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Ayer — Octubre 2nd 2025Tus fuentes RSS

New regimens of benznidazole for the treatment of chronic Chagas disease in adult participants in indeterminate form or with mild cardiac progression (NuestroBen study): protocol for a phase III randomised, multicentre non-inferiority clinical trial

Por: Marques · T. · Forsyth · C. · Barreira · F. · Lombas · C. · Blum de Oliveira · B. · Laserna · M. · Molina · I. · Bangher · M. d. C. · Javier Fernandez · R. · Lloveras · S. · Fernandez · M. L. · Scapellato · P. · Patterson · P. · Garcia · W. · Ortiz · L. · Schijman · A. · Moreira · O. C.
Introduction

Chagas disease (CD) is one of the most neglected diseases in the world. In Latin America, CD is endemic in 21 countries, with an estimated 70 million people at risk of infection. Current treatments are limited to two nitroheterocyclic compounds: nifurtimox and benznidazole (BZN). Each has significant limitations, including long duration and safety concerns. However, data from recently completed studies suggest that reduced-duration regimens may be equally effective while enhancing safety.

Methods and analysis

NuestroBen is a phase III, randomised, multicentre clinical trial designed to assess whether shorter (2- and 4-week) regimens of BZN are non-inferior to the standard 8-week treatment. A total of 540 adult participants with no evidence of organ damage (the indeterminate form) or with mild cardiac progression (mild electrocardiographic alterations and without systolic dysfunction or symptoms), all in the chronic phase of CD, will be recruited at six study sites in Argentina and two study sites in Bolivia. Participants will be randomised to receive one of the two shortened regimens of BZN (300 mg per day for 2 or 4 weeks) or standard treatment (300 mg per day for 8 weeks). The primary endpoint is sustained elimination of parasitaemia from the end of treatment through 12 months of follow-up. Secondary endpoints will assess sustained clearance of parasitaemia at 1, 4, 6 and 8 months of follow-up from the end of treatment, drug tolerability and adherence to treatment. NuestroBen will also evaluate whether two shortened regimens of BZN improve drug tolerability and treatment adherence compared with the current standard treatment while maintaining efficacy in participants with the indeterminate form of CD or with mild cardiac involvement.

Ethics and dissemination

In Argentina, this study was approved by Fundación de Estudios Farmacológicos y Medicamentos ‘Luis M. Zieher’ for its conduct at the Instituto de Cardiología de Corrientes ‘Juana Francisca Cabral’ (reference: NuestroBen-2020/2021) and the Instituto Nacional de Parasitología ‘Dr. Mario Fatala Chaben’ (reference: NuestroBen-2020/2021) by Comité Institucional de Ética de Investigación en Salud for the Centro de Chagas y Patología Regional de Santiago del Estero (reference: NuestroBen-2020-088/2021), by Comité de Ética en Investigación for the Hospital de Infecciosas F.J. Muñiz (reference: NuestroBen-2020–4037) and the Hospital General de Agudos D.F. Santojanni (reference: NuestroBen-2020–4039) and by Comité de Bioética for the Fundación Huésped (reference: NuestroBen-2020/2021). In Bolivia, it was approved by Comité de Ética en Investigación en Salud from the Universidad Autónoma Juan Misael Saracho (reference: NuestroBen-2020/2025). All participants are asked to provide written informed consent to participate. Recruitment processes started in July 2023, and as of 15 June 2025, 140 participants have been recruited. Findings will be shared with Argentinian and Bolivian public health officials and with the Chagas and tropical medicine communities via international conferences. Findings will also be published in medical journals.

Trial registration number

NCT04897516.

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Effects of an early behavioural change strategy following COPD exacerbation in hospital and outpatient settings in Brazil: protocol for a randomised clinical trial on cardiovascular risk, physical activity and functionality

Por: Kawakami · D. M. d. O. · Karloh · M. · Araujo · G. H. G. · Colucci · M. G. · Pires Di Lorenzo · V. A. · Mendes · R. G.
Introduction

Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.

Methods and analysis

This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p

Ethics and dissemination

This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.

Trial registration number

Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.

Trajectories of Recovery after Intravenous propofol versus inhaled VolatilE anaesthesia (THRIVE) randomised controlled trial in the USA: A protocol

Por: Tellor Pennington · B. R. · Janda · A. M. · Colquhoun · D. A. · Neuman · M. D. · Kidwell · K. M. · Spino · C. · Thelen-Perry · S. · Krambrink · A. · Huang · S. · Ignacio · R. · Wu · Z. · Swisher · L. · Cloyd · C. · Vaughn · M. T. · Pescatore · N. A. · Bollini · M. L. · Mashour · G. A.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT05991453.

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT): protocol for a randomised controlled trial in adult trauma inpatients with painful rib fractures

Por: Kotcher · R. E. · Rosengart · M. R. · La Colla · L. · Lin · H.-H. S. · Vogt · K. M. · Xu · Y. · Neal · M. D.
Introduction

Blue light (peak wavelength 442 nm) has been shown to modulate the immune response in preclinical models of intra-abdominal sepsis and pneumonia. In vivo pathways involve optic nerve stimulation with transmission to the central nervous system, activation of parasympathetic pathways terminating at the spleen, and downstream immune effects including decreased inflammatory tissue damage and improved pathogen clearance. Related effects on pain mediators including proinflammatory cytokines (interleukin 6, TNF- α) and autonomic tone (increased parasympathetic outflow) suggest possible analgesic properties that would be highly relevant to a trauma population.

Methods and analysis

This is a randomised controlled trial in which adult trauma inpatients (18 years) with painful rib fractures will be allocated 1:1:1 to three arms: bright blue light intervention (peak 442 nm, ~1400 lux), bright full-spectrum light comparison (~1400 lux) and usual ambient light control. Bright light exposures will be administered for 4 consecutive hours daily for up to 3 days. The primary outcome will be any measurable changes in chest wall pain intensity during deep breathing, quantified using an 11-point Numerical Rating Scale. Secondary outcomes will assess chest wall pain intensity at rest, opioid requirements, delirium incidence, pulmonary complication incidence, hospital-free and intensive care unit-free days, and physiological markers of autonomic nervous system, circadian, and immune activation. Sample size analysis yields a total of 75 participants needed to detect a 2-point difference in pain scores with >80% power and assuming a 20% non-completion rate.

Ethics and dissemination

Full ethical approval for this trial has been granted by the University of Pittsburgh Institutional Review Board. On study completion, results will be published in the peer-reviewed literature and at ClinicalTrials.gov.

Trial registration number

NCT06626334.

Catch-up growth following early-life stunting in a low-resource area in rural Tanzania: the MAL-ED Metabolic study

Por: Nemati · K. · Michael · Y. Z. · Hhando · B. P. · Jatosh · S. · Houpt · E. R. · Mduma · E. · DeBoer · M. D.
Background

Poor linear growth over time can lead to stunting, a significant public health problem in low-resource settings. Catch-up growth, the process of accelerated growth following growth faltering, is important for mitigating the long-term impacts of early stunting. This study aimed to identify key predictors of growth over time, stunting and catch-up growth among children in rural Tanzania.

Methods

We evaluated 182 children from the Etiology, Risk Factors, and Interactions of Enteric Infections and Malnutrition and the Consequences for Child Health and Development cohort, whose anthropometric measurements were collected at six points from birth to 11.5 years. We assessed outcomes of height-for-age z-score (HAZ), stunting and catch-up growth using mixed-model linear and logistic regression to assess associations of maternal education, household income, socioeconomic status, insulin-like growth factor 1 (IGF-1) and thyroid function tests. We defined stunting as HAZ ≤–2 and catch-up growth both as stunting resolved from age 2 years to 11.5 years and a HAZ increase of >0.5 from 2 years to 11.5 years.

Results

Cohort participants exhibited a moderate amount of catch-up growth, with per cent stunting decreasing from 72.6% at 2 years to 39.0% at 11.5 years. Maternal education, household income, socioeconomic status and IGF-1 were positively associated with HAZ (eg, IGF-1 point estimate 0.141±0.067, p=0.036) and negatively associated with odds of stunting across time points, while thyroid-stimulating hormone was negatively associated with HAZ and positively associated with odds of stunting (all p

Conclusions

These findings highlight the need for comprehensive interventions that address socioeconomic, hormonal and biological factors to promote catch-up growth and reduce stunting in resource-limited settings. The results offer valuable insights towards improving child health outcomes in similar contexts.

Trial registration number

NCT02441426 (post-results) and NCT05121935.

Self-directed arm-crank exercise to improve volitional control of the trunk in patients with subacute spinal cord injury: a multicentre, parallel-group, randomised controlled trial protocol

Por: Hidalgo Mas · M. d. R. · Kearney · J. · Middleton · V. · Chiu · C.-Y. · Duda · J. L. · Nightingale · T. E. · Martinez-Valdes · E. · Ahmed · Z. · Chiou · S.-Y.
Introduction

A spinal cord injury (SCI) disrupts synaptic connections between the corticospinal tract and motor neurons, impairing muscle control below the injury site. Many individuals with an SCI have impaired trunk control, affecting the performance of activities of daily living and quality of life. Work has shown improvements in trunk control after home-based, unsupervised arm-crank exercise training (ACET) in people with chronic motor-incomplete SCI. However, no studies have examined ACET’s impact on trunk control in individuals with subacute SCI. This study aims to investigate ACET’s effects on trunk control in adults with subacute incomplete SCI, and its mechanisms, and its long-term benefits on neuropathic pain, psychological well-being, physical activity levels and health-related quality of life.

Methods and analysis

This multicentre, parallel-group, randomised controlled trial will evaluate self-directed ACET in 60 individuals with subacute SCI (

Ethics and dissemination

This study was approved by The Health Research Authority and Health and Care Research Wales (22/NS/0054). Results will be published in peer-reviewed journals. Findings will be presented at National and International conferences for researchers and clinicians. Finally, results will be disseminated to the SCI community.

Trial registration number

ISRCTN17247972

Association between self-reported vision and mental well-being: a cross-sectional secondary analysis of Health Survey for England data

Por: Crossland · M. D. · Dekker · T. M. · Tibber · M. S.
Objectives

Eye disease and vision impairment are known to be associated with reduced mental well-being, but less is known about the well-being of people with near-normal levels of vision. Here, we examined the association between self-reported eyesight and mental well-being, controlling for eye disease, mental ill-health and demographic factors, for adults with a wide range of age and vision.

Design

Population-based cross-sectional study.

Participants

7705 adults (56% women; median age 49 years, range 16–104 years) who participated in the Health Survey for England 2013, self-reported their eyesight status and completed the Warwick-Edinburgh Mental Well-Being Scale.

Primary outcome measure

Mental well-being, controlling for self-reported mental ill health, self-reported eye disease, age, sex, socioeconomic group and ethnic origin.

Results

Poorer self-reported eyesight was strongly associated with lower mental well-being (univariate linear model, F(4,7700)=94.7, p2=0.047). Relative to reporting ‘poor’ vision, each subsequent level of vision predicted better well-being, with the exception of ‘fair’ vision, which was not significantly different from ‘poor’ reported vision. This association remained significant after controlling for self-reported mental ill health, self-reported eye disease, age, sex, socioeconomic group and ethnic origin.

Conclusions

Self-reported eyesight is strongly associated with mental well-being, irrespective of whether people have vision impairment or a diagnosed eye disease. This relationship exists in people with and without mental ill-health. Mental well-being should be considered in people with reduced eyesight, regardless of whether they have a diagnosed eye disease or mental ill-health. Interventions which improve vision may have a positive impact on mental well-being.

Frailty, quality of life and nutritional status for the prediction of morbidity and mortality in individuals with chronic heart failure in southern Brazil (FPROHEART): a cohort study protocol

Por: Nascimento · D. M. d. · Wolffenbüttel · P. I. · Goldraich · L. A. · Schaan · B. · Clausell · N.
Introduction

Heart failure (HF) is a debilitating condition associated with high morbidity, mortality and healthcare resource use. Frailty in HF patients is associated with poorer outcomes, including increased morbidity, mortality and reduced quality of life (QoL). Nutritional disorders, such as malnutrition, are common in patients with HF and contribute to functional decline and increased mortality. The Meta-Analysis Global Group in Chronic HF (MAGGIC) risk score was developed to predict 1-year and 3-year hospitalization and mortality in patients with HF. This study aims to assess the added value of frailty, QoL and nutritional status to the MAGGIC risk score.

Methods and analysis

This prospective cohort study, conducted at a tertiary public hospital in southern Brazil, will include 316 patients with chronic HF who are followed up at the HF Outpatient Clinic. Frailty will be assessed using the Fried scale, health-related QoL will be assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and nutritional status will be assessed using the Mini Nutritional Assessment. These variables will be incorporated into the MAGGIC risk score. Continuous variables with a normal distribution will be described as mean±SD, skewed variables as median±IQR and categorical variables as absolute and relative frequencies. Survival analysis will be performed using the Kaplan-Meier method with log-rank test comparisons. The prognostic value of frailty, its components, the MLHFQ score and nutritional status will be assessed by Cox regression, which will be adjusted for the MAGGIC risk score. Net Reclassification Improvement and Integrated Discrimination Improvement will assess the accuracy of the MAGGIC score when including frailty, MLHFQ and nutritional status. A p value

Ethics and dissemination

This study adheres to the Declaration of Helsinki and was approved by the Institutional Committee for Scientific Ethics and Research (No 20220558) and the Brazilian Government Registry (No 66474223200005327). The data will be available on reasonable request from the corresponding author. The results will be disseminated via peer-reviewed manuscripts and shown at national and international conferences.

Current practices for assessing usability of novel point-of-care diagnostics for infectious diseases: a scoping review protocol

Por: Castro · M. d. M. · Ismail · H. M. · Montenegro-Quinonez · C. A. · Reipold · E. I. · Shilton · S. · Denkinger · C. · Yerlikaya · S.
Introduction

Novel diagnostics, particularly point-of-care (POC) tests, play a crucial role in the early detection and management of infectious diseases, especially in resource-limited settings. Ensuring test performance and quality while minimising the risk of human error becomes more relevant when shifting testing tasks from highly controlled settings like centralised laboratories to people with minimal training. Applying usability and human factors engineering principles can reduce the challenges related to human errors. Despite existing frameworks and tools, the practical application of usability guidelines remains variable across different settings.

Methods and analysis

This scoping review protocol outlines a systematic investigation of current practices in assessing the usability of novel diagnostics, particularly POC tests for infectious diseases intended for use in low-income and middle-income countries. The review will analyse original research studies of all designs and product dossiers that report on the usability evaluation or validation of a diagnostic test for an infectious disease. A qualitative synthesis of the data extracted from the articles will be conducted. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols and the Joanna Briggs Institute guidelines for this scoping review.

Ethics and dissemination

No ethical approval is required because individual patient data will not be included. The findings will be disseminated through publication in a peer-reviewed journal.

Are minimum nurse-to-patient staffing ratios needed in hospitals? An observational study in British Columbia, Canada

Por: Lasater · K. B. · Brom · H. · Aiken · L. H. · McHugh · M. D.
Objective

To evaluate staffing conditions, patient outcomes, quality of care, patient safety and nurse job outcomes in British Columbia (BC), Canada hospitals.

Design

Cross-sectional study of 58 hospitals in BC with surveys of nurses and independent measures of patient outcomes.

Setting

58 hospitals in BC.

Participants

6685 hospital-based nurses working in a direct patient care role.

Exposures

Hospital-wide and unit-specific patient-to-nurse staffing ratios derived from registered nurse reports of how many patients and how many nurses were on their unit during their last shift worked.

Main outcomes and measures

Objective patient outcome measures included the Hospital Standardized Mortality Ratio (HSMR) and 30-day Readmission Rate, from 2022 to 2023 Canadian Institute for Health Information data. Nurses4All@BC provided data from 2024 using validated items on multiple measures (eg, nurse burnout, missed health breaks, intentions to leave, quality and safety measures such as culture of patient safety, quality of nursing care, missed nursing care).

Results

Burnout (59.4%), missed health breaks (41.7%), job dissatisfaction (36.0%), intentions to leave (19.3%) and patient outcomes (HSMR mean 95.4, median 96.0, range 26–180; readmission rate mean 10.0%, median 9.5%, range 7.9%–13.8%) were high and varied across hospitals. 68.3% of nurses reported there were not enough staff, and 77.3% reported their workloads were unsafe for patients. 60.6% of nurses gave their hospital an unfavourable patient safety rating. More patients per nurse were associated with poorer hospital mortality and readmission rates, poorer job outcomes for nurses, more adverse events for patients, less favourable ratings of quality of care and patient safety, more missed nursing care and poorer ratings of staffing adequacy and management.

Conclusions

Given the variability in staffing, quality and patient outcomes across BC hospitals, the implementation of a minimum nurse-to-patient ratio policy has the potential to improve patient care safety and retention of nurses.

NutriNet-Brasil, a web-based prospective study on dietary patterns and risk of chronic diseases: cohort profile

Por: Costa · C. d. S. · Gabe · K. T. · dos Santos · F. S. · Leite · M. A. · Quinta · F. P. · Torquato · B. M. d. A. · Martinez Steele · E. · Rauber · F. · Rezende · L. F. M. · da Costa Louzada · M. L. · Levy · R. B. · Monteiro · C. A.
Purpose

Non-communicable diseases (NCDs), such as diabetes, cardiovascular diseases and cancer, are major global public health concerns. Diet quality—particularly the consumption of ultra-processed foods—has been associated with increased risk of NCDs. Traditional cohort studies are often expensive and logistically complex. The NutriNet-Brasil cohort leverages a web-based approach, offering a cost-effective and practical solution for comprehensive data collection and long-term follow-up.

Participants

Recruitments began in January 2020 through mass media, social media campaigns and collaborations with health organisations. Eligible participants are adults (aged ≥18 years) living in Brazil with internet access. Participants complete self-administered online questionnaires covering dietary intake, health status and other health determinants. Dietary assessment is based on the Nova classification system, which categorises foods by their level of processing.

Findings to date

Over 88 000 participants have completed the initial questionnaire. The cohort is predominantly women (79.9%) and highly educated (67.9% had completed higher education). The web-based design enabled the development and application of innovative dietary assessment tools, including the Nova24h and the Nova24hScreener, specifically designed to evaluate food processing levels. These tools have shown good performance in capturing dietary patterns and are central to the cohort’s aim. The online platform facilitates efficient recruitment, data collection and participant retention.

Future plans

NutriNet-Brasil is pioneering the development of web-based cohort methodologies and instruments tailored to food processing research. Future work includes leveraging collaborations with national and international research centres to conduct multidisciplinary analyses and inform public health policies.

Interventions with milk proteins supplementation combined with exercise on musculoskeletal function in older adults with sarcopenia, osteoporosis and osteosarcopenia: a systematic review protocol of randomised controlled trials

Por: Brito · M. D. · Neto · N. J. · Gomes · C. d. S. · Barbosa Sales · W. · Guerra · G. C. B. · Guerra · R. O.
Introduction

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.

Methods/analysis

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

Ethics and dissemination

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.

PROSPERO registration number

CRD42024555933.

Enhancing Aboriginal and Torres Strait Islander research trial leadership and participation: insights from the initial stages of the Australian Fans in Training Project in the Northern Territory of Australia

Por: Brickley · B. · Bonson · J. · Danvers · J. · Ah Mat · J. · Stephensen · P. · McDonald · M. D. · Quested · E. · Maiorana · A. · Pavey · T. · Wharton · L. · Bennett · E. · Smith · J. A.
Introduction

Advancing equity, diversity and inclusion in health research trials is essential for improving health outcomes among priority populations. While evidence increasingly highlights the importance of cultural diversity in research trial leadership and participation, evidence-based strategies for enhancing this remain limited. This article outlines approaches to strengthen Aboriginal and Torres Strait Islander involvement in health research trials, drawing on insights from community engagement at the Darwin (Northern Territory) trial site of the Australian Fans in Training (Aussie-FIT) project.

Methodology

Community engagement at this site aimed to (1) build mutually beneficial relationships with community leaders, specifically Aboriginal and Torres Strait Islander men; (2) codesign engagement standards to enhance the quality of engagement with these leaders and more broadly with local community members and stakeholders. A culturally diverse community advisory group was established, which codesigned engagement standards tailored to community needs and preferences.

Strengths and limitations

While the codesigned standards supported Aboriginal and Torres Strait Islander trial leadership and participation during the trial, the extensive consultation needed to build cross-cultural relationships and develop the standards meant they were finalised only after trial recruitment had ceased. As a result, researchers were unable to fully implement them in the early stages of the trial.

Conclusions

This paper shared and critically discussed approaches used in the early stages of the Aussie-FIT trial to foster more equitable and inclusive practices in research trials. Implementation of these approaches and community-informed recommendations has the potential to enhance research quality, build trust with priority populations and address participation inequities, thus supporting effective trial design and improved health outcomes.

Trial registration number

This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12623000437662).

Right-restricting measures implemented by Public Health Surveillance services during the COVID-19 pandemic: a systematic review protocol

Por: Vivas · M. D. · Correia · T. · Bragagnolo · L. · da Silva · I. A. L. · Tureck · F. · Santos · R. · Kielmann · S. · do Carmo · D. · Avarca · C. · da Silva · F. · Paes · M. · Tofani · L. F. N. · Chioro · A.
Introduction

The COVID-19 pandemic’s unprecedented nature has exposed significant vulnerabilities in most public health systems and highlighted the importance of coordinated responses across various levels of government. A global debate emerged on the types of health measures necessary to curb the rapid spread of contagious and/or lethal diseases. However, some of these measures involved restricting individual rights, raising significant ethical, legal and public health questions. The protocol of this systematic review aims to address a critical gap in the literature by analysing how Public Health Surveillance services worldwide implemented compulsory right-restricting measures during the COVID-19 pandemic, and what impacts these measures had on public health outcomes and individual rights.

Methods and analysis

This protocol focuses on studies about right-restricting measures enacted by Public Health Surveillance services during the COVID-19 pandemic. It will be unrestrictive as to period (starting in 2019, when the outbreak was identified), language or publication status in a preliminary stage. It will include only peer-reviewed publications, discarding opinion articles, editorials, conference papers and non-peer-reviewed publications. Considering the PICo strategy, the research question of this systematic review can be formulated as follows: Problem—right-restricting measures enacted by Public Health Surveillance services; Interest—implementation modalities and impacts on individual rights and public health outcomes; Context—COVID-19 pandemic. This protocol will use the following databases: Pubmed, Cochrane/CENTRAL, Embase, Scopus and Web of Science. Considering the various measures that may have been adopted, the following categories of analysis will be used: (i) Public Health Surveillance as a field, (ii) the various specific areas of Health Surveillance, (iii) law enforcement, (iv) right-restricting measures and consent, (v) interactions between right-restricting measures and routine Public Health Surveillance functions, (vi) differences between countries and (vii) Health Surveillance lessons learnt from the COVID-19 pandemic. These categories are not strictly mutually exclusive; however, each study will be assigned to the category most aligned with its primary focus. To ensure the validity and reliability of findings, each study will have its risk of bias assessed at both the study and outcome levels.

Ethics and dissemination

Patients and the public were not involved in the design, conduct, reporting or dissemination plans of this systematic review. The results will be presented in one or more articles to be submitted to scientific journals and may also be presented at scientific conferences and to public policy makers.

PROSPERO registration number

This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 20 November 2024 (registration number CRD42024613039).

Incidence, progression and predictors of chronic kidney disease among adult HIV/AIDS patients on antiretroviral treatment in comprehensive specialised hospitals in the Amhara Region, Ethiopia, 2022: a multi-centre retrospective follow-up study

Por: Abate · M. D. · Kassa · M. A. · Yilak · G. · Habtie · T. E. · Temesgen · D. · Mulu · B. · Feleke · S. F. · Baylie · A. · Bizuayehu · M. A.
Objective

To assess the incidence, progression and predictors of chronic kidney disease among adult patients living with HIV/AIDS who are receiving antiretroviral therapy.

Design

An institution-based, multicentre retrospective follow-up study was conducted among a randomly selected sample of 535 adult patients. Data were entered into Epi Data version 4.6.0 and analysed using STATA version 14.0. A Cox proportional hazards regression model was fitted to identify independent predictors of chronic kidney disease incidence. Variables with p

Setting and participants

The study was conducted at comprehensive specialised hospitals in the Amhara Region of Ethiopia. Adult patients with HIV/AIDS receiving follow-up antiretroviral therapy between 1 April 2012 and 31 September 2022 were the cohort participants.

Results

Of the 528 adult patients included in the final analysis, 15 (2.84%) developed chronic kidney disease during the follow-up period, resulting in an overall incidence rate of 4.1 per 1000 person-years of observation. Significant predictors of chronic kidney disease included baseline age (adjusted HR (AHR)=1.053; 95% CI, 1.001 to 1.108), serum creatinine (AHR=1.698; 95% CI, 1.302 to 2.215), blood urea nitrogen (AHR=1.031; 95% CI, 1.001 to 1.061) and baseline viral load ≥1000 copies/mL (AHR=3.464; 95% CI, 1.104 to 10.871).

Conclusion

The incidence of chronic kidney disease among adult patients with HIV was clinically significant. Older age, baseline viral load ≥1000 and high blood urea nitrogen and creatinine levels were significant predictors of higher risk. Proactive measures, such as closer kidney monitoring, targeted care for older patients and ensuring optimal viral suppression with effective antiretroviral therapy, can delay or prevent the development of chronic kidney disease.

Developing an evidence brief for policy on implementing deprescribing practices across different levels of healthcare: a protocol

Por: Moura · M. D. G. · Lopes · L. P. N. · de Oliveira · J. C. · Neiva · L. · Fulone · I. · Mazzei · L. G. · Santos · D. M. d. S. S. d. · Lopes · L. C.
Objectives

To identify and contextualise evidence-based strategies for implementing deprescribing practices at different levels of healthcare in Brazil, through the development of an evidence brief for policy that includes stakeholder deliberation and considers barriers, facilitators and equity aspects.

Methods and analysis

This protocol outlines the development of an evidence brief for policy using a mixed-methods design. It involves synthesising evidence for health policies by integrating global research and local evidence through three stages: stakeholder exchange, evidence brief development and external endorsement. The Supporting Policy-Relevant Reviews and Trials tools for evidence-informed health policies will guide both the synthesis of strategies and the facilitation of deliberative dialogues. The synthesis will encompass evidence from systematic reviews and meta-analysis on deprescribing strategies across healthcare levels, focusing on effectiveness, harms, costs, perceptions, barriers, facilitators and equity. Studies proposing strategies not yet implemented will be excluded. Study selection and data extraction will be conducted independently and in duplicate. The methodological quality of included studies will be assessed using the A Measurement Tool for Assessing the Methodological Quality of Systematic Reviews-2 criteria. Synthesised evidence will be used to develop evidence-based strategies, which will then be presented in deliberative dialogues for endorsement by stakeholders and adaptation to the Brazilian context. Endorsement rates will be classified as high, moderate or low based on predefined criteria.

Ethics and dissemination

This study was approved by the University of Sorocaba Research Ethics Committee (certificate 82098324.7.0000.5500). Informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42024548845.

Association between vitamin B12 deficiency and metformin use in type 2 diabetic patients: a cross-sectional study in a South Vietnam tertiary hospital

Por: Phan · H. H. · Nguyen · A. T. T. · Do · M. D.
Objectives

Vitamin B12 deficiency is a common and neglected adverse effect experienced by type 2 diabetic patients treated with metformin. A lack of vitamin B12 may have severe consequences, such as fatigue, macrocytic anaemia and worsened peripheral diabetic neuropathy. This study aims to identify the rate of vitamin B12 deficiency and the associated factors in type 2 diabetic patients treated with metformin.

Design

Cross-sectional study.

Setting and participants

This study involved 145 type 2 diabetic patients treated with metformin in Cho Ray hospital, a tertiary healthcare centre in South Vietnam. The levels of vitamin B12 and associated clinical and paraclinical parameters were measured and collected.

Results

The study population’s mean age was 61.5 years, of which 51.7% were women. The median duration of metformin use was 10 years, and the median metformin dose was 1700 mg. The vitamin B12 deficiency rate was 22.1%. HbA1c, duration of metformin use and metformin dose were independent factors statistically associated with vitamin B12 deficiency.

Conclusions

This study identified the rate of vitamin B12 deficiency and associated factors in type 2 diabetic patients treated with metformin. These findings can be helpful in screening patients and replacing vitamin B12 in high-risk populations with vitamin B12 deficiency.

Trial registration number

Ethical Committee of Cho Ray Hospital (approval number 1711/CN-HĐĐĐ)

Paediatric oncology short learning programmes for nurses: a scoping review

Por: Majamanda · M. D. · Chisoni · F. · Selemani · A. · Kearns · I. · Maree · J.
Objective

This scoping review aimed to map the content, duration, delivery methods and modes of assessment for paediatric oncology nursing education and training programmes.

Design

Scoping review.

Data sources

Published articles were retrieved from Cumulative Index to Nursing and Allied Health Literature, Dimensions, Embase, PubMed and Scopus. Additional articles were identified from the reference list of the included studies.

Eligibility criteria

Articles that described or reported on a paediatric oncology nursing education and training programme, from any setting, published in English from 2012 to 2022.

Data extraction and synthesis

Two reviewers independently screened the titles, abstracts and full texts. Data were extracted using a standardised data extraction tool. Content analysis using basic coding of data was performed. The findings are presented in figures and tables, and the results are described narratively.

Results

This review included 15 articles. Content identified for paediatric oncology education and training programmes included supportive care, chemotherapy, overview of paediatric oncology, management of venous access devices, oncological emergencies, nursing considerations, infection prevention and control, paediatric cancers, patient and family education, communication, ethical legal considerations, grief and bereavement, and overview of haematological cancers. Didactic methods used included traditional face-to-face and virtual approaches to deliver theoretical and practical content. The duration of the programmes ranged from 2 hours to 6 months. Both qualitative and quantitative methods of assessment were used before, during and after the training.

Conclusion

This review offers valuable insights for the development of paediatric oncology education and training programmes for nurses. It provides comprehensive guidance on key content, duration, delivery methods and modes of assessment. However, there is a need to consider context-specific issues and availability of resources when developing the programmes to ensure relevance and sustainability.

Study registration

Open Science Framework (https://doi.org/10.17605/OSF.IO/X3Q4H).

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