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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.

AnteayerTus fuentes RSS

How can post-COVID care be improved using patient experiences with received care and perceived health? A qualitative study of focus groups with 30 patients having post-COVID in the Netherlands

Por: Gruiskens · J. · Gidding-Slok · A. H. · van Meulenbroek · T. · Huijnen · I. · Muris · J. W. M. · Verbunt · J. · van Schayck · O. C. · Burgers · J. S.
Objectives

To provide bottom-up guidance on improving post-COVID care using patients’ experiences with received care and their perceived health

Design

Qualitative study design using focus group interviews

Participants

30 patients with post-COVID condition recruited through purposive sampling based on patient complexity and diversity

Results

Three dimensions for potential improvements of post-COVID care were identified: (1) building, supporting and maintaining patient resilience, (2) redesigning healthcare pathways to meet patient needs and (3) embedding post-COVID care in health systems and organisations. A conceptual framework that could guide improvements in post-COVID care was developed.

Conclusion

This study revealed several opportunities for improving and implementing post-COVID care following a person-centred approach in multidisciplinary integrated care pathways with an integrative vision of health.

Antepartum Anxiety, Dyadic Coping, and Stress Among Chinese Pregnant Couples: The Actor‐Partner Interdependence Mediation Model

ABSTRACT

Introduction

Pregnancy can cause stress for couples, potentially leading to anxiety. However, most studies on antepartum anxiety focus on expectant mothers, ignoring the expectant fathers and the stress transmission between couples. We aim to examine the mediation of dyadic coping between antepartum anxiety and stress in expectant mothers and fathers.

Design

We implemented a cross-sectional study in Guangzhou, China, from October 2023 to January 2024.

Methods

Three-hundred and twenty-nine Chinese pregnant couples completed the Perceived Stress Scale, the Dyadic Coping Inventory, and the State–Trait Anxiety Inventory. The actor-partner interdependence mediation model was used for data analysis.

Results

Expectant mothers experienced antepartum anxiety symptoms at a rate of 42.6%, while the rate for expectant fathers was 32.5%. Regarding the actor effects, stress was positively associated with antepartum anxiety in expectant mothers (β = 0.66, 95% confidence interval CI [0.56, 0.74]) and fathers (β = 0.58, 95% CI [0.42, 0.70]), with dyadic coping acting as a mediator (expectant mothers: β = 0.08, 95% CI [0.03, 0.14]; fathers: β = 0.11, 95% CI [0.04, 0.19]). Regarding the partner effects, maternal dyadic coping was positively associated with paternal stress (β = 0.10, 95% CI [0.01, 0.19]).

Conclusion

The study highlights the interplay of stress, dyadic coping, and antepartum anxiety in expectant mothers and fathers, emphasizing the need to assess their antepartum anxiety and implement couple-centered interventions to enhance their psychological well-being during the first trimester of pregnancy.

Clinical Relevance

This study highlights the importance of assessing antepartum anxiety in both expectant mothers and fathers, emphasizing the mediation of dyadic coping in reducing stress and anxiety. The findings support the integration of couple-centered mental health interventions into routine antepartum care to enhance psychological well-being during pregnancy.

Acceptability, fidelity and implementation of systematic integrated pain management in oncology outpatient services: a process evaluation protocol for a multicentre clustered randomised pilot trial

Por: Robinson · O. C. · Day · F. · Boland · E. G. · Collinson · M. · Fallon · M. · Farrin · A. · Flemming · K. · Girvan · S. · Hartup · S. · Meads · D. · Hurlow · A. · Mayland · C. · ODwyer · J. · Pini · S. · Swinson · D. · Richards · S. H. · Mulvey · M. R.
Introduction

In the UK National Health Service (NHS), most people with cancer are cared for at oncology outpatient services, where there are no standardised procedures for managing pain. As a result, patients with cancer may receive inadequate care for pain. The Cancer Pain-assessment Toolkit for Use in RoutinE oncology outpatient services aims to assess the feasibility of conducting a multicentre cluster-randomised trial of a systematic pain assessment and management programme integrated within routine care at UK NHS oncology outpatient services. This protocol describes an embedded process evaluation that aims to evaluate the acceptability, fidelity and implementation of the intervention and trial procedures.

Methods and analysis

A combination of methods will be used in the process evaluation. Quantitative data on fidelity and intervention implementation will be collected using case report forms completed at sites, capturing details on training, intervention delivery and adherence. Qualitative data on acceptability and trial experience will be collected through semistructured interviews with intervention recipients (participants), intervention deliverers (healthcare professionals), research nurses and intervention champions. Researcher fieldnotes will also document trial acceptability throughout the trial. Quantitative data will be summarised descriptively. Qualitative data will be analysed using thematic analysis, guided by the framework of acceptability.

Ethics and dissemination

The trial received ethical approval from South Yorkshire Research Ethics Committee and Health Research Authority (21/HRA/5245). Site-specific approvals were obtained from the research and innovation offices at Leeds Teaching Hospital and Hull Teaching Hospital. Trial findings will be disseminated through peer-reviewed publications and via participating sites.

Trial registration number

ISRCTN86926298.

Cost-effectiveness analysis of the Assessment of Burden of Chronic Conditions (ABCC) tool in primary care in the Netherlands

Por: Peters · L. H. · Joore · M. A. · Gidding-Slok · A. H. · Keijsers · L. C. · Twellaar · M. · Boudewijns · E. A. · van Schayck · O. C. · Muris · J. W. · Kimman · M. L.
Objectives

The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.

Design and setting

This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.

Participants

The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.

Interventions

The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.

Outcome measures

Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.

Results

The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.

Conclusion

While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.

Trial registration number

NCT04127383.

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