Acne vulgaris is a chronic inflammatory condition primarily caused by Cutibacterium acnes, which disrupts skin homeostasis, thereby triggering immune responses and sebum metabolism. Dysbiosis is an imbalance in the skin and gut microbiota identified as a significant factor contributing to acne progression. Standard therapy often relies on antibiotics, but the long-term use has increased antibiotic resistance, including in Indonesia. Consequently, alternative methods, such as probiotics and mesenchymal stromal cell secretomes, are gaining attention for immunomodulatory and regenerative properties. These novel therapies have shown promising results in modulating the skin and gut microbiota while reducing inflammation.

A phase 2 double-blind randomised controlled trial will be conducted using a parallel group design with four arms, namely: (1) standard therapy with oral probiotics and topical secretome (placebo), (2) standard therapy with oral probiotics (placebo) and topical secretome, (3) standard therapy with oral probiotics and topical secretome and (4) standard therapy with oral probiotics (placebo) and topical secretome (placebo). Sixty-four patients with mild to moderate acne vulgaris will be randomly allocated to these groups. Interventions will be administered over a period of 8 weeks, with outcomes to be measured at baseline and post-therapy. This study will be conducted at the Dermatology and Venereology Department of Bali Mandara General Hospital (RSBM). The primary outcome will be the reduction of comedones and inflammatory lesions, assessed using the Yolov8 method. Secondary outcomes will include gut and skin health parameters, such as tryptophan metabolites, collagen, pH, moisture, sebum levels and IL-6, to explore the relationship between microbiome balance, skin condition and inflammation in acne.

This study will be conducted in accordance with the ethical principles outlined in the Declaration of Helsinki and the International Conference on Harmonisation–Good Clinical Practice guidelines. Ethical approval has been granted by the Health Research Ethics Committee of Bali Mandara Regional Hospital (Approval Reference Number: 060/EA/KEPK.RSBM.DINKES/2024). All participants will provide written informed consent prior to enrolment. Data confidentiality and participant safety will be upheld throughout the trial. The results of this study will be disseminated through journals, scientific conferences and relevant academic platforms to ensure wide accessibility and to support further research and clinical application in the field of dermatology, particularly in addressing antibiotic resistance and microbiome-based acne therapies.

NCT06925386.

Maternal and newborn morbidity and mortality are a global concern. Understanding the epidemiology of post-discharge complications could identify opportunities for interventions. We aimed to quantify mortality, care-seeking events and readmission among mothers and newborns in Uganda following facility-based delivery.

This prospective observational study (Apr 2022-Sep 2023) enrolled women presenting for delivery at two regional referral hospitals in Uganda. Data were collected during admission and 6 weeks after delivery by phone.

Overall, 7131 women delivered 7359 newborns, of whom 7129 (99%) women and 6968 (94%) newborns were discharged alive. The newborn mortality rate was 2.7% and 32% of deaths occurred post-discharge. Following discharge, 230 (3%) women and 287 (4%) newborns were readmitted. Suspected sepsis and infections were the most common reasons for readmission among mothers (62.2%) and newborns (89.9%). Caesarean delivery (OR:2·26 (1·75-2·93)) and perinatal death (OR:3·18 (2·09-4·69)) were associated with post-discharge maternal readmission. Both maternal and newborn readmission were associated with household food insecurity during pregnancy (maternal OR:1·56 (1·15-2·08); newborn OR: 1·73 (1·31-2·25)). Newborn resuscitation with oxygen was associated with maternal readmission (OR:2.24 (1.24–3·78)), newborn readmission (OR: 2·74 (1·54-4·56)) and newborn death (OR: 4·01 (1·73-8·21)). Although >99% of women had ≥1 antenatal care visit, only 511 (7%) had ≥1 routine postnatal care visit. There were no routine postnatal care visits among 211 (91·7%) readmitted mothers, 276 (96·2%) newborns and 57 (91·9%) newborns who died.

Post-discharge complications occur in a context of low routine postnatal care use. Risk-informed discharge planning, postnatal care and health education strategies may improve outcomes in mothers, newborns and their families.

While compassion is widely recognised as an essential component of high-quality patient care, the compassion needs of clinicians often go unrecognised and unmet. Clinicians face multifaceted sources of workplace suffering, both sources inherent to working with the sick and avoidable sources due to healthcare systems and leadership challenges. Organisational compassion, defined as the continuous and systematic identification, prevention and alleviation of sources of suffering for healthcare workers, offers a paradigm shift in mitigating and preventing clinician suffering and burnout. Yet little is known about how clinicians experience suffering and compassion from their organisations, teams and leaders.

Our overarching goal is to develop a clinician-reported experience measure of organisational compassion. The purpose of this study was to explore how clinicians experience suffering and compassion in healthcare organisations.

This qualitative study used semistructured interviews of interdisciplinary paediatric hospice and palliative care clinicians from across the USA. A moderator’s guide was developed based on the literature of organisational compassion in management and healthcare and validated through practice interviews with clinicians. 22 participants were recruited via national paediatric hospice and palliative care email list serves. Video interviews were conducted via Zoom. Transcripts were analysed using a hybrid grounded theory-thematic analysis methodology to identify themes and to construct a theoretical framework of compassion experiences.

Five major themes of experiencing compassion emerged: (1) Feeling cared about, characterised by authentic, empathetic responses to clinician distress; (2) Dignity, encompassing being valued, respected and recognised as a whole person and professional; (3) Proximal (team) compassion, including camaraderie, shared workload and mutual support within teams; (4) Structural (organisational) compassion, reflecting policies, practices and benefits that alleviate or exacerbate suffering and (5) Compassionate leadership behaviours, such as presence, empathy and connection to frontline staff needs.

Healthcare work includes sources of both inherent and avoidable suffering for clinicians. In this study, we sought to understand how clinicians experience compassion from their organisations, leaders and team members during times of distress. We found five themes of experiencing compassion in healthcare organisations: feeling cared about; dignity; proximal (team) compassion; structural (organisational) compassion and compassionate leadership behaviours. These qualitative data and results will provide an empiric foundation for the development of a clinician-reported experience measure of compassion for use in healthcare settings. Such a measure will enable future research examining how compassion experiences in healthcare may predict workforce outcomes such as burnout, satisfaction, engagement and thriving. Ultimately, this work may support the design of interventions aimed at strengthening compassionate organisational cultures and improving conditions for the healthcare workforce and both experiences and outcomes of the patients they serve.

Australian studies investigating parental factors often lack meaningful inclusion of Aboriginal and Torres Strait Islander families, limiting our understanding of current influences on positive developmental trajectories within communities. There is growing recognition of the need for culturally safe and responsive longitudinal research that is co-designed and co-led by the community for the community. An Indigenous-led birth cohort study of Aboriginal and Torres Strait Islander families in Queensland, Australia, has therefore been developed to better understand health across generations.

The Strong Families Study is a co-designed prospective longitudinal birth cohort study that will follow 400 Indigenous families in Queensland from pregnancy until the child reaches 5 years of age. Eligible participants include pregnant individuals (

This study was approved by the Mater Misericordiae Ltd Human Research Ethics Committee (HREC/MML/105191) and ratified by the University of Queensland Human Research Ethics Committee (2025/HE001924). Endorsement letters were secured from partner services at each study site. Findings will be shared with partnering hospitals and funding bodies at conferences and through reports and peer-reviewed publications.

Mycoplasma pneumoniae (MP) is a major cause of community-acquired pneumonia in children. In East Asia, the prevalence of macrolide-resistant MP (MRMP) has surged, leading to treatment failures and prolonged illness. While doxycycline is an effective alternative, its use in young children has historically been limited due to concerns about tooth discolouration. This study aims to evaluate the efficacy and safety of doxycycline compared with azithromycin as a first-line treatment for children with pneumonia suspected of MRMP infection.

This is a multicentre, randomised, open-label, parallel-group superiority trial conducted at 14 tertiary hospitals in South Korea. A total of 208 children (aged 3–17 years) with pneumonia and confirmed or suspected MP infection will be randomised 1:1 to receive either doxycycline (4 mg/kg/day in two divided doses for 7–14 days) or azithromycin (10 mg/kg on day 1, then 5 mg/kg on days 2–5) (). Randomisation will be stratified by age (3–7 years vs 8–17 years). A standardised ‘rescue therapy’ protocol ensures patient safety by allowing control group patients to switch to doxycycline if no clinical improvement is observed within 48–72 hours. The primary outcome is the defervescence rate within 72 hours after randomisation. Secondary outcomes include treatment failure rate, length of hospital stay, symptom duration and adverse events. Safety assessment will specifically include tooth discolouration evaluation at Day 28, focused on children aged

This study has been approved by the Institutional Review Boards (IRB) of all participating centres. Written informed consent will be obtained from parents or legal guardians, and assent will be obtained from children aged 7 years and older. Results will be disseminated through peer-reviewed publications and conference presentations.

NCT07306234.

To develop machine-learning (ML) models during the COVID-19 pandemic and adjacent time periods to evaluate the impact of data drift on model performance.

This prognostic study used population-level administrative health data to develop ML prediction models.

Alberta, Canada during 2019–2023.

All patients over 18 who received at least one opioid dispensation from a community pharmacy within the province of Alberta between 2019–2023.

Each opioid dispensation served as the unit-of-analysis.

Opioid-related outcomes were identified from linked health administrative datasets. Light Gradient Boosting-machine models were developed on pre-pandemic, pandemic and endemic data and temporally validated on 2023 data (pre-pandemic model was also validated on 2020–2021 data) to predict the risk of emergency department visit, hospitalisation or mortality within 30-days of an opioid dispensation. We described key feature distributions across the study time period and changes in model prediction performance on the validation sets using relevant metrics.

Among 1.2 million study participants representing over 13 million opioid dispensations, there were 59 809 (2.1%), 134 402 (2.4%) and 62 143 (2.3%) events reported in the pre-pandemic (2019), pandemic (2020 and 2021) and endemic (2022) time periods, respectively (estimated 2023 validation set pre-test probability of 2.8%). Notable differences in key features were observed in the 2020–2021 model relative to other years. In the 2023 validation set, discrimination performance was highest for the pre-pandemic and endemic models compared with the pandemic model (0.81, 0.83, 0.74, respectively). A similar trend regarding changes from pre-test to post-test probabilities in higher categories of predicted risk (23%, 40%, 16%) was observed. 2020–2021 had the lowest discrimination performance (0.71) and uninformative post-test probabilities (

COVID-19 pandemic health data contributed to significant ML drift. Although ML approaches allow for quick re-training to mitigate drift, health regulators should approach ML prediction with caution when using pandemic-times data.

Cocaine use disorder (CUD) is a significant public health concern in the USA, with considerable prevalence and mortality and no Food and Drug Administration (FDA)-approved pharmacotherapies. Recent advances in addiction science emphasise the need for novel, mechanism-based treatments. Glucagon-like peptide-1 receptor agonists, such as semaglutide, have shown promise in modulating reward-related behaviours and may offer therapeutic benefits for CUD. We present a study protocol evaluating semaglutide, as an adjunct to cognitive behavioural therapy (CBT), as a novel approach for treating CUD.

This is a randomised, double-blind, placebo-controlled trial enrolling 75 treatment-seeking adults with CUD. Participants will be randomised 1:1 to receive either once-weekly semaglutide (0.25–1.0 mg) or placebo injections over 14 weeks, alongside weekly individual CBT. Primary outcomes include changes in neurophysiological reactivity to drug-related and non-drug-related motivationally relevant cues (late positive potential), behavioural economics (cocaine demand), craving (Cocaine Craving Questionnaire) and cocaine use (self-report, urine drug screens). Exploratory aims assess associations between mechanistic changes and cocaine use, consumption of other substances (ie, tobacco, alcohol and cannabis) and dose–response relationships. Data will be analysed using Bayesian statistical methods using an intention-to-treat approach.

The study has been approved by the UTHealth Committee for the Protection of Human Subjects (HSC-MS-25-0412) and is registered on ClinicalTrials.gov. All participants will provide written informed consent. Findings will be disseminated through peer-reviewed publications and scientific conferences.

NCT07227948.

Despite the intention of international psoriasis treatment guidelines to cover all patients globally, disparities persist in the availability and accessibility of adequate therapy in many countries. The Global Healthcare Study on Psoriasis (GHSP) aims to study patient characteristics, disease impact, treatment accessibility and healthcare systems worldwide. This study provides a description and data analysis of 22 countries.

The GHSP cohort was initiated in 2020, and the number of recruiting centres has gradually grown. Participants are recruited by dermatologists at reference centres worldwide. Data are collected using a standardised assessment questionnaire comprising 88 items, administered by trained experts.

By 26 October 2024, cross-sectional data had been collected from 3950 psoriasis patients at 130 reference centres in 22 countries on six continents. The majority (55.7%) of patients were male, and the median (IQR) body mass index was 26.5 (23.7–30.1) kg/m². The median (IQR) Psoriasis Area and Severity Index was 5.0 (2.0–11.4), and median (IQR) Dermatology Life Quality Index was 7.0 (2.0–14.0). Psoriatic arthritis was present in 20.2% of the patients and nail psoriasis in 36.7%. Additionally, 16.5% of patients were current smokers, and 26.4% reported regular alcohol consumption.

By identifying inequalities, special patient populations and country-specific differences, the GHSP will guide the development of strategies to enhance psoriasis care on a global level. Future directions include expanding the study to additional countries and sites worldwide, while transitioning into a long-term global registry of skin diseases, including atopic dermatitis and hidradenitis suppurativa, termed ‘Global Healthcare Registry on Skin Diseases’.

Cardiovascular disease (CVD) is the leading cause of death worldwide and is associated with a broad range of physical, emotional and social burdens. Existing tools such as Systematic Coronary Risk Evaluation and WHO CVD risk charts identify clinical risk factors but fail to capture patient-perceived burden and the risk of burden awareness. The Assessment of Burden of Chronic Conditions (ABCC)-tool, a validated, person-centred instrument, offers a more holistic approach. The aim of the current study is to develop and validate a new module within the ABCC-tool for patients with an elevated cardiovascular (CV) risk or CVD (cardiovascular risk management (CVRM) module).

A mixed-methods design was used across four phases and expert meetings to identify the items for the module. All phases took place in the Netherlands. Phase 1 (literature search) was performed in 2021, phase 2 (semistructured interviews) was completed between January and October 2021, phase 3 (survey) was completed in November 2023 and December 2024, and phase 4 (semistructured interviews) was completed in January 2025.

Phase 2 involved 14 experts by experience (patients with CVD or people at elevated risk) and 10 healthcare professionals in the field of CVD. Phase 3 included 86 healthcare professionals. Phase 4 included 12 experts by experience. In total, four expert meetings took place, attended by three experts by experience, nine healthcare professionals and seven researchers.

The module was refined iteratively, using qualitative and quantitative insights at each phase of development. The model was only finalised after thorough content validation.

No suitable patient-reported outcome measures (PROMs) focusing specifically on CVRM were identified in the literature. Interviews revealed significant burdens in terms of physical, emotional and social burdens. Feedback from expert meetings and validation rounds led to substantive refinement. The final module contains 10 items and was deemed valid by both experts by experience and healthcare professionals.

The CVRM module of the ABCC-tool has been systematically developed and validated in terms of content. The final module focuses on the multidimensional burden of CVD and dealing with its risk factors and aims to support self-management. The module complements existing risk assessment tools by focusing on the burden experienced by the patient and the burden resulting from risk awareness.

Many industries where safety is a priority (eg, aviation) use safety management systems (SMSs), but evidence on their use in healthcare is needed to determine whether they could support patient safety improvement. We investigated the application of national-level SMSs to patient safety in terms of effectiveness, implementation and experience.

Systematic review using a case study approach.

We identified patient safety organisations in each country and searched their websites. We also searched MEDLINE (in December 2023) and Embase (via Ovid), CINAHL (EBSCO) and Web of Science (in February 2024).

Any evidence from five high-income countries that have publicly funded healthcare systems with universal coverage: Australia, Canada, Ireland, New Zealand and the Netherlands. We included publications on the effectiveness, implementation or experience of the patient safety approach in each country.

Included evidence was summarised and mapped onto an initial analytical framework based on analysis of SMSs in high-risk industries, enabling cross-country comparisons. Drafts were shared with experts from patient safety organisations in each country for comment. Formal quality appraisal was not possible as most evidence was non-evaluative.

53 publications were included, from Australia (5), Canada (7), Ireland (8), New Zealand (9) and the Netherlands (24). Only the Netherlands implemented a patient safety programme explicitly based on an SMS approach. Some aspects of patient safety in hospitals improved as a result, but there was significant variation in both the implementation of the programme and attributed outcomes.

In the other four countries, the main components of an SMS were identified to some extent, along with evidence that their patient safety approaches had been influenced by concepts from high-risk industries and ‘safety science’ more widely.

Emerging ideas from high-risk industries (beyond SMSs) and broader safety science have influenced all countries, reflecting increasing awareness of the need for initiatives to be context-specific to be successful. However, their implementation and impact need further evaluation.

CRD42023487512.

Every 2 minutes, a woman dies from cervical cancer, resulting in over 300 000 preventable deaths globally. Nearly all cervical cancers are caused by human papillomavirus (HPV) and are preventable with HPV vaccination and screening through Papanicolaou (Pap) and HPV tests. In Canada, cervical cancer mortality rates have declined in recent decades with more accessible cervical cancer screening programmes. However, screening rates remain low, particularly among Black women and people with a cervix (WPC).

Cervical cancer screening studies of Black WPC in Ontario—Canada’s most populous province—are limited. These studies indicate Black WPCs are at elevated risk for under-screening, with many overdue for screening.

An innovative approach to begin addressing delays is HPV self-sampling (HPVSS). Self-sampling is a cost-effective and more accurate test for detecting high-risk HPV infections associated with precancerous changes versus the Pap test. Self-sampling supports Canada’s action plan—a response to WHO’s global strategy—to eliminate cervical cancer by 2040.

Despite Canada’s plan, research on the state of Black WPCs’ HPV knowledge and self-sampling interventions tailored to them is scant. These scarcities are concerning as Ontario plans to implement HPV primary screening and offer HPVSS soon.

The study objective is to codevelop an HPVSS intervention tailored for and made by Black WPC in Peel region, Ontario. This protocol focuses on phase one of a two-phased study.

In phase one, a qualitative, community-informed approach, co-led by community research assistants, will be used to purposively recruit 10 service providers (eg, clinicians, social workers, community care workers) and 40 Black WPC who will undergo one-on-one semistructured interviews and sociodemographic surveys to explore the state of: (1) Black WPC’s level of HPV, cervical cancer and cervical cancer screening knowledge; (2) Black WPC’s motivators, beliefs, attitudes and misconceptions towards HPVSS; (3) Black WPC’s perceived barriers and facilitators to HPVSS and (4) service providers’ perspectives on Black WPC’s barriers and facilitators to HPVSS. Charmaz’s grounded theory approach and intersectionality will guide data collection and analysis.

Ethical approval has been obtained from the Trillium Health Partners Research Ethics Board (ID#1207). Study findings will be disseminated through community healthcare events, conference presentations, peer-reviewed publications and virtual and physical pamphlets. Additionally, summaries of the findings will be shared and tailored to collaborators, healthcare leadership and researchers and community health centres. Wide dissemination will help enhance understanding of the state of cervical cancer screening, HPV and HPVSS among Black WPC. Given Canada’s commitment to eliminating cervical cancer, study findings will be used to begin developing an HPVSS intervention for Black communities.

Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours.

This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity.

This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications.

NCT06505109.

Cadmium is a metal that poses significant health risks, particularly in occupational environments where exposure can happen. The main objective of this scoping review is to review the cadmium exposure levels in the different occupational settings in the European Union (EU), considering the regulatory measures currently in place. The secondary objectives, depending on the availability of data, are (a) to identify the occupational settings where higher exposure levels occur, (b) to identify any geographical and temporal differences and trends within the EU and (c) to identify the most relevant co-exposures reported.

A scoping review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews reporting guidelines. Studies reporting quantitative occupational data on cadmium exposure obtained through human biomonitoring and/or air monitoring will be included. A descriptive analysis of the findings will be performed.

This protocol for a scoping review does not require ethical approval as it is based on secondary data. The dissemination plan of the scoping review includes its publication in a scientific journal of reference, as it is expected that it will provide important knowledge to support ongoing and future occupational health interventions in the EU, at the technical and regulatory levels.

This study is registered at the Open Science Framework (OSF), 7 April osf.f2w3h.