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Developing a typology of proximity healthcare interventions and system-level characteristics in Denmark: an exploratory qualitative interview study

Por: Carstensen · K. · Fyrstenborg · A. · Nielsen · C. P. · Terkildsen · M. D. · Duvald · I. · Torp Lohse · C. · Uhrskov Sorensen · L. · Risor · B. W.
Objectives

Proximity healthcare interventions aim to provide or support health services geographically close to, or in, citizens’ own homes, involving the actors needed to deliver appropriate care across sectors. However, the field remains conceptually ambiguous, and systematic knowledge of how such interventions are organised is limited. This study therefore aims to develop an empirically grounded typology of proximity healthcare interventions in Denmark and explore system-level characteristics that characterise their development and organisation.

Design

Exploratory qualitative study based on semi-structured interviews with key informants responsible for cross-sectoral healthcare planning and implementation.

Setting

The Danish healthcare system, a publicly funded, decentralised system undergoing structural reform to strengthen proximity healthcare and cross-sectoral coordination.

Participants

28 informants across the 5 Danish regions, including health cluster coordinators, regional administrators and municipal representatives.

Methods

Data were collected through 20 semi-structured interviews and analysed using thematic analysis informed by Braun and Clarke’s approach. A typology was developed inductively from the data and iteratively refined through collaborative coding and analytical discussion.

Results

The analysis revealed a heterogeneous field of proximity healthcare interventions differing in objectives, organisation and scope. The typology comprised healthcare delivery functions, including hospital outreach, delegation of treatment to municipal staff, shared healthcare models and self-administered healthcare supported by professionals, alongside supporting functions such as coordination roles, advisory partnerships, training and patient and family education. Across categories, three system-level characteristics were identified: substantial functional and organisational variation, including hospital anchoring of many interventions; reliance on short-term project funding and locally negotiated arrangements; and greater patient and relative involvement supported by digital infrastructure. These findings characterise proximity healthcare as both adaptive and fragmented within a decentralised system.

Conclusions

This study provides a system-level overview of proximity healthcare in Denmark through a typology that brings together healthcare delivery and supporting functions. By highlighting their interdependence and the characteristics shaping intervention development, the study contributes conceptual clarity in a policy field often ambiguously defined. The typology and identified system-level characteristics offer a practical tool for policymakers and planners to navigate a complex intervention landscape and a foundation for comparative and practice-oriented research on strengthening sustainable proximity healthcare in decentralised health systems.

Trial registration number

Not applicable.

Is targeted next generation sequencing for drug-resistant tuberculosis feasible in a high-burden setting: a qualitative study from Indonesia

Por: Annisa · S. N. · Alifia · A. · Larasmanah · A. N. · Ramadhani · N. S. · Indriani · S. · Soeroto · A. Y. · van Crevel · R. · Hill · P. C. · Lestari · B. W.
Objectives

Targeted next-generation sequencing (tNGS) offers promise in the rapid detection of drug-resistant tuberculosis (DR-TB) directly from sputum. While pilot studies on tNGS are emerging, there is limited empirical qualitative evidence on tNGS implementation. This study, therefore, aimed to explore the experiences of tNGS programmatic implementation by clinicians, laboratory technicians and policymakers to identify perceived key operational barriers and enablers.

Design

An exploratory qualitative study employing inductive thematic analysis. Data were collected via semi-structured interviews and focus group discussion. Analysis was guided by the theoretical framework of acceptance.

Setting

This study was conducted between March and October 2025 as part of a broader implementation study evaluating tNGS potential programmatic integration in West Java, Indonesia. Participants were recruited from a DR-TB reference laboratory and a tertiary care hospital.

Participants

A purposive sample of 18 tNGS users participated, including clinicians (n=7), laboratory technicians (n=9) and policymakers (n=2).

Results

Analysis revealed a dual challenge for tNGS implementation: technical-operational complexity and unguided clinical utility. Technical barriers include laboratory workflow optimisation and the need for highly skilled technicians for routine operation. From a clinical point of view, lack of local tNGS guidelines for clinicians and absence of local evidence such as cost-effectiveness and diagnostic performance at the policy levels hampered clinical adoption. Several enablers for tNGS implementation were identified, namely technicians with prior sequencing experience, perceived clinical value for complicated cases and advocacy within professional networks.

Conclusion

Successful scale-up of tNGS for DR-TB in high-burden settings requires a coordinated multisectoral strategy. Generating local evidence on robust laboratory data for technical guidelines, clinical utility and cost-effectiveness are warranted to support tNGS adoption. This evidence can then be integrated into the national tNGS roll-out strategy to enable sustainable and nationwide adoption of tNGS.

Dihydroartemisinin for the treatment of polycystic ovary syndrome: study protocol for a multi-centre placebo-controlled randomised clinical trial

Por: Mu · L. · Shen · Y. · Wang · G. · Liu · C. · Yang · H. · Li · W. · Mol · B. W. · Li · X. · Dong · X. · Jiang · J.
Introduction

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder that affects reproductive-aged individuals. Our previous single-arm pilot trial showed that dihydroartemisinin (DHA) normalised menstrual cycles, ameliorated hyperandrogenaemia and reduced antral follicles in individuals with PCOS. However, no comparative evidence confirms the efficacy of DHA in individuals with PCOS when compared with placebo.

Methods and analysis

This is a multi-centre randomised, double-blinded, placebo-controlled trial of individuals with PCOS who have irregular menstrual cycles and hyperandrogenism, with or without polycystic ovary morphology. A total of 150 participants will be randomised in a 1:1 ratio to receive oral tablets of 40 mg DHA three times per day or placebo for 90 days. The primary outcome is the return of regular menstrual cycles within 6 months after treatment initiation, with antral follicle count and metabolic profile being secondary outcomes. The primary analysis will follow the intention-to-treat principle.

Ethics and dissemination

This study has been approved by the ethics committees of Zhongshan Hospital, Fudan University and all participating centres. All participants will provide written informed consent before randomisation. The results will be published in a peer-reviewed journal and will be presented at international meetings.

Trial registration number

NCT06842524.

Outcomes of invasive mechanical ventilation in critically ill patients with interstitial lung disease: protocol for a systematic review and meta-analysis

Por: Kola · N. · Parker · R. · Hall · A. · Spencer · L. G. · Fletcher · S. V. · Welters · I. D. · Johnston · B. W.
Introduction

Interstitial lung diseases (ILDs) represent a heterogeneous group of disorders, which have in common persistent inflammation and/or pulmonary fibrosis, involving mainly but not exclusively the interstitium. This results in restrictive ventilatory physiology and limited respiratory reserve. Patients with ILD can have frequent exacerbations of their disease, with subsequent acute respiratory failure that may require admission to the intensive care unit (ICU). The diagnosis and management of ILD in the ICU presents unique challenges due to the paucity of evidence supporting survival benefits of organ support in this cohort of patients.

Methods and analysis

This systematic review will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement, and the protocol will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guideline. MEDLINE, Embase, Emcare and CENTRAL will be searched for studies published from inception to 2026, involving adult patients with ILD requiring invasive mechanical ventilation (IMV), with or without comparison to non-invasive respiratory support such as high-flow oxygen, non-invasive ventilation (NIV), continuous positive airway pressure or bilevel positive airway pressure. Eligible studies will include randomised controlled trials and observational studies (cohort and case–control) in adults with ILD and acute respiratory failure requiring IMV in the intensive care setting. Case series with fewer than 10 patients, non-human or in vitro studies and studies involving perioperative lung transplant or lung cancer as the primary diagnosis will be excluded. The primary outcomes assessed will be in-hospital and 1-year mortality, and secondary outcomes will include ventilator-free days, ICU and hospital length of stay, NIV failure, reintubation and postdischarge respiratory outcomes where available. Where feasible, meta-analysis will be conducted using a random-effects model. Heterogeneity will be assessed using the I² statistic. Prespecified subgroup analyses will be performed, including ILD subtype (eg, idiopathic pulmonary fibrosis (IPF) vs non-IPF), presence of pulmonary hypertension, timing of IMV initiation (early vs late), baseline lung function (forced vital capacity ≥50% vs

Ethics and dissemination

This systematic review will be based on published data, and as such, no ethical approval is required. Findings from this study will be disseminated through peer-reviewed publications as well as presentations in healthcare-based settings.

PROSPERO registration number

CRD420251265836.

Tobacco use and associated factors among adults in Ghana: evidence from the 2022 Ghana Demographic and Health Survey

Por: Logo · D. D. · Kodali · P. B. · Ouner · J. J. · Anaman-Torgbor · J. · Chaffee · B. W. · Bialous · S. A.
Objective

To examine the prevalence and sociodemographic factors associated with tobacco smoking, smokeless tobacco and dual use among adults in Ghana using the 2022 Demographic and Health Survey (GDHS).

Setting

Ghana, nationwide sample of males and females aged ≥15 years.

Design

This was a cross-sectional secondary analysis of the 2022 GDHS.

Population

A representative sample of 22 058 individuals (females, 15 014 aged 15–49; males, 7044 aged 15–59)

Primary and secondary outcome measures

Current tobacco smoking, smokeless tobacco use and dual use.

Results

Prevalence for smoking, smokeless tobacco and dual use was 4.7 (4.1–5.4), 1.6 (1.3–2.0) and 0.6 (0.4–0.9) among males and 1.0 (0.8–1.3), 0.08 (0.05–0.1) and 0.1 (0.05–0.1) among females, respectively. Among males, smoking was associated with higher age (30–44 years: AOR: 2.3, 95% CI 1.7 to 3.1; 45–59 years: AOR: 2.6, 95% CI 1.8 to 3.7). Higher education was protective for both sexes [(males: AOR: 0.4, 95% CI 0.2 to 0.8) and (females: AOR: 0.4, 95% CI 0.2 to 0.8)] compared with their counterparts who had no education. Males in the Coastal zone had higher odds of use (AOR: 1.8, 95% CI 1.3 to 2.3) compared with males in the Middle zone, while females in the Northern/Savanna zone had lower odds of tobacco use (AOR: 0.5, 95% CI 0.3 to 0.8) compared with the Middle zone. Being Christian was associated with lower odds of smoking among males (AOR: 0.3, 95% CI 0.2 to 0.5) compared with others, while being Mole-Dagbani ethnic is associated with higher odds of smoking among females (AOR: 3.0, 95% CI 1.7 to 5.4).

Conclusion

The study provides the first national analysis across Ghana’s 16 regions and investigates patterns of smoking, smokeless tobacco and dual tobacco use. While tobacco use in Ghana remains predominantly smoked and male-driven, the divergent patterns of use across educational, regional and ethnic groups, especially the emerging risk among females, represent a significant public health shift that demands focused gender-sensitive tobacco control interventions.

Randomised, triple-blind, placebo-controlled trial of atosiban in women with previous embryo implantation failure and abnormal uterine contractions undergoing single blastocyst-stage embryo transfer: a study protocol

Por: Cai · H. · Li · W. · Mol · B. W. J. · Liu · D. · Lei · D. · Ran · X. · Zhang · D. · Xue · X. · Gao · L. · Shi · J.
Introduction

Atosiban may confer therapeutic benefits to specific subpopulations in assisted reproductive technology. The Phase I Atosiban study indicated potential improvements in live birth rates among women with previous implantation failure undergoing frozen-thawed blastocyst transfer who exhibited abnormal uterine contractions, although these findings did not reach statistical significance. Therefore, further investigations are warranted to thoroughly elucidate the efficacy of atosiban and to evaluate whether uterine contractions can serve as a reliable biomarker for its targeted application.

Methods and analysis

This is a single-centre, randomised, triple-blind, placebo-controlled trial aiming to enrol 792 infertile women aged 20–40 years with a history of at least one previous embryo implantation failure and abnormal uterine contractions prior to single blastocyst-stage embryo transfer. Eligible participants will be randomly assigned in a 1:1 ratio to receive either intravenous atosiban or a placebo before embryo transfer. The primary outcome is live birth rate, with secondary outcomes encompassing various pregnancy and perinatal parameters. Randomisation will be stratified by age and transfer type. Intention-to-treat analysis will be performed using generalised linear models. The trial will be monitored by an independent data and safety monitoring committee, including one interim analysis.

Ethics and dissemination

This study has been approved by the Institutional Ethics Committee of Northwest Women’s and Children’s Hospital (No. 2025-058-02). Written informed consent will be obtained from all participants. The study results will be disseminated at scientific conferences and published in peer-reviewed journals.

Trial registration number

NCT07185230.

Efficacy and safety of Doxycycline versus Macrolides for Mycoplasma pneumoniae INfectiOn in Children (DOMINO): a protocol for a multicentre, randomised, open-label, superiority trial

Por: Choi · Y. Y. · Kang · C. · Choe · Y. J. · Yoo · Y. · Shin · A. · Kim · D. R. · Ahn · B. · Eun · B. W. · Kim · G. · Kang · H.-M. · Kim · Y. J. · Cho · Y. K. · Lee · H. · Kim · Y. K. · Choi · J. H. · Yun · K. W. · Jo · K. J. · Kim · K.-R. · Lee · T. J. · Choi · U. Y. · Yoon · Y. S. · Kim · J. · Kang
Introduction

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.

Methods and analysis

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

Ethics and dissemination

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.

Trial registration number

NCT07306234.

Longitudinal real-world surveillance of infection outcomes in CAR-T and bispecific therapy recipients: the CLARITY study protocol

Por: Reynolds · G. K. · Anderson · M. A. · Thursky · K. · Teh · B. W. · Slavin · M. A.
Introduction

Infections are a leading cause of non-relapse mortality following chimeric antigen receptor T-cell therapy (CAR-T) and bispecific antibody (BsAb) therapies. However, infection data from clinical trials are often incomplete, lack pathogen-level detail and rarely capture late infectious complications. This CAR-T treatment in Lymphoma: Analysis of Risk of Infection following Therapy (CLARITY) study aims to generate real-world, longitudinal infection data with extended follow-up to characterise infection timing, including late events and inform risk prediction in patients with lymphoma and myeloma receiving novel immunotherapies.

Methods and analysis

CLARITY is a multicentre observational cohort study across six Australian centres enrolling adults treated with CAR-T or BsAb therapies. A co-designed REDCap (Research Electronic Data Capture) instrument captures infections classified as microbiologically defined, clinically defined or fever of unknown origin, using internationally standardised definitions. Patients were enrolled between 2019 and 2023, with at least 2 years follow-up per patient, allowing time-updated data on immunosuppressive exposures, haematological recovery and prophylaxis. Multivariable regression and landmark analyses will estimate infection incidence and identify dynamic risk factors over time. Incidence rate ratios will assess prophylaxis effectiveness. Data integrity is supported by central adjudication and site-level audits.

Ethics and dissemination

The study has received a waiver of consent (HREC/PMCC/89002) and was co-designed by haematology and infectious diseases investigators. Findings will be disseminated through peer-reviewed publications, scientific meetings and national guideline committees to inform infection prevention and late effects surveillance in immunotherapy-treated populations.

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