FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus 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.

Challenges of using and managing medication: a meta-ethnography of the experiences and perceptions of people with intellectual disability and people who support them

Por: Ghosh · I. · Adams · D. · Auguste · P. · Brown · A. · Chaplin · E. · Flynn · S. · Gauly · J. · Gill · P. · Langdon · P. E. · Mahon · D. · Martin · K. · Patterson · S. · Sutherland · D. · Tromans · S. J. · Chen · Y.-F. · Seers · K. · Supporting Medication use In people with a LEarning d
Objective

To explore the challenges experienced by people with intellectual disability, their carers and health and social care professionals when using and managing medication.

Design

A synthesis of qualitative research using meta-ethnography.

Data source

We searched seven databases: MEDLINE, Embase, CINAHL, Science, Social Science and Conference Proceedings Citation Indices (Web of Science), Cochrane Library, PsycINFO and Proquest Dissertations and Theses from inception to September 2022 (updated in July 2023).

Eligibility criteria for selecting studies

We included studies exploring the challenges and perceptions of people with intellectual disability, their carers and health and social care professionals regarding medication management and use.

Results

We reviewed 7593 abstracts and 475 full texts, resulting in 45 included papers. Four major themes were identified: (1) Medication-related issues, (2) navigating autonomy and relationships, (3) knowledge and training needs and (4) inequalities in the healthcare system. We formulated a conceptual framework centred around people with intellectual disability and described the interconnectedness between them, their carers and health and social care professionals in the process of managing and using medication. We identified challenges that could be associated with the person, the medication and/or the context, along with a lack of understanding of these challenges and a lack of capability or resources to tackle them. We developed an overarching concept of ‘collective collaboration’ as a potential solution to prevent or mitigate problems related to medication use in people with intellectual disability.

Conclusions

The effective management of medication for people with intellectual disability requires a collaborative and holistic approach. By fostering person-centred care and shared decision-making, providing educational and practical support, and nurturing strong relationships between all partners involved to form a collective collaboration surrounding people with intellectual disability, improved medication adherence and optimised therapeutic outcomes can be achieved.

PROSPERO registration number

CRD42022362903.

The Effects of Race, Ethnicity, and Maternal Education on Infant Mortality

imageBackground The state of New Jersey has a large Black/African American (AA) versus White racial disparity in infant mortality and educational level at childbirth. This disparity, measured by rate ratio, increases with greater maternal education among varied racial–ethnic groups. The nature of this disparity measured by rate differences has not been explored. Objectives Infant birth and mortality data were used to examine whether racial or ethnic disparities in infant mortality increased with greater maternal education, comparing rate differences and rate ratios. Racial and ethnic variations in the association between maternal education and infant mortality were examined. Methods Data were from the New Jersey State Health Assessment Data for all New Jersey births between 2014 and 2018 stratified by race and ethnicity, maternal education, and infant mortality (n = 481,333). R software was used to create a data set and estimate additive and multiplicative interactions, rate differences, and rate ratios for infant mortality by maternal race/ethnicity and educational levels among four racial–ethnic groups. Results Infant mortality was significantly greater for Black/AA and Hispanic mothers than for White mothers. At all educational levels, Black/AA mothers had the highest prevalence of infant mortality compared to other racial or ethnic groups. Rate differences in infant mortality showed a decrease in Black/AA–White differences for mothers with a high school education or less compared to mothers with a college degree. However, rate ratios showed an increase in Black/AA–White ratio with increasing education levels for mothers with high school education or less than mothers with a college degree. Risk ratios comparing infant mortality for Black/AA versus Hispanic or Asian mothers showed more than a twofold greater risk at all education levels for Black/AA infants. Finally, college-educated Black/AA mothers had significantly higher rates of infant mortality than White or Hispanic mothers with a high school education or less. Discussion/Implications Black/AA mothers with a college degree had a higher infant mortality rate than White, Hispanic, or Asian mothers with a high school education or less. Future research should address contextual/systemic contributors to this disparity.

Feasibility, Acceptability, and Preliminary Effectiveness of a Sleep Intervention in Adults at Risk for Metabolic Syndrome With Short Sleep Duration

imageBackground The prevalence of short sleep duration is rising and is linked to chronic comorbidities, such as metabolic syndrome (MetS). Sleep extension interventions in adults with MetS comorbidities and short sleep duration are limited and vary widely in terms of approach and duration. Objectives This pilot study aimed to test the feasibility and acceptability of a personalized 12-week systematic sleep time extension intervention on post-intervention sleep outcomes in middle-aged adults at risk for MetS with actigraphy-estimated short sleep duration. Methods A single-arm, 12-week, 12-session systematic sleep time extension intervention was delivered weekly via videoconferencing. Feasibility and acceptability were assessed using retention rates and mean sleep diary completions. Sleep was estimated for 14 consecutive days prior to and immediately following the 12-week intervention using wrist actigraphy. Daytime sleepiness was assessed using the Epworth Sleepiness Scale. Paired sample t-tests modeled changes in study outcomes. Results Study participants (N = 41) had a mean age of 52 years and were mostly female and White; 86% attended >80% of sessions, and mean sleep diary completion was 6.7 diaries/week. Significant improvements in sleep from pre- to post-intervention included increased total sleep time, earlier sleep onsets, more regular sleep onsets, a higher sleep regularity index, and reduced daytime sleepiness. Extending sleep, as well as improving sleep timing and regularity in middle-aged adults with actigraphy-estimated short sleep duration and at risk for MetS, is feasible and acceptable. Discussion Behavioral sleep characteristics may be modifiable and present a novel behavioral paradigm for mitigating MetS risk. This pilot study provides a proof of concept for the feasibility, acceptability, and preliminary effectiveness of a systematic sleep time extension for middle-aged adults at risk for MetS with actigraphy-estimated short sleep duration.
❌