Conectar
To qualitatively explore patients’ lived experiences and coping mechanisms following mitral valve replacement (MVR) at the National Cardiac Institute in Tanzania.
A descriptive qualitative study using in-depth interviews and thematic analysis.
The study was conducted at the National Cardiac Institute, located in Dar es Salaam, the sole tertiary cardiac centre in Tanzania offering open-heart surgery.
17 participants were purposively sampled. Inclusion criteria were as follows: patients aged ≥18 years, had at least 28 days post-MVR, without chronic conditions (eg, diabetes and HIV) and attending postoperative cardiac clinics.
Semi-structured interviews conducted in May 2024 using an interviewer guide explored post-MVR challenges, daily life adjustments, patient-provider interactions and coping strategies. Thematic analysis was employed to identify key themes.
Three primary themes emerged: (1) Quality of life after MVR, encompassing physical, social, economic and psychological challenges; (2) Quality of care after MVR, highlighting patient-provider interactions and access to services; and (3) Adapting to post-MVR life, including psychological adaptation and lifestyle modification. Participants reported improved quality of life through shared experiences and support.
Patients experienced physical, socio-economic and psychological challenges post-MVR. However, quality of life improved through access to care, peer support and adaptive coping. Adaptation to life with an artificial valve is feasible with robust support systems, even in resource-limited settings.
Total mesorectal excision (TME) is highly effective for early-stage rectal cancer, but is associated with considerable morbidity, which can substantially impair the quality of life (QoL) of patients. For very early tumours (low-risk cT1), local excision (LE) offers the possibility of organ preservation (OP) with reduced morbidity; however, its application is limited to a selected group. For early tumours where upfront LE is not feasible, primary OP with (chemo)radiotherapy as an alternative to TME surgery has been evaluated in the STARTREC phase II/III studies, which reported promising 1-year OP rates.
The STARTREC-3 trial aims to increase the 2-year OP rate from 60% to 80% in early rectal cancer (cT1–3abN0) and from 30% to 60% in early-intermediate rectal cancer (cT1–3abN1, ≤3 mesorectal nodes measuring ≤8 mm) by intensifying neoadjuvant treatment in different study arms.
STARTREC-3 is embedded in the STARTREC master trial protocol, which uses an adaptive platform study design allowing early termination of inferior treatment arms and the addition of novel arms. The multicentre STARTREC-3 trial investigates three parallel, non-comparative treatment strategies for patients with early and early-intermediate rectal adenocarcinoma who prefer OP over primary TME surgery. All arms start with 5x5 Gy radiotherapy, followed by: an endoluminal boost via contact X-ray brachytherapy (arm 1), an external beam radiotherapy (EBRT) boost by MR-guided EBRT (arm 2) or three cycles of capecitabine oxaliplatin systemic treatment chemotherapy (arm 3). Treatment allocation is predefined and centre-dependent. Response evaluations (MRI and endoscopy) are planned at 14–16 weeks and 26 weeks after onset of radiotherapy. The primary endpoint is the proportion of patients with successful OP at 24 months from onset of therapy. Secondary endpoints include toxicity, QoL, functional and oncological outcomes. Data will be analysed separately for early (cN0) and early-intermediate (cN1) disease. The total planned sample size is 210 patients across the three arms. Interim analyses will be performed for each study arm to determine early failures and discontinue ineffective arms.
The trial was approved by the medical ethics committee NedMec of the Netherlands and is registered in the EU Clinical Trials Information System (CTIS). The results will be published in an international peer-reviewed journal.
CTIS EU 2024-514620-17-00
The Veterans Health Administration (VA) integrated mental and physical health services to better detect and treat depression. Primary care nurses conduct screening annually. Clinicians, including Primary Care Mental Health Integration (PCMHI) specialists, follow-up as needed for treatment. Depression detection and management processes are complex, involve multilevel stakeholders, and are subject to significant disruption from COVID-19 and from the resulting expansion of telehealth, aiming to preserve care access. This study aimed to examine whether the COVID-19 pandemic worsened depression-related care quality and/or patient outcomes (eg, suicide).
Given hypothesised care disruption (lowered care quality) during COVID-19, we will first assess the VA population’s trajectory from a new positive depression (and suicide risk) screen to appropriate treatment (ie, medication, therapy) in the Fiscal Year 2019–2323. We will also examine the changing mix of virtual and in-person depression care delivered. Second, we will use interrupted time series analyses to explore the extent to which psychiatric emergency visits and hospitalisations may be mitigated by clinician detection of depression. As well as compare mental health-related mortality rates between patients detected and not detected to have depression. Subanalyses will reveal where (eg, clinics with low PCMHI access) and for whom (eg, minorities) detection does not systematically occur, and downstream negative sequelae, to guide future intervention. Finally, we will interview 40 veterans, half of whom were detected and half not detected to have depression and 40 VA primary care and PCMHI providers about changes brought on by the pandemic and the expansion of virtual care across three VA facilities. In addition to contextualising disrupted care findings, qualitative data will help identify best practices on patient-to-provider and provider-to-provider interactions in hybrid in-person/telehealth depression care models.
Ethics approval was granted by the VA Greater Los Angeles Healthcare System Institutional Review Board. Alongside journal publications, dissemination activities include briefings to our policy and operational partners, and presentations to clinical, research and policy-oriented audiences.
To explore the perspectives of librarians and information specialists (LIS) on their experience and impact as peer reviewers of systematic reviews (SRs), and on facilitators and barriers to LIS methodological peer review.
Survey and focus groups.
We surveyed LIS who completed a peer review of an SR in a randomised controlled trial conducted in BMJ, BMJ Open and BMJ Medicine from 3 January 2023 to 2 January 2024. The questionnaire sought to understand their experience, what aspects of manuscripts they focused on, perceived impact on editorial decision-making and authors’ revisions and willingness to peer review again. To better understand factors that might impact decisions to review again, we contacted survey respondents to participate in a focus group concentrating on facilitators and barriers to peer reviewing SRs.
88 LIS were eligible for participation. From the survey respondents, 27 LIS who had volunteered were randomly selected and invited to participate in a follow-up focus group.
Of the 88 LIS invited to participate in the survey, 70 (80%) responded. Most respondents had six or more years of experience as an LIS (67/70; 96%) and advising researchers on doing SRs (55/70; 79%) and had peer reviewed for a journal prior to the study (57/70; 81%). Most focused on the search and SR methods when reviewing but also commented on aspects such as research question formulation, plagiarism, study results and conclusions. Two-thirds (44/66; 67%) believed they impacted editors’ decision-making and 59% (39/66) believed they impacted the authors’ revisions. Only three factors were considered extremely or very likely to impact their decision to review again: their schedule and/or lack of time, review turnaround time and their sense of professional duty. 17 LIS (63.0%) participated in a focus group. Time was the primary barrier identified in the focus groups, followed by a sense of intimidation. LIS reported being motivated by feeling valued by editors, the enjoyment of peer reviewing, the desire to improve SR quality and peer review as a learning experience. Several expressed surprise and delight at being asked to peer review for the journals.
LIS may be an underused peer reviewing resource with methodological experience that can help editors make decisions and improve the quality of SRs. Efforts to engage LIS as peer reviewers by journal editors are likely to be well-received when LIS expertise is clearly valued, sought and heeded. We encourage both journal editors and LIS to creatively advance efforts to promote LIS as methodological peer reviewers.
Essential care partners (ECPs), also known as family caregivers, play a critical role in the Canadian healthcare system across the continuum of care, particularly in managing complex conditions like stroke. With the rising number of stroke incidents occurring in Canada each year, there is an increased need for caregiver assistance to help manage the care needs of stroke survivors as they transition to home and community services. Although existing research has highlighted the practical and psychosocial needs of stroke ECPs, these challenges have been mainly overlooked. The lack of integrated intersectoral care services across stroke care pathways places additional significant burdens on caregivers, leading to increased stress, social isolation and a decreased quality of life. Nelson and colleagues’ novel Discharge Assistance and Supports at Home model uses community-based interventions mobilised through intersectoral partnerships and volunteers as human resources to facilitate grassroots solutions to the discharge and transition challenges often faced by stroke survivors. As an extension of this work, this rapid review will investigate and detail community-involved or community-led interventions that have been proven effective in addressing the unmet needs of stroke ECPs during critical care transitions. The findings of this review will identify what works, for whom and in what context regarding community-involved caregiver-centred transition interventions to inform the creation of an actionable Research Agenda—DASH-Caregiver.
This rapid review will be conducted using the updated guidance on methods used in Cochrane rapid reviews of effectiveness. The search strategy will be refined by the study team with assistance from an information specialist and applied to six databases: Medline, Cochrane, Embase, CINAHL and PubMed. Grey literature will be searched using Google search engines, targeted websites and consultation with knowledge holders. Two research team members will conduct a two-stage screening process to determine study eligibility. Data from eligible studies will be extracted using a piloted charting form and synthesised narratively.
This review protocol does not require ethics approval, as no data have been collected or analysed. The results will be shared with key knowledge holders through publications and presentations and incorporated into the team’s future research.
To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.
Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.
Australian training general practices.
3024 GP trainees in community-based vocational training.
The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.
A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.
Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.
This study examined factors associated with the use of Indonesia’s National Health Insurance (NHI) among its beneficiaries in Maluku province.
Cross-sectional study.
The individual-level data were derived from the 2021 Social Health Insurance Sample Data. National health reports of Indonesia were used to provide the district-level variables. We performed multivariable logistic regression analyses to identify factors associated with NHI use among its beneficiaries in Maluku province.
Data were collected from 31 517 NHI beneficiaries registered in Maluku.
The primary outcome was the use of NHI insurance when accessing healthcare services (yes/no).
Only 14.79% of NHI beneficiaries in Maluku had ever used their insurance for healthcare services. Individual factors associated with higher NHI use included being under 60 years, females (adjusted OR (aOR)=1.29, p
Strengthening primary healthcare accessibility, improving the distribution of healthcare workers and addressing socioeconomic and geographical disparities are essential to ensure that the NHI scheme achieves equitable use across all regions in Maluku and other areas with similar settings.
To explore how parents of children with de novo retinoblastoma (RB) experience the diagnostic process and acute treatment phase, and to identify factors that may support parental coping and adaptation.
A qualitative interview study using reflexive thematic analysis.
National Retinoblastoma Unit at Aarhus University Hospital, Denmark.
Thirty-one parents (21 mothers, 10 fathers) of 21 children diagnosed with de novo RB were recruited via hospital follow-up clinics and a support group day.
For most parents, the diagnostic process was short. In cases of diagnostic delay, parents described frustration and guilt due to missed symptoms. Receiving the RB diagnosis was described as a surreal experience, accompanied by feelings of shock, grief and loss of control. Parents faced challenges in adapting to rapid medical decisions and the unfamiliar demands of hospital protocols. However, meeting the clinical experts was a relief, as parents felt they were in capable hands, experiencing empathetic communication and a clearly framed treatment plan. Parents emphasised the importance of support systems, including family, healthcare professionals and the child’s resilience, as crucial for coping with and managing the diagnosis.
Parents faced a sudden and disruptive transition from symptom recognition to life-altering diagnosis and treatment. While professional care and communication were experienced as supportive, they did not eliminate the emotional impact. Clinical pathways should prioritise early validation of parental concerns and provide transparent communication, both prior to referral and throughout treatment. Future research should examine longer-term parental adjustment and identify interventions that support emotional resilience beyond the acute phase.
Mental skills training (MST), which systematically uses techniques to build mental skills, is a popular intervention approach that may benefit dancers. However, information presented in existing MST interventions in dance is dispersed, making it difficult to offer evidence-based recommendations. To address this, the Template for Intervention Description and Replication (TIDieR) can improve transparency and replicability in intervention reporting, thus supporting researchers in assessing existing evidence and enhancing future intervention design. Guided by this framework, the aim of this mixed-methods systematic review was to provide an overview of existing MST interventions in dance and examine (1) the characteristics of effective MST interventions in dance and (2) how the reporting of these interventions aligned with the 12 TIDieR items.
Mixed-methods systematic review.
PsycInfo, Medline, Embase, SportDiscus, Web of Science and the first 30 pages of Google Scholar were searched from database inception until August 2024.
Quantitative, qualitative or mixed-methods approaches investigating MST interventions in which dancers used mental techniques, developed mental skills or enhanced mental qualities to improve physical and mental well-being.
Two reviewers independently screened identified studies in Covidence. Using the TIDieR framework, one reviewer extracted data while a second checked 30% of studies for accuracy. A convergent integrated synthesis was conducted.
Findings from the 21 included studies indicated that intervention effectiveness was determined by characteristics relating to both recipients and deliverers. While TIDieR items describing intervention content were most reported, few studies described fidelity.
Future MST interventions in dance should consider multiple aspects of effectiveness and involve dancers and deliverers in mapping needs, values and outcomes. Structured reporting tools like TIDieR may enhance reporting clarity and intervention replicability.
CRD42024537249.
Photobiomodulation (PBM) has shown promising effects in managing postoperative pain following conventional periapical surgery, although current evidence remains limited. This study aims to assess the effect of PBM on postoperative pain 24 hours after periapical surgery.
A randomised, controlled, double-blind trial will include 34 patients undergoing periapical surgery in the maxillary region, randomly assigned to an experimental group (n=17) or control group (n=17). The experimental group will receive PBM (GaAlAs diode laser, 808 nm, 100 mW, 4 J/cm², applied at five vestibular points) and placebo ibuprofen immediately and 24 hours postoperatively. The control group will receive simulated PBM and active ibuprofen. The primary outcome is postoperative pain assessed by the visual analogue scale at 24 hours. Secondary outcomes include pain at the seventh day, paracetamol intake, oedema, ecchymosis, soft tissue status and temperature at 24 hours and 7 days. Radiographic evaluation of healing will be performed at 1 and 3 months. Statistical analysis will be conducted based on data distribution, using repeated measures ANOVA (Analysis of Variance) or non-parametric equivalents for longitudinal outcomes, and appropriate tests for categorical variables. Significance will be set at p
The study was approved by the Human Research Ethics Committee of Universidad Católica del Uruguay (process no. 220914). Results will be disseminated to participants, healthcare professionals, the public and scientific communities.
Addressing physical inactivity is a promising dementia risk reduction strategy due to its direct benefits for brain health, and indirect benefits for other modifiable dementia risk factors. A potential limitation of previous interventions is that they often overlook how increasing physical activity affects other behaviours throughout the 24-hour day, such as sleep and sedentary behaviour, which are also important for brain health. Further, interventions are rarely tailored to the individual, considering their needs, preferences and constraints that may serve as barriers or facilitators to behaviour change. The current phase I randomised controlled trial, Small Steps, aims to investigate feasibility, acceptability and preliminary effectiveness of a personalised 24-hour time-use intervention to improve lifestyle and cognitive health in older adults.
Participants aged ≥65 years from Adelaide, South Australia will be recruited and randomised to either the Extended or Condensed programme. During the first 12 weeks, participants in the Extended programme will use a tailored website to set personalised weekly goals to move towards their ‘optimal’ 24-hour day for brain health, facilitated by weekly website ‘check-ins’ and weekly phone calls with a research staff member. Participants randomised to the Condensed programme will have access to the website educational resources only but will not undergo personalised goal setting or telephone calls. Following the introductory phase (first 12 weeks), phone calls will be gradually withdrawn for the Extended programme. Primary (feasibility and acceptability) and secondary outcomes (changes in time use, cognitive function and behaviour change metrics) will be assessed 12, 24 and 36 weeks after the beginning of the intervention.
Ethics approval has been obtained from the University of South Australia’s Human Research Ethics Committee (205989). Study findings will be disseminated through peer-reviewed journal articles, conference presentations, media releases and community engagement.
Excessive opioid prescribing after surgery can lead to adverse events and exacerbate the opioid crisis. Patients undergoing outpatient breast surgery are often prescribed opioids to manage pain at home; however, the value of this approach is uncertain. The Postoperative Analgesia Intervention with Non-opioid Alternatives (PAIN Alt) trial will address the following research question: among patients undergoing outpatient breast surgery, does opioid-free analgesia (OFA) result in non-inferior 7-day pain intensity and pain interference in comparison to opioid analgesia (OA)?
This is a parallel, assessor-blind, open-label randomised trial conducted at seven university-affiliated hospitals in Canada. A sample of 540 adult patients (>18 years) undergoing outpatient mastectomy or lumpectomy will be included. Participants are allocated 1:1 to receive OA (around-the-clock non-opioids and opioids for breakthrough pain) or OFA (around-the-clock non-opioids, with adjustment of non-opioid drugs and/or non-pharmacological interventions for breakthrough pain). The co-primary outcomes are 7-day pain intensity and pain interference (measured using the Brief Pain Inventory). Secondary outcomes include adverse drug events, physical and mental health status, satisfaction with pain management, postoperative complications, chronic pain, opioid misuse, persistent opioid use, healthcare utilisation and costs. The primary statistical analyses will follow the intention-to-treat principle and be conducted using mixed-effects modelling.
This trial is coordinated by the McGill University Health Centre (ethics approval MP-37-2024-102530), with ethics approval being sought at all participating sites. Our results will be published in an open-access, peer-reviewed journal, presented at relevant conferences and disseminated to the public through press releases.
To examine the longitudinal impact of time-varying factors on US youth’s trajectories of initiation and use of e-cigarettes and cigarettes during the transition from adolescence to young adulthood.
Longitudinal.
Nationally representative US survey, the Population Assessment of Tobacco and Health (PATH) Study.
2682 US youth (aged 16–17) at wave (W)1 of the PATH Study across six waves (2013–2020) into young adulthood (aged 22–23).
Unweighted longitudinal latent class analyses identified trajectory classes of e-cigarette and cigarette use, separately. Nationally representative weighted multinomial logistic regression analyses examined time-varying harm perceptions, substance use problems and tobacco product first tried as predictors of these trajectory classes.
Five e-cigarette classes (2013–2020; 41.5% Persistent Never Use, 12.6% W5 Initiation, 19.9% W3 Initiation, 15.2% Prior Initiation, 10.8% High Frequency Past 30-Day (P30D) Use) and five cigarette classes (2013–2019; 58.6% Persistent Never Use, 11.5% W4 Initiation, 10.9% W2 Initiation, 9.6% Prior Initiation, 9.5% High Frequency P30D Use) were identified. Time-varying harm perceptions and substance use problems were associated with trajectories of initiation and use for both products. Cigarettes, cigarillos, other combustibles and any smokeless tobacco as first product tried were associated with e-cigarette initiation and/or progression to high frequency use. E-cigarettes and hookah as first product tried were associated with later cigarette initiation. High Frequency P30D Cigarette Use was less likely if the first product tried was e-cigarettes, cigarillos, hookah or any smokeless tobacco product.
Results reinforce the need for identification and intervention of early substance use among younger adolescents and targeted public health messaging to address changing harm perceptions and prevent initiation among older adolescents.
Implementation science research increases the uptake of evidence-based interventions, which may improve health equity among racial and ethnic minorities. However, it is unclear how anti-racism and anti-colonialism practices have been integrated into implementation science research. The objectives of this scoping review are to describe the current conceptualisations of racism and colonialism within the USA, examine racism or colonialism-conscious approaches and analyse gaps in the operationalisation of anti-racism or anti-colonialism within implementation science studies.
This scoping review will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for scoping reviews guidelines. The Center for Chronic Disease Reduction and Equity Promotion Across Minnesota conceptual framework and an implementation science anti-racism lens will guide the study design and analysis. To determine study eligibility for the scoping review, articles will undergo abstract and full-text screening by two independent reviewers and discrepancies will be settled together. Data charting will be extracted from included articles by eight independent reviewers. The search strategy will use controlled vocabulary and natural language keywords related to health equity, health disparities and anti-racism/colonialism on six databases. The scoping review will include studies that applied implementation science theories, models or frameworks among US-based populations. Additionally, included studies will report any of the following implementation activities: implementation strategies, implementation outcomes, adaptations to evidence-based interventions, or evaluations of pre-implementation or implementation context.
No ethical approval was required for the scoping review. Dissemination will be through publication in a peer-reviewed journal and conference presentations.
Genomic diagnostics have accelerated therapeutic and preventative breakthroughs in oncology and cancer genetics. Despite increased access, the implementation of genomics-based care faces serious fragmentation and scalability issues due to a lack of system support. The Precision Care Initiative aims to develop a novel and scalable Precision Care Clinic (PCC). It is designed to coordinate precision medicine in oncology and streamline decision support for referring oncologists and geneticists. The PCC will enhance quality of care through multifaceted, patient-centred communication. It will also improve translational capacity by integrating team expertise in precision oncology, implementation science, clinical informatics, cancer genetics, health economics and patient-reported measures.
This programme uses a type I and type II hybrid effectiveness-implementation trial design sequentially. The complex clinical intervention is precision oncology—matching the targeted treatment or risk management strategy to the right patient, based on their genomic, cancer staging, environmental, lifestyle and biological characteristics, etc. The service intervention is the PCC, providing centralised multidisciplinary review to facilitate shared decision-making with clinicians for the provision of optimal precision oncology care for their patients. The implementation intervention is the co-designed implementation platform—applying evidence-based implementation approaches and Learning Health System principles to enhance feasibility and sustainability. All adult patients across Australia referred to the PCC (n=est. 100–150/year), and healthcare professional interest holders involved in the delivery of precision oncology services, are eligible to participate. Over the study course, phase I involves using a mixed-methods approach to inform iterative co-design and pilot testing of the first PCC with an accompanying implementation platform, and a suite of outcome measures to assess effectiveness; phase II (hybrid type I) includes the implementation of the PCC and evaluation of the outcome measures designed in phase I; phase III (hybrid type II) involves a co-design of local adaptations and testing the effectiveness of the PCC model nationally.
The study received ethical approval from the St Vincent’s Hospital Human Research Ethics Committee (2023/ETH00373). Study results will be presented at relevant conferences and published in peer-reviewed journals.
Intermittent physiological monitoring and early warning scores (EWS) are limited in their ability to detect deteriorating patients in a timely manner. Wearable physiological sensors allow continuous remote monitoring and may be more timely and accurate in the identification of those at risk, compared with manual collection. This study aims to determine if wearable physiological sensors can be used for the early detection of postoperative deterioration, while being acceptable to patients and healthcare staff.
This is a prospective observational cohort study that will recruit adults undergoing major surgery in Benin, India, Ghana, Guatemala, Mexico, Nigeria, Rwanda and the UK. Participants will wear wearable physiological chest and limb sensors before, during and after surgery for up to 10 days or until discharge. In this ‘shadow-mode’ study, continuous physiological observations collected using the devices will not be made available to clinical teams. No changes in participant care will result. Standard of care clinical data will be collected contemporaneously. Continuous sensor data will be used to design algorithms to predict deterioration and specific complications in this population. Usability and feasibility testing, through focus groups, interviews and questionnaires, will be undertaken with healthcare professionals and people undergoing surgery.
Our stakeholder panel are directly involved in all aspects of this study, which will be conducted in accordance with the principles of the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (ICH GCP) in addition to the principles of the ethics committee(s)/Institutional Review Boards (IRBs) who have reviewed and approved this study. Artificial intelligence (AI) prediction models will be reported in accordance with the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis+Artificial Intelligence (TRIPOD+AI) and Developmental and Exploratory Clinical Investigations of DEcision support systems driven by Artificial Intelligence (DECIDE-AI) reporting guidelines frameworks.
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.
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.
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.
Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.
This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.
This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.
This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).
Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is an intensive rehabilitation programme for children with cerebral palsy (CP) delivered in a day camp setting recognised to promote the acquisition of specific functional abilities and independence. Currently, during HABIT-ILE camps, families are minimally involved in their child’s motor learning processes. This explains the challenges reported by both families and therapists, including difficulties in reinforcing skills at home, limited transfer to other functional goals and a lack of confidence in parents’ adaptive competence (self-determination and empowerment). Increasing family involvement in intensive motor rehabilitation programmes and the child’s developmental process by reinforcing skills at home could help reduce the parental impact of the child’s disability, enhance family satisfaction and strengthen their resources to support their child’s daily learning during and after the camp.
To address this, we developed the PARTNER programme, which combines HABIT-ILE with a structured home component focused on parent coaching.
We designed a non-inferiority, mixed-methods, multicentre randomised controlled trial to compare the efficacy at 3 months of the PARTNER programme (35 hours HABIT-ILE+15 hours home programme) with the standard HABIT-ILE programme (50 hours) on the bimanual performance (Assisting Hand Assessment) of children with unilateral CP aged 3–5 years. The secondary aims are to compare the 3-month efficacy of the programmes on occupational performance, functional skills and upper limb activity levels, as well as families’ resources, the parent–child relationship, the quantity and quality of resources available in the home to stimulate the child’s motor development, and parental perceptions of their child’s disability and their child’s abilities (qualitative study). The tertiary aim is to conduct a cost-effectiveness analysis of care consumption in each group up to 6 months after the end of the programmes.
Target recruitment is 66 children (33 in each group) from 3 centres in France. Outcomes will be evaluated before the interventions, immediately after, at 3 months and up to 6 months for the cost-effectiveness analysis. Families in the PARTNER group will receive specific coaching and extensive support to perform the home programme. The coaching will focus on enhancing their resources.
The study protocol has been reviewed, and ethics approval obtained from the Protection of Persons Committee (PPC) (PPC number: 2024-A01051-46). The results from this study will be actively disseminated through manuscript publications and conference presentations.
The Cardiometabolic function in Offspring, Mother and Placenta after Assisted Reproductive Technology (COMPART) study is a prospective cohort study aiming to explore health outcomes in mothers and children following assisted reproductive technology (ART), with a particular focus on frozen embryo transfer (FET) versus fresh embryo transfer (fresh-ET). The increasing prevalence of ART and FET emphasises the need to assess potential health risks associated with the procedures, both in pregnancy, such as pre-eclampsia and large for gestational age offspring, and in the children, such as obesity and cardiometabolic dysfunction.
The cohort will include 600 pregnant women, their potential partner and their offspring in a 1:1:1 ratio of pregnancies achieved after ART with FET, ART with fresh-ET and women who conceived naturally. The study will involve extensive data collection from electronic medical records; parental questionnaires; biochemical, genetic and epigenetic analyses in blood, urine and placental tissue; and medical imaging (fetal ultrasound and PEA POD scan) and clinical examinations. Outcomes are grouped into six work packages (WPs) related to fetal growth (WP1), pregnancy (WP2), placenta (WP3), offspring (WP4), genetics (WP5) and epigenetics (WP6).
The COMPART study aims to provide valuable insights into the impact of ART and FET on maternal and offspring health and the underlying mechanisms responsible. The study seeks to advance reproductive medicine, shape clinical practice and guidelines and ultimately ensure maternal-fetal health following ART. The study has been approved by the Danish Ethics Committee (H-23071266; February 2024).
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