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An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.
The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.
This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.
Accurate chronic wound classification is essential for appropriate management, yet diagnostic variability persists in routine practice. Transparent, rule-based decision-support tools may improve standardisation but require validation against expert judgement under clearly defined conditions. To evaluate inter-expert agreement, agreement between a rule-based algorithm and an expert-consensus reference standard, diagnostic accuracy as a complementary measure, exploratory comparison with a non-expert nurse, and expert agreement with algorithm-generated therapeutic recommendations. Thirty anonymised standardised clinical cases were classified by the algorithm and one non-expert nurse. Thirty wound-care experts, including 26 nurses, three physicians, and one researcher, were organised into six independent panels of five and classified case subsets, yielding 150 ratings. A consensus reference diagnosis was defined a priori as agreement by at least 3/5 experts. The primary outcome was algorithm–consensus agreement using Cohen's κ. Expert reliability was assessed using Krippendorff's α and Fleiss' κ. Recommendation agreement was dichotomised and analysed exploratorily. Expert agreement was low to moderate (Krippendorff's α = 0.26–0.60), highest for pressure ulcers/injuries and venous leg ulcers, and lowest for mixed or unknown leg ulcers and diabetic foot ulcers. Consensus was reached in 29 of 30 cases. The algorithm achieved 86.2% accuracy (25/29) and substantial agreement (κ = 0.70, 95% CI 0.46–0.94). Nurse accuracy was 72.4% (21/29, p = 0.219). Experts endorsed 85.2% of therapeutic recommendations. The algorithm showed promising agreement under controlled conditions, supporting further prospective validation in larger, balanced real-world datasets.
To evaluate the effectiveness of simulation on nursing students' translation into practice of clinical judgement, knowledge about the nursing process self-confidence and to comprehend the learning process and translation into clinical practice of competencies developed through clinical simulation in nursing students.
Two-arm, experimental, randomized controlled study designed using the explanatory sequential mixed method with qualitative step anchored in grounded theory.
Eighty undergraduate nursing students were allocated in practice groups and the groups were randomly assigned to an experimental (simulation; n = 39) or control group (study case; n = 41) and, after the intervention, participated in 3-day clinical practice activities and were assessed regarding clinical judgement, knowledge of the nursing process and self-confidence. Students in the experimental group were invited to focus groups.
Seventy-six students were analysed. The findings showed the effectiveness of simulation combined with clinical practice in the development and translation of clinical judgement (β = 5.03; p = 0.001) and knowledge of nursing process (β = 2.20; p < 0.001). There was no difference regarding self-confidence. A grounded theory emerged with three categories related to consolidation of prior knowledge, translating competencies into clinical practice and application of these competencies in nursing care that explain the theoretical category ‘learning and translating into clinical practice’.
Findings suggest that simulation combined with clinical practice can effectively enhance nursing students' clinical judgement and knowledge of the nursing process, facilitating the translation of these competencies into real-world practice. The qualitative findings suggest that simulation promotes meaningful learning and supports the practical application of nursing competencies.
This study supports the integration of simulation into nursing curricula to enhance clinical judgement and nursing process competencies. By promoting meaningful learning and facilitating knowledge transfer to clinical settings, simulation prepares students for real-world decision-making and strengthens the quality and safety of nursing care delivery.
No patient or public contribution.
RBR-7v374c6 (Brazilian Clinical Trials Registry) https://ensaiosclinicos.gov.br/rg/RBR-7v374c6
Cancer-related cognitive impairment is frequently reported by patients with breast cancer after chemotherapy. These difficulties can hinder return to work. It is therefore particularly important to assess and manage these impairments, especially to facilitate employment. We propose the Cog-VR pilot study to assess patient adherence to a virtual reality (VR)-based cognitive rehabilitation programme to support employment.
This prospective interventional pilot study aims to assess adherence to a VR-based cognitive rehabilitation programme in patients with breast cancer (n=23) treated by chemotherapy reporting cognitive complaints following cancer and its treatments. The programme consists of six weekly individual sessions (1 hour/week), including cognitive training, psychoeducation and VR immersion (10–15 min). VR tasks train executive functions, attention, memory and processing speed. The primary endpoint is the programme adherence, defined as completing at least five out of six VR sessions, each lasting a minimum of 5 min. The main secondary endpoints are objective cognitive tests and patient-reported outcomes (subjective cognitive functioning (Functional Assessment of Cancer Therapy—Cognitive Scale), anxiety/depression (Hospital Anxiety and Depression Scale) and fatigue (Functional Assessment of Chronic Illness Therapy—Fatigue)) assessed before and after the programme. Furthermore, cyber sickness (Simulator Sickness Questionnaire) at each session, VR usability (System Usability Scale—third session) and patient satisfaction to the programme will also be assessed.
The study was approved by the local ethics committee (French Ouest II personal protection committee no. ID RCB: 2023-A02163-42) on January 2024. It was validated by the review board of the participating center. An individual participant data-sharing statement is not planned. Written informed consent will be obtained from all patients before any study procedure. The results of this pilot study will be disseminated through peer-reviewed journals and conference presentations.
by Alicia Núñez García, Sofia de la Fuente García, Erfan Lowemi, Masood Masoodian, Renata Vieira, Aurea Rodrigues, Saturnino Luz
Background: While interventions have been designed which use extended reality (XR) technology in promoting physical, mental and social well-being through cultural heritage experiences, well-defined methodologies for the assessment of such interventions is lacking. Objectives: We present a protocol for evaluating the usability and effectiveness of an XR system that mediates and facilitates access to intangible cultural heritage experiences. We aim to assess the effects of these experiences on user well-being and attitudes across four case studies: ageing societies, sustainable tourism, disappearing communities, and immigration and multiculturalism. Methods and analysis: Participants will be randomly assigned to control or intervention groups. The effects of the XR intervention on well-being will be assessed through statistical analysis of the participants’ salivary cortisol and cortisone levels, physiological signals, and subjective ratings, both pre- and post-intervention and between control and intervention groups. Usability will be measured through a system usability scale. Speech will be recorded for qualitative and natural language processing analysis. Machine learning models will be developed for prediction of affect and well-being on multimodal data. Discussion: This is one of the first international and multidisciplinary studies to explore the effects of XR-mediated intangible cultural heritage experiences on well-being and attitudes towards issues of societal importance. One of the main strengths of this study is the range of data modalities it collects, and the range of methods it employs to analyse these data in a complementary manner, including qualitative, statistical and advanced machine learning methods. Conclusion: This protocol offers a method and four case studies to assess the potential of immersive XR experiences and interventions of intangible cultural heritage as contributors to increased well-being and as actors of societal change. It stands as a reference model for further similar interventions in the field.Adolescent pregnancy is a global issue. Early childbearing is strongly linked to poverty and negative health outcomes, including increased neonatal death risk. This study explores spatial patterns of adolescent pregnancies and neonatal deaths and their association with socioeconomic characteristics.
This population-based study used spatial analysis techniques to investigate the geographical distribution of adolescent pregnancies, socioeconomic characteristics and neonatal mortality rate (NMR).
The 645 municipalities of State of Sao Paulo, Brazil.
All live births to mothers residing in the State of Sao Paulo, Brazil, between 2004 and 2020.
The socioeconomic indicators used were: municipal human development index and per capita income (PCI). Spatial patterns were assessed for spatial autocorrelation (Moran’s I, LISA), and smoothed using local Bayesian estimation. Spearman’s correlation was used to ascertain the relationship between the percentage of live births to adolescent mothers and socioeconomic indexes. This calculation was also undertaken between different maternal age groups of NMR.
The study analysed over 10 million live births, with 14.3% attributed to adolescent mothers. Spatial analysis revealed significant clustering of adolescent pregnancies, strongly associated with lower socioeconomic indicators. NMR also exhibited spatial clustering, particularly after smoothing. Statistically significant differences were observed in PCI medians between high–high and low–low clusters for adolescent births. High and low incidence areas of NMR, both in all maternal ages and stratified by adolescent and non-adolescent mothers, demonstrated considerable overlap.
The results indicated the existence of clustering areas of adolescent pregnancy and neonatal deaths and suggested that the prevalence of births to adolescent mothers is not distributed equally and is higher in lower socioeconomic developed areas.
Scoping reviews, mapping reviews and evidence and gap maps (collectively known as ‘big picture reviews’) in health continue to gain popularity within the evidence ecosystem. These big-picture reviews are beneficial for policy-makers, guideline developers and researchers within the field of health for understanding the available evidence, characteristics, concepts and research gaps, which are often needed to support the development of policies, guidelines and practice. However, these reviews often face criticism related to poor and inconsistent methodological conduct and reporting. There is a need to understand which areas of these reviews require further methodological clarification and exploration. The aim of this project is to develop a research agenda for scoping reviews, mapping reviews and evidence and gap maps in health by identifying and prioritising specific research questions related to methodological uncertainties.
A modified e-Delphi process will be adopted. Participants (anticipated N=100) will include patients, clinicians, the public, researchers and others invested in creating a strategic research agenda for these reviews. This Delphi will be completed in four consecutive stages, including a survey collecting the methodological uncertainties for each of the big picture reviews, the development of research questions based on that survey and two further surveys and four workshops to prioritise the research questions.
This study was approved by the University of Adelaide Human Research Ethics Committee (H-2024-188). The results will be communicated through open-access peer-reviewed publications and conferences. Videos and infographics will be developed and placed on the JBI (previously Joanna Briggs Institute) Scoping Review Network webpage.
This study aimed to describe the process of construction, validation, and usability of the chatbot ESTOMABOT to assist in the self-care of patients with intestinal ostomies. Methodological research was conducted in three phases: construction, validation, and usability. The first stage corresponded to the elaboration of a script through a literature review, and the second stage corresponded to face and content validation through a panel of enterostomal therapy nurses. In the third phase, the usability of ESTOMABOT was assessed with the participation of surgical clinic nurses, patients with intestinal elimination ostomies, and information technology professionals, using the System Usability Scale. The ESTOMABOT content reached excellent criteria of adequacy, with percentages of agreement equal to or greater than 90%, which were considered adequate, relevant, and representative. The evaluation of the content validity of the script using the scale content validity index/average proportion method reached a result above 0.90, and the Fleiss κ was excellent (P 
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