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Association between completing at least eight antenatal care contacts and maternal anaemia in Ghana: a cross-sectional study using causal machine learning

Por: Agbedinu · E. S. · Owusu · F. O. · Boakye · K. · Addai- Manu · H. · Karikari · J. K. · Konadu · E. · Akanwariwiak · R. A. · Asenso · L. · Addae · M. · Kanfra · M. · Opoku · D. A.
Background

Maternal anaemia remains a pressing global health challenge, with a notable burden in low- and middle-income countries. Existing studies in sub-Saharan Africa have largely relied on average associations, thereby concealing key variation among women and failing to account for heterogeneity.

Objective

To assess the association between completing at least eight antenatal care (ANC) contacts and maternal anaemia in Ghana and to explore heterogeneity in this association using causal machine learning.

Design

An institution-based cross-sectional study was conducted using a retrospective review of medical records and causal machine learning analysis.

Setting

Juaben Government Hospital.

Participants

Of 2326 women who delivered at the hospital, 2114 with complete data on the main exposure and outcome variables were included in the analysis.

Main exposure

Completion of at least eight ANC contacts. ANC contact was defined as the in-person visit to the clinic with a healthcare professional for routine ANC services and follow-up.

Main outcome

Maternal anaemia, defined as a haemoglobin level below 11 g/dL in the last ANC before delivery.

Methods

A causal forest model was used to estimate the association between completing at least eight ANC contacts and maternal anaemia. Conditional average treatment effects were used to explore individual-level variation in these associations, providing policy-relevant insights.

Results

Completing ≥8 ANC contacts was associated with a 6 percentage-point lower probability of maternal anaemia compared with having fewer visits (average treatment effect: -0.06, 95% CI –0.11 to –0.02). Predicted individual-level effects ranged from –0.21 to 0.09. Participants’ age, malaria prophylaxis, marital status, parity and educational level were the five most important contributors to the observed heterogeneity.

Conclusions

This study demonstrated that completing ≥8 ANC contacts is associated with a lower probability of maternal anaemia, with heterogeneity across subgroups. We recommend differentiated, context-specific ANC interventions that focus on high-impact subgroups while strengthening the effectiveness and quality of care delivered at each visit.

Type 3 hybrid effectiveness-implementation study implementing and evaluating the Comprehensive High-dose Aphasia Treatment (CHAT) programme in Australian rehabilitation services: a protocol

Por: McSween · M.-P. · Dignam · J. K. · Shrubsole · K. · Levine · R. · Power · E. · Lannin · N. A. · Wallace · S. J. · Cadilhac · D. A. · Kilkenny · M. F. · Hill · A. J. · Ryan · B. J. · Copland · D. A.
Introduction

The Comprehensive High-dose Aphasia Treatment (CHAT) programme is an intensive comprehensive aphasia programme, which aims to address evidence-practice gaps in aphasia rehabilitation where there are known barriers to service delivery requiring implementation strategies. The aims of this study are to (1) evaluate the clinical implementation of the CHAT programme, (2) assess the clinical effectiveness of CHAT compared with usual care in rehabilitation services and (3) determine whether the real-world implementation of CHAT compared with usual care is cost-effective.

Methods and analysis

Four participant groups will be recruited across six hospital and health services Australia-wide to participate in a type 3 hybrid effectiveness-implementation study: (1) people with aphasia, (2) support persons, (3) treating clinicians and students and (4) clinical stakeholders (eg, managers). This before-and-after study will include three time periods: (1) ‘usual care’ where people with aphasia will receive their usual care aphasia therapy, (2) ‘implementation transition’ where clinicians will be trained to deliver CHAT and (3) ‘intervention implementation’ where people with aphasia will receive the CHAT programme (ie, 50 hours of evidence-based aphasia therapy over 8 weeks). Evidence-based implementation strategies will be used to facilitate implementation within participating rehabilitation services. The primary outcome is delivery of evidence-based aphasia treatment (ie, CHAT) as measured by a composite score of quality indicators. Clinical effectiveness outcomes, measuring change in language impairment, communication effectiveness, confidence and quality of life, and implementation outcomes will also be examined. We will also conduct an embedded mixed-methods process evaluation and economic evaluation.

Ethics and dissemination

This study has been approved by the Royal Brisbane and Women’s Hospital Human Research Ethics Committee (HREC/2021/QRBW/72154). Outputs will include conference presentations, publications and a training package to optimise implementation of aphasia treatment in rehabilitation service contexts.

Registration details

Australian New Zealand Clinical Trials Registry (ANZCTR) prospective registration ACTRN12621001765819. Trial registered 23 December 2021. https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381365&isReview=true.

Diagnostic accuracy of the Xpert MTB Host-Response assay for tuberculosis disease in adolescents and adults: a systematic review and individual patient data meta-analysis protocol

Por: Muchie · K. F. · Tobian · F. · Gaeddert · M. · Denkinger · C. M. · Wright · J. K. · Gupta-Wright · A.
Introduction

Tuberculosis (TB) remains a major global health challenge, with an estimated 10.8 million new cases and 1.25 million deaths in 2023. Despite advances in molecular detection of Mycobacterium TB (MTB), significant diagnostic gaps remain: in 2023, only 48% of newly diagnosed TB cases received rapid diagnostic testing, far below the 100% target. These challenges are intensified in high-burden settings, where sputum collection and distinguishing TB from other illnesses are difficult. The Xpert MTB Host Response (Xpert-HR) assay measures host immune gene expression from blood, shows promise but variable accuracy across studies. Hence, this study will perform an Individual Patient Data Meta-Analysis (IPDMA) to evaluate the diagnostic accuracy, subgroup performance, predictive values and clinical benefit of Xpert-HR compared with conventional sputum-based testing.

Methods and analysis

This systematic review and IPDMA will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Diagnostic Test Accuracy guidelines. Prospective studies including adolescents (>12 years) or adults with presumed TB tested using the Xpert MTB Host-Response assay will be identified through PubMed, Embase and Web of Science. Study quality will be assessed using an adapted diagnostic accuracy tool. Diagnostic accuracy will be pooled using random-effects models, with subgroup analyses where applicable. Decision curve analysis will evaluate clinical utility. Predictive values will be estimated across TB prevalences of 1-10%. Both one-stage and two-stage IPDMA approaches will be explored, and the proportion of unevaluable samples will be reported.

Ethics and dissemination

The review will be based on deidentified individual patient data to be obtained upon request from the corresponding authors of studies fulfilling all the data sharing agreement. Ethical approval has been obtained from the Ethical Committee of the Medical Faculty of Heidelberg University (Approval No. S-043/2026). The results will be disseminated through publication in a peer-reviewed journal, and through presentations at academic conferences.

PROSPERO registration number

CRD420251071857.

Patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) used in ambulatory palliative care for adult patients with cancer in low-income and middle-income countries: a systematic review protocol

Por: Mathew · M. · Ghoshal · A. · Kabukye · J. K. · Shetty · N. · Dhyani · V. S. · Chakraborty · S. · Shetty · D. K. · B · B. · Salins · N.
Introduction

The global burden of cancer is increasingly concentrated in low-income and middle-income countries (LMICs), where health systems face significant challenges such as late-stage diagnosis, limited resources and restricted access to specialised care. Palliative care plays a vital role in improving symptom control and quality of life for patients with cancer, particularly as care delivery shifts toward ambulatory and community-based settings. In this context, patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) are crucial for capturing patients’ perspectives on the quality of care. However, the use and characteristics of these instruments in ambulatory palliative care settings within LMICs remain poorly understood. This systematic review aims to identify and map PROMs and PREMs used among adult patients with cancer receiving ambulatory palliative care in LMICs, and to examine their content, psychometric properties and alignment with key domains of quality palliative care.

Methods and analysis

This systematic review protocol was developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA) guidelines. The search will be conducted across seven databases from the database inception to December 2025. Two independent reviewers will screen titles, abstracts and full-text articles using Rayyan software to identify studies involving adults (≥18 years) with cancer in ambulatory palliative care settings. Data extraction will capture study characteristics, instrument content and psychometric properties. The final review will be reported in accordance with the PRISMA-COSMIN for Outcome Measurement Instruments. A narrative synthesis will be conducted, mapping the identified instruments against the eight domains of the National Consensus Project Clinical Practice Guidelines for Quality Palliative Care to identify measurement gaps and inform future instrument development. A meta-analysis will be conducted if sufficient homogeneity exists.

Ethics and dissemination

This review will include only published data; therefore, no approval is required. The findings of this review will be presented at conferences and published in an open-access peer-reviewed journal.

PROSPERO registration number

CRD420251273579.

Burnout, associated factors and coping strategies among nursing professionals in Kerala, India: a cross-sectional study

Por: Ambujam · J. K. · Francis · P. T. · Olickal · J. J. · Sarma · P. S. · Thankappan · K. R.
Objectives

To determine burnout prevalence, associated factors and coping strategies used by nursing professionals.

Design

Cross-sectional analytical study.

Setting

Public and private healthcare institutions in Kerala, India.

Participants

Nursing professionals in Kerala (n=349).

Primary and secondary outcome measures

Burnout levels (assessed with the Burnout Assessment Tool (BAT)) and coping strategies. Log-binomial regression was performed to identify factors associated with burnout.

Results

High burnout was reported by 36.1% of participants (126/349; 95% CI 31.1 to 41.4). Burnout prevalence was higher among nurses with an MSc (Master of Science) or higher educational qualification (adjusted prevalence ratio (APR)=1.46; 95% CI 1.04 to 2.03); those working in urban settings (APR=1.41; 95% CI 1.04 to 1.90); those who were single, divorced or separated (APR=1.58; 95% CI 1.18 to 2.12); those with travel time ≥30 min (APR=1.36; 95% CI 1.03 to 1.79); and those engaged in clinical/direct patient care duties (APR=1.75; 95% CI 1.18 to 2.59). Commonly reported coping strategies included active coping (59.6%), seeking instrumental social support (58.7%) and venting (54.4%), whereas negative strategies, such as substance use, were less frequent (22.9%).

Conclusions

Over one-third of the nurses in our study reported high burnout. Efforts to reduce burnout should focus on nurses with higher qualifications, those working in urban settings, those with higher travel time, those who are single/divorced/separated and those involved in clinical duties to enhance healthcare quality.

Sick leave and engagement as workforce well-being proxies in hospital departments: a cross-sectional study of routinely collected organisational data in a Dutch academic hospital

Por: Bazuin · T. · Oerbekke · M. S. · Bontjer · S. · Reijmerink · I. M. · Dongelmans · D. A. · Franx · A. · Wietasch · J. K. G. · Hooft · L. · van der Laan · M. J.
Objectives

Well-being of healthcare professionals (HCPs) is vital for care quality, staff retention and overall healthcare system effectiveness. This study aims to identify the organisational and workplace variables associated with sick leave and measures of engagement of HCPs on department level within a single Dutch academic hospital.

Design

Cross-sectional study using routinely collected organisational data.

Setting

A tertiary-care academic hospital in the Netherlands.

Participants

25 clinical departments were included. Department level variables were derived from routinely collected hospital databases. Availability of data varied across variables. Analysis included information on patient population, human resources, care processes, quality of care and employee and patient experiences to assess differences, correlations and predictors for sick leave and engagement.

Primary and secondary outcome measures

Primary outcome measures were (1) sick leave (%) and (2) engagement, assessed through two staff-survey items (vitality and connectedness; 0–10 Numeric Rating Scale). Both outcomes were analysed at department level.

Results

Employee population data showed the most consistent patterns across analyses. Departments with higher staffing capacity had higher sick leave and lower engagement in group comparisons (p=0.009, p=0.030, respectively). In multivariable models, higher staffing capacity remained associated with increased sick leave (B=1.38, 95% CI 0.53 to 2.23, p=0.003). Engagement was positively associated with higher inflow (B=0.92, 95% CI 0.06 to 1.77, p=0.037) and negatively associated with outflow (B = –1.36, 95% CI –2.08 to –0.63, p=0.001). No consistent associations were found with patient population and patient experience measures.

Conclusions

Workforce-related factors, particularly staffing capacity and inflow and outflow, are strongly linked to sick leave and engagement. Routinely collected hospital data can be used to identify at-risk departments and inform targeted strategies for improving workforce sustainability. Future studies should explore more granular, team-level data to better support staff well-being and care quality.

Biological impacts of rising temperatures on maternal, fetal and newborn health: protocol for a cohort study (BIRTH-Cohort)

Por: Das · J. K. · Malik · A. A. · Papageorghiou · A. T. · Piryani · S. · Ambareen · M. · Zuberi · N. · Islam · Z. · Mohammed · N. · Hussain · N. F. · Samad · Z. · Baloch · F. M. · Qazi · S. · Rizvi · A. · Chauhadry · I. A. · Iqbal · J. · Mohsin · S. S. · Ali · F. · Sheikh · L. · Begum · K. · Zub
Introduction

Climate change has led to extreme heat events, disproportionately affecting vulnerable populations. Heat stress during pregnancy is linked to adverse health outcomes, yet the biological mechanisms remain poorly understood. This research study aims to investigate the effect of environmental heat on maternal, fetal and infant health and examine the biological pathways linking heat stress to adverse pregnancy outcomes.

Methods and analysis

This prospective cohort study will recruit 6000 pregnant women from three districts in Sindh, Pakistan. Eligible participants ≥18 years old, will have a minimum of five scheduled visits from

Ethics and dissemination

The study has received ethical approval from the Aga Khan University (AKU) (Ref: 26249) and the Pakistan National Bioethics Committee (Ref: 1065/23/1736). Written informed consent will be obtained from all participants before enrolment. Referral pathways to healthcare facilities will be established to ensure timely management of pregnancy complications. Findings will be disseminated through peer-reviewed publications, scientific conferences, and engagement with policymakers and public health stakeholders to inform climate-resilient maternal health strategies. Results will also be shared with participants and communities through meetings and informal sessions to raise awareness and support evidence-based heat adaptation.

Trial registration number

NCT01234567.

Promoting CHANGE cluster randomised controlled trial to improve food outlet healthiness in Australian sport and recreation facilities: protocol

Por: Lalchandani · N. · Romaniuk · H. · Cameron · A. · Orellana · L. · Ananthapavan · J. · Peeters · A. · Backman · B. · Adam · M. · Allender · S. · Nguyen · P. · Sacks · G. · Brimblecombe · J. K. · McMahon · E. · Blake · M.
Introduction

Food retail outlets in sports and recreation facilities often fail to support healthy eating, despite aligning with healthy lifestyles and goals of local governments (LGs) that often own or manage them. LGs face barriers to implementing facility changes including inadequate staffing, training and incentives. The Promoting CHANGE initiative was co-designed to support LGs in improving and sustaining healthier food and drink offerings in these settings.

Methods and analysis

A 3-year, type 2 effectiveness-implementation hybrid cluster randomised controlled trial will evaluate the Promoting CHANGE capacity-building and support package in three Intervention and four Control LGs in Victoria, Australia (August 2023–July 2026). The co-designed initiative includes human resource support, training, tools, technical assistance, community-of-practice groups, feedback based on food outlet audit and sales data and small grant incentives. Using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) evaluation framework, the trial’s co-primary outcomes are the percentage of least healthiest food and drinks (1) displayed (implementation) and (2) sold weekly (effectiveness). Key secondary outcomes are effectiveness (sales and revenue); facility-level adoption, implementation, maintenance of healthy changes; cost-effectiveness (within-trial modelled economic evaluation). Findings will provide evidence of the initiative’s effectiveness and scalability, informing recommendations for advancing healthier food environments in over 6000 community-based food outlets across 500 Australian LGs, with implications globally.

Ethics and dissemination

This study has received approval from the Deakin University Human Research Ethics Committee (reference number HEAG-H 92_2023). The results will be published in scientific peer-reviewed journals along with plain language summaries for participants.

Trial registration number

ACTRN12621001120864.

Womens health and well-being over the life course: conceptual framing supported by a scoping review

Por: Iyer · A. · Sen · G. · Rao Seshadri · S. · Snow · R. · Ataullahjan · A. · Liang · M. · Baird · S. · Drake · J. K. · Sharafi · L. · Bhutta · Z.

As a framework to conceptualise well-being, the capability approach (CA) combines structural drivers with personal freedoms, making it a compelling approach for understanding women’s health and well-being (WHW). The WHW Project of the Exemplars in Global Health initiative chose the CA for its conceptual framing, while emphasising the influential role of gender and other intersecting inequalities (intersectional gender inequality) in shaping health and well-being over the life course. We discuss the Exemplars in Global Health – Women’s Health and Well-being (EGH-WHW) Framework and a scoping review that supports it.

Objectives

  • To identify well-established and/or validated CA-based frameworks and measures attuned to intersectional gender inequality that analyse women’s well-being over the life course and across multiple geographies.

  • If needed, to develop a new conceptual framework to analyse WHW over the life course through an intersectional gender inequality lens.

  • Design

    The scoping review, which was carried out between January and May 2024 and re-run in May 2025, adhered to the methodology by Arksey and O’Malley, Levac et al and Daudt et al, and the PRISMA-ScR (Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews) checklist. The EGH-WHW Framework was developed by a multidisciplinary Working Group comprising representatives of organisations in the WHW Project consortium.

    Data sources

    The review drew upon database searches (Scopus, PubMed) and targeted online hand searches for CA-based frameworks and measures.

    Eligibility criteria

    All CA-based frameworks and measures of multidimensional well-being were included. CA-based empirical research was considered if it applied a framework or measure; or if it analysed multidimensional well-being across multiple geographies.

    Data extraction and synthesis

    Information about each type of CA-based application—its choice of well-being dimensions, methods, focus on inequality, intersectionality and the life course—was recorded in a data charting form. Thematic summative syntheses of publications about each CA-based framework or measure led up to an overall evaluative synthesis of the fit between existing work and our requirements.

    Results

    The review culminated in 94 publications, including six frameworks and 14 measures that met only some of the WHW Project’s requirements: multidimensionality of well-being; attention to intersectional gender inequality and the life course; as well as demonstrated and intended measurements across multiple geographies.

    Discussion

    The review reaffirms the need for the EGH-WHW Framework, which recognises that WHW depend on their freedom ‘to be’ and ‘to do’, and proposes three interconnected clusters of dimensions depicting key capabilities, agency and functionings that are sensitive to intersectional gender inequality and the life course. Each dimension is mapped to specific indicators to support comparative assessments of country performance and drivers of progress across low-income and middle-income countries.

    Conclusion

    The EGH-WHW Framework distinguishes itself from other CA-based frameworks by incorporating both an intersectional gender lens and a life course perspective. The framework’s conceptualisation of multidimensional well-being allows for a rich and nuanced foundation on which to build policies and programmes that address the complex determinants of health, well-being and human rights of different groups of girls and women.

    Comparing community-based monitoring to hospital-based care of patients with quiescent age-related macular degeneration: a qualitative study of patient and practitioner perspectives on acceptability and access

    Por: Vougioukalou · S. · Read · S. M. · Csontos · J. K. · Jones · A. · Jaber · A. · Sharma · A. · Balaskas · K.
    Objectives

    This process evaluation explores patient and healthcare professional acceptability of community-based monitoring versus hospital-based care for patients with quiescent neovascular age-related macular degeneration (QnAMD).

    Design

    Qualitative process evaluation was conducted as part of a randomised controlled trial.

    Setting

    Six hospitals and six community-based practices.

    Participants

    25 patients and 16 healthcare professionals (ophthalmologists and optometrists). This approach helped differentiate between common issues and those specific to community-based monitoring.

    Intervention

    The Quality-Assured Follow-Up of QnAMD by non-medical practitioners trial aimed to examine whether non-medical practitioners follow-up patients with QnAMD in the community in a safe and clinically and cost-effective way. The process evaluation aimed to examine whether the intervention was acceptable by patients and professionals. The process evaluation was based on interviews which contained open-ended questions focused on patient experience and confidence in community-based care, issues concerning the practicalities of the organisation and management of the clinic, and resources including IT and digital equipment. The theory of acceptability framework was used to interpret the findings.

    Results

    Patients reported positively on the experience of receiving QnAMD services in the community and highlighted staff professionalism and clear communication. Key themes were the proximity of care provision for patients, IT interoperability and the real-world costs of running the service. Some patients randomised to the hospital showed preference for the intervention to take place in the hospital, mediated mainly by prior experience of hospital care and travel distance. The location of the clinic and transport routes affected the experience of attending appointments, with strong preference expressed for proximity to one’s home. Inaccessibility due to non-modifiable internal building structures in the community and parking in hospital eye services was reported by a small proportion of patients. Healthcare professionals reported positively about their ability to deliver QnAMD services in community settings but raised concerns about the compatibility of technological infrastructure that facilitates the sharing of optical coherence tomography image and video files. Some optometrists were also concerned about the financial sustainability of the intervention after the end of the trial due to the costs involved in the administration of QnAMD follow-up care.

    Conclusions

    The delivery of QnAMD services in the community by non-medical personnel was broadly accepted by both patients and practitioners. This implies that non-medical practitioners can follow up patients with QnAMD in the community in a safe way. Further research would be needed to establish whether similar results would be obtained during routine practice outside a research project and whether the long-term follow-up for QnAMD would be financially sustainable for independent as well as chain community optometry practices.

    Trial registration number

    NCT03893474.

    Exploring the role of symptom monitoring in self-management of chronic physical health conditions experienced by women: protocol for a scoping review

    Por: Thompson · H. · Boivin · J. · Csontos · J. K. · Jackowich · R.
    Introduction

    Self-management is essential for girls, women and individuals assigned female at birth (AFAB) living with chronic physical health conditions. Evidence suggests that symptom monitoring can support self-management and empower individuals, yet limited research has explored how symptom monitoring is conceptualised, implemented and integrated within self-management frameworks considering the unique needs of biological, gendered and social factors affecting women and people AFAB. This scoping review aims to explore the role of symptom monitoring in self-management for girls, women and individuals AFAB. To achieve this, this review aims to define and conceptualise symptom monitoring and self-management, map existing symptom monitoring interventions and mechanisms linked to self-management and identify how sex, gender and systemic influences are considered in the context of chronic physical health conditions.

    Methods and analysis

    This scoping review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews checklist. Six bibliographic databases (Cochrane Library, Scopus, PsycINFO (Ovid), MEDLINE (Ovid), EMBASE (Ovid) and CINAHL (EBSCO)) were searched from inception to 13 May 2025. Eligible studies will include primary research from Organisation for Economic Co-operation and Development countries, published in English, involving girls, women and individuals AFAB with chronic physical health conditions that involve symptom-monitoring tools linked to self-management. Studies focusing solely on obesity without reference to chronic conditions, acute illnesses or mental health conditions will be excluded. Screening will be undertaken independently by two reviewers in Rayyan, and citation management will be supported through reference software. Data extraction will follow Joanna Briggs Institute (JBI) guidance, capturing study characteristics, participant demographics and definitions related to symptom monitoring and self-management. Both inductive and deductive qualitative content analyses will be used: deductively, data will be organised according to the population, concept and context framework and research objectives. Inductively, descriptive categories will be developed from the data. Two complementary approaches will guide coding such as direct extraction of data and content coding of structured textual information, and thematic coding of interpretive data, supported by Microsoft Excel and SPSS. A small subset (5%–10%) will be double-coded to ensure consistency. Key outputs will include descriptive tables showing representation of girls, women and people AFAB by condition and context, following a synthesis of symptom monitoring and self-management (through theory/models). Tables summarising symptom-monitoring tools, mechanisms and a table outlining moderating factors influencing symptom monitoring and self-management experiences will be presented. Results will be presented through narrative summaries and visual diagrams to illustrate key relationships and concepts.

    Ethics and dissemination

    Formal ethical approval is not required for this study, as no primary data will be collected. The results of this scoping review will be shared with a wide range of audiences, including healthcare professionals, researchers, the public, policymakers, charities and patient advocacy groups. In the efforts of dissemination, this work strives to promote inclusive, evidence-based and equitable approaches to symptom monitoring and self-management among girls, women and people AFAB living with chronic physical health conditions.

    Study registration

    This protocol has been registered on the Open Science Framework, .

    Attitudes towards addressing environmental sustainability in patient-provider interactions: a qualitative study among Dutch physicians

    Por: Cohen · E. S. · Grandiek · F. · Kringos · D. S. · Kouwenberg · L. H. J. A. · Sperna Weiland · N. H. · Richie · C. · Aarts · J. W. M. · Hehenkamp · W. J. K.
    Objectives

    To investigate the attitudes of physicians towards addressing environmental sustainability in patient conversations, and to identify barriers and facilitators to doing so.

    Design

    A qualitative, nation-wide study was conducted using semi-structured online focus groups and interviews. Reflexive thematic analysis was used to analyse transcripts, guided by the Theoretical Domains Framework.

    Setting

    Secondary and tertiary healthcare institutions in the Netherlands.

    Participants

    Participants were medical specialists and residents in obstetrics and gynaecology (OB-GYN physicians) in the Netherlands. Participants were purposefully identified to capture diverse demographics and practice settings.

    Primary and secondary outcome measures

    Physicians’ attitudes towards discussing the environmental impact of healthcare and the health effects of environmental pollution with patients. Themes were identified and categorised using the Theoretical Domains Framework.

    Results

    The study included 28 OB-GYN physicians working across 23 healthcare institutions in the Netherlands. Six themes were developed: (1) strong sense of urgency to reduce healthcare's environmental impact, (2) knowledge gaps impair communication about environmental impact to patients, (3) prioritisation of individual patient health over environmental concerns in decision-making, (4) perceived lack of patient interest in environmental outcomes, (5) system-level support facilitates discussions about environmental sustainability with patients and (6) limited perceived value in discussing the health effects of environmental pollution and climate change with patients.

    Conclusions

    OB-GYN physicians are supportive of discussing the environmental impact of healthcare services when clinically appropriate. Addressing knowledge gaps, providing evidence-based guidance and embedding sustainability into clinical guidelines and decision aids may facilitate the integration of environmental sustainability into patient-provider interactions.

    Fair access to higher surgical training in the UK: an equity, diversity and inclusion analysis of national selection in 2024

    Por: Seehra · J. K. · Ellis · R. · Doleman · B. · McLarty · E. · Lund · J.
    Objectives

    To assess the impact of gender, age, ethnicity and country of primary medical qualification (CoQ) on outcomes in the 2024 UK ST3 surgical national selection process.

    Design

    Retrospective cross-sectional analysis of national recruitment data.

    Setting

    UK-wide ST3 surgical training recruitment.

    Participants

    2009 unique ST3 applicants to six surgical specialties (otolaryngology, plastic surgery, urology, paediatric surgery, trauma and orthopaedics and general surgery); neurosurgery, cardiothoracic surgery and oral and maxillofacial surgery were excluded.

    Primary outcome measure

    Offer of a ST3 National Training Number (NTN).

    Results

    CoQ was the strongest factor associated with success. International medical graduates had lower odds of receiving offers in all specialties, notably in general surgery (adjusted OR (aOR)=0.21, 95% CI 0.14 to 0.33, p

    Conclusions

    ST3 selection outcomes are primarily associated with CoQ. UK-trained applicants have a consistent advantage. Women remain less likely to be offered an NTN than men in Trauma and Orthopaedics. This analysis enables detailed and timely equity monitoring across surgical specialties and flags areas for intervention.

    Aspirin to prevent cardiovascular events in patients with community-acquired pneumonia or influenza (ASCAP study): protocol for a multicentre, randomised, double-blind, placebo-controlled trial

    Por: Hovsepjan · V. · Thijs · A. · van Diemen · J. J. K. · Bogaards · J. A. · Winter · M. M. · Bosmans · J. E. · Prins · J. M. · ASCAP study group · Altenburg · Bogaards · Bosmans · van Diemen · Hovsepjan · Prins · Thijs · Winter · Fritsma-Terwisscha van Scheltinga · Weijer · Berk · H
    Introduction

    Cardiovascular events (CVEs), in particular acute coronary syndrome (ACS), complicate the course of a significant number of patients hospitalised for community-acquired pneumonia (CAP) or influenza. Emerging evidence suggests that this increased risk of CVEs could be mitigated by the use of acetylsalicylic acid (aspirin). The ASCAP study investigates whether the addition of aspirin to standard therapy in hospitalised patients with moderate-to-severe CAP or influenza can reduce the incidence of CVEs.

    Methods and analysis

    The ASCAP study is a multicentre, double-blind, placebo-controlled randomised trial in 16 university and general hospitals in the Netherlands, in which patients are randomised to acetylsalicylic acid or matching placebo for 90 days. Eligible patients are adults hospitalised for moderate-to-severe CAP or influenza. Patients with antithrombotic or anticoagulant drugs, or those with contraindications for aspirin, are excluded. The primary outcome is the incidence of ACS up to day 180. Secondary outcomes include the incidence of 4-point major adverse cardiovascular events up to day 180, as well as the incidence of major bleeding and clinically relevant non-major bleeding events up to day 90, all-cause mortality up to day 180 and quality of life and societal costs up to day 180. Survival time will be analysed by the log-rank test, stratified for CAP and influenza, with a two-sided alpha of 0.05. Assuming an average baseline ACS risk of 7.5% over 180 days with up to 30% variation across strata, and a 60% hazard reduction due to aspirin, the required sample size to achieve 80% power is 760 patients. Currently, 114 patients are enrolled in the study.

    Ethics and dissemination

    This study is approved by the Medical Ethics Committee Amsterdam UMC (Amsterdam, The Netherlands) under reference number 2023.0741 and registered under EU trial number 2023-504553-12-01 in the EU portal CTIS (Clinical Trials Information System). Results of the study will be published in a peer-reviewed journal.

    Trial registration number

    EU CTIS: 2023-504553-12-01.

    High-Intensity Statin versus Upfront Equivalent-Dose Combination of Moderate-Intensity Statin with Ezetimibe Following Acute Myocardial Infarction (ROSUZET-AMI): protocol of a multicentre, open-label, randomised non-inferiority trial

    Por: Choo · E. H. · Kim · C. J. · Hwang · B.-H. · Lee · K. Y. · Oh · G. C. · Lim · S. · Choi · I. J. · Kim · D.-B. · Kwon · O. S. · Lee · S. · Choi · Y. · Park · C.-S. · Park · M.-W. · Kim · H.-Y. · Lee · H. C. · Kang · T. S. · Sung · J. K. · Woo · S.-I. · Park · H. S. · Yun · K. H. · Chang · K. · On
    Introduction

    High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

    Methods and analysis

    The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

    Ethics and dissemination

    Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

    Trial registration number

    NCT04499859.

    Do people prefer to take part in a clinical trial from home or come to site? A discrete choice experiment in type 2 diabetes mellitus

    Por: Kopanz · J. · Lagerwaard · B. · Veldwijk · J. · Mader · J. K. · Tews · D. · van Sloten · T. T. · Grobbee · D. E. · Zuidgeest · M. G. P. · on behalf of the Trials@Home consortium
    Objectives

    To determine what drives participation in clinical trials with decentralised elements and to estimate trial participation probabilities for trials with different degrees of decentralisation.

    Design

    Patient preference study using a discrete choice experiment.

    Setting

    Recruitment in primary, secondary, tertiary care and other settings in the Netherlands (NL), Austria (AT) and Germany (DE).

    Participants

    People with type 2 diabetes mellitus (T2DM) aged ≥18 years. A total of 787 people (NL n=276, AT n=265, DE n=246) participated in the study.

    Main outcome measures

    Preferences for participation in clinical trials with different options for location and type of contact with the study team, activities to perform by participant, use of digital technologies by participant, number of scheduled contacts, trial duration, known safety and efficacy of the drug.

    Results

    How much was known about the safety and efficacy of the drug was the most important element in the decision whether to participate in a clinical trial in all countries. The trial duration, location and type of contact with the study team, and number of scheduled contacts were other important elements. Participation probabilities for hypothetical trial scenarios differed between countries, with the highest rates for a decentralised trial involving video contact (NL: 89%; AT: 99%; DE: 84%).

    Conclusions

    People with T2DM prefer to take part in clinical trials with decentralised approaches. Information on preferences can help trialists and protocol developers to design and plan future trials that integrate patients’ needs and thus reduce barriers to participation.

    Five Nested Dolls Framework: enhancing transparency and collaboration in community-engaged research through researchers reflexivity and disclosure

    Por: Kakim · S. · Cooper · J. K. · Mullins · C. D.
    Introduction

    Despite the widespread use of community-engaged research (CEnR) in public health, there is a lack of practical guidance for ensuring research transparency while fostering collaboration between researchers and patient communities.

    Objective

    In this article, we propose the Five Nested Dolls Community-Engaged Research Framework (Five Dolls CEnR) as a tool to assist researchers in enhancing the transparency of CEnR and fostering collaboration between researchers and patient communities throughout all phases of CEnR.

    Framework

    Each of the five dolls represents a meaningful aspect of CEnR, such as patient engagement in research, conceptual framework, research design, findings and researchers’ positionality. In alignment with feminist standpoint theory, Five Dolls CEnR is based on a nesting design principle to demonstrate the influence of researchers’ experiences, perspectives, values, beliefs and assumptions on a research process.

    To ensure transparency of the research process and foster collaboration in CEnR, the authors have described self-reflexivity and self-disclosure, two multidisciplinary concepts, as strategies. This framework consists of a series of steps and questions to promote self-reflexivity and self-disclosure of researchers at each doll level.

    Conclusion

    As a multidisciplinary framework, Five Dolls CEnR can be used across disciplines and throughout the planning, implementation and dissemination phases of a study.

    Association between hyperglycaemia, diabetes complications and development of fibrotic conditions among people living with type 1 and type 2 diabetes in England: a retrospective cohort study using UK Clinical Resource Datalink Aurum and Hospital Episode S

    Por: Massen · G. M. · Cook · S. · Moss · S. T. · Chambers · R. · Jenkins · G. · Allen · R. J. · Wain · L. V. · Stewart · I. · Oliver · N. · Morganstein · D. L. · Quint · J. K. · on behalf of the DEMISTIFI Consortium
    Objective

    Fibrosis is a pathological feature that can occur in a wide range of diseases including diabetes mellitus. We investigated whether in people with type 1 (T1DM) or type 2 diabetes mellitus (T2DM), glycaemia or diabetes-related complications are associated with fibrotic diseases.

    Design and setting

    Retrospective cohort study using UK Clinical Resource Datalink (CPRD) Aurum and Hospital Episode Statistics.

    Participants

    We included people with prevalent T1DM or T2DM as of 31 December 2015 (recorded in CPRD Aurum), eligible for linkage with Hospital Episode Statistics and followed up for 3 years.

    Outcome measures

    We defined diabetes status using blood/urine biomarkers and complications. In the T2DM cohort, we also investigated exposures of hyperglycaemia, insulin resistance and metformin prescription. Fibrotic condition diagnoses were determined from both primary and secondary care records. Logistic regression analyses were undertaken to understand the strength of association between diabetes status/diabetic complications and fibrotic conditions, respectively.

    Results

    The T1DM cohort consisted of 9669 people while the T2DM cohort included 504 066 people. In T1DM, we found that albuminuria was associated with lung fibrosis (ORadj: 2.07, 99% CI 1.35 to 2.17), and microvascular complications were associated with atherosclerosis (ORadj: 1.81, 99% CI 1.18 to 2.77) and cardiomyopathy (ORadj 1.53, 99% CI:1.15 to 2.04). In the T2DM cohort, both glycaemia above target and diabetes complications were associated with most fibrotic conditions.

    Conclusions

    Within the T1DM population, no consistent association between diabetes status and all fibrotic diseases was observed. More research is required to understand whether the association between diabetes complications and fibrotic diseases is due to shared risk factors or whether glycaemia in T2DM may be influenced by fibrotic pathology.

    Community-based mental health screening & referral for flood-affected women in rural Pakistan: an intervention feasibility study protocol

    Por: Das · J. K. · Gaffey · M. F. · Ansari · Z. N. · Mirani · M. · Tabassum · F. · Niaz · M. · Siddiqui · A. · Rabbani · F. · Rizvi · A. · Ahmed · I. · Khan · M. · Bhutta · Z. A.
    Introduction

    South Asia carries the burden of a rapidly changing climate with floods and extreme heat. These disasters further translate into mental health distress, financial stress and detrimental effects on well-being, with women being the most vulnerable. This study aims to demonstrate that mental health screening, referral and resilience-building group sessions can be successfully administered by community health workers and primary health facility staff in a flood-affected rural population of women in Pakistan and provide evidence on the effectiveness of this approach for improving their mental health status.

    Methods and analysis

    A quasi-experimental design with a comparison group will be used for the study, preceded by a formative phase. The formative phase evaluated the feasibility of mental health screening by Lady Health Workers (LHWs) in flood-affected areas using a qualitative approach such as focus group discussions and in-depth interviews. Manuals developed by the study team of mPareshan will be used to train LHWs, Lady Health Supervisors (LHS) and health facility staff. Following this, LHWs will briefly screen women aged 18 to 49 years, administer awareness-raising and resilience-building sessions and refer women who screen positive for depression or anxiety to a primary health facility. Physicians at the health facility will confirm the diagnosis and provide counselling to mild-moderate cases, while severe cases would be referred to specialists. Statistical evaluation of quantitative data and thematic content analysis of qualitative data will be conducted to assess the feasibility and impact of the intervention. This trial is registered at clinicaltrials.gov with number NCT06756165.

    Ethics and dissemination

    The study acquired ethical approval from the Ethical Review Committee at Aga Khan University (2024-10475-30776) and the National Bioethics Committee (4-87/NBC-1158/23/481) in Islamabad. Approval was obtained from relevant provincial authorities. The trial will adhere to the ethical principles of autonomy, anonymity, confidentiality, equity and respect. All eligible participants will be provided with informed consent, details regarding the purpose and procedure of the study, and the right to withdraw at any time. Data and information will be anonymised and stored securely. Dissemination of the results of the trial will occur after its completion to stakeholders, participants and the public.

    Trial registration number

    NCT06756165.

    Emergency department-initiated palliative care screening among older adults: a systematic review and meta-analysis protocol

    Por: Lin · D. E. · Gunaga · S. · Mowbray · F. I. · Isaacs · E. D. · Markwalter · D. · George · N. · Hay · A. E. · Manfredi · R. · Westlake · E. · Akhter · M. · Bowman · J. K. · Rebollo-Lee · N. · Gacioch · B. · Ginsburg · A. D. · Brooten · J. K. · Pajka · S. · Selman · K. · Bain · P. · Davis · J
    Introduction

    The rapidly growing population of older adults (individuals aged 65 years and older) presents a new set of challenges for healthcare providers in the emergency department (ED), given the prevalence of severe and life-threatening conditions among this group, such as chronic cancer, Alzheimer’s disease/dementia and congestive heart failure. ED encounters often represent a critical point in an older patient’s trajectory of care and can thus be an important opportunity for various interventions such as palliative care consultation. Therefore, identifying those who will benefit most from palliative care is of high importance, especially in determining the course of future treatment. Thus, we aim to conduct a systematic review assessing the efficacy of palliative care screening in the ED by assessing inpatient length of stay as the primary outcome and quality of life, percentage of hospitalisation and cost of care as secondary outcomes.

    Methods

    This study will use Ovid MEDLINE, Embase, EBSCO CINAHL, Web of Science and Cochrane as databases. The study population comprises adults aged 60 years and older, with no focus on any specific clinical specialty or disease. Patients who have not received palliative care screening will serve as the comparator. Only studies with an applicable comparator will be considered. Studies published from 1 January 2000 to 1 July 2025 will be included.

    All articles will be reviewed independently and in duplicate, and every author will participate in the review, data abstraction and conflict resolution process.

    Ethics and dissemination

    Ethical approval is not required as it is a protocol for a systematic review. Findings will be disseminated through peer-reviewed publications and conference presentations.

    PROSPERO registration number

    CRD42024562389.

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