High-intensity statin therapy is recommended as a first-line strategy for lowering low-density lipoprotein cholesterol (LDL-C) levels in patients with acute myocardial infarction (AMI). A combination of moderate-intensity statin and ezetimibe at an equivalent dose to high-intensity statin may achieve similar LDL-C reduction with fewer side effects. This study evaluates the long-term efficacy and safety of this approach, initiated following AMI, compared with high-intensity statin monotherapy.

The ROSUZET-AMI trial is a multicentre, prospective, open-label, randomised, non-inferiority trial. Patients with AMI who underwent percutaneous coronary intervention were randomised 1:1 to receive either moderate-intensity statin with ezetimibe (rosuvastatin 5 mg with ezetimibe 10 mg) or high-intensity statin monotherapy (rosuvastatin 20 mg). The primary endpoint is the composite of cardiovascular death, major coronary events (non-fatal myocardial infarction, documented unstable angina requiring hospitalisation and all coronary revascularisation events occurring at least 30 days after randomisation), or non-fatal stroke.

Ethics approval for this study was obtained from the Institutional Review Board of Seoul St. Mary’s Hospital (No. 2020-0424-0003). Informed consent is obtained from every participant before randomisation. The results of this study will be submitted for publication in international peer-reviewed journals, and the key findings will be presented at international scientific conferences.

NCT04499859.

In the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP.

We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications.

This study has been reviewed and approved by the local ethical review body, ‘The Medical Ethics Committee Leiden The Hague Delft’, under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals.

NCT06719245. Dutch trial registry: NL87196.058.24

The aim of this study was to prioritise a set of indicators to measure World Health Organization (WHO) quality-of-care standards for small and/or sick newborns (SSNB) in health facilities. The hypothesis is that monitoring prioritised indicators can support accountability mechanisms, assess and drive progress, and compare performance in quality-of-care (QoC) at subnational levels.

Prospective, iterative, deductive, stepwise process to prioritise a list of QoC indicators organised around the WHO Standards for improving the QoC for small and sick newborns in health facilities. A technical working group (TWG) used an iterative four-step deductive process: (1) articulation of conceptual framework and method for indicator development; (2) comprehensive review of existing global SSNB-relevant indicators; (3) development of indicator selection criteria; and (4) selection of indicators through consultations with a wide range of stakeholders at country, regional and global levels.

The indicators are prioritised for inpatient newborn care (typically called level 2 and 3 care) in high mortality/morbidity settings, where most preventable poor neonatal outcomes occur.

The TWG included 24 technical experts and leaders in SSNB QoC programming selected by WHO. Global perspectives were synthesised from an online survey of 172 respondents who represented different countries and levels of the health system, and a wide range of perspectives, including ministries of health, research institutions, technical and implementing partners, health workers and independent experts.

The 30 prioritised SSNB QoC indicators include 27 with metadata and 3 requiring further development; together, they cover all eight standard domains of the WHO quality framework. Among the established indicators, 10 were adopted from existing indicators and 17 adapted. The list contains a balance of indicators measuring inputs (n=6), processes (n=12) and outcome/impact (n=9).

The prioritised SSNB QoC indicators can be used at health facility, subnational and national levels, depending on the maturity of a country’s health information system. Their use in implementation, research and evaluation across diverse contexts has the potential to help drive action to improve quality of SSNB care. WHO and others could use this list for further prioritisation of a core set.

This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control.

This was a retrospective diabetes registry-based cohort study.

Singapore.

Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period.

Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal–Wallis test, respectively.

Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (px 10^-16).

The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.

Non-communicable diseases (NCDs) and their associated risk factors are becoming increasingly prevalent worldwide. NCDs are both a health burden and an economic burden, but many can be prevented by public health interventions that include screening and treatment. The primary objective was to determine the prevalence of NCDs pre-diabetes, suspected diabetes, hypertension and high total cholesterol (TC)/high-density lipoprotein (HDL) ratio, as well as the prevalence of high cardiovascular risk (CVR) in the United Arab Emirates (UAE). The secondary objective was to assess modifiable risk factors for NCDs and investigate correlations between these risk factors and age, sex and emirate of residence.

A health screening programme (HSP) for the early detection and treatment of NCDs was launched in 2021 to screen, diagnose and treat NCDs. This retrospective cross-sectional study analysed HSP data collected from April 2021 to December 2023.

Primary healthcare centres in the UAE.

34 290 participants in the HSP who were screened for the first time.

Of the participants, 60.4% were female, and 51.8% were 18–39 years old. Pre-diabetes was found in 17.3% (95% CI, 16.9% to 17.7%), suspected diabetes type 2 in 6.1% (95% CI, 5.8 to 6.3), hypertension in 13.9% (95% CI, 13.5% to 14.3%), and high TC/HDL ratio in 8.1% (95% CI, 7.8% to 8.4%). A high CVR was found in 11.5% (95% CI, 11.1% to 11.8%) of overall participants and 52.5% (95% CI, 50.5% to 54.5%) of people with diabetes. The OR of high CVR was 11.95 for suspected diabetics. Modifiable risk factors, such as smoking, physical inactivity, overweight and obesity, were all associated with age and sex; in addition, age and sex interacted in their effect on these factors.

The prevalence of the four NCDs and high CVR was high in the northern emirates. High CVR was especially common among people with diabetes. A large majority of participants had one or more modifiable risk factors. Age, sex and their interaction correlated strongly with the modifiable risk factors. These results can guide the introduction of specialised preventive and curative services to enhance public health and well-being.

Sarcopenia, osteoporosis and osteosarcopenia are conditions prevalent in ageing that impair muscle strength and bone density, increasing the risks of fractures, falls, disability and mortality. Recent studies highlight the benefits of milk protein supplementation (MPS) combined with exercises to improve musculoskeletal health in the older population. This systematic review protocol will enable the production of a compilation of evidence that will elucidate the effects of MPS combined with aerobic exercise, resistance exercise or both on the musculoskeletal function of older individuals with these three conditions.

Studies will be selected from electronic databases, including PubMed/MEDLINE, EMBASE, Scopus, Web of Science and the Cochrane Library, without restrictions on language or publication date. The outcomes evaluated will include muscle mass, muscle strength, BMD and physical performance after combined interventions of MPS and physical exercise of any type. The risk of bias will be assessed using the Cochrane Risk of Bias 2 tool. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to classify the certainty of the evidence into four levels: high, moderate, low and very low. Meta-analysis will be performed given the homogeneity of the studies, using random effects methods in the face of the expected heterogeneity. The standardised mean difference (SMD) will be used for continuous data, and the I² index will assess heterogeneity (I² > 50%). Sensitivity analysis, ‘leave one out’ and a strategy for dealing with missing data will be carried out. Statistical analysis will be conducted using the STATA 18 software with a 95% CI and p

Formal ethical approval will not be required as primary data collection will not be performed. The results will be disseminated through peer-reviewed publications and presentations at conferences dedicated to the relevant field of study.

CRD42024555933.

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.