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.

Women living with HIV (WLHIV) face a higher risk of developing cervical cancer. India carries a significant burden of HIV, with an estimated 2.5 million people living with HIV in 2023. While the introduction of more effective antiretroviral therapy has improved the life expectancy of WLHIV, it has also extended the risk window for persistent human papillomavirus (HPV) infection and cervical disease progression. Cervical cancer prevention through HPV vaccination and regular screening remains the cornerstone of public health efforts. This study specifically aims to evaluate the cost-effectiveness of various cervical cancer screening strategies (at different intervals) among WLHIV in India.

The study will be conducted in three interlinked components. First, a meta-analysis will be undertaken to evaluate the diagnostic accuracy of different screening strategies in detecting cervical lesions in WLHIV. Second, primary data collection will be carried out to estimate the treatment costs of cervical cancer and HIV among WLHIV. This phase will also include the collection of health-related quality of life (HRQoL) data, to inform utility estimates for the modelling component. A total of 135 participants will be enrolled for cost data assessment. Of these, a subset of 71 participants will also be included for HRQoL assessment. This data collection will be undertaken in four tertiary public sector hospitals located across four Indian states, that is, Mizoram, Maharashtra, Tamil Nadu and Karnataka. Lastly, a decision analytical model will be developed to simulate the process of screening, diagnosis and treatment for cervical cancer in a hypothetical cohort of WLHIV. A structured comprehensive review of literature will be undertaken to inform model input parameters related to the natural history of cervical disease, progression and mortality among WLHIV. Model calibration will be performed using a likelihood-based approach to ensure consistency with empirical epidemiological data. Probabilistic sensitivity analysis will also be conducted to assess the impact of joint parameter uncertainty on model outcomes.

Ethical approval has been obtained from Ethics Committees of Indian Council of Medical Research–National AIDS Research Institute (NARI), Pune (Protocol No. NARI/EC/Approval/2024/716); B. J. Medical College and Sassoon General Hospitals, Pune (Ref. No. BJGMC/IEC/Pharmac/ND-0824297-297); Cancer Institute (WIA), Adyar, Chennai (Ref. No. IEC/2024/Nov-07); the Mizoram State Cancer Institute, Zemabawk, Aizawl (Ref. No. D.12016/2/2013-MSCI/IEC) and the KLE Academy of Higher Education and Research, Belagavi, Karnataka. The study findings will be disseminated through publications in peer-reviewed journals.

People experiencing severe and multiple disadvantage (SMD: homelessness, substance use and criminal offending) have multiple intersecting unmet health and social care needs and high mortality rates, often due to street-drug overdose. Pilot randomised controlled trials (RCTs) suggest an integrated, holistic, collaborative outreach intervention (Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx)) involving generalist-trained pharmacists, nurses or General Practitioners accompanied by staff from third sector homeless organisations may improve outcomes, including reducing overdose.

Multicentre, parallel group, prospective RCT with parallel economic and process evaluation. Set in six areas of Scotland, UK, 378 adults with SMD will be recruited and randomised (stratified by setting and previous non-fatal overdoses) to PHOENIx intervention in addition to usual care (UC) or UC. Aiming to meet participants weekly for 9–15 months, PHOENIx teams assess and address health and social care needs while referring onwards as necessary, co-ordinating care with wider health and third sector teams. During a person-centred consultation, in the participants’ choice of venue, and taking account of the participant’s priorities, the NHS clinician may prescribe, de-prescribe and treat, for example, wound care, and refer to other health services as necessary. The third sector worker may help with welfare benefit applications, social prescribing or advocacy, for example, securing stable housing. Pairings of clinicians and third sector workers support the same participants. The primary outcome is time to first fatal/non-fatal street-drug overdose at nine months. Secondary endpoints include health-related quality of life, healthcare use and criminal justice encounters. A health economic evaluation will assess cost per quality adjusted life year of PHOENIx relative to standard care. A parallel qualitative process evaluation will explore the perceptions and experiences of PHOENIx, by participants, stakeholders and PHOENIx staff.

The primary and other time-to-event secondary outcomes will be analysed by Cox proportional hazards regression.

IRAS number 345246, approved 23/10/2024 by North of Scotland Research Ethics Service. Results will be shared with participants, third sector homelessness organisations, health and social care partnerships, then peer-reviewed journals and conferences worldwide, from the first quarter of 2027.

ISRCTN12234059 registered on 20/2/2025 (ISRCTN).

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.