Increased risks and concerns regarding patient safety in early-phase studies exist because knowledge about the new intervention is still accumulating. This means that narrow eligibility criteria are needed. However, if early-phase studies are narrow in their inclusion, for example, by not including diverse populations, there is a potential risk that new therapies have insufficient relevant efficacy and safety data. Existing research has explored equity, diversity and inclusion (EDI) factors in early-phase pharmaceutical studies, but it has not been possible to find studies that have systematically examined whether EDI factors have been considered in surgical studies reporting innovative procedures. We aim to examine how EDI factors are considered in early-phase surgical studies and surgical innovation reports to explore how this may impact on later-phase evaluation and inclusive intervention implementation.

A scoping review following the JBI (Joanna Briggs Institute) and Arksey and O’Malley’s five-step process is being conducted. We will search Scopus, PubMed and Web of Science for surgical early-phase studies. A two-step screening process for eligibility is being used. Independent double screening will take place for 20% of the papers. Eligible articles will report early evaluation of an innovative surgical/invasive procedure. Excluded will be comparative and later-phase studies and early evaluations of pharmaceutical products even in a surgical setting. Data on article details, patient eligibility and whether protected characteristics are reported and considered will be extracted. Information about EDI considerations reported in the introduction or discussion of the papers will also be extracted. Findings will be discussed with a patient advisory group. A content synthesis approach will be undertaken and descriptive summaries presented.

This study does not require ethical approval being a secondary analysis. The findings will be disseminated through academic journal publications and oral presentations.

Significant advances in systemic therapy have improved survival for patients with advanced-stage non-small cell lung cancer (NSCLC). However, the present treatment strategies and dose-fractionation for high-dose palliative radiotherapy (RT) are based on trials from the 1990s, when RT planning was simple with less precise delivery. Contemporary lung RT uses 4D-CT, volumetric modulated arc radiotherapy, aided by online verification using cone beam CT, which enables greater accuracy and better target volume coverage, while reducing doses to normal organs at risk. The Shortened High-dose Palliative Radiotherapy for Lung Cancer study aims to evaluate the safety and feasibility of reducing the number of RT fractions and RT duration, using contemporary planning, verification and delivery techniques.

This single-arm, multicentre, phase-II study will test the shortened hypofractionated accelerated palliative RT regimen of 30 Gy in 6 alternate-day fractions, with strict normal tissue dose constraints. We aim to recruit 37 patients across 4 sites within the West Midlands. Quality assurance for the RT is supported by the Radiotherapy Trials Quality Assurance Group (RTTQA). Patients with locally advanced or metastatic NSCLC, who are candidates for high-dose palliative RT, before or after first-line systemic therapy, are eligible for recruitment. The primary objective of this study is to assess the safety of the proposed dose-fractionation. Secondary objectives include evaluating toxicity profiles, patient-reported outcome measures, time to progression, feasibility and the National Health Service cost-saving.

This study is conducted in accordance with the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines and all applicable regulatory frameworks, including, but not limited to, the UK policy framework for health and social care research, as well as the Health Research Authority and Health and Care Research Wales regulations. Approval for the study was granted on 18 April 2024 (IRAS project ID: 332998; REC reference: 24/WM/0032). The chief investigator is responsible for obtaining informed consent from participants. Any individual delegated this responsibility is thoroughly authorised, trained and competent to conduct the informed consent process. On completion of the trial, the results will be shared with participants in a plain language summary and will be submitted for publication in a peer-reviewed journal. If successful, this study will inform a phase III randomised controlled trial to assess efficacy. For updates on the study, visit the study web page (https://research.mededcoventry.org/About-Us/Meet-The-Team/TMU/Ship-Rt).

NCT06483308.

Fetal alcohol spectrum disorder (FASD) is a diagnostic term that describes the neurodevelopmental and physical effects resulting from prenatal exposure to alcohol. Individuals living with FASD can experience lifelong challenges, yet with a diagnosis and sufficient support for the individual and their whānau (families), people can live fulfilling lives. Currently, little is known of the prevalence and impact in Aotearoa, New Zealand (NZ). Our aim is to identify the prevalence and understand the needs of young people living with FASD and other neurodevelopmental disorders in Youth Justice (YJ) residences in Aotearoa, NZ. One study will investigate the prevalence of FASD in this setting. The outcomes of both studies may demonstrate barriers and enablers, as well as strengths and gaps in YJ services of Aotearoa, NZ. The outcomes of both studies may guide reinforcing of current best practices as well as highlight necessary and novel initiatives together providing best support for the children and adolescents and their whānau as well as staff across YJ residences.

Extensive consultation with Māori and Pacific Advisory groups, researchers and experts in FASD and justice settings, individuals living with FASD and YJ staff together informed the development of this study.

Children and adolescents (hereafter young people) aged 10 to 18 years and currently residing in YJ residences are eligible for participation and assessment for FASD through assenting and consenting to provide personal and social histories and completed physical and neuropsychological assessments. The comprehensive FASD histories, screening and assessment will be conducted by a neuropsychologist and paediatrician employing standardised assessment practices and instruments. The team will also collect information from health, education and care and protection records; from the young people themselves; and from their family and staff. The study will reference Whakakotahitanga, the newly released (2024) guidelines for screening and diagnosing FASD in Aotearoa, NZ while also acknowledging the differences imposed under constraints of funding research including, for example, time and money. An individualised report will be prepared for each young person and their whānau. Study data will be analysed with descriptive statistics as appropriate. Our findings will be considered by the Māori and Pasifika advisory groups for framing and culturally secure translation, disseminated with all participating young people, translated to YJ services and staff, government and community neurodiversity sectors. Outcomes will be made available through community hubs, conferences, reports and peer-reviewed journal publications.

The study has received ethical approval from the Southern Health and Disability Ethics Committee (2024 Full 20065). Locality ethical approval has been granted from Oranga Tamariki (Ministry of Children), and a privacy impact evaluation has been undertaken. The findings will be shared through peer-reviewed publication, local and national conferences and with key agencies including Oranga Tamariki.

Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). No therapy currently halts disease progression. The strong gut–liver axis implicated in PSC pathogenesis supports the investigation of microbiome-targeted treatments. Oral vancomycin (OV), an antibiotic with potential immunomodulatory properties, has shown encouraging results in improving clinical symptoms and liver biochemistry in PSC. However, prospective data on its safety and efficacy remain limited.

Oral Vancomycin for primary sclerosing Cholangitis in ITaly (VanC-IT) is a phase II, dose-finding, randomised, placebo-controlled, trial designed to evaluate the efficacy and safety of OV in patients with PSC, with or without underlying IBD. Adults and adolescents aged 15–75 years will be enrolled following a 10-week screening and run-in period and randomised in a 1:1:1 ratio to receive either placebo, OV 750 mg/day or OV 1500 mg/day for 24 weeks. Randomisation will be stratified by baseline liver stiffness (

The protocol has been approved by the Ethics Committee CE Brianza on 10 February 2023, number 4017. Trial registration number NCT05876182. Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

NCT05876182.

This study aimed to explore the psychosocial adaptation processes and coping methods among patients with diabetic retinopathy (DR), emphasising the importance of understanding their lived experiences.

A qualitative study using semi-structured interviews.

A tertiary eye hospital in northeastern Iran.

The participants comprised patients with DR, their families and healthcare professionals.

Qualitative data were analysed based on transactional stress theory using deductive thematic analysis to identify psychosocial adaptation concepts.

65% of participating patients had DR for more than 5 years. Analysis of 49 patient and 14 healthcare professional interviews revealed 6 key themes encompassing 15 categories and 33 subcategories: primary appraisal (threat perception, motivational assessment, self-blame), secondary appraisal (perceived control over disease outcomes, perceived control over emotions, self-efficacy), coping efforts (problem management, emotional regulation), meaning-based coping (positive reassessment, reinforcement of religious beliefs, constructive approach), moderators (seeking information, all-encompassing assistance) and adaptation (emotional health, individual-social functioning).

The analysis revealed that deficits in disease awareness, financial and systemic barriers and emotional distress significantly impeded adaptive coping. Conversely, self-efficacy, social and organisational support, and meaning-based coping strategies were key facilitators. Our findings suggest that facilitating positive psychosocial adjustment in patients with DR may require interventions that address these specific barriers and leverage these facilitators, such as providing comprehensive disease knowledge and constructing robust support systems. This study highlights the potential value of a holistic care approach that integrates medical treatment, targeted patient education and psychological support to improve the overall quality of life for these patients.

To explore the challenges and opportunities in clinical skills teaching and learning among faculty, final-year medical students and patients at a private medical university in Pakistan, within the context of a low- and middle-income country (LMIC) medical education system.

An exploratory descriptive qualitative design using inductive thematic analysis utilising in-depth interviews and focus group discussions, framed within a metaphorical lens.

A single private-sector tertiary care teaching hospital and affiliated undergraduate medical college in an urban setting in Pakistan.

A total of 48 participants were included in the study: 12 clinical faculty members representing various disciplines and levels of experience, 16 final-year medical students and 10 house officers and 10 patients from adult inpatient wards. Participants were purposively selected to ensure maximum variation in perspectives.

Six key metaphorical themes emerged, each reflecting both the challenges and opportunities within the clinical learning journey: (1) The Safety Harness—simulation as an opportunity for structured, risk-free skill development, yet limited by authenticity; (2) The Underwater Life—the irreplaceable but unpredictable nature of bedside learning in fostering empathy and communication; (3) The Stormy Seas—systemic and cultural barriers such as patient availability, gender constraints and limited faculty resources; (4) The Ship—students navigating self-development amid evolving expectations, digital distractions and shifting motivations; (5) The Engine Room Tools—balancing diverse teaching modalities while seeking optimal time distribution between simulation and bedside learning; and (6) The Guiding Compass—the pivotal role of clinical teachers as mentors and professional exemplars. Triangulated perspectives revealed that while structured simulation and bedside experiences complement one another, significant institutional, ethical and pedagogical challenges persist, many amplified by the realities of resource-limited LMIC settings.

This study underscores the complexities of clinical teaching and learning in an LMIC context, highlighting the need for a balanced, context-sensitive model that integrates simulation with authentic bedside exposure, supported by mentorship and reflective practice. Addressing structural and faculty-related barriers is essential to advancing equitable, patient-centred clinical education in resource-constrained environments.

With the rapid increase in the number of older adults living with chronic diseases and disabilities, there is a growing need to prepare nurses with positive attitudes and a willingness to work with older adults. This study aims to examine attitudes towards and willingness to work with older adults among nurses.

A cross-sectional survey was conducted among a purposive sample of 267 nurses at the University Hospital of Kotelawala Defence University, Sri Lanka. Participants completed a self-administered questionnaire consisting of socio-demographic variables, Kogan’s Attitudes Toward Old People Scale and questions related to willingness to work with older adults. Descriptive statistics and linear and logistic regression analyses were used in data analysis.

The majority were female nurses (71.9%, n=192) and held slightly negative (58%, n=155) or slightly positive (41.9%, n=122) attitudes towards working with older adults. Only 35.2% (n=94) were willing to work with older adults in this study. A male nurse (beta coefficient (β)=4.644, CI 2.392 to 6.896, p

Most nurses express slightly negative to positive attitudes and have little interest in working with older adults. Various socio-demographic factors have an impact on attitudes towards and willingness to work with older adults. Since nurses play a significant role in providing care for older adults, the development of positive attitudes is essential, and interventions and strategies are crucial to increasing their willingness to work with older adults.

This study aims to determine the incidence and impact of ocular injuries among the different combat sports disciplines of boxing, mixed martial arts (MMA), kickboxing and Muay Thai in Texas, USA.

A case–control study was conducted to analyse retrospective postmatch physical reports from combat sports matches that took place in the state of Texas from January 2019 to January 2022. Ocular injuries and other match characteristics such as sport type and match outcome were identified by postmatch physical reports. Postmatch physical reports were collected from the Texas Department of Licensing and Regulation database. Statistical analysis was used to stratify injuries and compare the impact of injuries on match outcome.

Combat sports fighters in Texas, USA.

3070 participants were included in the study. Participants were fighters who participated in combat sports matches in Texas, USA, between January 2019 and January 2022.

The original plan was to measure the incidence of ocular injuries across different combat sports including boxing, MMA, kickboxing and Muay Thai. However, due to a limited sample size of kickboxing and Muay Thai matches, the ocular injury incidence was only measured for boxing and MMA. The association between ocular injury and match outcome was assessed using ² statistical analysis.

The respective incidence rates of ocular injuries in boxing and MMA were 9.7 and 12.2 injuries per 100 matches. The association between ocular injury and match outcome (win, lose or draw) was statistically significant in boxing but not statistically significant in MMA matches.

Our findings revealed that ocular injuries are significantly associated to losing a boxing match (p=0.011), but not associated to match outcome in MMA (p=0.232). Additionally, MMA matches report a larger variety of ocular injuries compared with boxing matches.

To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.

Cross-sectional study.

PHC facilities across various provinces in Nepal.

A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.

The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.

Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).

Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.

Coronary artery bypass grafting (CABG) remains one of the most commonly performed cardiac surgeries worldwide. Despite surgical advancements, a significant proportion of patients experience psychological distress following surgery, with depression being particularly common. Current evidence regarding the effectiveness of preoperative psychological interventions in improving postoperative mental health outcomes remains inconclusive. There is a critical need for predictive models that can identify patients at risk of developing clinically significant depressive symptoms (CSDSs) and related psychological conditions after CABG. This multicentre observational study aims to develop and validate prognostic models for predicting CSDSs and other psychological outcomes, including anxiety, post-traumatic stress symptoms and quality of life, 6 weeks after elective CABG surgery.

The study will recruit 300 adult patients undergoing elective CABG (with or without valve intervention) across two Swiss hospitals. Data collected will include demographic, clinical, psychometric, inflammation-related and interoceptive variables. A training set (n=200) will be used to develop predictive models using machine learning, while a held-out test set (n=100) will be used for model validation. The primary outcome prediction will focus on CSDSs, assessed using the Patient Health Questionnaire-9 (PHQ-9), with analyses conducted both categorically (PHQ-9 total score ≥10) and continuously as complementary approaches. Secondary models will address anxiety, using the General Anxiety Disorder Scale-7, post-traumatic stress, using the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders-5 and health-related quality of life, using the 12-item Short Form Survey. A simplified ‘light solution’ model with fewer predictors will also be developed for broader applicability. This study will address an important gap in perioperative mental healthcare by identifying key predictors of psychological morbidity following CABG, particularly CSDSs. The resulting models may inform future screening and preventive strategies and improve postsurgical outcomes through early identification and intervention in high-risk individuals.

The responsible ethics committee has reviewed and approved this project (Kantonale Ethikkommission Zürich, BASEC number: 2023-02040). The study minimises participant burden by integrating brief validated instruments and limiting psychiatric interviews to relevant outcomes, while ensuring ethical safeguards and respect for participant rights (including written consent). Results will be shared through peer-reviewed publications, conference presentations and stakeholder meetings involving clinicians and mental health professionals. Findings will also be communicated to participating centres and patient communities in accessible formats.

Prescribing antibiotics may reinforce patients’ beliefs that antibiotics are needed and increase future consultations for similar symptoms. This review determines the effect of antibiotic prescribing for respiratory infections in primary care on future reattendance.

A systematic review and meta-analysis of randomised controlled trials (RCTs) and cohort studies and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Participants were adults or children presenting with respiratory infection in primary care.

MEDLINE (Ovid), PubMed, Embase, the Cochrane Central Register of Controlled Trials, clinical trial registries and grey literature sources were searched from inception until 6 February 2024.

Eligible studies included open-label RCTs or cohort studies of antibiotics compared with no antibiotics in adults or children with respiratory infections. The outcome of interest was reattendance at least 28 days after the initial consultation.

Two reviewers independently screened, selected, assessed the quality and extracted data. Separate meta-analyses were presented for RCT and cohort studies and a combined meta-analysis of all studies.

We identified 2128 records and reviewed 48 full texts, of which five met the inclusion criteria. These reported three RCTs (1207 randomised to antibiotics, 672 controls) and three cohort studies (209 138 exposed to antibiotics, 46 469 controls). In the meta-analysis of RCTs, relative risk (RR) of reattendance with antibiotics was 1.10 (95% CI: 0.99 to 1.23), and in cohort studies, RR was 1.21 (95% CI: 0.94 to 1.49). An important limitation is that most studies were in UK primary care.

Evidence suggests prescribing antibiotics for acute respiratory tract infections in primary care probably modestly increases future reattendance for similar conditions. Reducing antibiotic prescribing may help decrease demand for primary care.

CRD42023470731.

Misinformation about cardiovascular health has the potential to negatively impact public health outcomes. Understanding the nature and spread of such misinformation is crucial for developing effective interventions to mitigate this potential risk. However, despite the critical importance of this issue, there is a gap in comprehensive reviews mapping the existing literature on cardiovascular health misinformation. This scoping review aims to map the existing literature on cardiovascular health misinformation, identifying its spread, prevalence, impact and strategies for correction across diverse populations and settings.

This review will follow the Joanna Briggs Institute guidelines for conducting a scoping review. A comprehensive search will be conducted across multiple databases, including MEDLINE, EMBASE, SCOPUS and Web of Science, along with grey literature sources. The last date of search was January 2025. The review will include studies without date that involve individuals affected by cardiovascular disease (CVD) misinformation, examine the spread, prevalence, impact or correction of misinformation related to cardiovascular health, and capture various cultural, geographic or setting-specific factors. The exclusion criteria include studies that do not directly address misinformation related to CVD. All identified records will be imported into Covidence systematic review software. Two reviewers will independently screen titles and abstracts, followed by full-text reviews of potentially relevant studies. Discrepancies will be resolved through discussion or by consulting a third reviewer. Data extraction will be conducted by two reviewers using a pre-piloted tool, and a descriptive presentation of the findings will be done. Both inductive and deductive content analysis methods will be employed for objectives related to the impact and strategies to combat misinformation.

Given that the study involves synthesising data from existing published literature, ethical approval is not required. The findings will be disseminated through international conference presentations, published in a peer-reviewed journal and shared with public health organisations and policymakers.