To explore aspects of interpersonal relationships in palliative care nursing, focusing on confidential conversations between patients and registered nurses (RN).
A qualitative study employing focused ethnography.
Data were collected through unstructured participant observations, field notes and interviews with patients and RN in specialist palliative care. Data were analysed using reflective thematic analysis.
Confidential conversations in palliative care are founded on trust that is fragile and develops dynamically through consistent interactions. Small talk, presence and silence are essential for initiating and maintaining trust and the interpersonal relationship. The environment, patient condition and RN emotional presence and competence shape these conversations. As the relationship evolves, conversations adapt to the patient's changing needs. Missed signals or interruptions can disrupt flow, but the potential for repair remains, allowing for restoration and strengthening of trust and connection.
Confidential conversations in palliative care are grounded in fragile, dynamic trust, necessitating ongoing presence, sensitivity and adaptability from RN. To support these interactions, healthcare environments must prioritise privacy, relational continuity and communication training. Future research should investigate how organisational structures and clinical settings influence confidential conversations.
Healthcare environments should facilitate confidential conversations by ensuring relational continuity and minimising distractions. Communication training that emphasises presence and management of silence can strengthen nurse–patient relationships, enhancing patient care and emotional support.
This study explores key aspects of confidential conversations in palliative care, emphasising trust and emotional sensitivity. It addresses a research gap in palliative care using rare observational methods to deepen understanding of nursing relational aspects. The findings offer practical guidance for enhancing communication and relational skills, informing training and policy development and ultimately, improving emotional support and care.
Findings are reported in accordance with the Consolidated Criteria for Reporting Qualitative Research guidelines.
This study did not involve patient or public participation in its design, conduct or reporting.
To analyse current Glasgow Coma Scale practice among emergency nurses in China and identify factors influencing assessment quality.
A quantitative, multicenter cross-sectional design.
A convenience sample of 1740 emergency nurses from secondary and tertiary hospitals across 21 provinces completed a validated structured questionnaire between March and April 2025. Participants had at least 6 months of emergency nursing experience. Data analysis included descriptive statistics, chi-square tests, and multiple logistic regression to examine factors influencing correct Glasgow Coma Scale application.
Participants had a mean age of 29.8 years (SD = 6.2). Only 52.5% of nurses demonstrated correct Glasgow Coma Scale application despite 97.0% having theoretical knowledge of scoring criteria. While 56.8% had received Glasgow Coma Scale training, significant standardisation deficiencies emerged. Notably, 41.8% of departments lacked operational guidelines, and 53.7% of nurses experienced scoring disagreements with colleagues. Clinical utilisation varied substantially by patient population: traumatic brain injury (97.8%), neurological diseases (96.9%), and systemic critical illness (85.8%). Multivariate analysis identified six significant factors influencing correct application: standardised training (OR = 2.252, 95% CI: 1.789–2.825), manageable workload ≤ 4 patients/shift (OR = 1.652, 95% CI: 1.327–2.057), departmental guidelines (OR = 1.523, 95% CI: 1.233–1.881), extensive work experience ≥ 9 years (OR = 1.534, 95% CI: 1.182–1.992), while multidisciplinary collaboration issues (OR = 0.559, 95% CI: 0.439–0.712) and special patient experience (OR = 0.520, 95% CI: 0.406–0.666) were associated with reduced accuracy.
Substantial standardisation challenges exist in Glasgow Coma Scale practice among Chinese emergency nurses, characterised by significant gaps between theoretical knowledge and clinical application. Major barriers include insufficient standardised guidelines, inconsistent training approaches, and inadequate interdisciplinary collaboration.
Healthcare administrators should develop national standardised guidelines, implement simulation-based training programs, optimise emergency workflows, and integrate alternative assessment tools to enhance consciousness assessment accuracy and improve patient safety.
STROBE statement adherence.
No patient or public contribution.
To identify distinct social network types among young-old adults based on the characteristics of social network structure and to explore the relationship between different types, socio-demographic characteristics and subjective cognitive decline.
A cross-sectional study was conducted from July 2022 to October 2023.
A total of 652 young-old adults aged 60–74 years completed the sociodemographic questionnaire, the subjective cognitive decline questionnaire-9 and the self-designed egocentric social network questionnaire. The types of social networks were identified by latent profile analysis. Univariate analysis and binary logistic regression were used to analyse the influencing factors of subjective cognitive decline.
The incidence of subjective cognitive decline was 38%. Social networks of young-old adults tended to be large, predominantly family-centred and characterised by strong contact strength, high density and significant demographic heterogeneity among network members. Four social network types were identified: diverse-moderate, family-dense, family-strong and friend-loose. Young-old adults embedded in the family-dense and family-strong types were more likely to develop subjective cognitive decline than those in the diverse-moderate type. Additionally, age, education level, previous occupation, daily sleep duration and exercise were related to the incidence of subjective cognitive decline.
The findings highlight the relatively high incidence of subjective cognitive decline in young-old adults that is notably influenced by the type of social network they are embedded in. More attention needs to be paid to identifying and supporting young-old adults at high risk of subjective cognitive decline, especially to promote their social integration and friend network building, to improve their subjective cognitive function.
The findings emphasise the importance of considering the structure and composition of social networks when addressing subjective cognitive decline among young-old adults. A diversified social network incorporating both familial and friendship ties may provide enhanced cognitive protection. Therefore, interventions targeting subjective cognitive decline should promote the expansion of friendship-based relationships and foster the development of more heterogeneous and multi-source networks.
STROBE checklist.
Not applicable.
This study aimed to describe the types of psychological and physical symptoms experienced by healthcare professionals who became second victims after a patient safety incident and the impact of the incident on their social and professional lives.
Scoping review.
JBI methodology for scoping reviews and PRISMA-ScR for reporting were followed.
The search was conducted on June 13, 2024, using the CINAHL (EBSCO), Scopus, PubMed (Medline), Medic and PsycInfo (EBSCO) databases. A grey literature search was also conducted.
A total of 96 papers were included. Healthcare professionals experienced psychological symptoms such as anger, sadness and guilt after a safety incident. Physical symptoms were reported, including symptoms related to sleep and gastrointestinal symptoms. At the professional and social levels, the incident affected their work, relationships and well-being. Positive impacts were also noted.
This study provides a comprehensive overview of healthcare professionals' experiences after safety incidents. In addition, this study also captured the positive impacts of safety incidents, such as learning from mistakes.
By recognising the symptoms and impacts associated with the second victim syndrome, appropriate support can be provided for healthcare professionals.
The findings of this study can be used to identify the relevant harm to professionals after a safety incident, which could help to improve the well-being of these workers.
No patient or public contribution.
Open Science Framework, https://archive.org/details/osf-registrations-5cdmu-v1
Although healthcare infrastructure has improved in recent years, the preoperative journey of patients is often accompanied by anxiety. Allowing patients to walk to the operating theatre is a simple, yet underexplored strategy that may enhance their sense of autonomy and reduce anxiety. As patient-centred care gains importance, evaluating the effects of this approach on patient-reported outcomes may be more relevant than widely assumed.
In this scoping review, we aim to analyse the published literature on preoperative walking into the operating theatre and patient-reported outcomes, such as anxiety and satisfaction.
This study was a scoping review that followed the Joanna Briggs Institute methodology and Preferred Reporting Items for Systematic Reviews and Meta-Analyses, Scoping Review extension guidelines.
Inclusion criteria were adult patients undergoing elective surgery and walking to the operating theatre. Data were extracted using a standardised form, and critical appraisal was performed by using ROBINS-I V2.0, RoB2 and ROB-E tools.
Embase, MEDLINE, Cochrane databases (OVID) and CINAHL (EBSCOhost) were searched up to 31st January 2025.
Our search identified 958 articles, with seven trials included in the final analysis. The studies, published between 1994 and 2022, involved 3001 patients from North America, Asia and Europe. The interventions varied, but most patients reported improved satisfaction and reduced anxiety when walking to the operating theatre. No adverse events were reported, although patient preferences varied, with younger patients more likely to prefer walking.
Walking to the theatre positively impacts patient satisfaction and autonomy. However, patient selection is key, as not all individuals are physically or mentally prepared for walking. Future research could explore unaccompanied walking and its effects on hospital resource utilisation. Preoperative walking is a beneficial intervention that enhances patient satisfaction and reduces anxiety, providing a feasible alternative to bed transport for many elective surgical patients.
No patient or public involvement.
This study aimed to examine the level of vicarious posttraumatic growth among intensive care unit nurses in China and explore the mediating role of death coping ability in the relationship between moral resilience and vicarious posttraumatic growth.
A multicentre, cross-sectional study was conducted in accordance with the STROBE guidelines.
Between January and March 2025, a questionnaire survey was conducted among 666 intensive care unit nurses from nine tertiary Grade A hospitals across five provinces in China. Participants completed three standardised instruments: the Rushton Moral Resilience Scale, the Coping with Death Scale–Short Version, and the Vicarious Posttraumatic Growth Inventory. We used IBM SPSS 27.0 for descriptive statistics, univariate analyses, and correlation analyses, and employed AMOS 27.0 to perform structural equation modelling for testing mediation effects.
Intensive care unit nurses demonstrated a moderate level of vicarious posttraumatic growth. Moral resilience was positively associated with both death coping ability and vicarious posttraumatic growth. Death coping ability was found to play a partial mediating role in the relationship between moral resilience and vicarious posttraumatic growth.
Moral resilience and death coping ability are key factors associated with vicarious posttraumatic growth among intensive care unit nurses. Nurses with stronger moral resilience are more likely to cope constructively with death-related stress, which may support psychological growth in trauma-intensive environments.
This study highlights the need to enhance intensive care unit nurses' moral and emotional capacities through ethics education, emotional coping training, and institutional support strategies. Strengthening these competencies may foster professional development and mental wellbeing in critical care settings.
by Carol Kotliar, Lisandro Olmos, Martín Koretzky, Ricardo Jauregui, Tomás Delía, Oscar Cingolani
ObjectiveTo evaluate the effectiveness of the Mental Training Tech 24.5 (MTT24.5) cognitive stimulation program, designed to enhance cognitive performance and neuroplasticity in healthy adults.
BackgroundCognitive decline is a significant concern in aging populations, with research suggesting that neuroplasticity and cognitive reserve can be enhanced through targeted cognitive training. The MTT24.5 program aims to stimulate brain function through a combination of new knowledge acquisition (DATA) and learning techniques (TECHS), organized into a systematic algorithm. This approach may offer a novel way to prevent or mitigate age-related cognitive decline.
DesignPilot clinical study, active-controlled, open randomization.
SettingAdults from the general population with no clinical cognitive deterioration, recruited from three sites within the Autonomous City of Buenos Aires and its metropolitan area.
Participants120 volunteers were enrolled, of which 76 participants (56 in the intervention group, 20 in the control group) met the study requirements and selected a site closest to their residence.
MethodsThe MTT24.5 program consists of 12 weekly in-person sessions (totaling 24.5 hours), during which participants learned 40 knowledge units (DATA) and 100 learning techniques (TECHS). These were organized into binomials, where each unit of DATA was paired with 3–4 TECHS. Pre- and post-intervention assessments included medical history, lifestyle factors, cognitive reserve scale, Addenbrooke’s Cognitive Examination-Revised (ACE-R), and Mini-Mental State Examination (MMSE).
ResultsThe mean age was 59 years for both groups. Baseline ACE-R scores were comparable (91.3). The global cognitive score increased by 4.6 points (5%) in the intervention group compared to a decrease of 0.5 points in the control group (p Conclusions
The MTT24.5 program, based on a systematic algorithm for acquiring new knowledge and skills, significantly enhances cognitive reserve and overall cognitive performance, particularly in individuals with lower baseline cognitive scores. These findings suggest that structured cognitive stimulation could play a critical role in preventing cognitive decline and promoting cognitive health in healthy adults. Given the promising results, future studies involving larger populations and long-term follow-up are essential to validate these effects and explore the potential for mitigating age-related cognitive decline and enhancing quality of life.
RegistrationThe study was registered in accordance with local regulations at the National Council for Scientific and Technological Research (CONICET) – Institute of Biomedical Research (BIOMED), and also in the National Ethics Committee, and at clinicaltrials.gov (NCT06549517).
by Mireia Solé Pi, Luz A. Espino, Péter Szenczi, Marcos Rosetti, Oxána Bánszegi
A long-standing question in the study of quantity discrimination is what stimulus properties are controlling choice. While some species have been found to do it based on the total amount of stimuli and without using numerical information, others prefer numeric rather than any continuous magnitude. Here, we tested cats, dogs, and humans using a simple two-way spontaneous choice paradigm (involving food for the first two, images for the latter) to see whether numerosity or total surface area has a greater influence on their decision. We found that cats showed preference for the larger amount of food when the ratio between the stimuli was 0.5, but not when it was 0.67; dogs did not differentiate between stimuli presenting the two options (smaller vs. larger amount of food) regardless of the ratio between them, but humans did so almost perfectly. When faced with two stimuli of the same area but different shapes, dogs and humans exhibited a preference for certain shapes, particularly the circle, while cats’ choices seemed to be at chance level. Furthermore, cats’ and dogs’ reaction times were equal across conditions, while humans were quicker when choosing between stimuli in trials where the shape was the same, but the surface area was different, and even more so when asked to choose between two differently sized circle shapes. Results suggest that there is no universal rule regarding how to process quantity, but rather that quantity estimation seems to be tied to the ecological context of each species. Future work should focus on testing quantity estimation in different contexts and different sources of motivation.To assess the correlation between complete blood count (CBC)-derived inflammatory markers and sepsis-associated delirium (SAD) risk in older intensive care unit (ICU) patients.
Retrospective cohort study.
ICUs at Beth Israel Deaconess Medical Center (2008–2019), using the Medical Information Mart for Intensive Care IV V.3.0 database.
3412 critically ill patients aged ≥65 years with sepsis. Exclusion: repeated ICU admission, death/discharge within 24 hours, missing delirium assessment or pre-sepsis delirium from non-septic aetiologies. SAD was diagnosed by Confusion Assessment Method for the ICU.
Incidence of sepsis-associated delirium.
Among 3412 older sepsis patients, 2092 (61.3%) developed SAD. Significant differences in platelet-to-lymphocyte ratio, neutrophil-to-lymphocyte ratio, monocyte-to-lymphocyte ratio (MLR), systemic immune-inflammation index, systemic inflammation response index, pan-immune-inflammation value and neutrophil-monocyte-to-lymphocyte ratio were observed between SAD and non-SAD groups (all p0.05). Receiver operating characteristic and random forest analyses demonstrated predictive utility; incorporating markers into a baseline model significantly improved discrimination, with MLR providing the largest gain (area under the curve (AUC)=0.716 vs 0.703; AUC=0.013, DeLong test, p
CBC-derived inflammatory markers, particularly MLR, are associated with increased SAD risk in older adults and enhance the performance of a clinical prediction model in this population. Further research is needed to better understand the pathophysiological mechanisms underlying these associations.
Care (Education) and Treatment Reviews (C(E)TRs) are intended to reduce unnecessary psychiatric hospital admission and length of stay for people with intellectual disability and autistic people. The use and impact of C(E)TRs have not been systematically evaluated since their introduction in England in 2015. The aims of this study are to describe the demographic and clinical profiles of people who receive a community C(E)TR and to investigate their effects on admission, length of hospital stay and clinical and functional change.
We will conduct a retrospective cohort study using de-identified data from electronic health records derived from two large National Health Service mental health providers in London, England, including one replication site. Data will be extracted using the Clinical Record Interactive Search (CRIS) tool for all people with recorded intellectual disability and/or autism who received mental healthcare from 2015. We will identify community C(E)TR events using keyword searches. Community C(E)TRs will be examined in two ways: (1) In a community cohort, we will capture data in the 6-month periods before and after a community C(E)TR and compare this to a matched control group and (2) In a hospital cohort, we will compare groups who did and did not receive a community C(E)TR prior to their admission. We will describe the socio-demographic and clinical profiles of each group and their health service use, and compare C(E)TR and no C(E)TR groups using t-tests (or a non-parametric equivalent). The primary outcomes are admission to a psychiatric hospital (community cohort) and length of psychiatric hospital admission and clinical change (hospital cohort). Admission to psychiatric hospital will be estimated using propensity score weighting and difference-in-differences methods. Cox’s proportional hazard model will be used for length of hospital admission and repeated-measures analysis of variance (ANOVA) will be used to assess clinical change.
Use of CRIS to examine de-identified clinical data for research purposes has overarching ethical approval. This study has been granted local approval by the South London and Maudsley CRIS Oversight Committee. Findings will be disseminated in an open-access peer-reviewed academic publication, at conference presentations, and to service users and carers in accessible formats.
This study explored how Structured Medication Reviews (SMRs) are being undertaken and the challenges to their successful implementation and sustainability.
A cross-sectional mixed methods online survey.
Primary care in England.
120 clinical pharmacists with experience in conducting SMRs in primary care.
Survey responses were received from clinical pharmacists working in 15 different regions. The majority were independent prescribers (62%, n=74), and most were employed by Primary Care Networks (65%, n=78), delivering SMRs for one or more general practices. 61% (n=73) had completed, or were currently enrolled in, the approved training pathway. Patient selection was largely driven by the primary care contract specification: care home residents, patients with polypharmacy, patients on medicines commonly associated with medication errors, patients with severe frailty and/or patients using potentially addictive pain management medication. Only 26% (n=36) of respondents reported providing patients with information in advance. The majority of SMRs were undertaken remotely by telephone and were 21–30 min in length. Much variation was reported in approaches to conducting SMRs, with SMRs in care homes being deemed the most challenging due to additional complexities involved. Challenges included not having sufficient time to prepare adequately, address complex polypharmacy and complete follow-up work generated by SMRs, issues relating to organisational support, competing national priorities and lack of ‘buy-in’ from some patients and General Practitioners.
These results offer insights into the role being played by the clinical pharmacy workforce in a new country-wide initiative to improve the quality and safety of care for patients taking multiple medicines. Better patient preparation and trust, alongside continuing professional development, more support and oversight for clinical pharmacists conducting SMRs, could lead to more efficient medication reviews. However, a formal evaluation of the potential of SMRs to optimise safe medicines use for patients in England is now warranted.
Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.
A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.
This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.
ACTRN12623000598684p.
Medication returned by patients to healthcare facilities is a critical aspect of reverse logistics, intersecting healthcare delivery, patient safety and environmental sustainability, especially in low- and middle-income countries (LMICs) where systemic inefficiencies and socio-cultural factors may exacerbate the issue. While emerging medication return programmes are recognised for their potential to enhance resource efficiency and prevent misuse, they also signal inefficiencies in medical supply chains, prescribing practices and patient-provider interactions. This scoping review aims to systematically map the incidence and drivers of medication returned to health facilities by patients in LMICs.
This review follows Arksey and O'Malley’s scoping review framework and the PRISMA-ScR reporting guidelines. Searches will be conducted in Google Scholar, PubMed, CINAHL, Embase, Web of Science and Scopus, supplemented by grey literature sources and reference list screening. Searches will include studies from January 2005 to December 2025 and English-language publications, reflecting both the relevance of recent evidence and practical considerations for screening and analysis. Eligible studies must address the incidence or drivers of medication returned in LMICs and meet predefined inclusion criteria based on the Population, Concept, Context framework. Data will be extracted using a standardised charting form and analysed using narrative synthesis, supported by descriptive statistics and thematic analysis.
No ethical approval is required as this scoping review will analyse publicly available literature. Findings will be disseminated through peer-reviewed publications, academic conferences and healthcare organisations, with all data and search strategies made openly accessible through Springer Nature’s protocols.io preprint repository to support transparency and future research.
Springer Nature’s protocols.io dx.doi.org/10.17504/protocols.io.3byl4wd5ovo5/v1.
El abordaje de la violencia de género en el ámbito sanitario, especialmente en Atención Primaria durante periodos como el embarazo, tiene un impacto emocional significativo en los y las profesionales, particularmente en enfermería. La exposición continua a relatos y situaciones traumáticas, sumada a factores organizacionales como la carga de trabajo y la falta de apoyo institucional y entre pares, puede derivar en desgaste profesional (burnout), estrés traumático secundario y fatiga por compasión. La confrontación con las propias vivencias y prejuicios, influenciados por la socialización en una cultura patriarcal, puede dificultar una valoración objetiva y generar respuestas emocionales disfuncionales como la sobre involucración o la evitación, perjudicando tanto el bienestar del profesional como la efectividad de la intervención.
Los principales conflictos en la atención primaria relacionados con la aplicación del Protocolo Actuación Sanitaria ante la Violencia de Género son la complejidad en el abordaje de la violencia psicológica, la confrontación con los hombres, la falta de tiempo y la falta de intimidad y confidencialidad en las consultas. Además, se enfrentan a la falta de registro adecuado, ya que algunos profesionales no están sensibilizados sobre cómo registrar los casos, lo que puede llevar a una atención insuficiente, y a la baja adherencia de las mujeres, quienes suelen resistirse a denunciar por miedo, amenazas y falta de soporte familiar, lo que complica el seguimiento de los casos. La ausencia de responsables específicos y la falta de formación continua son también barreras importantes.
Introducción. La transición del hospital al domicilio en pacientes oncológicos es un momento crítico que puede generar ansiedad y depresión debido a la autogestión de cuidados. Objetivo. evaluar el impacto emocional de los pacientes oncológicos al recibir el alta de enfermería. Metodología. Estudio observacional descriptivo. Se utilizará el cuestionario HADS para medir los niveles de ansiedad y depresión en una muestra de pacientes hospitalizados próximos a recibir el alta. Los resultados permitirán diseñar estrategias de apoyo emocional y educación sanitaria para mejorar la adherencia terapéutica y la calidad de vida post hospitalaria.
ABSTRACT
Introduction. The transition from hospital to home for oncology patients is a critical moment that may generate anxiety and depression due to self-management of care. Objective. To assess the emotional impact of oncology patients upon receiving nursing discharge. Methodology. Descriptive observational study The HADS questionnaire will be used to measure anxiety and depression levels in a sample of hospitalized patients close to discharge. The results will guide the development of emotional support strategies and health education to improve post-hospital therapeutic adherence and quality of life.
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 Quadrivalent human papillomavirus (HPV) Vaccine Evaluation Study with Addition of the Nonavalent Vaccine Study (QUEST-ADVANCE) aims to provide insight into the long-term immunogenicity and effectiveness of one, two and three HPV vaccine doses. Here, we describe the protocol for QUEST-ADVANCE.
QUEST-ADVANCE is an observational cohort study including males and females who are unvaccinated or vaccinated with the quadrivalent or nonavalent HPV vaccine in British Columbia, Canada. Female participants who are unvaccinated or vaccinated with 1–3 doses of the quadrivalent or nonavalent HPV vaccine at 9–14 years of age will be recruited approximately 5 or 12 years postvaccination eligibility. Male participants who are unvaccinated or vaccinated with 1 or 2 doses of the nonavalent HPV vaccine at 9–14 years of age will be recruited at approximately 5 years postvaccination eligibility. The study involves a maximum of four visits over a period of 4–5 years for female participants, and two visits over a 12-month period for male participants. At each visit, self-collected swabs (cervico-vaginal or penile) and questionnaire data will be collected. In each study group, a subset of participants will be invited to participate in a substudy evaluating the long-term humoral immunogenicity of the HPV vaccine. Additional blood samples will be collected from participants who are part of the immunogenicity substudy. The total required sample size is 7180 individuals. The primary objectives are (1) to examine vaccine effectiveness in males and females against prevalent genital HPV infections for one, two and three doses of the HPV vaccine compared with unvaccinated participants and (2) to evaluate if there is non-inferior immunogenicity as indicated by type-specific antibody response of one dose of the HPV vaccine in 20–27-year-old females vaccinated at 9–14 years of age compared with historical data of three doses of the HPV vaccine females vaccinated at 16–26 years of age up to 12 years postvaccination.
QUEST-ADVANCE was approved by the Research Ethics Board of the University of British Columbia/Children’s and Women’s Health Centre of British Columbia (H20-02111). Individual electronic informed consent or assent will be obtained from each participant before any study-specific procedures are undertaken. Results will be published in an international peer-reviewed journal and on the study website.
Lower gastrointestinal symptoms attributed to colorectal disease are common. Early diagnosis of serious colorectal disease such as colorectal cancer (CRC), precancerous growths (polyps) and inflammation is important to ensure the best possible outcomes for a patient. The current ‘gold standard’ diagnostic test is colonoscopy. Colonoscopy is an invasive procedure. Some people struggle to cope with it and require intravenous sedation and/or analgesia. It is also resource-intensive, needing to be performed in specialist endoscopy units by a trained team. Across the UK, the demand for colonoscopy is outstripping capacity and the diagnosis of colorectal disease is being delayed. A colon capsule endoscope (CCE) is an alternative colorectal diagnostic. It is a ‘camera in a pill’ that can be swallowed and which passes through the gastrointestinal tract, obtaining visual images on the colon. There is now established experience of CCE in the UK. CCE might provide a less invasive method to diagnose colorectal disease if found to be accurate and effective and provide a means by which to increase the National Health Service (NHS) diagnostic capacity.
The aim of this study is to determine the diagnostic accuracy of CCE when compared with colonoscopy in representative and clinically meaningful cohorts of patients. An evaluation of the experiences of CCE for the patient and clinical team and an assessment of cost effectiveness will be undertaken.
We will undertake three research workstreams (WS). In WS1, we shall perform a paired (back-to-back) study. Each participant will swallow the CCE and then later on the same day they will have a colonoscopy. The study has been designed in collaboration with our Patient Advisory Group and as closely mirrors standard care as is possible. 973 participants will be recruited from three representative clinical contexts; suspected CRC, suspected inflammatory bowel disease and postpolypectomy surveillance. Up to 30 sites across the UK will be involved to maximise inclusivity. Measures of diagnostic accuracy will be reported along with CCE completion rates, number of colonoscopy procedures potentially prevented and adverse events, such as capsule retention. A nested substudy of intraobserver and interobserver agreement will be performed. WS2 will develop models of cost-effectiveness and WS3 will evaluate the patient and clinician experience, with reference to acceptability and choice.
The study findings will provide the evidence base to inform future colorectal diagnostic services.
The study has approval from the North East—Tyne and Wear South research ethics committee (REC reference 24/NE/0178, IRAS 331349). The findings will be disseminated to the NHS, National Institute for Health and Care Excellence, other clinical stakeholders and participants, patients and the public.