Conectar
Primary biliary cholangitis (PBC) is a rare chronic cholestatic disease that despite current therapy has significant ongoing unmet needs, including risks of cirrhosis and life-impairing symptoms. The current treatment approach is a step-up model, wherein first-line therapy, ursodeoxycholic acid (UDCA), is given for a minimum of 12 months before the addition of second-line therapy is considered for non-responding patients. This ‘waiting to fail’ approach, focused on the needs of low-risk patients, allows, we postulate, a key process of biliary epithelial cell (BEC) senescence to become established, driving accelerated bile duct loss and aggressive disease. Preclinical mouse modelling has shown that early use of the farnesoid X receptor agonist obeticholic acid (OCA), currently only used as second-line therapy following UDCA failure, reverses BEC senescence, changing the clinical course of disease. Here, we describe the design of the Optimising Primary thErapy in pRimAry biliary cholangitis (OPERA) trial. The aim of OPERA is to explore a new paradigm for disease-modifying treatment of PBC: risk-informed early treatment stratification, with patients at increased risk offered UDCA and OCA combination with the goal of complete biochemical remission.
OPERA is a multicentre, randomised, double-blind, placebo-controlled trial of OCA in combination with UDCA, as first-line treatment for high-risk PBC. This is a multicentre trial in England, which will be undertaken in specialist clinics in secondary/tertiary referral centres (or as per local set up). These centres will be specialists in the area of PBC management and will manage patients from across their local region. OPERA will recruit and randomise 106 adults, within 6 months of PBC diagnosis, who are at an enhanced risk of non-response to standard first-line therapy, between either: (1) UDCA and OCA or (2) UDCA and matched placebo in a 1:1 ratio. The primary efficacy outcome measure is the percentage of participants showing normalisation of serum alkaline phosphatase and total bilirubin values at 26 weeks (disease remission).
Favourable ethical opinion was received from London – Riverside Research Ethics Committee (reference: 22/LO/0878). Potential participants will be fully informed of their rights and the benefits and harms of the trial by the research team before giving informed consent to participate in the trial. Results will be disseminated in peer-reviewed publications, at national and international conferences, in peer-reviewed journals and to participants and the public (using lay language).
Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.
This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.
Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.
Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022–23; Ethikkommission Nordwest- und Zentralschweiz, 2019–02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019–04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025–18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19–589; Komisja Bioetyczna przy Warmiłsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019–0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.
To report on the unique perspectives of senior nursing leaders on the value proposition of the Clinical Nurse Specialist (CNS) role, their organisational experience and the barriers and facilitators to optimise and promote the long-term sustainability.
A qualitative sub-study of a larger multi-method study focused on informing policy recommendations to optimise the CNS workforce, informed by integrated knowledge translation.
Chief Nursing Officers (CNOs) and other senior leaders in all health authorities in British Columbia, Canada, were invited to participate in semi-structured interviews via video call between August–December 2023. We recruited 13 participants from diverse health regions, including 5 CNOs.
Leaders collectively conveyed a renewed interest in the CNS role to support nursing and multidisciplinary teams to better meet patient and system needs, and a sense of urgency to optimise the role in diverse settings. The overarching theme of “success by design” was supported by three thematic priorities: (1) understanding the CNS role, (2) a role that needs protection and connections and (3) moving forward together. Views were aligned to co-construct implementation-ready policy recommendations to guide provincial strategies.
Senior leaders reported a common understanding of the value-add of the CNS workforce and had a shared experience of barriers to optimisation. Contemporary policy guidance is needed to equip health systems to address this gap.
Across international regions, the role of CNSs is not fully optimised. This is a wasted opportunity to address the pressing need for nursing practice leaders to transform health systems and improve outcomes. This study provides new knowledge about the perspectives of Chief Nursing Officers and other nursing leaders to shape comprehensive and targeted policy recommendations and address enduring and new challenges to realise the full impact of the CNS workforce.
We have adhered to COREQ reporting guidelines (See supplemental file).
This study did not include patient or public involvement in its design, conduct, or reporting.
Cutaneous T cell lymphoma (CTCL) is a group of non-Hodgkin lymphomas that primarily affects the skin and can mimic inflammatory dermatoses. Unlike many skin diseases, CTCL can lead to disabling symptoms, and advanced CTCL can even be fatal. Early studies investigating health-related quality of life (HRQOL) in patients with mycosis fungoides (MF) and Sézary syndrome (SS), common subtypes of CTCL, demonstrated significant impairment across numerous domains. The aim of this current study is to develop a core domain set (CDS) to identify the essential aspects of MF/SS that influence HRQOL that should be measured in therapeutic clinical trials. In the future, this set of core concepts will be used to identify the best patient- reported outcome measure(s) (PROM) for HRQOL for MF/SS clinical research.
Multiple strategies will be used to generate candidate concepts: systematic review of the literature, qualitative study and a survey study of healthcare providers. A Delphi consensus process including a comprehensive group of stakeholders (patients, caregivers/care partners, a multidisciplinary group of healthcare professionals, patient advocacy groups, pharmaceutical industry representatives, methodologists and government agencies) will be used to achieve consensus. Statistical corrections for multiple significance testing and false positive findings will be undertaken.
The study was submitted for and received institutional review board approval at the University of Washington (IRB# STUDY00018890 and STUDY00019407). Informed consent will be obtained from all participants where necessary. We will disseminate our findings through peer-reviewed, open access publications and presentations at national/international conferences. We will provide a plain language summary in lay terms for patients and families to patient advocacy groups for distribution to their network.
The protocol is registered in the Core Outcome Measures in Effectiveness Trials (COMET) database.
Psoriatic arthritis (PsA) is a form of inflammatory arthritis linked to psoriasis. Previous research from the UK has found that many people feel unsupported when diagnosed with PsA and lack confidence in managing their condition. This realist review aims to understand what works and does not work for whom and in what circumstances, in relation to healthcare professionals engaging with people to support them in developing self-management skills.
This protocol was developed by defining the scope of the review, using a brief directed literature review to support discussion by an expert group of researchers, healthcare professionals and a patient partner. A theoretical domains framework was generated, consisting of nine initial programme theories. These were further refined with input from Patient and Public Involvement and Engagement groups and used to develop a database search strategy.
A systematic search of MEDLINE, CINAHL, Embase, Emcare and APA PsycINFO will be carried out, supplemented by citation tracking, exploration of grey literature and a mixed methods survey of rheumatology health professionals. Data selection will be performed by a minimum of two reviewers and data from included sources will be extracted using a template. Data will be synthesised narratively with respect to the identified initial programme theories, using these data to refine or refute these theories. This will generate refined programme theories to explain what works for whom and in what circumstances.
Ethical approval for the health professionals survey was granted through the Research Ethics Committee, University of the West of England (Project ID: 10991848). Outputs will be disseminated to the research community through conference presentations and a peer-reviewed journal article. The strategy for sharing outputs with patients and health professionals will be discussed and agreed with knowledge user groups.
Obesity affects over a quarter of the UK population and can lead to serious health issues. NHS Specialist Weight Management Services (WMS) offer treatments including lifestyle advice, psychological support and medications, but access and availability vary by region. Although around 4 million people could be eligible for NHS Specialist WMS annually, capacity is limited to 35 000, severely limiting overall access for those who need it. While digital technology has started to be used in WMS, more evidence is needed to confirm its long-term effectiveness, acceptability and cost-effectiveness. This study explores the use of Gro Health W8Buddy, a digital platform and app providing remote Specialist WMS. It aims to determine the long-term health benefits of remote WMS pathway Gro Health W8Buddy compared with standard NHS WMS delivered in hospitals, and to improve patients access to services.
The study is a real-world evaluation with observational data collection. We will recruit 450 study participants from four NHS specialist WMS who will choose either standard NHS WMS or the digital pathway Gro Health W8Buddy. Participants are being given the option to choose their pathway to generate real-world evidence. We will measure and analyse health outcomes including weight loss, time taken to be treated and cost-effectiveness, at 18 months and follow up at 24 months for later analysis (outside of this core funding). We will gather experiential data from patients and healthcare professionals through surveys, observation and interviews.
Ethical approval has been obtained from NHS Health Research Authority (HRA) and Health and Care Research Wales (HCRW) (Supplementary Figure 3) (REC reference: 25/EM/0147). Our findings will be disseminated through academic publications, conference presentations and stakeholder engagement.
ISRCTN89168871; Pre-results.
Exploring the concept of patient agitation in the intensive care unit.
Patient agitation in the intensive care unit is of widespread concern and linked to negative outcomes for patients, staff, and family members. There is currently no consensus on what constitutes agitation in the intensive care context, hindering effective and tailored prevention and management.
Concept Analysis.
Walker and Avant's eight-step concept analysis approach.
A comprehensive search was carried out in the databases MEDLINE, PsychINFO and CINAHL. A total of 32 papers published between 1992 and 2023 were included, reviewed, and analysed to explore definitions, attributes, antecedents and consequences of patient agitation.
Patient agitation in the intensive care unit is characterised by excessive motor activity, emotional tension, cognitive impairment, and disruption of care, often accompanied by aggression and changes in vital signs. Antecedents encompass critical illness, pharmacological agents and other drugs, physical and emotional discomfort, patient-specific characteristics and uncaring staff behaviours. Consequences of agitation range from treatment interruptions and poor patient outcomes to the psychological impact on patients, families, and staff.
Agitation in the intensive care unit is a complex issue which significantly impacts patient treatment and clinical outcomes. For healthcare professionals, patient agitation can contribute to high workloads and job dissatisfaction. Due to the complex nature of agitation, clinicians must consider multifaceted strategies and not rely on medication alone. Further research is needed to fully understand patient agitation in the ICU. Such understanding will support the development of improved strategies for preventing and managing the behaviours.
A clearer understanding of patient agitation supports the development of tailored interventions that improve patient care, guide ICU training, and inform future research.
This concept analysis was developed with input from a patient representative.
Transcranial magnetic stimulation (TMS) and upper extremity manipulation training have demonstrated clinical effectiveness in stroke rehabilitation. Post-stroke, the affected cerebral cortex often shows reduced excitability, which can limit the optimal outcomes of conventional manual training. To address this, we developed a new upper limb training method integrating TMS with active sensory training (AST) to enhance the fine motor ability in the upper limbs following stroke, potentially improving overall rehabilitation efficacy. However, the clinical effectiveness of this approach remains unclear. Importantly, we demonstrated the efficacy of the new rehabilitation strategy by using TMS in conjunction with AST in patients experiencing upper limb motor dysfunction after stroke.
This single-centre, single-blind, sham stimulation, randomised controlled clinical trial investigated the efficacy of AST combined with TMS in patients with stroke and upper limb motor dysfunction post-stroke (1–24 months post-onset) at Brunnstrom stages III–V. Upper limb motor function was evaluated before and 2 weeks after the intervention. The primary outcome was the Action Research Arm Test result, and the secondary indicators included results on the Fugl–Meyer Assessment Upper Extremity Scale, Modified Barthel Index, Semmes–Weinstein Monofilament, Erasmus MC revised Nottingham Sensory Assessment Scale, Embodied Sense of Self Scale (stroke version), functional near-infrared spectroscopy and neuroelectrophysiology. Between-group differences were analysed using independent t-tests, and within-group differences were examined with paired t-tests, with statistical significance set at p
This study was approved by the Ethics Committee of the Second Rehabilitation Hospital of Shanghai for ethical application (Approval number: 2024-34-01). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.
ChiCTR2500097067.
In this commentary, I consider the disparity between the care we see as a necessity for cancer patients and the lack of care we afford to many persons with chronic disease.
I ground my arguments in my own clinical practice and research experiences over a 50-year period augmented by reference to available literature sources.
In tracing developments within the fields of cancer and chronic illness care, I draw on my own research and that of others.
Although chronic illness has long been recognised as causing the majority of the burden on our health care systems and as a significant source of suffering in our society, it has not attracted the level of enthusiasm from researchers, policy makers, and health care systems that we have seen in the context of other diseases such as cancer. Nurses have an intimate knowledge of the suffering occasioned by chronic illness; however, it has been difficult for nursing to mobilise coordinated action in prioritising a re-balance of health systems to better serve those with chronic conditions.
The advent of medical assistance in dying in Canada has shed a spotlight on the implications of the discrepancy between our prioritising patient need in the care and support of patients with conditions such as cancer, in contrast with the supports and services we make available to those with chronic conditions.
Although nursing intimately engages with the burden of chronic illness, it has not mobilized coherent advocacy toward strengthening our societal commitment to this aspect of our care systems.
There is an opportunity for nursing to make a meaningful difference in a fundamental health care system inequity if we can come to understand that chronic illness is as deserving of our collective research, practice change, and policy attention as is cancer.
No patient or public contribution.
To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.
A prospective cohort study.
A large tertiary care centre.
12 245 women who delivered after 22 weeks gestation in the year 2022.
Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.
The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.
The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.
Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.
Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.
CTRI/2022/03/041343.
To develop an updated core dataset for acute stroke care in Ireland, informed by international audit benchmarking and national stakeholder consensus, for integration into the Irish National Audit of Stroke (INAS).
Scoping review and three-round Delphi process.
Medline Ovid, Embase, CINAHL EBSCOhost, Google Scholar, audit websites and grey literature (2010–2024). Additional audit documentation was obtained via direct author contact.
National stroke audits or registries with a country-wide scope, ≥1 year of continuous data collection and active in 2021 were eligible. Only audits covering acute stroke care were included in this study phase. All records were screened for inclusion.
Audit documentation (data dictionaries, item definitions and contextual metadata) was retrieved from eligible audits. Acute stroke care items were extracted, charted and benchmarked against existing INAS items and each other to identify commonalities and gaps. Frequently collected international items (appearing in ≥4 audits/registries) were shortlisted. A three-round Delphi process with 24 national stakeholders (clinicians, nurses, allied health professionals, researchers, policymakers and patient representatives) was conducted to audit and refine the dataset through structured, anonymised item rating, iterative feedback and consensus-building discussions.
Twenty-one eligible international stroke audits/registries were identified, yielding ~4500 audit items. Benchmarking against existing INAS items (n=103), frequently collected international items (n=97) and expert-suggested items (n=22) informed the Delphi consultation. The final dataset expanded INAS by 18 items, totalling 86 acute care and 35 thrombectomy-specific items. New additions included stroke-related complications and risk factor documentation.
This structured, consensus-led process resulted in an internationally benchmarked, stakeholder-informed core dataset to enhance standardised stroke auditing in Ireland. The expanded dataset supports enhanced clinical monitoring, quality improvement and health system planning. This approach may inform audit development and research efforts in other contexts.
Perineal warm compresses in the second stage of labour have been demonstrated by clinical guidelines as an effective intervention for improving perineal outcomes and mothers’ psychological well-being, yet their adoption in clinical practice remains suboptimal. Therefore, this study aims to bridge the evidence-practice gap through the application of implementation science models and frameworks to facilitate clinical adoption. The investigation will systematically explore the barriers and facilitators to the application of perineal warm compresses in the second stage of labour and subsequently develop a corresponding implementation strategy addressing identified barriers.
This study was guided by the PEDALs model. Using a scoping review and a parallel mixed-methods study to systematically investigate the barriers and facilitators to the application of perineal warm compresses in the second stage of labour. The identified barriers and facilitators were mapped to the domains of the Consolidated Framework for Implementation Research (CFIR). Then we will use a modified nominal group technique to determine seven priority barriers that need to be addressed. These barriers will be input into the CFIR-ERIC implementation strategy matching tool to obtain expert-recommended implementation strategies. Finally, the Delphi method will be employed to select and refine the implementation strategies into a clear and actionable implementation strategy bundle.
This study has been approved by the Ethics Committee of Hebei Medical University, with approval number 2024043. Written informed consent will be obtained from all participants. Study findings will be disseminated through articles in scientific, peer-reviewed journals, and at national and international conferences. This study will begin in August 2025 and be completed in June 2026.
In low-income and middle-income countries, significant geographical and socioeconomic inequalities affect access to eye care. This study explores an equity-focused approach to improve access to eye care services provided by a community-based eye care organisation in northern India.
A sequential exploratory mixed-method approach.
A high-volume eye screening programme in north Indian villages. Individuals identified with eye care needs during the screening were referred to the six nearby primary eye care centres.
7578 individuals identified with eye needs through a community-based eye screening programme. Of these, 4431 (58.6%) were women and 3137 (41.4%) were men.
Socioeconomic questions, developed by experts and lay representatives, were integrated into an ongoing digitally supported (Peek Vision) eye screening programme in north Indian villages. Data from referred individuals identified with eye needs were analysed using logistic regression with a mixed-effect model to identify socioeconomic characteristics most strongly associated with poor access to care after referral. A sequential exploratory mixed-method approach, including in-person interviews and follow-up telephonic surveys of individuals with these characteristics, was used.
To identify barriers and gather suggestions for improving attendance from groups least likely to attend services.
Of 7627 individuals referred for eye care, 7578 (99.3%) participated in the study. Of those, 2937 (38.5%) attended the Vision Centre, to which they were referred. The least likely to attend were individuals aged >16, those with dependents, and those referred for non-cataract conditions. Among the 3939 individuals with all three characteristics, the attendance rate was 35.3% compared with 42.5% (p
Suggested programme improvements, including better counselling, reminder calls and transportation, could increase access among those least likely to access services after referral. This study demonstrates a two-step approach for identifying solutions from individuals facing the most significant barriers to care. We will go on to conduct trials of these suggested interventions.
The aim of this study was to determine the prevalence of groin rash among Thai military personnel and to identify associated risk factors, clinical features and patient perceptions. We also evaluated care-seeking behaviour and treatment practices.
Cross-sectional, questionnaire-based study.
Conducted among Thai military personnel in a tropical environment.
A total of 500 male military personnel were recruited between August 2022 and September 2023. Of these, 475 participants were included in the analysis, while 25 were excluded due to non-participation in field training. Eligibility was restricted to those actively engaged in field exercises at the time of study.
Not applicable.
Primary outcome was the prevalence of groin rash, defined by self-report aided by standardised clinical images. Secondary outcomes included risk factors, rash morphology, symptom severity, treatment practices and healthcare-seeking behaviour. Associations were analysed using multivariable logistic regression adjusted for age, body mass index (BMI) and other covariates.
Lifetime prevalence of groin rash was 22.3% (106/475), and the point prevalence was 3.8% (18/475). Among those with rash, 39.6% were classified as probable fungal infections. Independent risk factors included reusing underwear (aOR 2.25; 95% CI 1.27 to 3.99; p=0.005) restricted bathing time (aOR 1.73; 95% CI 1.06 to 2.83; p=0.030) and higher BMI (aOR 1.10; 95% CI 1.02 to 1.42; p=0.030). Most affected participants (54.7%) reported minimal impact on daily life, and only 18.9% sought professional care. Self-medication was common, with 50% using topical over-the-counter antifungals alone, while 16% used a combination of oral and topical drugs. Relapse occurred in 36.1% of cases.
Groin rash is relatively common among young Thai military personnel and is associated with modifiable hygiene-related factors. Only a small proportion of affected individuals appear to present for medical evaluation. Educational interventions emphasising regular laundering and adequate bathing during training may assist in reducing its prevalence.
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.
Clinical research nurses work at the fulcrum of clinical trials with clearly defined roles and responsibilities. In England, the National Institute for Health Research (the main funder of health research) has broadened its scope to encompass social care research. The expectation is that clinical research nurses will expand their skill set to support these new studies, many of which will employ qualitative and mixed methods. This discussion paper explores the challenges of facilitating this clinical academic workforce development through a case study of a homeless health and social care research project. This was one of the first studies to engage clinical research nurses in this new and expanded role.
Much of what is known about the research nurse workforce has been generated through studies of clinical trials in oncology. The ‘caring-recruiting’ dichotomy has been used as a heuristic device for identifying workforce issues that can impact on study delivery such as how intense pressure to recruit study participants leads to low job satisfaction.
This case study reflects on the authors' experiences of employing a clinical research nurse in a social care research project concerned with the discharge of homeless people from hospital. The ‘caring-recruiting’ dichotomy is used to generate new information about the relationship between workforce development and the successful delivery of social care research.
The case study illuminates how social care research can generate different pressures and ethical challenges for research nurses. The time and skill it took to recruit study participants identified as ‘hard to reach’ was suggestive of the need to move beyond performance measures that prioritise recruitment metrics. The need for different types of staff supervision and training was also warranted as supporting study participants who were homeless was often distressing, leading to professional boundary issues.
This study highlights that performance management, training and supervisory arrangements must be tailored to the characteristics of each new study coming onto the portfolio to ensure research nurses are fully supported in this new and expanded role.
Idiopathic pulmonary fibrosis (IPF), an unknown aetiology type of interstitial lung disease (ILD), carries the poorest prognosis and is more common in males and the elderly. Gender differences in baseline presentation, lung function and comorbidities may have an impact on prognostic outcomes.
The aim of this study was to explore gender differences in clinical features, comorbidities and outcomes in IPF in a UK cohort.
This was a retrospective cohort study analysing data from the British Thoracic Society UK IPF ILD Registry from January 2013 to February 2024. We compared baseline characteristics between males and females, and a survival analysis in both genders was performed using the Cox proportional hazards model.
We identified 6666 IPF patients with a mean age at diagnosis of 74.1±8.1. Our cohort was predominantly male (5197, 78%), with a higher proportion of current and ex-smokers compared with females (69.9% vs 59.9%, p
Gender differences in baseline characteristics and prognostic factors were observed in IPF. A gender-based approach in managing IPF is warranted, and further studies are needed to clarify these differences and their impact on IPF management.
The purpose of the study is to construct a postoperative nausea and vomiting (PONV) risk prediction model for day-case laparoscopic cholecystectomy (LC) using a machine learning combination algorithm and evaluate its performance.
A retrospective cohort study.
The Hospital Information System (HIS) and the Surgical Anaesthesia Information Management System (SAIMS).
Patient data are collected from the day surgery ward of Sichuan Provincial People’s Hospital from February 2023 to April 2024. The research subjects are adult patients (18–75) who underwent day-case LC, excluding patients with unexpected termination of the day surgery plan, such as the patient who was transferred to hepatobiliary surgery due to intraoperative conversion to laparotomy.
The study employed two data filling methods, two data sampling methods, two variable screening methods and six machine learning algorithms to construct 48 predictive models. Area under curve (AUC), accuracy, precision, recall rate and F1 value were used to evaluate the predictive performance of the model. The AUC of the test set is mainly used to evaluate the prediction performance, and the Shapley weighted explanatory value is used to determine the weight of the variable’s prediction contribution. We will collect patient data from this unit in July 2025 to evaluate the model’s performance.
A total of 2709 patients were selected for model construction in the study. 20 input variables were retained for developing the predictive model. The combined model of KNN, BSMOTE, RFEL and GBM shows the best AUC performance (0.9600). The five most important variables in the prediction model were postoperative pain, LESS method, citraturia dosage, gender and sufentanil dosage. An additional 211 patients were collected to validate the model performance with an AUC of 0.79.
The study finds that postoperative pain, LESS method and cisatracurium dosage are closely related to the occurrence of PONV in day-case LC. However, these three variables have rarely been reported in the previous literature and worth further research. The prediction model obtained in this study provides a meaningful reference for the perioperative prevention and treatment of PONV in day surgery.
The Intensive Care Unit Randomised Trial Comparing Two Approaches to Oxygen Therapy Trial (ICU-ROX) compared conservative oxygen therapy with usual care in mechanically ventilated adults in Australian and New Zealand intensive care units. Dissemination focused on publication and presentation, with no targeted approach.
The current study aimed to investigate whether health practitioners from intensive care units that participated in ICU-ROX were more likely to report they knew the trial results and had read the publication than those from intensive care units that did not participate; explore whether there was a difference between doctors' and nurses' knowledge of the ICU-ROX results and whether they read the publication.
Survey using a self-administered, quantitative design, developed for this study.
Convenience sample of 197 Australian and New Zealand intensive care specialist doctors and nurses.
There was no difference in the knowledge of the study results between respondents from intensive care units that participated in ICU-ROX compared to those that did not. Nurses were significantly less likely to have knowledge of the trial results or have read the publication than doctors. The commonest way for doctors and nurses to get the results was by word of mouth at work.
Participation in ICU-ROX did not make a difference to knowledge of the findings. While the dissemination of trial results was extensive, it failed to adequately reach nurses, who play an important role in administering oxygen in intensive care.
This study has provided further evidence that nurses working in intensive care were unlikely to read the research results of an important study about oxygen management.
Researchers, unit management and nurse leaders need to ensure dissemination methods that will reach nurses are used for research findings.
This study followed the STROBE reporting guidelines for observational studies.
No patient or public contribution.
This study is a substudy of a trial that was prospectively registered before the first participant was recruited: ACTRN12615000957594
To explore oncology nursing advance care planning practices and understand how to better support nurses in conducting advance care planning with patients and their families.
Qualitative interpretive descriptive methodology.
Semi-structured, individual telephone or Zoom interviews with 19 oncology nurses in a Western province of Canada between May and August 2022. Interviews were audio-recorded, transcribed, de-identified, and analysed using inductive, thematic, and constant comparative techniques.
Oncology nurses highlighted several factors affecting their ability to engage in advance care planning, including (1) uncertainties related to the nursing role in advance care planning, such as how and when a nurse ought to engage; (2) the educational, experiential, and training environment; and (3) structural barriers, such as a lack of time, space, and privacy; models of care that inhibit nurses from developing longitudinal relationships with their patients; and team dynamics that affect advance care planning interdisciplinary collaboration.
To create environments that support oncology nurses to conduct advance care planning, the findings suggest uncertainties be addressed through a clear and cohesive organisational approach to advance care planning and ongoing, integrated educational opportunities. Further, service delivery models may need to be restructured such that nurses have dedicated time and space for nurse-led advance care planning and opportunities to develop trusting relationships with both patients and their interdisciplinary colleagues.
Oncology nurses recognised the value of advance care planning in supporting patient-centred care and shared decision making, yet they reported limited engagement in advance care planning in their practice. To support oncology nurses in conducting advance care planning, healthcare leaders may address (1) advance care planning-related uncertainties and (2) structural barriers that prevent nurses from engaging in advance care planning with patients and their families. Findings may guide modifications to care models, enhancing support for oncology nurses in conducting advance care planning.
We selected and adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ) as the most applicable guideline.
No patient or public contribution.
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