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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.
Pain is an experience that is socially conditioned, like all human experiences. The scientific study of pain from a biopsychosocial perspective involves considering its complexity and multidimensionality. This means accounting for the anatomical and physiological elements of pain, as well as the psychological, social and cultural elements of pain. Despite the increasing acknowledgement of the biopsychosocial model, pain research still lacks standardised criteria for evaluating its social dimension. Moreover, the integration of social variables into empirical studies remains limited and fragmented. The aim of this review protocol is to analyse whether and how pain studies account for the social dimension, understood as the cultural, relational and contextual factors that shape the perception and experience of pain.
A systematic review will be conducted by consulting five international databases: PubMed, Web of Science Core Collection, Scielo Citation Index, Scopus and CINAHL Complete. The review will include empirical or theoretical studies on pain that consider its social dimension, are written in Spanish or English, are applied to human beings and align with the review’s objectives. The studies will then be exported to the Zotero bibliographic manager for further processing. The selection of studies will be carried out in two phases. The initial stage of the review process will involve a title and abstract analysis of the identified studies, followed by a full-text review. Data will be extracted using a bespoke tool created for this research. The quality of the studies will be assessed using a tool developed by our research group. Data synthesis will be carried out through descriptive and narrative analyses.
This systematic review protocol did not require ethical approval; however, the project in which it is framed has been approved by the CSIC Ethics Committee (271/2023). These findings will be disseminated by publication in high-impact, peer-reviewed journals and by presentation at relevant scientific conferences and academic congresses. The results will provide an overview of the integration of the social dimension of pain into the scientific literature, thereby contributing to the advancement of the field and informing future research, interventions and public policy.
CRD42024601863.
Osteoporosis requires long-term self-care engagement, yet little is known about how individuals experience and manage self-care in everyday life. Understanding these experiences is essential to inform tailored nursing interventions. The objective of the study was to explore and describe the experience of self-care maintenance, monitoring, and management in people with osteoporosis.
A qualitative descriptive study.
We conducted semi-structured interviews. Data were analyzed using Mayring's qualitative content analysis with a deductive approach based on Riegel's theory of self-care. We reported data in accordance with the Consolidated Criteria for Reporting Qualitative Studies (COREQ) checklist.
Participants (1 Male, 19 Females; Aged 55–80) Identified Four Themes of self-care: maintenance (e.g., Medication Adherence, Physical Activity), monitoring (e.g., Symptom Recognition, Test Interpretation), management (e.g., Lifestyle Reflections, Prevention), and general self-care. Key factors included motivation, trust in healthcare professionals, and integration of health behaviors into daily life. Barriers were low self-efficacy, poor symptom recognition, and inconsistent adherence.
Self-care in osteoporosis is a multidimensional and dynamic process influenced by individual beliefs, contextual factors, and support from healthcare professionals. Recognizing the variability in patients' self-care behaviors is essential to develop personalized education and support. Strengthening general health behaviors may enhance disease-specific self-care. This understanding can guide healthcare professionals in designing more effective, tailored care strategies.
To evaluate the predictive capacity of the Integrated Care for Older People screening tool for the risk of falls in older people receiving care at a healthcare service.
A cross-sectional study.
This study was conducted in a geriatric healthcare service in the southeast region of Brazil. The convenience sample included older people aged 60 and over living at home. The study used the Fall Risk Score to assess the risk of falls and the Integrated Care for Older People screening tool to track intrinsic capacity. The data was analysed using logistic regression to analyse the association between the six Intrinsic Capacity domains, for the early detection of impairment and risk of falls.
A total of 253 older adults participated in the study, most of whom were identified as having a high risk of falls. Logistic regression analysis across six association models revealed that the models including the Intrinsic Capacity domains of locomotion and hearing had a significant association with having a higher risk of falls. Care plans should prioritise the domains most strongly associated with fall risk, guiding targeted strategies to enhance older adults' safety.
The Integrated Care for Older People screening tool, in the locomotion and hearing domains, is associated with the risk of falls in older people from the community receiving care in a geriatric healthcare service. Future longitudinal studies could show whether other domains of intrinsic capacity can predict the occurrence of falls.
This study highlights the Integrated Care for Older People screening tool as essential in nursing practice, especially for assessing the locomotion and hearing domains of intrinsic capacity. Early detection of impairments helps identify increased fall risk in older adults, enabling nurses to implement targeted, person-centred interventions that enhance safety, autonomy and overall quality of life.
No patient or public contribution.
This study complied with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for cross-sectional studies.
To explore the enablers of and barriers to implementing advanced practice nursing in primary health care in Germany and Brazil.
A qualitative cross-country comparative study.
Nine focus groups were conducted: 4 in Brazil and 5 in Germany with 48 participants (23 primary health care policy stakeholders and 25 nurses practicing in primary health care and general practitioners) between May 2022 and June 2023. The data were analysed by content analysis using a deductive–inductive approach.
Our findings reveal a need for clarity around the concept, specific roles and responsibilities of advanced practice nurses in primary health care. Although there is still no regulation in place for practising advanced practice nursing in either country, clear drivers can be observed, with Germany strengthening community health nursing and Brazil following clinical protocols in nursing practice. Dialogue among stakeholders—at both the policy and practitioner levels—is essential to bridge communication gaps. Additionally, involving patients in the implementation process is crucial for the holistic integration of advanced nursing roles.
Political, organisational and financial barriers persist, such as the need to establish both legal foundations and regulatory frameworks, enhance political participation within the nursing profession, and involve stakeholders in dialogue and consensus-building efforts. Giving advanced practice nursing a higher priority on political and research agendas—with policy adjustments and input from practitioners—can help integrate advanced practice nursing into primary health care.
Our findings highlight that actively involving nursing as an equal partner in political discourse is seen by stakeholders as crucial to drive the implementation process forward sustainably.
This study addresses the lack of data on the enablers and barriers to implementing advanced practice nursing in primary health care in Germany and Brazil. It underscores the need for clearer definitions of advanced practice nursing in primary health care, as well as sufficient regulation and funding. Dialogue is essential to bridge gaps and foster mutual understanding. The findings support future practice development and research, especially in countries that have introduced advanced nursing practice roles in primary health care.
The COnsolidated criteria for REporting Qualitative research (COREQ).
No involvement of patient and public contribution.
Our study highlights the growing adoption of expanded nursing responsibilities even in countries that have not yet formally implemented advanced practice nursing roles.
To explore the topics and themes covered in published research studies in nursing about neurodegenerative disease, synthesise the available evidence, and discuss future directions.
Scoping review following the Joanna Briggs Institute guidelines.
A multi-step search strategy was applied across different databases to identify studies published in English or Italian up to September 2023. Data were analysed using a Nursing Data Matrix based on the nursing meta-paradigm and the Child Health and Nutrition Research Initiative (CHNRI) 4D-framework. Screening and data extraction were performed independently by pairs of reviewers; data were extracted and thematically analysed to identify existing research questions and potential priorities.
Cumulative Index to Nursing and Allied Health Literature (CINAHL), PubMed, and Embase databases were searched for studies published from 2013 to 2023.
A total of 351 studies met inclusion criteria. The majority of studies originated from the United States (35%). Parkinson's disease and Alzheimer's disease were the most studied conditions, while rare diseases were scarcely represented. Most studies focused on nursing care (39%), with limited attention to rehabilitation (0.8%) and cost-effectiveness (1%). Although 70% of articles included at least one nurse author, 22% lacked any nursing authorship despite addressing nursing-related topics. Thematic and matrix analyses revealed an uneven distribution of research, with a predominance of descriptive studies and limited work in discovery-oriented research.
This review provides a comprehensive overview of nursing research in neurodegenerative diseases, highlighting key themes and gaps. The findings informed the preliminary identification of new nursing research priorities in neurodegenerative diseases to guide future studies and enhance evidence-based nursing care.
The study highlights key trends and gaps in nursing research on neurodegenerative diseases, calling for a more inclusive, equitable, and comprehensive research agenda.
PRISMA-ScR guidelines.
This study did not include patient or public involvement in its design, conduct or reporting.
Review registration was done on Open Science Framework, and can be viewed at https://osf.io/tn5v9 (https://doi.org/10.17605/OSF.IO/TN5V9)
Hypertensive ulcer, also known as Martorell ulcer, comprises cutaneous lesions induced by microvascular arteriolitis, which leads to ischaemia and subsequent ulceration in patients with long-standing hypertension. These lesions predominantly affect women and have traditionally been considered rare; however, recent studies suggest that their prevalence may be significantly higher than previously assumed. Early and accurate diagnosis is crucial, as these ulcers are often mistaken for lesions of alternative aetiologies, such as venous ulcers or pyoderma gangrenosum, thereby contributing to their frequent underdiagnosis. Moreover, this pathology is associated with pronounced painful symptomatology and exhibits a suboptimal response to both analgesic regimens and conventional wound care protocols, potentially necessitating alternative management strategies. This diagnostic delay or misdiagnosis consequently escalates the utilisation of healthcare resources. The primary objective of this study was to develop a predictive model for the differential diagnosis of Martorell ulcers. The investigation entailed a systematic case review, during which the most prevalent signs and symptoms, medical histories and demographic characteristics associated with these lesions were scrutinised. A comprehensive descriptive and inferential analysis of the various variables was performed, followed by a binomial logistic regression to construct the predictive model. In this logistic regression analysis, systolic blood pressure (SBP) emerged as the principal predictor among the cases examined. Additionally, pain intensity was incorporated into the predictive model as a clinically relevant variable, thereby confirming its utility in conjunction with SBP for the identification of this pathology. These findings underscore the importance of integrating key variables, such as elevated SBP and severe pain, into diagnostic tools to enhance early detection and clinical management of Martorell ulcers.
To synthesise current evidence on physiotherapists’ use of electronic health records (EHRs), with a focus on the determinants of adoption, implementation processes and associated implementation outcomes.
A systematic review employing a narrative synthesis approach.
PubMed, Cochrane, Scopus and Web of Science, covering all records from the inception of each database to 10 May 2024.
Studies conducted in physiotherapy clinical settings and using the International Classification of Functioning, Disability and Health (ICF).
Two authors independently screened articles and assessed methodological quality. Risk of bias was assessed using the Critical Appraisal Skills Programme tool for qualitative and for cohort studies, the Mixed Methods Appraisal Tool for mixed-methods studies and the JBI Critical Appraisal Checklist for analytical cross-sectional studies.
From 3820 records screened, 9 observational studies met inclusion criteria. Key factors influencing EHR adoption included organisational readiness, perceived usefulness, managerial support and training availability. Implementation patterns clustered into three domains: recorded content, ICF framework integration and record quality. Reported outcomes focused on care quality metrics and evidence of clinical effectiveness.
Persistent challenges in physiotherapy EHR use were identified, notably in data quality, completeness and alignment with the ICF framework. Improving EHR practices is crucial to improve clinical assessment and support digital health integration. However, limited evidence and methodological heterogeneity remain key limitations.
CRD42023420267.
To conduct a concept analysis of ‘safe mobility’, with specific application in hospitalised older adults, identifying its defining attributes, antecedents and consequences.
The promotion of safe mobility is essential for maintaining the functionality of hospitalised older adults. However, this idea is not yet clearly defined in the scientific literature, requiring a conceptual analysis for better understanding and applicability in nursing practice.
Concept analysis.
The concept analysis methodology of Walker and Avant was employed, consisting of eight steps. Sources from the scientific literature (BDENF/VHL, Scopus, CINAHL/EBSCO, Embase, Web of Science, PEDro, MEDLINE/PubMed and CAPES Thesis and Dissertation Catalogue, as outlined in a scoping review previously published by the authors) and terminologies from dictionaries and nursing practice, such as SNOMED CT, ICNP, NANDA, NIC and NOC, were analysed.
The concept of ‘safe mobility’ does not have a consolidated definition but was identified through three defining attributes: active movement, prevention of fall-related harm and prevention of immobility-related harm. The antecedents include the older adults' conditions, adaptation of the hospital environment, training of the multidisciplinary team, patient behaviour and family involvement. The consequences involve the maintenance of functionality, improvement of quality of life, reduction of hospital length of stay and costs, as well as a decrease in rates of readmission, referrals to long-term care institutions and mortality.
The concept analysis revealed that safe mobility involves promoting active movement and preventing harm related to both immobility and falls.
Strategies based on this concept can improve the quality of life of older adults, reduce complications and optimise hospital costs.
This concept analysis examines existing literature and does not require patient-related data collection. The methodological approach does not necessitate collaboration with the public.
Introducción: Algunas prácticas ambientales arraigadas culturalmente ocasionan enfermedades infantiles como: diarreas, neumonías, dermatitis, lesiones domésticas no intencionales, etc. Objetivos: Describir las prácticas culturales y ambientales del ámbito rural de Perú que influyen en la salud infantil. Metodología: Investigación cualitativa, descriptiva, el escenario fueron los hogares de 15 madres de familia, residentes rurales de la costa norte de Perú; la muestra fue delimitada por saturación y redundancia, el muestreo no probabilístico por conveniencia. Los datos se recolectaron mediante entrevista semiestructurada y procesados según el análisis de contenido. Resultados: A) Riesgo en la salud infantil por práctica cultural y ambiental de cocina a fuego abierto, B) Práctica cultural y ambiental en la eliminación de excretas, C) Costumbre de quema de residuos sólidos. Conclusiones: La mayoría de las madres de la zona rural cocinan a fuego abierto, usan leña, esto es un riesgo para los niños que permanecen con ellas. Eliminan las excretas en pozos ciegos, debido a la falta de saneamiento. Además, manifiestan un inadecuado manejo de residuos sólidos, eliminados en espacios abiertos que favorecen la proliferación de vectores, para posteriormente ser quemados.
En el presente artículo se presenta la ciencia como un producto cultural occidental que ha evolucionado desde la modernidad. Debido a ello se obtuvo su forma actual, la cual logró imponerse, por su efectividad, a nivel global. Se reflexiona también sobre el origen y la evolución de lo que se conoce como “método científico” y se problematiza la naturaleza de la hipótesis y su corroboración empírica. El objetivo de este trabajo es reflexionar epistemológicamente sobre la práctica social de la ciencia, el método y la hipótesis científica. El escrito está estructurado en tres apartados. El primero, presenta la ciencia y el método científico desde sus orígenes hasta la actualidad. El segundo, se centra en los supuestos epistemológicos del método científico, profundizando en el inductivismo y las diversas alternativas que Bunge, Popper y Hempel plantean. Por último, se analiza la hipótesis científica, estudiando su naturaleza y los requisitos obligatorios que esta exige. Concluye sosteniendo que la “ciencia” es un producto occidental con tendencias empiristas y en muchos casos experimentales. Además, se logró determinar los componentes fundamentales del método científico, el cual no es estático, pues varía cada vez que cambia la concepción o la práctica social de la ciencia. Asimismo, se estableció que la contrastación empírica es fundamental para confrontar la hipótesis con la realidad.
El vínculo entre las artes y la salud tiene una larga historia, desde el uso clínico de la creatividad hasta el uso recreativo y ambiental de las artes. La cultura puede ofrecer estrategias sanitarias no médicas que mejoran notablemente el bienestar, la salud y la calidad de vida de los ciudadanos. Esta perspectiva abre un nuevo campo de acción a los agentes culturales y creativos conectándolos con las necesidades de su entorno social e incrementando su capacidad para producir valor público. Este trabajo pretende mostrar algunas prácticas realizadas en el contexto de la cultura y la salud que podrían ser consideradas como activos sociales y culturales de la salud por su repercusión en el bienestar de la población; un segundo objetivo se acerca a la terminología de activos para la salud para tratar de incluir la cultura como activo en la frontera del “Cultural prescribing”, un “turismo de receta”.
Introducción: El cáncer es una enfermedad compleja y desafiante que afecta no solo la salud física, sino también las dimensiones emocionales, sociales y espirituales de los individuos. Objetivo: Describir las experiencias de un grupo de personas sobrevivientes al cáncer. Método: Se llevó a cabo un estudio cualitativo de tipo etnográfico. La saturación teórica se alcanzó con la participación de 15 personas sobrevivientes de cáncer seleccionadas mediante muestreo en bola de nieve. La recolección de datos se realizó mediante entrevistas semiestructuradas, previo consentimiento informado de los participantes, utilizando la guía propuesta por Leininger para el análisis de datos cualitativos. Resultados: La experiencia de los participantes al haber superado el cáncer se describió en cuatro categorías: el cáncer como sinónimo de muerte, el apoyo familiar, la resiliencia como recurso psicológico crucial y la importancia de la fe en Dios como un bálsamo de vida. Conclusiones: La experiencia de recuperación ante un cáncer comienza con incertidumbre y miedo, asociando inicialmente el diagnóstico con la muerte; pero, con el tiempo, los sobrevivientes logran enfrentar la enfermedad desarrollando una actitud resiliente.
by Chie Kurosaka, Shinji Miyake, Makoto Kobayashi, Chika Tagata, Yuka Tatsumi
This study examined green tea’s effects on task performance, mental fatigue, workload, and flow experience. Twenty-two healthy young male participants (mean ± SD age = 21.86 ± 1.96 years, range = 18–26 years) completed two 5-min mental tasks (arithmetic and sequential digit search) under three beverage consumption conditions: no beverage (NONE), WATER, and TEA (green tea). In the WATER and TEA conditions, participants consumed 70 mL of beverage three times during the session (total: 210 mL). Subjective Fatigue Feelings was assessed before and after each condition, and subjective evaluations including NASA Task Load Index, Flow Experience Checklist, and Duration Judgment Ratio, were conducted after each task. Results showed no significant differences in task performance across conditions (p > 0.05, η² = 0.11 and η² = 0.02 for MATH and SDS tasks, respectively), likely due to ceiling effects (accuracy > 95%). In the TEA condition, arousal levels were maintained and no increase in mental fatigue was observed, unlike the other conditions. The flow state score in the TEA condition was significantly higher than that in other conditions (NONE vs TEA: p = 0.0009), and participants perceived shorter task duration (NONE vs TEA: p = 0.0016, WATER vs TEA: p = 0.0061). These effects were observed even with small amounts of beverage and short consumption periods, suggesting that habitual intake of low-dose green tea may enhance task engagement and flow experience in everyday tasks.by Ana Paula Cândido Oliveira, Daniela Alencar Vieira, Cristiane Wanderley Cardoso, Tereza Magalhães, Rosangela Oliveira Anjos, Eduardo José Farias Borges Reis, Kionna Oliveira Bernardes Santos, Guilherme Sousa Ribeiro
Work ability is a subjective concept that reflects the balance between an individual’s perception of the physical, mental, and social demands of work and their competence and resources to meet those demands. The COVID-19 crisis significantly impacted health, work, and socioeconomic conditions worldwide. However, few studies have examined work ability in disadvantaged urban communities during this period. To analyze factors associated with work ability within the context of social vulnerability during the COVID-19 pandemic, we conducted a cross-sectional study in a low-income neighborhood in Salvador, Brazil, between February and June 2022. Sociodemographic, health, and labor data were collected, and work ability was assessed using the Work Ability Index (WAI), a widely used tool for evaluating work ability. Multivariable analyses based on a hierarchical model were run to investigate factors associated with low WAI scores. The study included 292 workers aged ≥16 years (59.6% women; median age 41 years). Most workers (84.6%) were classified as having adequate work ability based on their WAI scores. Multivariable analyses found that inadequate work ability was more frequent among women (prevalence ratio [PR]: 1.89, 95% confidence interval [CI]: 1.02-3.48), individuals who self-rated their health as moderate/good (PR: 5.91; 95% CI: 1.45-24.05) or poor/very poor (PR: 21.62; 95% CI: 5.14-90.91) compared to those with excellent/very good health, and those reporting diabetes (PR: 2.1; 95% CI: 1.13-3.9). Working >40 hours per week (PR: 0.47; 95% CI: 0.28-0.96) was negatively associated with inadequate work ability, suggesting that individuals with adequate work ability may be selected for longer working hours. A history of COVID-19 was not associated with inadequate work ability. These findings suggest that targeted interventions to improve work ability in low-income communities should prioritize women and workers with chronic health conditions, such as diabetes.To describe the prevalence and determinants of workplace violence against nurses in the Italian home care setting.
Secondary cross-sectional analysis of data from the multicentre study AIDOMUS-IT.
Nurses employed in home care services provided by Italian Local Health Authorities were interviewed using a variety of instruments. A multivariable binary logistic regression model was performed to model the risk of workplace violence against nurses in the last 12 months. Variables related to violence were selected among sociodemographic characteristics (such as age and gender), work-related factors (including years of experience, team composition, overtime working, previous experience in mental health care, burnout) and organisational elements (including leadership and support, workload, staffing and resources adequacy, and time to reach the patients' homes). Adjusted odds ratios (aOR) were used to present the results.
A total of 3949 nurses participated in the study and 20.49% of them reported to have experienced an episode of violence in the last 12 months. Determinants of higher risk of violence episodes were younger age (aOR = 1.02, p = 0.002), higher workload (aOR = 1.01, p = 0.002), working in a multiprofessional team (aOR = 1.24, p = 0.018), perception of inadequate managerial leadership and support (aOR = 1.38, p = 0.003), and higher burnout levels (aOR = 1.01, p < 0.001).
The prevalence of workplace violence against Italian home care nurses is high. Several modifiable determinants were found to be associated with a higher risk of violence, which can potentially be mitigated with tailored interventions.
Effective preventive strategies must be developed to lessen workplace violence against nurses in the home care setting. These strategies should focus on strengthening nursing managers' leadership and support skills, enhancing team-building strategies, avoiding inadequate workload, monitoring nurses' burnout, estimating optimum staffing levels, and assigning advanced-career nurses to home care services. These measures are imperative to guarantee the quality and safety of home care organisations and to attain favourable outcomes in the provision of care.
This study aimed to explore the prevalence and determinants of workplace violence against nurses in the Italian home care settings. We found that out of the 3949 nurses surveyed, 20% of the sample reported one episode of violence during the last 12 months. Determinants of this violence included younger age, higher workload and burnout, being in a multiprofessional team, and perception of lack of leadership and support by the nurse manager. The results of this study can be used to tailor interventions aimed at mitigating the risk factors of violence, particularly those that can be modified (e.g., workload, burnout, and leadership).
The study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
No patient or public contribution.
Direct oral anticoagulants (DOACs) are preferred over vitamin K antagonists for stroke prophylaxis in non-valvular atrial fibrillation. Yet, DOAC use is regarded as a contraindication for intravenous thrombolysis in acute ischaemic stroke. The stratification of patients into ‘on-therapy’ and ‘off-therapy’ categories based on their plasma DOAC concentrations is particularly crucial in the acute phase of stroke when decisions for thrombolysis or anticoagulation reversal are time-sensitive. The novel point-of-care DOAC dipstick assay (DOASENSE) rapidly assesses urine for clinically significant DOAC levels, potentially broadening eligibility for thrombolysis or targeted reversal therapy. This multicentre prospective observational registry study aims to evaluate the accuracy and clinical utility of DOAC dipstick testing compared with plasma DOAC assays in acute stroke management across regional Australian hospitals.
This multicentre, prospective, observational study will enrol participants presenting to hospitals across Victoria and Tasmania with acute ischaemic stroke or intracerebral haemorrhage with DOAC ingestion within 48 hours of presentation. Plasma DOAC concentrations measured by chromogenic assays will be compared with rapid urine dipstick results from DOASENSE testing. There is a target sample size of 146 participants. The primary outcomes are as follows: (1) proportion of ischaemic stroke participants with off-therapy plasma DOAC levels and (2) eligibility for reperfusion therapy based on DOASENSE and plasma DOAC concentrations. Secondary outcomes are follows: (1) ischaemic stroke aetiology for participants with on-therapy vs off-therapy DOAC levels; (2) proportion of participants meeting criteria for pharmacological DOAC reversal based on DOASENSE outcomes; (3) incidence of false-negative and false positive DOASENSE results in clinically significant DOAC plasma concentrations at a threshold of ≥30 ng/mL and (4) an exploratory analysis of any false negative DOASENSE assays to identify potential contributing factors.
Ethics approval has been granted by the Eastern Health Human Research Ethics Committee (reference number: 99628). Dissemination of findings will occur through peer-reviewed publications and academic conferences.
Obstructive sleep apnoea (OSA) affects 1–5% of the paediatric population, including 55–90% of children with Down syndrome (DS), and has been associated with negative effects on neurocognitive development, cardiovascular health, immune development and quality of life. In-lab attended polysomnography (PSG) is currently the gold standard for the diagnosis of OSA in children, but it poses challenges due to the burden on families and limited testing facilities. Home sleep apnoea testing (HSAT), an unattended sleep test done at home, is an accepted alternative for adults but lacks sufficient evidence to be used clinically for the evaluation of OSA in children. HSAT may be especially beneficial for children with DS or others with sensory issues or those who struggle with sleeping in a laboratory setting overnight.
This single-centre trial compares HSAT to PSG for the diagnosis of OSA in children, including those with DS. The trial will enrol 317 children 5–12 years old, including approximately 100 with DS. The primary outcome is the diagnostic accuracy of HSAT compared with PSG for OSA evaluated through ROC. Secondary outcomes include the agreement between HSAT and PSG for therapeutic decision-making and comparison of preference and acceptability of HSAT versus PSG. This trial seeks to evaluate HSAT as an alternative diagnostic tool for paediatric OSA, potentially expanding testing options for clinicians and families.
This study has been approved by the Institutional Review Board at Children’s Hospital of Philadelphia (#21–0 19 533). Informed consent will be obtained from all participants, and no identifiable data will be reported.
FreshRSS 