Haemophilia is a rare inherited bleeding disorder with complex support and costly treatment. Comprehensive care for people with haemophilia (PwH) must take place in structured and continuously evaluated treatment centres. The aim of the Public Assistance for People with Haemophilia in Brazil Project (PATCH Project) is to assess the infrastructure, human resources and healthcare delivery processes of Brazilian Blood Centres (BC) involved in the provision of haemophilia care.

This is a nationwide cross-sectional study involving 98 BC across Brazil’s 26 states and the Federal District, focusing on the care provided to PwH. A self-administered structured questionnaire was prepared, based on national and international recommendations for management, treatment and outcomes assessment in PwH. The criteria of the World Federation of Haemophilia and the European Association for Haemophilia and Allied Disorders will be used to define standards of quality.

Ethical approval for this study was granted by the Human Research Ethics Committee of the Federal University of Goiás, the coordinating centre (protocol CAAE 53863221.8.0000.5078), and subsequently by all participating institutions. Written informed consent is obtained from all participants prior to enrolment. Study findings will be disseminated through publication in peer-reviewed journals and presentation at international scientific conferences. Research data will be managed in accordance with ethical and legal standards and will be made available on reasonable request to support future investigations.

Not applicable

To provide population-level insights into COVID-19 testing behaviour and test results among all pregnant women in the Netherlands and to assess the effects of SARS-CoV-2 infection during pregnancy on maternal and neonatal health outcomes.

Retrospective population-based cohort study.

Dutch registry data on maternal and neonatal health outcomes linked with COVID-19 testing and sociodemographic data for the study period 2020 and 2021.

To study testing behaviour, all pregnant women who gave birth in the Netherlands during 2020 and 2021 were included (N=322 720). To study the effects of maternal infection, women who gave birth between June 2020 and September 2021 and who were tested for COVID-19 were included (N=68 059).

For testing behaviour: number of COVID-19 tests performed and COVID-19 test results. For neonatal health outcomes: preterm birth, low birth weight for gestational age (small for gestational age (SGA)), BIG2 (preterm birth and/or SGA), Apgar score at 5 min below seven (low Apgar), Apgar score at 5 min below four (very low Apgar), neonatal intensive care unit admission, congenital anomalies and mortality. For maternal health outcomes: major postpartum haemorrhage (>1000 mL), severe ruptures (third or fourth degree), type of delivery and episiotomy.

Compared with the reference group (women aged 30–34), women under 20 had the lowest probability of being tested (16.5% vs 31.3%; OR 0.43, 95% CI 0.38 to 0.49), but when tested, they had significantly higher odds of testing positive (19.3% vs 12.9%; OR 1.62, 95% CI 1.21 to 2.14). Women originating from ‘other African’ countries were least likely to be tested (15.1%; OR 0.37, 95% CI 0.35 to 0.39), while women whose country of origin was ‘Morocco’ were most likely to test positive when tested (33.4%; OR 3.63, 95% CI 3.35 to 3.93). While over all trimesters a SARS-CoV-2 infection during pregnancy did not show significant effects, an infection during the first trimester was associated with an increased risk of preterm birth (5.2% vs 6.4%; OR 1.25, 95% CI 1.03 to 1.52) and a low 5-min Apgar score (1.9% vs 2.9%; OR 1.50, 95% CI 1.12 to 2.02). No significant adverse maternal health effects were observed.

There were significant differences in testing behaviour and the probability of testing positive for COVID-19 among pregnant women from different age groups, countries of origin and socioeconomic backgrounds. SARS-CoV-2 infection during pregnancy was not associated with significant effects on maternal health outcomes, and only limited effects on neonatal health were observed. Only infections occurring in the first trimester were linked to an increased risk of preterm births and low 5-min Apgar scores.

Most oral cancers in India present in advanced stages and tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers, but its role in oral cancer is still not well-defined in curative settings beyond radiosensitisation. Despite an excellent response rate, neoadjuvant chemotherapy trials have failed to show an oncological advantage. Earlier studies were limited by their heterogeneous patient population, including all head and neck subsites, and included both inoperable cancer and early-stage operable cases. Due to such patient selection, the intended results were never met. Patients with biologically aggressive diseases (advanced nodal disease) may derive greater benefit from induction chemotherapy (ICT). Therefore, we aim to determine the oncological advantage of adding ICT to oral squamous cell cancer with advanced nodal disease (N2–N3).

The study is an open-label, multicentre, randomised controlled trial, with an allocation ratio of 1:1, being conducted at seven leading cancer centres in India. The primary objective is to compare survival outcomes with and without ICT before surgery in patients with oral squamous cell carcinoma (OSCC) and advanced nodal disease, specifically focusing on 2-year disease-free survival (DFS). Secondary objectives include assessing overall survival (OS), clinical and pathological response rates, treatment compliance, treatment completion rates, adverse events, treatment-related toxicity (using Common Terminology Criteria for Adverse Events, V.5.0), quality of life (measured with Functional Assessment of Cancer Therapy-General and Functional Assessment of Cancer Therapy-Head and Neck) and postoperative complications (using the modified Clavien-Dindo classification).

The study population consists of patients with operable OSCC and advanced nodal disease (N2–N3), adequate organ function, aged 18–65 years and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2. The treatment arms are the standard arm Surgery arm (SURG), which involves surgery followed by adjuvant radiotherapy with or without concurrent chemotherapy, and the experimental arm (ICT), in which patients will receive two cycles of ICT using either cisplatin, docetaxel and 5-fluorouracil or cisplatin, docetaxel and capecitabine, followed by surgery and adjuvant radiotherapy with or without concurrent chemotherapy. The sample size was calculated to detect an HR of 0.67 with 80% power. A total of 184 events are required, and with an accrual rate of 15 patients per month, 300 patients will be recruited. DFS analysis will occur 32 months after the trial begins, and follow-up will continue for 5 years. OS analysis will be conducted when 184 deaths are observed. Taking 10% of the withdrawal of consent, a total of 346 patients need to be included.

This trial aims to establish the potential superiority of ICT or definitively determine its futility in OSCC with advanced nodal disease. A positive outcome could provide practice-changing data, particularly for Indian patients, whereas negative results could halt the use of ICT in this setting, directing research efforts towards more effective treatment strategies.

CTRI/2024/03/064586; NCT06737822; Institutional Ethics Committee (IEC) number: AIIMS/IEC/2023/4622 (lead site).

The healthcare system is complex, involving multiple interactions among individuals, organisations and systems. Many patients, particularly those with limited health system literacy, struggle to navigate it. A reliable instrument is crucial for accurately measuring individuals’ navigational abilities. However, a systematic review of psychometric properties of existing instruments for measuring health system literacy has not been conducted. This review aims to provide a comprehensive assessment of methodological quality and measurement properties of these instruments.

A search was conducted in MEDLINE, EMBASE, CINAHL, APA Psyfor, SCOPUS, Web of Science and Google Scholar from the date the database was created to 14 December 2024. Eligible studies include those published in English and focusing on developing and validating an instrument for measuring the construct of health system literacy in adults aged 18 or older. Two researchers will independently review, select and extract eligible studies, while all members of the research team will be involved in assessing methodological quality and the quality of measurement properties. This systematic review will adhere to the Consensus-based standards for the selection of health measurement instruments (COSMIN) guidelines for conducting systematic reviews of psychometric properties. We will provide summary tables of study characteristics and instrument characteristics used to measure health system literacy. Measurement properties and their quality will be assessed using the COSMIN standard criteria and the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). We will also evaluate methodological quality of measurement properties using the COSMIN Risk of Bias checklist.

This review does not collect original data, so obtaining ethical approval is not applicable. The findings will be disseminated through peer-reviewed journals, which can assist researchers and providers in choosing the appropriate instrument measuring health system literacy.

CRD420251004362.

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

Cross-sectional study.

PHC facilities across various provinces in Nepal.

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

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

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

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

Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility.

This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes.

The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the National Medicines Regulatory Authority (Sri Lanka). The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.

Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).