Anaphylaxis is a sudden onset multiorgan allergic reaction that infrequently but regularly causes fatalities which may be preventable with appropriate organ support. There is limited data about the type of organ failure leading to death or near-fatal episodes resulting in permanent neurological disability. To assist clinicians facing anaphylaxis in diverse clinical settings, we aimed to quantify the frequency of organ failure type contributing to death or neurological disability from anaphylaxis according to allergen trigger.
Systematic review of published peer-reviewed literature.
Three databases were searched to January 2025: MEDLINE from 1946, Embase from 1947 and Web of Science from 1900.
Studies were eligible if they contained data about the type of clinical deterioration during anaphylaxis resulting in death or permanent neurological disability. No language restriction was implemented. Exclusion criteria were: hydatid anaphylaxis; five or more stings from an insect; death from acute atheromatous myocardial infarction and where anaphylaxis was only a differential diagnosis.
We extracted information using pre-specified criteria to determine the primary organ failure involved: either upper airway obstruction, lower respiratory obstruction (bronchospasm) or cardiovascular failure. Baseline demographics including age and asthma status were collected along with the allergen trigger, time course and treatment. We reported frequencies according to allergen trigger for case reports and a narrative analysis of case series weighted by risk of bias assessment.
277 case studies and 14 case series were identified reporting 896 deaths and 28 disabilities. There were no other study types. Separate case series and case report analyses produced similar findings despite varying quality of published clinical data. Respiratory failure was the most common primary organ failure in case reports (73.4%), whereas primary cardiovascular failure was reported in 26.6% of case reports. Primary organ failure type differed in frequency by allergen trigger and was primarily caused by: respiratory failure when food was the allergen trigger (95%); respiratory failure in 65% of cases of drug allergen triggers; cardiovascular failure in 65% venom allergen triggers.
In this review, respiratory failure (primarily bronchospasm) is the most common primary physiological event leading to decompensation in fatal anaphylaxis, particularly for food and drug allergen deaths. Emphasising the significance of respiratory involvement, particularly from bronchospasm, in both patient and clinician facing anaphylaxis treatment guidelines may help further reduce the risk of fatalities. Prospective anaphylaxis management registries or whole population data are needed to better capture primary organ failure present in fatal anaphylaxis to validate this finding.
CRD42023434206.
Teenagers widely use digital devices for information sharing and other daily activities. Their heavy reliance on smartphones and tablets may contribute to repetitive-use injuries of the thumb.
This study aimed to investigate the prevalence of texting thumb (TT) among medical students and to identify the potential associations between TT and behavioural patterns during digital device use.
This cross-sectional study employed an online, self-developed questionnaire to assess demographic and behavioural patterns associated with smartphone use. Data on thumb pain and its features were evaluated for diagnostic purposes. This study comprised medical students from six medical schools in Jordan. Data were collected from 482 medical students, excluding those who did not meet the inclusion criteria.
The prevalence of TT was 34%, predominantly on the right side (53%) and at the thumb base (69%). The findings suggest that TT was significantly associated with specific behavioural patterns, including supporting the forearm (p=0.026, adjusted OR: 1.611; 95% CI 1.059 to 2.449), number of texting per day (p=0.005, adjusted OR: 1.319; 95% CI 1.086 to 1.603) and studying hours per day using a digital device (p=0.002, adjusted OR: 1.586; 95% CI 1.193 to 2.109). Also, students’ attitudes toward thumb pain were significantly associated with the TT (p=0.005, adjusted OR: 1.351; 95% CI 1.094 to 1.668).
Students’ attention to behavioural patterns is crucial when using digital devices. Supporting the forearm, limiting text message use, avoiding prolonged use of digital devices, never ignoring hand pain and resting the hand significantly reduce the risk of thumb overuse injury.
Patients in intensive care units (ICUs) and their families face existential physical, psychosocial and spiritual distress. Integrating palliative care (PC) into ICU care may benefit patients, relatives and ICU clinicians. Prior PC studies have shown a reduction in ICU length of stay (LOS) and distressing symptoms without altering overall mortality. A shorter ICU LOS may alleviate the burden for patients and relatives and help optimise the use of limited intensive care resources. PC in the ICU, however, remains underused, partly due to limited access and knowledge of ICU clinicians. Also, robust data regarding the effectiveness and cost-effectiveness of PC treatment in the ICU are scarce. We established the ‘enhancing palliative care in ICUs’ (EPIC) study to implement a system-based harmonised practice model across European ICUs. The aim is to investigate if early integration of PC via telemedicine, clinician education and bedside tools is effective and cost-effective, ultimately benefiting patients, relatives and ICU clinicians.
This multicentre, controlled, cluster-randomised, non-blinded stepped-wedge design trial with crossover phase aims to recruit around 2,000 patients from five European countries. All adult patients admitted to participating ICUs—with an ICU LOS exceeding 72 hours, where cancer is not the primary cause of critical illness, and who are not expected to die within the next 24 hours—are screened for the need for specialised PC based on the attending physician’s judgement. This judgement is triggered by the presence of one or more of the following: (1) significant disagreement among ICU team members and/or relatives about the appropriateness of current ICU treatment, (2) considerations of limiting life-sustaining therapy or (3) the anticipation that a specialised PC consultation may benefit the patient, their relatives or the ICU team. Patients identified as needing specialised PC and their relatives are then enrolled after obtaining written informed consent.
The complex intervention consists of (a) a blended-learning programme to foster knowledge and attitude about PC among ICU clinicians, (b) bedside tools, including a checklist to identify patients in need of PC and a factsheet and (c) standardised telemedical consultations from trained EPIC interventionists. Patient and relative follow-up is conducted 3 months post-ICU discharge. Outcomes include clinical measures (including ICU LOS (primary outcome), severity of critical illness, invasive treatments and health-related quality of life), economic endpoints (resource use, costs, cost–consequence situation, cost-effectiveness), ICU clinician burnout and distress, and patient and family perception about the quality of symptom management, care and communication. Endpoint analyses will employ generalised linear mixed models, accounting for the clustered data structure and stepped wedge design.
EPIC complies with the Declaration of Helsinki and has been approved by all local ethics committees. A decision-making structure is established to ensure trial procedures are carried out according to Good Clinical Practice. Study findings will be published in peer-reviewed journals and communicated to participants, healthcare professionals and the public. Sets of anonymised study data will be made available following Findable, Accessible, Interoperable, and Reusable principles.
Population ageing is a global phenomenon that has resulted in an increase in the number of patients with chronic diseases and geriatric syndromes. Frailty, sarcopenia and neurocognitive disorders are among the most prevalent conditions affecting older adults and have a direct effect on their quality of life, and can impact the burden and budgets of health systems. Recently, the oral microbiome has gained attention as it may be a factor that potentially influences the onset and progression of these syndromes. However, this is still a new line of research that has not been deeply explored. This scoping review protocol aims to explore how the oral microbiome may be associated with the onset of prevalent geriatric syndromes, frailty, sarcopenia and neurocognitive disorders, providing a picture of the current evidence and potential gaps for future research.
The scoping review will follow the Johanna Briggs Institute (JBI) methodology and will be reported accordit to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews guidelines (PRISMA-ScR). Searches will be conducted in Medline, Embase, Cochrane Central, CINAHL, LILACS and Epistemonikos from inception to December 2025. Independent reviewers will perform the study selection and data extraction. A descriptive analysis of information will be conducted, highlighting oral microorganisms associated with these syndromes and emerging trends in the evidence. Original research studies in any language will be included. We will include randomised controlled trials, cohort studies, case–control studies and other relevant designs if they investigate the oral microbiome and its relation to geriatric syndromes in adults aged 65 or older, regardless of geographic location or setting.
Ethics approval is not required.
To investigate associations between shift work patterns and sleep disturbance, and to assess if the association is modified by demographic factors, socioeconomic factors, anthropometric and lifestyle factors, health conditions or sleep traits.
Analysis of cross-sectional data obtained from the UK Biobank baseline assessment.
UK Biobank, a large-scale prospective cohort study which recruited half a million participants aged 40–69 years between 2006 and 2010 from across the UK.
A total of 285 175 employed or self-employed participants at baseline (2006–2010), including 148 296 (52.0%) females and 136 879 (48.0%) males. The sample comprised 94.0% White, 0.7% Mixed race, 0.36% East Asian, 2.0% South Asian, 1.8% Black and 0.89% from other ethnic backgrounds.
Sleep disturbance was defined as the presence of both insomnia and excessive sleepiness symptoms.
A total of 42 181 (14.8%) participants had sleep disturbance defined based on insomnia and excessive sleepiness. 236 200 (82.8%) were non-shift workers, while 48 975 (17.2%) were shift workers, which included 24 062 (49.1%) working day shifts only, 17 940 (36.6%) working night shifts sometimes or usually, and 6973 (14.2%) working night shifts always. Compared with non-shift workers, all shift workers had higher multivariable-adjusted odds of sleep disturbance: (non-night shifts: OR in model 3 (OR) 1.21 (95% CI 1.16 to 1.27); sometimes/usually night shifts: OR 1.37 (95% CI 1.30 to 1.44) and always night shifts: OR 1.50 (95% CI 1.38 to 1.63)). The association between shift work pattern and sleep disturbance was modified by age (pinteractioninteraction=0.0005) and smoking status (pinteraction=0.04).
Shift work is associated with a higher odds of sleep disturbance compared with non-shift work in all participants, with greatest odds observed among those always working night shifts. The association was stronger among individuals who were younger than 55 years old, from an ethnic minority background and never smokers. Future large-scale longitudinal studies are needed to further investigate these associations.
To explore patient and public views and experiences of health professional access to patient health records and advance care planning information to support care at the end of life.
A cross-sectional national online survey of patients and the public using a convergent-parallel approach.
The survey was distributed across the UK by Compassion in Dying and promoted via newsletters and social media channels of the Professional Records Standards Body and NHS England’s digital workstream network. These partners were purposively selected for their active involvement in end-of-life care, including hospices, clinicians and related charities.
A total of 1728 participants from 103 UK counties responded, including people with a terminal condition (n=33), with long-term condition (n=442), who provide or have provided care to a person with a long-term or terminal illness (n=229) and who identified as healthy and interested in planning for the future (n=1024).
Both quantitative data (multiple-choice responses and numerical ratings) and qualitative data (open-ended comments) asking about experiences and views of access to their health and advance care planning information to support their care at the end of life.
Confidence that recorded care preferences would be accessed when needed was low for carers (median=2, IQR 1–4) and moderate for patients (median=3, IQR 1–4). Four themes derived from free-text responses included (1) experience of sharing health information; (2) preparation, communication and understanding; (3) concerns, unknowns and assurance seeking; and (4) preserving dignity and respect: understanding individual contexts.
Respondents acknowledged the opportunity for digital systems to enable access to health and advance care planning information but expressed doubts that professionals would retrieve it when needed, citing past failures. Confidence in record accuracy could be strengthened by patient and carer access. Future research should examine whether such access improves alignment of care with patients’ wishes.
The WHO Safe Childbirth Checklist (SCC) has been implemented in diverse settings to improve the quality and safety of intrapartum care, but implementation strategies and their relationship with adoption and fidelity remain heterogeneous and incompletely described.
To describe the landscape of SCC implementation, map the implementation strategies used and explore how these strategies were reported in relation to adoption and fidelity.
We included primary studies reporting SCC implementation in healthcare settings that described at least one implementation strategy, with no restrictions on country or language. Studies that did not report implementation strategies or did not involve SCC use in real-world care settings were excluded.
We searched PubMed, Embase, CINAHL, Global Health and Global Index Medicus (June 2024), screened reference lists and consulted grey literature for the period 2009–2024.
This scoping review followed JBI methodology (Peters et al) and was reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. We extracted study characteristics and implementation findings, coded strategies using the Expert Recommendations for Implementing Change (ERIC) taxonomy and grouped them by clusters. Adoption (initial uptake) and fidelity (adherence to core components) were categorised following Proctor’s implementation outcomes. We created a descriptive implementation intensity score and conducted exploratory analyses (tertiles, boxplot).
34 studies described 19 SCC implementation projects across 16 countries. We identified 24 distinct ERIC strategies, with most projects using 5–11 strategies. Frequently reported strategies included educational meetings, audit and feedback, supervision, contextual adaptation and leadership or champions. Exploratory analyses did not show consistent associations between implementation intensity and adoption or fidelity. ‘Change infrastructure’ strategies (such as record system or equipment changes) were variably defined and warrant cautious interpretation. Adaptations (eg, translation and alignment with national guidelines) were common and aimed at improving local fit, but heterogeneous reporting limited cross-study comparability.
SCC implementation has relied on diverse, multicomponent strategies, yet reporting—especially of strategy content and adaptations—remains insufficient, constraining comparison and synthesis across settings. As a pragmatic bundle, implementers may prioritise brief team training, unit-level champions and leadership signals, point-of-care audit and feedback, light-touch SCC adaptation that preserves core content and structured supervision or peer coaching, combined with systematic inclusion of women and families through codesign and companion-mediated prompting. Using theory-informed frameworks (such as Exploration, Preparation, Implementation, and Sustainment and Consolidated Framework for Implementation Research [CFIR]) and standardised reporting tools (eg, Proctor’s outcomes; Template for Intervention Description and Replication / Standards for Reporting Implementation Studies [TIDieR/StaRI]) can make SCC implementation strategies more transparent, comparable and scalable.
Open Science Framework: https://doi.org/10.17605/OSF.IO/RWY27.
Paediatric palliative care (PPC) improves the quality of life of children with life-limiting and life-threatening conditions, with caregivers playing an important role. Providing PPC in low-income and lower-middle-income countries (LMICs) is challenging due to limited resources, inadequate access to specialised care, financial constraints, and cultural or religious beliefs. This study aims to synthesise qualitative research on the experiences of primary care givers caring for children with cancer receiving palliative care in LMICs.
A systematic search will be conducted using electronic databases: MEDLINE (Medical Literature Analysis and Retrieval System Online), Embase, CINAHL (Cumulative Index to Nursing and Health Literature), Web of Science, and PsycINFO. Additional articles will be searched in the reference list of the selected articles. Review questions will be framed into different components according to the Population, phenomena of Interest, Context, and Outcome (PICO) framework. Primary caregivers of children with cancer will be the population of interest. Both title and abstract screening and full-text screening will be done by two independent reviewers. The quality of included studies will be assessed using the Joanna Briggs Institute critical appraisal checklist for qualitative research. The thematic synthesis approach will be followed as it will allow a transparent summarising of the qualitative data.
This study is not subject to ethics approval, as the work is carried out on published documents. The findings of this review will be disseminated among a broader audience through scientific channels, including publication in open-access journals and presentations at both national and international forums.
CRD420251065491.
To evaluate the association between cumulative radiation dose and haematological parameters among radiation workers and compare the prevalences of abnormalities in blood counts with those in the general population.
Retrospective cohort study.
Nationwide radiation dose registry in Korea, linked with occupational health examination data. Cumulative doses were estimated using annual personal dose equivalent (Hp(10)) records from 1984 onward.
The study included 20 414 radiation workers, comprising 17 651 men (86.5%) and 2763 women (13.5%), with baseline survey data, dosimetry records and at least one complete blood count (CBC) record between 2014 and 2019.
The primary outcome was the continuous haematological parameters, including white blood cell (WBC), platelet (PLT) and haemoglobin (Hb) counts, in relation to cumulative radiation dose. Associations were evaluated using linear mixed-effects models incorporating repeated measurements and adjusting for age, smoking status and body mass index. The secondary outcome was the prevalence of abnormal blood counts among radiation workers.
Most haematological parameters among radiation workers were within normal ranges. In male workers, cumulative radiation dose was associated with increased Hb levels (β=0.5 mg/dL per 1 mSv; 95% CI 0.006 to 0.9) after adjusting for age, smoking status and body mass index. No significant associations were observed between cumulative dose and WBC or PLT counts in either sex. Overall, compared with the general population, radiation workers had significantly lower standardised prevalence ratios for abnormal WBC and PLT counts.
No substantial adverse changes in haematological parameters were found among radiation workers exposed to prolonged low-dose radiation. The findings suggest that cumulative doses at occupational levels may not substantially affect CBC profiles, although continued monitoring and follow-up are warranted.
Sepsis-associated acute kidney injury is common in intensive care and is linked to high morbidity and mortality, yet no specific therapy exists beyond supportive care. Excess circulating labile iron contributes to oxidative stress, mitochondrial dysfunction and cell death via ferroptosis. We hypothesise that targeted removal of labile iron during dialysis may reduce this pathogenic process. This study will evaluate the performance and safety of adding a novel iron chelator named MEX-CD1 (Metal EXtraction - Chitosan DOTAGA 1) to dialysate during continuous veno-venous haemodialysis (CVVHD) in critically ill patients with sepsis-associated acute kidney injury.
This is a single-centre, randomised, open-label, crossover phase I–II pilot study in the intensive care unit of Nîmes University Hospital, France. 14 adult patients with sepsis-associated acute kidney injury requiring renal replacement therapy will receive two consecutive 24-hour CVVHD sessions: one with standard dialysate and one with dialysate supplemented with MEX-CD1 at 50mg/L. Each patient serves as their own control. The primary outcome is the iron concentration in the effluent to measure iron removal performance. Secondary outcomes include plasma iron clearance, trace element loss, biomarkers of oxidative stress and inflammation, and safety outcomes monitored up to 28 days. Statistical analyses will use paired tests and mixed linear regression models.
Ethical approval has been obtained from the Comité de Protection des Personnes (no. 25.01220.000448) and the French National Agency for Safety of Drugs and Medical Devices (no. 2024-A01530-47). Results will be disseminated through peer-reviewed publications and conference presentations.
Functional foods have demonstrated potential in preventing gastrointestinal and musculoskeletal (osteo-related) disorders; however, evidence from cross-sectional studies in adults remains limited. This study aimed to examine the relationship between the frequency of functional food consumption and the prevalence of gastrointestinal and osteo-related conditions among adults in Bangladesh.
Cross-sectional study.
A face-to-face interview was conducted in Southern Bangladesh.
A total of 959 adults participated. Socio-demographic characteristics, lifestyle factors, health status and patterns of functional food consumption were collected using a structured questionnaire.
The prevalence of gastrointestinal and musculoskeletal (osteo-related) diseases, as well as their associations with the frequency of functional food consumption, were assessed using binary logistic regression.
Gastrointestinal and musculoskeletal (osteo-related) diseases were reported by 55.4% and 44.1% of participants, respectively. Multivariate logistic regression showed that several functional foods were associated with lower odds of gastrointestinal conditions, including regular seed intake (OR=0.35, p=0.034), weekly fibre-rich foods (OR=0.48, p=0.021), weekly probiotics (OR=0.26, p=0.012), monthly probiotics (OR=0.33, p
The consumption of functional foods, particularly seeds, probiotics, fibre-rich foods, nuts, tea/coffee and natural products were associated with a lower risk of gastrointestinal and musculoskeletal diseases in adults. These findings provide robust evidence to inform future prospective studies and support public health strategies in Bangladesh aimed at promoting the consumption of functional foods to prevent diet-related health conditions.
To examine the impact of the extent of education and/or training on sex trafficking among healthcare, social and community service providers and the impact of education and/or training on their capacity to respond to sex trafficked persons.
Cross-sectional survey.
An anonymous, online survey assessing perceptions of, and capacity to respond to, sex trafficking was distributed between February and August 2023 via social media platforms and with professional healthcare, social service and community associations and organisations across Canada to share with their members.
553 healthcare, social and community service providers.
Seven 6-point Likert scale items were used, as part of a larger survey, to measure capacity to respond to sex trafficking. Specifically, respondents were asked to rate their awareness of red flags and capacity to identify, talk to, interview, enhance the safety of, provide appropriate resources or referrals for and collaborate with other professionals to support sex trafficked persons.
Although most respondents (86.8%) reported having received some education and/or training on sex trafficking, the vast majority (94.8%) believed that they would benefit from additional education and/or training. Compared with those with no previous sex trafficking education and/or training, those who received less than 5 hours of education and/or training (b=3.56, p
As the number of hours of education and/or training on sex trafficking increased, so did respondents’ capacity to respond to sex trafficked persons. These results highlight a need for more education and training to help build capacity among healthcare, social and community service providers in identifying sex trafficked persons and providing appropriate care. Appropriately trained service providers can better support sex trafficked persons’ complex needs and potentially mitigate adverse outcomes.
Telerehabilitation (TR) programmes are increasingly recognised for their feasibility and potential benefits, such as eliminating travel time, reducing costs and providing a more comfortable rehabilitation experience at home. However, the comparative efficacy of remote physiotherapy compared with traditional in-person sessions for individuals with Parkinson’s disease (PD) remains uncertain. This study aims to evaluate the effects of TR compared with in-person physiotherapy in individuals with PD, focusing on both motor and non-motor outcomes.
This is a randomised, single-blind clinical trial with a mixed-methods approach. A total of 22 individuals diagnosed with PD will be randomly assigned to one of two groups. The experimental group will receive TR, consisting of remote physiotherapy sessions conducted once a week for 1 hour over a 4-month period. The control group will receive the same interventions in person. Interventions will include global muscle strengthening exercises, balance training, gait and motor coordination exercises, and cognitive training. The primary outcome will be motor function, measured using part III of the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale. Secondary outcomes will include cognition (Montreal Cognitive Assessment), gait (Functional Gait Assessment), mobility (Timed Up and Go Test) and quality of life (Parkinson’s Disease Questionnaire). Data will be analysed using repeated measures analysis of variance to compare outcomes between groups across four assessment points (baseline, midpoint, postintervention and 2 months follow-up). Additionally, a qualitative phase will explore participants’ perceptions and experiences regarding TR and in-person interventions, with assessments carried out 2 months after the completion of the 24-week interventions, through semistructured interviews that will be analysed using Bardin’s Content Analysis technique.
This protocol was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte (approval number: 5.553.701). All participants will provide written informed consent before inclusion. Results will be disseminated through peer-reviewed publications, scientific conferences and communication with participants and healthcare professionals.
RBR-6h5knrj.
Our study investigated the age-adjusted incidence rates of non-fatal overdoses by HIV status and sex, and examined trends over time.
We used data from the Comparative Outcomes and Service Utilization Trends study, a population-based cohort study that includes clinical and administrative health data on virtually all people with HIV (PWH) and a 10% random sample of people without HIV in the province.
British Columbia, Canada.
Between April 2012 and March 2020, 11 050 PWH (81.8% male) and 473 952 people without HIV (50.3% male) who were 19 years and older contributed 68 035 and 3 285 824 person years (PY) of follow-up, respectively.
The primary outcome was age-adjusted incidence rates of non-fatal overdose events stratified by sex and HIV status. Trends over time were also assessed.
Age-adjusted non-fatal overdose incidence rates among males with and without HIV were 36.4 and 3.12 per 1000 PY, respectively (incidence rate ratio (IRR) = 11.7, 95% CI 10.9 to 12.5). For females with and without HIV, the age-adjusted incidence rates were 61.4 and 2.33 per 1000 PY, respectively (IRR=26.3, 95% CI 24.0 to 28.7). Between 2013 and 2019 (calendar years with full-year data), the age-adjusted non-fatal overdose rate increased significantly among males and females without HIV but not among PWH.
We observed a significantly higher non-fatal overdose rate among PWH compared to people without HIV. The rate was highest among females with HIV. These findings underline the need for policies and programmes oriented towards PWH to mitigate overdoses, especially for females.
The prevalence of depression and mood disorders has been steadily rising in Australian youth, with a concomitant increase in antidepressant pharmacotherapy prescription rates. Yet, the tolerability and efficacy of antidepressant drugs in youth remain poor. Pharmacogenetic (PGx) testing, or the personalised and guided treatment of medication based on genetic data, has been suggested to improve the effectiveness and tolerability of antidepressants. However, limited studies have evaluated the utility of antidepressant PGx-guided treatment in adolescent and young adult populations. Thus, this pilot randomised controlled trial (RCT), the GENE-YD Study, will evaluate the feasibility for a large-scale RCT assessing the effect of PGx-guided antidepressant prescription vs treatment as usual in youth with major depressive disorder (MDD).
Eighty young people between 16 and 24 years of age and in the early stages of pharmacotherapy treatment for MDD will be recruited. Following initial screening, participants will be randomised on a 1:1 ratio to either the intervention or control study group. Participants in the intervention condition will have their treatment tailored based on their PGx profile. Participants randomised into the control group will have their prescription based on current best practice recommendations, or treatment as usual. Individuals will be assessed at drug prescription baseline and again 6 and 12 weeks following drug prescription. The primary outcome of the study will be to evaluate the feasibility and acceptability of the GENE-YD protocol. Specifically, this study will explore participation recruitment strategies and attrition to the study protocols to guide the recruitment processes of a large-scale RCT, along with participating satisfaction in overall study protocols. Secondary outcomes will inform the utility and variability of specific measures (eg, depression rating scales, quality of life measures and medication adherence scales) that may be scaled up for use in a future full-scale trial.
Ethics approval was granted by the Department of Health, Western Australia’s Human Research Ethics Committee (RGS0000006822) and recognised by the University of Western Australia’s Human Research Ethics Committee (2024/ET000685). All participants will be required to provide written informed consent. Results will be published in international peer-reviewed journals.
ACTRN12624000760572.
The incidence of anal carcinoma is increasing, with the current gold standard treatment being chemoradiotherapy. There is currently a wide range in the radiotherapy dose used internationally which may lead to overtreatment of early-stage disease and potential undertreatment of locally advanced disease.
PLATO is an integrated umbrella trial protocol which consists of three trials focused on assessing risk-adapted use of adjuvant low-dose chemoradiotherapy in anal margin tumours (ACT3), reduced-dose chemoradiotherapy in early anal carcinoma (ACT4) and dose-escalated chemoradiotherapy in locally advanced anal carcinoma (ACT5), given with standard concurrent chemotherapy.
The primary endpoints of PLATO are locoregional failure (LRF)-free rate for ACT3 and ACT4 and LRF-free survival for ACT5. Secondary objectives include acute and late toxicities, colostomy-free survival and patient-reported outcome measures. ACT3 will recruit 90 participants: participants with removed anal tumours with margins ≤1 mm will receive lower dose chemoradiotherapy, while participants with anal tumours with margins >1 mm will be observed. ACT4 will recruit 162 participants, randomised on a 1:2 basis to receive either standard-dose intensity modulated radiotherapy (IMRT) in combination with chemotherapy or reduced-dose IMRT in combination with chemotherapy. ACT5 will recruit 459 participants, randomised on a 1:1:1 basis to receive either standard-dose IMRT in combination with chemotherapy, or one of two increased-dose experimental arms of IMRT with synchronous integrated boost in combination with chemotherapy.
This study has been approved by Yorkshire & The Humber – Bradford Leeds Research Ethics Committee (ref: 16/YH/0157, IRAS: 204585), July 2016. Results will be disseminated via national and international conferences, peer-reviewed journal articles and social media. A plain English report will be shared with the study participants, patients’ organisations and media.
A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.
This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).
The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.
In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.
The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.
In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.
TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.
Assess the magnitude of adverse pregnancy outcomes and associated factors among mothers who had operative vaginal delivery in Amhara Region Comprehensive Specialized Hospitals, 2024.
A cross-sectional study was conducted from 1 November 2024 to 20 February 2025.
Seven comprehensive specialised hospitals were included in the study.
The study was employed on 389 mothers who had operative vaginal delivery.
Systematic sampling was used. Data were collected via questionnaires, chart reviews and observation. Data were entered into Epi Data V.4.6 and analysed using V.25 statistical package of social sciences. Variables with p
Adverse pregnancy outcomes of operative vaginal delivery.
Adverse pregnancy outcomes of operative vaginal delivery were 42.2%. Among them, 46 (11.8%) had only maternal complications, 55 (14.1%) had only neonatal complications and 63 (16.2%) had both maternal and neonatal complications. Perineal tear 29 (7.5%) and episiotomy extension 31 (8%) were the most common maternal complications, while caput succedaneum 45 (11.6%) was the most neonatal complication. The most common indication of operative vaginal delivery was prolonged second stage 203 (52.2%). Vacuum-assisted delivery (AOR 0.53; 95% CI 0.29 to 0.96), two tractions (AOR 2.19; 95% CI 1.23 to 3.90), birth weight less than 2.5 kg (AOR 1.85; 95% CI 1.21 to 2.83) and mid fetal station (AOR 2.9; 95% CI 1.49 to 5.64) were significantly associated with adverse pregnancy outcomes.
Adverse pregnancy outcomes following operative vaginal delivery were high. Type of instrumental vaginal delivery, number of tractions, fetal birth weight and fetal station were significantly increased risks. Therefore, operators should minimise traction attempts during operative vaginal delivery to reduce adverse outcomes.
To understand experiences of stigma and discrimination among adults who are homeless across multiple care and support system contexts.
Cross-sectional survey embedded within an ethnographic case study.
South London, UK, 2024.
Convenience sample of 74 people experiencing homelessness, aged over 18 years.
Participants most commonly reported unfair treatment in public settings (85%), legal settings (72%), housing and homelessness services (68%) and health settings (65%). These experiences were attributed to a range of factors and identities, with homelessness the most commonly cited; people commonly linked unfair experiences to multiple identities. People with more comorbidities reported experiencing unfair treatment across more system settings, including and beyond health systems.
Unfair treatment was reported across multiple care and support systems with greater ill-health associated with more unfair treatment. Future larger-scale surveys should measure the extent of stigma and discrimination across the population.
Ovarian cancer remains a significant clinical challenge due to its aggressive nature and high mortality rate. Tumour-infiltrating lymphocytes (TILs) play a critical role in the tumour microenvironment, influencing treatment response and patient survival across various cancer types, including ovarian cancer. A systematic review is warranted to consolidate evidence on TILs as prognostic biomarkers in ovarian cancer, with the goals of integrating them into clinical practice to enhance patient outcomes. This study aims to assess the prognostic significance of TILs in ovarian cancer.
A comprehensive literature search will be conducted across multiple databases, including PubMed, Embase, Web of Science, Scopus, Cochrane Library, CINAHL, ScienceDirect and LILACS. No restrictions regarding publication date or language will be applied. Original studies evaluating the role of TILs in women with ovarian cancer will be considered for inclusion. Two independent authors will screen titles and abstracts, and any discrepancies will be resolved through discussion with a third author. The risk of bias in included studies will be assessed using the Quality in Prognosis Studies (QUIPS) tool. Data synthesis will be performed using R software (V.4.3.1).
This study reviews the published data; thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal.
CRD42024543955.