Non-communicable diseases are the leading causes of premature mortality worldwide. Both genetic predispositions and environmental exposures affect disease risk. While biobanks have increased understanding of genetic predictors of these diseases, environmental influences are expected to have a greater impact on disease development. Individuals also create their own environments and lifestyles based on genetically regulated preferences, leading to gene–environment interactions that require large datasets to study. Finnish biobanks typically lack sufficient lifestyle and environmental data, which limits their use. We present a protocol for a biobank-recall study (BioRecall) to collect data on lifestyle and environmental exposures and combine these findings with genotypes, biological samples and clinical outcomes.

All previously genotyped donors from the Central Finland Biobank who have been diagnosed with type 2 diabetes and have consented to recall will be invited to participate in the pilot study. The preliminary feasibility assessment reveals that there are 1580 suitable candidates. Participants will complete an electronic questionnaire on a secure online platform. The questionnaire includes validated questions on lifestyles, anthropometrics, weight loss history, health, symptoms, work characteristics, emotional states and residential environments. Postcode information will facilitate the addition of spatial environmental data. Genotype and related clinical data will be provided in the study in accordance with the Finnish Biobank Act and combined with questionnaire data.

The Human Sciences Ethics Committee of the University of Jyväskylä delivered a favourable statement regarding the study protocol (1671/13.00.04.00/2023). Central Finland Biobank approved the research plan (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the participants’ consent. Permission for data usage can then be applied through standard protocols of the Fingenious service (https://site.fingenious.fi/en/). If successful, the study will be expanded to other donors and Finnish biobanks.

Suboptimal feeding practices in children under five remain a critical concern, particularly in low- and middle-income countries. Integrated Supplementary Feeding programmes (SFPs) combined with Social and Behaviour Change Communication (SBCC) interventions have shown potential, yet global evidence on their design and effectiveness remains scattered across diverse settings and varies widely in scope and quality. This review aims to map global evidence on integrated SFP and SBCC interventions for children aged 6–59 months, assessing their impact on anthropometric, biochemical, nutritional, health, developmental, functional, microbiological and infant and young child feeding (IYCF) outcomes, and to identify contextual factors, evidence gaps and successful strategies. The review will also aim to document cost effectiveness and economic outcomes of this integrated intervention.

The review will follow Joanna Briggs Institute (JBI) methodology, applying the Population–Concept–Context framework and the review title has been registered in Open Science Framework (OSF) (https://doi.org/10.17605/OSF.IO/ZJ5BG). Eligible studies published between 2000 and 2025 will include community-based interventions for children under five that combine SFP and SBCC. The review will focus on SFP interventions delivered through community-based or public health platforms, including but not limited to take home ration, hot cooked meal, micronutrient powders, coupled with SBCC modalities such as home visits, mobile health and mass media campaigns. Comprehensive searches will be conducted in MEDLINE (PubMed), Cochrane CENTRAL, Google Scholar and organisational websites. Two independent reviewers will screen, extract and appraise studies using Covidence and JBI tools. Data will be analysed using descriptive statistics to summarise study characteristics, intervention types and reported outcomes, helping understand patterns across time and settings. Qualitative findings will be synthesised through descriptive content analysis involving coding and theme development. Expected outcomes include a range of study designs from different settings across the globe, covering diverse delivery models of integrated SFP and SBCC with reported outcomes including dietary indicators, anthropometry, nutritional biomarkers, caregiver practices and cost-effectiveness.

This review is part of a larger cluster randomised controlled trial (NECCTAR) which has received ethical approval from the independent institutional ethics committee of all the participating institutes. The current review will involve only publicly available literature and does not have a separate institutional ethics committee approval. Findings will be disseminated through academic conferences and publications in peer-reviewed journals.

The review title has been registered in OSF (https://doi.org/10.17605/OSF.IO/ZJ5BG).

Alcohol is causally related to more than 200 diseases and injuries. Alcohol health warning labels are a promising intervention to address alcohol-related harm with multiple possible roles, but research on its real-world impacts is lacking. This study aims to experimentally evaluate the impact of exposure to two types of content (responsibility and cancer message) and positioning of the message (front or back) on knowledge of alcohol causing cancer as the primary outcome and alcohol consumption behaviour, intentions, risk perception, emotional response, product appeal and policy support as secondary outcomes. The study also aims to assess the potential testing effect of pre-measurement on the primary outcome.

Participants (of the legal drinking age in Spain (18 years or older), purchased at least one alcoholic beverage (with alcohol by volume (ABV) ≥ 1.2% for their own consumption and speaking Catalan or Spanish) will be recruited outside of supermarkets in Barcelona after purchasing alcohol, randomly assigned into one of the eight experimental groups, complete a baseline questionnaire (with half of the sample answering baseline questions measuring knowledge) and receive label stickers displaying either responsibility or cancer message, and applied to either front or back of every alcohol container they have purchased. They will complete follow-up surveys measuring the primary and secondary outcomes 1 week and 1 month after the intervention, either online or via telephone. The key hypotheses are that the label containing a cancer message will have a greater impact on the primary and secondary outcomes compared with the responsibility label. To evaluate the impact of health warning labels on knowledge of alcohol causing cancer, logistic regression will be employed to model the probability of a correct response as a function of the key independent variables, with results reported as ORs. Secondary outcomes will be modelled through linear regressions for continuous variables, and through logistic regressions for dichotomic variables or categorical variables that will be dichotomised a priori. The target sample size is 1300 participants.

The study has been approved by the Ethical Committee for Research with Medicines (CEIm) IDIAP Jordi Gol (24/228-P) and the Ethical Research Committee of the WHO (ERC.0004213). The results will be disseminated in peer-reviewed journals, on social media and policy fora in national, European and global context, and will inform WHO and European Union-level policy recommendations.

European Commission, Directorate General for Health and Food Safety, SANTE/2022/SI2.883729.

NCT06915298. https://clinicaltrials.gov/study/NCT06915298

Women who use drugs in Tanzania face a disproportionately high burden of HIV and mental health disorders. Despite the availability of pre-exposure prophylaxis (PrEP), uptake remains low, highlighting the need for integrated, scalable interventions that address co-occurring substance use and mental health challenges. Motivational interviewing (MI) and cognitive-behavioural approaches, such as the Common Elements Treatment Approach (CETA), show promise for enhancing HIV prevention outcomes in this population. This study presents the protocol for a pilot feasibility trial assessing the acceptability, feasibility and preliminary efficacy of MI for PrEP (MI-PrEP) and a combined CETA and MI-PrEP intervention (CETA + MI-PrEP) to improve PrEP engagement among women who use drugs in Tanzania.

This individually randomised, parallel-group pilot trial will be conducted in Dar es Salaam, Tanzania, guided by the situated Information, Motivation and Behavioral Skills model. Eligible participants are adult women who use heroin, report recent drug-related or sex-related HIV risk behaviours, are HIV-negative and exhibit symptoms of depression, anxiety or post-traumatic stress disorder. Participants are randomised to one of three arms: MI-PrEP, CETA + MI-PrEP or enhanced treatment as usual. Interventions are delivered face-to-face by trained counsellors. Feasibility and acceptability will be assessed using recruitment and retention data, surveys and qualitative interviews. Preliminary effects will be measured for PrEP initiation, symptoms of common mental disorders and substance use.

Ethical approval has been obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board (25580), the Muhimbili University of Health and Allied Sciences Ethics Review Committee (MUHAS-REC-12-2023-1994) and the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4830). Results will be disseminated through ClinicalTrials.gov, peer-reviewed publications, conferences, presentations and research briefings to community stakeholders.

ClinicalTrials.gov ID: NCT06835751. Initially registered 14 February 2025, https://clinicaltrials.gov/study/NCT06835751, last updated 5 December 2025.

Older inpatients face a higher risk of delirium, falls and functional decline during hospital stays. Volunteer programmes have been shown to improve patient outcomes in single settings, but little is known about their implementation and spread across multiple care environments. This study describes the implementation and system-wide spread of Maximizing Ageing Using Volunteer Engagement (MAUVE)—a volunteer-based programme supporting older patients’ cognitive, physical and social well-being—and evaluates its impact on healthcare staff satisfaction.

A prospective observational service evaluation.

Emergency department, seven acute in-patient care units and two transitional care units within a Canadian hospital system from January to December 2019.

Older patients receiving care, volunteers delivering interventions and front-line nursing staff.

Trained volunteers delivered up to six types of interventions targeting patients’ cognitive stimulation, physical activity, social engagement, functional support, orientation and companionship.

Staff satisfaction with the MAUVE programme was measured using a structured survey administered 6 months after programme implementation. Data on patients and volunteers—including the number and type of interventions delivered, volunteer hours and patient reach—were also collected to assess feasibility and programme uptake.

Over 12 months, 94 volunteers delivered 31 593 interventions to 3568 unique patients across three care settings. Front-line staff reported high satisfaction with the MAUVE programme, noting that volunteers enhanced patient care and enabled more direct patient interaction by staff.

The MAUVE programme is the first known volunteer-led patient engagement programme to be successfully implemented across acute, emergency and transitional care settings. This service evaluation demonstrates that structured volunteer engagement can support older patients’ well-being while enhancing staff satisfaction and enabling front-line care providers to deliver more direct care.

Immunisation is one of the most valuable, impactful and cost-effective public health interventions which delivers positive health, social and economic benefits. Globally, 4 million deaths worldwide are prevented by childhood vaccination every year. In Ethiopia, despite huge progress being made, the routine immunisation coverage has never reached the targeted figures and planned goals. Pastoralist communities are often disproportionately under-vaccinated, and there is often a confluence of interrelated factors that drive this outcome. This study enables us to identify factors affecting immunisation service utilisation in the pastoralist communities of Ethiopia, which helps to design effective and context-specific interventions.

This study aims to explore the behavioural and social drivers (BeSDs) of routine immunisation among the communities with high numbers of zero-dose and under-immunised children in Afar, Somali and Gambella regions of Ethiopia.

A qualitative exploratory study was conducted in three selected regions of Ethiopia (Gambella, Somali and Afar) from 9 November 2023 to 30 December 2023. Purposive sampling was used. A total of 33 interviews were conducted in the three regions. Sample size was determined based on idea saturation. Data was collected using interview guides. The interview guide was developed after reviewing relevant literature, desk review and using the journey to health and immunisation framework. A separate interview guide was developed for the journey mapping exercise, in-depth interview, healthcare workers discussion guide, focus group discussion and observation. Data was analysed thematically.

Behavioural (lack of awareness, lack of reminder/forgetting, misperception about vaccines, negative previous experience, lost card and fear of post-vaccination adverse events).

Structural (language barrier, long distance from home to facility, high cost of transportation, long waiting time, limited training of healthcare professionals and incentives, inconvenient service hours, shortage of health professionals, disrespect by the healthcare provider), Socio-cultural (competing priorities, low community engagement, lack of decision-making autonomy, limited husband involvement, workload, rural residence and larger family size were the commonly mentioned barriers to routine immunisation uptake. On the other hand, structural (house to house visit by health extension workers, counselling about adverse events, presence of outreach service, affordability (free of charge)), behavioural and socio-cultural (knowledge of adverse event management, and respect from community) were enablers to routine immunisation service uptake in pastoralist communities.

The study found several individual and contextual factors affecting routine immunisation uptake in pastoralist communities. Context-specific and tailored interventions which address zero dose drivers should be designed so as to enhance vaccine uptake. The findings suggested the need to design context-specific interventions to address the aforementioned barriers to immunisation.

To explore the experiences of different stakeholders on the balance of package training and deployment of highly skilled Human Resources for Health for specialised services in Tanzania.

An exploratory qualitative case study was used as part of a larger tracer study conducted by Muhimbili University of Health and Allied Sciences (MUHAS) for its postgraduate programmes being a requirement for quality assurance. Semi-structured interview guides were used for in-depth interviews (IDIs) and focus group discussions (FGDs). Qualitative content analysis was adopted to analyse the data.

The trace study was carried out in all seven geopolitical zones of the Tanzania mainland and Unguja in Zanzibar.

We conducted 14 FGDs and 301 IDIs. Participants included alumni, immediate supervisors at employment sites, MUHAS faculty, continuing students at MUHAS and management of professional councils in Tanzania.

Key findings revealed variations in demands and recognition within the scheme of services, even after registration by professional councils. Five main themes emerged from the qualitative interviews: Package training to improve service provision, Unprofessional collegial relationships or issues related to professionalism within interdisciplinary teams, Silence of scheme services on super specialisation in the medical cadre, Silence of scheme services on specialisation in the nursing cadre, Integrated scheme of services for specialties in pharmacy.

The findings highlight the demand for specialised training, challenges with professionalism and inconsistencies in the recognition and remuneration of specialists across medical, nursing and pharmacy cadres within existing service schemes. There is a need for harmonisation between specialisation/super specialisation and the scheme of services. This harmonisation is crucial to ensure the provision of quality healthcare services. Furthermore, harmonisation requires multistakeholder engagement to realise universal health coverage strategies.

Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.

A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.

The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.

The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).

This study aimed to assess the clinical severity and risk factors of diabetic ketoacidosis (DKA) at type 1 diabetes (T1D) diagnosis in children under 18 years in Greater Poland from 2006 to 2023, including temporal trends and the impact of COVID-19.

A retrospective cross-sectional study.

Greater Poland Province, Poland.

The study cohort comprised 2432 European Caucasian children (boys: 1335) aged 0–18 years with newly diagnosed T1D admitted to one hospital between 2006 and 2023.

DKA and its severity were classified according to the International Society for Pediatric and Adolescent Diabetes criteria. The multivariable analysis assessed the following risk factors for DKA at T1D diagnosis: age, sex, seasonality and the presence of T1D autoantibodies. Poisson regression models with a log link were used to assess the impact of the COVID-19 pandemic on monthly DKA cases at T1D onset, including time, pandemic period and their interaction as predictors.

DKA was diagnosed in 51.4% (1248) of newly diagnosed T1D patients, with 24.9% classified as mild, 14.4% as moderate and 12.1% as severe. Modest sex-related differences were observed, with DKA at T1D onset slightly more common in males than females (52.8% vs 47.2%). However, when comparing the DKA and non-DKA groups, a higher proportion of females presented with DKA (47.2%) than those without DKA (42.9%) (p=0.034). Children aged 0–2 years showed the highest DKA prevalence at T1D onset (76.4%), with a significant proportion experiencing severe DKA (33.6%). Factors like age, sex, season, glycaemia, glycated haemoglobin and autoantibodies did not independently predict DKA risk. The COVID-19 pandemic did not affect DKA rates at diagnosis.

The frequency of DKA is high, and its severity is substantial among children with newly diagnosed T1D in Greater Poland. Children aged 0–2 years are at the greatest risk of severe DKA at onset, underscoring the need for earlier recognition and intervention in this age group. Our findings emphasise the critical importance of increased awareness, education, point-of-care glucose testing, and targeted strategies such as T1D screening programmes to reduce the occurrence of DKA.

Patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA) are considered to have a symptomatic venous thromboembolism (VTE) risk of 1.0%–1.5% despite thromboprophylaxis. Fast-track treatment protocols have substantially lowered the VTE risk in most patients. Hence, the majority of patients may be unnecessarily exposed to the burden and risk of thromboprophylaxis. On the contrary, there are still patients with a high VTE risk who develop VTE despite thromboprophylaxis. Thus, tailored thromboprophylaxis treatment may potentially reduce both VTE and bleeding risk.

The DISTINCT (inDividual, targeted thrombosIS prophylaxis versus the standard ‘one-size-fits-all’ approach in patients undergoing Total hIp or total kNee replaCemenT) trial is a national, multicentre, randomised, multiarm, open-label trial. The main objective is to study whether tailored thromboprophylaxis reduces the occurrence of symptomatic VTE (primary outcome) and major bleeding (primary safety outcome) within 90 days after THA/TKA in comparison with standard thromboprophylaxis. Patients with a low, intermediate or high predicted VTE risk (based on the Thrombosis Risk Prediction following total hip and knee arthroplasty score (TRiP(plasty) score)) will be included in the DISTINCT-1, DISTINCT-2 or DISTINCT-3 studies, respectively. In the DISTINCT-1 trial, 3478 patients will be randomly allocated to receive either in-hospital thromboprophylaxis or standard prophylaxis. In the DISTINCT-2 cohort study, 2500 patients will receive standard prophylaxis. In the DISTINCT-3 trial, 4100 patients will be randomly allocated to receive either 6 weeks of high-dose thromboprophylaxis or standard prophylaxis. Standard prophylaxis consists of a low dose of any approved thromboprophylactic agent for 4 weeks. We hypothesise that (1) the efficacy of in-hospital only thromboprophylaxis is non-inferior in preventing VTE and equally safe compared with standard prophylaxis in patients with a low VTE risk (DISTINCT-1) and (2) prolonged high-dose thromboprophylaxis is superior in preventing VTE as compared with standard prophylaxis in patients with a high VTE risk (DISTINCT-3). Patients with intermediate VTE risk will be observed to evaluate VTE and bleeding rates (DISTINCT-2).

The protocol has been approved by the Medical Research Ethics Committee Leiden-Den Haag-Delft, EU-trial-number 2023-510186-98. Study results will be disseminated through peer-reviewed journals and during international conferences.

NCT06581965.

Challenges within prehospital emergency care (PEC) have significant implications for the provision of emergency department (ED) care. However, ED overcrowding is a prevalent issue with negative impacts on patient outcomes. It can be attributed to multiple factors, such as non-emergency attendances, inaccessible alternative care service pathways (ACSPs) and inefficiencies in emergency medical service operations. ED overcrowding has prompted healthcare systems worldwide to implement interventions. These include tele-triaging, virtual ED and non-conveyance protocols that primarily aim to reduce demand for ED care and increase the supply of alternative services. However, despite such efforts, there remain unaddressed limitations that prevent PEC interventions from being successfully implemented. Moreover, prior studies and reviews have found mixed results, and that ED overcrowding interventions remain underused. Therefore, there is a need for this qualitative systematic review and meta-synthesis to capture the complexities of implementation challenges and identify enablers required to complement PEC interventions.

This systematic review and meta-synthesis aims to offer a consolidated overview of PEC interventions intended to reduce ED overcrowding. It focuses on presenting international perspectives on the current challenges these interventions face. The enablers presented in this review could also better inform the actions taken by healthcare systems aiming to implement similar interventions.

A comprehensive search of PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature Complete, PsycINFO, Web of Science and Scopus was conducted to obtain a set of qualitative studies. Following a quality appraisal with the Critical Appraisal Skills Programme tool, data from the included studies were extracted and meta-synthesised.

A final 21 qualitative intervention-based studies were included. Through these studies, four themes were identified: (1) types of PEC interventions to alleviate ED demands and right-site patients, (2) perceived benefits of interventions, (3) challenges in implementing interventions and (4) key enablers for successful implementation of interventions. Our results describe key factors such as the importance of ACSPs and support for PEC healthcare workers in the form of standardised guidelines, as well as education and training.

We further discuss how enablers can integrate into current PEC systems to complement the interventions explored. Discussions are concentrated on several key interventions (tele-triaging, virtual ED and non-conveyance protocols) as they were perceived to hold significant potential in addressing PEC challenges and could be further elevated through various enablers. Overall, we could conclude that each intervention needs to be complemented by enablers to optimise its benefits.

To assess the quality of amoxicillin products in Indonesia’s private market by surveying the range of products available across different areas, followed by product sampling and laboratory testing.

A cross-sectional survey employing mystery shoppers to purposively sample the widest possible range of amoxicillin products available to patients across different areas in Indonesia.

Licensed and unlicensed medicine outlets in remote, rural and urban areas and online.

Amoxicillin products that are sold to patients as oral solid and dry liquid formulations.

Quality of amoxicillin products, assessed using compendial testing of active pharmaceutical ingredient content and dissolution. Samples that failed any quality test were classified as substandard or out-of-specification (OOS). The raw prevalence of substandard amoxicillin was adjusted based on the national market volume of each product variant.

We surveyed 476 outlets, mostly pharmacies (68.5%), websites (19.7%) and drug stores (10.9%). Among the 120 collected samples, there were 59 distinct products, collectively representing 95% of the estimated market volume for oral solid products and 65% for dry syrups. 12 out of 110 oral solid samples tested OOS (10.9%), as did 3 out of 10 dry syrups (30%). The samples that failed originated from various areas and types of outlets. We found no relation between the price and quality of amoxicillin.

The oral solid amoxicillin products that tested OOS represent an estimated 12.7% of the national market volume. We found no relation between the price and quality of amoxicillin. Combining product-variety sampling with data on market volume presents a promising approach to gain insight into the prevalence of poor-quality medical products using a relatively small sample size.