Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.

This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD.

We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks’ gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5–20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary).

All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations.

NCT05186272.

People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.

OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care. The primary endpoint is a composite of initiation or increase of guideline-directed CRMP therapies. The secondary endpoints are the components of the primary endpoint, time to primary endpoint, diagnosis of new CRMP diseases or risk factors, time to diagnosis of new CRMP diseases or risk factors, initiation or increase of guideline-directed CRMP therapies for participants with recorded CRMP disease, initiation or increase of guideline-directed CRMP therapies for participants with newly diagnosed CRMP disease and change in participant-reported quality of life.

The study has ethical approval (the North East & North Tyneside 2 Research Ethics Committee reference 24/NE/0188). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.

Clinicaltrials.gov NCT06444711.

Progressive supranuclear palsy (PSP) is a devastating neurodegenerative disease characterised by cognitive, behavioural and motor problems. Motor symptoms are highly disabling, while cognitive and behavioural changes have a major impact on carer burden, quality of life and prognosis. Apathy and impulsivity are very common, often coexistent in PSP, and negatively predict survival. In preclinical models and other diseases, apathy and impulsivity are associated with noradrenergic deficits, which can be severe in PSP.

Noradrenaline for Progressive Supranuclear Palsy Syndromes trial is a randomised, double-blind, placebo-controlled, crossover design, Phase IIb clinical trial to evaluate the efficacy and safety of oral atomoxetine for the treatment of cognitive and behavioural changes in PSP. Participants receive atomoxetine 40 mg (10 mg/mL oral solution) once daily or a matched placebo solution, in random order, each for 8 weeks. An ‘informant’, who knows the patient with PSP well, is co-recruited to complete some of the trial outcome measures. Participants remain in the trial for 22 weeks after randomisation. The primary objectives are to assess (1) safety and tolerability and (2) efficacy versus placebo on challenging behaviours as reported in a subscale of the Cambridge Behavioural Inventory. Secondary and exploratory measures relate to cognition, the PSP Rating Scale, mood and potential baseline predictors of individual response to atomoxetine computed from imaging, genetic and cognitive measures at baseline.

The trial was approved by the South Central-Oxford B Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (REC reference: 20/SC/0416). Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences and engagement with patients, the public, policymakers and practitioners.

ISRCTN99462035; DOI: https://doi.org/10.1186/ISRCTN99462035; EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)/CTIS (Clinical Trial Information System) number: 2019-004472-19; IRAS (Integrated Research Application System) number: 272063; Secondary identifying numbers: CPMS (Central Portfolio Management System) 44441.

To evaluate whether remdesivir is associated with cardiac adverse events (CAEs), addressing concerns raised by basic experiments, clinical case reports and observational studies.

Systematic review and meta-analysis.

MEDLINE and Embase, searched from January 2020 to December 2023.

Randomised controlled trials (RCTs) comparing remdesivir with placebo or standard care in patients with COVID-19, with a primary focus on cardiac safety.

We included RCTs that evaluated the safety of remdesivir in patients with COVID-19 . Eligible studies were those that compared remdesivir with placebo or standard care in adult patientsCOVID-19 . Inclusion criteria emphasised safety outcomes, particularly CAEs, as primary endpoints.

Two reviewers independently extracted data. Reporting followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-Harms guidelines. Risk of bias (RoB) was assessed using the Cochrane Collaboration tool. A random-effects model was used for data synthesis. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was applied to assess the certainty of evidence. The primary outcome was the incidence of any CAEs, defined as a composite of all reported cardiac-related harms. Secondary outcomes included specific CAEs such as arrhythmias, heart failure and myocardial disorders.

We identified 1698 studies, of which seven RCTs met the inclusion criteria, comprising a total of 4566 participants. The RoB was assessed across multiple domains, with four RCTs showing low risk and three showing moderate risk in specific areas. Pooled analysis revealed no significant association between remdesivir use and CAEs (RR=0.84, 95% CI: 0.68 to 1.04, p=0.118). Subgroup analyses showed consistent findings across different patient demographics and comorbidities. GRADE assessment indicated moderate certainty for overall CAEs, low certainty for arrhythmias and heart failure (due to imprecision and study-level bias), and very low certainty for myocardial disorders (due to small sample size and indirectness).

Contrary to preliminary concerns and case reports, our meta-analysis found no evidence of a statistically significant association between remdesivir and CAEs among patients with COVID-19 . These findings provide reassurance to clinicians regarding the safety profile of remdesivir in this patient population, supporting its use as an antiviral therapy in the treatment of COVID-19. Further research is warranted to validate these findings and to clarify whether remdesivir may have a neutral or potentially protective effect on cardiac outcomes.

CRD42022383647.

Maintaining a healthy workforce is crucial for safe, high-quality care. To enhance well-being and engagement in Dutch university medical centres (UMCs), an overview of staff well-being and job perceptions is needed first. Surveys are widely used to improve working conditions, but varying questionnaires hinder a comprehensive view. This study aimed to evaluate the content of employee surveys currently used in UMCs in the Netherlands from a well-being perspective and to analyse the survey results at a national level.

All seven UMCs were approached to participate in the study and share employee survey data. The primary outcome of interest is work experience; a secondary analysis was conducted. Items were categorised following the Job Demands-Resources model. Descriptive statistics were presented as percentages, means and medians with IQRs.

Two UMCs participated and 31 862 completed surveys were included. Variation in survey items (eg, 15–18 subcategories, 21–33 question items), response options (eg, 1–5, 1–10), frequency (1–3 times per year) and timing were found. Scores on the following outcomes are presented: work overload, coworker support, job control, organisational justice, participation in decision-making, performance feedback, possibilities for learning and development, recognition, task variety, team atmosphere, team effectiveness, trust in leadership, other job resources, connecting/inspiring leadership, self-efficacy, goal-directiveness, boredom, burnout, job satisfaction, work engagement, other employee well-being, commitment organisation/team and work ability. Results should be interpreted with caution, and solely found for hospital A, for certain job control items, median scores of 2 or 3 were observed, whereas the majority of other question items revealed a median score of 4.

There is a significant lack of cohesion across employee surveys. As it stands, employee surveys in Dutch UMCs are not effective tools for monitoring the work experience or well-being of the healthcare workforce. While these surveys may support management decisions, this support is not reflected in interventions related to work and the work environment.

Knee osteoarthritis (OA) is a serious public health problem since it is linked to loss of muscular function and independence, especially in older adults. In this study, the researchers have proposed a randomised controlled trial with a three-arm study strategy to explore the effectiveness of an oral nutritional supplementation containing hydroxymethylbutyrate and undenatured type-II collagen combined with exercise training (ET) on the OA-related symptoms and biomarkers among adults with knee OA.

Adults with knee OA aged between 50 years and 75 years will be invited to participate in the study and thereafter will be randomly assigned to either one of three groups: oral nutrition supplementation+ET, ET or usual care. The primary outcomes include changes in OA-related symptoms and biomarkers. The secondary outcomes include changes in body composition, blood profiles, physical fitness, quality of life, dietary intake, disability, psychology status and morphological changes of the knee.

Ethics approval was granted by the Medical Research Ethics Committee of the National University of Malaysia (reference number JEP-2024–264). Findings of this study will be disseminated via peer-reviewed presentations at scientific conferences as well as open access publications.

ISRCTN14284561.

Prospective, real-world clinical studies of the association between skin color and pulse oximeter (SpO2) accuracy in children are needed to address the limitations of previous research. Such studies are essential for generating evidence for clinicians, regulators and industry. This is the protocol for a multisite study funded by the National Heart, Lung, and Blood Institute (R01HL171313; 1 January 2024–31 December 2028).

In this pragmatic, observational study conducted in three large paediatric cardiac catheterisation centres in the USA, children undergoing cardiac catheterisation with directly measured arterial oxygen saturation will be prospectively enrolled. The outcome variable (SpO₂ bias) is the difference between contemporaneous paired measurements of pulse oximetry (SpO₂) and the standard reference comparator, arterial blood sample oxygen saturation (SaO₂), obtained during the catheterisation procedure. The independent variable is an objective measure of skin colour obtained via spectrophotometry. Our primary analysis is a multivariable regression model testing the relationship between skin colour and SpO₂ bias, after adjusting for covariates. We will also conduct a moderator analysis to identify factors that may affect the magnitude of the association. The target sample size is 584 participants.

This study was approved by the University of Pennsylvania Institutional Review Board (#854895) under expedited review. Study risks are minimal. Parental permission, and child assent when applicable, are obtained prior to enrolment. In accordance with the NIH Public Access Policy, publications associated with the study will be made publicly available through PubMed Central. The analytic dataset will be contributed to a repository for future use. In collaboration with a children’s hospital-based research family advisory council, interpretation and dissemination of the results for lay, clinical and scientific audiences will be considered.

Although not a clinical trial, this observational study is registered on ClinicalTrials.gov (identifier: NCT06529575) for public awareness.