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Sympathetic activation is the hallmark of cardiac disease, driving disease progression and triggering ventricular arrhythmia (VA). Despite optimal medical therapy, many patients experience recurrent VAs refractory to medical therapy, leading to repetitive implantable cardioverter defibrillator (ICD) therapy, worse quality of life and adverse outcomes. Cardiac sympathetic denervation (CSD) through surgical removal of the stellate ganglia is an effective treatment for refractory VAs but carries a high complication rate. We hypothesise that high precision image guided radiotherapy can be used to target the stellate ganglia to achieve CSD non-invasively.
RADIO-STAR (hypofractionated radiotherapy to the stellate ganglia for ventricular arrhythmia) is a first-in-human, phase 1 safety and dose finding study of radiotherapy to the stellate ganglia in patients with recurrent VAs. Patients with structural heart disease requiring recurrent ICD therapy for VAs are invited to undergo radiotherapy bilaterally to their stellate ganglia with a predetermined sample size of n=13. Radiotherapy dose will be determined by a prespecified dose escalation protocol. The primary outcome is safety defined as any treatment-related grade 3–5 toxicity occurring within 6 months of radiotherapy treatment, as defined by the Common Terminology Criteria for Adverse Events or any treatment-related side effects detected on patient symptom questionnaires and clinical examination during study visits. Secondary outcome measures to evaluate feasibility and efficacy include ability to safely deliver radiotherapy and consequent changes in circulating catecholamines and neuropeptide-Y, heart rate variability, structural changes in the stellate ganglia on MRI imaging and ICD therapy burden.
This study has received ethical approval by the South Central—Oxford B Research Ethics Committee (REC/SC/0005). Study findings will be submitted for publication in peer-reviewed scientific journals and presented at national and/or international scientific conferences.
Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.
This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.
This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.
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.
Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.
The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.
Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.
Women with overweight or obesity tend to engage in low levels of exercise and face challenges in initiating and maintaining exercise throughout pregnancy.
This study aimed to evaluate the effectiveness of a peer-led walking and mobile health (mHealth) app intervention on self-efficacy and change in exercise behavior stage, based on the transtheoretical model (TTM), of women with overweight or obesity from pregnancy to one month postpartum.
The study was a randomized controlled trial with an experimental design. A total of 114 pregnant women (BMI ≥ 24 kg/m2 and gestation < 16 weeks) were recruited from prenatal clinics in Taiwan from July 2021 to May 2022. The intervention group (IG) received the peer-led walking program with mHealth support, while the control group (CG) received standard antenatal care. Follow-ups were conducted at 24–28 weeks (T2), 36–40 weeks (T3), and one month postpartum (T4).
The IG had significantly higher exercise self-efficacy scores from T1 to T3 compared to the CG. IG participants showed notable progress in exercise behavior stages, transitioning from the contemplation stage at T1 to preparation and action stages at T2 (χ 2 = 13.208, p < 0.01), with some reaching the maintenance stage by T3 (20.9%, χ 2 = 9.49, p < 0.05). In contrast, most of the CG participants remained at the contemplation stage throughout pregnancy to early postpartum.
The peer-led walking intervention with mHealth has the potential to enhance self-efficacy and promote sustained exercise behavior of women with overweight or obesity during and after pregnancy and is a valuable approach to establishing long-term exercise behavior.
ClinicalTrials.gov: NCT 05022680
Active self-management by patients following acute coronary syndrome (ACS) can reduce recurrent events. Patient education for transitioning from hospital to home promotes effective self-management but can be limited in the acute setting due to time and resource pressures. Patients from ethnic minority and immigrant backgrounds face additional language, cultural and health literacy barriers to receiving patient education. Self-administered virtual patient education presents an innovative solution to these challenges. This study aims to evaluate a co-adapted, virtual avatar nurse-guided, discharge education application (app) for Chinese-speaking patients following ACS.
This multicentre, assessor-blinded, randomised controlled trial will recruit 98 Chinese-speaking inpatients following ACS with evaluation at 1 and 3 months postdischarge. Control participants in the control group will receive the usual ward-based patient discharge education. Intervention participants will additionally receive the education app installed on their devices before hospital discharge with unlimited access during the study period. Cultural relevance and linguistic accuracy for this Chinese version of an existing app were ensured through co-adaptation with Chinese-speaking consumers; the primary outcome will be coronary heart disease (CHD) knowledge, and secondary outcomes will include knowledge, attitudes and beliefs regarding heart attack symptoms and responses, CHD self-management behaviours, utilisation of healthcare services and quality of life. A process evaluation will be conducted alongside the trial to assess the acceptability and feasibility of the app. Between-group comparisons will be made using 95% CIs, accounting for baseline differences using linear mixed effects or mixed effects logistic regression models.
The Western Sydney Local Health District Human Research Ethics Committee has approved this study protocol (26 February 2024, amendment number 2) (2024/STE00147), with site-specific authorisations obtained from each participating hospital. The results will be disseminated through peer-reviewed journal articles and presentations at scientific conferences.
ACTRN12624000408583.
Colorectal cancer (CRC) is the fourth most common cancer in the UK and second leading cause of cancer-related deaths. The faecal immunochemical test (FIT) is a non-invasive home-based test used for both symptomatic assessment and population-based screening. However, approximately 30% of screening FIT kits and 10% of symptomatic FIT kits are never returned. Under-served populations, including ethnic minorities, socioeconomically deprived communities and those with mental health conditions, experience particularly low FIT return rates, contributing to health inequalities in CRC outcomes. This systematic review aims to synthesise evidence on the effectiveness and acceptability of interventions to improve FIT returns in both asymptomatic screening and symptomatic populations, with particular focus on under-served communities.
We will conduct a systematic review of qualitative and quantitative evidence. We will search Scopus, MedLine via Ovid, CINAHL via Ebsco and Cochrane Central Register of Controlled Trials from September 2010 onwards, supplemented by reference screening and trial registry searches. Eligible studies will include randomised controlled trials, quasi-experimental studies, observational studies, qualitative studies, mixed-methods studies and implementation studies examining FIT interventions in screening or symptomatic populations. Two reviewers will independently screen search results for eligible studies. Data extraction will capture study characteristics, population demographics, intervention components and outcomes including FIT return rates, acceptability, feasibility and implementation factors. Quantitative data will undergo systematic tabulation and meta-analysis where appropriate, with narrative synthesis for heterogeneous studies. Qualitative data will be analysed using framework-based thematic analysis, mapping findings to both the theoretical domains framework and theoretical framework of acceptability. A mixed-methods synthesis will integrate quantitative and qualitative findings to identify intervention characteristics, implementation strategies and contextual factors associated with improved outcomes across different population groups.
Ethics approval is not required as this systematic review will analyse published studies. Findings will be disseminated through peer-reviewed publication and conference presentations.
CRD420251111663.
To investigate the effects of organisational interventions on the incidence, healing and management of pressure injuries in adult patients in acute hospital settings.
Systematic review.
The review included adult patients at risk of or with pre-existing pressure injuries in acute hospital settings, excluding mental health units, emergency departments or operating theatres. Interventions employed in the included studies were categorised using the Cochrane Effective Practice and Organisation of Care taxonomy.
Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Ovid Embase, EBSCO CINAHL Complete and Web of Science Core Collection were searched from 01 January 2012 to 31 December 2023.
Of 8861 records identified, 7 prevention studies met the inclusion criteria. Six studies reported reductions in pressure injury incidence. Included studies employed various combinations of 14 organisational strategies to enhance practices. Educational interventions were utilised in six studies, including educational meetings, materials and outreach visits. Other common strategies included audit and feedback, communities of practice and continuous quality improvement. The interventions targeted patients and clinicians, primarily nurses, with some involving multidisciplinary teams. The focus was on enhancing healthcare practices through systematic approaches and stakeholder engagement.
Organisational strategies targeting both patients and clinicians as part of an intervention bundle may enhance the prevention of pressure injuries in acute hospital settings. Further, high-quality effectiveness–implementation hybrid trials are required to evaluate these strategies.
Organisational factors influence clinicians' ability to implement evidence-based practices. The effectiveness of specific organisational strategies in acute settings is uncertain. Multiple organisational strategies targeting patients and clinicians may improve the implementability of a pressure injury prevention intervention.
This study adhered to PRISMA guidelines.
Neither patients nor the public were directly involved in this study.
by Fang-Yi Chen, Chin-Chu Chen, Chuan-Chin Chiao
The regenerative capacity of mammalian RGC neurites after damage, such as glaucoma, is limited. Numerous studies have utilized herbal extracts to promote neural regeneration and exert neuroprotective effects in the hope of mitigating glaucoma. In the present study, we investigated the effect of extracts from the cicada fungus (Cordyceps cicadae) and the Lion’s mane mushroom (Hericium erinaceus) on neurite outgrowth of retinal explants and isolated RGCs. We also examined whether these extracts affect the number of apoptotic cells and neurite outgrowth activity of RGCs. The results showed that an aqueous extract of Cordyceps cicadae, an ethanol extract of Hericium erinaceus, and the purified compound Erinacine Sare able to promote neurite outgrowth in retinal explants. Given its role as a key bioactive compound, Erinacine S was further investigated on isolated RGCs, where it also significantly enhanced neurite outgrowth, demonstrating a direct effect on RGC regeneration. In addition, these extracts have no significant drawbacks in terms of cell apoptosis and RGC neurite outgrowth activity at specific concentrations. The present study thus demonstrates that while excessively high concentrations of these extracts may inhibit neurite growth, at moderate concentrations some extracts from Cordyceps cicadae and Hericium erinaceus have the potential of promoting neurite regeneration in the mammalian retina. Further research targeting the molecular mechanisms behind these effects may shed light on their potential application as a medicine or nutraceutical for facilitating neural regeneration.Mobile health (mHealth) technologies have become increasingly popular for monitoring mental health symptoms and lifestyle behaviours, and are largely reported to be feasible and acceptable to users. However, to date, the efficacy of such technologies to improve perinatal mental health outcomes has been mixed. Within the perinatal context, much of this work has been done in the context of postpartum depression, stemming from electronic health records as well as cohort studies. There is, however, a dearth of studies focusing on depression in pregnancy, and machine learning-based clinical decision support systems remain underexplored. The HappyMums application has been developed to meet this need, and its use across Europe will be tested in this study.
A total of 1000 pregnant people currently suffering from, or at risk of, antenatal depression will be recruited across six countries. All participants will be between 13 and 28 weeks’ gestation and will be given access to the new purposefully developed HappyMums mobile application, to use from enrolment until 2 months postpartum. The application leverages passively collected data from smartphone sensors relating to physical activity and behaviour, as well as requiring active engagement from the user to complete mental health questionnaires and ‘game-like’ activities. Digital data types will be combined with traditional mental health measurement methods, such as standardised questionnaires and interviews, to develop novel predictive models capable of identifying mental health trajectories in women at risk of developing antenatal depression and to test the app’s utility for use as personalised risk prediction and depression identification tool. The primary outcome of this study is to determine what proportion of users will continue to use the mobile application and engage with its tasks and activities at least weekly, while secondary exploratory outcomes include assessing usability of the app and testing the predictive ability of a novel machine learning-based model. These outcomes will, for the first time, be assessed by integrating active as well as passive data.
Ethical approval has been granted by local research ethics committees in each recruiting centre. At King’s College London (leading the clinical study), the study was reviewed by the East of England—Essex Research Ethics Committee and granted favourable opinion (REC reference 24/EE/0129). All other sites collecting participant data have the study approved for local delivery. Findings relating to the primary and secondary outcomes will be submitted for publication in open access, peer-reviewed journals, as well as presentations at conferences as symposia or posters. Findings will be made available to a non-specialist audience through open access digital mental health magazines and promotion on social media.
Cancer survivors often receive inadequate pain management, leading to impaired quality of life. Despite their importance, evidence on the global prevalence of chronic pain in cancer survivors remains insufficiently clear.
The systematic review and proportional meta-analysis aimed to estimate the pooled global prevalence of chronic pain among cancer survivors and to explore heterogeneity stratified by geographic region, cancer type, pain duration, and pain assessment tool.
Five databases (PubMed, Embase, Cochrane Library, CINAHL, and China National Knowledge Infrastructure) were searched up to September 2024 for studies in English or Chinese. The review followed MOOSE and PRISMA guidelines with PROSPERO registration (CRDxx). Studies were included if they reported chronic pain prevalence in cancer survivors using validated instruments or solely reported chronic pain. Two reviewers independently screened studies, extracted data, and assessed quality using the JBI Critical Appraisal Checklist for Analytical Cross-Sectional Studies. Pooled prevalence and 95% prediction intervals were calculated using a random-effects model with Freeman–Tukey double arcsine transformation. Subgroup analysis was used to explore heterogeneity. Leave-one-out analysis explored robustness. Funnel plot and Egger's test were used to examine publication bias.
In total, 36 studies involving 39,806 participants were included. The pooled prevalence of chronic pain among cancer survivors was 41% (95% CI: 34%–49%) after testing robustness, with significant heterogeneity (I 2 = 99.32%). Subgroup analysis indicated significant group differences in prevalence rates by geographic region, cancer type, and pain duration (all p < 0.001).
These findings stress the need for more extensive and tailored chronic pain management in current clinical practice. Additional research on chronic pain outcomes among pediatric cancer survivors, cancer populations within Africa and South America, and those with cancer types other than breast cancer is needed.
PROSPERO Registration: CRD42024597090.
The Generation Study is a large-scale research initiative led by Genomics England in partnership with the National Health Service, aiming to evaluate the use of whole genome sequencing in newborn screening, as well as ongoing research use of these genomic data. The Generation Study will sequence 100 000 newborn genomes in England to potentially identify approximately 200 rare and treatable conditions. This paper outlines the study’s approach to embedding ethics from inception through implementation. A model of ‘ethical embeddedness’ that emphasises transparency, trustworthiness and responsiveness to uncertainty is utilised. Drawing on the deliberations of a multidisciplinary Ethics Working Group, public dialogue findings and design research, the paper presents key decisions and our approach to complex ethical challenges including consent, potential impact of the study on clinical services and navigating uncertainty. The paper also reflects on the ethical tensions inherent in balancing research ambitions with operational realities, particularly in a context of evolving genomic science and sometimes limited regulatory clarity. By embedding ethics into the study’s design and delivery, we hope to foster public trust and inform future policy and practice.
Hypotension is a frequent complication after induction of general anaesthesia leading to end-organ injury, for which elderly and multimorbid patients are particularly susceptible. The extent of hypotension depends, among other factors, on the dose and rate of propofol administration. Target-controlled infusion systems are widely used to administer short-acting anaesthetics such as propofol and remifentanil. Commonly, induction is started with a fixed effect-site concentration. Titration, an alternative method of induction using an incremental augmentation of propofol, leads to a reduced induction dose and rate of propofol. We hypothesise that the titration method improves haemodynamic stability compared with conventional induction.
This multicentre, expertise-based randomised controlled trial takes place at four Swiss hospitals. Patients ≥55 years of age undergoing non-cardiac surgery under general anaesthesia using propofol target-controlled infusion are randomised to either a conventional or a titrated anaesthesia induction method. Patients, statisticians and, if resources allow, outcome assessors will be blinded. The primary endpoint is the mean arterial pressure under the individual baseline mean arterial pressure (area under threshold) during the first 30 min after start of induction. Secondary endpoints include the maximum deviation from baseline mean arterial pressure, haemodynamic rescue methods, propofol consumption and neurocognitive recovery after regaining consciousness.
A total of 320 patients are required to have an 80% chance of observing superiority of titration for the area under the threshold as significant at the 5% level, assuming a true difference of 100 mm Hg*min. The area under threshold and the maximum deviation will be compared between arms using mixed linear regression models.
Ethical approval has been obtained from all responsible ethics committees (BASEC2025-01007). The results will be presented at international meetings and published in peer-reviewed journals and may contribute to a change in clinical practice for anaesthesia induction using target-controlled infusion systems with propofol.
clinicaltrials.gov (NCT06980688) and www.humanforschung-schweiz.ch (HumRes67022).
This review identified and mapped the current evidence on emergency presentation of colorectal cancer in Africa.
Scoping review based on methodology by Arksey and O’Malley.
Medline (via PubMed), Embase and African Journals Online were searched between 29 January 2025 and 6 March 2025.
Studies published in English and describing the burden, risk factors and management options for emergency presentation of colorectal cancer in Africa were included. Full-text articles of all epidemiological study designs were considered with no publication date limit. Grey literature such as conference abstracts and letters to the editor were considered if sufficient study detail was provided to map data to the research questions.
Two independent reviewers extracted data from the included studies onto a standardised electronic form. Data were narratively synthesised using predefined themes.
Twenty-seven studies are included in this review. There was wide variability in reported emergency presentation colorectal cancer rates (8.3% to 64.9%). There were few data on early mortality, and none on long-term outcomes following surgery for colorectal cancer. Emergency presentation of colorectal cancer was characterised clinically by bowel obstruction, bowel perforation and peritonitis. Only one study reported on risk factors for emergency presentation of colorectal cancer. Use of diagnostic modalities was variable and depended on resource availability. Surgery was the mainstay of treatment. Endoscopic stenting was only available as a treatment option in South Africa.
Emergency presentation of colorectal cancer is a significant clinical, oncological and health system metric, yet there is a dearth of evidence on the subject in the African context. Available evidence demonstrates the need for more studies on emergency presentation of colorectal cancer, focused on risk factors, prevalence, treatment options and short-term and long-term outcomes.
The objective was to assess whether frailty is associated with an increased risk of postoperative delirium (POD) in intensive care unit (ICU) patients aged 65 years and older.
A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. MEDLINE (via PubMed) and the Cochrane Library were searched for studies published between August 2014 and January 2025, assessing frailty with validated instruments and reporting POD during ICU stay. While the search strategy was not limited to a specific study design, only observational studies met the inclusion criteria. Study quality was appraised using the Newcastle-Ottawa Scale (NOS). Due to methodological heterogeneity, results were synthesised narratively.
This review targeted the intensive care setting specifically, including studies conducted in hospital-based ICUs in various countries.
Of 655 records, five studies (n=3045) met inclusion criteria. Frailty prevalence ranged from 10% to 34.9%. Tools used included the Fried Frailty Scale, modified Frailty Index (mFI), FRAIL Scale (Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight), Comprehensive Assessment of Frailty and Edmonton Frailty Scale. Frail patients had higher POD incidence and experienced more complications such as acute kidney injury, prolonged mechanical ventilation and reoperation. NOS scores ranged from 5 to 7, indicating moderate quality.
Frailty appears to be associated with an increased risk of POD in ICU patients aged 65 and older. Given the limited number and heterogeneity of studies, further research is needed to validate this relationship and to inform targeted prevention strategies in critical care.
FreshRSS 