Cardiovascular diseases (CVDs) are the leading cause of death worldwide, making the development of self-management strategies crucial for preventing complications and improving clinical outcomes. This process involves symptom monitoring, treatment adherence, emotional management and a healthy lifestyle, among others. Reliable instruments are necessary to measure self-management, requiring robust psychometric properties. In this way, this COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic review aims to assess the quality of specific self-management instruments for adults with CVDs.

This systematic review will follow the COSMIN and be reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol. Searches will be conducted in seven databases: MEDLINE, Web of Science, Scopus, PsycINFO, EMBASE and CINAHL. Additionally, a manual search will be performed on PROQOLID, PROMIS and The Medical Outcome Trust websites. Studies on the development and validation of patient-reported instruments measuring specific self-management for individuals with CVDs will be included, without language or date restrictions. The search will be performed in November 2025, with the final version of the review expected to be completed in October 2026. Data extraction will follow COSMIN recommendations. The Modified Grading of Recommendations, Assessment, Development and Evaluation approach will be used to determine the quality of evidence. Instruments will be categorised according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer involved in case of discrepancies. Additionally, the content of the instruments will be analysed and linked to the International Classification of Functioning, Disability and Health, following international recommendations.

This study does not require ethics committee approval as it is a review of published data. The review results will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

CRD42024605969.

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

NCT04780971.

Rapid identification of high-risk and low-risk patients presenting to the emergency department (ED) influences clinical management and can help optimise patient outcomes as well as resource allocation. This study aims to externally validate the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) score in adult patients in the ED with suspected infection. Furthermore, generalisability was assessed by comparing the discriminatory ability of the RISE UP with the quick Sequential Organ Failure Assessment (qSOFA) as well as the Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS).

Retrospective cohort study.

Single-centre study in the ED of a tertiary, university-affiliated hospital.

Adult patients with suspected infection presenting at the ED for internal medicine from 2016 to 2022.

The primary outcome was all-cause 30-day mortality. Secondary outcomes were all-cause 14-day mortality, 7-day mortality and intensive care unit (ICU) admission.

Prognostic performance was evaluated using discrimination (area under the receiver operating characteristic curve (AUC)) and a calibration plot.

Of the included 5038 ED visits, there was a 30-day mortality of 7.1%. Discrimination of RISE UP for 30-day mortality was good (AUC 0.809; 95% CI 0.786 to 0.832) and significantly higher than that for the other risk scores: qSOFA (AUC 0.675; 95% CI 0.644 to 0.707), MEWS (AUC 0.688; 95% CI 0.658 to 0.718) and NEWS (AUC 0.725; 95% CI 0.696 to 0.754) (p

The RISE UP score outperformed the qSOFA, MEWS and NEWS in predicting 30-day mortality. It is generalisable to an adult infection-specific cohort and may facilitate distinction between high-risk and low-risk patients in the ED, particularly to rule out poor outcomes.

The highest childhood mortality rates are observed from external causes of death. Our study aims to investigate the trends in deaths from external causes among children aged 0–14 years between 2000 and 2022, comparing the pre-pandemic (2000–2019) and the COVID-19 pandemic (2020–2022) periods.

This is a population-based retrospective cohort study.

From the ‘Dissemination Database’ of the Hungarian Central Statistical Office, we collected the monthly and annual mortality of all external causes (International Classification of Diseases, 10th Revision: V01–Y89) and the two most common external causes (traffic accidents and drownings) for the period 2000–2022.

Children aged under 15 years, and the relevant population, were available from this database by gender, 5-year age group and region.

The trends were characterised by the incidence rate ratio (IRR) and its 95% CI.

During the study period, 1813 deaths (1142 boys and 671 girls) occurred. There was a significant decreasing trend in all external-cause mortality (IRR=0.94; 95% CI 0.93 to 0.95; p

There is a significant decreasing annual trend in childhood external-cause mortality in Hungary. Mortality from drowning was significantly higher around our larger natural water bodies in the summer months, while mortality from traffic accidents was the highest in the HU33.

Major depressive disorder (MDD) is among the most common psychiatric disorders in children and adolescents. While previous meta-analyses have synthesised evidence on the efficacy and acceptability of newer-generation antidepressants in this population, specific adverse events (AEs) remain poorly characterised. This is of high clinical importance, as AEs are burdensome for patients, can reduce treatment adherence and lead to discontinuation. Here, we present a protocol for a network meta-analysis designed to evaluate the specific AE profile and comparative tolerability of newer-generation antidepressants in children and adolescents with MDD.

The planned study will include double-blind randomised controlled trials that compared one active drug with another and/or placebo for the acute treatment of MDD in children and adolescents. The following antidepressants will be considered: agomelatine, alaproclate, bupropion, citalopram, desvenlafaxine, duloxetine, edivoxetine, escitalopram, fluoxetine, fluvoxamine, levomilnacipran, milnacipran, mirtazapine, paroxetine, reboxetine, sertraline, venlafaxine, vilazodone and vortioxetine. The primary outcomes will include the number of patients experiencing at least one AE, specific non-serious AEs, serious AEs (eg, suicidal ideation) and AEs leading to treatment discontinuation. Published and unpublished studies will be retrieved through a systematic search in the following databases: PubMed, Embase, Cochrane Library (including the Cochrane Central Register of Controlled Trials), Web of Science Core Collection, PsycInfo and regulatory agencies’ registries. Study selection and data extraction will be performed independently by two reviewers. For each outcome, a network meta-analysis will be performed to synthesise all evidence. Consistency will be assessed through local and global methods, and the confidence in the evidence will be evaluated using the Confidence in Network Meta-Analysis web application. All analyses will be conducted in the R software.

The planned review does not require ethical approval. The findings will be published in a peer-reviewed journal and may be presented at international conferences.

CRD420251011399.

This study aimed to assess the psychosocial determinants of psychological distress among people with disabilities in Ethiopia.

A cross-sectional study was conducted at an institution from 01 to 30 May 2021, using a census sampling approach.

A total of 269 individuals aged 18 and older with disabilities were present at the University of Gondar in Ethiopia.

The Kessler psychological distress scale (K10), the multidimensional scale of perceived social support, the actual help-seeking behaviour and the stigma scale for chronic illness-8 were used to assess the dependent and independent variables, respectively. Binary logistic regression analyses were performed; a p value less than 0.05 was considered statistically significant at a 95% CI.

In this study, the prevalence of psychological distress was 34.6% with a 95% CI (29.40 to 40.10). Factors, such as older age (adjusted ß=1.09; 95% CI 1.04 to 1.15), low perceived social support (adjusted OR (AOR)=1.83; 95% CI 1.16 to 2.89), experiencing stigma (AOR=2.50; 95% CI 1.12 to 5.61) and cognition problems (adjusted ß=0.73; 95% CI 0.62 to 0.85), were significantly associated with increased psychological distress. Of the participants with psychological distress, professional help-seeking behaviour was 7.5%.

Psychological distress was notably high among individuals with disabilities, while professional help-seeking remained very low. This underscores the urgent need for targeted mental health interventions to reduce stigma, strengthen social support and improve access to appropriate psychological care.

The necessity of enhancing resuscitation training has been encouraged by The International Liaison Committee on Resuscitation and the American Heart Association to reduce mortality, disability and healthcare costs. Resuscitation training is a complicated approach that encompasses various components and their mixture. It is essential to identify the most effective of these components and their combinations, to measure the corresponding effect size and to understand which participant groups may enjoy the greatest advantage.

We will systematically search 12 databases and two clinical trial registries for randomised controlled trials (RCTs) that examine different resuscitation training methods from inception to April 2025. The analysis will be carried out using the standard network meta-analysis and component network meta-analysis models. Resuscitation skills of staff will be the primary outcome of this analysis. Paired reviewers will independently screen and extract data. A consensus will be sought with the principal investigators to resolve any disagreements that cannot be achieved through regular meetings. Each intervention in each RCT will be decomposed according to its constituent components, such as delivery method, interactivity, teamwork, digitalisation and type of simulator. The analysis will be conducted using the frequentist and bayesian approach in the R environment. RoB V.2.0 and Confidence in Network Meta-Analysis will, respectively, be used to assess the risk of bias and the certainty of the evidence.

As we will use only aggregated secondary data without individual identities, ethical approval is not required. Results of this review will be shared through a peer-reviewed publication and presentation of papers at any relevant conferences.

CRD42024532878

Despite growing evidence to characterise cancer-associated cognitive decline (CACD) in women with breast cancer, interventions to mitigate CACD are limited. Emerging evidence suggests aerobic exercise may enhance cognition after breast cancer diagnosis and treatment; yet, CACD remains an understudied outcome of exercise, and few high-quality studies have been conducted. In addition to knowledge gaps in effectiveness, the translation of exercise interventions to community settings remains challenging. The Breast cancer Reasoning and Activity INtervention (BRAIN) investigates the effectiveness of aerobic exercise training, delivered in a community-based setting, for improving cognitive function in women with breast cancer and gathers information on the implementation success of the intervention.

This Hybrid Type I effectiveness–implementation study is conducted at an academic medical centre in the southwestern United States in partnership with a non-profit, community health and wellness organisation. The study enrols 160 women diagnosed with stage I–IIIa breast cancer and within 3–36 months of treatment completion into a 1:1 randomised controlled trial. Individuals randomised to the exercise group receive a 6-month, individually tailored aerobic exercise programme delivered by exercise trainers employed at local community fitness centres. The programme is progressive in nature and designed to help participants achieve aerobic exercise levels consistent with guidelines for cancer survivors. Individuals randomise to the control group receive a 6-month health education control intervention delivered virtually by hospital-based health educators. Cognitive performance (primary), self-reported cognition, patient-reported outcomes, physical activity and cardiorespiratory fitness are measured at baseline, 6 months (postintervention) and 12 months (follow-up). Brain structure and function are measured via magnetic resonance imaging (MRI) at baseline and 6 months. Implementation outcomes are defined by the RE-AIM framework, which includes reach, effectiveness, adoption, implementation and maintenance. RE-AIM outcomes are measured at baseline, 6 months, 12 months and ongoing during the study.

This study was approved by the Mayo Clinic Institutional Review Board (#23-000020). All participants provide informed consent prior to participation. Findings will be disseminated to scientific, clinical and community audiences through manuscripts, presentations and newsletters.

NCT04816006.

The prevalence of women with primary dysmenorrhoea is high and negatively impacts physical and mental health. The intense cyclic episodes of pain generate central nervous system dysfunctional processing. In this sense, strategies focused on the central nervous system are important to re-establish normal functioning. Home-based self-administered transcranial direct current stimulation (tDCS) emerges as a strategy to modulate dysfunctional brain areas and improve the symptoms. This protocol aims to evaluate the effects of home-based self-administered tDCS for pain, premenstrual symptoms, physical performance, quality of life, electroencephalography and patient global impression in women affected by primary dysmenorrhoea.

This is a single-centre, parallel, randomised, double-blinded clinical trial protocol. 40 women affected by primary dysmenorrhoea will be randomised into two groups (active-tDCS or sham-tDCS). Then, 20 consecutive sessions of home-based self-administered tDCS will be performed. The assessments will occur at five time points: baseline, after the 20th sessions, at the first, second and third cycles after tDCS interventions (follow-ups). Primary outcome will be pain according to visual analogue scale. Quality of life, premenstrual symptoms screening, depression, anxiety, physical performance, electroencephalography and participants’ satisfaction will be the secondary outcomes. A mixed analysis of variance will calculate the effect of stimulation.

The study was approved by the ethics committee of the Federal University of Rio Grande do Norte (No. 6.037.756) and registered in the Brazilian Clinical Trials Registry (n° RBR-747k8vb). Participants may withdraw at any time without penalty. Free support will be available from the lead researcher if needed. All procedures will follow Good Clinical Practice and international ethical standards.

https://ensaiosclinicos.gov.br/rg/RBR-747k8vb

Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

NCT06010719.