To assess the acceptability and adoption of multiparameter point-of-care testing (POCT) devices for the diagnosis and management of non-communicable diseases (NCDs) at the primary healthcare level in a resource-limited region of Peru.

Qualitative case-control process evaluation.

Eight primary healthcare facilities in northern Peru, including both urban and rural centres, where routine chronic care and laboratory services are provided.

Sixty-three participants: 36 patients, 12 laboratory technicians, 10 healthcare professionals and five facility heads. Eligible patients were ≥18 years, residing in the catchment area, with or without prior NCD diagnoses. Healthcare workers, including physicians, nurses, laboratory staff and facility managers.

Multiparameter POCT devices were installed in four intervention facilities, accompanied by staff training and community awareness activities, while four control facilities continued with conventional laboratory diagnostics.

Primary outcome: perceptions of patients and healthcare workers regarding the acceptability and adoption of POCT devices. Secondary outcomes: identification of facilitators and barriers to implementation, including infrastructure, supply chains and training gaps.

(1) Individuals: POCT was valued for speed and comfort, but concerns over accuracy were mentioned. (2) Intervention characteristics: laboratory staff valued POCT’s practicality in emergencies, but noted limitations in handling multiple samples. (3) Outer setting: urban centres outperformed rural facilities, with more staff and longer operating hours. (4) Inner setting: calibration gaps impacted POCT and conventional test reliability, requiring quality control and training. (5) Process: clear staff communication boosted patient confidence in POCT, but inconsistent training could lead to reliability doubts.

Multiparameter POCT devices show promise for enhancing NCD care in resource-limited primary healthcare settings, particularly in rural areas. However, their sustainability depends on broader health system reforms, including reliable supply chains, expanded training and stronger quality assurance mechanisms. Further research should examine strategies for embedding POCT within national regulatory and policy frameworks.

Diagnostic errors in primary care are common, particularly in the interpretation and follow-up of abnormal haemoglobin (Hgb) and estimated glomerular filtration rate (eGFR) results. These errors frequently result in missed or delayed diagnoses of serious conditions such as anaemia and chronic kidney disease. This protocol describes a stepped-wedge cluster randomised controlled trial designed to evaluate a novel, evidence-based, team-based intervention aimed at improving diagnostic safety and efficiency.

The study will be conducted across 12 University of Texas Physicians (UTPs) primary care clinics in Houston, Texas, USA. Adult patients (≥18 years) with newly identified abnormal Hgb or eGFR results will be eligible for inclusion. The intervention integrates automated tracking of abnormal laboratory results, nurse navigators to support patient follow-up and engagement, and clinical pathologists to provide diagnostic guidance to primary care providers. The primary outcome is diagnostic safety, defined as the proportion of patients who receive a correct diagnosis within 6 months. Secondary outcomes include diagnostic efficiency, appropriate test utilisation, cost-effectiveness, patient activation and implementation metrics such as acceptability, fidelity and sustainability. The study will also explore barriers and facilitators to successful implementation using mixed-methods evaluation.

This trial has been approved by the Institutional Review Board at The University of Texas Health Science Center at Houston. Study results will be disseminated through peer-reviewed publications and conference presentations, and findings will be reported to UTP leadership to inform potential system-wide implementation.

NCT05735314.

Music-based training programmes, such as learning how to play an instrument or sing in a choir, have been suggested as potential interventions for promoting healthy brain ageing in older adults at risk of cognitive decline because of their ability to enhance cognitive functions and potentially promote neuroplasticity. However, there is limited empirical evidence in older adults at risk of dementia, especially that evaluates both piano and singing interventions and their effects on cognition and neuroplasticity. In this protocol, we outline a study to assess the efficacy of keyboard and singing music training programmes on reducing cognitive decline and other outcomes in older adults with Mild Cognitive Impairment (MCI).

This randomised, single-blind, controlled, parallel-group trial aims to enrol 432 individuals with MCI from the community in Sydney, Australia. Participants are randomly allocated to participate in either keyboard lessons, singing lessons or a film discussion control group once a week for 3 months. The primary objective is to assess the effectiveness of two music training programmes (keyboard and choral singing) for enhancing verbal memory after 3 months compared with control. Additionally, we will examine how these music-based interventions affect other aspects of cognition, mood, sleep, overall well-being, markers of brain plasticity and blood biomarkers of Alzheimer’s disease and neurodegeneration. Tertiary objectives are to identify factors that impact the success of the interventions, such as participation rates, engagement levels and key demographic and clinical features. Outcomes are collected at baseline and at 3 and 9 months. The primary endpoint analysis will include all randomised participants to estimate the treatment effect using intention-to-treat principles. Primary and secondary outcomes will be analysed using linear mixed models and effect size measures will be calculated.

This study will be the first robust, randomised controlled trial to assess the potential and relative value of music engagement for cognitive decline in high-risk MCI individuals, as well as broader effects on other markers of mental health, well-being and neurodegeneration. Co-designed with implementation in mind, the music interventions can potentially be delivered within memory clinic or community settings.

The Sydney University Human Research Ethics Committee (2023-026) has approved this protocol. The trial findings will be shared through conferences, publications and media.

Australian and New Zealand Clinical Trials Registry (ACTRN12623000407695), Registered 21/04/2023 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385552

2.02 29/11/2024.

Proactive and easily accessible interventions are needed to support people with long-term health conditions who experience limitations in activities of everyday life. However, there is a lack of interventions that promote self-management skills that prevent deterioration and improve health. The internet-based programme ‘Strategies for Empowering Activities in Everyday Life’ (SEE) supports people with long-term health conditions in developing self-management skills through knowledge, self-analysis and management strategies, promoting active and healthy daily life. This study protocol aims to evaluate the feasibility of SEE 2.0 and the study design.

This feasibility study employs a pretest and post-test design with no control group, embedded within a mixed-method approach. The participants will include 30–40 clients, occupational therapists and managers involved in delivering SEE 2.0 in primary healthcare and hospital-based services. Data will be collected through assessments and forms at baseline, 4 months and 12 months after inclusion. Additionally, qualitative methods will be used to enhance the understanding of participants’ experiences.

The study was approved by the Swedish Ethical Review Authority. The results will inform the refinement of SEE 2.0 and guide decisions on whether to proceed with planning a full-scale evaluation to assess the intervention’s effect. The results will be published in peer-reviewed scientific journals on websites and presented at conferences and seminars to reach various user groups.

NCT06484322.

Eating disorders are complex mental health conditions characterised by pathological behaviours related to food intake, often accompanied by a chronic obsession with weight control. Their prevalence is increasing, with an earlier onset and greater severity among young people. Universal prevention, through multicomponent strategies that tackle modifiable risk factors, has emerged as a promising tool. This paper reports the study protocol designed to assess the effectiveness and cost-effectiveness of the PRETA (Prevención de los Trastornos de la Alimentación) programme in reducing the risk of eating disorders and related modifiable risk factors among preadolescents in the school setting.

The PRETA programme will be assessed by means of an open, community-based, multicentre, controlled trial using 1:1 matched-pairs cluster randomisation at the school level. Schools in Tenerife (Spain) will be assigned to the PRETA programme or a waitlist control group. Participants include 5th- or 6th-grade students (10–13 years old), their parents and teachers. The PRETA programme is a universal, school-based, multicomponent programme designed to reduce eating-disorder risk and modifiable risk factors. Its main component is an interactive online platform called e-PRETA, complemented by training sessions for families and teachers. e-PRETA includes nine 45-minute sessions addressing risk factors, such as dietary habits, beauty standards, media literacy, self-esteem, emotional regulation and social skills. A total of 1068 children from 12 schools will participate. The primary outcome will be the risk of developing eating disorders (Children’s Eating Attitudes Test-26 item version). Secondary outcome measures are body dissatisfaction (Adapted Contour Drawing Rating Scale), eating disorder traits (Eating Disorder Inventory-2), internalisation of appearance ideals (Sociocultural Attitudes Towards Appearance Questionnaire-4) and self-esteem (Rosenberg Self-Esteem Scale). Outcomes will be assessed at baseline and postintervention (3 months). Additional baseline covariates such as electronic device use, parental feeding attitudes, physical activity, sleep duration and screen time will also be collected. Programme effectiveness will be analysed using generalised mixed models. Cost-effectiveness will be assessed by comparing the incremental costs associated with the implementation of the PRETA programme with its estimated effectiveness.

Ethics approval has been obtained from the Ethics Committee for Research with Medicines at the University Hospital of the Canary Islands (CHUC_2021_78). Written informed consent will be obtained from the parents or legal guardians of all participants. Results will be disseminated through scientific publications and conferences.

NCT06792981.

Leishmaniasis poses a significant public health problem in Kenya, where effective case management and treatment rely on accurate diagnosis. This review aims to summarise the research landscape on leishmaniasis diagnostics in Kenya and identify gaps.

This scoping review expands a previously published scoping review on leishmaniasis in Kenya to further analyse studies focusing on diagnostics. The field of diagnostics was chosen because of recent pushes for novel tools and because of the role timely diagnosis plays in disease elimination. A comprehensive search of PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO ICTRP and the Pan African Clinical Trials Registry was conducted, covering studies up to 5 January 2024.

After dual, blind screening with conflict resolution by a third reviewer, 41 studies were included in the review. These studies examined a range of diagnostic tools; however most were assessed in one or few studies, and none evaluated real-time PCR. Additional gaps in the research landscape include a lack of diagnostics for cutaneous leishmaniasis and post-kala-azar dermal leishmaniasis in Kenya, outdated literature surrounding the Direct Agglutination Test and randomised trials for any diagnostic tool.

Future research should focus on solidifying the validity and reliability of diagnostic tools in the Kenyan context and updating previous work.

Vector control is imperative for eliminating leishmaniasis as a public health problem in Kenya. As elimination efforts expand in East Africa, it is crucial to understand the current research landscape. To address that need and identify gaps, a scoping review was conducted to characterise the landscape of leishmaniasis vector research in Kenya.

Building on a previously published scoping review by this team, we updated database searches in PubMed, Embase via Embase.com, Web of Science Core Collection, the Cochrane Library, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) and the Pan African Clinical Trials Registry to incorporate literature up to 4 January 2024 and focused on vector-related papers. Studies classified as ‘prevention’ in the original scoping review were included due to overlapping definitions.

A total of 95 studies were included in the analysis. Although a wide range of sandfly species have been documented, most of the research is outdated, having taken place 20–40 years ago. Existing studies are mostly epidemiological with little focus on basic and clinical research. There are also no studies on post-kala-azar dermal leishmaniasis despite its potential contribution to the disease transmission cycle. The geographical scope of the research is largely limited to traditional transmission foci with little attention to new disease hotspots such as North Eastern Kenya.

These research gaps need to be addressed to better inform the country’s leishmaniasis prevention and vector control strategy.

To estimate the association between municipal multidimensional poverty (MMDP) and the risk of a first hospitalised acute myocardial infarction (AMI) among users of the Chilean public health system, and to examine whether this association differs by sex.

Multilevel analysis of a retrospective cohort study.

Primary level of care across 138 municipalities in Chile.

A total of 137,162 individuals aged ≥45 years were included, comprising 83,598 women and 53,564 men, all enrolled in the cardiovascular health programme of the Chilean public health system due to the presence of cardiovascular risk factors such as hypertension, type 2 diabetes, dyslipidaemia or tobacco use. Individuals with a prior history of AMI were excluded. Participants were clustered by municipality and followed from 1 January 2015 to 30 April 2019. Sociodemographic and clinical data at the individual level were obtained from electronic health records and linked to municipal-level poverty indicators from the National Socioeconomic Characterization Survey.

The primary outcome was the time to first hospitalised AMI . Cox proportional hazard models with a shared frailty term were used to assess the association between MMDP (defined as being in the upper quartile of the index) and AMI incidence. Models were adjusted for individual sociodemographic characteristics, behavioural risk factors (eg, smoking, diet and physical activity), and biological conditions (eg, hypertension, type 2 diabetes and dyslipidaemia). Sex-stratified analyses were conducted to explore potential differences in the association.

MMDP was significantly associated with an increased risk of AMI (HR 1.32, 95% CI 1.06 to 1.64) after adjustment for individual-level risk factors. In stratified models, the association remained significant among women (HR 1.30, 95% CI 1.01 to 1.68), but not among men (HR 1.10, 95% CI 0.93 to 1.31).

Residing in municipalities with high levels of multidimensional poverty is associated with an increased risk of AMI among individuals with cardiovascular risk factors, particularly women. These findings underscore the need for intersectoral policies to address the structural determinants of cardiovascular health.

Millions of patients receive general anaesthesia every year with either propofol total intravenous anaesthesia (TIVA) or inhaled volatile anaesthesia (INVA). It is currently unknown which of these techniques is superior in relation to patient experience, safety and clinical outcomes. The primary aims of this trial are to determine (1) whether patients undergoing (a) major inpatient surgery, (b) minor inpatient surgery or (c) outpatient surgery have a superior quality of recovery after INVA or TIVA and (2) whether TIVA confers no more than a small (0.2%) increased risk of definite intraoperative awareness than INVA.

This protocol was co-created by a diverse team, including patient partners with personal experience of TIVA or INVA. The design is a 13 000-patient, multicentre, patient-blinded, randomised, comparative effectiveness trial. Patients 18 years of age or older, undergoing elective non-cardiac surgery requiring general anaesthesia with a tracheal tube or laryngeal mask airway will be eligible. Patients will be randomised 1:1 to one of two anaesthetic approaches, TIVA or INVA, using minimisation. The primary effectiveness endpoints are Quality of Recovery-15 (QOR-15) score on postoperative day (POD) 1 in patients undergoing (1) major inpatient surgery, (2) minor inpatient surgery or (3) outpatient surgery, and the primary safety endpoint is the incidence of unintended definite intraoperative awareness with recall in all patients, assessed on POD1 or POD30. Secondary endpoints include QOR-15 score on POD0, POD2 and POD7; incidence of delirium on POD0 and POD1; functional status on POD30 and POD90; health-related quality of life on POD30, POD90, POD180 and POD365; days alive and at home at POD30; patient satisfaction with anaesthesia at POD2; respiratory failure on POD0; kidney injury on POD7; all-cause mortality at POD30 and POD90; intraoperative hypotension; moderate-to-severe intraoperative movement; unplanned hospital admission after outpatient surgery in a free-standing ambulatory surgery centre setting; propofol-related infusion syndrome and malignant hyperthermia.

This study is approved by the ethics board at Washington University, serving as the single Institutional Review Board for all participating sites. Recruitment began in September 2023. Dissemination plans include presentations at scientific conferences, scientific publications, internet-based educational materials and mass media.

NCT05991453.

Diabetes mellitus (DM) affects over 422 million individuals globally. Diabetic foot ulcers (DFUs) stand out as a challenging complication of DM, affecting up to 34% of individuals with DM. Despite the prevalence of DFUs, clinical trials for DFUs often face slow and insufficient patient recruitment. We aimed to identify key determinants that impact subject recruitment rates in DFU clinical trials.

Systematic review.

ClinicalTrials.gov and PubMed were searched to identify DFU clinical studies published from 1 January 1990 to 9 April 2025.

We included English-language publications of clinical trials aimed at healing DFUs that reported enrolment numbers, duration of enrolment and number of study centres.

Records were extracted and subjected to two independent rounds of review by five authors (LZ, SP, RN, HL-T, and RK). Data were pooled and analysed using negative binomial regression, Kaplan-Meier methods and Cox proportional hazards models. Study enrolment and site enrolment rates, as well as time to complete study enrolment, were analysed. Between-study heterogeneity was assessed using the likelihood ratio test.

397 trials involving 31 955 participants were included. On average, DFU studies enrolled 4.24 patients per month (median: 1.65). US-based studies had slower recruitment than non-US studies, with a mean enrolment rate of 1.51 patients per site per month (median: 0.58). The average time to complete enrolment was 1.28 years. Studies that employed a higher number of study sites, were conducted outside the USA, studied behavioural or dietary supplement interventions, and began enrolment more recently, were more likely to have a higher enrolment rate. Longer time to complete enrolment was associated with a larger number of study sites, trials involving at least one US site, earlier starting enrolment year, and longer follow-up duration.

These findings have potential practical implications for the design and conduct of future DFU trials.