There are substantial barriers to initiate advance care planning (ACP) for persons with chronic-progressive disease in primary care settings. Some challenges may be disease-specific, such as communicating in case of cognitive impairment. This study assessed and compared the initiation of ACP in primary care with persons with dementia, Parkinson’s disease, cancer, organ failure and stroke.

Longitudinal study linking data from a database of Dutch general practices’ electronic health records with national administrative databases managed by Statistics Netherlands.

Data from general practice records of 199 034 community-dwelling persons with chronic-progressive disease diagnosed between 2008 and 2016.

Incidence rate ratio (IRR) of recorded ACP planning conversations per 1000 person-years in persons with a diagnosis of dementia, Parkinson’s disease, organ failure, cancer or stroke, compared with persons without the particular diagnosis. Poisson regression and competing risk analysis were performed, adjusted for age, gender, migration background, living situation, frailty index and income, also for disease subsamples.

In adjusted analyses, the rate of first ACP conversation for persons with organ failure was the lowest (IRR 0.70 (95% CI 0.68 to 0.73)). Persons with cancer had the highest rate (IRR 1.75 (95% CI 1.68 to 1.83)). Within the subsample of persons with organ failure, the subsample of persons with dementia and the subsample of stroke, a comorbid diagnosis of cancer increased the probability of ACP. Further, for those with organ failure or cancer, comorbid dementia decreased the probability of ACP.

Considering the complexity of initiating ACP for persons with organ failure or dementia, general practitioners should prioritise offering it to them and their family caregivers. Policy initiatives should stimulate the implementation of ACP for people with chronic-progressive disease.

The effect of prophylactic clipping for colorectal cold snare polypectomy (CSP) on delayed bleeding (DB) in patients with antithrombotic drugs remains unverified. The aim of the PERCOLD study is to demonstrate the non-inferiority of DB rates in cases without prophylactic clips compared with cases with prophylactic clips in patients taking antithrombotic drugs for colorectal CSP through randomised controlled trial (RCT).

This study is a multicentre prospective parallel-group RCT phase 3 trial that is being conducted at 14 institutions in Japan at the time of writing this manuscript. After providing consent, patients will undergo screening and assessment for study enrolment eligibility. Patients taking antithrombotic drugs (aged 20 years or older at the time of consent and who have agreed to participate in this study) will be selected if they have a preoperative suspected adenoma (including sessile serrated lesion) with an endoscopic diameter of

The trial protocol has been approved by the Chiba University Certified Clinical Research Reviewer Board (CRB3180015), which serves as the central ethics committee, and registered with Japan Registry of Clinical Trials. The current protocol V.1.7, dated 4 October 2024. Written informed consent for participation in the study will be obtained from all participating patients. All participating institutions have formally agreed to conduct the study in accordance with this central approval, and local site permissions were obtained as required by each institution. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences.

Japan Registry of Clinical Trials (jRCT1032230086).

To explore health professionals’ perspectives on the barriers and enablers of healthcare access for older adults in Cambodia.

A qualitative study based on semi-structured interviews conducted in Khmer, recorded, transcribed, translated into English and analysed using an abductive thematic analysis approach.

Phnom Penh, Cambodia.

A purposive sample of 11 health professionals serving in diverse roles and sectors participated in the study.

Three key barriers emerged: (1) institutional barriers, (2) patient-specific access barriers and (3) communication barriers. However, four key enablers were also identified: (1) supportive healthcare environment, (2) reaching out to improve access to health services, (3) peer and community engagement and (4) government direct support to access healthcare. Despite previous policy efforts, gaps in the implementation of healthcare services for older adults persist across all health facilities. Health professionals identified that improving healthcare access for older adults in Cambodia requires a multifaceted strategy involving proactive outreach, health promotion, financial assistance and stronger community and family support.

Effective policy implementation requires collaboration among stakeholders and the active involvement of older adults in programme design to enhance dignity and well-being in Cambodia’s ageing population.

Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m²) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

NCT06457750.

Patients’ sense of gain experience (PSGE) is the comprehensive feeling throughout the treatment process, which is a critical benchmark for evaluating comprehensive medical and health system reform in China. This study aims to assess the current status of PSGE in public hospitals and identify important associated factors, providing evidence-based recommendations for improving healthcare services.

This was a cross-sectional study conducted from October to November 2023.

A total of 14 public hospitals in Foshan, Guangdong Province, China.

There were 3223 responses, including 1592 from outpatients and 1631 from inpatients.

PSGE was assessed across five domains: time accessibility, service accessibility, cost affordability, patient participation and efficacy predictability. Participants were also asked to provide an overall rating of the PSGE.

The overall score for PSGE was 4.47±0.53 (mean±SD), with service accessibility receiving the highest score (4.68±0.50) and affordability the lowest (4.17±0.86). Secondary hospitals scored an overall PSGE of 4.55±0.50, while tertiary hospitals scored 4.42±0.54. Key factors associated with PSGE were overall satisfaction (β=0.164, p

This study found that patients reported a positive PSGE with service accessibility but reported a less positive PSGE with cost affordability. A tier-based disparity was evident, with secondary hospitals outperforming tertiary hospitals in overall PSGE outcome. Stronger PSGE was positively associated with higher scores in overall satisfaction, treatment satisfaction, satisfaction with medical reforms, patient loyalty and hospital reputation. Demographic and institutional factors, such as hospital level, patient type and household registration, were associated with the PSGE. Efforts can be focused on enhancing clinicians’ willingness and competence in discussing treatment costs during clinical encounters. It is essential for policymakers to address disparities in healthcare experiences among patient groups across hospital tiers to advance equitable, patient-centred systems.

Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

Care pathways are crucial for patients with mental health disorders and should be designed to support integrated rehabilitation while reducing the burden of these disorders. The contemporary shift toward an outpatient follow-up model of care presents an opportunity to improve mental health care beyond the stagnation in advancements in pharmacological treatments. Various pharmacist-led interventions exist and can serve as levers to address ongoing challenges in mental health care pathways: they could help manage difficult transitions, ensure continuity between inpatient and outpatient care, and reduce high rehospitalisation rates. However, the contexts in which these solutions benefit patients and improve care outcomes remain unclear. Thus, the primary objective of this study will be to identify how pharmaceutical solutions contribute to improving mental health care pathways, what works, for whom and in what context. The secondary objective will be to identify the key outcomes currently used to evaluate the impact of pharmaceutical solutions on care pathways.

A systematic realist review will be conducted, following 5 iterative steps to synthesise heterogeneous evidence: (1) Scope definition with a general review of the literature and experts’ discussions, (2) Initial programme theory development based on the preliminary searches, (3) Systematic review for evidence, to refine and test initial programme theory across PubMed, Embase and Web Of Science, (4) Data extraction, including context-mechanism-outcome configurations, and evidence appraisal and (5) Data analysis, synthesis and refined programme theory construction with the realist logic. This process will involve consensus among expert researchers, incorporating insights from individuals with lived experience.

The final programme theory modelling will result in a new framework for pharmaceutical solutions applied in diverse mental health contexts. The findings of this systematic realist review could serve as a guide for implementing pharmaceutical solutions across healthcare settings, ensuring that interventions are evidence-based, contextually relevant and grounded in real-world needs.

As this realist review will collect previously published data and will not involve human or animal participants, no ethical approval is required. Since this manuscript is a review protocol, no datasets were generated or analysed. All data extraction forms will be made available as part of the publication of the realist review.

Systematic review registration PROSPERO 2025 CRD420251011954.

Dates of the study: September 2025 to September 2026.

This study assesses the knowledge, attitudes and practices (KAP) of licensed dietitians in Saudi Arabia regarding artificial intelligence (AI) in dietetics and identifies sociodemographic factors associated with higher AI knowledge and use, along with perceived benefits and concerns.

Descriptive, cross-sectional study with an analytical component.

Conducted online across Saudi Arabia, targeting licensed dietitians in public and private healthcare sectors.

161 licensed dietitians completed the study. Inclusion criteria consisted of current registration and active practice in either clinical or community settings.

The primary outcomes were levels of AI-related KAPs assessed via a structured questionnaire. The secondary outcomes examined associations between KAP and demographic factors.

Among participants, 62.7% reported using AI in practice; 72.3% found it easy to use and 63.4% believed it improved their work. Higher knowledge was significantly linked to being aged 24–40, female, married, Saudi, a university graduate and employed (p

Dietitians in Saudi Arabia generally recognise AI’s value in dietetic practice, particularly in programme development and personalisation. However, concerns about diminished human interaction remain. Structured training and further longitudinal research are recommended to support balanced AI integration.

Global urbanisation is intensifying alongside steadily expanding older adult populations. The resulting air pollution profoundly impacts human health by exacerbating diseases, particularly among vulnerable elderly groups. Evidence demonstrates that green spaces mitigate air pollutant effects on health. Recent studies indicate green space exposure benefits older adults physiologically, psychologically and socially. However, existing systematic reviews have not synthesised the health impacts on this demographic. Consequently, this protocol outlines a systematic review and meta-analysis to evaluate how green space exposure affects health outcomes in older adults.

This systematic review protocol adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols guidelines. A comprehensive search strategy will be applied across: (1) electronic databases (eg, PubMed, Web of Science), (2) the National Institute for Health and Care Excellence and (3) the Guidelines International Network database. Grey literature will be searched via GreyNet International, covering records from each database’s inception to November 2024. The study will analyse associations between green space exposure and health outcomes in older adults. Two researchers will independently screen literature, extract data and assess risk of bias. Heterogeneity will be assessed with a focus on study design, exposure variables and outcome measures. If sufficient homogeneity exists, a meta-analysis will be undertaken; otherwise, a narrative synthesis will be performed.

This study requires no ethics approval because it uses publicly available data from published studies. The completed review will be published in a peer-reviewed journal and disseminated at relevant conferences.

PROSPERO (CRD42024619700).

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Documenting evidence on global health strategies and programmes that provide safeguards for vulnerable populations and strengthen overall pandemic preparedness is essential. This study aimed to identify factors associated with adherence to COVID-19 mitigation measures, COVID-19-related symptoms and testing, as well as pandemic-related income loss among internally displaced persons (IDPs) in urban and remote areas of Burkina Faso, Niger and Mali.

This cross-sectional study used fixed-site respondent-driven sampling (RDS).

Primary care settings across six urban and remote locations in Burkina Faso, Mali and Niger.

4144 internally displaced adults, who had been forced from their homes within 5 years of the survey, participated in the study. The survey was conducted between August and October 2021 in two selected locations in three countries: Kaya (n=700) and Ouahigouya (n=715) in Burkina Faso; Bamako (n=707) and Ménaka (n=700) in Mali; and Niamey (n=733), and Diffa (n=589) in Niger. Participants were included if they were born in the study countries, displaced due to conflict, violence or disaster, aged 18 years or older, and living or working in the study site for at least 1 month.

The primary outcomes measured were adherence to COVID-19 mitigation measures, presence of COVID-19 symptoms, COVID-19 testing and vaccination rates and pandemic-related income loss.

Among 4144 IDPs surveyed across 6 sites in Burkina Faso, Mali and Niger, over half (52%) reported experiencing at least one COVID-19 symptom in the preceding 2 weeks. However, 8% had ever been tested for COVID-19, and fewer than 5% had received a vaccine in all sites except Diffa, where 54% reported vaccination. While willingness to be vaccinated was high (ranging from 56.6% in Bamako to 89.5% in Niamey), access remained limited. Compliance with public health measures varied; for example, 41.7% of IDPs were able to maintain physical distance from non-household members, and just 60.2% reported wearing a mask. Chronic health conditions were consistently associated with higher odds of COVID-19 symptoms (Ménaka OR: 14.65; 95% CI: 7.36 to 29.17). Economic vulnerability was widespread, with more than half of IDPs in Bamako (58.1%) and Niamey (66.4%) reporting income loss due to the pandemic, and average monthly income declining by over 50% in most sites. IDPs in urban areas generally reported greater exposure to COVID-19 risk factors, while those in remote settings reported lower adherence and poorer access to basic preventive measures.

This is the first known RDS study to explore the impact of the COVID-19 pandemic on IDPs. Findings suggest that IDPs in urban areas may face heightened risks of exposure and infection, underscoring the need to prioritise them in public health efforts. Low testing and vaccination rates and significant income loss call for advocacy and economic relief to address these vulnerabilities. Future pandemic responses should integrate health interventions with targeted support, especially mitigating income loss to bolster IDPs’ resilience.

To evaluate the effectiveness of levosimendan in promoting weaning from veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in patients with refractory cardiogenic shock through a meta-analysis of clinical trials.

Systematic review and meta-analysis.

PubMed, Embase, the Cochrane Library and Web of Science were systematically searched from inception to January 2025.

Studies were included if they were clinical trials comparing outcomes between patients receiving levosimendan and those not receiving it during VA-ECMO support. Eligible studies reported on at least one of the predefined outcomes.

Two independent reviewers extracted data and assessed study quality. The primary outcome was successful VA-ECMO weaning. Secondary outcomes included 30-day mortality, in-hospital mortality, duration of ECMO support and length of stay in the intensive care unit (ICU). A random-effects model was used to synthesise data and estimate pooled effect sizes, with heterogeneity assessed using the I² statistic.

Involving 2083 patients across 16 studies, levosimendan significantly improved VA-ECMO weaning success (OR=2.44, 95% CI: 1.72 to 3.48; p2=57%) compared with the control group. Additionally, it notably reduced 30-day mortality (OR=0.48, 95% CI: 0.29 to 0.81; p=0.006; I²=56%) and in-hospital mortality (OR=0.47, 95% CI: 0.26 to 0.88; p=0.02; I²=70%). Noteworthy, however, is the association of levosimendan with prolonged VA-ECMO support (days; n=1314; weighted mean difference (WMD): 2.86, 95% CI: 1.73 to 4.00; p2=60%) and extended ICU stay (days; n=629; WMD: 5.69, 95% CI: 2.19 to 9.20; p=0.001; I²=61%).

Levosimendan improves VA-ECMO weaning success and reduces mortality. Further high-quality randomised controlled trials (RCTs) are required to confirm its clinical benefits in VA-ECMO patients. While the findings consolidate existing evidence favouring levosimendan, they also highlight residual heterogeneity and moderate-to-high risk of bias in several included studies. Therefore, future investigations, particularly well-powered RCTs with robust methodology, may help further delineate its role in specific patient populations.

Cancer remains a major public health concern worldwide. Patient navigation, developed in the 1990s to address disparities in cancer outcomes, aims to guide patients through the complex healthcare system and improve access to timely, quality care. Despite its proven benefits, little is known about the implementation or impact of patient navigation programmes in African settings.

This scoping review aims to map the current evidence on components, procedures, outcomes and impact, as well as barriers and challenges to implementation of patient navigation programmes in cancer care across Africa.

This scoping review will follow Arksey and O’Malley’s scoping review framework, as further developed by Levac et al. A systematic search will be conducted across PubMed, African Journals Online and Google Scholar to identify relevant studies published from database inception to the date of the final search, using a combination of relevant keywords and MeSH terms. Eligible studies must be reported in English, have been carried out in Africa, involved patients diagnosed with cancer or navigating the cancer care continuum, and report on the description, implementation or evaluation of patient navigation programmes. Screening will be managed with Rayyan and carried out through a two-stage process: screening by titles and abstracts, then by full-text screening based on the prespecified inclusion and exclusion criteria. Data will be extracted into a structured Excel spreadsheet and synthesised using qualitative content analysis to identify programme characteristics, outcomes, barriers and implementation challenges.

This scoping review does not require ethical approval. Our findings will be published in a peer-reviewed, open-access journal on completion.

Peripheral arterial disease (PAD) affects approximately one in five people over 60 in the UK. In severe cases, revascularisation, such as surgical bypass or endovascular methods, is often required to restore limb perfusion. Between 2000 and 2019, 527 131 revascularisation procedures were carried out in the UK. Postprocedural surveillance is essential to detect restenosis and maintain vessel patency. However, standard surveillance using duplex ultrasound (DUS) is resource intensive. Ankle Doppler waveform assessment is quick, inexpensive and accurate for PAD diagnosis, yet its role in postrevascularisation surveillance remains unexplored. This study aims to evaluate the diagnostic accuracy of ankle handheld Doppler waveform assessment (ankle HHD) for detecting restenosis after lower limb revascularisation, as compared with formal DUS.

This is a prospective diagnostic accuracy study (ClinicalTrials.gov Identifier NCT06619223). We aim to recruit 121 people with PAD undergoing planned lower limb revascularisation at Imperial College Healthcare NHS Trust. Follow-up assessments will take place at 3 months, 6 months and 12 months post revascularisation. At each visit, a vascular scientist will perform the index test (Ankle HHD) followed by DUS as the reference standard. A subset of participants will undergo repeat testing to assess interobserver and intraobserver reliability. Restenosis will be defined as one or more arterial lesions of ≥50% stenosis or tandem lesions with a combined value of ≥50%. The primary outcome is the sensitivity of ankle Doppler waveform assessment for detecting restenosis, compared with DUS.

The study has received approval from Health Research Authority (HRA) and Health and Care Research Wales (REC reference 24/LO/0462). Results will be disseminated through research presentations and papers.

ClinicalTrials.gov, NCT06619223.

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

A retrospective cohort study.

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Hepatitis C virus (HCV) remains a leading cause of infectious disease-related morbidity in the USA, disproportionately affecting people who inject drugs and people who are incarcerated. Despite the availability of highly effective, highly tolerated direct-acting antivirals, treatment uptake in jails remains limited due to short stays, unpredictable release dates and system-level barriers. The original MINMON trial demonstrated that a low barrier ‘minimal monitoring"’ model can achieve high cure rates in community settings. This study, MINMON-J, aims to adapt and evaluate a modified version of the MINMON model for use in a jail setting, addressing the urgent need for scalable, low-barrier treatment approaches among justice-involved individuals.

MINMON-J is a single-arm, hybrid effectiveness-implementation pilot study protocol planned to recruit at the Rhode Island Department of Corrections. 40 people who are incarcerated with positive HCV RNA, who are treatment-naïve, without cirrhosis and awaiting trial, will receive 12 weeks of sofosbuvir/velpatasvir with no required lab monitoring during treatment. If released before treatment completion, participants will receive their remaining medication at discharge. Community health workers will provide post-release support. Mixed-methods evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation and Maintenance/Practical, Robust Implementation and Sustainability Model framework. Primary outcomes include feasibility, acceptability and adherence. Data will be collected through administrative records, surveys (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Brief Adherence Rating Scale) and qualitative interviews with participants and other relevant parties. This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections Medical Research Advisory Group.

This study was reviewed and approved by the Brown University Health Institutional Review Board (2240400) and the Rhode Island Department of Corrections (RIDOC) Medical Research Advisory Group. All participants will provide written informed consent prior to enrolment. People who are incarcerated will be assured that participation is voluntary, will not impact their clinical care and that they may withdraw at any time without penalty. Study procedures follow ethical principles outlined in the Declaration of Helsinki and comply with federal regulations regarding research involving vulnerable populations.

Dissemination of findings will include peer-reviewed publications and presentations at national conferences focused on infectious diseases, implementation science and/or correctional health. Lay summaries will be shared with RIDOC leadership and community partners. De-identified data and associated metadata may be archived in a publicly accessible repository in accordance with National Institutes of Health data sharing policies, contingent on final institutional review board approval and participant protections.

NCT06953479.

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

NCT04897516.

Diabetic retinopathy (DR) in pregnancy can cause blindness. National guidelines recommend at least one eye examination in early pregnancy, then ideally 3-monthly, through to the postpartum for pregnant women with pregestational diabetes. Here we examined adherence rates, barriers and enablers to recommended DR screening guidelines.

Cross-sectional survey study, as part of a larger prospective cohort study.

Participants were recruited from two tertiary maternity hospitals in Melbourne, Australia.

Of the 173 pregnant women with type 1 (T1D) or type 2 diabetes (T2D) in the main cohort study, with an additional four who participated solely in this survey study, 130 (74.3%) completed the survey.

This study calculated rates of adherence to guideline-recommended DR screening schedules and collected data on the enablers and barriers to attendance using a modified Compliance with Annual Diabetic Eye Exams Survey. Each of the 5-point Likert-scale survey items was compared between adherent and non-adherent participants using the Wilcoxon rank-sum test and logistic regression models were constructed to quantify associations as ORs.

A retinal assessment was undertaken at least once during pregnancy in 86.3% of participants, but only 40.9% attended during their first trimester and only 21.2% attended the recommended number of examinations. Competing priorities were the main barriers to adherence, with eye examinations ranked as the fourth priority (IQR 4th–5th) among other health appointments during pregnancy. Meanwhile, knowledge of the benefits of eye screening examinations, eye-check reminders and support from relatives was identified as enablers.

Despite the risk of worsening DR during pregnancy, less than half of the participants adhered to recommended screening guidelines, suggesting that eye health is not a priority. Proactive measures to integrate care are needed to prevent visual loss in this growing population.