Childhood obesity has surged globally, leading to various metabolic comorbidities and increased cardiovascular risks. Early intervention in lifestyle and feeding practices during infancy is crucial to mitigate these risks. This study evaluates the efficacy of a mobile web app-based intervention tool, named the Feeding, Lifestyle, Activity Goals (FLAGs) to promote healthier eating behaviours and lifestyle habits in infants from birth to 12 months.

This two-arm randomised controlled trial will enrol 220 caregiver-infant pairs per arm at KK Women’s and Children’s Hospital, Singapore, with recruitment expected from January to December 2025. Eligible participants include women at ≥34 weeks’ gestation or up to 3 days post delivery with pre-pregnancy overweight/obesity (body mass index (BMI) >23 kg/m²) and/or a diagnosis of diabetes. Caregiver-infant pairs will be randomised to the FLAGs intervention or control group. Over 12 months, both groups will receive standard infant care. The intervention group will undergo regular assessments via the FLAGs web app built-in assessment tool, assessing infant feeding practices, sedentary behaviour and physical activity. The intervention group will also receive FLAGs personalised guidance and weekly digital nudges. Maternal and infant data will be collected at baseline and at 12 months. Primary outcomes are infant BMI, weight-for-length and body composition at 12 months. Secondary outcomes include lifestyle behaviours and eating habits assessed through validated questionnaires when the infants are 1 year old. We will perform both intention-to-treat and per protocol analysis.

Ethical approval has been obtained from the SingHealth Centralised Institutional Review Board (Ref: 2024/3224). Written informed consent will be obtained from all participants. Study findings will be disseminated via peer-reviewed publications and academic conferences, with de-identified data available on reasonable request. This trial is registered on ClinicalTrials.gov (ID: NCT06457750).

NCT06457750.

Radiological imaging is a central facet of the multidisciplinary evaluation of suspected child physical abuse. Current guidelines for the imaging of suspected child physical abuse are often unclear, incomplete and highly variable regarding recommendations on critical questions, thereby risking clinical heterogeneity, unstructured decision-making and missed diagnoses. We, therefore, aim to develop and report an evidence-based and consensus-derived international guideline for the radiological investigation of index and contact children in the context of suspected physical abuse and to ascertain areas of scientific uncertainty to inform future research priorities.

The international guidelines for the imaging investigation of suspected child physical abuse (IGISPA) consensus group includes formal representation from 127 recognised experts across 14 subspecialties, six continents and 32 national and/or international organisations. Participants will be divided into five longitudinal subgroups (indications for imaging, skeletal imaging, visceral imaging, neuroimaging and postmortem imaging) with three cross-cutting themes (radiography, genetics and adaptations for low- and lower-middle-income countries). Each subgroup will develop preliminary consensus statements via integration of current evidence-based guidelines, systematic literature review and the clinical expertise of a multinational group of experts. Statements will then undergo anonymised voting in a modified e-Delphi process and iterative revision until consensus (≥80% agreement) is achieved. Final statements will undergo both internal and external peer review prior to endorsement.

As an anonymous survey of consenting healthcare professionals, this study did not require ethical approval. Experts provided written informed consent to participate prior to commencement of the modified Delphi process. The IGISPA consensus statement and any subsequent guidance will be published open access in peer-reviewed medical journals.

Recent legislation in the UK regarding requirements for new developments to increase biodiversity may have significant implications for the environment and population health. Despite this, relatively little is known regarding the health and social benefits of increasing biodiversity in densely populated urban areas.

This protocol outlines plans for a mixed-method, longitudinal, natural experiment study which will evaluate the planned, biodiversity-focused redevelopment of six small urban parks in Edinburgh, Scotland (UK). Using systematic observation (at baseline, 1 month post-intervention and 1 year post-baseline) and a longitudinal household survey (at baseline and 1 year post-baseline), the primary outcomes of personal well-being, and secondary outcomes of nature connectedness and park usage behaviours, will be assessed, respectively. Consent for data linkage of respondent’s health records will also be sought. Process evaluation will employ semi-structured, qualitative interviews with stakeholders and walk-along interviews with local residents in order to understand implementation processes. Space-related well-being will also be assessed using citizen science approaches.

This study was approved by the University of Edinburgh’s School of Health in Social Sciences ethics committee. This study will provide further evidence for policymakers, the public and researchers of the health and social well-being effects of urban biodiversity interventions. Study findings will be disseminated via public forums such as community workshops and through publication in peer-reviewed journals and presentation at scientific conferences.

Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.

HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.

The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.

This study aimed to examine the reproductive concerns and their influencing factors among adolescents and young adults with acute leukaemia and to explore the relationship between reproductive concerns and patients’ quality of life.

A cross-sectional study.

The haematology departments of four tertiary-level hospitals in Hunan province, China.

Convenience sampling method was used to recruit 233 adolescents and young adults with acute leukaemia, from June 2024 to December 2024.

The primary outcome was assessed using the Chinese version of the Reproductive Concerns After Cancer and the secondary outcome was measured by the 12-item Short Form Health Survey.

Adolescents and young adults with acute leukaemia had a mean reproductive concerns score of 55.57±7.57, a quality of life physical component summary (PCS) score of 38.54±8.58 and a mental component summary (MCS) score of 39.84±8.78. Univariate analysis showed significant differences in reproductive concerns based on fertility status, place of residence, education level, fertility counselling and family history of acute leukaemia (p

Adolescents and young adults with acute leukaemia exhibited moderately high levels of reproductive concerns, particularly those who had no children, had a low education level, resided in rural areas, had a family history of acute leukaemia or had received fertility counselling. Therefore, we suggest that healthcare providers prioritise addressing reproductive concerns in high-risk patients by offering tailored, high-quality and continuous fertility counselling and psychological support. Strengthening these strategies can help alleviate reproductive concerns and improve both mental health and overall quality of life in this population.

Guideline-directed medical therapy (GDMT) for patients with heart failure with reduced ejection fraction (HFrEF) reduces morbidity and mortality and remains widely underused. An HFrEF polypill containing all four pillars of GDMT has been proposed as an implementation strategy to improve GDMT treatment rates and subsequent patient outcomes. We present the design and protocol for a proof-of-concept, pilot type I hybrid randomised clinical trial evaluating an HFrEF polypill compared with usual care among patients with HFrEF in Sri Lanka to evaluate short-term feasibility.

This multi-centre, open-label, pilot type I hybrid randomised clinical trial will recruit 40 adults with HFrEF from two public hospital sites in Colombo, Sri Lanka. Participants will be randomised to an HFrEF polypill (containing bisoprolol, losartan, eplerenone, and dapagliflozin in three available strengths) or usual care and followed for 4 weeks. The primary outcome is feasibility of recruitment measured by recruitment rate and adherence to study protocols measured by completion rate of study-related procedures. Other key outcomes include adherence to GDMT and assessment of serious adverse events among other exploratory outcomes.

The study has been approved by the ethics review committee at the Faculty of Medicine, University of Kelaniya (Sri Lanka), the institutional review board at Washington University in St. Louis (United States), and the National Medicines Regulatory Authority (Sri Lanka). The findings of this pilot trial will inform the design and implementation of a future large-scale type I hybrid trial to assess the efficacy and safety of an HFrEF polypill in improving clinical outcomes.

Sri Lanka Clinical Trials Registry (SLCTR/2024/003); ClinicalTrials Registry (NCT06831864).

Adolescent girls living in low-income urban informal settlements face unique challenges that elevate their susceptibility to early childbearing. However, there has been limited research attention, especially qualitative studies, on their use or non-use of antenatal care (ANC) services. Informed by the socioecological theory, we examined the obstacles to and facilitators of ANC services use among pregnant adolescent girls in a low-income urban informal settlement in Kenya.

The study adopted a qualitative explanatory design. We purposively selected 22 adolescent girls aged 13–19 who were either pregnant or had given birth, 10 parents and three health providers to participate in individual interviews. We employed inductive and deductive thematic analyses informed by socioecological theory to explain the barriers to enablers of antenatal services use among pregnant adolescent girls in low-income informal settlements.

Most adolescent girls interviewed faced barriers at multiple socioecological levels, resulting in delayed ANC initiation and fragmented engagement with services. At the intrapersonal level, girls grappled with internalised stigma and late pregnancy recognition and acceptance, often dismissing early signs due to fear or denial. Their young age and limited knowledge of maternal health left them terrified in fear, caught between societal judgement and the daunting prospect of confronting their condition. At the interpersonal level, societal stigma and discrimination pushed many into secrecy, hindering their access to antenatal services. However, parents, other family members, and health providers played a key role in enabling access to care by offering various forms of support to pregnant girls, including offering counselling and accompanying girls to clinics. At the organisational level, user fees and condescending health providers’ attitudes hindered ANC use. Yet, good patient-provider communication, privacy and confidentiality played a key role in enabling ANC attendance.

Pregnant adolescent girls face unique challenges that prevent them from accessing ANC early and completing the recommended number of visits. These challenges range from intrapersonal factors to interpersonal and organisational factors. Programmes to improve early initiation of ANC for pregnant adolescents should include interventions that address the social stigma associated with early and unintended pregnancy, promote family support and make health facilities responsive to the needs of pregnant girls.

Prompt recognition and treatment of patients with sepsis improve survival. Patients transported to hospital with sepsis often do not receive treatment until they are assessed in emergency departments. Initiation of treatments by paramedics at the point of first contact may improve outcomes for these patients.

The study design involves two randomised controlled trials (RCTs) conducted using a 2x2 factorial design comparing use of (1) early intramuscular ceftriaxone versus placebo and (2) an early liberal intravenous fluid strategy (up to 2 L normal saline) versus usual care resuscitation guided by paramedic medical directives. Patients who are ≥18 years of age will be eligible for inclusion if they have sepsis, defined as (1) paramedic suspicion of infection, (2) fever (temperature ≥38.0°C measured by paramedic or history of fever during the previous 24 hours), and (3) hypotension: SBP 250 mL) within 24 hours of hospital arrival; total amount of crystalloid infused during transport and first 24 hours of hospitalisation; and proportion of enrolled patients not suspected to have sepsis or infection by emergency department physicians. Safety outcomes include the proportion of patients with pulmonary oedema during transport to hospital and on initial chest X-ray and the proportion of patients with anaphylaxis or suspected allergic reactions to study medication.

This study has been approved through Clinical Trials Ontario’s streamlined ethics review process (board of record, Sunnybrook Health Sciences Centre). It will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. The final results will be disseminated to participating paramedic services through educational materials, presentations and interactive training. We anticipate our trial will achieve wide dissemination through publication in a peer-reviewed medical journal and presentation at international conferences targeting the fields of prehospital and emergency medicine, resuscitation and critical care.

NCT03068741.

Hearing loss (HL) affects 20% of the world’s population, with shortages of audiologists and audiometric sound booths unable to meet demand for hearing care services. We aimed to assess the accuracy of tablet-based audiometry (TA) to screen for HL at standard (0.25–8 kHz) and extended high frequencies (>8 kHz).

Diagnostic accuracy study.

Two secondary care audiology and ear, nose and throat outpatient clinics in the UK between April 2022 and September 2023.

Adults aged≥16 years undergoing sound booth audiometry (SBA).

TA, hearing-related questionnaires and patient usability questionnaires.

Sensitivity, specificity and accuracy of TA compared with SBA for detecting HL. Patient usability assessment of TA and SBA.

129 patients were enrolled with 127 patients (254 ears) included in the final analysis. Median age was 43 years (IQR 33–56), 55% (70/127) were women. 76% (96/127) and 68% (86/127) of patients had HL defined by British Society of Audiology (BSA) and American Speech–Language–Hearing Association (ASHA) criteria. Age was significantly associated with HL (p85%, respectively, between 0.25 and 12.5 kHz. In terms of patient usability, TA showed significantly higher scores in attractiveness (p

TA demonstrated good sensitivity with high specificity for detecting HL at frequencies 0.25–12.5 kHz and would be an acceptable accurate alternative to SBA. This would increase the accessibility of HL screening and has the potential to be used as a diagnostic test in those without tinnitus where resources are limited.

NCT05847556.

Patients with mental disorders and a history of childhood trauma show an early onset of psychopathology and often a poor response to standard disorder-specific treatments. They represent a patient group which requires more personalised interventions targeting the transdiagnostic mechanisms related to early trauma and its functional consequences. The mechanism-based modular psychotherapy (MeMoPsy) approach is conceptualised as an innovative framework for psychotherapy development. It comprises independent, flexibly applicable interventions from various theoretical backgrounds and evidence-based programmes within a systematic treatment algorithm, thereby tailoring module selection to the specific needs of traumatised adolescents.

In a randomised controlled feasibility trial (RCT), N=80 outpatients between 15 and 25 years of age diagnosed with various mental disorders will receive 28 individual sessions with MeMoPsy or standard cognitive behavioural therapy. MeMoPsy includes a basic module that addresses trauma history and three additional modules focusing on functional impairments known to be associated with childhood trauma: rejection sensitivity, emotion regulation and relationship difficulties. These modules are selected based on a self-report algorithm. Techniques from mentalisation-based therapy, cognitive behavioural analysis system of psychotherapy, dialectical behaviour therapy and systemic therapy are integrated in this personalised modular procedure. This proof-of-concept study aims to provide initial evidence for acceptability, feasibility and changes in self-rated and diagnostician-rated psychopathology (post-treatment and 3 months follow-up) of MeMoPsy and elucidate the mechanisms of change using psychotherapy process research, Ecological Momentary Assessment and functional magnetic resonance imaging (fMRI).

This RCT obtained approval from independent ethics committees of participating centres and is accompanied by a data and safety monitoring board. Findings will be communicated within the research community as well as with patients and the public by the dissemination strategies of the German Center for Mental Health.

German Clinical Trials Register DRKS00034058.

Chronic health conditions are the leading causes of morbidity and mortality worldwide, with a disproportionately high burden in low-income and middle-income countries. The burden arising from these conditions presents immense challenges to countries with dysfunctional public healthcare systems, such as South Africa. This necessitates patients to have a good understanding of the conditions and optimal self-management approaches. We explored patients’ understanding of chronic health conditions and self-management practices, including self-monitoring, in the rural South African community of Agincourt in the subdistrict of Bushbuckridge, Mpumalanga Province.

We randomly selected patients receiving routine care for chronic health conditions in primary healthcare facilities who were linked to the Agincourt Health and Demographic Surveillance System to participate in focus group discussions. Six focus groups (three with men and three with women) were conducted, with 17 male and 19 female participants (n=35) living with different chronic health conditions. Data were collected using body mapping exercises and semistructured focus group discussions facilitated by two experienced qualitative research assistants. An inclusive thematic approach was used for analysis.

Participants identified most chronic health conditions and their progression. Participants expressed that some consequences of chronic health conditions were unavoidable and some were attributed to medications. Three themes emerged on the management of chronic health conditions: (1) individual-level management, where participants actively changed or managed lifestyle factors associated with the conditions; (2) clinic-level management and support, where participants believed that following instructions from healthcare providers facilitates better management of their condition(s); and (3) prevention and screening, to prevent disease progression and development of complications. Participants also highlighted the role of religion in the control of chronic disease risk factors and traditional treatments for uncommon conditions such as epilepsy. Costs associated with lifestyle changes and equipment to manage and monitor health were highlighted as barriers to self-management of chronic health conditions.

Our findings contribute to emerging research on chronic health conditions and self-management approaches. Participants in our study demonstrated a good understanding of various chronic health conditions but lacked knowledge of self-management practices and faced barriers to self-management. There is a need for further studies on self-management of chronic health conditions, including self-monitoring among patients in rural sub-Saharan settings.