Over 50% of patients participating in cardiac rehabilitation (CR) experience poor sleep and/or, closely related, psychological stress. Although stress management interventions are generally available, they are typically underutilised in CR, and sleep remains an underaddressed component within CR. This is concerning, as poor sleep and stress not only reinforce each other but are also associated with poorer cardiovascular health and lower quality of life. Therefore, the primary aim of the OPtimising CArdiac REhabilitation by REfining Sleep and STress (RESST) study is to investigate the (cost-)effectiveness of adding a behavioural intervention targeted at improving sleep and managing stress during CR (RESST intervention) on sleep and psychological stress. Furthermore, the study aims to explore the (bidirectional) associations between sleep, stress and lifestyle behaviours.

This parallel-arm multicentre randomised controlled trial will include 200 CR patients across 3 major CR centres in the Netherlands who experience poor sleep and/or stress. Patients will be randomised in a 1:1 ratio to standard CR or standard CR with the RESST intervention. Standard CR is a structured programme combining exercise, lifestyle guidance and risk management. On top of standard CR, the RESST intervention consists of 5 in-person group sessions targeting sleep and stress and is based on Acceptance and Commitment Therapy and Cognitive Behavioural Therapy. Primary outcomes are accelerometer-assessed and self-reported sleep and perceived stress. Secondary outcomes include quality of life, psychosocial well-being, chronic stress biomarkers (hair cortisol and cortisone), momentary fatigue, momentary stress and physical activity. Linear mixed models will be used to assess changes in outcomes at 3-month (after intervention and/or CR completed) and 6-month follow-up. The momentary data collected with ecological momentary assessment and accelerometry will be analysed using multilevel linear mixed models to explore the (bidirectional) relationship between sleep, stress and other lifestyle components such as physical activity.

This study was approved by the ethics committee of Erasmus MC, Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2024-0238). The findings will be disseminated through publications in peer-reviewed journals, presentations at academic conferences and professional and patient publications.

NCT06505109.

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.

Hyperkalaemia (HK) is common in the emergency department (ED) and can cause life-threatening arrhythmias. Patiromer is a potassium binder whose role in acute HK management is uncertain; therefore, we investigated the efficacy and safety of patiromer as an adjunct to the standard of care treatment of HK in the ED.

A prospective, randomised, double-blind, placebo-controlled study.

16 ED sites across the USA.

Patients aged ≥18 years treated at a participating ED who were found to have serum potassium ≥5.8 mEq/L.

Participants were randomised 1:1 to standard combination therapy (25 g intravenous dextrose, 5 units intravenous insulin and 10 mg albuterol) with either patiromer or placebo. The initial dose was given within 1 hour of the potassium result, and the second dose 24 hours later.

The primary endpoint was net clinical benefit (NCB) at 6 hours, defined as the change in number of potassium-lowering interventions minus change in serum potassium. Adverse events (AEs) were also recorded.

The study was terminated early and did not reach the prespecified sample size. Overall, 111 patients (53 patiromer and 58 placebo) were analysed. Mean (SD) age was 61.34 (15.21) years, 34% were female, 48% white and 22.5% received chronic haemodialysis. Mean baseline potassium was 6.5 mmol/L. NCB at 6 hours was similar between patiromer and placebo (–0.6 vs –0.4; p=0.44). Potassium levels at 2, 4 and 6 hours were similar between the groups (5.50 vs 5.70, 5.45 vs 5.65, 5.50 vs 5.60; patiromer and placebo (all p>0.05)). The number of interventions per patient was similar (p>0.05) between groups at each time point. The proportion of patients experiencing AEs was not significant between the patiromer and placebo groups (16.98% vs 32.76%; p=0.08).

No differences in efficacy were reported in this study, which was underpowered to detect statistical efficacy of patiromer over placebo.

NCT04443608.

Since 1985, the international healthcare community has recommended the ideal rate of caesarean section (CS) to be 10%–15% at the national level. The literature has reported that overused CS without necessary medical indications can be harmful to both maternal and child health. To generate evidence to support policy on CS, this study evaluated the trend over time of CS in Thailand during January 2016 to October 2021 (which included the COVID-19 pandemic period) and explored predictors of CS use.

This study was a retrospective secondary data analysis of de-identified hospitalisation data under the Universal Coverage Scheme (UCS) from the National Health Security Office’s e-Claims database. Descriptive analyses were conducted to explore the number and rate of CS over time and across different characteristics (ie, age, hospital type, COVID-19 status and delivery day) including a multivariable logistic analysis to explore predictors of CS. Interrupted time series analysis was adopted to investigate the effect of the COVID-19 pandemic on CS rate.

569 321 CS cases under UCS from 2016 to 2021.

The results showed an increasing trend of CS rate, from 30% in January 2016 to 35% in October 2021. Both clinical (eg, medical indication and age) and non-clinical (eg, region and day of delivery) factors were significantly associated with CS. Furthermore, the COVID-19 pandemic had no significant effect on CS rate (level: –0.0016, 95% CI –0.0085 to 0.0053, p=0.66).

This study highlighted an increasing trend of CS in Thailand and could present supportive evidence that Thailand might have been facing an overuse of CS. More awareness and actions are warranted to ensure the movement towards reduction of unnecessary CS in Thailand.

Digital health interventions (DHIs) are changing the healthcare landscape. However, using these tools effectively for people with chronic conditions in rural areas comes with challenges, highlighting the need to understand their lived experiences. No systematic review was found that examines the inclusion of lived experience in DHI for individuals with chronic conditions in rural areas and how this impacts their acceptance of technology. A systematic review grounded by Technology Acceptance Model (TAM) will be conducted to examine the lived experiences of individuals in rural areas who use DHIs. Individuals with chronic conditions will be examined specifically and how their experiences influence the adoption, use and satisfaction with DHI for managing their health needs. This systematic literature review is significant because it will be used as a crucial starting point for a larger project aimed at creating digitally transformed primary healthcare in rural areas, particularly for Indigenous communities. The insights gained will inform the development of a digital transformation model for the larger project.

Guided by the TAM and PRISMA to explore the lived experiences of patients and caregivers with digital health, a search will be conducted for peer-reviewed studies on DHIs, including qualitative, quantitative and mixed-method approaches, including systematic reviews. The studies must be published in English from 2019 to the present and will be sourced from databases such as PubMed, EBSCO, Cochrane Library, Scopus and Web of Science. MeSH will be utilised to identify terms like user experience, acceptability and engagement with DHIs. Eligibility will be based on relevance, population, intervention and outcomes. A standardised data extraction form will be developed and tested to capture important information from each study included in the review. Data extraction and quality appraisal will be performed independently by two reviewers, with a third reviewer addressing any discrepancies. Software will be used to manage extracted data, assess risk of bias and synthesise the data. Meta-analysis will be included to enhance our findings if sufficient quantitative data is available. Our findings will be reported in accordance with the PRISMA guidelines. This review protocol was refined in June 2025; commencement of the study will be in July 2025 and will be completed in 2026.

This study used previously published literature and did not collect primary data from humans or animals. No ethical committee approval was required. Findings will be disseminated through peer-reviewed publication and will be presented at conferences related to the field.

osf.io/jw5yp.

Evaluating skin reactions is crucial in topical product development. Turmeric/epigallocatechin-3-gallate (EGCG) emulgel demonstrates therapeutic potential for cutaneous diseases, warranting further investigation in human studies. The Human Repeat Insult Patch Test (HRIPT) of skin irritation and sensitisation potential caused by the turmeric/EGCG emulgel is designed to evaluate the safety of the investigational product in healthy volunteers prior to conducting the efficacy study in patients with dermatological diseases.

60 healthy Thai volunteers will be enrolled in this single-centre, double-blind HRIPT pilot clinical trial to evaluate skin irritation and sensitisation potential caused by turmeric/EGCG emulgel. Primary endpoints include the number and proportion of participants exhibiting skin irritation and sensitisation, while secondary endpoints focus on the frequency and severity of adverse events. The study will comprise a screening period, a 3-week induction phase, a 2-week rest phase and a 1-week challenge phase. Fully occlusive adhesive patches containing study products will be applied to participants’ backs 10 times. Skin irritation will be assessed using the Draize dermal irritation scoring system, and skin sensitisation will be evaluated using the International Contact Dermatitis Research Group scoring system.

The Research Ethics Committee of the Faculty of Medicine, Chiang Mai University, approved this study protocol and related documents on 6 March 2025 (Ref. No. 108/2025).

TCTR20250317007.

The management of autism spectrum disorder (ASD) involves a varied and comprehensive range of support services at various stages of an autistic individual’s life. In Thailand, parents/legal guardians of children with ASD often encounter challenges such as difficulty travelling from rural areas to access support services. The aim of the present study is to investigate the effectiveness of a computer-based intervention programme for caregivers of children with ASD called the Thai Early Intervention for Autism—Assistive Technology for Caregivers (TEI4A-ATC), designed and implemented by a multidisciplinary team.

160 children and their caregivers are being recruited. They will be randomised 1:1 into two treatment arms: access to TEI4A-ATC for the intervention group and standard care for the control group. Before enrolment, ASD diagnosis will be conducted using the Thai Diagnostic Autism Scale: children’s ASD scores will be determined using the Thai Autism Treatment Evaluation Checklist for evaluating communication, sociability and sensory/cognitive awareness and the Thai Early Developmental Assessment for Intervention for evaluating motor skills, social interaction, language development and problem-solving. Both assessment tools will be used again after 3 months of treatment. Similarly, the caregivers’ knowledge, attitude and practice (KAP) for ASD care will be assessed using a questionnaire at enrolment and again after treatment. Comparison of the children’s ASD scores and caregivers’ KAP responses between the treatment groups and before and after treatment will be performed based on the intention-to-treat principle.

This study was approved by the Human Research Ethics Committee for Mental Health and Psychiatry, Department of Mental Health, Ministry of Public Health (DMH.IRB.COA 037/2565). Written informed consent will be obtained from the participants prior to enrolment. The study’s findings may be disseminated through scientific publications and conference presentations. The results of the study will be shared with key stakeholders, including caregivers, psychiatrists, policymakers and the general public, via appropriate dissemination channels to aid in creating appropriate practice and policy guidelines.

This study was registered with the Thai Clinical Trials Registry (TCTR20240320010) on 20 March 2024.