To explore the perspectives and experiences related to caring for older people during clinical placement among undergraduate nursing students.
A qualitative exploratory study analysing individual interview data.
Department of Nursing, Faculty of Allied Health Sciences, University of Peradeniya, Sri Lanka.
Participants: A purposive sample of 14 undergraduate nursing students.
Semi-structured in-depth interviews were conducted, audio-recorded and transcribed. Data were analysed using Braun and Clarke’s reflexive thematic analysis framework.
Five themes emerged: (1) understanding ageing: The concept of ‘Age’, (2) Complexity of care: navigating challenges, (3) Care provision: rewards, growth and fulfilment, (4) Addressing challenges: barriers to support and (5) Reaching the horizon: enhancing geriatric education. Nursing students encountered both positive and negative experiences related to caring for older people. Positive experiences included increased self-awareness, learning opportunities, skill development and personal satisfaction. Negative experiences involved student-related and patient-related challenges, initial difficulties in providing care and inadequate support and mentoring during clinical placements.
Despite the complexities of caring for older people, nursing students are motivated to learn and provide the necessary care. This study highlights the need for quality care for older people, the importance of early geriatric education and the need for enhancing clinical supervision and mentoring.
Although the health impacts of floods are well described, there is limited research on how flooding affects health systems, services and the health workforce—despite their central role in mitigating and responding to these impacts. This scoping review examines the nature and extent of existing research evidence on the impact of flooding events on Australia’s health system.
A scoping review following the Johanna Briggs Institute methodology.
MEDLINE, Embase, CINAHL, Scopus, Web of Science, ProQuest Central and PsycINFO were searched through to 22 October 2024. Reference lists of included publications were screened for additional publications.
We included studies that reported any health system or health service disruption associated with flooding in Australia. Disruptions encompassed impacts on hospitals, primary care, health information systems, infrastructure, public health and health promotion activities, and the health workforce. We included peer-reviewed publications, including original research, commentaries, perspectives, editorials, letters to the editor, modelling studies and reviews. Grey literature was excluded.
Screening of full texts and data extraction were completed by two independent reviewers. A health system disruption analytical framework was iteratively developed and was used to categorise the findings.
Our search identified 6687 publications, of which 28 were included in the final review. 13 publications were original research publications and 15 were commentaries or reviews, with the majority published in the past ten years. Of the publications included, most focused on disruptions to hospital services and transport systems, including a reduction in health workforce availability, primarily due to the latter. Less than one-third reported impacts on health services for socially vulnerable populations. Floods affect multiple levels of the health system, intersecting with impacts across three key domains: infrastructure and health information systems, access to healthcare and the health workforce.
Original research on how floods impact Australia’s health system, its services and workforce has been limited, particularly in relation to general practice, allied health and the differential impacts on socially vulnerable populations. Further research is needed to inform targeted disaster preparedness and response strategies and to understand the complex and intersecting impacts. The analytical framework developed in this review provides a way to conceptualise how floods disrupt different components of the health system and offers a foundation for future research and policy development to strengthen system resilience in the face of increasing flood risk.
To synthesise the current evidence about practices, preferences and challenges related to returning aggregate research results to participants, with implications for public health, health equity and policy development.
Scoping review conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews framework.
Four electronic databases—PubMed (National Library of Medicine), Excerpta Medica Database (Elsevier), Cumulative Index to Nursing and Allied Health Literature (Elton B. Stephens CO(mpany)) and Cochrane Library (Wiley)—were from inception to February 2025.
English-language, peer-reviewed articles reporting practices or preferences for returning aggregate clinical research results to participants. Studies reporting only individual/incidental findings, opinion pieces and non-original research were excluded.
Two reviewers independently screened studies and extracted data. Study quality was assessed using a modified Oxford Centre for Evidence-Based Medicine scale. Thematic synthesis identified patterns in dissemination methods, participant preferences and implementation barriers.
Of 272 articles screened, 12 published between 2002 and 2019 were included. They employed cross-sectional, qualitative and mixed-methods design across North America, Europe, Africa and Australia. Half focused on cancer; others addressed malaria, autism, hypothyroidism, HIV prevention and preterm labour. Most (8/12) included patients; others also included researchers, caregivers or mixed stakeholders. Participants were predominantly middle-aged or older, female and well-educated. Only two studies assessed literacy, both using unvalidated self-reports. Eight studies explored preferences without returning results; four implemented disseminations via mailed reports, printed summaries, in-person discussions or digital platforms. Participants favoured mailed letters and face-to-face meetings over online methods. Six themes emerged: receiving results as respect; preference for personalised, timely formats; importance of cultural tailoring; emotional and ethical considerations; institutional barriers; and community engagement as a facilitator.
Returning aggregate research results to participants is ethically supported and strongly desired yet rarely practised. Bridging this gap requires clearer policy guidance, institutional support and equity-focused dissemination strategies. Health systems and researchers should adopt scalable, participant-centred approaches to fulfil ethical obligations and strengthen public trust in science.
The objective of this study was to explore medical practitioners’ understanding of antimicrobial resistance (AMR) and its aspects, such as its causes, possible outcomes and how doctors can contribute to its prevention.
This qualitative study was conducted in Sri Lankan healthcare settings.
Using convenience sampling, the study included allopathic medical practitioners aged 18–60 years, excluding intern-medical officers, until data saturation.
One-on-one interviews were conducted online or in person, depending on each participant’s preference. A structured questionnaire was used to triangulate the information.
Data were categorised into four: (1) understanding, awareness and identifying AMR as an issue among medical practitioners, (2) knowledge and understanding of factors that contribute to AMR development among medical practitioners, (3) knowledge and understanding of the outcome of AMR and (4) knowledge and understanding of preventive measures against AMR among medical officers. Interviewees showed an awareness of AMR; however, their knowledge was not up to date. Key reasons for inappropriate antibiotic use included unavailability and poor quality of antibiotics and unawareness of updated guidelines, especially in the government sector. In the private sector, patient pressure, the need to attract patients and the high cost of investigations contributed to misuse. Additionally, low patient literacy about AMR was a significant factor.
This study revealed that although medical practitioners in Sri Lanka are aware of AMR, their knowledge remains limited in certain areas. Several challenges contributed to inappropriate antibiotic use, including the availability and quality of antibiotics, external pressures from patients and financial constraints. The findings of this study highlight the urgent need for continuous medical education and public awareness campaigns to improve both practitioner and patient understanding of AMR. Addressing these issues is essential for effectively preventing and managing AMR in healthcare settings in Sri Lanka.
Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.
Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.
This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).
by Subash Bhatta, Nayana Pant, Suresh Raj Pant
BackgroundTo study the significance and correlation of choroidal and retinal pigment epithelial changes with disease activity in Central Serous Chorioretinopathy (CSCR) eyes.
MethodsThis was a retrospective analysis of clinical records and optical coherence tomography (OCT) images of CSCR cases presenting to a tertiary eye hospital in Nepal between October 2021 to November 2022. The study included 145 CSCR eyes from 132 cases compared with 290 eyes of 145 age- and sex-matched healthy volunteers. Chi square test, Paired T-test and Independent sample t-test were used for statistical analysis.
ResultsAverage subfoveal choroidal thickness (SFCT) of the CSCR eyes (453.13 um) and the fellow eyes (403.44 um) was significantly greater (p p p = 0.04 and p = 0.023, respectively). Flat and irregular PEDs were more common in chronic CSCR eyes compared to acute CSCR eyes (p = 0.027).
ConclusionsIncreased SFCT and PED are significant pathophysiological markers in CSCR, exhibiting distinct variations between acute and chronic forms. However, the lack of a direct correlation of SFCT with CST and PED underscores the limitation of relying solely on SFCT to fully characterize choroidal changes in CSCR. Further exploration of additional OCT biomarkers may offer deeper insights into the complex pathophysiology of these changes, paving the way for enhanced understanding and more targeted therapeutic strategies.
Overuse of CT scans is associated with multiple harms, such as an increased risk of cancer development, particularly in children. However, the rate of CT scan use is high and unwarranted worldwide.
This study aimed to identify the patterns and reported indications for head CT scans ordered for non-traumatic paediatric cases in Palestine.
This was a retrospective, cross-sectional study based on a desk review.
The study was carried out from June 2024 to September 2024 in five hospitals located in five major Palestinian governorates in the West Bank.
The study included records of children aged 14 or younger, presenting with non-traumatic complaints and having undergone head CT between January 2020 and September 2024. A total of 3715 patient records were explored, of which 2977 were included in the final analysis; 1764 (59.3%) males and 1213 (40.7%) females.
A pilot review of 100 records was conducted, and the data collection spreadsheet included demographic and clinical characteristics, presentations, reported reasons for CT requests, CT results, and information on lumbar puncture (LP) performance.
The mean age of patients was 4.3 years (SD±3.3), with 59.3% aged 3 to 11 years, and 47.7% presenting to hospitals in northern governorates. The most commonly reported presentation was fever and convulsion (8.2%), followed by convulsions (7.7%), and a combination of fever, headache and vomiting (6.5%). Only 12.9% of the CT scans yielded positive findings, including dilated ventricles (19.3%), sinusitis (18.8%), brain oedema (12.9%), and brain mass (11.1%). Most CT scans were requested to check for contraindications to LP, with only 4.1% having a positive CT finding indicating a contraindication. At the multivariate level, a positive CT result was associated with being a neonate, having a past medical condition, ordering CT to check for contraindication to LP and presenting with convulsions.
CT scans were found to be overused without justification, particularly for ruling out contraindications to LP. The development of clear and specific national guidelines is recommended. This process can be supported through training, decision support tools, alternative management pathways and specialist consultations to ensure compliance. Additionally, enhancing reporting quality and using health information systems are vital for monitoring and improving radiological safety.
Physical activity improves physical and psychosocial outcomes in healthy children and in children with a range of chronic health conditions. Unfortunately, children with chronic health conditions have lower levels of physical activity compared to their healthy peers due to multiple restrictions in physical activities and therefore tend to have lower levels of physical activity compared with their peers. This paper describes the protocol for Move to Improve, a pragmatic trial of an individualised physical activity intervention for children with chronic health conditions.
Using the RE-AIM framework, this study aims to test the feasibility of Move to Improve, an 8-week hospital-based individualised physical activity intervention. We will recruit 100 children aged 5–17 years who are diagnosed with type 1 diabetes, cancer, postburn injuries and cerebral palsy to a single-arm, pragmatic feasibility trial. The primary outcomes (objective moderate to vigorous physical activity, quality of life and goal attainment) and secondary outcomes (including aerobic capacity, body composition, motor function, grip strength and psychosocial outcomes) will be assessed at baseline, post intervention and at 6-month and 12-month follow-ups. We will conduct semistructured interviews with participants and their primary caregiver at a 2-month follow-up to capture aspects of feasibility. Quantitative data will be reported descriptively, and qualitative data will be analysed using thematic analysis. Data gathered from this study will inform service decision-making and future trials.
The study has received ethics approval from the Government of Western Australia Child and Adolescent Health Service Human Research Ethics Committee (RGS6677). Findings of this research will be communicated to the public through peer-reviewed publications, conference presentations, reports, infographics and information sheets. Modifications to the protocol will be outlined in the trial registry and journal publications. Authorship will be in accordance with the International Committee of Medical Journal Editors.
Australian and New Zealand Clinical Trials Registry Number: ACTRN12624000836538.
by Nayuki Numata, Aisa Ozawa, Motoharu Sakaue
Hair gets its color from melanin produced by melanocytes in the hair matrix. The coloration patterns observed in most terrestrial mammals arise from the diverse color combinations within their fur, which depends on the distribution pattern of melanocyte-containing hair follicles. Albino rats genetically produce no melanin and their coats are thus white, but we speculated that melanocytes differentiate and localize within these rats’ hair matrix. We conducted a reverse transcription-quantitative polymerase chain reaction (RT-qPCR) analysis, which revealed both the mRNA expressions of two melanocyte markers (dopachrome tautomerase and tyrosinase) in skin of male albino (SD, Wistar, and F344) rats and the differences in the markers’ expression levels among skin areas. Immunohistochemistry using anti-Dct antibody demonstrated that immunopositive cells, i.e., melanocytes, were localized in the rats’ hair matrix, and that melanocytes containing hair bulbs were distributed in head, dorsal thorax, and dorsal midline areas, which is similar to hooded rats. Our results suggest that differences in the melanocyte presence among the skin regions should be considered when the results of gene expression analyses of albino rat skin are interpreted.Cognitive impairments, such as dementia and Alzheimer’s disease, are considered a significant public health challenge as they affect mental functions like memory, attention, language and decision-making. With the growing number of older individuals, the prevalence of these diseases is also increasing and is projected to reach 152 million worldwide by 2050. These disorders result in difficulties with judgement, communication and daily activities, leading to more hospitalisations and risks such as disorientation in the environment and a higher likelihood of falls. Current hospital safety assessment tools mainly focus on physical aspects and overlook other crucial factors. Therefore, this study aims to clarify the concept of safety challenges for patients with cognitive impairment and to develop and psychometrically validate a multidimensional instrument for use in hospital settings.
A sequential exploratory study with mixed methods will be conducted. In the first qualitative phase, based on a content analysis approach, the aim is to explain and clarify safety issues in patients with cognitive impairment. Participants will be purposively selected until saturation is reached in educational-therapeutic centres affiliated with the University of Medical Sciences, and unstructured in-depth interviews will be conducted. The data will be analysed simultaneously using MAXQDA V.20 software. Additionally, a literature review on safety issues in patients with cognitive impairment will be conducted to supplement aspects that may not have emerged in the interviews.
In the second phase, an instrument based on the inductive–deductive method will be developed. The items will be created based on the participants’ experiences and the literature review. Face, content and construct validity, as well as reliability, will be assessed. Data synthesis will involve a linkage strategy, where the qualitative data will be linked to the quantitative data immediately after the completion of the qualitative phase, once the protocols are developed.
This study is part of a postdoctoral project approved by the Tehran University of Medical Sciences Research Ethics Board (IR.TUMS.FNM.REC.1403.006). Findings will be disseminated at the local, national and international levels.
With the rapid increase in the number of older adults living with chronic diseases and disabilities, there is a growing need to prepare nurses with positive attitudes and a willingness to work with older adults. This study aims to examine attitudes towards and willingness to work with older adults among nurses.
A cross-sectional survey was conducted among a purposive sample of 267 nurses at the University Hospital of Kotelawala Defence University, Sri Lanka. Participants completed a self-administered questionnaire consisting of socio-demographic variables, Kogan’s Attitudes Toward Old People Scale and questions related to willingness to work with older adults. Descriptive statistics and linear and logistic regression analyses were used in data analysis.
The majority were female nurses (71.9%, n=192) and held slightly negative (58%, n=155) or slightly positive (41.9%, n=122) attitudes towards working with older adults. Only 35.2% (n=94) were willing to work with older adults in this study. A male nurse (beta coefficient (β)=4.644, CI 2.392 to 6.896, p
Most nurses express slightly negative to positive attitudes and have little interest in working with older adults. Various socio-demographic factors have an impact on attitudes towards and willingness to work with older adults. Since nurses play a significant role in providing care for older adults, the development of positive attitudes is essential, and interventions and strategies are crucial to increasing their willingness to work with older adults.
by Sishir Poudel, Laxman Wagle, Tara Prasad Aryal, Binay Adhikari, Sushan Pokharel, Dipendra Adhikari, Kshitiz Bhandari, Kshitiz Rijal, Jyoti Bastola Paudel
BackgroundMultidrug-resistant tuberculosis (MDR-TB) continues to be a major public health concern, especially in high-burden countries like Nepal. While individual risk factors are known, the cumulative impact of cardiometabolic factors on MDR-TB is not well understood.
MethodsA health-facility-based, age- and sex-matched 1:2 case-control study was conducted at MDR-TB treatment centers in Gandaki Province, Nepal. MDR-TB patients (cases) and drug-sensitive tuberculosis (DS-TB) patients (controls) were enrolled. Cases were defined as adults (≥18 years) with confirmed MDR-TB; controls were adults with sputum-positive DS-TB. Data on sociodemographics, cardiometabolic risk factors (alcohol, tobacco, abnormal body mass index, hypertension, diabetes), TB literacy, and treatment history were collected using a structured, pretested questionnaire by trained medical officers. Data were analyzed using Stata v13.0. Binary logistic regression was used to assess associations between risk factors and MDR-TB. Ethical approval was obtained from the Nepal Health Research Council and written informed consent was obtained from all participants.
ResultsA total of 183 participants (61 cases, 122 controls) were included. Mean age of participants was 42.5 years (SD = 18.5); 73.8% were male. Most participants were from urban areas (74.9%), and 66.7% were unemployed. Cardiometabolic risk factors were present in 79.2% of participants. Alcohol and tobacco use were reported by 59.6% and 45.9%, respectively; 9.8% had diabetes and 7.1% had hypertension. Known TB contact and prior TB history were reported by 26.8% and 31.1% respectively. In multivariate analysis, unemployment (AOR: 5.24, 95% CI: 1.33–20.64), and known TB contact (AOR: 8.89, 95% CI: 2.46–32.15) were significantly associated with MDR-TB. Cardiometabolic risk factors were not significantly associated.
ConclusionKnown TB contact and unemployment were significantly associated with MDR-TB, while the cumulative effect of cardiometabolic risk factors showed no significant impact, indicating that interventions should prioritize established TB-related risk factors.
Patients receiving haemodialysis are at very high risk of fragility fracture, yet there are no proven treatments for fracture prevention. We will advance a pilot study on the feasibility of a large, pragmatic, randomised controlled trial (RCT) of denosumab for fragility fracture prevention in haemodialysis.
PRevEnting FracturEs in REnal Disease-1 is a pragmatic, open-label, pilot study of an RCT of a denosumab care pathway embedded in routine care haemodialysis centres.
We will recruit at least 60 participants at high risk of fracture from at least 6 haemodialysis centres in Ontario, Canada. They must be aged 40 years or older, have access to provincial drug coverage, have appropriate baseline calcium and parathyroid hormone levels and be deemed suitable for denosumab by their kidney care provider. Participants will be randomised 1:1 to denosumab (with supports to mitigate hypocalcaemia) versus usual care using block randomisation by a central statistician (computer-generated sequence). Primary outcomes include recruitment feasibility and adherence. Secondary outcomes include safety (hypocalcaemia) and participant satisfaction with our protocol and processes. Study investigators and data analysts will be blind to treatment allocation.
We will present results descriptively. The trial was approved by Clinical Trials Ontario and local research ethics boards across study sites.
Primary and secondary outcomes will be published on trial completion.
This pilot will inform the feasibility of conducting a large-scale, efficiently run, pragmatic RCT to test whether a denosumab care pathway safely reduces the risk of fragility fracture in patients receiving haemodialysis. Results have the potential to transform fracture care in real-world patients with kidney and metabolic bone disease.
Alzheimer’s disease (AD) impacts over 55 million individuals worldwide and remains the leading cause of dementia (60–70% of cases). By 2050, South and Southeast Asia are projected to have an older adult population more than double, bearing a major share of Alzheimer’s disease burden. This will exert a heavy strain on healthcare systems, particularly in resource-limited countries where support and infrastructure are already stretched. Despite this, no review has yet explored the regional epidemiology and associated risk factors in this context. Thus, this study protocol outlines to synthesise prevailing evidence from these densely populated regions, particularly low- and middle-income nations within South and Southeast Asia.
This review will include studies that reported epidemiological characteristics including prevalence, age of onset, mortality, and risk factors of AD and related dementias comprising in South and Southeast Asian regions. Studies published in any language from inception to date will be extracted from PubMed, Scopus, CINAHL, EMBASE and APA PsycNet, following Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) and Meta-Analysis of Observational Studies in Epidemiology (MOOSE) guidelines. We will also search grey literature sources and screen the reference lists of the articles selected for full-text review to identify additional relevant studies. Observational studies including case–control, cohort, and cross-sectional designs reporting desired outcomes will be included and appraised for quality assessment with the modified Newcastle-Ottawa Scale (mNOS). The included articles will be appraised by two independent reviewers, with a third resolving any conflicts. Pooled estimates of prevalence, age of onset and mortality will be analysed using random effect meta-analysis (REML) model. Associated risk factors, including modifiable and non-modifiable will be narratively synthesised. Forest plots will be used to visualise the findings, and heterogeneity across the included studies will be assessed using the I² and Cochrane’s Q statistics. Potential publication bias will be assessed using a funnel plot along with the Begg’s and Egger’s tests. Sensitivity and subgroup analyses will also be conducted to assess the robustness of pooled estimates and to explore potential sources of heterogeneity. Statistical analysis will be conducted using Rstudio (v.4.3.2) and GraphPad Prism V.9.0.2.
The systematic review is focused on the analysis of secondary data from published literature; thus, no ethical approval will be needed. The protocol will follow international standard guidelines, findings will be reported in a reputed journal and disseminated through (inter)national conferences, webinars and key stakeholders to inform policy, research and AD management strategies.
CRD 420251047105.
Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.
The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.
This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.
Central venous catheters (CVCs) are commonly used in intensive care but should be removed as soon as they are no longer needed to reduce infection risk. Peripheral venous access then becomes necessary, but can be challenging due to oedema. Near-infrared light devices, simple non-invasive tools, may assist nurses in this procedure. We hypothesise that a near-infrared light device (AccuVein AV500) could improve the first-attempt success rate of peripheral venous catheter (PVC) placement in intensive care patients no longer requiring a central catheter.
This investigator-initiated, prospective, multicentre, randomised controlled superiority trial compares the near-infrared light device to the landmark approach for PVC insertion in critically ill patients with an existing CVC. A total of three hundred and eighty patients are to be randomised in two parallel groups with a stratification on centre and anticipated difficulty of peripheral venous access.
The study objective is to compare the first-attempt success rate of PVC placement in adult critical care patients for whom a central catheter is no longer indicated.
The protocol and amendments have been approved by the French ethics committee (Comité de Protection des Personnes Sud Ouest et Outre Mer II, Toulouse, France, number 2023-A00429-36), and patients are included after informed consent. The results will be submitted for publication in peer-reviewed journals.
Clinicaltrials.gov: NCT06234293.
The hospital-at-home (HaH) model has gained traction as a viable alternative to traditional inpatient care, allowing patients to receive care in their own homes. Despite its growing popularity, there is a lack of comprehensive research addressing effectiveness, safety and factors critical to the successful implementation of HaH programmes. We conducted a scoping review to comprehensively map and summarise the evidence on both admission avoidance and early-supported discharge up until now.
A scoping review of randomised controlled trials (RCTs), conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis: extension for Scoping Reviews (PRISMA-ScR) guidelines.
Ovid MEDLINE, Embase, CINAHL and Web of Science were systematically searched up to July 2024
We included English-language RCTs published from 2005 onwards, involving adults (≥18 years) receiving acute care at home who would otherwise require hospital admission. Eligible studies evaluated admission avoidance or early supported discharge within HaH settings for acutely ill patients. Studies focusing on outpatient care, non-acute conditions or interventions not aligning with the widely accepted HaH definition were excluded. COVID-19-related studies were also excluded to avoid context-specific bias.
Two reviewers independently extracted data on study characteristics, interventions and outcomes including mortality, length of stay, escalation rates, costs and patient and caregiver satisfaction. Implementation facilitators and barriers were also collected. Discrepancies were resolved by a third reviewer. Results were synthesised descriptively in accordance with PRISMA-ScR guidelines.
Nine RCTs were identified. The review shows that the HaH model is at least as safe as usual care, with lower or comparable mortality rates. Length of stay varied, with some studies reporting longer stays in the HaH group due to cautious clinical practices. Cost analyses often indicate lower healthcare costs with staffing as the largest expense. Patient and caregiver satisfaction was high, but essential implementation factors were not clearly addressed.
The HaH model represents a promising alternative to acute inpatient care for suitable patients. Future research should focus on conducting larger RCTs, expanding the range of conditions suitable for HaH. Despite favourable clinical outcomes, substantial implementation barriers remain underexplored in current RCTs. This underscores the need to identify strategies for successful implementation, including the integration of technological advancements and qualitative insights into patient and caregiver experiences.
Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility.
This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes.
The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the National Medicines Regulatory Authority (Sri Lanka). The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.
Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).
Variations in mental health and sexual and reproductive health (SRH) outcomes of girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, gender fluid, agender, queer, gender neutral) youth with intersectional identities exist and have largely been ignored in the literature. There is a lack of information on how these health services meet the health needs of girls/women and gender-diverse youth with intersectional identities and the quality of such services. The objective of this global realist review is to identify how, why, for whom, in what contexts and to what extent mental health and SRH services meet the health needs of girls/women (cisgender and transgender) and gender-diverse youth (10–25 years) with intersectional identities.
The protocol has been registered with PROSPERO and will follow Realist and Meta-narrative Evidence Syntheses Quality Standards for Realist Reviews. We will identify the programme theory and implementation determinants of mental health and SRH services for girls/women (cisgender and transgender) and gender-diverse (nonbinary, Two-Spirit, fluid, agender, queer, gender neutral) youth (10–25 years). The scope of the review will be defined in the first stage and will include consultations with youth Advisory Group members and initial programme theory development. An iterative search of scholarly bibliographic databases (MEDLINE, Embase, APA PsycInfo, CINAHL, Web of Science, IBSS) in addition to a grey literature search will take place in the second stage. The third stage will include evidence extraction and synthesis. In the final stage, the narrative will be developed and refined in consultation with Youth Advisory Group members, and findings will be disseminated.
The study was approved by the Research Ethics Board at the Centre for Addiction and Mental Health (2023/153). Findings will be disseminated through peer-reviewed publications, youth-friendly materials and webinars and national and international conferences.
CRD42024532422.