To assess factors associated with the adoption of the WHO Package of Essential Non-Communicable Diseases (PEN) Protocol 1 at primary healthcare (PHC) facilities in Nepal after healthcare workers received training.

Cross-sectional study.

PHC facilities across various provinces in Nepal.

A total of 180 healthcare workers trained in PEN, recruited from a random selection of 105 basic healthcare facilities.

The adoption of PEN Protocol 1 components: blood pressure measurement, blood glucose screening, 10-year cardiovascular disease (CVD) risk assessment using WHO/International Society of Hypertension risk charts and body mass index (BMI) assessment. Factors associated with protocol adoption were assessed using generalised estimating equations for ORs.

Among participants, 100% reported measuring blood pressure, while 56% measured blood sugar, 28% assessed CVD risk and 27% assessed BMI. The adoption of the CVD risk prediction chart was positively associated with the availability of amlodipine (adjusted OR (aOR) 3.00; 95% CI 1.09 to 8.27). The adoption of BMI assessment was positively associated with access to a stadiometer (aOR 3.23; 95% CI 1.26 to 8.30) and a glucometer (aOR 3.07; 95% CI 1.12 to 8.40), and negatively associated with lack of motivation/inertia of previous practice (aOR 0.60; 95% CI 0.42 to 0.87) and environmental factors such as lack of time and resources (aOR 0.57; 95% CI 0.37 to 0.89). Blood glucose level measurements were positively associated with being at a PHC centre (aOR 7.34; 95% CI 2.79 to 19.3) and the availability of metformin (OR 2.40; 95% CI 1.08 to 5.29).

Adoption of PEN Protocol 1 varied by component and was influenced by resource availability, provider motivation and system barriers. Addressing these factors is key to optimising implementation in low-resource settings.

Ischaemia reperfusion injury (IRI) is inevitable in kidney transplantation and negatively affects patient and graft outcomes. Anaesthetic conditioning (AC) refers to the use of anaesthetic agents to mitigate IRI. AC is particularly associated with volatile anaesthetic (VA) agents and to a lesser extent to intravenous agents like propofol. VA like sevoflurane interferes with many of the processes underlying IRI and exerts renal protective properties in various models of injury and inflammation. We hypothesise that a sevoflurane-based anaesthesia is able to induce AC and thereby reduce post-transplant renal injury, reflected in improved graft and patient outcome, compared with a propofol-based anaesthesia in transplant recipients of a deceased donor kidney.

Investigator-initiated, multicentre, randomised, controlled and prospective clinical trial with two parallel groups. The study will include 488 kidney transplant recipients from donation after brain death (DBD) or donation after circulatory death (DCD) donors. Participants are randomised in a 1:1 design to a sevoflurane (intervention) or propofol (control) group. The primary endpoint is the incidence of delayed graft function in recipients of DCD and DBD donor kidneys and/or 1-year biopsy-proven and treated acute rejection. Secondary endpoints include functional delayed graft function defined as failure of serum creatinine levels to decrease by at least 10% per day for three consecutive days; primary non-function is defined as a permanent lack of function of the allograft; length of hospital stay and postoperative complications of all kinds, estimated glomerular filtration rate at 1 week and 3 and 12 months calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula; readmissions at 3 and 12 months, graft survival and all-cause mortality at 12 months.

The study is approved by the local ethical committees and national data security agencies. Results are expected to be published in 2025.

NCT02727296.

Sweden, as many other high-income countries, has adopted guidelines to offer induction of labour at 41+0 gestational weeks to decrease the risk for perinatal death. As more than 20% of the pregnant population reach this gestational age, and along with other contributing factors, induction rates have increased up to 30% in many countries. Both women and care providers have raised the question if outpatient induction could be a convenient, safe and economic alternative, reducing the burden on inpatient care in maternity hospitals. Before introducing outpatient induction into clinical routine, studies need to assure safety for the child and woman as well as efficacy of the method.

A register-based randomised controlled multicentre non-inferiority trial to study if outpatient induction in low-risk inductions is (1) as safe for the child (perinatal composite of mortality and morbidity) and (2) as effective (proportion of vaginal deliveries) as inpatient induction at the hospital. Secondary outcomes are further health outcomes, experiences of pregnant women, partners and care providers, health economics and future pregnancy outcome. Participating women with a singleton pregnancy and unripe cervix between 37+0 and 41+6 gestational weeks planned for low-risk induction will undergo induction of labour with either a balloon catheter or oral misoprostol according to clinical practice at the study site and the woman’s informed choice. Randomisation will allocate women to either outpatient (home or patient hotel) or inpatient induction (standard care). Women undergoing outpatient induction can remain at home for up to 2 days, with an assessment after 24 hours including cardiotocography. Once active labour ensues, all women will receive standard care in the hospital.

The assessment of non-inferiority will involve a two-sided 95% CI and 80% power, requiring randomisation of 8891 women to ensure a probability of at least 0.80 that the upper limit of a two-sided 95.7% CI for a difference in the primary safety outcome is below the non-inferiority margin of 1.5%. 31 of the 45 delivery units in Sweden are currently recruiting. Data will be collected from the electronic case report form and Swedish healthcare registers. Questionnaire and qualitative interview-based studies will be performed to explore experiences of pregnant women, partners and care providers. Additionally, a health economic evaluation will be performed.

The Swedish Ethical Review Authority approved the study (3 June 2020; 2020-02675 with amendments 2021-03045, 2022-00865-02, 2023-01252-02, 2024-00560-02, 2024-2024-04597-02). The Swedish Medical Products Agency approved the study for the medication arm (25 August 2020, EudraCT number: 2020-000233-41; 5.1-2020-60240 with amendments 5.1-2022-73500, 5.1-2023-630). Due to changed regulation, in 2023, the study medication arm was transferred and approved by the European Medicines Agency (23 October 2023, EU CT Number: 2023-507164-39-00; CTIS 5.1.2-2023-099775 with amendments 5.1.2-2024-081916, 5.1.2-2025-036291). The Swedish Medical Products Agency approved the study for the medical device arm (6 April 2021, CIV-ID: CIV-20-09-034712; 5.1-2021-14812 with amendments 5.1-2022-14252, 5.1-2023-596, 5.1-2024-8886, 5.1-2024-55554). The medical device arm was transferred to Regulation (EU) 2017/745 (23 December 2024, 5.1-2025-24242 and amendment 5.1-2025-6050). The study will involve more than 80% of all delivery units in Sweden, which will allow for a smooth implementation of any new routine after the study’s conclusion. Results will be published in relevant scientific journals, presented at national and international conferences, and communicated to participants and relevant institutions through the Outpatient Induction study homepage (www.optionstudien.se), the webinars of the Swedish Network for National Clinical Studies in Obstetrics and Gynecology (www.snaks.se) as well as social and public media.

EudraCT No: 2020-000233-41, after transfer to the European Medicines Agency EU CT Number: 2023-507164-39-00; CIV-ID 20-09-034712.

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

ClinicalTrials.gov: NCT06117605 and NCT06117618.

Elder neglect by both informal and formal caregivers is common, particularly among persons with dementia, and has serious health consequences but is under-recognised and under-reported. Persons with dementia are often unable to report neglect due to memory and language impairments, increasing their vulnerability. Screening for elder mistreatment and initiation of intervention in primary care clinics may be helpful, but few evidence-based tools or strategies exist. We plan to: (1) develop a novel primary care screening tool to identify elder neglect in persons with dementia, (2) develop an innovative technology-driven intervention for caregivers and (3) pilot both for feasibility and acceptability in primary care.

We will use a multistep process to develop a screening tool, including a modified Delphi approach with experts, and multivariable analysis comparing confirmed cases of neglect in patients with dementia from the existing data registry to non-neglected controls. We will develop an evidence-based, technology-driven caregiving intervention for neglect with an expert panel and iterative beta testing. Following the development of the protocol for implementation of the tool and intervention with associated training, we will pilot test both the tool and intervention in older adult patients and caregivers. We will conduct provider focus groups and interviews with patients and caregivers to assess usability and will modify the tool and intervention. These studies are in preparation for a future randomised trial.

Initial phases of this project have been reviewed and approved by the Weill Cornell Medicine Institutional Review Board, protocol #22-06024967, with initial approval on 1 July 2022. We aim to disseminate our results in peer-reviewed journals, at national and international conferences and among interested patient groups and the public.

The COVID-19 pandemic’s unprecedented nature has exposed significant vulnerabilities in most public health systems and highlighted the importance of coordinated responses across various levels of government. A global debate emerged on the types of health measures necessary to curb the rapid spread of contagious and/or lethal diseases. However, some of these measures involved restricting individual rights, raising significant ethical, legal and public health questions. The protocol of this systematic review aims to address a critical gap in the literature by analysing how Public Health Surveillance services worldwide implemented compulsory right-restricting measures during the COVID-19 pandemic, and what impacts these measures had on public health outcomes and individual rights.

This protocol focuses on studies about right-restricting measures enacted by Public Health Surveillance services during the COVID-19 pandemic. It will be unrestrictive as to period (starting in 2019, when the outbreak was identified), language or publication status in a preliminary stage. It will include only peer-reviewed publications, discarding opinion articles, editorials, conference papers and non-peer-reviewed publications. Considering the PICo strategy, the research question of this systematic review can be formulated as follows: Problem—right-restricting measures enacted by Public Health Surveillance services; Interest—implementation modalities and impacts on individual rights and public health outcomes; Context—COVID-19 pandemic. This protocol will use the following databases: Pubmed, Cochrane/CENTRAL, Embase, Scopus and Web of Science. Considering the various measures that may have been adopted, the following categories of analysis will be used: (i) Public Health Surveillance as a field, (ii) the various specific areas of Health Surveillance, (iii) law enforcement, (iv) right-restricting measures and consent, (v) interactions between right-restricting measures and routine Public Health Surveillance functions, (vi) differences between countries and (vii) Health Surveillance lessons learnt from the COVID-19 pandemic. These categories are not strictly mutually exclusive; however, each study will be assigned to the category most aligned with its primary focus. To ensure the validity and reliability of findings, each study will have its risk of bias assessed at both the study and outcome levels.

Patients and the public were not involved in the design, conduct, reporting or dissemination plans of this systematic review. The results will be presented in one or more articles to be submitted to scientific journals and may also be presented at scientific conferences and to public policy makers.

This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 20 November 2024 (registration number CRD42024613039).

Breast cancer risk can be substantially reduced with risk-reducing medications (RRMeds). Despite their efficacy, and guidelines which support their use for women at substantially increased risk of breast cancer, they are underused. Barriers to their use in Australia include a lack of awareness of RRMeds by women and clinicians, and a primary care workforce that reports a lack of knowledge and confidence in discussing and/or prescribing these medications. In contrast, Australian clinicians have reported specialist support and guidance as a key facilitator. The Preventing Cancer with Medications (PCMed) Telehealth Service was therefore developed to provide this specialist support and to bridge the evidence–implementation gap. The PCMed Service endeavours to increase the appropriate use of RRMeds and support women and their doctors throughout treatment. The aim of this research is to evaluate the effectiveness, adoption, acceptability, feasibility, fidelity and cost of this new Service, and to determine any adaptations that might be required.

The research uses a mixed methods approach. Effectiveness of the PCMed Service will be evaluated by determining whether the PCMed Service is associated with increased uptake of RRMeds compared with historical data. Secondary outcomes include: adoption of the Service, specifically, the proportion of women who attend a PCMed Service consultation; acceptability of the Service for clients and referring clinicians (using a brief survey and semistructured interviews); feasibility and fidelity by evaluating the adherence to the planned Service processes; and the cost, by reporting the difference between funding received per woman and the cost for service delivery.

This study was approved by the institutional Human Research Ethics Committee (EC00235): HREC/101142/PMCC. The findings will inform future iterations of the Service prior to scaling up. Research findings will be disseminated at scientific meetings and in peer-reviewed journals.

ISRCTN15718519.

Multi-disciplinary discussions (MDDs) improve diagnosis and management of interstitial lung disease (ILD). The value of a virtual multi-centre MDD (V-MCMDD) incorporating expertise from multiple institutions remains underexplored. This study aimed to evaluate the impact of a V-MCMDD on diagnosis and management in ILD.

We conducted a retrospective multi-centre cohort study involving tertiary and secondary hospital clinics, private practices and community outpatient centres, all participating via a virtual platform. Between August 2020 and June 2023, patient cases were reviewed through V-MCMDDs, which included clinical, radiological, pathological and laboratory data. Each case was discussed to reach a consensus diagnosis and management plan.

Following the V-MCMDD review, the diagnosis was revised in 51% of patients (p=0.031), and management plans were modified in 41% of cases. A significant shift in treatment was observed in patients with changed diagnoses vs unchanged diagnoses (p value=0.002).

Our findings suggest that the implementation of V-MCMDDs can be valuable in the diagnostic and therapeutic process for ILD. Incorporating input from multiple centres via a virtual format can lead to significant changes in both diagnosis and management, potentially improving patient outcomes.

This study explored the experience of stigma and access to healthcare by persons with long COVID from the majority Dutch and two ethnic minority populations (Turkish and Moroccan) living in the Netherlands.

This was a cross-sectional qualitative study that employed inductive and deductive thematic approaches to data analysis using MAXQDA.

Between October 2022 and January 2023, 23 semi-structured interviews were conducted with participants of Dutch, Moroccan and Turkish ethnic origins with long COVID living in the Netherlands. Participants were men and women aged 30 years and above.

Guided by the concepts of stigma and candidacy, the findings are structured according to the broader themes of stigma and access to care. The findings show that people with long COVID suffer self and public stigma resulting from the debilitating illness and symptoms. Especially among Turkish and Moroccan ethnic minority participants, strong filial obligations and gendered expectations of responsibility and support within their communities further worsen self-stigma. This experience of stigma persisted within healthcare where lack of information and appropriate care pathways led to feelings of frustration and abandonment, especially for participants with pre-existing health conditions which further complicate candidacy. Under the access to healthcare theme, the findings show multiple challenges in accessing healthcare for long COVID due to several multifaceted factors related to the various stages of candidacy which impacted access to care. Particularly for Turkish and Moroccan ethnic minority participants, additional challenges resulting from limited access to information, pre-existing structural challenges and experience of stereotyping based on ethnicity or assumed migrant identity by health professionals further complicate access to health information and long COVID care.

The findings call for urgent attention and research to identify and coordinate healthcare for long COVID. There is also a need for accessible, informative and tailored support systems to facilitate patients’ access to information and care pathways for long COVID. Providing tailored information and support, addressing the various barriers that hinder optimal operating conditions in healthcare and leveraging on social networks is crucial for addressing stigma and facilitating candidacy for persons with long COVID towards improving access to care.

Paediatric cervical spine injury (CSI) is uncommon but can have devastating consequences. Many children, however, present to emergency departments (EDs) for the assessment of possible CSI. While imaging can be used to determine the presence of injuries, these tests are not without risks and costs, including exposure to radiation and associated life-time cancer risks. Clinical decision rules (CDRs) to guide imaging decisions exist, although two of the existing rules, the National Emergency X-Radiography Low Risk Criteria and the Canadian C-Spine Rule (CCR), focus on adults and a newly developed paediatric rule from the Pediatric Emergency Care Applied Research Network (PECARN) is yet to be externally validated. This study aims to externally validate these three CDRs in children.

This is a multicentre prospective observational study of children younger than 16 years presenting with possible CSI following blunt trauma to 1 of 14 EDs across Australia, New Zealand and Singapore. Data will be collected on presenting features (history, injury mechanism, physical examination findings) and management (diagnostic imaging, admission, interventions, outcomes). The performance accuracy (sensitivity, specificity, negative and positive predictive values) of three existing CDRs in identifying children with study-defined CSIs and the specific CDR defined outcomes will be determined, along with multiple secondary outcomes including CSI epidemiology, investigations and management of possible CSI.

Ethics approval for the study was received from the Royal Children’s Hospital Melbourne Human Research Ethics Committee in Australia (HREC/69436/RCHM-2020) with additional approvals from the New Zealand Human and Disability Ethics Committee and the SingHealth Centralised Institutional Review Board. Findings will be disseminated through peer-reviewed publications and future management guidelines.

Registration with the Australian New Zealand Clinical Trials Registry prior to the commencement of participant recruitment (ACTRN12621001050842). 50% of expected patients have been enrolled to date.

Individuals with stroke or spinal cord injury (SCI) often have poor balance control, leading to falls and activity limitations. One intervention that targets balance control—functional electrical stimulation with visual feedback balance training (FES+VFBT)—may improve balance control but needs modifications for clinical use.

To use a participatory design approach to identify potential challenges and solutions for the clinical implementation of FES+VFBT as a balance intervention.

A descriptive qualitative study involving four semi-structured focus group meetings was conducted to explore the perspectives of individuals with stroke and SCI, physical therapists and a hospital administrator on the feasibility and challenges of implementing FES+VFBT into clinical settings. The interviews were transcribed and analysed using deductive and inductive content analyses. The deductive analysis was based on the social ecological model (SEM) levels, while the inductive approach was used to identify categories and codes.

Virtual.

Two individuals with chronic SCI and one individual with chronic stroke who were able to stand but reported deficits in their balance control. Two physical therapists who had experience with FES and the rehabilitation of individuals with SCI or stroke. One hospital administrator who worked within a neurological rehabilitation setting.

Themes were organised according to the SEM’s four levels: intrapersonal, interpersonal, organisational/training environment and society/policy. Identified categories included potential challenges at the intrapersonal level (ie, lack of knowledge, safety and tolerance of user) and organisational/training environment level (ie, technical challenges, cost, physical space and time). The categories also included possible solutions at all SEM levels, such as intrapersonal (ie, reading and education), interpersonal (ie, practising together), organisational/training environment (ie, technology characteristics and creating resources) and society/policy (ie, purchasing options, guidelines and foundation grants).

End-users identified anticipated challenges and solutions to using the FES+VFBT system clinically. The results will inform the design and clinical implementation of a revised version of the system and other FES devices.