Conectar
Intrahepatic cholangiocarcinoma (ICC) has a high recurrence rate after curative surgery, with no standard neoadjuvant therapy. Hepatic arterial infusion chemotherapy (HAIC) has shown efficacy in locally advanced ICC, while immune checkpoint inhibitors and anti-angiogenic agents have demonstrated promising response rates. The NEO-ERA-01 study evaluates the feasibility of neoadjuvant HAIC-GEMOX plus lenvatinib and Adebrelimab in high-risk resectable ICC.
NEO-ERA-01 is a prospective, multicentre, phase II trial using Simon’s two-stage design. Thirty patients with histologically confirmed resectable ICC and high-risk recurrence factors will be enrolled in China. Neoadjuvant therapy consists of HAIC-GEMOX (gemcitabine 800 mg/m², oxaliplatin 85 mg/m² every 3 weeks), lenvatinib (8 mg/day from Day 5) and Adebrelimab (1200 mg on Day 3, every 3 weeks) for 2–4 cycles. Surgery eligibility will be assessed post-treatment. Resected patients will receive adjuvant capecitabine (1250 mg/m² two times per day on Days 1–14, every 3 weeks) and Adebrelimab (1200 mg on Day 1, every 3 weeks) for 6 months.
The primary endpoint is the completion rate of study treatment. Secondary endpoints include safety, R0 resection rate, response rate, event-free survival, disease-free survival and overall survival. Exploratory endpoints include immune microenvironment and biomarker analysis.
The study is approved by the ethics committee of all sites and follows the Declaration of Helsinki and good clinical practice guidelines. Results will be disseminated via peer-reviewed publications and conferences.
Statins are a cornerstone of cardiovascular disease prevention yet remain underused among eligible patients. Clinical decision support systems embedded in electronic health records (EHRs) are commonly used to encourage guideline-concordant prescribing. Interruptive reminders (eg, pop-ups) may be effective but interfere with clinical workflows and contribute to alert fatigue. Non-interruptive alerts are less intrusive, but their effectiveness remains unclear. The Interruptive versus Non-Interruptive Reminders for Statin tHerApy in Primary Care (INIRSHA-PC) trial is designed to evaluate the comparative effectiveness of interruptive and non-interruptive reminders on statin-prescribing rates.
INIRSHA-PC is a single-centre, pragmatic, three-arm, parallel-group randomised controlled trial embedded in the EHR at Vanderbilt University Medical Center. The trial will enrol adults aged 18–74 seen in primary care who are eligible for, but not currently prescribed, statin therapy. The planned sample size is 3000 patients (1000 per arm). Enrolled patients will be randomised 1:1:1 to (1) interruptive reminder, (2) non-interruptive reminder or (3) no reminder (usual care). The primary outcome is statin prescription within 24 hours of enrolment. Secondary outcomes are statin prescribing within 12 months and low-density lipoprotein cholesterol levels measured between 30 days and 12 months after enrolment. Enrolment began on 14 August 2024. The study is expected to be completed on 19 November 2025.
The trial has been approved by the Vanderbilt University Medical Center Institutional Review Board with waiver of patient informed consent (IRB number: 240419). Results will be disseminated through peer-reviewed publication and presentation at scientific conferences.
Qualitative evidence in ovarian cancer (OC) doctor-patient-caregiver communication is scarce. This study explored the information needs of patients and caregivers, comparing these to healthcare professionals’ (HCPs) perspectives, to uncover why gaps exist.
Qualitative, observational, multicentre and cross-sectional study with OC patients, their caregivers and HCPs. Qualitative data were collected through remote semistructured interviews. Themes were identified using thematic analysis. The EORTC QLQ-C30 and the disease-specific EORTC QLQ-OV28 were collected as quality of life measures and analysed descriptively.
Patients were recruited during their routine visits in five university hospitals in Spain.
Patients were ≥18 years of age in stages III or IV according to FIGO classification, were on first line treatment or recurrent and platinum sensitive with the most complex molecular profiles. 19 patients, 7 caregivers and 10 HCPs participated in the study.
Three main themes emerged: (a) patient information needs about the disease and pharmacological treatments, (b) patient information needs about non-pharmacological support and (c) caregiver information needs. The first theme was viewed through three differing attitudes (the Involved, Trusting and Indecisive), with HCPs’ agreeing with the attitudes but without adjusting transmitted information accordingly. For the second theme, patients expressly desired more information on psychosexual issues, psychological support and patient associations (PAs), and HCPs concurred with a need for more non-pharmacological support. Regarding the third theme, caregivers expressed not being engaged by HCPs, despite HCPs recognising their importance, with nurses being more empathetic than oncologists on this matter.
These results highlight the importance of understanding the information needs of OC patients and their caregivers. This understanding enables HCPs to provide better support, helping patients and caregivers make more informed health decisions.
Treatment failure remains a major challenge in tuberculosis (TB) management. Rapid and objective assessment of treatment response is essential, as existing tools have limited accuracy and slow turnaround times. The PATHFAST TB LAM Ag assay (PATHFAST-LAM), an automated chemiluminescent enzyme immunoassay, was developed to quantify lipoarabinomannan (LAM) in sputum within 1 hour. Previous studies have shown a strong correlation between sputum LAM concentration and culture-based bacterial load. However, its clinical utility for predicting poor outcomes during treatment has not been prospectively evaluated.
We will conduct a prospective longitudinal study enrolling newly diagnosed, bacteriologically confirmed patients with pulmonary TB at Rhodes Chest Clinic and Mbagathi County Referral Hospital in Nairobi, Kenya. We will follow participants throughout the 6-month treatment course, attempting to collect sputum weekly during weeks 1–4, biweekly during weeks 5–12 and monthly during months 3–6. We will measure LAM concentrations at these time points using the PATHFAST-LAM assay. The primary outcome is to assess whether changes in sputum LAM concentration during the intensive phase (baseline to week 4 and/or week 8) predict a composite poor outcome, defined as positive sputum culture at month 6, treatment failure, death during treatment or relapse within 3 months after treatment completion. The primary endpoint is the area under the curve from the receiver operating characteristic analysis, representing the predictive performance of changes in sputum LAM concentration for the composite poor outcome. We will identify the optimal cut-off value for LAM change and estimate sensitivity and specificity with 95% CIs using 2x2 tables. We will apply an adaptive design that allows sample-size re-estimation after interim analysis.
The study was approved by the Kenya Medical Research Institute (KEMRI/SERU/CRDR/124/5241) and Nagasaki University (250619327). Findings will be disseminated through peer-reviewed publications and scientific meetings.
Understanding the epidemiological shifts of respiratory syncytial virus (RSV) is essential to inform public health interventions, particularly given its increased burden on healthcare systems post-COVID-19 pandemic. This study aimed to examine age-specific trends and seasonal variations in RSV incidence, considering the recent introduction of a newborn RSV immunisation programme in Ireland.
A surveillance time series study analysing routinely collected RSV notification data.
National-level weekly RSV notifications collected by the Health Service Executive-Health Protection Surveillance Centre in Ireland from 2012 to 2024.
Infants (
Annual trends in RSV epidemiology with special reference to the pre- and post-COVID-19 winter surges, and the time lag in age-related transmission to peak incidence among the various age groups. Data were analysed to evaluate incidence rates, peak timing, age-related transmission trends and lag times before and after the COVID-19 pandemic.
The study examined the increasing incidence of RSV post-COVID-19 and a significant shift toward earlier RSV peaks in recent years (2021/2022, 2022/2023 and 2023/2024 seasons) in Ireland, with the onset and peak of the season nearly 2 months earlier than in pre-COVID-19 pandemic seasons (p
This analysis highlights an early seasonal onset and intensified RSV burden among infants in recent winters (2021/2022, 2022/2023 and 2023/2024 seasons). Quantifying the time lag for the community-level RSV transmission from infants and young children to older adults will offer insights to optimise RSV intervention strategies as a ‘life-course approach’ to alleviate healthcare system pressures during peak seasons.
This study assessed whether a previously developed Monte Carlo simulation model can be reused for evaluating various strategies to minimise time-to-treatment in southwest Netherlands for endovascular thrombectomy (EVT) in patients who had an ischaemic stroke.
Reuse of a previously developed simulation model to simulate various strategies in another region, using prospectively collected data from stroke centres and retrospective data from emergency medical services.
Data from 509 patients who had an ischaemic stroke (≥18 years) treated with EVT (2014–2018) were used.
Input for the simulation model reuse included distributions of observed time delays along the acute stroke pathway. Validation of the baseline models was based on face validity and statistical measures (patient data vs model output) using the Assessment of the Validation Status of Health Economic decision models tool. We simulated strategies for a subregion: interhospital patient transfer by helicopter, transport of the neurointerventionalist to the primary stroke centre (‘drive-the-doctor’), interhospital patient transfer to a thrombectomy-capable stroke centre (TSC) outside the region and prehospital triage using the Rapid Arterial Occlusion Evaluation (RACE) scale.
Onset-to-groin time was the outcome.
Reuse of the original simulation model was obtained by minimal effort, implying limited adaptation. Compared with the baseline model, interhospital patient transfer by helicopter or to a TSC outside the region and prehospital routing using the RACE scale reduced mean onset-to-groin time by 16, 13 and 39 min, respectively (95% CrI for all: equal to the point estimate). ‘Drive the doctor’ reduced mean onset-to-groin time by 27 (car), 49 (ambulance) or 58 min (helicopter), each with a 95% CrI equal to the point estimate.
The original simulation model can be applied to different regions in the Netherlands. Strategies tested within the subregion resulted in promising results of ‘drive the doctor’ and prehospital patient routing using the RACE scale.
To elicit the benefits of shared decision-making to doctors who are champions of this approach.
A qualitative interview study that used practical thematic analysis.
We identified a purposive international sample of doctors in active clinical practice who were recognised champions of shared decision-making, working in various clinical disciplines.
24 doctors in active clinical practice were interviewed; 14 were male and 10 were female; 20 had been in clinical practice for over 10 years (range 1–30). 12 practised in North America, 10 in Europe, 1 in South America and 1 in Asia; 4 doctors worked in internal medicine, 4 in primary care, 5 in surgery, 3 in paediatrics, 3 in oncology and 1 in each of the following disciplines: emergency medicine, palliative care, geriatrics, physical medicine and rehabilitation, anaesthesiology, and cardiology.
This selected sample of doctors consistently reported that shared decision-making provided benefits to themselves, their patients and their teams. Shared decision-making reinforced and enhanced their self-identity as ethical professionals, supporting patient autonomy, increasing their professional fulfilment and reducing their risk of burnout. These intrinsic benefits accompanied reports of other consequential benefits, namely, patients’ achieving better-informed, preference-sensitive decisions, a higher likelihood of improved patient outcomes, improved efficiency and team function. The doctors viewed the approach as providing connectedness, shared responsibility resulting in a lighter burden, acting as a buttress against moral injury and the emotional strain of clinical work and, where relevant, mitigation against becoming the second victim of a bad or unexpected outcome.
Doctors who champion shared decision-making report significant benefits to themselves and their patients. These benefits have not been widely reported, which has implications for motivating doctors to adopt shared decision-making. Instead of addressing presumed gaps in communication skills, it might be better to highlight the positive impact on professional fulfilment and the protective effect of shared decision-making.
For large primary spontaneous pneumothorax (PSP), drainage or simple aspiration are the two first-line treatment options. Outpatient ambulatory strategies have a success rate of almost 80% with few complications. New French recommendations suggest that an outpatient strategy should be preferred if an appropriate care network is in place. However, establishing this care network remains the main obstacle to the use of this strategy. Thus, outpatient management of PSP remains rare, which is neither optimal for the patient, with a likely impact on quality of life (QOL) and satisfaction with care, nor for the healthcare system, with increased costs. We hypothesise that outpatient treatment of PSP compared with usual inpatient management could improve quality of care and represent a more efficient, generalisable and sustainable strategy.
In this multicentre, cluster-controlled, randomised interventional study with stepped wedge implementation, patients aged 18–50 presenting to the emergency department (ED) with a first episode of large PSP will be enrolled in seven university hospitals in France. The main objective of this study is to evaluate the impact on changes in QOL of an ambulatory strategy for the management of large PSP in the ED compared with usual inpatient management. The primary outcome is the difference in QOL as measured by SF-36 score, between drain placement and 6 months. Clinical criteria (pulmonary expansion at 6 days, pain, dyspnoea, complications, recurrence), perceived quality of care (satisfaction, patient preference, anxiety) and ease of implementation of the care pathway will also be assessed. A cost-utility analysis will be carried out to evaluate the incremental cost-utility ratio at 1 year, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores.
Ethics approval has been obtained by the Comité de Protection des Personnes Nord Ouest III N° 2024-36. Study findings will be disseminated by publication in a high-impact international journal. Results will be presented at national and international emergency healthcare meetings, and participating patients notified of the main conclusions.
This trial is registered with Clinical Trials Registry NCT06471608. The trial protocol and statistical design are fully described in this study protocol. Additional data can be provided on reasonable request to the sponsor. Protocol version: V2.1 - 21/11/2024.
Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to severely active ulcerative colitis (UC). While etrasimod demonstrated efficacy in randomised controlled trials, understanding its effectiveness in an observational setting is crucial.
EFFECT-UC is a prospective, multinational, non-interventional study to evaluate the real-world effectiveness of etrasimod in adults with moderately to severely active UC. The study consists of a 52-week treatment period and a 28-day safety follow-up period and aims to enrol ~300 patients per cohort. Eligible patients (18–64 years) are advanced therapy naïve or experienced and are initiating etrasimod in a real-world clinical setting. Treatment will be guided independently by the clinician’s judgement. Patient-reported outcomes will be collected electronically throughout the study and daily for the first 2 weeks. Exploratory data, including faecal calprotectin, endoscopy and intestinal ultrasound, will be collected at predefined visits or during standard care. Primary endpoints are symptomatic remission at week 12 and week 52. Secondary endpoints include patient-reported outcome 2 (combined rectal bleeding and stool frequency subscores) response at week 12 and week 52 and corticosteroid-free symptomatic remission at week 52.
Ethics approval was obtained for all sites. Recruitment is underway for cohort 1, comprising patients from the UK, Germany and Canada. Interim results for this cohort are expected in 2026 and final results in 2028; these will be submitted for publication in peer-reviewed journals and presented at appropriate congresses.
To map the implementation and adaptation of life skills training programmes for individuals with schizophrenia spectrum disorder across diverse settings, identifying frameworks, intervention components, outcomes and implementation strategies.
A scoping review following Arksey and O’Malley’s methodology and Preferred Reporting Items for Systematic Reviews extension for Scoping Reviews reporting guidelines.
Six electronic databases (MEDLINE (Ovid), PubMed (National Library of Medicine), PsycINFO (APA PsycNET), CINAHL (EBSCO), ThaiJo (Thai Journals Online) and TCI-Thailand (Thai-Journal Citation Index) were searched from 1970 to 10 December 2024, supplemented by handsearching reference lists and relevant organisational websites.
Primary studies targeting life skills training for adults with schizophrenia spectrum disorder, including at least three life skills components (medication management, social skills, communication, organisation/planning, transportation, financial management) and providing intervention details.
Data were extracted using the Template for Intervention Description and Replication checklist. Outcomes were analysed using Kirkpatrick’s four-level training evaluation framework. Implementation adaptation, barriers and enablers were identified through narrative synthesis.
33 studies from 7 countries (France, Italy, Spain, Canada, USA, Turkey and China) met inclusion criteria. Three major programme frameworks emerged: University of California, Los Angeles Social and Independent Living Skills Programme, Functional Adaptation Skills Training and Cognitive-Behavioural Social Skills Training. Cultural adaptations were crucial for implementation success, with programmes demonstrating adaptability across diverse settings while maintaining core therapeutic components. Implementation barriers included cognitive deficits, transportation difficulties and workforce limitations; enablers included structured formats, diverse teaching methods and family involvement. Most studies showed positive behavioural changes, but only one-third reported broader systemic outcomes.
Life skills training programmes had been reported to be implemented across diverse settings when appropriately adapted to cultural contexts and resource constraints. Most programmes combine structured learning with real-world practice, accommodate cognitive limitations through diverse teaching methods and engage families in the intervention process. Future research should focus on implementation strategies enhancing skill generalisation, addressing resource limitations in low-income and middle-income countries, and evaluating longer-term outcomes.
To explore barriers and facilitators to a good death in patients with respiratory disease when advanced respiratory support, including non-invasive ventilation (NIV) and continuous positive airway pressure (CPAP), is used. Specifically, we examined healthcare professionals’ perspectives on what constitutes a good death in this context, how treatment failure is recognised, how decisions to continue or withdraw therapy are made, and the impact of providing this care on staff.
Qualitative study using semistructured interviews and reflexive thematic analysis.
Secondary care services in a large UK National Health Service Trust, including acute medicine, general medicine, respiratory medicine and palliative care.
25 healthcare professionals (19 female, 6 male) from multidisciplinary backgrounds, including doctors, nurses and physiotherapists. Participants self-identified as experienced in the provision of NIV/CPAP at the end of life. Staff working primarily in intensive care units were excluded.
None.
Not applicable.
Healthcare professionals described the complexity of caring for patients dying while receiving or recently withdrawn from NIV/CPAP. Five interrelated themes were identified: beliefs around dying well, symptom management during active treatment, recognition of treatment failure, negotiated decision-making and the process of withdrawal. Staff reported tensions between providing active treatment and ensuring comfort, inconsistent practices regarding symptom control and withdrawal, and conflicts within multidisciplinary teams. Nurses highlighted hidden psychological and relational labour in supporting patients, while doctors often described delays in decision-making to align families with treatment withdrawal.
Caring for patients using NIV/CPAP at the end of life presents ethical, clinical and emotional challenges for staff, patients and families. Variation in practices and perspectives highlights the need for structured training, interdisciplinary approaches and greater recognition of the often hidden relational and emotional labour involved in this work, particularly among nursing colleagues. Further research should evaluate strategies to support consistent and compassionate withdrawal practices.
Tobacco consumption is a significant preventable cause of death worldwide. This study aimed to assess the prevalence and associated factors of tobacco consumption among Cambodian individuals aged 15–49, utilising data from the 2021–2022 Cambodia Demographic and Health Survey (CDHS).
Cross-sectional study based on secondary analysis of the 2021–2022 CDHS.
Nationwide household survey conducted across urban and rural areas of Cambodia.
A total of 28 321 respondents aged 15–49 years were included in the analysis.
Tobacco consumption categorised as no use, smoking tobacco, smokeless tobacco and dual use. Descriptive statistics, 2 tests and multinomial logistic regression were used to assess associations between background characteristics and tobacco consumption, with ‘no consumption’ as the reference category. Statistical significance was set at p
Among the 28 321 respondents (68.8% female), 91.8% were non-users of tobacco (reference group), while 6.9% reported smoking (predominantly males; adjusted relative risk ratios (ARRR)=39.29, 95% CI 29.70 to 51.96, p
While Cambodia has made notable progress in reducing tobacco consumption, the persistent challenges highlighted by the prevalence of smoking, particularly among specific demographics, indicate the need for targeted public health interventions.
To develop survey items for a national patient registry on Long COVID using a modified Delphi process.
This study was based on a modified Delphi process involving three rounds of anonymous, online surveys to develop consensus on and prioritise survey elements to be included in a minimum dataset for use in a national patient registry in Canada. Initial Long COVID items were identified through an environmental scan of the literature.
This study focused on healthcare systems in Canada and was conducted online.
A panel of 52 experts (patients, caregivers, clinicians and researchers) participated in all three rounds of the online survey. These participants were recruited through the Long COVID Web network and word of mouth.
In total, 243 survey elements related to care, quality of life and symptoms were included in round 1 of the survey. 200 reached consensus and moved to round 2 with two additional elements being developed based on open-ended responses. In round 2, participants ranked these survey elements and 34 advanced. In round 3, 33 survey elements met the threshold of consensus with one added a priori. The 33 survey elements were then used to develop a Long COVID minimum dataset, which consists of 48 items.
The findings affirm broad consensus for collecting data related to fatigue, post-exertional malaise, cardiovascular issues, respiratory problems and cognitive issues. This highlighted the desire for quality-of-life indicators and information related to care utilisation, quality and access.
This project explores the feasibility of setting up a neuropsychiatric de-identified database (DiD) and a Research Register (RR) to collect, analyse, monitor and systematically report clinical data for people with intellectual disabilities (PwIDs) and epilepsy.
A multicentre project designed to collect de-identified data from clinical records at three adult ID specialist services in England and Wales and to develop an RR of PwID and epilepsy. Patients added to the DiD will be identified from patient clinic lists, clinic letters, in-house databases and electronic systems. Patients to be added to the RR will also be identified through attendance for regular review at clinic appointments. The collected data will be entered into the Research Electronic Data Capture (REDCap) database. Personal details of PwID and their consultees will also be collected from participants who consent to be on the RR. Around 600 PwID and epilepsy (200 per site) will be added to the DiD at the three sites, while around 45–60 participants (15–20 per site) are anticipated to be added to the RR. Data analysis will involve using descriptive statistics to summarise feasibility outcomes, such as screening and recruitment rates, as well as the completeness of the collected data. The characteristics of the participants (demographic, ID classification, clinical, epilepsy history and antiseizure medication) will be summarised descriptively. Progression will be assessed using the Red/Amber/Green stop-go criteria to determine if a national register should be created.
Ethical approval (24/NW/0210) has been obtained from the Northwest-Haydock Research Ethics Committee and the University of Plymouth Faculty Research Ethics and Integrity Committee (reference no. 5284). The project is funded by Jazz Pharmaceuticals as an independent investigator-initiated support grant and, as such, has received independent peer review.
To evaluate and map research examining clinical associations with the Duffy-null variant.
Scoping review of the existing literature.
We conducted a systematic search of PubMed, Embase, CINAHL and Web of Science for studies published in English between 1 January 2000 and 25 June 2024.
Studies were eligible for inclusion if they examined associations relevant to current standard clinical practice and met our protocol’s inclusion criteria.
We extracted the following information from included studies: study year(s), patient population, sample size, study design, primary outcome and primary findings. Studies were grouped by outcome and synthesised in tabular and qualitative formats.
A total of 2737 studies were screened, and 44 met our inclusion criteria. Most studies were observational, and the most common research question examined was the association with resistance to Plasmodium vivax malaria (9/44). Overall, we observed that the association between the Duffy-null variant and asymptomatic lower absolute neutrophil count (ANC) is demonstrated in large prospective cohort studies. The association with resistance to P. vivax malaria is primarily supported by large cross-sectional studies. There were no studies examining the practical applications of these findings, for example, optimal Duffy-genotype adjusted ANC thresholds for clinical decision-making in patients receiving chemotherapy. Finally, we observed that 19 different associations with this trait have been explored, several in conditions with no clear link to the Duffy trait, for example, progression rates in HIV/AIDS, risk of diabetes, etc.
We found established associations between the Duffy-null variant and asymptomatic lower ANC and with resistance to P. vivax malaria but a lack of data for the practical utilisation of these findings in clinical care. Future studies, such as those examining safe ANC values for entry into clinical trials and for ANC nadir for Duffy-null patients receiving medications associated with increased risk of neutropenia, for example, clozapine, are needed. We observed numerous reported associations of unclear clinical utility. Studies investigating associations with the Duffy trait should be guided by biologic plausibility and clinical utility of positive findings.
Barcode medication administration (BCMA) systems are increasingly being implemented in hospital settings, with the aim of decreasing medication administration errors. However, the majority of the literature demonstrating the value of BCMA in supporting patient safety is from the USA. Furthermore, little is known about the underlying mechanisms that support its use. This study aims to explore the impact of BCMA on patient safety including medication admisntration errors and nursing time spent providing direct patient care, in terms of what works, for whom, under what circumstances, and how.
We will use a mixed-methods realist evaluation. The study will be conducted in four phases, at two London NHS teaching trusts and one South West Region NHS Trust using different electronic health record systems. Phase 1 will involve documentary analysis and a narrative review to develop an initial programme theory for how BCMA is expected to work. Phase 2 will use interviews with key informants to refine this programme theory. The programme theory will then be tested in phase 3 using mixed methods: (1) observation of nurses’ medication administration; (2) analysis of alert data from the BCMA systems to understand the alerts’ clinical significance and utility and (3) interviews with nurses and hospital inpatients to explore their views. These data will be triangulated to refine and finalise the programme theory in phase 4, together with recommendations for practice.
The Study Coordination Centre has obtained approval (24/SC/0326) from the Oxford B NHS Research Ethics Committee and the Health Research Authority. The study’s findings will be presented at scientific meetings and published in peer-reviewed journals. Additionally, summaries of the findings will be produced, targeted at relevant groups such as healthcare professionals, policy-makers and study participants.
Cleft lip and/or palate (CL/P) is a lifelong condition affecting one in 700 births. In the UK, individuals born with CL/P follow a care pathway at specialist regional cleft centres, which includes input from a range of professionals including surgeons, speech and language therapists, cleft specialist nurses, orthodontists, dentists and clinical psychologists. The cleft centres provide care from diagnosis to early adulthood. Individuals born with CL/P are typically discharged from routine care at their cleft centre between the ages of 15 and 25 years.
Outcome measures of cleft care are currently gathered at different timepoints across the treatment pathway nationally and include outcomes for speech, growth, dental health and psychosocial well-being. However, there is no consistent reporting of outcomes for young adults when they complete routine care, meaning we do not know whether variation in outcomes exists and what this might look like.
This research programme will investigate whether outcomes vary based on factors such as geographical location, biological sex, socioeconomic status or ethnicity. By understanding how outcomes might vary, and the scale and type of variation, we plan to work with young adults born with CL/P and specialist clinicians to develop ways to ensure that everyone born with CL/P in the UK receives the optimum care to meet their needs.
Cleft@18–23 is an observational study of young adults born with CL/P. Recruitment is planned across all regions of the UK, beginning in April 2025 with research clinics scheduled to run between June 2025 and May 2027. The recruitment target is 640 participants born with CL/P. Participants with all cleft diagnoses, including those with additional syndromic diagnoses, will be eligible for recruitment. We will recruit participants from all ethnic and socioeconomic backgrounds. Data collection will include self-report participant questionnaires, speech samples, a hearing screen, two-dimensional and three-dimensional medical photographs, an intraoral scan and a dental assessment. A range of descriptive and inferential statistical analyses will explore variation in outcomes across different groups.
The Cleft@18–23 study obtained ethical approval from the South West-Frenchay Research Ethics Committee on 26 November 2024 (REC reference: 24/SW/0128). Informed consent will be required for participation. Findings from the Cleft@18–23 study will be disseminated through peer-reviewed publications, conference presentations, newsletters, the study website (https://www.bristol.ac.uk/cleft18-23) and social media.
Cellulitis is a common bacterial skin infection causing significant pain, swelling and impact on daily activities, frequently leading to emergency department presentations and hospital admissions. While antibiotics are the mainstay of treatment, they do not directly address inflammation, often resulting in persisting or worsening symptoms in the initial days. Corticosteroids, with their potent anti-inflammatory effects, have shown benefit in other acute infections but are not currently standard care for patients with cellulitis. This trial aims to determine if adjunctive oral dexamethasone can reduce pain and improve outcomes in adults with cellulitis presenting to UK urgent secondary care settings.
This is a pragmatic, multicentre, double-blind, placebo-controlled, randomised, parallel group, phase 3 superiority trial, with an internal pilot and parallel health economic evaluation. Adult patients (≥16 years) with a clinical diagnosis of cellulitis (at any body site except the orbit) presenting to urgent secondary care will be screened for eligibility. 450 participants will be randomised (1:1) to receive either two 8 mg doses of oral dexamethasone or matched placebo, administered approximately 24 hours apart, in addition to standard antibiotic therapy. The primary outcome is total pain experienced over the first 3 days postrandomisation, calculated using the standardised area under the curve from pain scores (Numerical Rating Scale 0–10) across up to seven timepoints. Secondary outcomes include health-related quality of life (EuroQol 5 Dimension 5 Level), patient global impression of improvement, analgesia and antibiotic usage, hospital (re)admissions, complications, unscheduled healthcare use, cellulitis recurrence and cost-effectiveness at 90 days. The primary estimand will apply a treatment policy approach to intercurrent events.
The trial has received ethical approval from South Central—Oxford B Research Ethics Committee (reference: 24/SC/0289) and will be conducted in compliance with Good Clinical Practice and applicable regulations. Informed consent will be obtained from all participants. A model consent form can be seen in . Findings will be disseminated through peer-reviewed publications and conference presentations, and to patient groups and relevant clinical guideline committees.
Postoperative pulmonary complications (PPCs) are common after cardiac surgery and are associated with significant morbidity and mortality. Lung-protective ventilation strategies have been proposed to reduce PPCs, but the optimal level of positive end-expiratory pressure (PEEP) and the use of alveolar recruitment manoeuvres (RMs) remain controversial.
In this investigator-initiated, multicentre, open, randomised, parallel-group, superiority clinical trial, elective cardiac surgery patients at risk of PPCs will be assigned to one of two intraoperative ventilation strategies: (1) an open-lung ventilation strategy with protective ventilation, moderate PEEP and RMs or (2) a standard protective ventilation with low PEEP and no RM. The primary outcome will be a composite of prolonged (>24 hour) postoperative mechanical ventilation, reintubation for any cause or hospital-acquired pneumonia within 7 days of surgery, or death within 28 days of surgery. Data will be analysed on an intention-to-treat basis.
The VACARM (impact of intraoperatiVe moderAte positive end-expiratory pressure with reCruitment mAnoeuvres versus low positive end-expiRatory pressure on major postoperative pulMonary complications and death after on-pump cardiac surgery in high-risk patients) trial has been approved by an independent ethics committee for all study centres. Recruitment began in July 2021. Results will be published in international peer-reviewed medical journals.
ClinicalTrials.gov NCT04408495.
Genomic diagnostics have accelerated therapeutic and preventative breakthroughs in oncology and cancer genetics. Despite increased access, the implementation of genomics-based care faces serious fragmentation and scalability issues due to a lack of system support. The Precision Care Initiative aims to develop a novel and scalable Precision Care Clinic (PCC). It is designed to coordinate precision medicine in oncology and streamline decision support for referring oncologists and geneticists. The PCC will enhance quality of care through multifaceted, patient-centred communication. It will also improve translational capacity by integrating team expertise in precision oncology, implementation science, clinical informatics, cancer genetics, health economics and patient-reported measures.
This programme uses a type I and type II hybrid effectiveness-implementation trial design sequentially. The complex clinical intervention is precision oncology—matching the targeted treatment or risk management strategy to the right patient, based on their genomic, cancer staging, environmental, lifestyle and biological characteristics, etc. The service intervention is the PCC, providing centralised multidisciplinary review to facilitate shared decision-making with clinicians for the provision of optimal precision oncology care for their patients. The implementation intervention is the co-designed implementation platform—applying evidence-based implementation approaches and Learning Health System principles to enhance feasibility and sustainability. All adult patients across Australia referred to the PCC (n=est. 100–150/year), and healthcare professional interest holders involved in the delivery of precision oncology services, are eligible to participate. Over the study course, phase I involves using a mixed-methods approach to inform iterative co-design and pilot testing of the first PCC with an accompanying implementation platform, and a suite of outcome measures to assess effectiveness; phase II (hybrid type I) includes the implementation of the PCC and evaluation of the outcome measures designed in phase I; phase III (hybrid type II) involves a co-design of local adaptations and testing the effectiveness of the PCC model nationally.
The study received ethical approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00373). Study results will be presented at relevant conferences and published in peer-reviewed journals.
FreshRSS 