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.

Although as many as 92% of survivors of physical intimate partner violence (IPV) report impacts to the head and/or non-fatal strangulation (NFS) that raise clinical suspicion of brain injury (BI), there are no evidence-based methods to document and characterise BI in this vulnerable population, limited clinical practice guidelines and insufficient understanding about long-term risks for conditions including Alzheimer’s Disease and Related Dementias (ADRD). This leaves most survivors of IPV-caused BI (IPV-BI), overwhelmingly women, without adequate access to medical care and support, safe housing, back-to-school/work accommodations or follow-up care for long-term neurocognitive health. Although traumatic brain injury (TBI) is an established ADRD risk factor, little is known about the attributable risk of ADRD due to IPV-BI, particularly in women.

Our overarching objectives are to (1) use plasma biomarkers as novel tools to assist clinicians to improve diagnosis of IPV-BI at the acute, subacute and chronic stages in a manner sensitive to the needs of this vulnerable population and (2) raise awareness of the importance of considering IPV-BI as a potential ADRD risk factor. A prospective observational study funded by the US Department of Defense (HT9425-24-1-0462), Brain Canada (6200) and the Canadian Institutes of Health Research (523320-NWT-CAAA-37499) leverages collaborative research at multiple clinical sites in British Columbia to maximise equity, diversity and inclusion among participants, with a target enrolment of n=600 participants.

The Advocates, Academics, Survivors and Clinicians to END Intimate Partner Violence Biomarkers study, which is predicated on pre-specified research questions, represents one of the most significant community-based studies on plasma biomarkers affected by an IPV-BI incident. Of particular significance is the fact our study uses robust biomarker approaches being applied in the TBI and ADRD fields to determine how the biomarker profile after IPV-BI compares to typical TBI and the early stage of neurodegenerative disorders.

This study was approved by the University of British Columbia Clinical Research Ethics Board (H24-01990, H22-02241 and H16-02792) and the Island Health Research Ethics Board (H22-03510). Upon publication of primary papers, de-identified data and biospecimens will be made widely available, including the US Federal Interagency Traumatic Brain Injury Research (FITBIR) federated database. Our data and integrated knowledge translation activities with persons with lived experience of IPV-BI and those working in the healthcare sector will be synthesised into co-designed and implemented knowledge tools to improve outcomes for survivors of IPV-BI.

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.

Globally, the circulation of influenza and other seasonal respiratory viruses changed dramatically during the COVID-19 pandemic. This study aims to determine the trends of acute respiratory infections (ARIs) caused by SARS-CoV-2, influenza A, influenza B and respiratory syncytial viruses (RSVs) in patients presenting to hospitals in the Lao People’s Democratic Republic (PDR) (Laos).

Prospective surveillance study.

Four provincial hospitals across Laos between March 2021 and July 2023.

Participants of all ages who met our case definition for an ARI (axillary temperature ≥37.5°C or history of fever AND cough or other respiratory symptoms/signs OR loss of smell and/or taste) presenting to the hospital less than 10 days after symptom onset were eligible to be enrolled in the study. Combined nasopharyngeal and throat swabs were tested for SARS-CoV-2, influenza A, influenza B and human RSV (hRSV) using probe-based real-time RT (Reverse transcription)-PCR assays.

The proportion of patients in whom SARS-CoV-2, influenza A, influenza B and hRSV was detected.

There were 4203 patients recruited, of whom 898 (21%) were children aged under 5 years. SARS-CoV-2 was detected in 16.9% of patients, followed by influenza A, influenza B and hRSV (8.4%, 7.2% and 4.7%, respectively). 98 patients (2.3%) were diagnosed with probable co-infection, with at least two viruses detected. After May 2022, the number of cases of influenza A, influenza B and hRSV increased rapidly. Six per cent of patients (263) had a quick Sequential Organ Failure Assessment score of ≥2, and 34 (0.8%) patients died, of whom 11 tested positive for a respiratory virus.

During the COVID-19 pandemic in Laos, few respiratory viruses were detected by passive surveillance until the relaxation of non-pharmaceutical interventions implemented for infection control. After restrictions were lifted, influenza A, influenza B and hRSV emerged rapidly, showing the importance of continuous surveillance.

Hepatic impairment, especially hepatitis, is a growing public health concern in the general population globally. Viral hepatitis, a key driver of liver impairment, remains endemic in many countries across sub-Saharan Africa (SSA). We conducted an umbrella review to assess the prevalence of viral hepatitis among the general population in SSA.

We conducted an umbrella review, using standardised methods to assess multiple systematic reviews and meta-analyses (SRMAs) on the prevalence of viral hepatitis.

We systematically searched PubMed and Embase to retrieve systematic reviews published from 2013–2024.

We retrieved systematic reviews published during 2013–2024 that examined the prevalence of viral hepatitis among the general population within SSA.

Two independent reviewers used standardised methods to search, screen and identify included studies. We conducted an umbrella review, which was a comprehensive and systematic collation and assessment of SRMAs focused on the prevalence of viral hepatitis in SSA.

The final analysis included 21 studies. Among these, one study focused on hepatitis A, 13 on hepatitis B, 10 on hepatitis C, 2 on hepatitis D and 1 on hepatitis E. Only one study reported the overall prevalence of hepatitis A and E in SSA as 90 200 and 46 860 per 100 000 population, respectively. Across SSA, hepatitis B exhibited a pooled prevalence ranging from 6000 to 18 900, while hepatitis C ranged from 720 to 7820 and hepatitis D from 50 to 28 990 per 100 000 population. Heterogeneity was high and ranged from I²=63.14% to 99%.

We present an umbrella review on viral hepatitis prevalence in SSA, providing an overall view of study quality, effect sizes, heterogeneity and bias across the search field. We found that the prevalence of viral hepatitis in many SSA countries is higher than the global estimate. However, these results are mainly based on seropositivity tests; nonetheless, the findings from this study provide an overarching picture of the burden of viral hepatitis within populations in SSA.

Selecting an optimal initial dosage of opioid agonist treatment (OAT) balances effectiveness and safety, as initial doses that are too low may be insufficient, potentially prompting clients to seek unregulated drugs to alleviate withdrawal symptoms, which may increase the likelihood of treatment discontinuation. Conversely, initial doses that are too high carry a risk of overdose. As opioid tolerance levels have risen in the fentanyl era, linked population-level data capturing initial doses in the real world provide a valuable opportunity to refine existing guidance on optimal OAT dosing at treatment initiation. Our objective is to determine the comparative effectiveness of alternative initial doses of methadone, buprenorphine-naloxone and slow-release oral morphine at OAT initiation, as observed in clinical practice in British Columbia (BC), Canada.

We propose a population-level retrospective observational study with a linkage of nine provincial health administrative databases in BC, Canada (1 January 2010 to 31 December 2022). Our study includes two time-to-event primary outcomes: OAT discontinuation and all-cause mortality during follow-up. We propose ‘initiator’ target trial analyses for each medication using both propensity score weighting and instrumental variable analyses to compare the effect of different initial OAT doses on the hazard of time-to-OAT discontinuation and all-cause mortality. A range of sensitivity analyses will be used to assess the robustness of the results.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. Results will be disseminated to local advocacy groups and decision-makers, national and international clinical guideline developers, presented at international conferences and published in peer-reviewed journals electronically and in print.

Primary care electronic health records provide a rich source of information for inequalities research. However, the reliability and validity of the research derived from these records depend on the completeness and resolution of the codelists (ie, collections of medical terms/codes) used to identify populations of interest. The aim of this project was to develop comprehensive codelists for identifying people from ethnic minority groups, people with learning disabilities (LDs), people with severe mental illness (SMI) and people who are transgender.

We followed a three-stage process to define and extract relevant codelists. First, groups of interest were defined a priori. Next, relevant clinical codes, relating to the groups, were identified by searching Clinical Practice Research Datalink (CPRD) publications, codelist repositories and the CPRD Code Browser. Relevant codelists were extracted and merged according to group, and duplicates were removed. Finally, the remaining codes were reviewed by two general practitioners (GPs).

The curated codelists were compared using a representative sample in the UK. The frequencies of individuals identified using the curated codelists were assessed and compared with widely used alternative codelists.

Comprehensiveness was assessed in a representative CPRD population of 10 966 759 people.

After removal of duplicates and GP review, codelists were finalised with 325 unique codes for ethnicity, 558 for LD, 499 for SMI and 38 for transgender. Compared with comparator codelists, an additional 48 017 (76.6%), 52 953 (68.9%) and 508 (36.9%) people with LD, SMI or transgender code were identified. The proportions identified for ethnicity, meanwhile, were consistent with expectations for the UK (eg, 6.50% Asian, 2.66% black and 1.44% mixed).

The curated codelists are more sensitive than those widely used in practice and research. Discrepancies between national estimates and primary care records suggest potential record/retention issues. Resolving these requires further investigation and could lead to improved data quality for research.

Opioid use disorder (OUD) during pregnancy is associated with increased rates of adverse perinatal, foetal and neonatal health events. Opioid agonist treatment (OAT) can substantially reduce the risk of these potential harms. In British Columbia (BC), methadone and buprenorphine/naloxone are first-line treatment options for pregnant people with OUD. However, the comparative effectiveness of these regimens during pregnancy remains poorly understood, particularly in terms of how dosage may impact clinical outcomes. This protocol outlines a proposed population-based retrospective study to evaluate the comparative effectiveness of methadone compared with buprenorphine/naloxone during pregnancy on perinatal and neonatal health outcomes.

We propose to conduct a retrospective observational study using population-based data from individuals who received methadone or buprenorphine/naloxone during pregnancy between 1 April 2010 and 31 March 2022. Data will be collected from 10 linked population-level administrative databases. We will emulate target trials using intention-to-treat and per-protocol approaches. We will use a pooled logistic regression approach to assess the impact of methadone versus buprenorphine/naloxone on time to OAT episode discontinuation and a dose-response marginal structural model to evaluate neonatal health at delivery. An exploratory observational analysis will also be conducted to describe the impact of methadone vs buprenorphine exposure during the first trimester of pregnancy on congenital malformations and anomalies.

This study has been determined to meet the criteria for exemption per Article 2.5 of the 2018 Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Study databases have been made available by the BC Ministries of Health and Mental Health and Addiction as part of the provincial opioid overdose public health emergency response. Results will be disseminated to policymakers, clinical partners, community programmes and people with lived and living experience of substance use and published in peer-reviewed journals.

Opioid agonist treatment (OAT) prescribing patterns have shifted in recent years in British Columbia (BC), Canada due to the increasingly toxic unregulated drug supply. Experimental evidence to support guidelines on the effectiveness of maintaining clients at different maintenance dosage levels is incomplete and outdated for the fentanyl era. Our objective is to assess the risk of treatment discontinuation and mortality among individuals receiving different maintenance dosage strategies for OAT with methadone, buprenorphine/naloxone or slow-release oral morphine (SROM) at the population level in BC, Canada.

We propose a retrospective population-level study of BC residents initiating OAT on methadone, buprenorphine/naloxone or SROM between 1 January 2010 and 31 December 2022 who were ≥18 years of age with no known pregnancy, no history of cancer diagnosis or receiving palliative care and not currently incarcerated. Our study will employ health administrative databases linked at the individual level to emulate a target trial per OAT type where individuals will be assigned to discrete maintenance dosing strategies, according to the full range observed in BC during the study period. Primary outcomes include treatment discontinuation and all-cause mortality. To determine the effectiveness of alternative maintenance doses, we will emulate a ‘per-protocol’ trial using a clone-censor-weight approach to adjust for measured time-dependent confounding by indication.

The protocol, cohort creation and analysis plan have been classified and approved as a quality improvement initiative by Providence Health Care Research Ethics Board and the Simon Fraser University Office of Research Ethics. All data are deidentified, securely stored and accessed in accordance with provincial privacy regulations. Results will be disseminated and shared with local advocacy groups and decision-makers, developers of national and international clinical guidelines, presented at national and international conferences and published in peer-reviewed journals electronically and in print.

To estimate the prevalence of established atherosclerotic cardiovascular disease (eASCVD) and the prevalence of ASCVD high-risk patients as defined by the European Society of Cardiology (ESC) among the Egyptian population of the Prevalence and Clinical Management of Atherosclerotic Cardiovascular Diseases in Patients With Type 2 Diabetes (PACT)-Middle East and Africa study.

An observational, multicentre, cross-sectional study.

Eight secondary care centres in Egypt.

550 adult males and females who provided informed consent and had been diagnosed with type 2 diabetes mellitus (T2DM) for at least 180 days. Participants were excluded if they had participated previously in the study, had been diagnosed with T1DM, experienced mental incapacity, were unwilling to participate, had a known language barrier precluding adequate understanding or cooperation or had a known congenital heart disease or malformation.

The primary outcome was the proportion of patients with eASCVD, while the secondary outcome was the proportion of patients with T2D with high risk of ASCVD and without eASCVD.

Prevalence of eASCVD was 108/550 (19.6%, 95% CI 16.5% to 23.2%), and the prevalence of high risk for ASCVD in the population without eASCVD was 378/442 (85.5%, 95% CI 81.9% to 88.5%). Approximately 99% of the study population was categorised as ESC very high risk or high risk for CVD. On assessing utilisation of antidiabetic medications with cardiovascular benefit, only 20% were receiving sodium-glucose cotransporter-2 inhibitors, and 3% were receiving glucagon-like peptide-1 analogues.

The prevalence of eASCVD and high risk for ASCVD in Egypt is alarming, and the inadequate pharmacological control increases the ASCVD burden in the T2DM population. This calls for immediate, comprehensive action to reassess T2DM care.

NCT05317845.