To examine how menstruation, contraceptive use and gender-based violence intersect to shape the sexual and reproductive health and autonomy of girls and young women in Kenya.

Qualitative study exploring girls and young women’s experiences with contraceptive use and menstrual management, using in-depth interviews and focus group discussions analysed through a reflexive thematic approach.

Four county-run family planning clinics in Uasin Gishu County, Kenya.

77 girls and young women aged 15–19 years (via 35 in-depth interviews and 7 focus group discussions) and 27 family planning clinic providers (via 5 focus group discussions).

Interviewees’ contributions suggest that covert contraceptive use, when discovered through menstrual monitoring, provoked intimate partner violence. Heavy menstrual bleeding, whether related to contraceptive use or not, was viewed as a sexual restriction and also fuelled intimate partner violence. Furthermore, the inability to afford sanitary pads, combined with the stigma surrounding menstruation, drove some girls and young women into exploitative sexual relationships, often resulting in unwanted or unintended pregnancies.

Menstrual bleeding and contraceptive use, both independently and in combination, affect girls and young women’s reproductive autonomy and overall health and well-being, particularly in relation to gender-based violence. Improving menstrual hygiene management, challenging the stigma and harmful norms tied to menstruation and contraception and ensuring safe contraceptive use are integral to improving sexual and reproductive health and autonomy and are requisite for preventing and eradicating gender-based violence.

The effectiveness of humanitarian health and nutrition programmes in Somalia is critically dependent on seamless collaboration and coordination among a diverse array of actors. While existing literature acknowledges broad challenges to coordination such as insecurity, resource competition and fragmentation, a significant gap remains in understanding how these barriers and their corresponding enablers actively manifest in the daily operations and decision-making processes of frontline practitioners.

This study aims to provide a systematic, in-depth exploration of the barriers and enablers influencing collaboration and coordination mechanisms from the perspective of those directly involved in the response.

A qualitative study was conducted using semi-structured, in-depth interviews. Data were analysed using a deductive thematic approach guided by the Consolidated Framework for Implementation Research.

The study was conducted across the entire territory of Somalia, encompassing its five member states, the capital city Mogadishu, and the self-declared independent state of Somaliland.

A total of 26 participants, including executive directors, health and nutrition programme managers, coordinators from international and national non-governmental organisations (NGOs), government officials and community members, were interviewed.

Key barriers included poor adaptability and high complexity related to collaborative initiatives (intervention characteristics); armed conflicts, climatic shocks, deeply ingrained sociocultural practices and restrictive government policies (outer setting); inadequate information technology infrastructure and hierarchical communication (inner setting); high staff turnover (individual characteristics). Key enablers included strong inter-agency partnerships (outer setting); supportive organisational culture (inner setting); competent and motivated staff (individual characteristics); and robust planning, engaging and evaluation processes (process).

The study highlights the complex contextual factors that impact the effectiveness of collaboration and coordination mechanisms among humanitarianorganisations operating in Somalia. Policymakers should unify governance, agencies prioritise localisation and donors allocate quotas to local NGOs to enhance aid delivery.

Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.

We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.

The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.

NCT05828823.

The main objective of the Health Survey of São Paulo or Inquérito de Saúde de São Paulo (ISA) in Portuguese, is to generate health indicators to support research and policy planning. The ISA-Physical Activity and Environment Longitudinal Study has the primary objective of examining built and social environmental determinants of leisure-time physical activity and active transportation.

The baseline (2014–2015) study included 4042 participants aged 12 years and older, men and women, living across the five regions of São Paulo city. Data were collected through household interviews. The second wave (2020–2021) used telephone interviews and included 1434 participants aged 18 or older, 58.6% female and representing 35% of the baseline sample. The third wave (2023–2024) included 1583 participants through household or telephone interviews, 58.6% of female and represented 39% of the original cohort.

The study has collected extensive individual-level data, including physical activity behaviours, health status and related behaviours, self-report of diseases and sociodemographic characteristics; built environment features such as public open spaces, transport infrastructure, schools and healthcare facilities, walkability index, sidewalks, traffic control and social environment features, such as crime occurrence and socioeconomic index. Analyses have identified changes in the built environment and their associations with physical activity and obesity. Infrastructure improvements, such as the increase of bike paths and outdoor gyms, have been more frequent in wealthier areas, reinforcing spatial inequalities. Increased availability of public open spaces has been associated with increased leisure-time walking. Obesity has shown a growing trend, particularly among specific sociodemographic groups, while physical activity has demonstrated protective effects against obesity. Cycling for transportation has remained stable over time, with disparities by gender and physical activity status.

The plan is to conduct the fourth wave in 2026 and 2027 and the fifth wave in 2029 and 2030.

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

NCT04780971.

Type 2 diabetes (T2D) is a complex disease with a heterogeneous clinical presentation. Recently, five distinct clusters of T2D have been identified in the Emirati population of long-standing T2D with complications. This study aimed to validate these clusters in newly diagnosed T2D patients without any complications and determine whether severe and mild phenotypes are detectable early in the disease course.

Retrospective, cross-sectional, non-interventional study.

Primary healthcare centres in Dubai, UAE.

A total of 451 adults, including both Emiratis and expatriates, diagnosed with T2D in the last 5 years and without T2D-related complications at the time of visit, were enrolled. Patients with complications, incomplete clinical data or higher duration of T2D were excluded from the study.

Identification of distinct T2D clusters using machine learning-based clustering analysis. Five clinical variables: age at diagnosis, body mass index, glycated haemoglobin, fasting serum insulin and fasting blood glucose served as predictors. Overlap between clusters was assessed via the Silhouette Index and Bayesian probability.

Five clusters were identified, replicating prior findings: severe insulin-resistant diabetes (SIRD), severe insulin-deficient diabetes (SIDD), mild age-related diabetes (MARD), mild obesity-related diabetes (MOD) and mild early-onset diabetes (MEOD). As confirmed by a Silhouette Index and Bayesian probability of 1, 55.43% of the patients showed cluster-exclusiveness, while 44.56% of the cohort showed overlap between clusters. The highest overlap was recorded for mild forms of T2D in the order MOD>MARD>MEOD.

The study confirms that both severe and mild T2D phenotypes are present in newly diagnosed, complication-free patients, supporting the applicability of cluster-based classification early in disease. These results highlight the potential for personalised treatment strategies to optimise management and prevent complications. Future studies should investigate longitudinal outcomes and therapeutic response across clusters.

Internalised racism (IR) is broadly defined as the acceptance of negative racial stereotypes, beliefs and attitudes about one’s own racial or ethnic group. IR is increasingly recognised as a critical component and consequence of racial stress and trauma. Although IR has been linked to a variety of adverse mental and physical health outcomes, the phenomenon remains under-represented in intervention research. This scoping review addresses this gap by systematically mapping the range of interventions and intervention components that explicitly target IR among racially or ethnically minoritised communities and their health-related outcomes. This protocol paper will describe the process of the scoping review.

This review will follow methodology from the Joanna Briggs Institute and report using the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) checklist. Using identified controlled vocabulary and keywords, searches will be undertaken using the following databases: MEDLINE, PsycInfo, Embase and Web of Science. This review will include studies describing any intervention or intervention component designed to reduce IR that is conducted with racially or ethnically minoritised populations in any context or setting. No date limit will be applied, and the study must be available in English. Conceptual or opinion pieces without a clear intervention framework will be excluded. Two reviewers will independently screen and select sources and extract data on intervention characteristics, theoretical underpinnings, outcomes and implementation details. Descriptive statistics will summarise study characteristics and outcomes, while a narrative synthesis will explore how interventions conceptualise and address IR. The findings will map existing approaches, highlight research gaps and inform future clinical practice and intervention development.

As this review uses published and publicly available data, no ethical approval is required. The findings will be disseminated through a peer-reviewed publication, conference presentations and briefs to stakeholder networks.

This protocol is registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/4VDBX).

Functional constipation (FC) is prevalent among children and often persists despite standard pharmacological treatment with oral laxatives. Many parents turn to complementary therapies, including acupuncture, which has been shown to relieve symptoms in adults with FC. However, studies in children with FC are scarce and have important limitations. This study will evaluate the feasibility, safety and potential efficacy of acupuncture for children with FC.

Prospective, non-randomised, open-label pilot study in children with FC (6–18 years). Participants will undergo eight acupuncture sessions over 10 weeks. Concurrent pharmacological treatment with polyethylene glycol (≥0.2 g/kg/day) will continue as initiated prior to enrolment. The primary endpoint is feasibility, defined by an attrition rate of ≥70%. Secondary feasibility endpoints include consent rate, patient/parent satisfaction and personnel requirements. Safety will be assessed by systematic monitoring of adverse events. Efficacy endpoints include treatment success, defined as no longer meeting the Rome IV criteria for FC at the end of the intervention period, as well as defecation frequency, stool consistency, painful defecation, faecal incontinence frequency, abdominal pain, medication use and quality of life, based on a previously published core outcome set.

Ethical approval was provided by the Medical Ethics Committee of Amsterdam UMC (Netherlands; NL87083.018.24). Results will be published in peer-reviewed journals and presented to scientific and consumer audiences.

NCT06836362 and NL-OMON57236.

In Tanzania, acute myocardial infarction (AMI) is underdiagnosed, and uptake of evidence-based care is suboptimal. Using an implementation science approach, an intervention was developed to address local barriers to care: the Multicomponent Intervention for Improving Myocardial Infarction Care in Tanzania (MIMIC).

This sequential cohort design trial was conducted in a single northern Tanzanian emergency department (ED). During the preintervention phase (February–August 2023) and the postintervention phase (September 2023–August 2024), adults presenting with chest pain and/or dyspnoea were prospectively enrolled and their ED care was observed. AMI was defined by the Fourth Universal Definition criteria. Telephone follow-ups were conducted to ascertain 30-day mortality. Pearson’s ² was used to compare care before and after MIMIC implementation.

A total of 275 participants were enrolled in the preintervention phase and 577 were enrolled in the postintervention phase. Following MIMIC implementation, significant increases were observed in ECG testing (89.4% of postintervention participants vs 55.3% preintervention, OR 6.82, 95% CI 4.79 to 9.79, p

The MIMIC intervention was associated with large increases in uptake of AMI testing, case identification and evidence-based treatment in a single Tanzanian ED. Multisite studies are needed to evaluate the effect of MIMIC on AMI care in diverse settings across Tanzania.

NCT04563546.

TransformUs is a multicomponent school-based programme that offers teachers professional learning and resources aligned with the Australian curriculum to promote physically active teaching and learning, a supportive environment and physical activity opportunities during recess and lunch. The programme was originally developed for students in mainstream primary schools and has been proven efficacious for increasing physical activity and reducing sedentary behaviour in children without disability. The programme has been adapted for delivery with students with disabilities in primary and secondary schools (TransformUs All Abilities). This project aims to determine the implementation at scale and effectiveness of the TransformUs All Abilities programme to increase physical activity among primary and secondary school children and adolescents with disability. This protocol describes the hybrid implementation-effectiveness trial that will be used for this evaluation.

This study employs a hybrid type II implementation-effectiveness trial to evaluate the TransformUs All Abilities programme, targeting all government and independent, primary and secondary schools in Victoria, as well as special and mainstream secondary schools in Queensland and South Australia (n=2173 eligible schools). The effectiveness trial will focus on a subgroup of government/independent special schools for students with mild to moderate intellectual disability in Victoria, involving up to three intervention and three waitlist control schools (n=61 eligible schools). In both trials, outcomes will be guided by the RE-AIM framework focusing on reach, adoption and implementation (implementation trial) and effectiveness (effectiveness trial), with data collected at baseline and 6 months. The effectiveness trial will focus on students’ device-measured physical activity and sedentary behaviour—primary outcomes—and sleep, physical literacy and cognitive functions—secondary outcomes. Teacher feedback on the programme’s adaptation and their experience with programme implementation will also be collected, alongside qualitative feedback from a subsample of students regarding engagement/enjoyment and suggestions for improvements. Implementation data will be analysed descriptively and using linear mixed models to test changes over time. Effectiveness outcomes will be analysed using linear mixed models to compare intervention and waitlist control, accounting for confounding and school/classroom clustering. Interview data will be thematically analysed.

Ethical approval for this trial was obtained from the Deakin University Human Research Ethics Committee (2021-368). Clearance to conduct research in schools was also obtained from the Education Departments of Victoria (2023-004726), Queensland (550/27/2592) and South Australia (2022-0020). Informed consent is required for participation in the study. School staff can enrol in the implementation trial via the TransformUs website, while the effectiveness trial requires organisational, staff, parental/carer consent and student assent. Results will be disseminated through academic publications, scientific conference presentations and summary reports to schools, parents and partner organisations.

ACTRN12622001082796; Universal Trial Number: U1111-1281-1103; ACTRN12622001050741: U1111-1280-8828.

Several antibiotic stewardship interventions have been proven effective and safe for reducing the high number of antibiotic prescriptions in late preterm and term neonates at risk of early-onset sepsis (EOS). For successful translation of EOS interventions to clinical practice, implementation strategies should be employed targeting stakeholders. The primary aim of this study is to assess the impact of implementing an antibiotic stewardship bundle, including the EOS calculator, procalcitonin-guided therapy and intravenous-to-oral switch therapy on antibiotic exposure for EOS in Dutch secondary hospitals. Secondary aims are to examine additional clinical outcomes and implementation outcomes.

We will conduct a multicentre, prospective implementation study with interrupted time series and before-after analyses at the paediatric or specialised neonatal departments of 11 Dutch secondary hospitals and their surrounding neonatal care networks. A multimodal implementation strategy, designed using Implementation Mapping, is employed to facilitate implementation. The study population is twofold: (1) neonates born at 34 weeks of gestation or later with suspected EOS that will receive intervention-related care and (2) paediatricians, paediatric residents, neonatal nurses, maternity nurses and parents who are the focus of the implementation strategies. The primary outcome is days of antibiotic therapy per 1000 live-born neonates, which will be evaluated using interrupted time series analysis as well as before-after comparison. Secondary clinical outcomes will be assessed by comparing clinical data from the 12 months pre-implementation and post implementation. Implementation outcomes are adoption, fidelity, feasibility and acceptability of the interventions and fidelity and appropriateness of the implementation strategies. Implementation outcomes will be assessed using both qualitative and quantitative methods, including surveys, individual interviews and focus group interviews. A mixed-methods approach will be used to integrate clinical and implementation outcomes.

The Medical Ethics Committee United (MEC-U) declared (reference: W24.132) that this study does not fall under the Dutch Medical Research Involving Human Subjects Act (WMO). Subsequently, ethical approval was granted by the Scientific Committee of the Franciscus Hospital (T110). The scientific committees of all participating sites adopted this decision and granted permission for local conduct of the study. As electronic health record data are sampled retrospectively and anonymously, a waiver of consent was given to collect these data. Informed consent will be obtained from participants completing surveys or taking part in interviews and focus group discussions. The findings will be disseminated through journal publications and conference presentations. Furthermore, practice and policy recommendations will be collaboratively developed with partner organisations.

NCT06845332.

Systematic reviews (SRs) on the management of temporomandibular disorders (TMDs) have predominantly focused on evaluating the effectiveness of various treatments, identifying those that provide the greatest benefits. However, the economic evaluation of these treatments has not been systematically explored. This SR aims to address this gap by evaluating the economic outcomes of the most common treatment modalities for TMDs, including cost-effectiveness, cost-utility, cost-benefit, cost-minimisation and the burden of illness.

This SR will be conducted using the following electronic databases Business Source Complete, CINAHL, EconLit (ProQuest), Embase (Ovid), MEDLINE (PubMed), MEDLINE (Ovid) and Scopus to identify studies evaluating the economic outcomes of treatments for TMDs. The eligibility criteria are as follows: (1) studies examining the costs and/or impact of treatments for TMDs and (2) articles published between 2000 and 2025. The primary outcomes of interest are the economic findings outlined earlier. Data extraction will include the following: author(s), year of publication, country, study objectives, study design, eligibility criteria, TMD diagnosis and screening, study groups, randomisation, blinding, sample size, number of participants invited, enrolled and completed, duration of treatment, follow-up, study duration, settings, assessment instruments, study outcomes, statistical analyses, results, limitations, strengths and funding sources. The quality of studies will be evaluated using the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist, with risk of bias assessed using the Cochrane Effective Practice and Organization of Care’s risk-of-bias tool; where applicable, the Outcome Reporting Bias in Trials will be used to detect reporting biases. A narrative synthesis and summary tables will outline study characteristics, economic outcomes and the overall quality of evidence. We will conduct qualitative secondary and sensitivity analyses.

This SR does not require an ethics approval. The results will be disseminated through international and national conferences and peer-reviewed journals.

CRD42024613553.

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.

Deep vein thrombosis (DVT) in critically ill patients is often undetected. However, it is unclear whether ultrasound surveillance for early detection of DVT in high-risk medical-surgical intensive care unit (ICU) patients improves patients’ outcomes. The DETECT trial (Diagnosing deep-vein thrombosis early in critically ill patients) evaluates the effect of twice-weekly bilateral lower limb ultrasound compared to usual care on 90-day mortality of critically ill adult patients admitted to medical, surgical and trauma ICUs.

The DETECT trial is an international, parallel-group, open-label, randomised trial, which will recruit 1800 critically ill adults from over 14 hospitals in Saudi Arabia and Kuwait. Eligible patients will be allocated to twice-weekly bilateral lower limb ultrasound or usual care. The primary outcome is 90-day mortality. Secondary outcomes include lower limb proximal DVT, pulmonary embolism and clinically important bleeding. The first patient was enrolled on 21 March 2023. As of 8 April 2025, 711 patients have been enrolled from 14 centres in Saudi Arabia and Kuwait. The first interim analysis was conducted on 14 May 2025. We expect to complete recruitment by December 2026.

Institutional review boards (IRBs) of each participating institution approved the study. We plan to publish the results in peer-reviewed journals and present the findings at international critical care conferences.

Clinicaltrials.gov: NCT05112705, registered on 9-11-2021.

Health systems must guarantee access to quality, safe and effective medicines. Essential medicine lists (EMLs) are crucial prioritisation tools to inform coverage decisions and steward limited health resources under the context of universal healthcare. This study aims to develop a consolidated framework for prioritising the assessment of health technologies to review and update EML for treating diseases or health problems managed in primary healthcare (PHC).

A mixed-methods approach was designed to validate the framework. An initial scoping systematic review will be conducted to search for studies that describe criteria used to prioritise the assessment of health technologies for PHC. The relevant studies will be examined using the Joanna Briggs Institute methodological framework for scoping review studies. A comprehensive search was conducted in the following sources: PubMed, Embase, Cochrane Library, Virtual Health Library (LILACS, WHO IRIS, IBECS, PAHO-IRIS, PAHO, LIS, BRISA), Health System Evidence, Global Healths, Health Evidence and Epistemonikos from the inception until February 2025. Two review authors will screen and extract data independently. The extracted data will be qualitatively analysed and presented in a diagrammatic or tabular form, alongside a narrative summary, in line with Preferred Reporting Items for Systematic Reviews and Meta-Analysis: Extension for Scoping Reviews reporting guidelines. An iterative process online using the Delphi hybrid with stakeholders through predetermined consensus thresholds, a combination of a four-point Likert scale and open-ended questions will be conducted to select and validate the criteria identified in the scoping review.

We will provide a consolidated framework to inform decision-makers for prioritising the assessment of health technologies for the national EML for PHC. This is an important step in using evidence to inform public health policies. We plan to share findings through a variety of means, including publications in peer-reviewed journals, presentations at national conferences, invited workshops and webinars, email discussion lists affiliated with our institutions and professional associations, and academic social media.

There is an urgent need to better understand how information from circulating tumour DNA (ctDNA) can be integrated into routine care for patients with advanced solid cancer.

The implementation of liquid biopsies in routine care of patients with advanced solid cancer trial (LIQPLAT) is a single-centre, single-arm trial investigating the implementation of ctDNA in the routine care of patients with advanced solid cancer. We present a mixed-methods process evaluation embedded in the LIQPLAT trial, following Medical Research Council guidance and the Reach, Effectiveness, Adoption, Implementation, Maintenance framework. We show a logic model, which details the causal chain and related assumptions from recruiting patients into the trial to the goal of improving quality of life and survival. Data collection is longitudinal and includes: semistructured interviews with healthcare professionals (pathologists, biologists, oncologists; planned n=20) and patients (planned n=15) to identify implementation barriers and facilitators; recordings of molecular tumour board meetings to analyse clinical decision-making; the 23-item Normalisation MeAsure Development survey for healthcare professionals (planned n=20) at four time points. Quantitative data from hospital records will be used to assess implementation outcomes like patient acceptance rates and ctDNA workflow success. Qualitative data will undergo thematic and content analysis, and quantitative data will be analysed using a Bayesian framework.

The LIQPLAT trial was approved by the regional ethics committee of Northwestern and Central Switzerland (BASEC 2024-00358). The qualitative aspects of the process evaluation were exempted from ethics review according to the Swiss Human Research Act. We follow guidelines for data security, confidentiality and information governance. Results will be submitted for publication in peer-reviewed journals and discussed at conferences.

NCT06367751, SNCTP000005844.

To assess and compare the patterns of smoked and smokeless tobacco use in India and to identify demographic and socioeconomic factors associated with tobacco use through secondary data analysis of National Family Health Survey (NFHS-4) (2015–2016) and (NFHS-5) (2019–2021) datasets.

A comparative weighted sample secondary data analysis was conducted using individual sampling weights in SPSS V.29.0, encompassing all 29 states and 7 union territories of India.

A total of 8 11 808 individuals from NFHS-4 (699 686 women aged 15–49 years and 1 12 122 men aged 15–54 years) and 825 954 individuals from NFHS-5 (724 115 women aged 15–49 years and 101 839 men aged 15–54 years), were included in the analysis.

Changes in smoked and smokeless tobacco use between the two survey rounds, stratified by age, gender, residency, socioeconomic status, and education.

Prevalence estimates were summarised as percentages with 95% CIs. Differences between NFHS-4 and NFHS-5 were assessed using the Z test for proportions, with significance at p

Bidi and cigarette use declined modestly among men, while gutkha/paan masala use showed the sharpest reduction among women. The overall prevalence of tobacco use declined from 45.5% to 40.8% among men (–4.7 points) and from 6.8% to 4.0% among women (–2.8 points). Bidi use showed the steepest reduction in the study. Among men, it was (14.9%–14.2%), while cigarette use declined modestly (13.7%–13.3%). Rare smoked forms such as pipe, hookah and cigar remained uncommon. Among women, the prevalence of smoked tobacco was negligible, whereas smokeless forms were more frequent but that too showed decline, with the largest reduction observed in gutkha/paan masala (2.2%–1.4%).

Tobacco use in India declined modestly between NFHS-4 and NFHS-5, with greater reductions in smoked than in smokeless forms. Nonetheless, smokeless tobacco remains more prevalent among women, and significant disparities persist across gender, rural–urban residence and socioeconomic strata.

Cardiovascular autonomic neuropathy (CAN) is a serious, untreatable complication of diabetes that contributes to excess cardiovascular mortality and morbidity. CAN is associated with increased fibrosis and inflammation, possibly driven by increased sympathetic activity and overactive mineralocorticoid receptors (MRs). These may represent a potential therapeutic target. MR antagonists (MRAs) improve autonomic function in non-diabetic diseases, and finerenone, a non-steroidal MRA, has demonstrated promising results in managing diabetic kidney disease and cardiovascular complications, suggesting its potential as a novel therapy for early-stage CAN. This trial aims to evaluate whether daily administration of finerenone can modify the disease progression of early-stage CAN.

This trial is a two-centre, double-blind, parallel-group, 1:1 randomised, placebo-controlled study evaluating the effect of 78 weeks of intervention with finerenone or placebo on early-stage CAN in 100 individuals with type 2 diabetes in Denmark. The primary endpoint is the between-group difference in the expiration:inspiration ratio of the cardiovascular autonomic reflex tests (CARTs). Secondary endpoints are the between-group differences in the remaining CARTs, heart rate variability measures and fibrosis markers. Treatment effects on other forms of neuropathy and related pathological mechanisms will be explored.

The study complies with the Declaration of Helsinki and the International Counsil for Harmonisation good clinical practice guidelines, with ethics approval obtained from the Danish Medical Research Ethics Committee. All participants will provide written informed consent. Due to the risk of hyperkalaemia associated with finerenone, safety will be closely monitored throughout the study. Findings will be disseminated through peer-reviewed publications, conference presentations and clinical trial registries. A lay summary will be provided to participants on study completion.

ClinicalTrials.gov: NCT06906081; registration date: 25 March 2025. Clinical Trials Information System: EUCT no. 2024-516597-30-00; registration date: 3 September 2024.

Safety culture is essential to improving healthcare quality. Paediatric emergency departments are high-risk environments where evaluating safety culture helps identify areas for improvement. This study aimed to analyse the safety culture among professionals in paediatric emergency departments, according to job category and gender.

Multicentre cross-sectional study using the Hospital Survey on Patient Safety Culture (HSOPSC).

19 paediatric emergency departments, covering all levels of care.

1843 healthcare professionals were invited to participate; the response rate was 63.8%, and 33% of respondents were nurses. All clinical staff in paediatric emergency departments were eligible. Professionals from other specialties and non-clinical staff were excluded.

The primary outcome was the assessment of patient safety culture using the HSOPSC, following the methodology of the Agency for Healthcare Research and Quality. Secondary outcomes included comparisons by job category and gender, and an exploratory cluster analysis.

In terms of patient safety, the main strength was ‘teamwork within units’ (83.65% positive), while the main weakness was ‘staffing’ (61.92% negative). Patient safety was rated with an average score of 7.21 by the participants. Paediatricians rated ‘manager expectations’ significantly higher than nurses (p=0.023) and residents (p=0.026). Paediatricians gave more positive responses overall, with significant differences in ‘communication openness’, ‘feedback and communication’, ‘non-punitive response’ and ‘teamwork across units’, though none were classified as strengths. Cluster analysis showed that the group with more paediatricians identified more strengths and no weaknesses, while the group with more nurses and nursing assistants showed no strengths and significant weaknesses in ‘overall safety perception’, ‘staffing’ and ‘management support’.

Safety culture in paediatric emergency departments is acceptable, but still far from excellent, indicating ample room for improvement. Differences between professional categories, especially between paediatricians and nurses, highlight the need for targeted safety strategies and leadership involvement.

Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis are sexually transmitted pathogens that are highly prevalent in developing countries and are strongly associated with pregnancy complications. In Chad, screening for these sexually transmitted infections (STIs) in pregnant women is based solely on patient-reported symptoms, even though these infections are frequently asymptomatic. This study aims to determine the prevalence of M. genitalium, C. trachomatis, N. gonorrhoeae and T. vaginalis infections, as well as their associated risk factors.

In this cross-sectional study, we recruited pregnant women attending antenatal clinics at seven hospitals in N’Djamena. Endocervical swabs were collected, and DNA was extracted. Infections were diagnosed using PCR. Risk factors were identified using a structured questionnaire, and associations were assessed using logistic regression.

A total of 525 pregnant women were enrolled, of whom 78.5% resided in urban areas, with a mean age of 25.16±5.54 years. Overall, 23.99% of the study population were diagnosed with at least one STI. The individual prevalence of M. genitalium, N. gonorrhoeae, C. trachomatis and T. vaginalis infections was 13.33%, 5.14%, 0.95% and 4.57%, respectively. Coinfections were low, with M. genitalium-T. vaginalis at 0.95%, M. genitalium-N. gonorrhoeae at 0.38% and other combinations at 0.19% each. Women residing in rural areas had nearly two times the odds of M. genitalium infection compared with urban residents (OR=1.98), indicating a higher risk. AgeM. genitalium infection (OR=1.71) were also associated with significantly increased risk.

This study demonstrates a high prevalence of STIs among pregnant women in Chad, underscoring the need for systematic screening rather than solely relying on syndromic management.