Virtual Wards (VWs) facilitate hospital-level monitoring, diagnostics and treatment within patients’ homes, while the hospital team retains responsibility for care. International research indicates that VWs decrease hospital length of stay without increasing readmissions; however, the feasibility and key operational determinants within Dutch care remain uncertain. This protocol outlines the VW for Early Discharge in Patients Receiving Inpatient Care (VIP Care) study.

The VIP Care study is a single-centre prospective feasibility cohort study conducted at Erasmus University Medical Center (Erasmus MC), Rotterdam, the Netherlands. The study encompasses seven predefined subcohorts with n=51 eligible patients per subcohort: (1) bacterial, fungal or parasitic infections; (2) viral respiratory infections; (3) dehydration; (4) decompensated heart failure; (5) high-dose corticosteroid treatment; (6) post-transsphenoidal pituitary surgery follow-up and (7) severe inflammatory skin disease with or without bacterial or viral superinfection. Adults who require hospital-level monitoring and/or therapy may qualify for early discharge to the VW.

The VW integrates scheduled, patient-performed measurements using (European Conformity) CE-marked devices with structured symptom assessment submitted via a patient application, and data review in an electronic health record-integrated clinician cockpit. Submissions are evaluated by VW tele-nurses using prespecified Early Warning Score based thresholds and an escalation protocol. Patients receive a daily physician telephone review. Diagnostics and treatments are administered at home to hospital standards through established home-care services.

The primary outcome (feasibility) is adherence to transfer, defined as the proportion of eligible inpatients who provide written informed consent and are subsequently successfully transferred to the VW. The prespecified feasibility threshold is 30%. Secondary outcomes include reach (eligibility, invitation and consent rates among admitted patients), operational performance during the VW episode (alert frequency and handling, contact volumes and actions), length of stay on the ward and in the VW, emergency department reassessments and 30-day readmissions. Qualitative interviews will be conducted to identify implementation determinants.

The study received approval from the Erasmus MC Medical Ethics Committee (MEC-2024–0060; amendment MEC-2024–0060 A0001). Incremental risk is considered minimal. Written informed consent is obtained. Findings will be disseminated through peer-reviewed publications, conference presentations and an accessible lay summary.

ClinicalTrials.gov NCT06936891; CCMO NL85516.078.24. Recruitment began in May 2025 and is ongoing.

To examine differences in physical health conditions among female veterans compared with male veterans and female civilians.

Cohort analysis using data from the UK Biobank, incorporating self-reported and hospital-derived health information.

Veteran status was identified using Standard Occupational Classification codes. The study included female veterans (n=546), male veterans (n=2722) and female civilians (n=66 305).

Physical health conditions were identified through self-report and hospital records. Multivariable logistic regression models estimated associations between veteran status and selected health conditions, adjusting for age, sociodemographic factors, time in service, body mass index and current smoking status.

Compared with female civilians, female veterans had increased odds of chronic obstructive pulmonary disease (adjusted OR (aOR) 1.79, 95% CI 1.04 to 3.08) and lower odds of hypertension (aOR 0.74, 95% CI 0.59 to 0.93), with no significant difference in musculoskeletal conditions or osteoarthritis. Compared with male veterans, female veterans had significantly higher odds of osteoarthritis (aOR 1.61, 95% CI 1.25 to 2.08), migraine (aOR 2.63, 95% CI 1.66 to 4.19) and thyroid disorders (aOR 4.42, 95% CI 2.83 to 6.89).

Female veterans have distinct physical health profiles, including a greater burden of musculoskeletal and respiratory conditions compared with male veterans and female civilians. These findings highlight the need for targeted prevention and clinical interventions for women with a history of military service.

Glucocorticoid therapy is prescribed for a variety of inflammatory conditions and is associated with severe adverse effects. A glucocorticoid withdrawal syndrome (GWS) may occur after prolonged glucocorticoid treatment—with or without biochemical glucocorticoid-induced adrenal insufficiency (GIAI). Previously, GWS was not considered an entity, probably due to the overlap between symptoms of GWS and GIAI. The Addison’s disease-specific quality of life questionnaire (AddiQoL-30) is a validated tool for quantifying symptoms of adrenal insufficiency resembling GWS. In the present study, we test the hypothesis that patients with a low AddiQoL-30 score and/or low cortisol response to a short Synacthen test (SST), after cessation of prednisolone treatment, may benefit from low-dose hydrocortisone therapy without increasing the risk of metabolic and cardiovascular disease during prolonged cortisol exposure.

REPLACE is a multi-centre, double-blinded, placebo-controlled randomised controlled trial in patients with polymyalgia rheumatica or giant cell arteritis after cessation of prednisolone treatment. Criteria for randomisation are an AddiQoL-30 score ≤85 and/or plasma cortisol response to SST, 30-min p-cortisol >100 and 85; and (2) patients with a SST-stimulated cortisol ≤100 nmol/L.

The study is conducted in accordance with the Declaration of Helsinki, registered at the Clinical Trials Information System (CTIS: 2024-513822-53-00) and Clinicaltrials.gov (NCT05193396), and publications will be in accordance with the recommendations of the International Committee of Medical Journal Editors. The trial is monitored by local independent Good Clinical Practice units and overseen by the Danish Data Protection Agency (journal no. 21/27119), the Regional Committees on Health Research Ethics for Southern Denmark (project ID: S-20210076), the Danish Patient Safety Authority and the Danish Medicines Agency.

NCT05193396.

Chronic respiratory diseases (CRDs), such as asthma and chronic obstructive pulmonary disease (COPD), are among the leading non-communicable diseases (NCDs) worldwide. However, diagnosing CRDs in low-income and middle-income countries (LMICs) remains challenging due to limited access to spirometry and trained professionals. Aggravating the burden, CRDs often coexist with other NCDs, increasing healthcare costs, reducing quality of life and elevating mortality. These challenges highlight the need for simple case-finding approaches for CRDs, such as the COPD in Low-Income and Middle-Income Countries Assessment (COLA-6) questionnaire, to support prompt identification and appropriate care within NCD services in LMICs.

To evaluate the discriminative accuracy, feasibility and implementation of the COLA-6 questionnaire in identifying and managing CRDs in Brazilian Primary Healthcare (PHC) services for NCDs.

The Multimorbidity Approach for REspiratory Solutions (MARES) study consists of three work packages to be conducted in PHC services in São Carlos/SP and São Paulo/SP, Brazil.

MARES-1: A cross-sectional observational study enrolling 859 individuals with at least one NCD receiving care in PHC. The COLA-6 questionnaire will be administered by the research team and compared with quality-assured spirometry. The Chronic Airways Assessment Test (CAAT), Asthma Control Questionnaire (ACQ-7) and fractional exhaled nitric oxide (FeNO) will also be assessed. The diagnostic performance of COLA-6 for identifying CRDs—including COPD, asthma, preserved ratio impaired spirometry, restriction and overlaps—will be assessed using area under receiver operating characteristic curves and 95% CIs.

MARES-2: A cross-sectional observational study enrolling 20 healthcare professionals (physicians, physiotherapists, community health agents and nurses) from five PHC services. These professionals will apply the COLA-6 during routine NCD care to a total sample of 1000 patients. Qualitative interviews will be conducted to explore barriers and facilitators to the implementation of COLA-6, using deductive thematic analysis.

MARES-3: A longitudinal, prospective observational study in which patients from MARES-1 and MARES-2 will be reassessed at 6-month follow-up. A total sample of 473 participants with abnormal spirometry, a diagnosis of CRD or high risk for CRDs is expected. Participants will undergo spirometry, and a subset will be interviewed to explore their healthcare experiences through qualitative thematic analysis. Access to diagnostic and treatment services in Brazil will be assessed. Changes in spirometry values, FeNO, CAAT and ACQ-7 scores from baseline to 6 months in patients from MARES-1 will be analysed.

This study has been approved by the Ethics Committees of Federal University of São Carlos and University of Santo Amaro (UNISA). Ethical approval was also granted by the University College London. Results will be disseminated through peer-reviewed medical journals and presentations at international conferences. Results will improve identification of CRDs, addressing a significant gap in current PHC settings.

NCT07050823/NCT07093021/NCT07134855.

Implementation of low-intensity, evidence-based psychological interventions can help meet the mental health and psychosocial needs of people with cancer, especially in low-resource settings where there is a dearth of mental health specialists. In this study, we will conduct a feasibility randomised controlled trial (RCT) of the stress management intervention Self-Help Plus, which has been translated and adapted to Vietnamese, vSH+, among people newly diagnosed with breast or gynaecological cancer in Viet Nam.

At six participating hospitals, individuals diagnosed with breast or gynaecologic cancer within the past year will be recruited, consented and randomised into either enhanced usual care (EUC) or EUC plus the vSH+ intervention, which consists of four sessions each lasting approximately 75 min. Quantitative surveys will be administered at three time points: enrolment/baseline (T0), after 6 weeks (T1) and after 4 months (T2). A qualitative evaluation component, which will include in-depth interviews with patients, implementers and healthcare staff and managers, as well as focus group discussions with caregivers, will assess the acceptability and feasibility of the vSH+ intervention.

Ethical reviews for the study were obtained from Boston University, Hanoi University of Public Health (HUPH) and all the participating hospital sites. On completion of data collection and analyses, the research team will prepare and submit abstracts to scientific conferences as well as manuscripts to peer-reviewed journals. We will also conduct dissemination events to report the trial results to relevant stakeholders.

NCT06398067.

Many patients who are extubated after receiving mechanical ventilation for acute respiratory failure experience extubation failure (ie, require reintubation hours to days after extubation). High-quality evidence shows that extubating patients directly to non-invasive ventilation (NIV) or high-flow nasal cannula oxygen (HFNC), rather than conventional low-flow oxygen, can prevent extubation failure. These guideline-recommended interventions, however, require care coordination involving multiple intensive care unit (ICU) team members and are infrequently used. Interprofessional education (IPE), which teaches members of multiple professions together, could effectively address this implementation gap in complex, team-based, critical care settings, particularly when paired with a customisable protocol.

This batched, stepped-wedge, cluster-randomised, type 2 hybrid effectiveness–implementation trial will test three hypotheses: (1) when compared with traditional online education (OE), IPE increases implementation of preventive postextubation respiratory support, (2) the benefits of IPE are increased when paired with a clinical protocol and (3) preventive postextubation NIV for high-risk patients and preventive postextubation HFNC for low-risk patients reduce in-hospital mortality when compared with conventional postextubation oxygen therapy. The trial will recruit 24 clusters made up of one or more ICUs that care for at least 100 mechanically ventilated patients per year in a large multihospital health system in the USA. All clusters will receive OE, IPE and a clinical protocol, with timing determined by randomisation. We will also randomise half of the clusters to education promoting postextubation NIV for patients at high risk of extubation failure and preventive, postextubation HFNC for patients at lower risk, whereas the other half will be randomised to education promoting postextubation HFNC for all eligible patients. We will include all patients who are invasively mechanically ventilated for at least 24 hours. The primary implementation endpoint is the rate of use of postextubation NIV or HFNC among eligible participants. The primary clinical endpoint is in-hospital mortality truncated at 60 days from intubation.

This study was approved by the institutional review board of the University of Pittsburgh and an independent data safety monitoring board. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. We will disseminate results to participating healthcare providers, through publication in a peer-reviewed medical journal and via presentations at international conferences.

NCT05523479.

Children from refugee families resettled in the USA face higher risks of serious mental health challenges compared with their native-born peers. Research shows that refugee youth in high-income countries frequently suffer from trauma-associated disorders such as post-traumatic stress disorder (PTSD), depression and anxiety. The high prevalence of trauma-associated mental health problems among these youth may be attributed to their own trauma exposure, especially if born in conflict zones, and post-resettlement challenges like poverty, acculturation difficulties, racism and discrimination. However, they may also suffer from the effects of intergenerational trauma, where parental war trauma impacts them. This study aims to adapt and test an intervention addressing intergenerational trauma-related emotional and behavioural health outcomes among US-born children of refugee parents in Omaha and Lincoln, Nebraska.

This is a two-arm cluster randomised type I hybrid effectiveness-implementation trial. Guided by the Social Action and Family Systems theories and applying them to the intergenerational transmission of trauma framework, the combination intervention consists of family strengthening model delivered through multiple family groups+peer mentoring programme called TeenAge Health Consultants (TAHC) adapted for delivery in virtual environment (Virtual TAHC). A total of 154 US-born adolescents of parent resettled as refugees (77 per study arm), ages 14–17 and at least one biological parent per youth (dyads) will be recruited from four comparable communities utilising community-based participatory research approach and randomised to usual care or intervention group. The intervention will be implemented for up to 16 weeks, with assessments at baseline, after intervention completion and 6 months follow-up. To determine study feasibility, we will use binary metrics of participant enrolment of 70% or more and retention of 80% or more at 12 months. To assess study acceptability, we will determine participant satisfaction with the study based on the Client Satisfaction Questionnaire (CSQ-8). To maximise rigour, our analyses will follow an intention-to-treat (ITT) approach. For primary inferential analyses, we will fit two-level generalised linear mixed models to continuous primary outcomes. The models will include fixed effects for study arm, time and their interaction terms. We will perform time-averaged comparisons of post-baseline repeatedly measured observations across study arms to examine intervention effects over the duration of the postintervention study period. To delineate barriers and facilitators to implementation and implementation strategies, we will apply a more integrative approach, using both inductive and deductive approaches guided by the grounded theory and integrative theory that combines both deductive and inductive approaches. Finally, we will integrate findings from the quantitative and qualitative analysis to provide additional explanation and context for our quantitative findings.

Voluntary written informed assent and consent will be obtained from all participants, adolescents and their parents, respectively. All study procedures received approval from Washington University in St. Louis Institutional Review Board (IRB #202307081).

Study findings will be disseminated through publications in scientific journals and presentations at national and international conferences. We also plan to provide community education about the study through a dissemination conference at the end of the study.

NCT06176638.

To estimate the healthcare costs associated with post-stroke dysphagia during acute hospitalisation and to identify factors influencing these costs in a tertiary hospital setting in Vietnam.

A cross-sectional study using clinical and billing data from hospital records.

The study was conducted at the Neurology Center of Bach Mai Hospital, a tertiary care facility in Hanoi, Vietnam, between June 2020 and January 2022.

A total of 951 patients aged ≥18 years with acute ischaemic stroke confirmed by CT or MRI were included. Dysphagia was assessed using the Gugging Swallowing Screen.

Direct healthcare costs during hospitalisation were collected from the hospital billing system and categorised as medications, diagnostic imaging, medical supplies, accommodation, food, procedures and laboratory tests. All costs were converted to USD. Associations between patient characteristics and total healthcare costs were analysed using generalised linear models (Gamma distribution with log link), applying robust standard errors.

The median treatment cost was 10.08 million VND (436.24 USD) in the dysphagia group vs 6.37 million VND (275.78 USD) in the non-dysphagia group. Costs increased with dysphagia severity, reaching 22.64 million VND (979.49 USD) among patients with severe dysphagia. In multivariate analysis, dysphagia was associated with a 21% increase in costs (exp(β) = 1.21; 95% CI 1.10 to 1.33; p14, pneumonia, prolonged hospitalisation and higher educational level.

Post-stroke dysphagia substantially increases acute hospitalisation costs in Vietnam. Early screening, standardised management and preventive care for complications may improve outcomes and reduce costs.

The study was registered on the Research Registry website (https://www.researchregistry.com/) under the unique identification number: researchregistry8203.

This study aims to assess parents’ knowledge and attitude towards the human papillomavirus (HPV) vaccination of their daughters and the associated factors in Debre Tabor town, northwest Ethiopia.

A community-based cross-sectional study.

Debre Tabor town, Northwest Ethiopia.

A total of 702 participants were included in the study, with a response rate of 98.2%. Three out of the six kebeles in the town were randomly selected, and participants within the selected kebeles were recruited through a cluster sampling technique. An interviewer-administered structured questionnaire was used to collect data from 15 December 2021 to 15 February 2022.

Parents’ level of knowledge and attitude towards the HPV vaccination of their daughters, and the associated factors.

In the study, parents’ knowledge and attitude towards HPV vaccination were found to be 46.4% (95% CI 42.7% to 50.1%) and 61.5% (95% CI 58.0% to 65.2%), respectively. Parents with a higher level of education (adjusted OR (AOR)=2.27; 95% CI 1.39 to 3.69), media exposure (AOR=3.36; 95% CI 1.21 to 9.33) and a good attitude towards the HPV vaccine (AOR=8.81; 95% CI 5.78 to 13.44) were significantly associated factors that affect parents’ level of knowledge. Positive subjective norms (AOR=1.53; 95% CI 1.01 to 2.31) and perceived behavioural control towards the HPV vaccine (AOR=3.48; 95% CI 2.37 to 5.10) had statistically significant associations with parents’ attitude.

In this study, more than half of parents had poor knowledge of the HPV and its vaccination, while the majority of the participants showed a favourable attitude to the vaccine. Educational attainment, media exposure and a positive attitude were significantly associated with parental knowledge, and parents’ attitude was positively influenced by subjective norms and perceived behavioural control. This suggests a need to increase the parents’ level of awareness through educational interventions, particularly via media and community engagement. To improve the acceptance and uptake of the HPV vaccination, it is important to address negative attitudes and common misconceptions among parents on the safety, efficacy and necessity of the vaccine for their daughters.

Postoperative pulmonary complications (PPCs) represent a significant cause of postoperative morbidity and even mortality. However, there is a lack of consensus regarding this composite endpoint, the definition of the individual components, classification and optimal outcome measures. This study aims to refine the PPCs composite framework by evaluating its construct validity, assessing the necessity and risks of a composite measure and exploring the feasibility of differentiating severity categories.

A Delphi consensus process will be conducted, engaging an international multidisciplinary group of 30–40 panellists, including clinicians, researchers, patients, public representatives and health economists. Through iterative rounds, the study will seek agreement on the individual components of the PPCs composite. Additionally, consensus will establish a framework for a composite outcome measure based on a standardised severity classification, appropriate timeframes and weighted grading of PPCs.

Consensus, defined by ≥75% concurrence in multiple choice questions or on Likert–scale statements, will be evaluated from round 2 onwards. Delphi rounds will be continued until all statements have reached stability of responses evaluated by ² tests or the Kruskal-Wallis test.

The study will be conducted in strict compliance with the principles of the Declaration of Helsinki and will adhere to ACCORD guidance for reporting. Ethics approval has been obtained for this study from the University of Wolverhampton, UK (SOABE/202425/staff/3). Informed consent will be obtained from all panellists before the commencement of the Delphi process. The results of the study will be published in a peer–reviewed journal with the authorship assigned in accordance with ICMJE requirements.

NCT06916598 (clinicaltrials.gov).