Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.

To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.

Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.

Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.

Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.

CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.

CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.

The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.

Primary sclerosing cholangitis (PSC) is the classical hepatobiliary manifestation of inflammatory bowel disease (IBD). No therapy currently halts disease progression. The strong gut–liver axis implicated in PSC pathogenesis supports the investigation of microbiome-targeted treatments. Oral vancomycin (OV), an antibiotic with potential immunomodulatory properties, has shown encouraging results in improving clinical symptoms and liver biochemistry in PSC. However, prospective data on its safety and efficacy remain limited.

Oral Vancomycin for primary sclerosing Cholangitis in ITaly (VanC-IT) is a phase II, dose-finding, randomised, placebo-controlled, trial designed to evaluate the efficacy and safety of OV in patients with PSC, with or without underlying IBD. Adults and adolescents aged 15–75 years will be enrolled following a 10-week screening and run-in period and randomised in a 1:1:1 ratio to receive either placebo, OV 750 mg/day or OV 1500 mg/day for 24 weeks. Randomisation will be stratified by baseline liver stiffness (

The protocol has been approved by the Ethics Committee CE Brianza on 10 February 2023, number 4017. Trial registration number NCT05876182. Participants will be required to provide written informed consent. The results of this trial will be disseminated through national and international presentations and peer-reviewed publications.

NCT05876182.

This study examined factors associated with the use of Indonesia’s National Health Insurance (NHI) among its beneficiaries in Maluku province.

Cross-sectional study.

The individual-level data were derived from the 2021 Social Health Insurance Sample Data. National health reports of Indonesia were used to provide the district-level variables. We performed multivariable logistic regression analyses to identify factors associated with NHI use among its beneficiaries in Maluku province.

Data were collected from 31 517 NHI beneficiaries registered in Maluku.

The primary outcome was the use of NHI insurance when accessing healthcare services (yes/no).

Only 14.79% of NHI beneficiaries in Maluku had ever used their insurance for healthcare services. Individual factors associated with higher NHI use included being under 60 years, females (adjusted OR (aOR)=1.29, p

Strengthening primary healthcare accessibility, improving the distribution of healthcare workers and addressing socioeconomic and geographical disparities are essential to ensure that the NHI scheme achieves equitable use across all regions in Maluku and other areas with similar settings.

Children from refugee families resettled in the USA face higher risks of serious mental health challenges compared with their native-born peers. Research shows that refugee youth in high-income countries frequently suffer from trauma-associated disorders such as post-traumatic stress disorder (PTSD), depression and anxiety. The high prevalence of trauma-associated mental health problems among these youth may be attributed to their own trauma exposure, especially if born in conflict zones, and post-resettlement challenges like poverty, acculturation difficulties, racism and discrimination. However, they may also suffer from the effects of intergenerational trauma, where parental war trauma impacts them. This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US-born children of refugee parents in Omaha and Lincoln, Nebraska.

This is a two-arm cluster randomised type I hybrid effectiveness-implementation trial. Guided by the Social Action and Family Systems theories and applying them to the intergenerational transmission of trauma framework, the combination intervention consists of family strengthening model delivered through multiple family groups+peer mentoring programme called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). A total of 154 US-born adolescents of parent resettled as refugees (77 per study arm), ages 14–17 and at least one biological parent per youth (dyads) will be recruited from four comparable communities utilising community-based participatory research approach and randomised to usual care or intervention group. The intervention will be implemented for up to 16 weeks, with assessments at baseline, after intervention completion and 6 months follow-up. To determine study feasibility, we will use binary metrics of participant enrolment of 70% or more and retention of 80% or more at 12 months. To assess study acceptability, we will determine participant satisfaction with the study based on the Client Satisfaction Questionnaire (CSQ-8). To maximise rigour, our analyses will follow an intention-to-treat (ITT) approach. For primary inferential analyses, we will fit two-level generalised linear mixed models to continuous primary outcomes. The models will include fixed effects for study arm, time and their interaction terms. We will perform time-averaged comparisons of post-baseline repeatedly measured observations across study arms to examine intervention effects over the duration of the postintervention study period. To delineate barriers and facilitators to implementation and implementation strategies, we will apply a more integrative approach, using both inductive and deductive approaches guided by the grounded theory and integrative theory that combines both deductive and inductive approaches. Finally, we will integrate findings from the quantitative and qualitative analysis to provide additional explanation and context for our quantitative findings.

Voluntary written informed assent and consent will be obtained from all participants, adolescents and their parents, respectively. All study procedures received approval from Washington University in St. Louis Institutional Review Board (IRB #202307081).

Study findings will be disseminated through publications in scientific journals and presentations at national and international conferences. We also plan to provide community education about the study through a dissemination conference at the end of the study.

NCT06176638.

Equitable access to healthcare technology is a major public health issue. For adults with type 2 diabetes (T2D), continuous glucose monitoring (CGM) technology can improve diabetes self-management and clinical outcomes. Even though CGM is now recommended by professional guidelines for all patients with diabetes on insulin therapy, evidence suggests that CGM is underutilised and inequitably prescribed across health systems. As CGM is an emergent technology, it is vital to understand what approaches have been studied to overcome inequities in CGM access for adults with T2D, what aspects of equitable access have yet to be addressed and what are facilitators and barriers to CGM access at the individual, facility and health system levels.

We will use the Joanna Briggs Institute’s revised scoping review framework to conduct our analysis. The protocol is registered with Open Science Framework (https://osf.io/z2exn). We will search for peer-reviewed literature containing empirical evidence for the facilitators and barriers to equitable access to CGM technology for patients with T2D. Findings will be organised according to research objectives and the Framework for Digital Health Equity, and summarised using narrative synthesis of descriptive statistics for quantitative findings, and themes for qualitative findings. This review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews.

The findings from this review will provide valuable information and support for future research into the equitable implementation and use of CGM for patients with T2D. We will disseminate findings at conferences and publish in a peer-reviewed journal.

https://osf.io/z2exn.

Ultrasonography is a non-invasive and safe method for assessing muscle morphology. Among its parameters, echo intensity (EI), derived from grayscale image analysis, has emerged as a promising indicator of muscle quality and intramuscular fat infiltration. This study aims to validate EI as a marker for evaluating muscle quality in a population of Czech children, through integration with gold-standard assessments of muscle strength and body composition. The primary aim of this study is to assess the reliability and construct validity of quadriceps muscle EI using ultrasound as a proxy measure of morphological muscle quality in children aged 10–14 years.

Children aged 10–14 years will undergo ultrasound assessment of the quadriceps femoris (QF). EI will be derived from longitudinal scans of each QF head and the cross-sectional area (CSA_QF) from panoramic mid-thigh images. Muscle function will be assessed as maximal voluntary contraction (MVC) of isometric knee extension with muscle quality expressed as MVC/CSA_QF. A 30 s sit-to-stand test (30STS) will be used as an additional functional measure. EI reliability (intra-rater, inter-rater and test–retest) will be evaluated with intraclass correlation coefficients (ICC), Bland–Altman plots and complementary indices. Exploratory known-groups validity will be tested by comparing EI between weight-status groups. Control variables include dual-energy X-ray absorptiometry (DXA)-derived body composition, skeletal age (as determined by DXA hand scans) and physical activity (assessed using 7-day accelerometry).

This study will include 200 children (100 girls and 100 boys) aged 10–14 years using an a priori power analysis based on the primary objective of assessing construct validity through multiple linear regression, assuming an alpha level of 0.05 and 80% power. Participants will be recruited from paediatric outpatients of the Paediatric Obesity Clinic and individuals reached through a recruitment campaign. Inclusion criteria require general good health, while exclusion criteria include a history or symptoms of cardiovascular, pulmonary, metabolic or neurological disease, as well as the use of over-the-counter or prescribed medications. Informed consent and assent will be obtained from all participants.

Reliability of ultrasound-derived EI will be assessed for intra-rater, inter-rater and test–retest agreement using ICC coefficients, Bland–Altman plots and complementary indices such as SE of measurement, coefficient of variation and minimal detectable change at 95% CI, following Consensus-based Standards for the selection of health Measurement Instruments guidelines. Construct validity will be examined by modelling associations between EI and functional muscle quality (MVC/CSA_QF), with 30STS as an additional functional measure. Known-groups validity will be tested by comparing EI across weight groups, using generalised linear regression models adjusted for skeletal age, body composition and physical activity. All validity analyses will be conducted separately for girls and boys. Ultrasound-derived EI of the QF is expected to show high reliability (ICC≥0.80) and acceptable test–retest reproducibility. Construct validity should be supported by moderate associations with functional muscle quality (MVC/CSA_QF), while known-groups validity is expected to reveal higher EI values in children with obesity and/or insufficient physical activity.

The study will be conducted in accordance with the Declaration of Helsinki and was approved by the Ethics Committee of the Faculty of Physical Education and Sport, Charles University (EK 101/2024). Written parental consent and verbal assent from children will be obtained, with all data handled confidentially and anonymised. Results will be disseminated transparently to participants and their families in line with ethical principles of respect, beneficence and justice.

NCT06792279.

Polypharmacy, defined as the concurrent use of multiple medications, is a growing concern among the elderly, especially in low-income and middle-income countries such as Iran. This study aims to explore the prevalence and patterns of polypharmacy among the elderly in Iran, using health insurance claims data to identify common drug classes and coprescribed medications, with a focus on informing policy decisions and improving medication management.

Retrospective population-based observational study.

Nationwide data from the Iran Health Insurance Organization (IHIO) across 24 provinces.

1 876 527 individuals aged 65 years and older, insured by the IHIO from 2014 to 2017. Individuals with incomplete demographic information or lacking medication records in the database were excluded from the analysis.

Prevalence and patterns of polypharmacy, demographic factors associated with polypharmacy, and common drug classes used. Medications were classified using the Anatomical Therapeutic Chemical system. Polypharmacy was defined as the use of five or more medications, with cumulative polypharmacy considering total drug use over time, and consecutive polypharmacy focusing on the frequency of monthly drug use. Logistic regression and association rule mining were applied to explore demographic factors and medication patterns associated with polypharmacy.

Of the study population, 74.9% experienced cumulative polypharmacy over 6 months and 64.6% over 1 month, with 7.6% experiencing consecutive polypharmacy. Females and those aged 75–79 were more prone to polypharmacy. Systemic glucocorticoids were the most commonly used medications (50.02%), followed by HMG-CoA reductase inhibitors (42.73%) and platelet aggregation inhibitors (41.92%). Polypharmacy was most strongly associated with medications related to the alimentary tract and metabolism, cardiovascular system, nervous system and blood and blood-forming organs.

Polypharmacy is highly prevalent among the elderly in Iran, with significant variations by gender, age, insurance fund and region. The findings highlight the need for targeted interventions to manage polypharmacy and improve medication safety in this population.

To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.

We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.

Primary Care Health Madrid region (Spain).

Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).

Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.

The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.

Admission to a surgical intensive care unit (ICU) following major surgery is associated with a number of discomforts, not only related to the disease itself but also to the care provided or the ICU environment itself (lights, sounds, pain, sleep deprivation, thirst, etc). This discomfort is real and can be associated with psychological consequences. We hypothesised that the use of immersive virtual reality (IVR) with HypnoVR is feasible and can help reduce discomfort in intensive care.

The ZION trial is a prospective, monocentric trial randomising 194 patients admitted to a surgical ICU after a major surgery. The inclusion criterion is patients admitted to a surgical ICU for at least 48 hours following major surgery (cardiac, thoracic or major abdominal surgery). Patients will be allocated to the intervention group (n=97) or the control group (n=97). In the intervention group, patients will receive IVR using HypnoVR two times a day during the ICU stay (2–5 days). In the control group, postoperative care will be conducted according to standard care without IVR. The primary endpoint will be the 18-item IPREA (Inconforts des Patients de REAnimation) questionnaire on the day of ICU discharge. The secondary endpoints will include intensity of discomfort symptoms (anxiety, pain, dyspnoea, thirst and sleep deprivation); the 18-Item IPREA Questionnaire assessed daily from randomisation to the V1 follow-up visit (ICU discharge); incidence of delirium; cumulative morphine consumption at ICU discharge; length of ICU stay and anxiety or depression at 1 month after discharge from intensive care and patient experience of device use.

Ethical approval was obtained from the institutional review board of the University Hospital of Amiens (Registration number ID: 2024-A01528-39) in January 2025.

NCT06830369.