in adolescents with sports-related concussion.
The multimodal investigation of a cohort of adolescents suffering from concussion in the context of community sports should offer broad insight into the effects of mTBI on the developing brain.
Frostbite is a common reason for emergency department (ED) presentations in Canada. Iloprost, a prostacyclin analogue, has been investigated to reduce the risk of amputation with its use expanding. Two Canadian cities implemented iloprost over different times leading to a practice variation that allowed for treatment comparison. Our objective is to evaluate the effectiveness of iloprost compared with non-iloprost treatment. Secondary objectives include assessing the impact of iloprost dosage and homelessness.
A retrospective cohort study was conducted on adult severe frostbite cases presenting to EDs in Calgary and Edmonton between November 2021 and April 2024. Data were abstracted from clinical databases and analysed for demographic and injury characteristics, treatment and amputation outcomes.
Of 1812 total ED encounters for frostbite, 257 patients with grades 2–4 extremity frostbite were included for analysis. Logistic regression found that overall patients receiving iloprost were associated with reduced likelihood of any amputation (OR=0.49, 95% CI 0.25 to 0.96) and fewer digit amputations (p
Iloprost infusion was associated with a reduction in amputation rates in grade 3 and 4 frostbite with the greatest association seen in grade 3 cases. Greater iloprost dosage was associated with improved digit salvage. Homelessness was associated with delayed ED presentation.
To review the literature reporting patient preferences for ambulatory heart rhythm monitoring (AHRM) and what factors affect experience and engagement.
The prevalence of arrhythmia continues to rise and contributes significantly to outpatient care burden. There is limited understanding of patient experience and compliance with monitoring. As innovative technologies are developed and healthcare strategies move towards surveillance and prevention, understanding this is key.
A scoping review was conducted using guidance from the Joanna Briggs Institute and reported using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. The review included studies of adults under investigation or surveillance for arrhythmia with a range of devices (Holter monitor, patch device, event recorder, mobile cardiac telemetry, external and implantable loop recorders, wearables and other implantable cardiac devices) in ambulatory care settings worldwide. The final search was conducted on 3 January 2026 across Medline (PubMed), Embase (Ovid), Web of Science (Clarivate Analytics), Cumulative Index to Nursing and Allied Health Literature (EBSCOhost), PsycINFO (Ovid) and Google Scholar. Quantitative, qualitative, mixed methods, multiple methods and any type of review articles were included.
54 studies were eligible for inclusion from the initial search that identified 1320 articles. Two overarching themes emerged from the quantitative and qualitative data: patient factors and device factors affecting experience and engagement. Patient factors included clinical and demographic factors, education and expectations, experience and preferences and impact on daily life and healthcare. Device factors could be common to several devices, for example, skin irritation or device specific, for example, the nature of activation.
Patient and device factors influence preferences for and experience and engagement with AHRM. While existing literature is incomplete and heterogeneous, it identifies key considerations that should be integrated into the development and testing of novel approaches for arrhythmia surveillance in healthcare contexts.
https://doi.org/10.17605/OSF.IO/6K3W8 (Open Science Framework).
Social prescribing has provided a lifeline to people, capturing the importance of quality support offered via community connections. It has not been exempt from difficulties, resulting in low-quality evidence on effectiveness in part due to high drop-out rates and lack of controls. While these have been the focus of recent research, less attention has been paid to the safety implications of social prescribing. This review aims to understand safety implications of social prescribing interventions and to build a dark logic model of how harms are produced.
Using review of review (umbrella) methodology, we searched nine databases to June 2024.
Medline/Ovid, Embase, PsycINFO, Cochrane Library/Wiley, Web of Science and Scopus) were searched from 1 January 2010 to 3 June 2024.
Included reviews were systematic/scoping/narrative reviews or meta-analyses, which synthesised primary data collected from any person in receipt, involved in delivery or the commissioning of social prescribing interventions. The context of the review was social prescribing interventions/services based in primary healthcare (statutory) or third sector (non-statutory) in any country. Only reviews that were published in English and in peer-reviewed journals were included.
Two independent reviewers extracted data from included reviews using the Typology of Harms Framework (which includes five categories of harms associated with interventions: physical, psychological, group/social, equity and opportunity harms) and to build a dark logic model to understand what contributes to these harms.
Sixteen reviews were included, reporting on social prescribing research including a link worker. Of the identified harms, we found that opportunity harms (harm related to the cost, inappropriate or ineffective interventions) were most reported. There was also evidence extracted to suggest plausible psychological, equity (impact caused by inequity in provision, delivery or access) and group/social harms (impact that overly or inadvertently excludes a person). No physical harms were identified.
Social prescribing, as with any delivery of care, has the potential to cause harm. We identified a range of potential harms (psychological, group/social, equity or opportunity harm) from social prescribing; however, it is unlikely to be an exhaustive list. We provide two clear outcomes: (1) the need for robust design of social prescribing research, including collection of data on the incidence and prevalence of harms, (2) recognition of the potential for harm from social prescribing and to address these where practicable.
To estimate the contribution of ultraprocessed foods (UPF) to total energy intake and to macronutrient and micronutrient intakes among very old people aged 85 years in the Newcastle 85+ Study.
Cross-sectional observational analysis of baseline dietary and demographic data from the Newcastle 85+ cohort.
Community-dwelling and institutionalised adults in Newcastle on Tyne and North Tyneside, UK, recruited through general practice registered between June 2006 and October 2007.
Eight hundred participants (62% female) aged 85 years at baseline, with two complete non-consecutive 24-hour dietary recalls.
The primary outcome was the contribution of UPF (Nova group 4) to total energy intake, macronutrient intakes, expressed as percentage of total energy for carbohydrate, protein, total fat, saturated fat and added sugars, as grams per day for fibre and to micronutrient intakes (vitamins A, B, B₁2, C, D, E and folate) and minerals (calcium, potassium, magnesium, zinc, selenium, phosphorus, iron and sodium). All evaluated across sex, education and socioeconomic status, adjusted tertiles of UPF intake.
Among the 800 participants included in the analysis, UPF contributed 56% of total energy intake, surpassing that from unprocessed foods (27%). Total energy intake did not differ across tertiles of UPF consumption (lowest vs highest tertile: 1759.5 kcal/day (95% CI 1684.6 to 1834.4) vs 1740.0 kcal/day (1667.3 to 1812.7)). Higher UPF intake was associated with a higher proportion of energy from carbohydrates and added sugars, and a lower proportion from protein and saturated fat. Intakes of several micronutrients were lower in the highest versus the lowest UPF tertile, including vitamin C (59.9 mg/day (49.8 to 70.0) vs 94.0 mg/day (83.7 to 104.4)) and potassium (2455.9 mg/day (2334.1 to 2577.6) vs 2786.3 mg/day (2660.8 to 2911.8)). By contrast, calcium from fortified foods increased across tertiles (6.3 mg/day (3.7 to 8.9) to 15.4 mg/day (12.9 to 17.9)).
This study highlights the potential role of UPF in the diets of very old people: higher UPF intake was not associated with higher energy intakes often observed in younger populations. Some UPF, particularly fortified products, may contribute to meeting micronutrient requirements in very old people where dietary inadequacies are common. Further research is needed to confirm these findings and to inform dietary guidance for very old people.
This real-world study investigated the changes of lipid lowering therapy (LLT) usage in patients with high or very high cardiovascular (CV) risk in the UK and the group of all other European countries in the SANTORINI study up to 1 year from baseline and the impact this treatment had on the attainment of low-density lipoprotein cholesterol (LDL-C) risk-adjusted goals set by the National Institute for Health and Care Excellence (NICE) and those in the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) dyslipidaemia guidelines.
Secondary analysis of the SANTORINI dataset (an international, prospective, observational, non-interventional study (NCT04271280)).
Primary and secondary care centres in the UK and the group of other European countries (Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden and Switzerland).
663 UK patients with high and very high CV risk were included in this analysis and 8502 from the group of other European countries. Of these, 380 UK patients and 6830 from the group of other European countries had LDL-C information available at baseline and 1-year follow-up.
The primary objectives were to describe patients’ lipid management, LDL-C levels at 1-year follow-up and their attainment of 2023 NICE (≤2.0 mmol/L) and 2019 ESC/EAS LDL-C 2019 guideline-recommended LDL-C goals (
Over the course of 1-year follow-up, the overall proportion of UK patients on no LLT reduced from 20.4% at baseline to 7.1%, similar to that observed in the group of other European countries (baseline–20.9%, 1 year–3.0%). The proportion of UK patients receiving LLT monotherapy increased from 74.8% at baseline to 84.9%, higher at both time points than that observed for the group of other European countries (baseline: 52.0%, 1 year: 55.0%). The use of any combination therapy increased slightly from baseline to 1 year in the UK overall cohort (4.9% vs 7.1%) and overall in the group of all other European countries, the cohort increased from baseline (27.1%) to 1 year (40.2%). Overall, mean (SD) LDL-C levels in the UK were 2.5 (1.2) mmol/L at baseline and 2.1 (1.0) mmol/L at 1 year and for the group of other European countries were 2.4 (1.2) mmol/L at baseline and 2.0 (0.9) mmol/L at 1 year. The overall proportions of UK patients achieving the UK NICE treatment goal and ESC/EAS 2019 guidelines at baseline versus 1-year follow-up were 40.3% vs 52.6% and 22.9% vs 32.9%, respectively; 21.1% and 30.9% of patients in the group of other European countries achieved the ESC/EAS 2019 guidelines at baseline and 1-year follow-up, respectively.
In this UK-focused analysis of the SANTORINI study, use of LLT increased modestly over 1 year, accompanied by a reduction in average LDL-C levels. However, mean LDL-C remained above the NICE goal, and attainment of both NICE and ESC/EAS LDL-C thresholds remained suboptimal. The findings highlight continued opportunities to optimise lipid management in UK clinical practice, including the potential for broader use of combination therapies.
Maternal human milk feedings continue an offspring’s exposure to the programming stimuli of maternal metabolism during the postnatal period. While considerable research focuses on associations between in utero environments and offspring metabolic disease, few studies have been able to specifically measure how human milk composition modifies programming of children’s growth in conjunction with comprehensive measures of maternal glycaemia during pregnancy.
The Glycemia Range and Offspring Weight and adiposity in response To Human milk (GROWTH) Study is a longitudinal cohort enrolling women with a singleton pregnancy who (1) undergo serial testing of glycaemia during pregnancy and (2) are intending to provide their breast milk through direct breastfeeding or pumped milk as the primary nutrition for their infant. Enrolment started in October 2023 and is expected to be completed in December 2026. Key procedures include virtual lactation support visits, serial human milk sampling at three time points, maternal and infant blood sampling, serial maternal and child anthropometric measurements and diet assessment. After delivery, mother–child dyads are followed until children turn 2 years of age. The primary exposure variable is maternal glycaemia obtained from a fasting, 3 hour 100 g oral glucose tolerance test performed at 24–28 weeks of gestation, and the primary outcome measure is the composite of human milk linoleic and docosahexaenoic acid concentrations in milk samples collected at 1 month postpartum.
Lurie Children’s Hospital Institutional Review Board (IRB) provides central oversight of the GROWTH Study in conjunction with each participating centre’s IRB. The GROWTH Study data has the potential to inform perinatal health and future research in lactation and human milk science by providing comprehensive measures of human milk composition and early childhood growth and body composition parameters impacted by maternal metabolism in pregnancy.
People living with HIV (PLHIV) frequently face psychological challenges, including stigma, stress and social isolation, which can negatively affect adherence to antiretroviral therapy (ART). Even in high-income countries where treatment is accessible, poor adherence can lead to drug resistance, reduced immune function and early morbidity. This systematic review aims to synthesise evidence on the relationship between psychological and mental health factors and ART adherence among PLHIV in high-income settings.
We will include studies published in any language between January 2015 and the date of the last searches. Reports of studies published in languages other than English, and which appear to be eligible for inclusion after the first level of screening, will be translated using Google Translate.
Studies will be included if they continue to meet the inclusion criteria and the quality of the translation is sufficient to extract the relevant data. PLHIV aged ≥15 years receiving ART in high-income countries. The studies to be included must assess psychological or mental health variables and ART adherence. Peer-reviewed journal articles will be the primary source of evidence. Grey literature identified from reference lists of key articles or using Google Advanced search techniques will be included. Searches for published studies will be done in OVID Medline, PsycINFO and Embase. Cochrane CENTRAL will be used to identify clinical trials in ClinicalTrials.gov and the International Clinical Trials Registry Platform.
Two independent reviewers will assess study quality and risk of bias using the Newcastle-Ottawa Scale, National Institutes of Health (NIH) Quality Assessment Tool and Jadad Scale. Discrepancies will be resolved by a third reviewer. Synthesis of quantitative data will be primarily descriptive. Predictors that have been examined in three or more studies will be reported in detail while those assessed in fewer studies will be presented concisely.
This study will be a review of the literature and will not involve primary collection of patients’ data. We will include amendments to the protocol in the final review. The final study will be published in a peer-reviewed journal and presented at conferences. The results of this systematic review will inform clinical practice, guide future research and support policy development that minimise mental health barriers to ART adherence.
CRD420251102248.
by Mohammad Nazmol Hasan, Md. Robin Islam, Rafee Shahrier, Md. Bayazid Hossen
Abiotic stressors, such as drought, salinity, and heavy metals, induce physiological changes, nutritional imbalances, molecular alterations, and oxidative stress in plants, which significantly reduce productivity. However, the secondary transporters, multidrug and toxic compound extrusion (MATE) proteins, transport substrates and metabolites. Accordingly, in response to abiotic stressors, these proteins strengthen plants’ immune systems, detoxify toxins, and enhance growth and development. Although the roles of MATE proteins responding to abiotic stresses have been investigated in several plants, their functions in sunflower have not yet been discovered. Therefore, this study identified 74 MATE proteins in sunflower (HanMATE) based on phylogenetic analysis, which were distributed into four subgroups. Their MATE-like properties were then validated using the domain, motif, gene structure, gene duplication, and physicochemical analysis. The HanMATE proteins in various cell organelles play a crucial role in abiotic stress tolerance, scavenging reactive oxygen species (ROS), and regulating transcription. Subsequently, Most HanMATE genes are enriched with biological processes and molecular functions that transport micro- and macro-molecules, drugs, negatively charged ions, organic anions, and citrate. The important Cis-regulatory elements (CREs), abscisic acid-, light-, and MeJA-responsive elements in HanMATE genes regulate plants’ growth and development in stress conditions. The synteny analysis indicated that 41 HanMATE proteins exhibit over 75% sequence similarity with 40 established stress-responsive (SR) MATE proteins from various plant species, suggesting their potential SR characteristics. Furthermore, this study identified 136 microRNAs linked to 58 HanMATE proteins, including 19 major hub microRNAs and 31 hub HanMATE proteins, which may enhance sunflower agronomic traits and abiotic stress resistance. The HanMATE proteins are conserved in other species that contribute to detoxification and have stable binding affinity with flavonoids and citric acid, validated from 3D structural modeling, molecular docking (MD), dynamic simulation, and functional prediction. These findings demonstrate that HanMATE genes are essential for sunflower abiotic stress tolerance (AST), and genetic engineering can be applied to develop more robust sunflower.Socioeconomic inequalities in neonatal mortality are observed globally but gaps remain in the evidence from current reviews, specifically: a wider range of socioeconomic indicators at the individual, household and area level than previous reviews, and alternative time frames to define neonatal mortality. Thus, a comprehensive updated review of the literature is required, focusing on multiple measures of socioeconomic status and alternative time frames, to assess the relationship between maternal socioeconomic status and neonatal mortality in high-income countries.
Three different search approaches will be used: electronic searching of three databases, grey literature searching and reference list checking. First, the three databases Medline, Scopus and Web of Science will be searched using relevant synonyms and adapted terms from medical subject heading terms (MeSH) in Medline for maternal socioeconomic status and neonatal mortality identified from previous systematic reviews on inequalities in adverse pregnancy outcomes. Second, grey literature will be searched by entering the relevant terms into Google. Title, abstract and full text screening will be conducted by the review team against the inclusion and exclusion criteria, with at least 10% checked by a second reviewer to assess for any bias and errors. We will also conduct the kappa statistic for inter-rater reliability. Third, the reference lists of included studies will be reviewed for any additional studies that meet the criteria. Data will be extracted using a data extraction form and extracted studies will be assessed using the Liverpool Quality Assessment Tool. A narrative synthesis will be conducted and, where appropriate, meta-analysis will be performed. If the data allow, subgroup analysis by neonatal care population and specific gestational ages will be performed.
Ethical approval is not required as all studies in this systematic review will be publicly available. The findings of this review will be presented at conferences and disseminated in peer-reviewed publications.
CRD42022315407.
by Robin Devey-Burry, Julia Lukewich, Dana Ryan, Myuri Sivanthan, Maria Mathews, Marie-Eve Poitras, Cheryl Etchegary, Shabnam Asghari, Margot Antle
BackgroundFamily Care Teams were introduced in Newfoundland and Labrador (NL) as a strategy to strengthen primary care through team-based models that optimize interprofessional collaboration. Nurses, including nurse practitioners (NPs), registered nurses (RNs), and licensed practical nurses (LPNs), play critical roles in these models; however, little is known about nurses’ transition to these settings or the supports shaping their integration and effectiveness. To address this gap, we explored nurses’ experiences transitioning into Family Care Teams, including supports for integration and the barriers and facilitators influencing this process.
MethodsAs part of a qualitative descriptive study, we conducted semi-structured interviews with 25 nurses (6 NPs, 13 RNs, 6 LPNs) employed in Family Care Teams across five NL health zones. During the interviews, nurses described their experiences working in Family Care Teams, available practice supports, current roles, and barriers and facilitators to maximizing scope of practice. Interviews were transcribed and analyzed using qualitative content analysis and constant comparison.
ResultsParticipants described their transition to Family Care Teams in two stages: 1) orientation and 2) supportive learning relationships. Orientation was highly variable, ranging in length and structure. Learning in this area was often self-directed, technology-focused, and asynchronous, with limited emphasis on clinical preparation or role expectations. Mentorship and shadowing opportunities were inconsistently available, with many nurses lacking access to experienced role models within the newly established teams. These gaps contributed to role ambiguity, underutilization of nursing scope of practice, and prolonged adjustment periods.
ConclusionsOur findings reveal gaps in orientation and mentorship during nurses’ transition into Family Care Teams in NL. A common yet adaptable transition framework, expanded student placements, and structured mentorship are critical to optimizing nursing roles in team-based care. Strengthening practice supports and clarifying nursing contributions can improve access and care quality while informing broader initiatives to support nurses’ transition into primary care.
To explore the views of health care professionals involved in initiatives that have led to successful research-related roles for nurses and midwives working in community settings.
A sequential mixed-methods study.
Between December 2022 and January 2023 a survey was completed by health care professionals with relevant experience of successful research-related initiatives for nurses and midwives in community settings. Survey responses were categorised into low, medium or high-priority examples of productive practice. Nineteen of the twenty responders who provided high-priority examples were interviewed between May and July 2023. The research capacity development for impact framework underpinned data collection and analysis. Data were thematically analysed using the framework method.
The seven themes of the research capacity development for impact framework: leadership and sustainability, skills and confidence building, infrastructures, linkages and collaborations, ownership and responsibilities, actionable dissemination and co-production were identified as important features of successful research-related roles in community settings. A new cross-cutting theme of trust and relationships was generated. The initiation, continued growth and ambition continuum guided the development of the planning change and features of success template.
This study highlighted the key features that matter when planning change and developing research-related roles for nurses and midwives in community settings.
Study findings have the potential to inform policy and practice for organisations focused on developing research capacity and capability in community settings.
This study adhered to the COREQ reporting guidelines.
No patient or public involvement.
by Claire L. Chan, Saskia Eddy, Jennie Hejdenberg, Ben Morgan, Heather M. Morgan, Gillian Lancaster, Clare Robinson, Sandra M. Eldridge
BackgroundThe National Institute for Health and Care Research accepts applications for pilot and feasibility studies to their Research for Patient Benefit (RfPB) programme. There has been limited work describing the design practices of these applications and funding status. Knowing some of the qualities which may contribute towards a pilot or feasibility study application successfully gaining funding could help researchers improve the quality of their applications. Therefore, this study describes the protocol for a review looking at the characteristics of funded and non-funded external pilot trial applications. In particular, the primary objective is to describe the planned sample size and sample size justifications.
MethodsThe study will be conducted on 100 applications from Competition 31–37 with a randomised feasibility design, identified and given access to us by RfPB where the lead applicant has consented. We will screen these applications to identify the external pilot trials, first looking through the titles and then the full text. Following this, we will extract data on information such as medical area, study design, objective(s), sample size, sample size justification, and funding outcome stage one and two. Validation will be performed on 20% of the data extracted; discrepancies will be resolved by discussion or a third reviewer will decide if there is no consensus. We will use descriptive statistics to summarise quantitative data, and will analyse qualitative data using thematic analysis. Findings will be summarised through discussion with the project contributors to produce a reader-friendly guidance document.
DiscussionThis work will provide a more complete picture of RfPB external randomised pilot and feasibility trials. The findings will assist researchers when planning their pilot trials, and could help improve the quality of submitted applications.
Protocol RegistrationOpen Science Framework protocol registration DOI: https://doi.org/10.17605/OSF.IO/PYKVG.
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.
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.
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.
Hyperkalaemia (HK) is common in the emergency department (ED) and can cause life-threatening arrhythmias. Patiromer is a potassium binder whose role in acute HK management is uncertain; therefore, we investigated the efficacy and safety of patiromer as an adjunct to the standard of care treatment of HK in the ED.
A prospective, randomised, double-blind, placebo-controlled study.
16 ED sites across the USA.
Patients aged ≥18 years treated at a participating ED who were found to have serum potassium ≥5.8 mEq/L.
Participants were randomised 1:1 to standard combination therapy (25 g intravenous dextrose, 5 units intravenous insulin and 10 mg albuterol) with either patiromer or placebo. The initial dose was given within 1 hour of the potassium result, and the second dose 24 hours later.
The primary endpoint was net clinical benefit (NCB) at 6 hours, defined as the change in number of potassium-lowering interventions minus change in serum potassium. Adverse events (AEs) were also recorded.
The study was terminated early and did not reach the prespecified sample size. Overall, 111 patients (53 patiromer and 58 placebo) were analysed. Mean (SD) age was 61.34 (15.21) years, 34% were female, 48% white and 22.5% received chronic haemodialysis. Mean baseline potassium was 6.5 mmol/L. NCB at 6 hours was similar between patiromer and placebo (–0.6 vs –0.4; p=0.44). Potassium levels at 2, 4 and 6 hours were similar between the groups (5.50 vs 5.70, 5.45 vs 5.65, 5.50 vs 5.60; patiromer and placebo (all p>0.05)). The number of interventions per patient was similar (p>0.05) between groups at each time point. The proportion of patients experiencing AEs was not significant between the patiromer and placebo groups (16.98% vs 32.76%; p=0.08).
No differences in efficacy were reported in this study, which was underpowered to detect statistical efficacy of patiromer over placebo.
Palliative care supports the physical, emotional, social and spiritual needs of people with serious life-limiting illness. Future research must align with the priorities of people approaching the end of their lives, and those close to them.
To undertake a refresh of the James Lind Alliance Palliative and End of Life Care Priority Setting Partnership, to identify and prioritise areas for future research.
The James Lind Alliance process was applied, between May 2023 and February 2025. An initial online survey collected areas for future research from participants. These were synthesised into a long list of questions and shortlisted through a second online survey. Final ranking of priorities was achieved using an adapted Nominal Group Technique within a prioritisation workshop.
People living with serious life-limiting illnesses, carers, friends and family members supporting them, bereaved people, health and social care professionals, volunteers working in palliative and end-of-life care and members of the public.
1032 and 626 responses were received to survey 1 and 2, respectively. 20 people with lived and professional experience attended the prioritisation workshop. An updated list of 24 priorities for palliative and end-of-life care research was produced.
The priorities reflect the range of issues shaping end-of-life experiences and serve as a call to action for researchers and funders.
Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.
This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.
This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.
Tongxinluo capsule (TXL) is widely used in China as an adjunctive therapy for patients with acute coronary syndromes (ACS) who underwent percutaneous coronary intervention (PCI), collectively referred to as ACS-PCI. However, current evidence on its therapeutic effects and safety remains limited and insufficiently synthesised. This review aims to evaluate the therapeutic effects and safety of adding TXL to Western medical therapy (WM) in this population.
A systematic literature search was performed in PubMed, the Cochrane Library, CNKI, VIP and Wanfang from inception to August 2024; a rapid supplemental search was conducted up to November 2025, without language restrictions, to identify randomised controlled trials (RCTs) evaluating the therapeutic effects and safety of adding TXL to WM in patients with ACS-PCI. Dichotomous outcomes were summarised using risk ratios (RRs) with 95% CIs; absolute risk reductions (ARRs) were estimated as risk differences, and corresponding numbers needed to treat (NNTs) were calculated. Continuous outcomes were summarised using mean differences (MDs) with 95% CIs. All meta-analyses were performed using a random-effects model. The included studies generally had limitations in methodological quality, heterogeneity across analyses was low to moderate and the potential for publication bias could not be excluded. The evidence certainty for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.
Eighteen RCTs involving 1800 participants were included. Low-certainty evidence indicated that adding TXL to WM may reduce the risks of restenosis (RR=0.30, 95% CI 0.10 to 0.91; ARR=0.056, NNT=18), revascularisation (RR=0.28, 95% CI 0.10 to 0.80; ARR=0.069, NNT=15), myocardial infarction (RR=0.44, 95% CI 0.20 to 0.98; ARR=0.033, NNT=31), angina (RR=0.32, 95% CI 0.17 to 0.61; ARR=0.076, NNT=14) and other cardiovascular events (RR=0.41, 95% CI 0.24 to 0.71; ARR=0.075, NNT=14). It also improved Seattle Angina Questionnaire scores (MD=8.82, 95% CI 6.58 to 11.05) and quality of life (qualitative synthesis). However, no statistically significant reductions were observed for sudden cardiac death (RR=0.39, 95% CI 0.12 to 1.27; ARR=0.022, NNT=45), or non-cardiovascular adverse events (RR=0.67, 95% CI 0.32 to 1.40; ARR=0.043, NNT=24) when TXL was added to WM.
Current evidence suggests that adjunctive TXL may reduce key cardiovascular events and improve symptoms and quality of life in patients with ACS-PCI, without increasing the risk of non-cardiovascular adverse events. However, all findings are based on low-certainty evidence. These results provide preliminary support for the use of TXL as an adjunctive therapy, but high-quality, multicentre RCTs are needed to confirm these effects and inform clinical guidelines.
CRD42024509453.
The COVID-19 pandemic accelerated telehealth adoption, offering remote consultations via phone and video. Allied health services are one part of the healthcare system where telehealth, in specific teleconsultations, has been applied and has shown promising results in improving healthcare access by breaking down financial, logistical and geographic barriers. However, more insight is needed into the consumer’s perspective. A consumer is anyone who has used, currently uses or will use telehealth for allied health services. Therefore, this study explores consumer experiences and preferences, identifying barriers and facilitators to telehealth for allied health services.
This qualitative study used focus group discussions to evaluate consumers’ experiences with telehealth for allied health services. Allied health was defined as healthcare professionals distinct from medical, dental and nursing fields. Eight focus groups with 57 participants were conducted. The participants were recruited from the general public as well as seldom represented communities such as a support service focused on improving and maintaining members’ mental health, the deaf and hard-of-hearing community, young disabled people and the Pacific Islander community. An inductive thematic analysis was used to analyse the data.
Five main themes were identified. First, the consumer with their individual characteristics and context played a major role in the suitability of telehealth. Second, the allied health practitioner and their skills influenced the quality and therefore the success of remote consultations. Further, the relationship between consumer and practitioner contributed to the success of telehealth. The appointment itself was equally often discussed. While telehealth improved access to care, remote appointments were seen as more suitable for questions and verbal exchanges. Lastly, the technology was an important factor with the availability of necessary technology and the accessibility of it playing a central role.
The findings reinforce existing research while highlighting new insights from often under-represented groups, emphasising the importance of telehealth choice, accessible technology and quality standards.
Patient safety is a central pillar of healthcare quality. However, with repeated examples of failure emerging across healthcare, there is an ongoing need to better understand how the safety of care can be improved for patients. Evidence suggests that some population groups are more likely to inequitably experience healthcare harm. This review will look at what evidence exists on understanding patient safety harm and its causes and impact on different population groups and particularly those from marginalised backgrounds. It will also focus on what actions can be taken to address patient safety disparities and service improvements, including with patient and public involvement.
A scoping review of empirical and grey literature will be conducted following the Joanna Briggs Institute guidance. Medical databases such as Medline, EMBASE, PsycINFO will be searched for peer-reviewed articles and grey literature sources such as BASE, institutional and government repositories will be searched for reports, independent reviews, confidential enquiries, etc. These will be searched from 2001 to present for publications in English. Title and abstract and full text screening will be undertaken by one or more people acting as first reviewers and validated by a second reviewer. A data extraction form will be used to extract data including equity considerations following the PRO EDI framework. Data will be grouped thematically and analysed using a narrative approach.
Ethics approval is not required for this work as the information used is publicly available. The findings of the review will be disseminated through stakeholder meetings, a peer-reviewed publication and conference presentations.
osf.io/4mfus.