Early childhood caries (ECC) continues to be a public health problem. The application of silver diamine fluoride (SDF) is a simple, non-invasive procedure. This study aims to evaluate SDF’s effectiveness, acceptability and oral health-related quality of life (OHRQoL) compared with atraumatic restorative treatment in managing ECC.

An open-label parallel superiority randomised clinical trial will be conducted involving children aged 2–5 years. Participants will include children with at least one active cavitated lesion (ICDAS 5+) of their primary teeth, with no signs of pulp involvement. The trial will occur at preschools in the La Araucanía and Metropolitan Regions of Chile from 2025 to 2027. The primary outcome variable will be the caries lesion arrest, acceptability and OHRQoL. We will also determine the presence of any adverse effects. Evaluations will be carried out at 6 and 12 months. A sample of 234 teeth with carious lesions per group is estimated. The primary inferential analysis will be performed on an intention-to-treat basis; a per-protocol analysis will be conducted for adverse effects. For caries lesion arrest, a multilevel logistic regression model adjusted for significant covariates will be used to account for within-child clustering. The acceptability will be assessed through quantitative and qualitative methods. The magnitude of change in OHRQoL between baseline and follow-up will be quantified using effect size estimates derived from the early childhood health impact scale survey data.

This study’s implementation benefits the study population, and the ethical principles of research have been considered and approved by the Science Committee of the University, Resolution N°049_19. The results and conclusions of the clinical trial will be published in academic conferences and peer-reviewed journals.

NCT06786975.

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

NCT07050823/NCT07093021/NCT07134855.

Despite the benefits of early diagnosis, most cancers in sub-Saharan African (SSA) countries are diagnosed at an advanced stage due to late presentation of symptoms, inadequate referral systems and poor diagnostic capacity. Health communication interventions have been used extensively in high-income countries to increase people’s awareness of cancer symptoms and encourage timely help-seeking. However, in SSA, there is still limited evidence on the effectiveness of these interventions and existing evaluations are mainly focused on communicable diseases rather than cancer.

A randomised, multisite, controlled community trial will evaluate a culturally tailored health infographic toolkit delivered in rural and urban settings in the Western Cape Province in South Africa and Harare and surrounding provinces in Zimbabwe. Participants will be randomised to receive one of three African aWAreness of CANcer and Early Diagnosis (AWACAN-ED) cancer awareness tools, coproduced with local communities, comprising health communication infographics with descriptions of breast, cervical and colorectal cancer symptoms plus messages to encourage consultation with primary care providers if symptoms occur, all presented in English and four local languages. We will recruit 144 participants in each of the three intervention groups (N=432). The primary outcome will be recall of symptoms and the secondary outcomes will be (1) intention to seek help, (2) emotional impact and (3) acceptability of the toolkit. Outcomes will be measured preintervention and at two points postintervention: after 15 min and 1 month.

Ethical approval was obtained in both participating countries, South Africa (148/2025) and Zimbabwe (363/2021). All participants will be required to provide written informed consent prior to participation. Findings will be disseminated through peer-reviewed publications, conference presentations and the AWACAN-ED programme website.

PACTR202505475803308.

Heart failure (HF) remains a major global health challenge, particularly in low-resource settings where access to comprehensive cardiac rehabilitation (CR) is limited. Yoga, a culturally contextualised mind-body intervention, holds promise as an adjunctive therapy in CR. The Yoga-EndOmics study aims to evaluate the effects of Yoga-based cardiac rehabilitation (Yoga-CaRe) on gene expression, endothelial function, vascular biomarkers and clinical outcomes in systolic HF, providing mechanistic insights into its potential integration into conventional cardiac rehabilitation.

This is a prospective, randomised, open-label, blinded-endpoint (PROBE) mechanistic trial enrolling 78 patients with HF with reduced ejection fraction (HFrEF). Participants will be randomised in a 1:1 ratio to receive either a structured Yoga-CaRe intervention or enhanced standard care for 3 months. The Yoga-CaRe group will attend 20 supervised sessions with guided home practice involving tailored asanas, pranayama and meditation. Primary outcomes are changes in endothelial-dependent flow-mediated dilation (FMD) and functional exercise capacity at 3 months. Secondary outcomes include changes in arterial compliance and stiffness, circulating biomarkers of endothelial dysfunction, oxidative stress and inflammation, and immediate changes in global gene expression profiles in peripheral blood mononuclear cells following the Yoga-CaRe intervention. Data will be analysed using analysis of covariance (ANCOVA) for between-group comparisons and significant analysis of microarray (SAM) for global gene expression profiles.

The study has received ethical clearance from the Institutional Ethics Committee of the SDM College of Medical Sciences and Hospital, India (SDMIEC/2025/1072) and is registered with the Clinical Trials Registry of India. Findings will be disseminated through peer-reviewed journals, scientific conferences and stakeholder engagement platforms to inform future integrative strategies in HF management.

CTRI/2023/12/060758

The objective of this study was to determine the association between viral subtype/clade and disease severity.

Multicentre retrospective cohort study.

This study used data from the Global Influenza Hospital Surveillance Network (GIHSN). The dataset comprised hospitalised influenza patients with viral sequencing data across 14 countries, collected from August 2022 through October 2023.

A total of 761 hospitalised patients were enrolled during the study period, and 745 patients were included in the analysis. We excluded patients with missing data on explanatory or outcome variables, those infected with viral clades represented by fewer than 11 sequences, and those enrolled at study sites contributing fewer than 5 patients.

Disease severity was defined by admission to intensive care unit (ICU), receipt of non-invasive oxygen supplementation, 3-variable definition (ICU, mechanical ventilation or death) or 4-variable definition (3-variable plus oxygen supplementation).

Outcomes were analysed in association with subtype or clade using the mixed-effects logistic regression models, adjusting for age group, sex, underlying medical conditions, influenza vaccination status, antiviral use, country income level and epidemic period, while study site was included as a random effect.

745 patients were included: 263 A(H1N1)pdm09, 380 A(H3N2), 102 B/Victoria. A(H1N1)pdm09 infection was associated with increased odds of ICU admission (adjusted ORs (aORs) 2.5, 95% CI 1.1 to 5.8) compared with A(H3N2). 6B.1A.5a.2a.1 clade of A(H1N1)pdm09 was associated with increased severity compared with 6B.1A.5a.2a clade (aOR 3.0, 95% CI 1.0 to 9.5) and (aOR 5.4, 95% CI 1.6 to 18.3) for the 3-variable and 4-variable definitions respectively. Among A(H3N2), the (3C.2a1b.2a.)2b clade showed a trend toward increased severity using the 4-variable definition compared with the 2a.1b clade (aOR 2.9, 95% CI 0.8 to 10.0).

This analysis highlights the differential impact of influenza subtypes and clades on disease severity in hospitalised patients. Future research should investigate the role of specific viral mutations of these clades in modulating immune evasion or disease severity. These findings reinforce the GIHSN’s critical role in global surveillance. Ongoing genomic surveillance is crucial for understanding the clinical impact of emerging influenza variants and informing public health responses.

Binge drinking in the previous month was reported in 23.5% of US adults, and 28.1 million adults met criteria for Alcohol Use Disorder (AUD) in 2023. Individuals with AUD face increased risks of oral health problems, including caries, periodontal disease and mucosal lesions. Poor oral hygiene, nutrition and dental care all contribute to these conditions, but individuals with AUD are often under-represented in oral health surveys. Understanding relationships between oral health behaviours, attitudes and general health is crucial for designing future interventions. This pilot aims to explore the relationship between oral and systemic health in subjects with AUD, focusing on oral health behaviours, salivary biomarkers and clinical phenotype, including systemic biomarkers of inflammation, to inform future research on oral–systemic interactions in AUD.

This protocol has two parts. Part 1 involves cognitive interviews to assess the content validity and interpretability of the Oral Health Behaviours Assessment (OHBA) questionnaire. Part 2 will collect biological and behavioural data from treatment-seeking patients with AUD and matched controls (age, sex and smoking status), including saliva, blood, dental exams, and health behaviour and symptom measures. Inpatients with AUD will provide biospecimens and answer symptom severity questionnaires at admission and again at the dental exam visit (7–12 days later), while controls will provide a single set of measures at their dental exam visit. Oral health will be assessed through structured dental and periodontal examinations, radiographs and validated questionnaires (including the OHBA). Additional data will include alcohol use history, psychiatric and medical history assessments, dietary recall, and measures of stress, sleep and mood to capture potential moderators of oral–systemic relationships. Biomarkers of inflammation and stress will be quantified from saliva and blood using immunoassays. Primary outcomes will compare oral health, salivary biomarkers and clinical measures between AUD and controls, while secondary outcomes will evaluate within-subject changes in patients with AUD during inpatient treatment and early abstinence.

This clinical protocol was approved by the National Institutes of Health Institutional Review Board (IRB #002005). Prior to enrolling, participants will be informed of the study purpose, risks and benefits, and study procedures, and evaluated for understanding prior to signing consent. Part 1 of the protocol is currently active and recruiting participants for cognitive interviews. The study findings will be disseminated through journals and conferences related to addiction medicine, psychology, immunology, neuroscience and dentistry. We expect the results of the pilot study will inform future research on oral health and salivary bioscience while also providing treatment-seeking patients with AUD targeted information on the importance of oral health behaviours for maintaining oral and systemic health.

NCT06684483; preresults.

In a rapidly evolving world shaped by digital transformation, digital technologies are increasingly being used in healthcare. To use them effectively, nursing staff, patients and their caregivers need the appropriate skills. To date, digital literacy in general, digital skills and (digital) technologies have played a minor role in German nursing curricula. In addition, little is known about the use of technology in nursing education and about effective ways to enhance digital competence. This scoping review aims to identify current literature on innovative and experiential-based teaching and learning methods for developing competence in technology and digitalisation for nurses and informal caregivers, as well as digital technologies that are being used in this educational context.

This scoping review, which will be designed and conceptualised using the Joanna Briggs Institute methodology for conducting scoping reviews, will take place from April 2025 to January 2026. The search will be conducted on the databases CINAHL, Emcare, Embase, Medline and ERIC. Screening and extraction will be peer reviewed and follow predefined criteria, as well as opportunities for free-text responses. The extracted data will be analysed using absolute and relative frequencies. Free-text responses will be analysed using qualitative content Analysis.

As an ethics vote is not required to conduct a scoping review, this will not be obtained. The results will be disseminated via open access publication in a peer-reviewed journal and through presentations at conferences.

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

The purpose of this article is to share insights from the National Institute for Health and Care Research Clinical Research Network (NIHR CRN) in delivering research for Multiple Long Term Conditions (MLTC) and to highlight lessons of wider relevance across the research ecosystem.

Designing health and care systems to be more responsive to the needs of people living with MLTC requires a considerable evidence base. When compared with research focused on a single disease area, research relating to MLTC raises unique considerations at the stages of planning, placing, and delivering research studies. Our article describes challenges associated with MLTC research outcomes and outlines different types of interventions to target MLTC, along with related research delivery considerations. Our article also raises important considerations for placing research in the most appropriate setting and highlights the vital role of robust feasibility studies, informed by the lived experience of patients and carers with MLTC, for ensuring that studies are conducted, recruited to, and completed in a timely and appropriate way.

Increasing the evidence base for the prevention and management of MLTC is a necessity for our health and care system. This presents novel challenges that require collaboration between multiple stakeholders. The UK benefits from a unique research infrastructure, including support for the stages of planning and delivery of health and care research. As the health and care system moves towards bringing care closer to patients and service users, the appropriate selection of the health and care settings and research sites in which to deliver MLTC research, in addition to understanding and removing barriers to recruitment and participation for people with MLTCs, are important considerations to enable us to collectively respond to this challenge.