Conectar
Post-intensive care syndrome (PICS) is defined as mental, physical, cognitive, and social sequelae in survivors of critical illness. Survivors of liver transplantation exhibit a complex clinical condition following discharge from the intensive care unit (ICU). There is a lack of knowledge about the lived experience of PICS in survivors after liver transplantation.
Describe the lived experiences of PICS in ICU survivors following liver transplantation.
A phenomenological study was carried out using interpretative phenomenological analysis (IPA). Semi-structured interviews were conducted with ICU survivors one month after discharge.
Twenty ICU survivors were enrolled and interviewed after critical illness. The main themes that emerged from the data analysis were: (1) Profound life reorientation, (2) Physical impairment, (3) Psychological distress experiences, (4) Human-Centred Nursing Care, and (5) Return to daily life. Our results showed a particular impact of the dimensions of PICS, such as mental, physical, and social dimensions, on ICU survivors after liver transplantation.
The study concludes that ICU survivors experience profound life reorientation, physical impairment, and psychological distress experiences, yet benefit from human-centred nursing care, which facilitates their eventual return to daily life.
The findings highlight the importance of human-centred nursing care in the post-ICU recovery process, where the multidisciplinary team plays a critical role in addressing both psychological distress and physical rehabilitation, supporting survivors' reintegration into daily life.
Post-liver transplant ICU survivors experience profound physical, psychological, and social impacts. Life reorientation, altered body image, and emotional distress emerge. Human-centred nursing facilitates rehabilitation, reintegration, and overall recovery.
Reporting was structured based on the COREQ checklist.
Prot. N. 00014635–31/05/2023
In middle-income to high-income countries, temporary accommodation (TA), regardless of type, is considered a form of homelessness. Families with young children living in these countries, in these circumstances, often become disconnected from friends, family and services (such as health and welfare support). The additional impact of pandemic restrictions on parents with children under 5 already living in TA had the potential to be considerable. However, this remains an area of limited research. To address this, this study explored the experiences of parents with children under 5, who lived in TA during the pandemic.
The research adopted a qualitative descriptive approach, using semi-structured telephone interviews with 41 families, to explore parents’ experiences of living in TA during the pandemic, with a child under 5. Interviews considered a broad range of factors such as housing quality, access to healthcare and education and the environment. Interviews were audio-recorded, transcribed verbatim and then analysed using a thematic analysis approach.
Parent interviews identified that living in TA with a child under 5 during the pandemic impacted their access to services such as healthcare and ability to gather resources, while also affecting their mental health and general well-being. These parent experiences were detailed in three themes, including: (1) effect of restrictions on access, which included healthcare, environment and basic necessities; (2) impact on parents, which included mental health, physical and social impacts and (3) supports, including support services and networks.
The challenges conveyed by COVID-19 restrictions, on those already parenting a young child while living in TA, caused concerning health impacts for those affected, while also having potential developmental side effects on their children. This indicates the urgent need for targeted interventions and policies to support vulnerable families in TA, ensuring their well-being during crises and beyond.
Parkinson’s disease (PD) is a chronic neurodegenerative condition that affects approximately 10 million people worldwide. As the second most common neurodegenerative disease, its prevalence is expected to double in the next 30 years. PD is characterised by both motor and non-motor symptoms that significantly impact patients’ quality of life. The disease leads to physical disabilities and can strain the social and emotional well-being of patients and caregivers. While pharmacological and surgical treatments are essential, non-pharmacological approaches, including self-care strategies, play a critical role in managing the disease. This study protocol aims to describe methodological steps required to explore the self-care behaviours of patients with PD and their caregivers, with a particular focus on the dimensions of self-care maintenance, monitoring and management.
This mixed-method study will involve dyads of patients with PD and their caregivers. Participants will be recruited from the PD and Movement Disorders Centre of the "Azienda Socio Sanitaria Territoriale (ASST) Gaetano Pini-Centro Traumatologico Ortopedico (CTO)". Validated questionnaires, such as the WHOQOL-Bref, the version 2 Self-Care of Chronic Illness Inventory, and the Caregiver Self-Efficacy in Contributing to Self-Care Scale, will be administered. The study will also include semistructured interviews to collect qualitative data on patients’ and caregivers’ perceptions of self-care. A non-probabilistic convenience sampling method will be employed, encompassing both patients at any stage of disease and their primary caregivers. The estimated sample size is 311 dyads, calculated to provide a 5% margin of error.
The study has been approved by the Lombardia 3 ethics committee (identification (ID) study 5732 12.03.2025 P bis). All participants will sign a written informed consent document. Ethical considerations include ensuring participant confidentiality, voluntary participation and the right to withdraw at any time without consequence. The study results will be disseminated through national and international conferences and published in clinical research journals to contribute to the broader understanding of self-care in the management of PD.
NCT06953050 (clinicaltrials.gov).
Transitions of care (TOC) between hospital, ambulatory and home settings for high-risk adults with chronic diseases are complex, costly and often result in poor health outcomes. Suboptimal care transitions lead to medication errors, non-adherence, decreased self-management skills and inadequate follow-up, all of which contribute to readmissions or emergency department visits. The Transitional Care Model aims to address these challenges through patient-centred, in-home interventions. We propose to implement and evaluate TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for Chronic Obstructive Pulmonary Disease (COPD) patients. This study will evaluate the added value of a virtual, pharmacy-based intervention integrated into an existing COPD TOC program within a single healthcare system.
Informed by the Proctor Framework implementation, service and health outcome domains, we will conduct a randomised controlled trial comparing the addition of at-home pharmacy team-based virtual visits to the standard of care (ie, our existing COPD TOC programme). Adult patients hospitalised for a COPD exacerbation will be randomised to receive the standard COPD TOC programme alone or the standard programme plus TELE-TOC virtual at-home pharmacy visits. We will use a pragmatic type II hybrid effectiveness-implementation trial. The primary effectiveness outcome is inhaler technique at 30 days postdischarge, and the primary implementation outcome is the proportion of patients receiving the intervention. Intention-to-treat analysis will be applied to all outcomes with ² and logistic regression models adjusting for demographic factors. Treatment effects through 30 days will be assessed with generalised estimating equations and generalised linear mixed models.
This study, the waiver of consent and the opt-out flyer were approved by the University of Chicago Institutional Review Board (23–0934). Dissemination of the findings is planned for up to 4 years of completion of the study to local, regional and national conferences and peer-reviewed journals.
To assess the capability of a convolutional neural network trained by transfer learning on anterior segment optical coherence tomography (AS-OCT) images, Placido-disk corneal topography images and external photographs to predict age and biological sex.
Development of a deep learning model trained on retrospectively collected data using transfer learning.
A multicentre secondary care public health trust based in London.
We included 557,468 scans from 40,592 eyes of 20,542 patients. Data were extracted from all patients who underwent MS-39 imaging within our trust from October 2020 to March 2023.
Primary outcome measures for biological sex classification included accuracy, precision, recall, F1-score and area under the receiver operating curve (ROC-AUC). Primary outcome measures for age prediction were Pearson correlation coefficients (r), coefficients of determination (R²) and the mean absolute error (MAE) to evaluate the predictive performance. The secondary outcome was to visualise and interpret the model’s decision-making process through the construction of saliency maps.
For age prediction, the MAEs for the Placido, AS-OCT and external photograph models were 5.2, 5.1 and 6.2 years, respectively. For gender classification, the same models achieved ROC-AUCs of 0.88, 0.73 and 0.81, respectively. No difference in performance was found in the analysis of corneas with pathological topography. The saliency maps highlighted the peri-limbal cornea for age prediction and the central cornea for gender discrimination.
Our study demonstrates that deep learning models can extract age and gender information from anterior segment images. These findings support the concept that the anterior segment, like the retina, encodes important biological information. Future research should explore whether these models can predict specific systemic conditions.
To examine the concept of obstetric violence culture and establish a working definition for application to practice, research, and policy in perinatal care.
Concept analysis.
Rodgers' evolutionary method guided the analysis and data organisation into antecedents, attributes, and consequences.
A systematic search using the phrase ‘obstetric violence’ was conducted in CINAHL and PubMed databases. Articles published in English between November 1, 2020, and December 31, 2024, were included.
Sixty-two articles were included. Antecedents reflected the historical medicalisation of birth, professional hierarchies, and structural inequities. Attributes—disbelief of harm, victim blaming, revictimisation, and disempowerment—mirror those identified in rape culture. Consequences spanned birthing people, clinicians, and systems, including mistrust, moral distress, and institutional silence. The resulting definition frames obstetric violence culture as an embedded and normalised set of practices and beliefs that sustain mistreatment in perinatal care.
Obstetric violence culture is not an outlier, but a pervasive and institutionalised framework to be systematically dismantled.
Nurses have an ethical obligation to recognise and disrupt obstetric violence culture. Structural change, clinical education, and institutional accountability are necessary to uphold patient autonomy and dignity.
This study followed Rodgers' evolutionary method and adheres to relevant EQUATOR guidelines for conceptual research.
This study did not include patient or public involvement.
To address the growing prevalence of sedentary behaviours among older adults and their associated adverse health outcomes, there is an urgent need to prioritise effective and accessible interventions. Mobile health (mHealth) delivers healthcare services and health-related information through portable electronic devices, enabling interventions to be administered directly in home settings. However, the evidence on the effectiveness of mHealth interventions in reducing sitting time among older adults remains inconsistent. To derive literature-based estimates of the effectiveness of mHealth interventions, we will systematically review and meta-analyse the impact of these interventions on sitting time in adults aged 55 years and older.
An electronic search of PubMed, Embase, Web of Science and Cochrane will be conducted from database inception to March 2025 to identify randomised controlled trials evaluating the effects of mHealth interventions on sitting time during waking hours, excluding sleep duration. Subgroup analyses will explore potential moderators (eg, participant characteristics, intervention specifics). Studies from all settings (eg, community, long-term care facilities, etc) will be considered. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines will be explicitly applied for structuring this report. Methodological quality will be assessed using the Cochrane Handbook tool. Two independent reviewers will screen the studies and extracted data, with methodological quality to be assessed using established criteria. Meta-analyses will be performed using Review Manager v.5.4 software.
This study uses secondary data and, therefore, does not require ethics approval. The findings will be communicated through presentations at international conferences and published in peer-reviewed journals. The results will inform the development of future mHealth interventions aimed at reducing sedentary behaviour in older adults and provide benchmarks for the effectiveness of technology-driven public health strategies. This protocol adheres to the PRISMA guidelines and follows the Cochrane Handbook for Systematic Reviews of Interventions for methodological rigour.
CRD42023443926.
To adapt and validate the HSOPS 2 instrument for the Italian context and to describe the current patient safety culture amongst healthcare personnel working in Italian hospitals.
Cross-sectional study.
We adapted and validated the HSOPS 2 instrument following the COSMIN guidelines: we performed a forward-backward translation, calculated the content validity index, evaluated face validity, acceptability (percentage of participants responding to all items on the questionnaire and to every specific item), construct validity (confirmatory factor analysis), and internal consistency (Cronbach's alpha for each dimension). We then performed a cross-sectional study following the guidelines of the original instrument: we categorised the responses into “positive,” “negative,” and “midpoints.” For each dimension we calculated the average percentage of positive responses. We repeated this process, dividing the responses by various sample characteristics (e.g., profession), and compared them using the chi-square test. Data were collected between April and November 2023.
A total of 633 hospital personnel participated in the survey, and 473 completed the questionnaire in its entirety. The dimensions of “teamwork”, “supervisor”, “manager”, or “clinical leader support”, and “communication about error” emerged as dimensions with higher percentages of positive responses, while those that received lower percentages were “hospital management support for patient safety”, “staffing and work pace”, and “response to error”. We identified statistically significant differences in many dimensions between gender, profession, and clinical inpatient units.
These findings provide a comprehensive overview of challenges and opportunities within the healthcare sector as regards patient safety culture and can inform the development of targeted interventions aimed at improving patient safety across healthcare organisations.
Proper assessment of safety culture, one of the main indicators of patient safety, can inform the development of effective strategies and interventions to enhance patient safety.
What problem did the study address? To effectively assess patient safety culture, it is essential to use valid and reliable tools. It is crucial to proactively assess patient safety culture in hospital personnel, whether employed in clinical units, in management, or in support services, to develop initiatives aimed at improving patient safety.
What were the main findings? The use of the adapted and validated version of the HSOPS 2 will produce valid and reliable evidence on patient safety culture. Perception of patient safety culture differs amongst respondents according to gender, profession, clinical setting. The dimensions of “hospital management support for patient safety”, “staffing and work pace”, and “response to error” were identified as those with the greatest need for improvement.
Where and on whom will the research have an impact? Patient safety heavily impacts care at every level; therefore, this study could have an impact on healthcare organisations as well as healthcare workers, patients, and their families. By making available an instrument that can contribute to a proper assessment of patient safety culture, this study might contribute to the development of appropriate strategies and targeted interventions to improve patient safety, quality of care and satisfaction while decreasing adverse events and related costs.
The COSMIN guidelines were used for the validation of the instrument; the STROBE reporting guidelines were used for the cross-sectional study.
No patient or public contribution.
Patients living with chronic obstructive pulmonary disease (COPD) experience periods of disease stability and exacerbations (ECOPD). COPD imposes a negative and impactful extrapulmonary impairment and commonly overlaps with multimorbidity, particularly cardiovascular disease. Pulmonary rehabilitation (PR) aims to improve physical activity (PA) and quality of life, while behavioural change interventions (BCIs) aim to promote lifestyle changes and autonomy. However, after ECOPD, a variety of barriers often delay patient referral to PR. This study aims to assess the effects of a BCI for patients after ECOPD, focusing on cardiovascular health, PA and functionality. Additionally, the study will assess 6-month sustainability of PA and conduct a cost-utility analysis comparing a non-intervention group in the Unified Health System.
This randomised clinical trial will assess patients with ECOPD over 12 weeks using a BCI based on self-determination theory to increase daily steps. First, the cardiovascular and functional profile will be evaluated. Afterwards, the patients will receive an accelerometer to monitor the PA level. After 7 days, questionnaires will be applied on quality of life, symptoms and motivational levels for PA. Patients will be randomised into control group or intervention groups, both will receive educational booklets and IG will also receive an educational interview. PA will be tracked using activPAL accelerometer at weeks 1, 4 and 12, and follow-up at 6 months. Data analysis will include unpaired Student’s t-test or Mann-Whitney test for group comparison, and a linear mixed model to assess intervention effects over time. Economic evaluation, using STATA (V.14), will involve correlation analysis, and p
This study has been approved by the Federal University of São Carlos’ Ethics Committee, Irmandade Santa Casa de Misericórdia de São Carlos and Base Hospital of São José do Rio Preto. All procedures will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and applicable regulatory requirements. All results will be presented in peer-reviewed medical journals and international conferences.
Brazilian Registry of Clinical Trials under the registration number RBR-6m9pwb7.
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.
Hospitalisation is one of the most stressful life events for older adults, particularly for those who are pre-frail or frail. Multi-component community-based interventions have the potential to address the complex needs of older adults post-acute care admission. While some available interventions have been developed with end-user engagement, fully involving older people who are pre-frail or frail in the design of interventions has been less common. Multi-component community-based interventions that address the needs of older adults and their care partners with potential implementation barriers informed by healthcare providers, community partners and health system decision makers are needed. This protocol paper describes the planned process of co-designing for older patients discharged into the community, a Post-Acute Care Intervention for Frailty using Information and Communication technology.
The development of a complex multi-component frailty intervention which meets older people’s needs involves several concurrent tasks and methodologies, each informed by co-design and conducted with consideration to eventual implementation. These tasks include: (1) establishing a Research Advisory Board, (2) assessing the feasibility and validity of using hospital administrative data to identify frail or pre-frail older adults and their needs, (3) conducting a needs assessment of patients returning to the community, (4) mapping community assets to identify existing programmes and services to help tailor the intervention, (5) co-designing a multicomponent frailty intervention, (6) selecting study outcome measures and (7) selecting and tailoring a digital health patient portal to support intervention delivery, data capture and communication.
Each task requiring ethics approval will be submitted to the Hamilton Integrated Research Ethics Board at McMaster University. Results will be disseminated through peer-reviewed journal articles, conferences and networks of relevant knowledge users who have the capacity to promote dissemination of the results. A toolkit will be developed to help researchers and healthcare providers replicate the methodology for other populations.
To identify distinct sleep quality patterns among patients with heart failure (HF) using a person-centred approach and explore demographic and clinical predictors of these patterns.
Secondary analysis of baseline cross-sectional data from the MOTIVATE-HF (MOTIVATional intErviewing to improve self-care in Heart Failure patients) randomised controlled trial. Latent class analysis (LCA) was applied to Pittsburgh Sleep Quality Index (PSQI) component scores to identify distinct subgroups of patients. Demographic, clinical and psychological variables were examined as potential predictors of cluster membership.
Three healthcare settings in Italy: hospital, outpatient and community-based care.
510 adult patients diagnosed with HF (New York Heart Association (NYHA) class II–IV) with poor self-care were included. Patients with severe cognitive impairment or recent myocardial infarction were excluded.
Primary outcome: Sleep quality, measured using the PSQI, analysed through LCA to identify sleep disturbance clusters. Secondary outcomes included demographic and clinical characteristics predicting cluster membership.
The mean age was 72.4 years (SD=12.3), with most participants married or partnered (62%) and retired or unemployed (83.9%). Mild comorbidities were present in 53.3% of the sample (mean Charlson Comorbidity Index (CCI)=2.91, SD=1.98), and 61.4% were classified in NYHA class II. Three sleep quality clusters emerged: (1) adequate sleep duration but disturbed sleep and daytime dysfunction (46.1%); (2) severe sleep problems with low use of sleeping medications (25.3%); and (3) minor sleep problems with mild disturbances (28.6%). Patients in Cluster 1 were older (mean age=73.3 years), had lower physical and mental quality of life (Short-Form 12 Physical Component Summary=33.66; Mental Component Summary=42.65), and higher anxiety (Hospital Anxiety and Depression Scale-A=8.82). Patients in Cluster 2 had more severe comorbidities (CCI=3.55), poorer cognitive function (Montreal Cognitive Assessment (MoCA)=21.5) and lower ejection fraction (mean=40%). Patients in Cluster 3 were younger (mean age=68.2 years), had better cardiac function (ejection fraction=46.6%), better cognitive status (MoCA=24.5) and the highest quality of life (Kansas City Cardiomyopathy Questionnaire=63.1).
Patients with HF exhibit heterogeneous sleep quality patterns with specific clinical and psychological profiles. These findings highlight the need for personalised interventions, systematic sleep assessments and the integration of cardiac rehabilitation strategies into standard HF care.
VALTIVE1 is a multi-centre, single-arm, non-interventional biomarker study for patients with advanced ovarian cancer. Plasma samples (Tie2 concentration) are collected to detect vascular control in tumours during standard treatment with chemotherapy and bevacizumab. This qualitative study embedded in VALTIVE1 aimed to assess the acceptability and feasibility of a potential VALTIVE2 trial. It explored the participants’ perceptions of the study and treatments and how they might feel if bevacizumab were discontinued based on the results from the biomarker test.
This qualitative study used semi-structured telephone interviews, which were analysed using deductive and inductive thematic analysis.
Cancer treatment sites in the UK.
Participants recruited to VALTIVE1 were invited to take part in qualitative interviews. 11 female participants took part from four clinical sites.
Participants reported that they experienced side effects attributed to bevacizumab, including stiffness, pain, fatigue, nose bleeds and muscle aches. Participants felt that combining chemotherapy and bevacizumab may have increased the severity of the side effects they experienced. Most participants felt that it was acceptable, if not preferable, to be allocated to a group in a future VALTIVE2 study where bevacizumab may be discontinued according to the results from the biomarker test. A clear preference of participants was to be informed of the biomarker test results, health status and treatment side effects.
A future trial should consider ensuring all participants have access to test results, as participants indicated a preference to know whether bevacizumab was working and to discontinue bevacizumab if it had not prevented tumour growth based on the biomarker results. Comprehensive and ongoing information and support regarding treatment side effects should be provided to all participants throughout their cancer pathways and trials.
Cardiovascular (CV) diseases are associated with adverse outcomes. However, attention has typically focused on outcomes considered relevant by doctors, whereas the potential gap in perception and relative importance of outcomes that may exist between patients and doctors has been scarcely explored. Evidence available reports the views of either patients or doctors alone, and data are analysed in aggregate. We investigated this issue by surveying for the first time patients’ and doctors’ opinions simultaneously, on a one-to-one basis.
Survey involving patients with different CV diseases. Each patient and their attending doctor were asked to simultaneously but independently gauge the importance each attached to a predetermined set of outcomes, filling out disease-specific questionnaires. Results were analysed by compositional analysis.
Inpatients and outpatients being seen by cardiologists and internal medicine specialists at hospitals affiliated with the National Health System in Umbria, Italy.
All-comer patients, presenting with one of the following conditions: atrial fibrillation (AF), myocardial infarction (MI), heart failure (HF) or considered at high CV risk.
Importance attached to outcomes relative to life path, quality of life, future clinical events.
From 337 paired questionnaires returned, significant differences between patients’ and doctors’ perspectives emerged. Specifically: (1) patients with AF were significantly less concerned about the risk of stroke than doctors; (2) worsening of HF was a greater concern for doctors than patients, whereas patients weighed the risk of disability more; (3) patients with a previous MI, or at high CV risk, weighed the risk of hospitalisation less relevant than doctors, but were significantly more concerned about the risk of disability.
Simultaneous, one-to-one assessment of patients’ and doctors’ opinion shows remarkable differences between patients’ perception and physicians’ judgement concerning the relevance of major CV outcomes. Appreciation and sharing of these issues may inform better tailoring of cardiac care.
To map the available evidence on genomic literacy among clinical nurses, nursing students and nursing faculty.
Systematic scoping review.
A comprehensive search was conducted in PubMed, CINAHL, Scopus, Web of Science, Academic Search Premier and OpenGrey. The review included studies published in English from 1 January 2001 to 28 May 2025.
Studies that referenced ‘genomic literacy’ in health-related or educational contexts and focused on nurses, nursing students or nursing faculty were included. Articles had to provide data on study design, population, setting, data collection tools and outcomes related to genomic literacy.
Two independent reviewers extracted and summarised data on study characteristics, including publication year, country, setting, aims, methods, population, assessment tools, outcomes and educational interventions. Findings were synthesised descriptively.
Of 1534 studies identified, 63 met the inclusion criteria. Most were observational (69.8%) and conducted in the USA (41.3%), focusing on clinical nurses (50.8%) in educational (47.6%) or clinical (46.0%) settings. Genomic literacy was predominantly assessed using ad hoc tools (46.0%) or the Genomic Nursing Concept Inventory, revealing low literacy levels. Mean scores ranged from 5.66 to 16.21 out of 31 (18.3%–52.3% correct answers). Educational interventions demonstrated effectiveness in improving genomic knowledge.
Genomic literacy among nurses, students and faculty remains low, with notable heterogeneity across countries. Many studies used non-standardised assessment tools with uncertain reliability and genomic literacy among nursing faculty remains underexplored. Educational interventions show promise in enhancing genomic literacy
Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.
This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.
This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.
NCT06815380 (Pre-results).
Vaccination against SARS-CoV-2 was a crucial public health measure during the COVID-19 pandemic. Among the multiple strategies developed to increase vaccine uptake, governments often employed vaccine mandates. However, little evidence exists globally about the impact of these mandates and their subsequent removal on vaccine uptake, including in Australia, France, Italy and the USA. The aim of this study is to provide a protocol to evaluate and quantify the impact of COVID-19 vaccine mandates and removals on vaccine uptake in these countries, with a specific focus on comparing Australian policies with those from Europe and the USA. Actualising the work outlined in this protocol will help to provide policy and technical guidance for future pandemic preparedness and routine immunisation programmes.
This protocol outlines a retrospective study using existing data sources including Australian Immunisation Register-Person Level Integrated Data Asset for Australia and publicly available data for France, Italy and California (USA). Causal inference methods such as interrupted time series, regression discontinuity design, difference-in-differences, matching and synthetic control will be employed to assess the estimated effects of vaccine mandates and removals on vaccine uptake.
The University of Newcastle’s human research ethics committee has approved the study (reference number: H-2024-0160). Peer-reviewed papers will be submitted, and results will be presented at public health, immunisation and health economic conferences nationally and internationally. A lay summary will be published on the MandEval website.
To (1) describe the characteristics of patients with advanced cancer receiving home-based care, (2) identify the nursing diagnoses associated with 6-month mortality and (3) explore the predictive power of nursing diagnoses on 6-month mortality for patients with an advanced cancer diagnosis.
Nursing diagnoses have been shown to capture the complexity of patients' experiences and the specific nursing care related to patients' responses to illness, including increased mortality risk. However, there is a lack of studies investigating the relationship between nursing diagnoses and mortality among cancer patients receiving home-based care.
Retrospective cohort study.
Between July 2021 and June 2023, patients with advanced cancer were consecutively admitted to a home-based care service. Medical data, prognostic indexes and nursing assessment data, including nursing diagnoses from NANDA International, assigned during the first home visit, were extracted from patient health records. Survival analysis was performed over the first 6 months using the Kaplan–Meier method and Cox proportional hazards model.
Among 344 enrolled patients, the most frequent nursing diagnoses were chronic pain and constipation. The 45.9% of patients died at home within 6 months after discharge. Multivariate Cox regression identified a Palliative Prognostic Index ≥ 5, palliative status, terminal phase of illness and two nursing diagnoses—imbalanced nutrition: less than body requirements and death anxiety—as significant predictors of 6-month mortality.
Survival in advanced cancer patients receiving home care was primarily predicted by the terminal phase of illness, Palliative Prognostic Index, palliative status and two specific nursing diagnoses: imbalanced nutrition: less than body requirements and death anxiety.
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines were adopted in this study.
No Patient or Public Contribution.
To cross-culturally adapt and psychometrically test the Italian version of the EPICC Spiritual Care Competency Self-Assessment Tool for clinical nurses (EPICC Tool-It).
Multicentre, cross-sectional validation study.
The 28-item EPICC Tool was translated into Italian and culturally adapted following a rigorous methodology. A nationwide survey was conducted. Psychometric evaluation included content validity, structural validity (exploratory and confirmatory factor analyses), construct validity (known group analysis) and reliability using Cronbach's alpha, McDonald's omega and factor score determinacy.
The sample included 725 clinical nurses (76% female, 80% hospital-based), on average 38.7 years old (SD 11.33), with 14.6 years (SD 11.03) of experience. Confirmatory factor analysis supported a four-factor model (Knowledge of spirituality, Attitudes towards spirituality and spiritual care, Knowledge of spiritual care and Skills in spiritual care), with a second-order factor for the EPICC Tool-It. Construct validity was supported through known group analysis, showing score variation based on nurses' experience, education and religiosity. Internal consistency was excellent across all factors and the overall scale.
A valid, multidimensional instrument is provided to assess spiritual care competencies in Italian-speaking nurses. The EPICC Tool-It is suitable for research and practice, facilitating evaluation of self-perceived competencies and educational effectiveness.
The use of the EPICC Tool-It by nursing managers, educators and clinicians is recommended in both clinical and research settings to support education on spiritual care competencies.
The EPICC Tool-It sets reliable measurement standards for spiritual care competencies, enhancing holistic care and comprehensive understanding of competencies globally.
This study adheres to the Strengthening the Reporting of Observational studies in Epidemiology (STROBE) guidelines.
Patients, service users, caregivers, or the public were not involved in the study. However, nurses as target users of the tool participated in the cultural adaptation and validation process.
FreshRSS 