To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

A healthy diet improves glycaemic control and reduces cardiovascular risk in type 2 diabetes (T2D). However, access to dietitians is limited. Several countries have implemented mandatory interpretive front-of-pack labelling to guide consumers towards healthier food choices, but Sweden has not. Smartphone applications may offer an alternative platform to provide such information. This study evaluates the dietary and clinical impact of a novel application providing interpretive labelling to Swedish adults with T2D.

This is a fully decentralised randomised controlled trial. 900 individuals with T2D for ≥2 years who regularly shop for groceries will be recruited via general practices and community advertisements. Participants will be randomised to receive either: (1) access to the FoodSwitch mobile application plus standard written dietary advice, or (2) standard written dietary advice only. The FoodSwitch application allows users to scan barcodes on packaged foods to receive recommendations of healthier alternatives within the same category. The primary outcome is the difference in change in mean self-measured glycated haemoglobin between groups after 6 months. Secondary outcomes include differences in changes in waist circumference, body weight, quality of life, medication use, hospitalisations and all-cause mortality at 26 weeks. Exploratory outcomes include omics analyses. Recruitment is ongoing. Expected study completion on 31 December 2026.

The trial has received ethical approval from the Swedish Ethical Review Authority (2023-06622-01, 2024-06668-02, 2024-07357-02 and 2025-01095-02) and is performed in line with World Medical Association Declaration of Helsinki and the General Data Protection Regulation. Results will be published in a peer-reviewed international journal.

NCT05977218.

In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.

We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.

This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.

NCT06719245. Dutch trial registry: NL87196.058.24

To explore the association between the degree of coronary artery calcium (CAC) and the progression of calcific aortic valve disease (CAVD).

A single-centre retrospective cohort study using a hospital-based database.

A total of 2898 patients who underwent coronary CT angiography and serial echocardiograms at ≥6 months apart were included. Initial echocardiography was performed within 6 months from the time of CCTA.

CAC was divided into four groups: 0, 1–99, 100–399 and ≥400 (Agatston units, AU). The progression of CAVD was defined in two ways: progression 1 as at least one grade of progression, progression 2 as at least moderate aortic stenosis (AS) at follow-up.

At the initial CAVD grade, patients with at least mild AS tended to increase with increasing CAC (p

CAC was significantly associated with the progression of CAVD. Particularly, CAC≥400 was linked to progression toward significant AS.

Cardiovascular autonomic neuropathy (CAN) is a serious, untreatable complication of diabetes that contributes to excess cardiovascular mortality and morbidity. CAN is associated with increased fibrosis and inflammation, possibly driven by increased sympathetic activity and overactive mineralocorticoid receptors (MRs). These may represent a potential therapeutic target. MR antagonists (MRAs) improve autonomic function in non-diabetic diseases, and finerenone, a non-steroidal MRA, has demonstrated promising results in managing diabetic kidney disease and cardiovascular complications, suggesting its potential as a novel therapy for early-stage CAN. This trial aims to evaluate whether daily administration of finerenone can modify the disease progression of early-stage CAN.

This trial is a two-centre, double-blind, parallel-group, 1:1 randomised, placebo-controlled study evaluating the effect of 78 weeks of intervention with finerenone or placebo on early-stage CAN in 100 individuals with type 2 diabetes in Denmark. The primary endpoint is the between-group difference in the expiration:inspiration ratio of the cardiovascular autonomic reflex tests (CARTs). Secondary endpoints are the between-group differences in the remaining CARTs, heart rate variability measures and fibrosis markers. Treatment effects on other forms of neuropathy and related pathological mechanisms will be explored.

The study complies with the Declaration of Helsinki and the International Counsil for Harmonisation good clinical practice guidelines, with ethics approval obtained from the Danish Medical Research Ethics Committee. All participants will provide written informed consent. Due to the risk of hyperkalaemia associated with finerenone, safety will be closely monitored throughout the study. Findings will be disseminated through peer-reviewed publications, conference presentations and clinical trial registries. A lay summary will be provided to participants on study completion.

ClinicalTrials.gov: NCT06906081; registration date: 25 March 2025. Clinical Trials Information System: EUCT no. 2024-516597-30-00; registration date: 3 September 2024.

Australian First Nations children bear 8.5 times greater burden of early and recurrent ear and nasopharyngeal infections compared with non-Indigenous children. These disparities are compounded by structural inequities in access to healthcare. To better understand these patterns, we analysed the state-wide epidemiology of childhood myringotomy procedures in South Australia and conducted spatial analysis for its main metropolitan region—Adelaide—to examine the associations with socioeconomic status and distance to healthcare facilities.

A cross-sectional, population-wide study.

All persons who had myringotomy procedures performed between 2007 and 2022.

Annual, age and sex-specific incidence was calculated at the local scale (Statistical Area level 2, SA2). We used admitted patient care data from SA Health, providing comprehensive coverage of otitis media procedures across the population, including First Nations. We applied negative binomial regression to assess associations with socioeconomic status and distance to healthcare facilities, accounting for count-based data and overdispersion.

Myringotomy incidence among First Nations children ranged from 2.2 to 6.1 per 1000 child-years across SA2 regions, compared with 2.4 to 3.7 among non-indigenous children. For the whole population, overall annual incidence ranged from 2.7 to 4.2 for males and 2.0 to 2.9 for females, with higher incidence observed in several suburban areas of Adelaide. Myringotomy procedures were associated with socioeconomic status, with increased socioeconomic advantage associated with a 17% reduction in cases (relative risk 0.83, 95% CI 0.76 to 0.92) among First Nations children. Distance to healthcare facilities was associated with myringotomy for non-indigenous children but not for First Nations children.

This study found a higher incidence of myringotomy procedures among First Nations children, particularly in later childhood. Socioeconomic disadvantage was a driver, while geographic proximity to healthcare had limited influence. Future initiatives may benefit by prioritising culturally informed, community-led strategies focused on early intervention, prevention and equitable service delivery.

To develop, evaluate and validate the musculoskeletal health climate questionnaire (MHCQ), a multidimensional questionnaire for measuring musculoskeletal health climate.

Cross-sectional test–retest study including systematic scale development and psychometric validation.

The questionnaire was developed following the best practice recommendations for scale development outlined by Boateng et al (2017), including item development, scale development and scale evaluation with input from experts, stakeholders and the target population. Validation was conducted among employees in three physically demanding occupations in Denmark (care workers, slaughterhouse workers and residential painters), where a total of 1420 participants were recruited through labour unions. Of these, 796 completed the retest survey 30 days later. Exploratory and confirmatory factor analyses (EFA and CFA, respectively), internal consistency (Cronbach’s α), test–retest reliability (intraclass correlation coefficients (ICC)) and SEM were used to assess the psychometric properties. Criterion validity was examined via associations with pain points, pain medication use and sickness absence. Construct validity was assessed using correlations with the prevent for work questionnaire (P4Wq).

EFA and CFA supported a four-factor model (supervisor’s practices, workplace practices, worker involvement practices and workers’ pain practices) with good to excellent fit (comparative fit index, 0.96–0.99; root mean square error of approximation, 0.04–0.06). All scales showed high internal consistency (α=0.80–0.88) and excellent test–retest reliability (ICC=0.86–0.92). Associations with musculoskeletal outcomes supported criterion validity. Weak to moderate correlations with the P4Wq subscales (rho

The MHCQ provides a validated, multidimensional tool to assess workplace climate related to musculoskeletal health. It can support workplace assessments and prevention efforts by capturing shared perceptions of leadership, support, involvement and pain-related norms. Further longitudinal research and the use of objective outcome data are needed to assess predictive validity and strengthen the instrument’s applicability across settings.

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

CRD420251011399.

Health emergencies continue to stimulate greater interest in health systems and services, particularly their ability to respond to such shock. While studies have been done on health system response to health emergencies, there has been no attempt to synthesise this body of evidence to inform future emergency preparedness and response plan, particularly in low- and middle-income countries (LMICs) where health systems are deemed to be weak. This paper aims to provide a systematic review protocol for synthesising evidence on health system response to health emergencies in LMICs.

The WHO building blocks of health system functioning will be used as a conceptual framework for the review. The review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. Nine electronic databases will be searched: Medline, Embase, Ovid Emcare, Scopus, ScienceDirect, Academic Search Complete, HINARI, CINAHL and African Index Medicus. The search will be supplemented by citation searching, searching reference lists of included articles, search for grey literature in Google Scholar and relevant websites. Studies focusing on health system response to health emergencies in LMICs, published in English and between 2007 and 2025, will be eligible for inclusion. A narrative synthesis will be performed on all the included studies. Studies will be mapped and categorised into the WHO six building blocks of health system functioning, exploring relationships between and within studies, identifying the response mechanisms of the health system during health emergencies and their barriers and facilitators.

The data to be used do not include individual patient data, so ethical approval is not required. The results of the systematic review will be disseminated through a peer-reviewed journal publication, presentations at conferences and seminars.

CRD42024556271

Exposure to prescription opioids following traumatic injury can increase the risk of developing tolerance, persistent opioid use and opioid use disorder. The mechanisms underlying opioid tolerance or dependence are not well understood, and no biomarkers predict risk. Opioid exposure causes epigenetic modifications, including alterations in microRNA (miRNA) expression. Several miRNAs, which regulate synaptic plasticity, are hypothesised to underlie substance use disorders and influence µ-opioid receptor levels, modulating opioid tolerance. This project aims to develop a bio-behavioural signature to predict persistent opioid use and chronic pain up to 6 months post-discharge.

The study will use a prospective cohort design, enrolling 180 adult patients at a Level I Trauma Center who are prescribed opioids at discharge. Prospective data will be collected in the hospital and at 7 days and 1, 3 and 6 months post-discharge. Biological data (genotyping and miRNA levels) and clinical measures of opioid use, pain, pain sensitivity (EEG) and psychosocial functioning will be collected at each time point. Bayesian regression methods will be used to identify baseline clinical, genetic, epigenetic and psychosocial predictors of opioid use and pain outcomes at 6 months post-discharge. Growth mixture modelling will identify distinct subgroups with varying trajectories, followed by Bayesian hierarchical modelling to predict trajectory classification based on predictor variables.

Ethics approval for this study was obtained from the University of Texas Health Science Center at Houston Committee for the Protection of Human Subjects (HSC-MS-24–0314). Findings will be disseminated in peer-reviewed scientific journals and at national and international conferences.

Prescribing patterns for hyperopia in children vary widely among eye care providers worldwide. This scoping review aims to identify and map the current literature on optical correction and catalogue outcomes reported, particularly in the domains of vision, vision-related functional outcomes and quality of life (QoL) in school-aged children with hyperopia.

This protocol was developed in accordance with the Joanna Briggs Institute’s Manual for Evidence Synthesis. We will include studies involving school-aged children with hyperopia without restrictions on sex, gender, race, ethnicity, type of optical correction, length of intervention, publication date or country of origin. We will include studies with internal or external comparison groups. We will exclude studies associated with myopia control treatments, ocular and visual pathway pathologies affecting vision or visual function. We will search Cochrane CENTRAL, Embase.com and PubMed. Examples of data to be extracted include population demographics, visual acuity, study-specific definitions for refractive error, treatment regimens for optical correction, vision and vision-related functional outcomes and QoL (general or vision-related) as quantified by validated instruments.

Informed consent and Institutional Review Board approval will not be required, as this scoping review will only use published data. The results from the scoping review will be disseminated by publication in a peer-reviewed scientific journal and at professional conferences.

Infertility resulting from cancer treatment is known to be a major factor that reduces the quality of life of young cancer survivors. However, discussions and decision-making about fertility preservation before cancer treatment have been insufficient owing to barriers in the clinical field. In addition, selecting a fertility preservation option requires a complex decision-making process that considers not only medical information but also the patient’s values and preferences. Hence, an environment that more easily supports patient decision-making about fertility preservation needs to be created. Therefore, this protocol will develop and test a web-based decision aid (DA) for fertility preservation among young patients with cancer, considering patient preferences and values, evaluate acceptability and usability of the developed DA and assess its effectiveness.

This protocol outlines the development of a web-based DA for fertility preservation targeting females of reproductive age diagnosed with cancer. It includes alpha testing to evaluate the usability and acceptability of the DA, as well as beta testing to assess its effectiveness outside of clinical settings, both based on an online survey. The web-based DA for fertility preservation consists of three modules: 1) an information collection module, 2) an option suggestion module and 3) a value communication module. The information collection module collects information essential to select appropriate fertility preservation options. The option suggestion module returns all applicable fertility preservation options based on the patient’s characteristics, which are essential for determining the appropriate option, such as menarche status and desire for pregnancy. The value communication module provides information on the extent to which each fertility preservation option satisfies the patient’s values and preferences. After the development of the DA, a small group of young patients with cancer (n=10) and health providers (n=5) will be asked to use this web-based DA for fertility preservation and assess the acceptability and usability of this DA based on a survey (alpha-testing). By reflecting the feedback of acceptability and usability testing, the DA will be updated for improvement, and clinical field testing (beta-testing pilot trial) will be performed using the updated DA. Beta-testing will be conducted on young patients with cancer (aged 18–40 years) before they receive any curative cancer treatment (n=32). These patients with cancer will be randomly allocated to the DA group (intervention group) or the usual care group (control group). The DA group will use the web-based DA before treatment, and the control group will not have access to the web-based DA and will be asked to decide whether to consult a fertility preservation specialist. The primary outcome of the beta testing will be the level of decisional conflict, and the secondary outcomes will include knowledge, decision self-efficacy, decision readiness, depression severity, quality of life, counselling on fertility preservation and decision-making about fertility preservation. Outcomes, including decisional conflict, knowledge, decision self-efficacy, quality of life and depression severity, will be measured before the intervention (T0), 1 week after the intervention (T1) and 1 month after the intervention (T2). The readiness for decision-making will be assessed at T1 for the intervention group only. Counselling on fertility preservation and decision-making about fertility preservation will be assessed once after testing (T2) for both the intervention and control groups.

The study will be conducted in accordance with ethical standards and was approved by the Institutional Review Board at the National Cancer Centre, Korea (IRB No. NCC2024-0050). All study participants will provide written informed consent before participation. The results generated from this study will be presented at conferences or scientific meetings and disseminated through publication in a peer-reviewed journal.

NCT07038174 (beta-testing phase).

Rehablines is a further use databank that was established to efficiently conduct high-quality research into patient characteristics and underlying disease processes, provide insight into treatment effects and efficiency and support personalised treatment in rehabilitation medicine.

Adult patients (age ≥18) receiving rehabilitation care at the University Medical Center Groningen, Center for Rehabilitation, are included. Inclusion is ongoing. As of December 2024, 1080 participants have been included, receiving diverse types of rehabilitation such as neurorehabilitation, orthopaedic rehabilitation, oncology rehabilitation, pain rehabilitation and rehabilitation for chronic illnesses.

The databank enables reuse of a wide array of routinely collected clinical data for research and educational purposes. Data included are from electronic health records, patient-reported outcomes, training equipment and physical measurements. A successful pilot was conducted with the pain rehabilitation team, and the procedure has been implemented across all adult rehabilitation teams.

The databank aims to expand to include paediatric rehabilitation by 2025. Future plans also involve linking data with other national and international databanks to enhance research opportunities and provide comprehensive insights into rehabilitation outcomes.

The Rehablines databank is registered with ClinicalTrials.gov (NCT06750601) and the UMCG Research Data Catalogue (https://doi.org/10.34760/668fd22e4c7be).

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.

Misinformation about cardiovascular health has the potential to negatively impact public health outcomes. Understanding the nature and spread of such misinformation is crucial for developing effective interventions to mitigate this potential risk. However, despite the critical importance of this issue, there is a gap in comprehensive reviews mapping the existing literature on cardiovascular health misinformation. This scoping review aims to map the existing literature on cardiovascular health misinformation, identifying its spread, prevalence, impact and strategies for correction across diverse populations and settings.

This review will follow the Joanna Briggs Institute guidelines for conducting a scoping review. A comprehensive search will be conducted across multiple databases, including MEDLINE, EMBASE, SCOPUS and Web of Science, along with grey literature sources. The last date of search was January 2025. The review will include studies without date that involve individuals affected by cardiovascular disease (CVD) misinformation, examine the spread, prevalence, impact or correction of misinformation related to cardiovascular health, and capture various cultural, geographic or setting-specific factors. The exclusion criteria include studies that do not directly address misinformation related to CVD. All identified records will be imported into Covidence systematic review software. Two reviewers will independently screen titles and abstracts, followed by full-text reviews of potentially relevant studies. Discrepancies will be resolved through discussion or by consulting a third reviewer. Data extraction will be conducted by two reviewers using a pre-piloted tool, and a descriptive presentation of the findings will be done. Both inductive and deductive content analysis methods will be employed for objectives related to the impact and strategies to combat misinformation.

Given that the study involves synthesising data from existing published literature, ethical approval is not required. The findings will be disseminated through international conference presentations, published in a peer-reviewed journal and shared with public health organisations and policymakers.