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There is limited research exploring the age-related difference in communication when describing pain experiences. This project aimed to identify key differences between adolescents’, young adults’ and adults’ (i) preferred communication method, (ii) language content and (iii) lexical amount and variety when discussing their persistent pain experience using chatbot technology.
An exploratory concurrent nested mixed-methods design using a comparative analysis.
Participants were recruited through a convenience sampling strategy from two tertiary multidisciplinary pain centres in Australia.
20 adolescents, 20 young adults and 20 adults completed a pain history assessment using the Dolores application. The inclusion criteria for this study were (i) persistent non-cancer pain for at least 3 months, (ii) 10 years of age and over and (iii) adequate expressive and receptive language skills to complete the required tasks in English, as determined by clinicians in the treating team.
Drawn, voice and typed responses provided by participants during the chatbot interaction were analysed using content analysis. Fisher’s exact tests and 2 tests were used to examine differences between age groups. Strong effect size estimates generated from comparative analyses suggested that adolescents were the most likely age group to utilise drawing (p=0.153, Cramer’s V=0.268), preferred typing over speaking (p==0.007, Cramer’s V=0.433). Young adults used the greatest number and variety of words in response to chatbot questions including evaluative language (p=0.097, Cramer’s V=0.296). Adults tended to use more metaphors (p=0.085, Cramer’s V=0.305) and had a strong preference for speaking over typing (p=
The results of this study provide insights into age-related differences in communication and preferences when using technology to communicate about persistent pain. Future research exploring individualised age-related approaches to pain assessment, supported by the findings of this study, in comparison to current standardised assessments administered by clinicians are warranted.
To evaluate the clinical effectiveness of a Nurse Practitioner led procedural support service for children with procedural anxiety, and identify facilitators and barriers to its sustained implementation and optimisation.
An effectiveness–implementation hybrid type 3 study used a prospective mixed methods evaluation approach.
From December 2022 to May 2023, data were collected from children, parents and clinicians using a nurse practitioner-led service at a quaternary paediatric hospital in Brisbane, Australia. A prospective audit assessed clinical outcomes, while qualitative interviews explored implementation barriers and facilitators.
The clinical audit (n = 40) confirmed the service was effective and safe, ensuring procedural completion with minimal distress. Descriptive statistics indicated low pain and anxiety scores. There was a moderate negative relationship between pain scores and the use of distraction techniques. Interviews with thirty-three participants showed the service improved access to procedural care, reduced the need for physical restraint and general anaesthesia, and enhanced clinical workflow through preadmission assessments.
Utilising a Nurse Practitioner support service represents a safe and effective strategy to enhance access for paediatric patients with procedural anxiety.
This study underscores the significance of specialised nursing roles in managing paediatric procedural anxiety, offering a replicable model to enhance procedural outcomes and mitigate medical trauma across healthcare settings.
Minimising pain and distress is important in all clinical encounters with children to reduce the risk of medical-related trauma and the future avoidance of healthcare.
The report of study outcomes was guided by the Standards for Reporting Implementation Studies (StaRI) initiative.
Patients or the public were not included in the design, conduct or reporting of the study.
Understanding contextual drivers of family planning is crucial for designing effective, context-specific policies and programmes. This study aimed to assess (1) the extent to which province-level contextual factors are associated with both coverage and wealth-related inequalities in demand for family planning satisfied by modern methods (mDFPS) across provinces in low- and middle-income countries (LMICs), and (2) whether these factors influence mDFPS at women’s level.
Observational study using multilevel modelling at both ecological and individual levels.
We analysed data from Demographic and Health Surveys between 2011 and 2022 in 46 LMICs.
Ecological analysis included 621 provinces. Individual-level analysis included 302 493 women aged 15–49 years, currently married or in union, and in need of contraception (unweighted).
Demand for family planning satisfied by modern methods (mDFPS) and wealth-related inequalities in mDFPS, assessed using the slope index of inequality (SII) and the concentration index (CIX).
In both income groups, at the province level, higher mean women’s schooling and greater proportion of employed women were positively associated with mDFPS coverage. In contrast, higher male-to-female educational attainment ratios were inversely associated with mDFPS. Provinces with higher means of women’s schooling also showed lower wealth-related inequalities in mDFPS. At the individual level, women residing in provinces with higher male-to-female educational attainment ratios were found to have lower odds of mDFPS, regardless of the income group. Additionally, the factors influencing individual women’s mDFPS varied depending on the income level of the country’s provinces.
Women’s empowerment and gender equality in education at the province level significantly influence family planning outcomes. Targeted interventions that address each region’s specific educational, economic and demographic contexts are crucial for improving coverage and reducing disparities in family planning services.
Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.
To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.
This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.
Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.
ACTRN12624000576527.
by Emmanuel O. Adewuyi, Asa Auta, Olumuyiwa Omonaiye, Mary I. Adewuyi, Victory Olutuase, Kazeem Adefemi, Olumide A. Odeyemi, Yun Zhao, Gizachew A. Tessema, Gavin Pereira
IntroductionNigeria currently has the highest maternal mortality ratio and one of the highest neonatal mortality rates worldwide. Home birth—childbirth outside health facilities, often without skilled attendance or timely access to emergency obstetric care—may contribute to these disproportionate and avoidable adverse maternal and neonatal outcomes. National estimates often mask substantial sub-national disparities. This study examines the prevalence of home birth and associated factors across national, rural, and urban settings in Nigeria.
MethodsWe analysed data from the nationally representative cross-sectional Nigeria Demographic and Health Survey 2018, guided by Andersen’s Behavioural Model. Multivariable logistic regression was used to examine the associations between home birth and various predictor variables at the national level, as well as separately for rural and urban areas in Nigeria.
ResultsNationally, 58.1% (95% CI: 56.5, 59.7) of mothers gave birth at home, with prevalence twice as high in rural areas (72.4%, 95% CI: 70.7, 74.0) compared to urban areas (36.1%, 95% CI: 33.6, 38.7) (p Conclusion
Home birth remains highly prevalent in Nigeria, particularly in rural settings and in the northern and South-South regions, where prevalence is disproportionately high. Reducing home births requires a comprehensive approach that addresses the interplay of factors identified in this study. From a social justice and health determinants perspective, these factors are interconnected and can influence both access to and use of services. In rural areas, policies should enhance women’s decision-making autonomy, reduce distance barriers, and address region-specific challenges (e.g., insecurity in northern regions). In urban areas, it is essential to address financial barriers, support young mothers, and provide culturally and religiously sensitive care. Nationally, efforts should focus on improving education, expanding and strengthening antenatal care, and increasing access to media and the internet. From an equity perspective, interventions must be tailored to specific contexts to reduce unsafe home births and ensure that all mothers, regardless of location, have equitable access to skilled, respectful, and high-quality childbirth care.
by Georgia Black, Reena Besa, Daniel Blumberger, Heather Brooks, Graham Collingridge, John Georgiou, Evelyn K. Lambe, Clement Ma, Bernadette Mdawar, Tarek K. Rajji, Sanjeev Sockalingam, Cara Sullivan, Quincy Vaz, Zhengbang Yao, Branka Agic
IntroductionIntegrated knowledge translation (iKT) is a collaborative research approach that emphasizes the meaningful and active participation of knowledge users throughout the research process. Evidence suggests that integrated knowledge translation has the potential to increase the relevance, applicability, and use of research findings. This approach has been increasingly utilized in health research in recent years. However, the extent to which it has been applied in preclinical research and its effectiveness are unknown. To address this gap, we will conduct a scoping review to map the current use, potential benefits, and challenges of iKT in preclinical research.
MethodsGuided by a modified Arksey and O’Malley’s scoping review framework, we will systematically search reference lists and key research databases including Medline, Embase, PsycINFO, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, and Web of Science. Peer-reviewed articles written or translated in English that focus on iKT or approaches that align with iKT within the context of preclinical research will be included. This review will be conducted as part of the Improving Neuroplasticity through Spaced Prefrontal intermittent-Theta-Beta-Stimulation REfinement in Depression (INSPiRE-D) project, which features preclinical research from mouse models to human work (Grant number CAMH File No.22-060). The project’s multidisciplinary team and knowledge user advisory committee will be consulted at key points throughout the scoping review process. A person with lived experience co-chairs the project advisory committee, co-authored this manuscript, and will be routinely included in the decision-making process of the scoping review.
Couples diagnosed with unexplained subfertility are advised to start mild ovarian hyperstimulation and intrauterine insemination (MOH-IUI) as a primary treatment. Natural feedback mechanisms and hormone release are affected by artificially stimulated cycles and induced ovulation. Additional luteal support could positively affect progesterone patterns in the luteal phase. The LUMO study evaluates whether the addition of exogenous progesterone in the luteal phase following MOH-IUI treatment cycle will improve pregnancy and live birth rates.
A multicentre randomised, double-blind, controlled trial will be conducted in Dutch fertility clinics, academic and non-academic hospitals. There are two treatment arms: group A progesterone luteal phase support; group B placebo, without crossover. All initiated MOH-IUI cycles within 6 months after randomisation are included (study period). Participants will start study medication, applying a daily dosage of 2dd 300 mg progesterone (Utrogestan) or 2dd 300 mg placebo in vaginal capsules on the second day after the IUI procedure. Treatment is continued until the onset of menstruation, a negative pregnancy test (IUI+14 days), a miscarriage or until 7 weeks of gestation in case of a viable pregnancy. Follow-up ends at 12 months after the end of study period (18 months after study randomisation). The primary outcome is cumulative pregnancy rate, achieved within 6 months after randomisation, leading to live birth. A total of 1008 patients (504 patients in each group) will be included.
The study was approved by the Central Committee on Research Involving Human Subjects on 30 January 2023. All participating sites have the approval of the local Board of Directors to participate in the LUMO study. An informed consent form will be signed by all participants. Study results will be presented at (inter)national conferences and published in peer-reviewed journals. It is expected that the results of this trial will be used to draft national guidelines on this issue.
The study is registered in the EU CTIS trial register (2022-501534-33-00), the Dutch trial registry (registration number: LTR 24508), ClinicalTrials.gov (NCT05080569) and the WHO registry (universal trial number: U1111-1280-9461).
Detecting chronic kidney disease (CKD) early can provide opportunities to optimise native kidney function, prevent further decline and plan for timely kidney transplantation if required. Understanding how children are found to have kidney disease and present to specialist kidney care may help tailor interventions to support a timelier diagnosis. The aim of this study was to examine the pathway to specialist care for UK children who present late to nephrology with advanced CKD (requiring kidney replacement therapy within 90 days of first nephrology review) to determine whether there are modifiable aspects to presentation and diagnosis.
Semi-structured, in-depth qualitative study. A topic guide based on the theoretical framework of health behaviour by Scott et al, The Model of Pathways to Treatment, was developed to capture differences in symptom appraisal and help-seeking before reaching nephrology care.
UK paediatric nephrology units (n=4) between December 2017 and December 2020.
Children and young people who experienced a late presentation of CKD and their parents/carers.
Twenty-two participants participated across 19 interviews: seven children (two male, median age 16, IQR 13–17.5 years) and 15 parents. A typology of presentation to healthcare was identified: commonly, families reported repeated cycles of primary care help-seeking before onward referral to specialist care, although long appraisal intervals were also noted. In all cases, secondary care referral led to onward nephrology care involvement. Narratives highlighted that not all cases of late presentation could be avoided.
A typology of symptom appraisal and help-seeking can inform interventions to improve CKD detection. Interventions that support symptom appraisal and consideration of targeted CKD testing in children may help reduce appraisal and help-seeking intervals, respectively.
Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.
This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) 10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.
Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.
Sexual and reproductive health (SRH) for adolescents is a global public health concern. Access to SRH information and services regarding contraception is necessary, particularly in underserved regions, such as the French overseas territories of Reunion Island and Guadeloupe, where indicators for teenage pregnancy and abortion are significantly high. This study protocol describes the methodology to be used to assess the feasibility of a peer-led contraception education programme for high school students using social media.
A multicentre, exploratory sequential mixed-methods with a pre-post design, prospective study is being conducted in Guadeloupe and on Reunion Island. The qualitative component started on 31 May 2025, and the study will continue until 30 June 2026. Participants will be aged 15 to 19 years and will attend high school. In Phase 1, focus groups will explore the adolescents’ perceptions of peer influencers in contraceptive education and their suggestions for organising a prevention programme on social media. These findings will directly inform the intervention in Phase 3. At this stage of this phase, peer influencers will also be identified. Phase 2 will train selected peer educators in SHR, digital content creation to prepare them for intervention design and delivery. Phase 3 consists of the co-construction, implementation and evaluation of the intervention. Outcomes will include feasibility, acceptability, adoption, fidelity and exploratory effectiveness. The primary outcome will be peer engagement defined as the completion of at least 70% of the planned educational tasks.
This study has received ethical approval from the Comité de Protection des Personnes under RIPH3 (ID-RCB: 2025-A00358-41) and will follow the French ethical standards for low-intervention research. Results will be shared in scientific publications and with participating schools.
To explore the barriers and facilitators influencing emergency department clinicians' adherence to the Australian Peripheral Intravenous Catheter (PIVC) Clinical Care Standard, using the Behaviour Change Wheel (BCW).
Suboptimal PIVC practices are frequently linked to a range of patient-important adverse outcomes. The first Australian Peripheral Intravenous Catheter Clinical Care Standard was introduced in 2021, aiming to standardize practice. However, a recent national survey revealed a lack of adherence to the Standard among emergency department clinicians.
A qualitative descriptive study.
The study was conducted across two Australian emergency departments in 2023. Utilizing purposive sampling, semi-structured interviews were conducted. The analysis incorporated both deductive and inductive approaches, mapping the findings to the BCW.
Interviews with 25 nurses and doctors revealed nine key subthemes. The main barriers were the stressful environment, insufficient education and training, and the absence of a feedback mechanism. The main facilitators were recognition of suboptimal practice, belief in the importance of patient engagement, and the desire to improve practice.
Multiple complex factors have an impact on clinicians' adherence to the Standard. The identified interventions will serve as a guide for future implementation of the Standard.
The findings inform healthcare organizations of the significance of implementing strategies to enhance clinicians' acceptance of the Standard. Clinicians should consider incorporating the multifaceted interventions developed in accordance with the BCW for future implementation projects.
Promoting adherence to standards opens avenues to challenge suboptimal practice and has the potential to instigate a culture shift in the fundamental skills of frontline clinicians.
The study is designed and reported according to the Consolidated Criteria for Reporting Qualitative Research checklist.
No patient or public contribution.
This qualitative study aimed to identify nurses' and allied health professionals' perceptions and experiences of providing hospital-acquired pressure injury (HAPI) prevention in a paediatric tertiary hospital in Australia, as well as understand the perceived barriers and facilitators to preventing HAPI.
A qualitative, exploratory study of hospital professionals was undertaken using semi-structured interviews between February 2022 and January 2023.
Two frameworks, the Capability, Opportunity and Motivation Model of Behaviour (COM-B) and the Theoretical Domains Framework (TDF), were used to give both theoretical and pragmatic guidance. Participants included 19 nursing and allied health professionals and data analysis was informed by the framework approach.
Analysis revealed nine core themes regarding professionals' beliefs about the barriers and facilitators to HAPI prevention practices across seven TDF domains. Themes included HAPI prevention skills and education, family-centred care, automated feedback and prompts, allocation and access to equipment, everybody's responsibility, prioritizing patients and clinical demands, organizational expectations and support, integrating theory and reality in practice and emotional influence.
These findings provide valuable insights into the barriers and facilitators that impact paediatric HAPI prevention and can help identify and implement strategies to enhance evidence-based prevention care and prevent HAPI in paediatric settings.
Overcoming barriers through evidence-based interventions is essential to reduce HAPI cases, improve patient outcomes, and cut healthcare costs. The findings have practical implications, informing policy and practice for improved preventive measures, education, and staffing in paediatric care, ultimately benefiting patient well-being and reducing HAPIs.
No patient or public contribution. The focus of the study is on healthcare professionals and their perspectives and experiences in preventing HAPIs in paediatric patients. Therefore, the involvement of patients or the public was not deemed necessary for achieving the specific research objectives.
To explore the perceptions and experiences of students raising concerns during pre-registration health and/or social care training in England.
Systematic review.
MEDLINE, CINAHL, ERIC, PsycINFO and Education Research Complete were systematically searched for studies published between September 2015 and August 2024. Grey literature searches were conducted using Google Scholar and ETHOS British Library. Reference lists from included studies were hand searched.
Joanna Briggs Institute methodological guidance for the conduct of systematic review informed conduct and the convergent integrated approach. Mixed methods appraisal tool was used for quality appraisal.
Eleven studies were included. Synthesis of findings generated three themes: (1) conflicting needs of self and others, (2) navigating the professional workspace and, (3) ‘choice to voice’.
Speaking up and raising concerns as a pre-registration student is a complex, multi-faceted and non-linear social phenomenon. Experiences and perceptions are impacted by the novice student position alongside individual, interpersonal and organisational factors. Open cultures within teams and organisations, leadership, support and feedback may enable students overcome barriers to raising concerns.
Raising concerns may reduce avoidable harm. Pre-registration students offer a ‘fresh pair of eyes’; however, they face barriers related to their student position. Synthesis of speaking-up experiences and perceptions of students in English settings can inform the design of learning environments which equip pre-registration students with the knowledge and skills required to cultivate safety behaviours. These skills contribute positively to safety culture and support learning and improvement in complex systems such as health and social care.
The review followed PRISMA reporting guidelines.
The conceptualisation of this project was informed by engagement events with higher education staff, students and Freedom to Speak Up Guardians.
To determine the quality of drug manufacturers’ fact sheets for patients for COVID-19 therapeutics for baricitinib, convalescent plasma, anakinra, molnupiravir, nirmatrelvir/ritonavir, remdesivir, tocilizumab and vilobelimab, and fact sheet readability.
Cross-sectional document analysis.
Fact sheets on COVID-19 drugs approved by the US Food and Drug Administration from 2020 to 2023.
Quality assessments with the 16-item DISCERN tool scored 16–80 points and 36-item Ensuring Quality of Information for Patients (EQIP) tool scored 0–36, where lower scores indicate low-quality information. We assessed readability with Flesch-Kincaid Reading Ease (ranges from 0 to 100 where higher scores correspond to reading ease). Higher grades indicated hard-to-read information: Flesch-Kincaid grade level (ranges from grades 0 to 18 (college graduate)), Gunning-Fog score (ranges from grades 0 to 20 (college graduate)), Coleman-Liau index (ranges from grade 4 to college graduate), automated readability index (ranging from grades 5 to 22 (college graduate)), Dale-Chall Readability (ranges from grade 4 to college graduate) and simple measure of gobbledygook (ranges from grade 3 to college graduate). Secondary outcomes were word, syllable and sentence counts. We reported percentages and the median (IQR).
We found 18 fact sheets that described 11 (63.5%) anti-virals (remdesivir (n=4), molnupiravir (n=4) and nirmatrelvir/ritonavir (n=3)) and 7 (37.5%) immune modulators (tocilizumab (n=2), baricitinib (n=2), convalescent plasma (n=1), anakinra (n=1) and vilobelimab (n=1)). DISCERN (median (IQR)) reliability was 4 (IQR 3–4) and 5 (1–5), while DISCERN treatment information was 3 (1–5) and 5 (1–5) for anti-virals and immune modulators, respectively. EQIP (median (IQR)) content was 12 (11–13) and 11 (11–13), identification of information was 4 (3–4) and 3 (3–3) and structure was 9 (8–9) and 9 (9–9) for anti-virals and immune modulators, respectively. Overall, fact sheets had median readability grade levels that ranged from 6.2 to 12.4. Anti-viral and immune modulator fact sheets had median readability grade levels from 6.1 to 12.5. Median (IQR) word, >4 syllable words and sentence counts were 1646.5 (1318.3–1934.8), 25.0 (21.3–29.8) and 118.0 (92.0–152.5) overall; 1758.00 (1200.0–2181.0), 23.0 (15.0–27.0) and 134.0 (82.0–185.0) for anti-virals; and 1461.0 (1341.0–1776.0), 29.0 (23.0–46.0) and 107.0 (105.0–122.0) for immune modulators, respectively.
Although of fair quality, the fact sheet reading level was high, and the transparency of sources used was low. Regulatory officials should enforce readable resources from drug manufacturers to guide patients’ decision-making surrounding COVID-19 therapeutics.
Poor oral health is a common but often overlooked concern in palliative care, negatively impacting patients' quality of life. There is limited understanding of how palliative care providers (PCPs) approach oral health promotion in this context. This review synthesises evidence on the knowledge, attitudes and practices of PCPs regarding oral health care and strategies to support them in this area.
Integrative review.
A systematic literature search was undertaken until January 2025 across multiple databases (MEDLINE, CINAHL, Cochrane, ProQuest, EMBASE and Scopus) and grey literature. Inclusion criteria focused on nurses, medical specialists and allied health professionals involved in palliative or end-of-life care, with no publication year restriction.
This review followed Whittemore and Knafl's (2005) framework for integrative reviews. Study quality was assessed using appropriate tools for qualitative and quantitative studies, clinical guidelines and screening tools. A hybrid thematic synthesis approach was used for analysis.
Twenty-five studies were included, mostly of moderate to high quality. Sample sizes ranged from 8 to 1339, with most participants being nurses and nursing assistants, followed by medical professionals. Findings revealed inconsistent knowledge, varied practices and limited prioritisation of oral health care. Barriers included system constraints, limited training and patient-related challenges. Supportive strategies such as guidelines, screening tools and educational interventions were identified.
A significant gap exists in PCP knowledge and practices regarding oral healthcare due to various barriers, with few supportive strategies documented in this field.
There is an urgent need for enhanced education, robust evidence-based guidelines and tailored training for providers to advance and integrate oral health care in palliative care settings.
PRISMA Checklist.
No patient or public contribution.
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.
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.
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.
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.
Poststroke depression affects approximately 30% of stroke survivors and is linked to worse functional outcomes, cognitive decline, reduced quality of life and increased mortality. While early treatment of poststroke mental health conditions is critical, current pharmacological options offer limited efficacy. Music listening interventions are a promising, low-risk, accessible and affordable alternative that may enhance recovery through engagement of reward-related brain circuits. However, most music listening studies have focused on the acute stage of stroke, lack objective measures of music engagement and rarely assess underlying neural mechanisms. To address these gaps, we propose a feasibility study of a remotely delivered music-listening intervention for individuals with chronic stroke, incorporating objective tracking of music exposure and multimodal assessments of mental health, cognitive, neural and physiological changes.
We will conduct a parallel group randomised controlled feasibility trial enrolling 60 patients with chronic stroke from a well-characterised stroke registry in New York City. Participants will be randomised to either an intentional music listening (IML) group or an active control group that listens to audiobooks. The study includes a 4-week preintervention period during which no treatment is administered; this phase is designed to assess the stability of outcome measures. Following this, participants will engage in 1-hour daily listening sessions over a 4-week intervention period. All listening activity (ie, track identity, duration and engagement) will be continuously tracked using custom open-source software, providing a measure of treatment dose. Behavioural outcomes related to mental health will be assessed at baseline, preintervention, postintervention and 3-month follow-up. Multimodal biomarkers (functional and structural MRI, electrodermal activity and heart rate) will be collected preintervention and postintervention. The primary objective is to establish feasibility, defined by rates of retention and adherence, treatment fidelity, feasibility, acceptability and participant burden. Secondary outcomes include recruitment and randomisation rates. This trial will provide essential data to inform the design of future large-scale clinical studies of IML for poststroke mental health recovery.
The study was approved by New York University’s Institutional Review Board (FY2024-8826). All human participants will provide written informed consent prior to participation and will be adequately compensated for their time. Results will be reported in peer-reviewed journals.
To identify views and establish agreements of key stakeholders on the features of an effective system for declaring and managing conflicts of interest in healthcare.
A modified Delphi study consisting of two surveys and semi-structured interviews. Surveys included closed and free-text questions.
UK, purposefully and generally invited participants including academics, researchers, healthcare professionals, regulators, patients and citizens from 10 countries, during 25 August 2024 and 20 January 2025.
Quantitative and qualitative analysis of two surveys and 21 interviews. Descriptive statistics were used to describe the sample and analyse closed survey questions. Thematic analysis was used to analyse free-text survey responses and interview data. Results were synthesised to describe the perceived importance and purposes of declaration of interest systems.
In the first survey round, 616 invitations were sent, along with social media advertisements. 237 questionnaires were returned and 200 full responses were analysable. 129 respondents consented to recontact on the online form. In the interview round, 37 invitations were sent and 21 interviews completed (response rate 59.5%). Invitations for the second survey were sent to all 129 participants who consented to recontact. 91 responses were received and 89 questionnaires were analysable (response rate 82%). Features of ideal systems to declare and manage the interests of healthcare professionals identified by participants were categorised under seven themes: regulatory issues, the healthcare environment, human vices, professional virtues, the use of judgement, features of a better system and patients and public. There was broad agreement on the need for transparency and clarity in declaration systems. The most agreed features were: clarity on what information was needed; it should be a centralised ‘deposit’ for all declarations; it should be publicly accessible, educating and informing people accessing and using the register. Having a lifelong personal identifier, some flexibility in declarations and some privacy features were also rated highly. Respondents were less concerned about scrutiny or a loss of trust. Small numbers of participants raised concerns about serious adverse effects, including loss of privacy, personal safety and the potential of information to contribute to conspiracy theories. There were also major disagreements between participants concerning whether or not healthcare professionals should work with industry, and whether conflicts of interest from working with industry can be safely managed. Individuals with each perspective felt they were acting ethically.
While many agreements were identified, disagreements were also found. If improved declaration systems are to be accepted by professionals and useful to regulators, patients and citizens, the potential for benefit and harm from new declaration systems must be addressed.
Prepublished, Open Science Framework https://osf.io/fbj5n.
To address the lack of accurate and accessible mental health medicines-information resources for children, young people and their parents/guardians using design thinking to co-design free-to-use, video resources tailored to this audience.
A multiphase qualitative case study using the Double Diamond model of Design Thinking: Discover, Define, Develop and Deliver. This included iterative prototyping, thematic analysis and public and patient involvement throughout.
Dublin, Ireland with online distribution of the final resources internationally through a free, open-access platform.
A multidisciplinary co-design team including two specialist mental health pharmacists, two academic pharmacists, five consultant psychiatrists, a psychiatric nurse, a youth content specialist, three youth activists and a parent representative.
26 co-designed, medicines-information videos were created, including versions for children (voiced by children), parents/guardians and young people. Videos feature storytelling formats with Bitmoji characters. Feedback from youth and parent collaborators guided design and content. Since launch, www.youthmed.info has had over 25 000 website views and more than 30 000 video views, with engagement from over 91 countries. The resources are also linked on national and international clinical and charity platforms.
Youth Med.Info addresses a gap in accessible, accurate mental health medicines-information by placing users – children, young people, parents/guardians and clinicians—at the centre of its design.
FreshRSS 