The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

Health literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.

In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.

This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.

Research for pandemic response needs to be timely to inform evidence-based decision making. The lack of epidemiological data at the start of the COVID-19 pandemic led experts to call for cohorts that could rapidly supply data about newly emerging infectious diseases. The ‘Bern, get ready’ (BEready) study aims to establish a prospective ‘pandemic preparedness cohort’ in the canton of Bern, Switzerland. This cohort can be pivoted to the needs of a new pandemic pathogen. The aim of this pilot study was to investigate the potential response and to test the feasibility of procedures for BEready.

Closed population-based cohort study.

Random sample of private households in the canton of Bern, Switzerland, that had previously responded to an online survey.

Adults, children and pets.

Enrolment as a percentage, associations between the agreement to participate and the demographic and socioeconomic variables of the invited household member, number of social contacts, proportion of samples collected, proportion of complete questionnaires and proportion of participants responding after 12 months.

After the initial in-person visit with venous blood sampling, participants were followed up for 1 year. We tested remote data collection methods, with online questionnaires and self-collected capillary blood and nasopharyngeal samples, and established a biobank.

The pilot study enrolled 106/1138 (9%) of invited households plus two additional households that had proactively contacted us. In total, we enrolled 193 people in 108 households (1.8 per household) and 44 pets between April and September 2023. We obtained and stored at least one venous and/or capillary baseline blood sample from 184/193 (95%) people and 40/44 (91%) pets. After 1 year, 172/193 (89%) people in 101/108 (94%) of households completed a follow-up survey, as did 22 owners of 34/44 (77%) pets. 151/172 (88%) respondents returned a follow-up capillary blood sample.

The response rate to the pilot study shows that obtaining high levels of participant enrolment in a pandemic preparedness cohort study is challenging. Data collection without face-to-face contact with a study team is feasible for household members and will be needed in BEready if control measures during a pandemic prevent in-person studies.

This study aimed to assess construct validity against commonly used patient-reported outcome measures (PROMs), test–retest reliability and responsiveness of seven Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) computerised adaptive testing (CATs) in Dutch adults with type 2 diabetes (T2D), and assess their acceptability in healthcare providers and people with T2D.

A cross-sectional observational study in people with T2D and qualitative study involving both people with T2D and healthcare professionals.

Participants with T2D were recruited from the ongoing Hoorn Diabetes Care System cohort in the West-Friesland area of the Netherlands. Additionally, people with T2D and advanced chronic kidney disease were recruited at the outpatient clinics of Amsterdam University Medical Centre and ‘Niercentrum aan de Amstel’, both in the Amsterdam area of the Netherlands. The healthcare professionals involved in the qualitative part were recruited at the Amsterdam University Medical Centre.

314 people with T2D (age 64.0±10.8 years, 63.7% men).

Participants completed seven PROMIS CATs (assessing (1) Physical Function, (2) Pain Interference, (3) Fatigue, (4) Sleep Disturbance, (5) Anxiety, (6) Depression and (7) Ability to Participate in Social Roles and Activities), and PROMs measuring similar constructs. After 2 weeks and 6 months, participants completed the CATs measures again, together with seven Global Rating Scales (GRS) on perceived change in each domain. Construct validity was assessed using Pearson’s correlations. Test–retest reliability was assessed by the intraclass correlation coefficient (ICC). Measurement error was assessed by the standard error of measurement (SEM) and minimal detectable change (MDC). Responsiveness was assessed by correlations between change scores on the PROMIS CAT and GRS. Acceptability was assessed through focus groups and interviews in healthcare providers and people with T2D.

Except for Fatigue, all PROMIS CAT domains demonstrated sufficient construct validity, since ≥75% of the results was in accordance with a priori hypotheses. All seven PROMIS CATs showed sufficient test–retest reliability (ICCs 0.73–0.91). SEM and MDC ranged from 2.1 to 2.7 and from 5.7 to 7.4, respectively. Responsiveness was rated as insufficient in this study design as there was almost no change in participants’ own rating of their health compared with 6 months ago according to a global rating of change.

During the focus groups and interviews, healthcare providers and people with T2D agreed that CATs could serve as a conversation starter in routine care, but should never replace personal consultations with a doctor. If implemented, participants would be willing to spend 15 min to complete the PROMIS CATs.

The PROMIS CATs showed sufficient construct validity and test–retest reliability in most domains in people with T2D. Responsiveness needs to be evaluated in a population with poorer diabetes control or in a study design with longer follow-up. The CATs are well accepted to be used in care to identify relevant topics, but should not replace personal contact with the doctor.

To determine whether hormonal contraceptives are associated with subsequent risks of suicidal behaviour and depression among women of reproductive age.

Nationwide register-based study.

Swedish national population using health and death registers. Nationwide registries provided individual-level information about the use of hormonal contraception, suicidal behaviour, depression and potential confounders.

All women in Sweden from 1 January 2006 to 31 December 2013.

Suicidal behaviour events or registered deaths due to suicide were identified through the National Patient Register and Cause of Death Register, respectively. Clinical diagnoses of depression were obtained from the patient register. Cox regression models were used to estimate HRs with 95% CIs of suicidal behaviour and depression in women using hormonal contraceptives.

We followed more than two million women for a median of 6.8 years (12.4 million person-years in total). No increased risk was observed among women using oral contraceptives or non-oral combined oestrogen/progestin formulations. Non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour using both population-based (HR=1.17, 95% CI 1.13 to 1.21) and within-individual (HR=1.16, 95% CI 1.11 to 1.21) analyses. Age-stratified analyses revealed that during late adolescence (age 15–18), use of oral contraceptives or non-oral combined formulations was associated with an increased risk of suicidal behaviour (range of HRs: 1.09–1.35), an effect that was not observed in adulthood. In contrast, non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour during both late adolescence and adulthood.

We found no overall increased risk of suicidal behaviour among women using oral contraceptives or non-oral combined formulations. However, the observed increased risk associated with hormonal contraceptive use during adolescence, as well as with non-oral progestin-only contraception—particularly gonane-containing formulations—across the entire reproductive window warrants attention and further investigation.

This study aims to assess the burden and predictors of age-related macular degeneration (AMD) among older age patients with diabetes attending comprehensive specialised hospitals in Northwest Ethiopia.

A multicentre cross-sectional study was conducted among older patients with diabetes using a systematic random sampling technique.

The study was conducted at five comprehensive specialised hospitals in Northwest Ethiopia from 8 May to 8 June 2023.

The study included 832 diabetic individuals aged 40 years and above.

Data were collected using a pretested structured questionnaire and physical examinations.

In this study, a total of 832 participants were involved, with a response rate of 96.85%. The burden of AMD was 15.4% (95% CI 13.0% to 18.0%). Male sex (adjusted OR (AOR) 2.04, 95% CI 1.17 to 3.56), older age (AOR 6.91, 95% CI 3.17 to 15.08), diabetes duration of 10 and more years (AOR 3.00, 95% CI 1.91 to 4.69), higher body mass index (AOR 2.56, 95% CI 1.15 to 5.71), presence of hypertension (AOR 2.45, 95% CI 1.56 to 3.85) and family history of diabetes mellitus (DM) (AOR 2.29, 95% CI 1.40 to 3.76) were positively associated with AMD.

This study found that the prevalence of AMD among patients with diabetes was 15.4%. Older age, male sex, longer DM duration, higher body mass index, presence of hypertension and family history of DM were significantly associated with AMD. Targeted screening of at-risk individuals for AMD, public health awareness campaigns focusing on these factors and further research to understand the burden and underlying mechanisms of these associations with AMD are recommended.

Electronic health register's (eRegisters) use have recently gained popularity in Africa. eRegisters are used to capture real-time patient information on several encounters with a healthcare provider. Given poor maternal and child health outcomes in Lesotho, eRegisters provide a promising innovative means of enhancing health outcomes, especially those related to midwifery. eRegisters capture maternal and newborn care services provided at healthcare facilities. Such data are important for informing evidence-based midwifery practice. Lesotho, a landlocked, sub-Saharan African country, piloted use of an eRegister in 2018. However, factors promoting eRegister and data use have not been fully documented. Therefore, this study explored factors promoting eRegister and data use for midwifery practice in Lesotho.

The study used a descriptive qualitative approach with interviews and focus group discussions used to collect data. Descriptive content analysis as outlined by Erlingsson and Brysiewicz (2017) was followed during data analysis.

The study was conducted at three of the eRegister piloting facilities in Lesotho to examine eRegister implementation across different levels of care. Data collection occurred between December 2023 and March 2024.

Purposive sampling was used to recruit healthcare workers across the three facilities. Participants were selected to capture the range of relevant roles and experience with eRegister across each facility, and 7, 6 and 5 participants were recruited.

Five categories emerged as factors promoting eRegister and data use: system readiness, organisational environment, data value and utility in practice, human resource competency and digital literacy and governance and stakeholder engagement.

This study identified critical factors that promote the use of the eRegister and data in Lesotho. The findings suggest that while external funding and partner responsiveness have been pivotal in sustaining eRegister operations, long-term sustainability will require stronger national ownership, including domestic investment in infrastructure, technical support and digital health governance. Future studies should explore the effect of eRegister use on clinical outcomes and examine strategies for scaling up digital health interventions in resource-limited settings.

Hearing loss is highly prevalent and impacts many aspects of a person’s life, including communication, social engagement, employment, general health and well-being. Yet, many people do not access hearing healthcare and are unaware of the range of hearing healthcare options available. Barriers to hearing healthcare include poor understanding of hearing loss and its impact; poor knowledge of help-seeking for hearing healthcare options; minimal support to help decide which option is best; and stigma related to hearing loss. These barriers lead to many people not receiving the hearing healthcare they need. Guided by theories of behaviour change and implementation science, HearChoice, an online tailored decision support intervention, has been co-developed to empower adults with hearing difficulties by offering them choice and control over their own hearing healthcare. HearChoice aims to facilitate informed decisions, accessibility and uptake of hearing healthcare, including a wide range of interventions, for adults with hearing difficulties. The objectives of the trial are to evaluate the effectiveness, health economics and feasibility of HearChoice.

This online randomised controlled trial will recruit participants with hearing difficulties across Australia, with an anticipated sample size of 640. Participants will be randomised to either HearChoice (treatment) or an Australia-specific Hearing Option Grid (active control), both delivered online. Outcomes will be assessed at baseline when the interventions will be offered, at 7 days post-intervention (primary endpoint) and at 3 months post-intervention. An email reminder will be sent at 1-month post-intervention. The primary outcome is decisional conflict. Secondary outcomes include measures of readiness and self-efficacy to take action, hearing-related quality of life and empowerment, assessment of the value and impact of HearChoice, work performance and health, and feasibility measures. Primary analysis will compare outcomes between HearChoice and the active control at the primary endpoint.

The study was approved by the Curtin University Human Ethics Committee (HRE2023-0024). All participants will provide written informed consent prior to participation. A broad dissemination plan of the study findings includes peer-reviewed publications, scientific conference presentations, articles and presentations for the wider community and public written in lay and accessible language, and social media.

Australian New Zealand Clinical Trials Registry (ACTRN12624001139561).

Research on modelling geographical accessibility to healthcare services has witnessed rapid methodological advancement and refinement. One of the contributing factors is the increasing availability of big data detailing the link between the population in need of care and the health facility such as infrastructure, travel modes and speeds, traffic congestion and the quality of road network. This has allowed more granular computation of geographic access metrics, particularly in low-and-middle income countries where data are scarce. However, there are no reviews providing a comprehensive overview of the availability and use of big data for assessing geographical accessibility to healthcare. This protocol aims to describe a methodological approach that will be used to review the existing literature on the application of big data (past or potential) in evaluating geographical accessibility to healthcare.

To characterise the big data that can be used to model geographical accessibility to healthcare, a scoping review will be undertaken and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extensions for Scoping Reviews guidelines. We will search seven scientific databases (PubMed, Scopus, Web of Science, EBSCOhost-CINAHL, Cochrane, Embase and MEDLINE via Ovid), grey literature, reference lists of identified publications and conference proceedings. Search engines will be used to identify relevant big data services not yet used in published academic literature. All literature published in English or French will be included, regardless of publication type, geographical location or year of publication provided it describes or mentions big data that may be useful for evaluating geographical accessibility to healthcare. Study selection and data extraction will be performed independently by two researchers with a third resolving any discrepancies. Analysis will be conducted to summarise big data providers, their characteristics and their usefulness in terms of types of spatial accessibility metrics that can be derived.

Formal ethical approval is not required, as primary data will not be collected in this review. Findings will be disseminated through peer-reviewed publication in a journal, conference presentation and condensed summaries for stakeholders through professional networks and social media summaries.

Open Science Framework (OSF): https://doi.org/10.17605/OSF.IO/S496F.

Gestational trophoblastic disease, characterised by abnormal proliferation of trophoblastic tissue in the placenta during pregnancy, contributes to maternal morbidity and mortality. This study aimed to estimate the pooled prevalence and histopathological patterns of gestational trophoblastic disease in Africa, where previous studies have reported inconsistent findings.

Systematic review and meta-analysis adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines.

We searched PubMed, ScienceDirect, Hinari and Google Scholar for studies published between January 2000 and January 2024.

Institution-based observational studies from African countries reporting the prevalence and/or histopathological patterns of gestational trophoblastic disease, using total deliveries as the denominator.

Data were extracted into Excel and analysed using Stata V.17. Pooled estimates were calculated using a random-effects model with Knapp-Hartung adjustment. Heterogeneity was assessed with Cochran’s Q test and the I² statistic, and study quality was evaluated using the Joanna Briggs Institute tool.

Of the 2252 studies identified, 33 were included, comprising 2885 gestational trophoblastic disease cases from eight countries. The pooled prevalence of gestational trophoblastic disease in Africa was 4.35 per 1000 deliveries (95% CI 3.26 to 5.45, I²=99.8%). The pooled prevalence of hydatidiform mole, invasive mole and choriocarcinoma in Africa was 3.49 per 1000 deliveries (95% CI 2.45 to 4.52, I²=99.7%), 0.47 per 1000 deliveries (95% CI 0.14 to 0.79, I²=72.2%) and 0.97 per 1000 deliveries (95% CI 0.54 to 1.40, I²=99.1%), respectively.

This review indicated the prevalence of gestational trophoblastic disease was high. Hydatidiform mole was the predominant histopathological pattern observed. Routine antenatal screening is needed for early detection. Further research should be conducted to identify risk factors and evaluate strategies for the prevention and management of the disease.

CRD42024504268.

Mental disorders are among the leading causes of the global burden of disease and are often associated with severe functional impairment and high societal costs. Psychotherapeutic, psychopharmacological and internet-based mental health interventions have proven to be helpful, but challenges remain, including only moderate response rates, high relapse rates and barriers to accessing mental healthcare. Much of the existing evidence stems from studies conducted in controlled, often standardised settings that only partially reflect real-world conditions, contributing to a ‘scientist-practitioner gap’. Moreover, the mechanisms of change, such as the interaction between treatment intensity, common factors (eg, the therapeutic relationship) and specific intervention techniques, have not been sufficiently investigated. In particular, the relationship of changes in personality functioning (PF) with mental and physical health has not yet been extensively researched.

The PSYMPACT (Psychological Impact Factors of Mental Health Treatments) study will use a longitudinal study design with a naturalistic sample (N 3000) to examine changes in psychopathology, PF and allostatic load in psychotherapeutic, psychopharmacological and internet-based treatments. The aim is to identify factors contributing to improvements and deteriorations in mental and physical health across different settings, including common and specific factors. Additionally, to provide patient perspectives, qualitative interviews will be conducted with individuals with varying levels of severity of mental health problems. Allostatic load will be assessed using repeated hair cortisol measurements. Furthermore, ecological momentary assessment will be used to examine the diurnal variability of PF as well as its more momentary correlates and longer-term outcomes. The central research questions and aims include (1) the assessment of common factors across different treatment settings, (2) associations of specific and common factors with improvements in mental health, including PF, (3 and 4) the importance of treatment intensity and interaction effects with common and specific factors, (5) the association of changes in psychopathology with changes in allostatic load, (6) the trait and state variability of PF, (7) the identification of patients who deteriorate under specific treatments and (8) patients’ perspectives on the effectiveness of different treatment modalities.

Approval was obtained from the Ethics Committee of the Department of Education and Psychology at the Freie Universität Berlin, Germany. Results will be submitted to peer-reviewed specialised journals and presented at national and international conferences.

Before data collection started in November 2024, the study was registered in the German Clinical Trials Register (https://www.drks.de/search/de/trial/DRKS00035560).

Ovarian cancer remains a significant clinical challenge due to its aggressive nature and high mortality rate. Tumour-infiltrating lymphocytes (TILs) play a critical role in the tumour microenvironment, influencing treatment response and patient survival across various cancer types, including ovarian cancer. A systematic review is warranted to consolidate evidence on TILs as prognostic biomarkers in ovarian cancer, with the goals of integrating them into clinical practice to enhance patient outcomes. This study aims to assess the prognostic significance of TILs in ovarian cancer.

A comprehensive literature search will be conducted across multiple databases, including PubMed, Embase, Web of Science, Scopus, Cochrane Library, CINAHL, ScienceDirect and LILACS. No restrictions regarding publication date or language will be applied. Original studies evaluating the role of TILs in women with ovarian cancer will be considered for inclusion. Two independent authors will screen titles and abstracts, and any discrepancies will be resolved through discussion with a third author. The risk of bias in included studies will be assessed using the Quality in Prognosis Studies (QUIPS) tool. Data synthesis will be performed using R software (V.4.3.1).

This study reviews the published data; thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal.

CRD42024543955.

To assess the time to first optimal glycaemic control and its predictors among adult patients with type 1 and type 2 diabetes at the University of Gondar Comprehensive Specialized Hospital in Ethiopia.

A retrospective cohort study.

University of Gondar Comprehensive Specialized Hospital, northwest, Ethiopia.

We recruited 423 adult diabetic patients who were diagnosed between 1 January 2018 and 30 December 2022 at the University of Gondar Comprehensive Specialized Hospital.

The primary outcome was the time from diagnosis to the achievement of the first optimal glycaemic control, measured in months. A Cox proportional hazards regression model was fitted to identify predictors of time to first optimal glycaemic control. Data were collected with KoboToolbox from patient medical charts and exported to Stata V.17. The log-rank test was used to determine the survival difference between subgroups of participants.

Median time to first optimal glycaemic control was 10.6 months. Among 423 adult diabetic patients, 301 (71.16%) achieved the first optimal glycaemic control during the study period. Age category (middle age (adjusted HR (AHR)=0.56, 95% CI 0.41 to 0.76), older age (AHR=0.52, 95% CI 0.33 to 0.82)), comorbidity (AHR=0.52, 95% CI 0.35 to 0.76), therapeutic inertia (AHR=0.20, 95% CI 0.13 to 0.30) and medication non-compliance (AHR=0.49, 95% CI 0.27 to 0.89) were significant predictors of time to optimal glycaemic control.

The median time to first optimal glycaemic control was prolonged. Diabetic care should focus on controlling the identified predictors to achieve optimal glycaemic control early after diagnosis.

Severe mental disorders are associated with increased risk of metabolic dysfunction. Identifying those subgroups at higher risk may help to inform more effective early intervention. The objective of this study was to compare metabolic profiles across three proposed pathophysiological subtypes of common mood disorders (‘hyperarousal-anxious depression’, ‘circadian-bipolar spectrum’ and ‘neurodevelopmental-psychosis’).

751 young people (aged 16–25 years; mean age 19.67±2.69) were recruited from early intervention mental health services between 2004 and 2024 and assigned to two mood disorder subgroups (hyperarousal-anxious depression (n=656) and circadian-bipolar spectrum (n=95)). We conducted cross-sectional assessments and between-group comparisons of metabolic and immune risk factors. Immune-metabolic markers included body mass index (BMI), fasting glucose (FG), fasting insulin, Homeostasis Model Assessment-Insulin Resistance (HOMA2-IR), C reactive protein and blood lipids.

Individuals in the circadian-bipolar spectrum subgroup had significantly elevated FG (F=5.75, p=0.04), HOMA2-IR (F=4.86, p=0.03) and triglycerides (F=4.98, p=0.03) as compared with those in the hyperarousal-anxious depression subgroup. As the larger hyperarousal-anxious depression subgroup is the most generic type, and weight gain is also a characteristic of the circadian-bipolar subgroup, we then differentiated those with the hyperarousal-anxious subtype on the basis of low versus high BMI (2 vs ≥25 kg/m², respectively). The ‘circadian-bipolar’ group had higher FG, FI and HOMA2-IR than those in the hyperarousal-anxious-depression group with low BMI.

Circadian disturbance may be driving increased rates of metabolic dysfunction among youth with emerging mood disorders, while increased BMI also remains a key determinant. Implications for assessment and early interventions are discussed.

Bangladesh is highly prone to recurrent flooding that disrupts all four pillars of food security. This study aimed to explore the effect of household food insecurity on the underweight status of women in flood-affected areas of Bangladesh, which remains underexplored.

This is a cross-sectional analysis.

This study was conducted in eight sub-districts (upazilas) across eight districts in Bangladesh that experience severe to moderate river flooding, flash floods and substantial tidal surges.

A total of 532 women participated in the study. The inclusion criteria for participation were as follows: (1) being at least 18 years of age, (2) residing in the household for at least 1 year and (3) having experienced limited food access in the 4 weeks before data collection due to flood-related constraints.

Household food insecurity was measured using the U.S. Agency for International Development Household Food Insecurity Access Scale questionnaire. An underweight status was evaluated through anthropometric measurements of women. Adjusted prevalence ratios (aPRs) were estimated using robust log-linear models.

Moderate food insecurity was the most common (58.3%) among the participants. The prevalence of underweight was the highest (52.1%) in the severely food-insecure group and decreased significantly with improved food security. Severe household food insecurity was strongly associated with a higher prevalence of underweight individuals (aPR = 4.12; 95% CI, 1.60 to 10.60). An underweight status was also prevalent in women from moderately food-insecure households (aPR = 1.75; 95% CI, 0.68 to 4.55).

This study reveals a significant association between household food insecurity and underweight status, highlighting the major challenges faced by women living in flood-prone areas of Bangladesh. These findings emphasise the urgent need to address household food insecurity to improve nutritional outcomes for women in vulnerable communities.

Although poor mental health among young people has been increasing in the past decades, many young people are reluctant to use traditional mental healthcare. To cater to the needs of young people, various youth-friendly treatment options have been developed. These include the youth-friendly health service (YFHS) standards put forth by the WHO in 2012 and the integrated youth services (IYS) for mental health developed in certain countries globally. However, no synthesis of the effect of these services on youth mental health has been conducted. The aim of the proposed study is to conduct a systematic review of the effect of mental health treatments conducted within YFHS and IYS clinics. The primary research question is what effect mental health interventions given at ‘youth-friendly’ clinics for treating mental health, such as IYS and YFHS, have on the mental health and quality of life (QoL) of young people?

A preliminary search for other reviews on the topic was conducted during the first half of 2024, after which a protocol of the present study was registered in PROSPERO. In May 2024, a search was carried out in the PubMed, PsycINFO, CINAHL and Web of Science databases, which gave references for 12 738 papers to be screened for inclusion in the review, and a follow-up search was carried out in April 2025, yielding a further 2182 references. For inclusion, studies must have participants between 12 and 25 years of age; interventions be given at clinics designed to be ‘youth-friendly’ or given at an IYS; control condition, if any, consisting of standard care or waiting list; outcomes must be mental health symptomology or QoL. To be included, studies must be published from 2012 and onwards. Screening of titles and abstracts in the initial search was carried out independently by two reviewers. Screening of studies found in the follow-up search and in the reference lists of included articles will be carried out in the same way. Data analysis of the initial search was conducted in the latter half of 2024, while final data analysis including the results from the follow-up search is ongoing. The Cochrane risk of bias assessment tools will be used to assess bias of included articles, and certainty of the evidence will be evaluated according to the GRADE methodology. A meta-analysis of the results will be performed if a sufficient amount of homogenous data is found; otherwise, a synthesis without meta-analysis will be conducted.

The proposed review may form a valuable synthesis of the state of the art of treatment options catering to young people. Investigating the effectiveness of YFHS or IYS in treating young people’s mental health may inform future directions for development and research. The present study does not need ethical approval, since only previously published, ethically approved data are used in the current study. The findings of the study will be disseminated through submissions to peer-reviewed journals and international conferences, as well as disseminated within the Swedish YFHS community.

ID nr CRD42024528687.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147

Infertility resulting from cancer treatment is known to be a major factor that reduces the quality of life of young cancer survivors. However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the clinical field. In addition, selecting a fertility preservation option requires a complex decision-making process that considers not only medical information but also the patient’s values and preferences. Hence, an environment that more easily supports patient decision-making about fertility preservation needs to be created. Therefore, this protocol will develop and test a web-based decision aid (DA) for fertility preservation among young patients with cancer, considering patient preferences and values, evaluate acceptability and usability of the developed DA and assess its effectiveness.

This protocol outlines the development of a web-based DA for fertility preservation targeting females of reproductive age diagnosed with cancer. It includes alpha testing to evaluate the usability and acceptability of the DA, as well as beta testing to assess its effectiveness outside of clinical settings, both based on an online survey. The web-based DA for fertility preservation consists of three modules: 1) an information collection module, 2) an option suggestion module and 3) a value communication module. The information collection module collects information essential to select appropriate fertility preservation options. The option suggestion module returns all applicable fertility preservation options based on the patient’s characteristics, which are essential for determining the appropriate option, such as menarche status and desire for pregnancy. The value communication module provides information on the extent to which each fertility preservation option satisfies the patient’s values and preferences. After the development of the DA, a small group of young patients with cancer (n=10) and health providers (n=5) will be asked to use this web-based DA for fertility preservation and assess the acceptability and usability of this DA based on a survey (alpha-testing). By reflecting the feedback of acceptability and usability testing, the DA will be updated for improvement, and clinical field testing (beta-testing pilot trial) will be performed using the updated DA. Beta-testing will be conducted on young patients with cancer (aged 18–40 years) before they receive any curative cancer treatment (n=32). These patients with cancer will be randomly allocated to the DA group (intervention group) or the usual care group (control group). The DA group will use the web-based DA before treatment, and the control group will not have access to the web-based DA and will be asked to decide whether to consult a fertility preservation specialist. The primary outcome of the beta testing will be the level of decisional conflict, and the secondary outcomes will include knowledge, decision self-efficacy, decision readiness, depression severity, quality of life, counselling on fertility preservation and decision-making about fertility preservation. Outcomes, including decisional conflict, knowledge, decision self-efficacy, quality of life and depression severity, will be measured before the intervention (T0), 1 week after the intervention (T1) and 1 month after the intervention (T2). The readiness for decision-making will be assessed at T1 for the intervention group only. Counselling on fertility preservation and decision-making about fertility preservation will be assessed once after testing (T2) for both the intervention and control groups.

The study will be conducted in accordance with ethical standards and was approved by the Institutional Review Board at the National Cancer Centre, Korea (IRB No. NCC2024-0050). All study participants will provide written informed consent before participation. The results generated from this study will be presented at conferences or scientific meetings and disseminated through publication in a peer-reviewed journal.

NCT07038174 (beta-testing phase).

‘Hotspotters’ are patients with complex care needs, defined by problems in multiple life domains and high acute care use. These patients often receive mismatched care, resulting in overuse of care and increased healthcare costs. As reliable data on effective interventions for this population are scarce, the goal of this study is to assess the cost-effectiveness of proactive, personalised, integrated care for this group.

The Hotspotters Project is planned as a stepped wedge cluster randomised controlled trial in 20 primary care practices in the Netherlands. All practices and participants will begin with standard care during the control period (2–8 months), followed by an intervention (12 months) consisting of a positive health intake with goal setting, multidisciplinary meetings, a personalised care plan and proactive care management. The study will conclude with a follow-up (2–8 months), resulting in a total study duration of 22 months. We plan to include 200 patients with (a) problems on two or more life domains and (b) at least two acute care encounters in the previous year. Possible Hotspotters are identified using an Adjusted Clinical Groups-based algorithm or via a local primary healthcare team.

Questionnaires and routine care data will be used to gather data on cost-effectiveness, which will then be assessed using multilevel analysis, with levels for the individual, cluster and duration of control period. Secondary outcomes will include psychological outcomes on self-regulation (proactive coping, patient activation, self-efficacy and intention), experience of care (satisfaction, perceived autonomy support and qualitative data from focus groups) and quality of life, qualitative analysis of the Positive Health approach, implementation outcomes and process evaluation including integration of care.

The Ethics Committee of Leiden University Medical Centre granted approval (METC-LDD, P21.123). Results will be shared through peer-reviewed publication and (inter)national conference presentations.

NCT05878054.