Conectar
To explore baseline activities of daily living (ADL) profiles and their association with memory decline over time in cognitively healthy, community-dwelling older adults.
Observational panel study.
This study analysed data from Waves 7–10 of the English Longitudinal Study of Ageing (the search was performed on May 28, 2024), including 2925 older adults aged above 65 with no dementia or cognitive impairments at baseline (Wave 7, 2014–2015). To categorise participants by their daily functional abilities at baseline, latent class analysis was conducted to derive participants' activities of daily living profiles. A linear mixed model was used to explore whether these baseline activity profiles might predict different memory decline rates (trajectories) over time, accounting for baseline demographic factors (gender, age, ethnicity, education, marital status and chronic diseases).
Social demographics (younger age, female gender, white ethnicity, higher education and being partnered) and ADL profiles outweigh health conditions in predicting participants' memory function. Different baseline profiles were linked to different memory decline trajectories. An impairment profile with grocery shopping capability was linked to slower memory decline.
This study showed that ADL profiles had a substantial correlation with memory decline, accounting for the significant impact of sociodemographic factors. An impairment profile that preserved grocery shopping abilities appeared to offer protective benefits and potentially slow memory decline.
Strengthening nursing strategies that support older adults in maintaining the ability to grocery shop, such as guiding caregivers to promote involvement rather than shopping for the older adults entirely, or accompanying older adults grocery shopping as part of community nursing care, might help delay age-related memory decline in this population.
Patients or members of the public were not directly involved in the study's design, conduct, reporting, or dissemination plans.
To examine practical, ethical, and organisational implications of the use of a key technology deployed in the care of hospitalised people with dementia—visual identifiers—through a comparative analysis with parallel interventions in other spheres of healthcare and social activity.
Discursive paper.
We contrast visual identification systems used for hospitalised patients with dementia with other, ostensibly similar, systems to understand how they differ in key characteristics: what they disclose, to whom and with what intended consequence.
Certain distinctive features of the ways identifier systems are used to improve dementia care appear particularly consequential for their impact. Given how much is expected of such identifiers, they are likely to fail at least a proportion of patients.
We argue that it is important to critically evaluate the interests served by visual identifiers, identifying the dimensions of quality they can enhance and those that may be negatively impacted.
Visual identifiers for people with dementia can contribute to the ‘taskification’ of nursing care, implying that achieving person-centred care is a matter of following defined protocols rather than an emergent, relational, time-consuming process. Staff may end up prioritising risk avoidance and hospital routines (tasks that are measurable and auditable) rather than embracing the unpredictability of developing relationships with patients.
Visual identifiers are a part of well-established strategies to improve hospital care for those with cognitive impairment. While these identifiers aim to prompt healthcare professionals to deliver individually tailored care, research suggests that they are unable to consistently ensure the desirable quality of care. Understanding influences on how they are deployed can help reshape the expectations placed on such low-tech interventions and inform more reflective use.
Patients and public were not directly involved in the development of this discursive paper.
To describe and enhance the understanding of healthcare professionals' perceptions of future leadership in digital healthcare.
A qualitative descriptive study.
The data were collected remotely between February and November 2022 through semi-structured interviews. A total of 26 healthcare professionals were interviewed individually or in focus group interviews at the university hospital and university in Finland. The data were analysed using inductive content analysis.
Results revealed seven main categories that described the professionals' perceptions of future leadership in digital healthcare: building a future-oriented healthcare, strengthening a digitally minded organisational culture, being interactive in a digital environment, leading sustainably in digital healthcare, leading expertise in digital healthcare, leading collaboratively in digital healthcare and using artificial intelligence in leadership in digital healthcare.
Future leadership in digital healthcare will be about leading people in a humane way. Leaders will be at the forefront of digital solutions, sharing their expertise and enabling stakeholders' engagement. Through collaboration, future leaders will be building a future-led digital health system.
Digital healthcare is improving due to the implementation of new digital solutions and the possibility of artificial intelligence. Thus, leaders' competencies in digital healthcare need to be further developed through education and guided by policy to meet the expectations of future professionals, nurses and customers.
No patient or public contribution.
The Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist was used in the reporting.
To define and clarify the concept of emotional intelligence in healthcare leadership.
Walker and Avant's concept analysis model.
The study was conducted using Walker and Avant's concept analysis model. In the search of the relevant literature, the Joanna Briggs Institute's methodology and search protocol for scoping reviews were applied. Searches were conducted in May 2023 with no time or geographical limits on Scopus, CINAHL, ProQuest, the Web of Science, Medic and Mednar and 42 studies were included. The data were analysed using narrative synthesis by categorising results using the steps of concept analysis.
Concept analysis identified defining attributes of emotional intelligence in healthcare leadership, including leadership qualities, management competencies, and sets of leadership styles which were related to supportive and transformational leadership behaviour. The antecedents were socio-demographic factors, well-being, and workplace resources. Finally, employee-, manager-, organisation- and patient-related consequences were identified, such as the well-being of both employees and managers, organisational performance and patient care quality.
Emotional intelligence in healthcare leadership contributes to better performing organisations, as emotionally capable leaders can inspire and empower their employees. Holistic management of organisational duties and people-oriented leadership is a crucial resource in healthcare organisations. Well-being and workplace resources can be vitally important for leaders to manifest emotional intelligence in their work.
Emotional intelligence can contribute to efficient leadership behaviour and have positive outcomes at the employee, manager, organisation and patient levels. Therefore, emotional intelligence should be addressed in leadership education, training programmes and recruitment procedures. Finally, policymakers should be encouraged to acknowledge the role of sufficient resources in health care to ensure effective leadership.
Emotional intelligence is a widely studied concept in the healthcare field. However, thorough conceptualisation regarding emotional intelligence in healthcare leadership has been lacking. Conceptualising this phenomenon was therefore outlined, providing a deeper understanding of the concept. The findings can be utilised in healthcare leadership development and research.
N/A.
No patient or public contribution.
by Panawit Hanpinitsak, Tatpong Katanyukul, Norrawit Tonmitr, Chanon Suntra, Sora-at Tanusilp, Arthit Phuphaphud
Monitoring cattle behavior plays an important role in improving farm productivity, maintaining animal welfare, and supporting efficient management practices. This study presents a multi-view behavior recognition system that uses synchronized top-view and front-view CCTV footage, combined with deep learning techniques. The system includes four main components: cow identification, behavior classification, identity-behavior association using Intersection-over-Union (IoU), and a decision-level ensemble to combine information from both views. YOLOv8 models are applied separately to each camera angle to detect individual cows and classify six key behaviors: drinking, eating, standing, lying, riding, and chin resting, with the latter two being relevant for estrus detection. The system matches cow identities to their behaviors within each view and then integrates the results to produce a final activity label for each cow.To provide a synthesis of the published research evidence on Muslims’ perspectives and preferences regarding end-of-life symptom management to inform future practice and research priorities aimed at providing sensitive end-of-life care.
Systematic review and narrative synthesis.
MEDLINE, EMBASE, CINAHL, PsycINFO, Web of Science, ASSIA, The Cochrane Library and Global Health were searched from 1 January 1994 to 10 July 2024, alongside reference searches of included papers and hand searches of two journals.
The included papers presented primary research on end-of-life care among Muslims in the British Isles.
Data were collected on publication details, study aims, participants, methods and results. Studies were appraised using Gough’s weight of evidence framework. An inductive narrative synthesis consisting of three steps was conducted. This involved conducting a preliminary synthesis of findings, exploring relationships between studies and assessing the robustness of the synthesis.
18 papers were included in the synthesis. Patients prioritised conformity between religion, culture and end-of-life symptom management. Symptom management preferences were also influenced by patients’ desire to maintain a sense of control at the end of life. Family-based care is culturally accepted, and indeed expected, to achieve a peaceful death. Healthcare professionals experienced challenges in providing sensitive symptom management given their unfamiliarity with the religious needs of Muslims.
Co-design research methods are essential to better understand care priorities within diverse Muslim communities. Meaningful collaboration among patients, families and healthcare professionals is necessary to identify mutually acceptable and beneficial approaches to promote culturally and religiously sensitive end-of-life symptom management.
This study aimed to determine the prevalence and factors associated with pre-diabetes and undiagnosed type 2 diabetes (UDD) in Cambodia.
This analysis used data from the WHO World Health Survey Plus, which was collected using a cross-sectional design with a GIS-based, three-stage sampling approach. Multiple logistic regression was used to identify key associated factors, based on a significance level of p
Data were collected from all 25 provinces in Cambodia between 12 March 2023 and 31 May 2023.
4427 individuals aged 18 years or older, residing in the selected household for at least 6 months in the past year.
Pre-diabetes (Haemoglobin A1c (HbA1c) 5.7%–6.4%) and UDD (HbA1c≥6.5%), without prior knowledge of having type 2 diabetes (T2D).
The weighted prevalences of pre-diabetes and UDD were 26.4% (95% CI 24.0% to 29.0%) and 9.3% (95% CI 7.9% to 11.0%). Pre-diabetes prevalence was higher in urban areas compared with rural areas (adjusted OR, aOR=1.2, 95% CI 1.0 to 1.4), males (aOR=1.7, 95% CI 1.3 to 2.3), individuals aged 40–49 (aOR=1.8, 95% CI 1.4 to 2.4), individuals aged 50+ years group (aOR=2.9, 95% CI 2.3 to 3.6) compared with the 18–39 years group, overweight individuals (aOR=1.7, 95% CI 1.4 to 2.0), obese (aOR=2.1, 95% CI 1.5 to 3.0) and those with elevated total triglycerides (aOR=1.3, 95% CI 1.1 to 1.5). Similar risk factors were identified for UDD, with the addition of hypertension (aOR=1.6, 95% CI 1.3 to 2.0) and high waist circumference (aOR=2.0, 95% CI 1.5 to 2.7).
The high prevalence of pre-diabetes and UDD in Cambodia is a pressing public health concern. Urgent and intensive interventions are needed to effectively prevent and manage T2D, particularly among urban residents, older persons and individuals with metabolic risk factors.
Gestational weight gain (GWG) is an important indicator of maternal nutrition to be monitored during pregnancy. However, there is no evidence-based tool that can be used to monitor it across all geographic locations and pre-pregnancy body mass index (BMI) categories. The WHO is undertaking a project to develop GWG charts by pre-pregnancy BMI category, and to identify GWG ranges associated with the lowest risks of adverse maternal and infant outcomes. This protocol describes all the steps that will be used to accomplish the development of these GWG charts.
This project will involve the analysis of individual participant data (researcher-collected or administrative). To identify eligible datasets with GWG data, a literature review will be conducted and a global call for data will be launched by the WHO. Eligible individual datasets obtained from multiple sources will be harmonised into a pooled database. The database will undergo steps of cleaning, data quality assessment and application of individual-level inclusion criteria. Heterogeneity of maternal weight and GWG will be assessed to verify the possibility of combining datasets from multiple sources and regions into a single database. Generalized Additive Models for Location, Scale and Shape will be applied for the construction of the centile curves. Diagnostic measures, internal and external validation procedures will also be performed.
This project will include an analysis of existing study de-identified data. To be included in the pooled database, each included study should have received ethics approvals from relevant committees. Manuscripts will be submitted to open-access journals and a WHO document will be published, including the GWG charts and cut-offs for application in antenatal care.
To develop a grounded theory that explains how formal care service providers experience caring for and supporting persons with early-onset dementia (EOD).
A grounded theory approach.
Thirty formal care service providers of persons with EOD were recruited from community-based dementia care facilities in northern and central Taiwan from August 2021 and February 2022 using purposive and theoretical sampling. Transcribed face-to-face, semi-structured interview data were analysed with constant comparative analysis. A theoretical framework was constructed from the data to describe the experience of being a formal care service provider for persons with EOD.
The core category of ‘client-as-partner care’ was the theoretical framework that explained the experience of formal care service providers and described how participants met the needs of persons with EOD. Five categories described the components of the process: (1) identifying clients' characteristics; (2) establishing a personal relationship; (3) enhancing self-esteem; (4) maintaining dignity; and (5) the influence of family members and community members. The first four categories were interactive and key to delivering client-as-partner care; the fifth category could alter any key component and reduce or improve the quality of care. Reflections shared by participants offered a window into the outcomes of successful client-as-partner care: quality of life improved for clients and job satisfaction increased for providers.
The client-as-partner care model for persons with EOD required knowledge of the client's unique characteristics, a strong provider-client relationship, offering strategies tailored to the client's abilities and interests, and fostering independence.
Client-as-partner care provides a person-centred approach that enhances support quality for persons with EOD and increases job satisfaction for formal care providers. Successful strategies can inform case management, strengthen support for this population and indirectly improve family caregivers' competencies.
No patient or public contribution.
COREQ (COnsolidated criteria for REporting Qualitative research).
Social prescribing is an approach to addressing non-medical issues affecting people’s health and well-being (eg, loneliness, housing or financial problems). It has gained international traction over recent years as complementary to medical care. A larger research project, comparing social prescribing across European countries, is considering how to tailor provision for the following groups: (a) LGBTIQ+persons, (b) refugees and first-generation immigrants and (c) older adults living alone. As part of this research, a qualitative study will address the question: What are the enabling and limiting factors associated with implementing social prescribing, across different European countries, from the perspective of key stakeholders?
Five European countries (Austria, England, Germany, Poland, Portugal) will be involved. Researchers from each country will conduct approximately 20 semi-structured interviews (total number will be 100). Interviewees will be people receiving, delivering, managing and funding/commissioning social prescribing. Interviews will be audio-recorded and transcribed. A cross-country analysis will be undertaken; framework analysis will support this process, with a chart developed in Excel in which data from across the five countries is summarised by the researchers involved. Summaries will be based on a thematic framework that researchers from the five countries develop together after initially analysing their own data.
Ethical approval was initially secured through the University of Oxford’s Medical Sciences Interdivisional Research Ethics Committee (IDREC 1806086) for data collection in England. This approved application was then used to secure ethics approval in Austria (through Ludwig Boltzmann Gesellschaft), Germany (through Bergische Universität Wuppertal), Poland (through Wroclaw Medical University) and Portugal (through NOVA University of Lisbon). Dissemination will include an academic journal article and presentation at relevant conferences. It will also include short videos, written summaries/policy briefs and an infographic.
This project has received funding from the European Union’s Horizon Europe Research and Innovation Programme under grant agreement No 101155873. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.
This retrospective cohort study evaluated the relationship between patient falls, Morse Fall Scale (MFS) items, patient demographics, length of stay and hospital site.
Data were acquired from 72 hospitals in a health system. Logistic regression models were conducted including MFS items, demographics, length of stay, and interaction terms. The final mixed effects logistic regression model included significant patient-level covariates as fixed effects and hospital site as a random effect.
6531 of 978,920 total admissions included a patient fall. Four MFS items (fall history, secondary diagnosis, gait weak/impaired, mental status—overestimates/forgets limitations) and three demographic items (male gender, increased age, longer length of stay) were associated with increased likelihood of falling. Two MFS items (ambulatory aids, intravenous therapy/lock) and Hispanic ethnicity were associated with decreased risk of falling. An interaction effect was present between male gender and mental status. Males who overestimate/forget limitations had 3.16 times higher odds of falling than females oriented to their own ability. The proportion of variance in falls between hospitals was 0.23 and the median odds ratio (MOR) 1.57.
This study uniquely assessed fall risk at the level of the patient and hospital, using data from nearly 1 million admissions at 72 hospitals. Controlling for patient characteristics, results demonstrate variability in fall risk among hospitals. Research informing hospital differences as well as gender and racial/ethnic differences in falls is needed to identify appropriate interventions.
As hospitals increasingly adopt risk-directed fall prevention, assessment tools should be re-evaluated for clinical utility and corresponding prevention practices. The MFS may be enhanced by removing intravenous lock as a risk and screening for additional risks such as medications and medical equipment. Quality improvement efforts must also consider the hospital's environment and processes that may further contribute to fall risk.
Authors adhered to STROBE guidelines for reporting.
No Patient or Public Contribution.
by Carmen Villagrasa, Giorgio Baiocco, Zine-El-Abidine Chaoui, Michael Dingfelder, Sébastien Incerti, Pavel Kundrát, Ioanna Kyriakou, Yusuke Matsuya, Takeshi Kai, Alessio Parisi, Yann Perrot, Marcin Pietrzak, Jan Schuemann, Hans Rabus
Biological effects induced by diverse types of ionizing radiation are known to show important variations. Nanodosimetry is suitable for studying the link between these variations and the patterns of radiation interactions within nanometer-scale volumes, using experimental techniques complemented by Monte Carlo track structure (MCTS) simulations. However, predicted nanodosimetric quantities differ among MCTS codes, primarily because each code employs distinct molecular-scale particle interaction models. This multi-code study examines these variations for low-energy electrons (20–10,000 eV), which play a critical role in energy deposition and biological effects by virtually all types of ionizing radiation. Specifically, the hypothesis tested in this work is that inter-code variability in nanodosimetry results is mainly caused by differences in assumptions regarding total interaction cross sections. Ionization cluster size distributions and derived nanodosimetric parameters were simulated with seven MCTS codes (PARTRAC, PHITS-TS, MCwater, PTra, and three Geant4-DNA options) in liquid water as a surrogate for biological tissue. Significant inter-code differences were observed, especially at the lowest energies. They were substantially reduced upon replacing the original cross sections in each code with a common, averaged dataset, created ad-hoc for this study and not based on theoretical assumptions. For example, for 50 eV electrons in 8 nm spheres, the variability in the predicted mean ionization numbers decreased from 23% to 5%, and in the probability of inducing two or more ionizations from 34% to 7% (relative standard deviations). This quantification demonstrates that total interaction cross sections are the primary source of uncertainty at low electron energies. A sensitivity test using DNA damage simulations with the PARTRAC code revealed that cross section variations notably affect biological outcome predictions. Replacing the code’s original cross sections with the averaged ones increased the predicted double-strand break yield by up to 15%. These findings underscore the urgent need for improved characterization of low-energy electron interaction cross sections to reduce uncertainties in MCTS simulations and enhance mechanistic understanding of radiation-induced biological effects.by Fezile Wagner, Unathi Kolanisi, Ryan G. Wagner, Lerato P. Makuapane, Mxolisi Masango, Francesc Xavier Gómez-Olivé
The COVID-19 pandemic exacerbated hunger levels in South Africa, with an increase from 10% pre-pandemic to 23% during the pandemic. Pre-pandemic national and global research identified university students to be more vulnerable to hunger compared to the general population. This elevated risk is commonly associated with prevalent financial mismanagement in this group. However, research investigating the prevalence of hunger during the pandemic among this at-risk group is limited. This cross-sectional study aimed to assess the prevalence and determinants of hunger among students at a South African university during the COVID-19 lockdown, with particular focus on the effect of returning home. An online, self-administered survey produced a sample of 596 students. The Household Hunger Scale (HHS) was used to assess hunger. Most students (84%) who resided in on- or off-campus residences before the lockdown returned home during the lockdown. The weighted prevalence of hunger during lockdown was 16.4% (95%CI 13.6%, 19.6%). Bivariate analyses found living alone to be significantly associated with hunger, while multivariate analyses found that first-generation students (adjusted odds ratio (aOR) = 1.78; 95%CI: 1.04, 3.07, p = 0.015), financial aid recipients (aOR = 2.69; 95%CI: 1.47, 4.91, p = 0.001), and those experiencing financial stress/worry (aOR = 3.38; 95%CI: 1.85, 6.18, pPre-exposure prophylaxis (PrEP) use among cisgender female sex workers (FSWs), a population at disproportionately high HIV acquisition risk in Uganda, remains suboptimal. Uptake and continued use are constrained by barriers, such as limited clinical hours, long distances to access facility-based PrEP services, and high mobility among FSWs. Community pharmacies may offer a more accessible PrEP delivery model due to extended operating hours and convenient locations. This study aims to evaluate the accessibility and capacity of pharmacies in Kampala, Uganda, to serve as potential sites for PrEP delivery.
We will conduct a concurrent mixed-methods study combining geospatial mapping, structured surveys, a discrete choice experiment (DCE), and in-depth interviews (IDIs). First, the study will compare the reach and accessibility of PrEP services through community pharmacies versus public healthcare facilities. To highlight PrEP service reach, we will use geospatial analysis to map pharmacies, PrEP clinics, FSW hotspots (i.e., areas where sex is exchanged), and HIV incidence. We will also calculate a PrEP facility needs ratio (number of PrEP facilities/HIV incidence) for each of Kampala’s administrative divisions and estimate travel distance and time to access PrEP services using cost–distance analysis. Perceived accessibility of PrEP services will be assessed through FSW surveys (n=50) and IDIs (n=20–30), guided by Levesque’s framework. Then, we will evaluate pharmacy capacity via surveys (n=274) and IDIs (n=20–30), exploring infrastructure, resources, and staff perspectives, informed by the Consolidated Framework for Implementation Research. Additionally, a DCE will be embedded in the pharmacy survey to elicit staff preferences for delivery approaches and analysed using mixed logit models. Finally, we will integrate quantitative and qualitative findings to provide a broad assessment of whether pharmacies are suitable venues for PrEP delivery to FSWs in Kampala. Enrolment will begin by April 2026 for FSWs and July 2026 for pharmacy staff.
Ethical approval has been obtained from the Infectious Diseases Institute Research Ethics Committee (IDI-REC-2025-175) and the Uganda National Council for Science and Technology (HS6178ES). Written informed consent will be obtained from all participants. We will disseminate study findings through stakeholder meetings, scientific conferences, and peer-reviewed publications.
To examine the associations between food-related behaviours and nutrient intake on nutritional status among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR) in Kelantan, Malaysia.
Cross-sectional analytical study.
Seven CBTaR centres (n=7) across the state of Kelantan, Malaysia.
A total of 393 adult clients (aged 18 years and above) enrolled in CBTaR programmes between June and December 2022 were selected through stratified random sampling.
The primary outcome was nutritional status, assessed using body mass index. Secondary outcomes included nutrient intake (macronutrients and micronutrients) and food-related behaviours (emotional eating, external eating, restrained eating and food addiction), measured through Bahasa Malaysia validated questionnaires and 24-hour dietary recalls. All variables were introduced into the structural equation modelling to examine the associations among these variables and their association with nutritional status.
The results revealed that food-related behaviour was significantly associated with the nutrient intake (β=–0.524, p≤0.001). Additionally, the drug use profile significantly determined the food-related behaviour (β=–0.129, p=0.006) and nutritional status (β=–0.134, p=0.007). Nutrient intake was found to be a significant predictor of nutritional status (β=–0.213, p≤0.001). Sociodemographic and drug use profiles were significantly correlated with nutritional outcomes through behavioural and dietary associations. Importance-performance map analysis identified nutrient intake as the most impactful variable, highlighting the need for urgent intervention (R2=0.272).
This study highlights that nutrient intake is a significant predictor associated with food-related behaviours on nutritional status among individuals with substance use disorder. Integrating nutrition counselling and behavioural interventions into CBTaR services may improve recovery and long-term health outcomes.
This study aims to describe the characteristics of hospitalised COVID-19 patients in a tertiary care hospital close to an international airport in Japan and to compare these characteristics among different waves during the pandemic.
Retrospective observational study.
Tertiary care centre in Japan.
All patients diagnosed with COVID-19 who were hospitalised between January 2020 and April 2022 were included.
Clinical characteristics, characteristics of admission, treatments and outcomes were investigated and compared among six pandemic waves.
A total of 827 patients were included. The median age was 58.0 years. More than half of the patients (58.3%) had at least one comorbidity. The majority of patients (89.0%) were domestically infected patients admitted under the Infectious Diseases Law, while the remaining patients (11.0%) were those diagnosed during airport quarantine and admitted under the Quarantine Act. Hospital-acquired COVID-19 infection occurred in 7.0% of cases, and mainly during the sixth wave. Overall, some form of oxygen therapy, high-flow oxygen devices, invasive mechanical ventilation (IMV) and extracorporeal membrane oxygenation was provided in 46.3%, 10.4%, 4.5% and 1.5% of cases, respectively. Only 1.8% of patients were treated in the intensive care unit (ICU), and 59.5% of patients on IMV were managed in the non-ICU ward. The in-hospital mortality rate was 5.8%. Median age, percentages of some comorbidities, vaccination coverage, medications for COVID-19, types of supportive care and ICU admissions differed significantly among waves.
This study suggests that patient characteristics, vaccination coverage, standard of treatment and severity of illness changed across waves during the COVID-19 pandemic. Intensive care delivery in non-ICU wards was unavoidable due to limited ICU capacity, which may be a key consideration when preparing for future pandemics.
Minimally invasive endoscopic procedures constitute the cornerstone of first-line treatment for bulbar urethral strictures, although their long-term effectiveness is limited by high recurrence rates. The Optilume drug-coated balloon (DCB) is a novel intervention combining mechanical dilation with localised delivery of paclitaxel to reduce recurrence by inhibiting scar tissue formation. While its efficacy has been demonstrated in patients with recurrent strictures, its potential as a first-line option in treatment-naïve patients remains unexplored. The FIRST-CARE trial aims to assess the efficacy and safety of Optilume DCB compared with standard endoscopic treatment in treatment-naïve patients with bulbar urethral strictures.
Design: Two-arm, randomised, single-blind (participant), investigator-initiated, parallel-group, multicentre clinical trial. Patients: The study will enrol 140 adult male patients with treatment-naïve, single bulbar urethral strictures ≤3 cm in length. Interventions: All patients will undergo the assigned procedure under general anaesthesia with 1.5 g intravenous cefuroxime. Optilume group patients will receive ≥5 min balloon dilation with localised paclitaxel delivery. The control group will receive standard endoscopic treatment (eg, direct visual internal urethrotomy, laser or dilatation). In both groups, a 12–14 French Foley catheter will be left in place for 3–5 days. Primary outcome: Freedom from repeat intervention within 12 months of follow-up. Primary analysis: Time-to-event will be defined from the date of intervention to the date a repeat intervention is decided (indicated and planned) due to confirmed recurrence, with censoring at 12 months. Groups will be compared using Kaplan-Meier survival analysis and the log-rank test. Cox regression and modified Poisson regression will be used to estimate HRs and relative risks.
The trial is approved by the Danish National Committee on Health Research Ethics (2401370) and will be conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. In line with national guidelines, all eligible patients are counselled regarding available treatment options prior to enrolment. Results will be disseminated via peer-reviewed publications and scientific presentations.
FreshRSS 