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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.

Understanding Canadian experiences of suicidality during the COVID-19 pandemic: protocol of a pan-Canadian qualitative study

Por: Baharikhoob · P. · Hollenberg · E. · Cuperfain · A. B. · Rudoler · D. · Nicoll · G. · Blumberger · D. · Bolton · J. · Chartier · G. B. · Crawford · A. · Furqan · Z. · Gajaria · A. · Gratzer · D. · Hatcher · S. · Husain · M. I. · Kurdyak · P. · Lam · J. S. H. · Lavergne · M. R. · Marshall
Introduction

The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

Methods and analysis

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

Ethics and dissemination

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Hospital discharge planning in cardiac care: study protocol for a mixed-methods study on the implementation, influencing factors and quality of care in Germany

Por: Imhof · L. · Bartels · R. · Blum · K. · Blume · K. S. · Fleischer · S. · Gottschalk · S. · Heber · R. · Horenkamp-Sonntag · D. · Meyer · G. · Remppis · B. A. · Schneider · U. · Schreyoegg · J. · Winter · V.
Introduction

Discharge planning (DP) is essential to ensure continuity of care during patient transitions between inpatient and outpatient settings. Although DP has been legally required for all hospitals in Germany since 2017, several studies show considerable variation in its implementation, likely due to differences in structural characteristics and organisational processes. Both quality and efficiency-enhancing DP processes are particularly important in the context of cardiovascular disease, which is the leading cause of mortality and a major contributor to healthcare costs in Germany. The ‘Ready to Discharge’ (R2D) project investigates the implementation status, influencing factors and outcomes of DP in cardiac units of German hospitals. By integrating quantitative and qualitative data, we aim to identify best practices and provide actionable recommendations for improving DP processes.

Methods and analysis

A mixed-methods study design will be used. Quantitative analyses will be based on primary data from hospital and patient surveys combined with secondary data from health insurance claims and hospital quality reports. Key outcome measures will include healthcare utilisation outcomes (eg, readmissions, emergency department visits), patient health status outcomes (eg, patient satisfaction, self-rated health) and medication-related outcomes (eg, medication adherence). Qualitative interviews with healthcare professionals will enrich the findings by providing insights into barriers and facilitators to DP.

Ethics and dissemination

This study was approved by the Ethics Committee of Bergische University of Wuppertal and the German Federal Office for Social Security. Informed consent will be obtained for all primary data collections. Hospital managing directors will be informed prior to the hospital survey and will be able to withdraw consent. Patients can withdraw their consent at any time. Secondary data will be analysed in pseudonymised form to ensure patient confidentiality. Results will be disseminated through workshops, regional and international conferences and peer-reviewed publications.

Association of part-time clinical work of hospitalists with efficiency and quality of care on medical wards: a retrospective study

Por: Bretagne · L. · Roten · C. · Mosimann · S. · Blum · M. R. · Debieux · M. · Martin · A. · Kraege · V. · Beck · T. · Aujesky · D. · Mancinetti · M. · Mean · M. · Baumgartner · C.
Background

Physicians are increasingly interested in part-time employment. However, the impact of part-time work on efficiency and quality of care of inpatients is unknown.

Objectives

To investigate the association between part-time clinical work of hospitalists in General Internal Medicine (GIM) and resource utilisation and short-term patient outcomes.

Design

Retrospective study.

Setting

GIM wards of 3 Swiss teaching hospitals.

Participants

Each inpatient was categorised as having received care mainly (>50%) by part-time or full-time hospitalists. Part-time clinical work was defined as employment of

Primary and secondary outcome measures

Primary outcome was length of hospital stay, secondary outcomes included 30-day readmission, in-hospital mortality, hospitalisation cost and time to completion of the discharge letter. We assessed the association between both groups and outcomes using generalised estimating equations, clustering for individual patients and adjusting for patient and hospitalist characteristics.

Results

There was no statistically relevant difference in length of stay in cases cared for mainly by part-time (mean 7.3 days, 95% CI 7.1 to 7.6) compared with full-time hospitalists (mean 7.6 days, 95% CI 7.3 to 7.8; p=0.18). Time to completion of the discharge letter was longer in the part-time (mean 11.4 days, 95% CI 11.0 to 11.8) versus full-time group (mean 10.9 days, 95% CI 10.6 to 11.2, p=0.049). There was no statistically significant difference between groups for the other outcomes.

Conclusion

We found no evidence that part-time clinical work of hospitalists negatively affects resource utilisation and short-term patient outcomes compared with full-time work.

Coronary atherosclerosis screening in asymptomatic adults using coronary artery calcium for cardiovascular prevention: a systematic review of randomised controlled trials and prospective cohorts

Por: Scheu · V. · Alwan · L. · Gräni · C. · Gencer · B. · Rodondi · N. · Blum · M. R.
Objectives

To review the available evidence of screening for atherosclerosis in adults in a primary prevention setting with coronary artery calcium scoring (CACS) on the impact on cardiovascular (CV) risk factor control, health behaviour and clinical events.

Design

Systematic review, reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

We searched MEDLINE, Embase and Cochrane Central Register of Controlled Trials through 22 January 2025.

Eligibility criteria

We included randomised controlled trials (RCTs) and prospective cohorts, without language restrictions, comparing adults without cardiovascular diseases undergoing CACS to a control group that either did not undergo CACS or where the participants and physicians were blinded to its result. Outcomes included changes in CV risk factor control, CV therapy, changes in health behaviour at follow-up and clinical events (all-cause and CV mortality and non-fatal CV events).

Data extraction and synthesis

Two independent reviewers extracted data and assessed the risk of bias. Due to substantial heterogeneity among the included studies, a quantitative analysis was not possible.

Results

We identified seven RCTs and one observational study, with participants ranging from 56 to 43 447 with a total of 51 554. Populations were heterogeneous with a mean age range of 42–64 years, % women ranging from 21% to 100% and mean baseline CACS from 1.37 to >100 Agatston units. Interventions following CACS were also heterogeneous, ranging from simply communicating results to participants to initiating statin therapy for detectable CACS. One RCT demonstrated improvement regarding blood pressure (BP) (n=2137; change in systolic BP: CACS: –5 mm Hg; control: –7 mm Hg; p=0.02), several an improvement in blood lipids between groups (five studies, n=3693; eg, low-density lipoprotein (LDL) cholesterol: range –6.0 to –4.9 mg/dL). Results regarding CV medication (seven studies, n=51 104) were more discrepant, with some studies showing a decrease and others an increase in indication for or usage of CV medication. Three trials (n=3338) investigated adherence to CV medication, with only one showing increased adherence to statins (CACS: 63.3%; control: 45.6%; p=0.03). Five trials (n=3692) investigated behavioural changes, with one showing an increased motivation to change lifestyle (CACS: 94%; control: 62.8%; p=0.002) and another a higher adherence in self-reported physical activity (CACS: 96%; control: 59%; p

Conclusions

CACS screening with a CACS-guided intervention might have a favourable effect on CV risk factor control and potentially on adherence to CV medication and increased motivation to change lifestyle in populations at intermediate to high risk. The available evidence is insufficient to determine whether screening asymptomatic patients with CACS has an impact on all-cause mortality or CV events. Despite its known strengths in predicting outcomes in individual patients, more evidence regarding the impact on clinical outcomes is needed to determine the clinical use of CACS for screening purposes in asymptomatic patients.

PROSPERO registration number

CRD42022377727.

Characterizing suicidal thoughts and behaviours in individuals presenting to a psychiatric emergency department: a protocol for a multimethod approach for suicide prevention research

Por: Baharikhoob · P. · Maslej · M. · Wong · A. H. C. · Mulsant · B. · Blumberger · D. · Courtney · D. · Husain · M. I. · Kurdyak · P. · Kleinman · R. A. · Torfason · A. · Gajaria · A. · Diaconescu · A. · Ma · A. · Sonley · A. · Abramovich · A. · Crawford · A. · Petronis · A. · Fage · B. · Orch
Introduction

Identifying individuals at risk of suicide remains an ongoing challenge. Previous research investigating risk factors for suicidal thoughts and behaviours (STB) has been informative for assessing suicide risk. However, the complex biological, psychological and sociocultural factors underlying STB have not been comprehensively captured to date, which has limited our understanding of how these factors interact to influence STB. Moreover, acute care settings, such as emergency departments (EDs), are often first points of contact for individuals with STB, highlighting a need for more research in these settings.

Methods and analysis

We aim to (1) characterize a cohort seeking care for STB and their clinical trajectories; (2) situate the cohort by comparing its characteristics and outcomes to other groups seeking emergency care; (3) explore their experiences of seeking care; and (4) examine blood-based biomarkers modulating risk for STB. Using a multimethod, prospective cohort design, we will follow up to 500 people aged 16 or older presenting to the ED with STB at a psychiatric hospital over 1 year. Analyses will involve descriptive statistics and latent profile analysis to characterize the cohort, hypothesis tests and regression models to situate the cohort, qualitative analysis based on a realist research framework to understand experiences, and within-participant comparisons of proteins, mRNA and epigenetic DNA modifications to examine biomarkers of contrasting states of STB.

Ethics and dissemination

This study was approved by the hospital’s Research Ethics Board with safeguards in place to ensure the well-being of participants and research team. An integrated knowledge translation approach will be used for dissemination, wherein patient and family advisors are engaged throughout each study phase. Findings will enhance our understanding of the multifactorial nature of suicide risk, inform strategies for prevention and provide important insights into characteristics, experiences and outcomes of individuals with STB, who are under-represented in mental health research.

Best Practices in Supporting Inpatient Communication With Technology During Visitor Restrictions: An Integrative Review

imageBackground Since the onset of the COVID-19 pandemic, healthcare workers around the world have experimented with technologies to facilitate communication and care for patients and their care partners. Methods Our team reviewed the literature to examine best practices in utilizing technology to support communication between nurses, patients, and care partners while visitation is limited. We searched four major databases for recent articles on this topic, conducted a systematic screening and review of 1902 articles, and used the Johns Hopkins Nursing Evidence-Based Practice for Nurses and Healthcare Professionals Model & Guidelines to appraise and translate the results of 23 relevant articles. Results Our evaluation yielded three main findings from the current literature: (1) Virtual contact by any technological means, especially video visitation, improves satisfaction, reduces anxiety, and is well-received by the target populations. (2) Structured video rounding provides effective communication among healthcare workers, patients, and offsite care partners. (3) Institutional preparation, such as a standardized checklist and dedicating staff to roles focused on facilitating communication, can help healthcare workers create environments conducive to therapeutic virtual communication. Discussion In situations that require healthcare facilities to limit visitation between patients and their care partners, the benefits of virtual visitation are evident. There is variance in the types of technologies used to facilitate virtual visits, but across all of them, there are consistent themes demonstrating the benefits of virtual visits and virtual rounding. Healthcare institutions can prepare for future limited-visitation scenarios by reviewing the current evidence and integrating virtual visitation into modern healthcare delivery.

Effects of a mattress cover with special airflow technology on the structure and function of the sacral and heel skin during loading: A two‐arm exploratory crossover trial

Abstract

Prolonged mechanical loading of the skin and underlying soft tissue cause pressure ulceration. The use of special support surfaces are key interventions in pressure ulcer prevention. They modify the degree and duration of soft tissue deformation and have an impact on the skin microclimate. The objective of this randomized cross-over trial was to compare skin responses and comfort after lying for 2.5 h supine on a support surface with and without a coverlet that was intended to assist with heat and moisture removal at the patient/surface interface. In addition, physiological saline solution was administered to simulate an incontinence episode on the mattress next to the participants' skin surface. In total, 12 volunteers (mean age 69 years) with diabetes mellitus participated. After loading, skin surface temperature, stratum corneum hydration and skin surface pH increased, whereas erythema and structural stiffness decreased at the sacral area. At the heel skin area, temperature, erythema, and stratum corneum hydration increased. These results indicate occlusion and soft tissue deformation which was aggravated by the saline solution. The differences in skin response showed only minor differences between the support surface with or without the coverlet.

Best practices for implementation of Kamishibai cards in the healthcare setting to improve nursing‐sensitive indicator associated outcomes: An integrative review

Abstract

Background

Many adverse events are identified as nursing-sensitive indicators (NSIs) and have evidence-based care bundles known to reduce risk of occurrence. Kamishibai cards are a tool from the manufacturing industry used for practice auditing and improvements. Use of Kamishibai cards is believed to be common in the healthcare setting, but true evidence-based guidelines do not yet exist to guide their implementation.

Aims

The aim of this integrative review was to identify best practices around the implementation of Kamishibai cards in the healthcare setting for improvement in NSI-associated outcomes.

Methods

Eleven nurses at three facilities worked through the evidence using the Johns Hopkins Evidence-Based Practice Model.

Results

Ten articles were included for this review. Broad themes included direct observation with non-punitive and timely feedback, clearly visualized results, use of evidence-based care bundles, pre-implementation education, and both leadership and frontline-staff involvement. All facilities showed improvement in NSI-associated outcomes after the implementation of K-cards.

Linking Action to Action

In health care, K-cards can be implemented and designed with additional focus on the bundles of care they are intended to audit and staff support, but further evidence would better define guidelines around implementation.

Adoption of evidence‐based end‐of‐life and bereavement support to families in cancer care: A contextual analysis study with health professionals

Abstract

Aims

To investigate the level of adoption of evidence-based family engagement and support during end-of-life cancer care and subsequent bereavement and its contextual facilitators and barriers from health professionals' perspectives, and to explore differences between professional groups.

Design

Contextual analysis using an online cross-sectional survey.

Methods

This study was conducted in four Swiss hospitals and three home care oncology and palliative care services. Non-parametric testing was used to investigate the level of adoption and differences between nurses, physicians, occupational- and physiotherapists and psychosocial professionals (chaplains, onco-psychologists and social workers). The STROBE checklist for cross-sectional studies was followed.

Results

The majority of the 111 participating health professionals were nurses. Adoption was statistically significantly higher during end-of-life care than bereavement, with nurses and physicians reporting higher levels than the other professional groups. Guidance on end-of-life family care was available in about half of the cases, in contrast to a quarter for bereavement care. Self-perceived knowledge, skills and attitudes were moderate to high, with nurses and physicians reporting higher levels than others, except for general skills in working with families. Organisational structures were experienced as rather supportive, with the psychosocial group appraising the organisational context as significantly less conducive to fully implementing end-of-life and bereavement care than others, particularly during the end-of-life phase.

Conclusion

Evidence-based family engagement and support were better adopted during end-of-life care than bereavement. Overall, nurses and physicians felt better enabled to care for families compared to other professional groups.

Patient or Public Contribution

No patient or public contribution.

Protocol registration

https://osf.io/j4kfh.

Implications for the profession and/or patient care

Implementation and quality improvement efforts should focus particularly on the bereavement phase and be tailored to professional groups.

Impact

The findings show that evidence-based family engagement and support practices during end-of-life were rather well adopted in contrast to subsequent bereavement care, with nurses and physicians better enabled than other professionals to provide care. A better understanding of health professionals' contributions and roles in family care is important to build interprofessional capacity for evidence-based end-of-life and bereavement support.

Reporting Method

The STROBE checklist for reports of cross-sectional studies was followed (von Elm et al., 2007).

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