Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

Mental health issues such as depression and anxiety are highly and disproportionally prevalent among university students. Beyond the academic rigour, stressors imposed by a new environment result in them being vulnerable to the onset and manifestation of mental health symptomatology. Leveraging smartphones and wearables for digital phenotyping capabilities is an innovative approach for monitoring and intervening in the mental health conditions of university students. This provides a unique opportunity to collect and identify digital and behavioural biomarkers, subsequently enabling the development of predictive models to identify university students at risk.

This study—Brightline—will employ an observational study design over a 6-month period, recruiting 500 students from a major public university in Singapore. Passive data collection will occur continuously throughout the monitoring period through a wearable device (Fitbit Charge 6) and smartphone sensors via the Brightline app, which uses a digital phenotyping data collection platform. Active data collection will consist of self-report questionnaires to be completed at the beginning of the study and follow-up assessments at 1, 3 and 6 months after. The passive and active data collected will be analysed to identify the digital biomarkers associated with depression, anxiety, stress, loneliness and affect among university students. Predictive models of these mental health issues will also be developed.

This study was approved by the Nanyang Technological University Institutional Review Board (IRB-2023-894). Findings from this study will be published in peer-reviewed journals and presented at academic conferences.

NCT06770075.

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

jRCT1062220035.

Infectious diseases are a major global health concern, responsible for significant morbidity and mortality. To advance the understanding and treatment of these diseases, biobanks and biorepositories play a crucial role in guaranteeing sample traceability through their entire life cycle (collection, acquisition and registration, processing, storage, distribution) and future analysis of clinical and biological data.

The INfectious DIsease REgistry BIObank (INDI-REBIO) is an observational, prospective, monocentric, open-ended registry with ad hoc procedures and a systematic collection of uniform clinical, laboratory, imaging and therapeutic data of patients with suspected or microbiologically documented bacterial, viral, fungal and parasitic infectious diseases from the IRCCS San Raffaele Hospital (Milan, Italy). The study aims to collect both uniform data and biological samples such as blood and other relevant specimens. The registry aims to include significant patient numbers across various conditions (among others: bloodstream infections, endovascular infections as infective endocarditis, central nervous system infections, bone and joint infections, multidrug-resistant organisms (MDROs) colonisation, sexually transmitted infections, HIV infection, emerging and re-emerging infectious diseases), enabling comprehensive research on disease evolution, treatment outcomes and the identification of biomarkers.

The study adheres to ethical principles outlined by the Helsinki Declaration and Good Clinical Practice guidelines. It has received ethical approval (Comitato Etico CET Lombardia 1, CET 138–2023) and is registered on clinicaltrials.gov (NCT06418048). Participants will provide informed consent and can withdraw at any time. The study results will be disseminated through major international conferences and submitted to peer-reviewed research journals.

ClinicalTrials.gov, NCT06418048.

Sarcopenia, osteoporosis and osteosarcopenia are conditions prevalent in ageing that impair muscle strength and bone density, increasing the risks of fractures, falls, disability and mortality. Recent studies highlight the benefits of milk protein supplementation (MPS) combined with exercises to improve musculoskeletal health in the older population. This systematic review protocol will enable the production of a compilation of evidence that will elucidate the effects of MPS combined with aerobic exercise, resistance exercise or both on the musculoskeletal function of older individuals with these three conditions.

Studies will be selected from electronic databases, including PubMed/MEDLINE, EMBASE, Scopus, Web of Science and the Cochrane Library, without restrictions on language or publication date. The outcomes evaluated will include muscle mass, muscle strength, BMD and physical performance after combined interventions of MPS and physical exercise of any type. The risk of bias will be assessed using the Cochrane Risk of Bias 2 tool. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to classify the certainty of the evidence into four levels: high, moderate, low and very low. Meta-analysis will be performed given the homogeneity of the studies, using random effects methods in the face of the expected heterogeneity. The standardised mean difference (SMD) will be used for continuous data, and the I² index will assess heterogeneity (I² > 50%). Sensitivity analysis, ‘leave one out’ and a strategy for dealing with missing data will be carried out. Statistical analysis will be conducted using the STATA 18 software with a 95% CI and p

Formal ethical approval will not be required as primary data collection will not be performed. The results will be disseminated through peer-reviewed publications and presentations at conferences dedicated to the relevant field of study.

CRD42024555933.

To assess the impact of opening a large community-based asynchronous review ophthalmic clinic on attendance delays among patients with stable chronic eye disease attending a London teaching eye hospital network.

Interrupted time-series analysis of routine electronic health records of appointment attendances.

A large eye hospital network with facilities across London, UK, between June 2018 and April 2023.

We analysed 69 257 attendances from 39 357 patients, with glaucoma and medical retina accounting for 62% (n=42 982) and 38% (n=26 275) of visits, respectively. Patients over 65 made up 54% (n=37 824) of attendances, while 53% (n=37 014) were from the more deprived half of the population, and 51% (n=35 048) were males.

An asynchronous review clinic opened in a shopping centre in London, in autumn 2021, following the COVID-19 lockdown in spring 2020.

Average attendance delays (days), calculated as the difference between follow-up attendance date and the latest clinically appropriate date determined at the preceding attendance.

Pre-COVID-19, attendance delays for chronic eye disease monitoring were increasing by 0.9 days per week (95% CI, 0.8 to 0.9) on average, worsening to 2.0 days per week (95% CI, 2.0 to 2.0) after the first COVID-19 national lockdown, mid-March 2020. Opening the asynchronous review clinic increased appointment capacity, with delays decreasing on average by 8.1 days per week (95% CI, 8.1 to 8.2) shortly after opening. The rate of decrease slowed to 0.3 days per week (95% CI, 0.3 to 0.3) after 5 months. We found no significant differences in average attendance delays by age, gender or level of deprivation.

The asynchronous review clinic significantly reduced attendance delays across the hospital network, addressing pre-existing backlog for stable chronic eye diseases. The reduction appeared to be maintained after the initial backlog had been cleared.

The purpose of this study was to analyse the speech-language pathology (SLP) literature from 2012 to 2022 and evaluate authorship trends and factors associated with gender disparities.

Authorship across journals published by the American Speech-Language-Hearing Association (ASHA) was evaluated. Outcomes collected from each article included the gender of the first and senior authors, author department affiliations, study type, reported funding source and the country of origin. Three sets of linear regression models were explored to determine the probability of male first authorship, of male senior authorship, and of a study being funded.

A total of 2754 articles were identified for inclusion. The majority of the literature was authored by females, with 77% of first authors and 68% of senior authors being female. Studies with a male senior author were shown to be 4.05–4.67 times more likely to have a male first author than with a female senior author. Male senior authors were over-represented relative to their proportion of ASHA membership compared with female senior authors. Male authorship was associated with certain subtopics, including voice, stuttering and motor speech. Funding probability decreased for all authors regardless of gender between 2012 and 2022.

Implicit gender bias and societal gender stereotypes lead to a greater number of women in the field of SLP; the same biases and stereotypes often limit the research productivity and academic leadership potential of women in the field. Addressing these biases and stereotypes is vital to move towards gender equity in the field.

Delays in getting injured patients to the hospital in a timely manner can increase avoidable death and disability. Like many low-income or middle-income countries, Rwanda experiences delays related to a lack of efficient prehospital communication and formal guidelines to triage patients for hospital care. This study describes the protocol to develop, roll-out and evaluate the effectiveness of a destination decision support algorithm (DDSA) integrated in an electronic communication platform, ‘912Rwanda’. The DDSA will facilitate the linkage of patients to health facilities able to treat their condition(s).

Work will be conducted in the prehospital emergency service ‘Service d'Aide Médicale Urgente’ and health facilities in Kigali city and Musanze district, which serve predominantly urban and rural populations, respectively. We will develop interfaces to capture facility and patient-relevant data, which feed into a guideline-based electronic DDSA to match patients to hospitals. We will assess existing trauma care processes using qualitative and quantitative methodologies. This will be followed by a series of consensus workshops to develop at-scene triage guidelines and agree on variables to capture in the interfaces. The DDSA will be developed based on outputs from these workshops and will be tested against historical ambulance data and expert opinion until acceptable thresholds of performance are achieved. User interfaces will be developed and tested using human–computer interface design principles.

The combined collaborative approach of bringing together experts and software developers, and with deep engagement of Rwandan stakeholders, including leadership of Rwanda Ministry of Health through its technical arm, Rwanda Biomedical Center, should lead to an ambulance communication system which is used, sustained and effective.

The project was approved by the Rwanda National Research Ethics Committee. Annual reports will be disseminated to relevant stakeholders, followed by the public. Publications will be open access as per the funding policy.

ISRCTN97674565. Registered on 29 July 2024. https://doi.org/10.1186/ISRCTN97674565.

Health disparities persist, posing significant health, social and economic challenges. Digital health technologies (DHTs) present a promising opportunity to address these inequities and advance health equity. Despite this potential, a comprehensive and structured overview of existing frameworks and guidelines on advancing health equity and a clear understanding of the potential of DHTs in their implementation to systematically close the healthcare gap is yet to be done.

To this end, our objectives are twofold: first, to identify frameworks and guidelines that promote health equity and second, to pinpoint the role of DHTs as an avenue for their implementation. We conducted a scoping review informed by Arksey and O'Malley’s five-stage framework, methodological guidelines by the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews.

A comprehensive search was conducted across seven databases on 6 December 2023: PubMed, EMBASE, Cochrane, PsycINFO, Scopus, Web of Science and WISO.

We included primary and secondary studies published in English between 2010 and 2023 focusing on advancing health equity for priority populations.

For the analysis, we applied multistaged coding approaches to answer our twofold objective.

The search identified 6419 studies, of which 38 met our final inclusion criteria and were included in this review. We extracted 559 recommendations on advancing health equity and synthesised these into 82 distinct recommendations across five levels of initiative and 19 areas of initiative. Thereby, 24% of the included studies explicitly mentioned the use of (digital) technology with 10 impact opportunities on advancing health equity.

Our synthesis offers key insights into the advancement of health equity across different levels of initiative and the role of DHTs in their implementation. This offers practitioners and researchers alike a comprehensive overview to make health equity advancement more tangible and actionable.

https://osf.io/94pht