by Daniel H. Nguyen, Debottama Das, Ali Bilgin, Dianne Patterson, Matthew Hook, Chris Butson, Alberto Cacciola, Vinod Kumar Jangir, Manojkumar Saranathan
Leveraging diffusion tractography, connectivity-based parcellation (CBP) is one of the oldest methods for thalamic nuclei segmentation. The goal of this work was to reassess CBP using higher spatial resolution diffusion MRI data and reconstruction algorithms, and to compare it with recent state-of-the-art methods for thalamic nuclei segmentation. Furthermore, these methods were systematically evaluated against three histological atlases and one functional MRI–based atlas to examine their relative anatomical similarities and differences. High resolution diffusion and T1-weighted MRI data from 67 healthy individuals in the Human Connectome Project Young Adult database were analyzed. CBP was performed using probabilistic tractography with cortical targets derived from combining labels of the Human Connectome Project Multi-Modal Parcellation 1.0 atlas into 8, 11, and 23 regions. Results were compared against three recent methods: orientation distribution function clustering (ODF), track density imaging (TDI), and structural MRI-based segmentation. Group level analyses were conducted in the Montreal Neurological Institute space, and Dice overlap coefficients were calculated using four atlases (three histological, one functional). CBP results using newer data and methods were still remarkably similar to the original CBP parcellation results. Across atlases, a consistent hierarchy was observed: HIPS-THOMAS performed best, followed by TDI, ODF, and CBP (Kendall’s W = 1.00, p = 0.007). Histological atlases showed strong mutual agreement (Pearson r = 0.71–0.85), whereas the Zhang atlas demonstrated lower concordance (Pearson r = 0.51–0.63). Despite methodological advances, CBP remains constrained in its ability to delineate thalamic nuclei with histological accuracy. By contrast, structural and diffusion microstructural approaches provided better nuclear localization. These findings highlight the need for hybrid workflows that integrate structural and diffusion-based information to enable more reliable thalamic segmentation for neuroscience research.To assess the relationship between the structural position of individuals within their village network and symptoms of depression and postpartum depression, among men and women.
Community-based, observational, cross-sectional study.
176 villages in the Copan region of Honduras.
Village residents, comprising 25 605 adults surveyed in a census-based study; using data collected between October 2015 and December 2019.
Symptoms of depression and postpartum depression, among men and women.
Across all participants, 34.99% reported depression symptoms (40.50% for women and 27.62% for men). Among recent parents with a new child in the last 6 months, 28.89% reported postpartum depression symptoms (31.29% for women and 24.31% for men). Women with higher social intransitivity (ie, a greater proportion of friend-pairs among their friends that were not themselves connected) had higher odds of depression symptoms (OR=1.27, 95% CI 1.14 to 1.41), an association not found for men nor in postpartum parents. Because this coefficient is estimated on a 0–1 scale, it corresponds to approximately 2.4% higher odds of depression per 10 percentage-point increase in social intransitivity. In a signed-network decomposition that also included adversarial ties, only the proportion of incomplete/no-tie friend-pairs was associated with depression in women (OR=1.03, 95% CI 1.01 to 1.04), corresponding to approximately 3% higher odds of depression per 10 percentage-point increase.
We report that structural social network position and connectedness beyond dyadic ties, including the friendships and adversarial ties of a person’s friends, are associated with depression. These findings highlight the importance of linking psychological health to broader social connections in the context of face-to-face relationships.
Despite implementation of the National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), screening coverage for oral, breast and cervical cancers remains below 2%. Screening quality is inadequately addressed and delays in diagnosis and treatment initiation continue to persist. This multisite implementation research aims to improve district-level coverage and quality of screening, early diagnosis and timeliness of treatment initiation through a model co-developed within the NP-NCD context.
The study will be conducted in three phases across seven districts in diverse regions of India. In phase I (formative), the current status, barriers and facilitators of cancer screening, diagnosis and treatment initiation under NP-NCD will be assessed. In phase II (optimisation), a model (package of implementation strategies) will be co-developed and iteratively optimised with multistakeholder engagement at the subdistrict level to improve screening coverage and quality and strengthen the referral system for early diagnosis and treatment initiation. In phase III (scale-up and evaluation), the model will be implemented at the district level and evaluated for improvements in screening, early diagnosis and treatment initiation. A convergent mixed-methods design will be used, incorporating household surveys, facility assessments and stakeholder interviews. Implementation Research Logic Model will guide planning, execution and evaluation in the present study. Determinants of screening coverage and quality, early diagnosis and treatment initiation will be assessed using the Consolidated Framework for Implementation Research. Implementation strategies for the model will be finalised using the Expert Recommendations for Implementing Change framework. Implementation and service outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance framework.
Ethical approval has been obtained from all study sites. The study findings will be disseminated at the state, national and global levels through meetings and conferences and submitted to a peer-reviewed journal for publication.
CTRI/2025/08/092672.
This study aimed to evaluate the prevalence and metabolic, hormonal and clinical characteristics of metabolic syndrome among women with polycystic ovary syndrome (PCOS) in the Oran region (western Algeria).
Cross-sectional study.
Outpatient endocrinology and gynaecology services in the Oran region, western Algeria.
A total of 313 women aged 16–45 years diagnosed with PCOS according to the Rotterdam 2004 criteria.
Prevalence of metabolic syndrome and differences in anthropometric (body mass index (BMI)), metabolic (fasting glucose and lipid profile), hormonal (gonadotropins, androgens, anti-Müllerian hormone (AMH), progesterone, vitamin D) and clinical features (hyperandrogenism, menstrual irregularity, infertility) between women with and without metabolic syndrome.
Of the 313 participants, 181 (57.9%) met the criteria for metabolic syndrome. These women had significantly higher BMI (26.70±5.93 vs 25.06±6.47 kg/m²; p=0.004), elevated fasting glucose (133.43±28.52 vs 105.41±28.54 mg/dL; p
More than half of women with PCOS exhibited metabolic syndrome, characterised by obesity, dyslipidaemia, insulin resistance and vitamin D deficiency. These findings highlight the need for early metabolic screening and holistic management in women with PCOS to reduce long-term cardiovascular and reproductive risks.
To examine whether Indigenous Peoples’ and Local Communities’ (IPLC) ontologies are associated with knowledge, attitudes and practices (KAP) related to wildlife cohabitation and zoonotic disease transmission in biodiversity-rich areas of Latin America.
Cross-sectional household survey using a standardised KAP questionnaire. Ontologies were classified using latent class analysis. Associations between ontology classes and outcomes were assessed using multivariable logistic regression models.
Urban, rural and protected areas in biodiversity-rich regions of Bolivia, Brazil, Chile and Guatemala.
A total of 2903 individuals aged ≥10 years were recruited through random household sampling (response rate 85%).
Primary outcomes were defined according to the KAP framework. Knowledge outcomes comprised combined knowledge of zoonotic disease transmission from wildlife to humans and knowledge of zoonotic risks associated with wildlife trade. Perceived training needs related to zoonotic disease prevention were analysed as a secondary knowledge outcome measure. Attitudes were measured through risk perception, operationalised as concern about zoonotic disease transmission. Practices included self-reported hunting and slaughtering of wildlife.
The analysis identified three distinct ontology classes: Relational environmentalism (52% of the population), characterised by strong spiritual connections to animals and a tendency to protect wildlife; Dualistic environmentalism (28%), with a weaker spiritual connection to animals but a commitment to wildlife conservation; and Neutral (20%), demonstrating little spiritual connection to animals and a neutral attitude towards wildlife conservation. In the logistic regression analyses, both environmentalism groups exhibited greater knowledge of zoonotic transmission and concern about outbreaks, with members of the Relational class demonstrating higher levels of these attributes. Furthermore, members of the Dualistic environmentalism class were less likely to have close contact with animals.
In Latin America’s biodiversity-rich regions, individuals whose ontology aligns with environmentalism appear to demonstrate a heightened awareness of zoonoses, particularly those who adhere to a Relational environmentalism perspective. Consequently, the integration of IPLC cultural knowledge holds potential to enhance wildlife conservation measures and contribute to the mitigation of disease transmission. Further research is needed to explore causal pathways and the integration of culturally grounded approaches into public health interventions.
This study aimed to describe the factors influencing mental health and wellbeing from the perspective of Moroccan youth.
This is a descriptive cross-sectional survey.
All 12 regions in Morocco.
Perceived priority drivers of mental health and well-being among youth.
A total of 1182 participants were included (mean age 20.5 years, 68.2% female, 85.7% from urban settings). Regarding health and nutrition, 46.3% valued sleep, 59.7% emphasised physical health, 53.1% highlighted access to quality healthcare and 56.5% prioritised clean air. In terms of connectedness and contribution, 75.7% rated family relationships as critical to their well-being, while 42.5% emphasised positive peer relationships. Regarding safety and supportive environments, 64.7% considered personal safety essential, 70% prioritised the fulfilment of basic needs and 63.7% valued personal information protection. For education and competence, 54.4% emphasised learning opportunities and 62.2% identified self-confidence as key drivers. Regarding agency and resilience, 59.4% valued independence, 68.5% stressed having a sense of purpose and 55% identified hope and optimism as key to their well-being. In digital well-being, 37.7% believed social media helped maintain connections, 38% viewed it as a learning tool while 31.6% reported it as a source of stress and anxiety
This study provides valuable insights into priority drivers of youth mental health in Morocco from the perspective of Moroccan youth which should be the target for future interventions aiming to promote youth well-being. The findings contribute to the limited data on youth mental health in low and middle-income countries, highlighting the urgency for comprehensive mental health services and further research on subjective well-being.
Poststroke depression (PSD) affects approximately 33% of stroke survivors and is associated with worse outcomes, poor quality of life (QOL) and mortality. Despite its prevalence and consequences, there is no consensus on the most effective strategy for PSD prevention. Behavioural activation (BA) is an effective intervention for depression across diverse populations and is considered safer, better tolerated and a longer-lasting alternative to antidepressant medications. This study aims to test the effectiveness of a remotely delivered BA intervention to prevent PSD (Tele-BA-S).
We will conduct a randomised effectiveness trial of 350 low-income adults (≥ 55 years) within 3 months of ischaemic or haemorrhagic stroke and with subthreshold depression (Patient Health Questionnaire-9 score
Ethical approval was obtained by the University of Texas Health Science Center at Houston’s (UTHealth Houston) Committee for the Protection of Human Subjects Institutional Review Board. The trial protocol, statistical analysis plan and code, and deidentified participant data will be made available via the National Institute of Mental Health Data Archive. The results will be presented at academic conferences and submitted for publication. The authors declare that they have no conflicts of interest relevant to the content of this manuscript.
To evaluate the effectiveness of simulation on nursing students' translation into practice of clinical judgement, knowledge about the nursing process self-confidence and to comprehend the learning process and translation into clinical practice of competencies developed through clinical simulation in nursing students.
Two-arm, experimental, randomized controlled study designed using the explanatory sequential mixed method with qualitative step anchored in grounded theory.
Eighty undergraduate nursing students were allocated in practice groups and the groups were randomly assigned to an experimental (simulation; n = 39) or control group (study case; n = 41) and, after the intervention, participated in 3-day clinical practice activities and were assessed regarding clinical judgement, knowledge of the nursing process and self-confidence. Students in the experimental group were invited to focus groups.
Seventy-six students were analysed. The findings showed the effectiveness of simulation combined with clinical practice in the development and translation of clinical judgement (β = 5.03; p = 0.001) and knowledge of nursing process (β = 2.20; p < 0.001). There was no difference regarding self-confidence. A grounded theory emerged with three categories related to consolidation of prior knowledge, translating competencies into clinical practice and application of these competencies in nursing care that explain the theoretical category ‘learning and translating into clinical practice’.
Findings suggest that simulation combined with clinical practice can effectively enhance nursing students' clinical judgement and knowledge of the nursing process, facilitating the translation of these competencies into real-world practice. The qualitative findings suggest that simulation promotes meaningful learning and supports the practical application of nursing competencies.
This study supports the integration of simulation into nursing curricula to enhance clinical judgement and nursing process competencies. By promoting meaningful learning and facilitating knowledge transfer to clinical settings, simulation prepares students for real-world decision-making and strengthens the quality and safety of nursing care delivery.
No patient or public contribution.
RBR-7v374c6 (Brazilian Clinical Trials Registry) https://ensaiosclinicos.gov.br/rg/RBR-7v374c6
Diabetic foot ulceration (DFU) contributes significantly to diabetes-related morbidity and amputation. In Barbados, where amputation rates are among the highest globally, the influence of socioeconomic factors on ulceration outcomes remains underexplored. Educational attainment, a social determinant of health, may influence health behaviours, engagement with healthcare services, and ultimately clinical outcomes. This study examines whether educational attainment is associated with diabetic foot ulcer severity, as measured by the SINBAD scoring system, and six-week healing outcomes among inpatients with DFU. A prospective observational study was conducted over 6 months at Barbados' sole public hospital. A total of 176 participants admitted with a diagnosis of DFU were recruited. Baseline demographics, comorbidities, and ulcer characteristics were collected, and SINBAD scores were determined. Random forest modelling was employed to evaluate predictors of complete healing at 6 weeks and to assess ulcer severity stratified by educational attainment. Of the cohort, 17.5% reported primary education as their highest attainment level, compared with 2.9% of the general adult population. The mean SINBAD score was 2.45 among those with primary education and 2.51 among those with secondary education (p > 0.05). No statistically significant association was found between educational attainment and healing outcomes at 6 weeks. Educational attainment in this inpatient DFU cohort was lower than that of the general Barbadian population; however, it was not significantly associated with ulcer severity or six-week healing outcomes. In a universal healthcare setting, equitable access to care may attenuate the effect of educational attainment on clinical outcomes. These null findings highlight the need for future adequately powered studies incorporating health literacy assessment and key clinical confounders. Nonetheless, the observed disparity in educational attainment among DFU inpatients suggests that foot health education initiatives should be designed to be accessible to individuals across all educational levels.
by Yared Asmare Aynalem, Pauline Paul, Zohra S. Lassi, Salima Meherali
BackgroundAlthough Ethiopia introduced its first national preconception care (PCC) guideline in 2024, PCC remains rarely integrated into routine practice, and existing studies have largely focused on women’s knowledge and behaviors. Little is known about how adults navigate PCC within broader social, cultural, and structural contexts. This study provides an in-depth urban Ethiopian analysis of how adults experience and negotiate PCC within intersecting gender, moral, and institutional systems, offering insights beyond individual-level understanding.
MethodsAn interpretive description design guided semi-structured interviews with 18 adults (10 women, 8 men; 19–45 years) recruited through maximum-variation sampling from two public hospitals in Addis Ababa. Interviews were conducted in Amharic, transcribed, translated, and analyzed inductively. Data analysis was guided by ID principles, complemented by thematic analysis techniques informed by grounded theory, including line-by-line coding, constant comparison, and analytic memoing. Field notes captured contextual and relational dynamics.
ResultsSeven interrelated themes highlighted complex dynamics in PCC. Knowledge was fragmented and often recognized only after complications, shaped by marital gatekeeping, faith-based beliefs, and exclusion of unmarried women. PCC was valued as protective and morally significant, but stigma, poverty, staff shortages, and inconsistent services constrained practice. Men were largely financial supporters, though many expressed a desire to participate, limited by gender norms and women-centered services. Pharmacies and digital media provide informal but sometimes unsafe guidance. Emotional experiences, fear, guilt, secrecy, and hope were central to PCC engagement. Education, peer influence, schools, and community leaders emerged as catalysts for uptake, yet participants emphasized that sustainable PCC required visible institutional support, reliable services, and government recognition. Strategies to enhance practice included simplifying communication, creating accessible clinic entry points, and mobilizing community networks to normalize pre-pregnancy preparation.
ConclusionsThis study reveals PCC in urban Ethiopia as a socially negotiated, morally contested, and structurally uneven practice, far more complex than knowledge deficits imply. These findings offer novel, actionable direction for implementing Ethiopia’s PCC guideline through visible, inclusive, relational, and community-anchored approaches that address the social conditions shaping PCC access.
This study aimed to explore how persons living with a hard-to-heal wound and their family members experience care. The inclusion criteria for patients were wounds that had persisted for more than 6 weeks or hard-to-heal wounds that had recently healed. The study included 16 participants (13 patients and 3 family members) from primary healthcare services in Örebro County, Sweden. The interview data were transcribed and analysed using reflexive thematic analysis. One overarching theme was generated: Navigating an uncertain path towards healing, along with three subthemes: (1) Striving to be an active agent, (2) Being part of collaboration efforts and (3) Being a bystander in the search for the right treatment. Together, these themes illustrate how patients and family members engaged in an uncertain care process as they sought to understand the condition and manage care in everyday life. These everyday efforts reflected forms of invisible agency, as participants did not always recognise them as meaningful contributions to wound care. The findings highlight the importance of person-centred approaches that recognise and value patients' and family members' everyday contributions to wound care and support self-management through partnerships among patients, family members and HCPs.
The diagnosis of cancer results in psychophysiological distress in patients, significantly reducing quality of life (QoL). Currently, self-management interventions based on e-health have been used to improve QoL among cancer patients, but the overall effects remain inconsistent.
To assess the impact of self-management interventions based on e-health on the QoL of cancer patients.
Studies were retrieved from six databases up to November 6, 2024. The methodological quality assessment was performed via ROB 2. Data synthesis and subgroup analyses were performed in Review Manager 5.3. Meta-regression was conducted using Stata 15.0.
Thirty RCTs were included. The results of meta-analysis revealed self-management interventions based on e-health significantly improved QoL (SMD = 0.18, 95% CI: 0.08 to 0.28, p < 0.01). Subgroup analyses showed that long-term, mixed-mode, theory-supported, or facilitator-supervised interventions were more effective, with greater improvements in QoL observed among patients with breast cancer than among other types.
Self-management interventions based on e-health were valuable supplements for enhancing the QoL of cancer patients. Intervention duration, delivery modes, cancer types, theoretical frameworks, and facilitators' involvement should be considered in the design of future interventions. However, additional high-quality studies are needed to confirm these findings.
The protocol was registered on PROSPERO (Registration number: CRD420251017709)
Numerous studies focus on women’s experiences of intimate partner violence (IPV), but there is a lack of qualitative studies focusing on women who, as victims, become perpetrators. The study explored the lived experiences and perceptions of incarcerated women convicted of IPV against their partner in Maputo, Mozambique.
A qualitative approach was utilised with females purposively sampled for one-on-one semi-structured interviews in the Maputo female prison setting. Data were analysed using Interpretive Phenomenological Analysis (IPA).
Nine females over the age of 18 convicted and incarcerated for perpetrating IPV against their violent partners.
The analysis revealed three themes: Theme 1: Childhood exposure to violence, with subthemes: direct violence in childhood, witnessing violence in the family and the role of alcohol consumption in violence within the family. Theme 2: Living in a violent intimate relationship with subthemes: psychological violence, coping strategies as victims of IPV and use of self-defence during violent episodes. Theme 3: Consequences of IPV perpetration, with subthemes incarceration experience, mistrust of prison psychology services, disintegration of their families and plans for the future.
Mozambican women incarcerated for IPV described their lived experiences marked by family violence growing up and IPV in their relationships and how this may have shaped their coping strategies, risk appraisal and responses to threat. These factors were central to understanding the circumstances that preceded their offence. The women identified a current need for psychosocial services independent of prison staff. Sustained investment in IPV prevention and victim protection services is warranted to potentially reduce both prolonged victimisation and the risk of subsequent lethal violence.
To summarise the evidence on long-term and infrequent harms following selected spinal and paraspinal injections and denervation procedures for chronic non-cancer spine pain.
Systematic review and meta-analysis.
MEDLINE, EMBASE and Cumulative Index to Nursing and Allied Health Literature from inception to October 2023.
Non-randomised studies reporting on harms of selected interventional procedures administered to adults living with chronic axial or radicular non-cancer spine pain with ≥4 weeks of follow-up.
A parallel guideline panel provided input on the scope, design and interpretation of this systematic review, including selection of adverse events for consideration. Systematic literature screening, data abstraction and risk of bias appraisal were conducted independently and in duplicate by pairs of reviewers. We used random-effects models for all meta-analyses and the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the certainty of evidence.
We included 60 longitudinal studies (56 non-comparative, 4 comparative) that enrolled 4966 patients with chronic non-cancer spine-related pain. 31 studies investigated radiofrequency ablation or denervation, 22 epidural injections and 11 joint injections or nerve blocks. Low certainty evidence suggests that joint targeted steroid injection and epidural steroid injection for chronic spine pain may result in temporary altered level of consciousness (incidence: 2.1%; 95% CI 1.1% to 4.0%), joint radiofrequency nerve ablation, joint targeted steroid injection and epidural injection of local anaesthetic and steroids may result in deep infection (incidence: 0.7%; 95% CI 0.3% to 2.0%), epidural steroid injection, joint radiofrequency nerve ablation and joint targeted injection of local anaesthetic and steroids may result in dural puncture (incidence: 1.4%; 95% CI 0.5% to 4.3%), and dorsal root ganglion radiofrequency and joint radiofrequency nerve ablation with or without joint-targeted injection of steroids may result in prolonged pain or stiffness (incidence: 8.6%; 95% CI 6.3% to 11.6%). Several interventional procedures may result in metabolic complications and prolonged sensory deficits, but the supporting evidence was only very low certainty. Most complications resolved spontaneously or with conservative management.
Low certainty evidence suggests that several common interventional procedures for chronic spine pain show risk of deep infection, dural puncture, temporary altered level of consciousness and prolonged pain or stiffness. Other harms are uncertain due to very low certainty evidence, and catastrophic outcomes were not reported in the small studies that contributed to our analyses.
To examine the prevalence and sociodemographic factors associated with tobacco smoking, smokeless tobacco and dual use among adults in Ghana using the 2022 Demographic and Health Survey (GDHS).
Ghana, nationwide sample of males and females aged ≥15 years.
This was a cross-sectional secondary analysis of the 2022 GDHS.
A representative sample of 22 058 individuals (females, 15 014 aged 15–49; males, 7044 aged 15–59)
Current tobacco smoking, smokeless tobacco use and dual use.
Prevalence for smoking, smokeless tobacco and dual use was 4.7 (4.1–5.4), 1.6 (1.3–2.0) and 0.6 (0.4–0.9) among males and 1.0 (0.8–1.3), 0.08 (0.05–0.1) and 0.1 (0.05–0.1) among females, respectively. Among males, smoking was associated with higher age (30–44 years: AOR: 2.3, 95% CI 1.7 to 3.1; 45–59 years: AOR: 2.6, 95% CI 1.8 to 3.7). Higher education was protective for both sexes [(males: AOR: 0.4, 95% CI 0.2 to 0.8) and (females: AOR: 0.4, 95% CI 0.2 to 0.8)] compared with their counterparts who had no education. Males in the Coastal zone had higher odds of use (AOR: 1.8, 95% CI 1.3 to 2.3) compared with males in the Middle zone, while females in the Northern/Savanna zone had lower odds of tobacco use (AOR: 0.5, 95% CI 0.3 to 0.8) compared with the Middle zone. Being Christian was associated with lower odds of smoking among males (AOR: 0.3, 95% CI 0.2 to 0.5) compared with others, while being Mole-Dagbani ethnic is associated with higher odds of smoking among females (AOR: 3.0, 95% CI 1.7 to 5.4).
The study provides the first national analysis across Ghana’s 16 regions and investigates patterns of smoking, smokeless tobacco and dual tobacco use. While tobacco use in Ghana remains predominantly smoked and male-driven, the divergent patterns of use across educational, regional and ethnic groups, especially the emerging risk among females, represent a significant public health shift that demands focused gender-sensitive tobacco control interventions.
Approximately one-third of people with epilepsy (PWE) experience resistance to treatment, including pharmacological therapies, epilepsy surgery, vagus nerve stimulation (VNS) and dietary interventions such as the ketogenic diet (KD). Emerging evidence suggests that the gut microbiota may influence seizure susceptibility and treatment response through the microbiota-gut-brain axis, potentially contributing to treatment resistance. The MiCrobiota-gut-brain Axis in Resistant Epilepsy project investigates how gut microbial features and associated host epigenetic signatures affect clinical outcomes in PWE undergoing diverse treatment strategies.
This is a multicentre, prospective, longitudinal study involving four clinical centres in Italy and one self-financing partner. Participants aged 3–50 years will be enrolled and stratified into four intervention cohorts: newly diagnosed drug-naïve epilepsy scheduled to start anti-seizure medications, focal drug-resistant epilepsy (DRE) undergoing epilepsy surgery, DRE receiving VNS, and DRE initiating KD. Clinical assessments (including body mass index calculation, self-reported monthly seizure count, dietary evaluation, quality of life scale and gastrointestinal symptoms scale), electroencephalography, MRI and biological sample collection (stool and blood) will be obtained at baseline and longitudinally at two or three timepoints over a 12-month observation period. Gut microbiota changes over time will be assessed via metagenomics (using 16S ribosomal RNA sequencing) and metaproteomics; the associated host DNA methylation profiles will be obtained from blood using Illumina EPIC arrays. Primary endpoints include identification of microbial or host methylation changes predictive of therapeutic response (ie, reduction from baseline in monthly seizure count) to the intervention. Data will be analysed using multivariate models and mixed-effect regression. Further, omics data and corresponding metadata will be integrated using multi-omics approaches to identify molecular signatures biomarkers predictive of treatment response and prognosis in PWE.
The study received ethical approval from the Research Ethic Board (Comitato Etico Territoriale Lombardia 3, ID 4896 – parere numero 4896_17.07.2024_N_bis). All participants or their legal guardians will provide written informed consent. Results will be disseminated through peer-reviewed publications, conference presentations or lay summaries targeting patient organisations.
ClinicalTrials.gov Identifier NCT07010445, registered on 2 May 2025.
Patient safety is crucial in healthcare, especially in home-based settings where unregulated environments and limited supervision pose unique challenges. With the expansion of home healthcare due to an ageing population and healthcare workforce shortages, there is a pressing need for tools to assess patient safety culture in this context. Current instruments, developed for hospitals, do not adequately address the specific dynamics of home healthcare, such as patient autonomy and caregiver involvement. This protocol outlines the development and validation of the Patient Safety Culture in Home Health Care Centers Instrument (PSCHCI), using a sequential exploratory mixed-methods approach.
This sequential exploratory mixed-methods protocol consists of three phases. Phase 1 fieldwork (semi-structured interviews with 15 participants, 3 participant observations and field notes) has been completed. Qualitative data are currently being analysed using conventional content analysis. The scoping review component of Phase 1 is planned but has not yet been conducted. Phase 2 (instrument development) is planned to include item generation from qualitative results followed by expert panel review. Phase 3 (psychometric evaluation), scheduled for late 2026, will employ a cross-sectional study to assess face, content and construct validity; reliability; interpretability; and feasibility. This phase features pilot testing (n=30–50), face and content validity assessment (n=10 each), test-retest reliability (n=15) and exploratory and confirmatory factor analyses (n=300–400).
Ethical approval was obtained from the Ethics Committee of Iran University of Medical Sciences. All participants will provide written informed consent. Confidentiality, voluntary participation and withdrawal rights are guaranteed. Findings will be published in peer-reviewed journals, presented at conferences and shared with participating home healthcare centres, policymakers and stakeholders.
To examine the impact of the COVID-19 pandemic on body mass index (BMI) and obesity status among Canadian residents and explore how this association varied by sociodemographic and health status.
Prospective cohort study.
Canada.
41 302 adults, aged 45–85 at baseline, participating in the Canadian Longitudinal Study on Aging.
BMI and BMI-defined obesity were measured at baseline, follow-up 1 and follow-up 2 (FUP2), with 33% of FUP2 data (n=13 444) gathered after 16 March 2020, when COVID-19 restrictions began. Correction factors were applied for self-reported BMI and weighted generalised estimating equations assessed BMI changes before and during the pandemic.
We found a significant interaction between follow-up time and timing of FUP2 data collection (before or during the pandemic). Participants measured during the pandemic had an excess BMI increase of 0.21 kg/m² (95% CI 0.15 to 0.28) and 1.06 times higher odds of obesity (95% CI 1.03 to 1.09) compared with prepandemic trends. Increases were more pronounced among females, middle-aged adults and those without diabetes.
The COVID-19 pandemic was associated with a modest increase in BMI and obesity among Canadian adults. Ongoing research is needed to assess long-term trends.