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In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.
STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.
The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.
Clinicaltrial.gov: NCT07042724.
This scoping review aims to map evidence or literature on improvement strategies used by health leaders and professionals to strengthen the safety climate in the operating room.
A scoping review was performed on the basis of the method proposed by the Joanna Briggs Institute and applied to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews (PRISMA-ScR) extension.
16 academic and grey literature data sources were searched using search terms on 17 January 2025, namely, Medical Literature Analysis and Retrieval System Online via Pubmed, Latin American and Caribbean Literature on Health Sciences via the Virtual Health Library, Cumulative Index to Nursing and Allied Health Literature, Scopus, Web of Science, Embase, PsycINFO, Cochrane Library, WorldCat, Digital Library of Theses and Dissertations, Brazilian Association of Surgical Center Nurses, Center for Material and Sterilization and Anesthetic Recovery, Association of Portuguese Operating Room Nurses, Association of PeriOperative Registered Nurses, Institute for Healthcare Improvement, WHO and Agency for Healthcare Research and Quality.
Study selection, data extraction and synthesis were based on the following eligibility criteria based on the acronym PCC (participants, concept, context): participants (health leaders and professionals), concept (strategies to improve the safety climate) and context (operating room). This scoping review considered studies published from 2009 onwards.
Information on the objective, method and findings addressing improvement strategies employed to strengthen the safety climate in the surgical centre was retrieved. The findings are presented in tables and in a qualitative thematic summary.
A total of 26 studies were analysed, published between 2009 and 2024, with the USA as the country of origin of the publications with the highest number (11 studies). As for the methodological approach, intervention and quasi-experimental studies stand out. When the studies in this review were mapped, strategies that strengthened the safety climate in the operating room were identified and grouped into two main axes that are interrelated: communication tools and training programmes.
It is evident that the implementation of tools that promote communication and training programmes enhances safe surgical care, as they contribute substantially to the domains of the safety culture. The use of communication protocols in the operating room is recommended as a perioperative safety tool.
This scoping review adhered to a protocol previously published in this journal and that is registered on the Open Science Framework website (https://osf.io/zg8nu/).
Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.
This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.
The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.
The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.
Australia New Zealand registration number ACTRN12624000732583.
Despite evidence of the cost-effectiveness of physical activity (PA) promotion interventions in healthcare settings, translating them into practice remains challenging. This study aimed to identify implementation barriers and facilitators of a Portuguese PA consultation programme implemented in primary healthcare of the Portuguese National Health Service. Additionally, it sought to inform future implementation strategies, using a theoretically based approach.
Qualitative interview study, using both deductive and inductive approaches.
Primary healthcare units across all health administration regions of mainland Portugal.
Twenty-eight participants (six medical doctors, five exercise professionals and 17 patients) from all health regions of the country, involved in the implementation of the Portuguese PA prescription consultation.
Fifty-three categories of determinants were identified, using the Tailored Implementation for Chronic Diseases framework. Key barriers included ineffective referral processes to the consultation, challenges in integrating the intervention with existing healthcare demands and insufficient local/regional prioritisation of PA promotion. Key facilitators included high intervention acceptability, diverse community PA resources and good interpersonal skills of implementers. Drawing on the Behaviour Change Wheel, theoretically based inputs to design strategies addressing each barrier were provided.
The implementation of PA consultation was influenced by a broad range of determinants. The most frequently reported barriers are primarily structural and opportunity-related, suggesting system-level implementation strategies are most appropriate. Future strategies should consider implementing clinical standards/orientations for PA promotion, providing institutional incentives based on the attainment of PA indicators, expanding consultation coverage and diversifying referral strategies, reinforcing health system-community partnerships and strengthening training opportunities for implementers. These findings offer relevant insights for enhancing the future implementation of PA consultations, for scaling them up and, ultimately, to increase their effectiveness.
Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.
Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.
The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.
To examine the association between nurse–patient mutuality (i.e., a good quality of the relationship between the nurse and the patient) and nurse professional quality of life.
A cross-sectional, multi-centre study was conducted across four tertiary hospitals in Italy.
Data collection took place from November 2023 to June 2024, enrolling 517 nurses. Both medical and surgical departments, as well as inpatients and outpatients departments were included. Data were collected on nurses caring for patients with chronic illness. Mutuality was measured with the Nurse–Patient Mutuality in Chronic Illness scale, which includes three dimensions: Developing and Going Beyond, Being a Point of Reference, Deciding and Sharing Care; Professional Quality of Life was measured with the Professional Quality of Life version 5, which includes three dimensions: Compassion Satisfaction, Secondary Traumatic Stress, Burnout. A Bayesian path analysis was employed to evaluate the contribution of mutuality dimensions to the dimensions of professional quality of life.
Nurses' sample consisted of 517 participants. The three dimensions of mutuality showed different associations with the three dimensions of professional quality of life. Specifically, Being a Point of Reference, along with Deciding and Sharing Care, was significantly associated with Compassion Satisfaction. The dimensions Developing and Going Beyond and Deciding and Sharing Care were significantly and negatively associated with Secondary Traumatic Stress. Additionally, Deciding and Sharing Care was significantly and negatively associated with Burnout.
As all the dimensions of mutuality were significantly associated with different aspects of professional quality of life, future interventions to improve nurses' professional quality of life may also consider nurse–patient mutuality.
Nurse–patient mutuality may be a novel area of research to enhance nurses' professional quality of life, with implications for clinical practice and organisational development.
Nurse–patient mutuality is a key indicator of a high-quality relationship, enabling shared goals and shared decision-making. Nurses' professional quality of life is one of the most important factors that influence their intention to leave. Little is known about the association between nurse–patient mutuality and nurses' professional quality of life. Mutuality influences nurses' and patients' outcomes. Understanding mutuality could enhance the professional quality of life for nurses, improving their compassion satisfaction and reducing their burnout.
We adhered to STROBE guidelines.
Patients were not included in the sample. Health workers were involved in the study.
by Joao M. Braz, Madison Jewell, Karnika Bhardwaj, Sian Rodriguez-Rosado, Veronica Craik, Allan I. Basbaum
Voltage-gated calcium channels (VGCCs) are multimeric proteins composed of alpha 1, β and γ subunits, as well as one of four auxiliary α2δ subunits. Although there is considerable preclinical and clinical evidence for a contribution of VGCCs to nociceptive processing, notably the gabapentin-targeted α2δ-1 subunit, unclear is the extent to which other α2δ subunits contribute to baseline or injury-altered pain and itch processing. Here, we investigated the anatomical and behavioral consequences of deleting α2δ-2, α2δ-3 or α2δ-4 in the mouse and report that selectively ablating each α2δ subunit leads to different, and in some cases, opposite effects on behavioral indices of pain and itch. Specifically, deleting α2δ2 resulted in mechanical and heat hypersensitivity, and an increase in spinal cord microglial immunoreactivity, but reduced scratching (presumptive) itch in response to a pruritogen. In contrast, ablation of α2δ3 led to thermal hyposensitivity, but no change in mechanical responsiveness or indices of itch. Mice deficient for α2δ4 exhibited hyposensitivity across pain modalities and only minor itch deficits. Interestingly, these differential effects were limited to baseline nociceptive responses, therefore we conclude that the α2δ-2, α2δ-3 and α2δ-4 subunits of VGCCs differentially contribute to pain and itch processing. The mechanisms underlying these differences remain however to be determined.
Since 2018, WHO has endorsed the use of whole-genome sequencing (WGS) of Mycobacterium tuberculosis complex isolates to detect drug-resistant tuberculosis (DR-TB). This endorsement was based on the assumption that a faster and more detailed description of the resistance profile would improve treatment prescription for DR-TB by healthcare providers, and hence the treatment outcomes of patients. Nonetheless, this assumption has not been tested in routine clinical practice and different scenarios. In Brazil, WGS is not routinely used for the diagnosis of DR-TB, having been carried out in only a few centres for research purposes. With this trial, we will evaluate whether a WGS-based drug-resistance report improves treatment adequacy in patients with pulmonary DR-TB, compared with the current standard-of-care diagnostic methods used in the state of São Paulo, Brazil.
We will conduct a non-randomised controlled clinical trial with two arms to compare the intervention group (ie, individuals receiving a WGS-based report) with a historical control group (i.e., individuals who received resistance diagnostics based on the standard of care of conventional genotyping and phenotyping techniques). The primary outcome will be the proportion of patients whose treatment scheme was adequate based on complete resistance profile determined by WGS and/or phenotypic drug-susceptibility testing (pDST). Other secondary outcomes will also be considered. The target sample size is 88 eligible patients per group. The intervention group will be prospectively recruited over 18 months and the control group will be composed of patients diagnosed with pulmonary DR-TB up to 2 years before the start of the trial. To ensure comparability, isolates from the control group will undergo WGS retrospectively, and pDST will be performed retrospectively in both groups. This clinical trial will take place in six medical centres for the treatment of DR-TB in the state of São Paulo. This study is intended to support the implementation of the WGS in the routine diagnosis of DR-TB in the state of São Paulo.
Ethical approval was obtained from the Human Research Committee of the Institute of Biomedical Sciences, University of São Paulo, Brazil (CAAE: 79497924.1.1001.5467). Study results will be published in peer-reviewed journals and disseminated to policymakers and stakeholders.
U1111-1308-4669.
Process evaluation provides insight into how interventions are delivered across varying contexts and why interventions work in some contexts and not in others. This manuscript outlines the protocol for a process evaluation embedded in a hybrid type 1 effectiveness-implementation randomised clinical trial of incremental-start haemodialysis (HD) versus conventional HD delivered to patients starting chronic dialysis (the TwoPlus Study). The trial will simultaneously assess the effectiveness of incremental-start HD in real-world settings and the implementation strategies needed to successfully integrate this intervention into routine practice. This manuscript describes the rationale and methods used to capture how incremental-start HD is implemented across settings and the factors influencing its implementation success or failure within this trial.
We will use the Consolidated Framework for Implementation Research (CFIR) and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks to inform process evaluation. Mixed methods include surveys conducted with treating providers (physicians) and dialysis personnel (nurses and dialysis administrators); semi-structured interviews with patient participants, caregivers of patient participants, treating providers (physicians and advanced practice practitioners), dialysis personnel (nurses, dieticians and social workers); and focus group meetings with study investigators and stakeholder partners. Data will be collected on the following implementation determinants: (a) organisational readiness to change, intervention acceptability and appropriateness; (b) inner setting characteristics underlying barriers and facilitators to the adoption of HD intervention at the enrollment centres; (c) external factors that mediate implementation; (d) adoption; (e) reach; (f) fidelity, to assess adherence to serial timed urine collection and HD treatment schedule; and (g) sustainability, to assess barriers and facilitators to maintaining intervention. Qualitative and quantitative data will be analysed iteratively and triangulated following a convergent parallel and pragmatic approach. Mixed methods analysis will use qualitative data to lend insight to quantitative findings. Process evaluation is important to understand factors influencing trial outcomes and identify potential contextual barriers and facilitators for the potential implementation of incremental-start HD into usual workflows in varied outpatient dialysis clinics and clinical practices. The process evaluation will help interpret and contextualise the trial clinical outcomes’ findings.
The study protocol was approved by the Wake Forest University School of Medicine Institutional Review Board (IRB). Findings from this study will be disseminated through peer-reviewed journals and scientific conferences.
by Kennedy M. Peter-Marske, Annie Green Howard, Kelly R. Evenson, Sara Jones Berkeley, Joanna Maselko, Mario Sims, Stuart D. Russell, Anna Kucharska-Newton, Kevin J. Sullivan, Wayne D. Rosamond
We assessed whether social isolation (SI), social support (SS), and subtypes of SS were associated with self-rated health trajectories and clinical heart failure (HF) outcomes among participants with incident HF hospitalizations. We included 2967 Atherosclerosis Risk in Communities study participants with incident HF hospitalization after Visit 2 (1990–1992). SI, SS, and subtypes of SS were measured at Visit 2. We identified incident HF hospitalization as ICD-9 code 428 and physician adjudicated events; on average HF occurred 17 (SD 8) years after Visit 2. We assessed associations with trajectories of annually measured self-rated health in the 4 years prior to and after incident HF hospitalization (excellent/good self-rated health on a 0–100 scale), using linear mixed effects models. We calculated hazard ratios (HR) and 95% confidence intervals (CIs) for associations with time to first all-cause rehospitalization and all-cause mortality using Cox proportional hazard models. Low overall SS had a 5.8 point (95% CI 7.8, 3.8) lower self-rated health value over time than high SS; associations of subtypes of SS with this outcome were similar. Low belonging SS was associated with greater days to first rehospitalization (HR 0.85; 95% CI 0.79, 0.96) compared to the highest tertile; however, belonging SS was not associated with mortality (HR 1.05; 95% CI 0.95, 1.17). Being socially isolated/high risk for SI was associated with greater hazard of all-cause mortality among females (HR 1.57; 95% CI 1.20, 2.06) but not males (HR 0.95; 95% CI 0.75, 1.19), compared to low SI. SI and SS were not associated with number of hospitalizations in the first year or percent of first year spent at home.
Nurses' burnout, work instability (WI), and job satisfaction (JS) in their practice environment (PE) are well established in the literature. However, perinatal missed care (PMC), a subset of missed nursing care, remains underreported among maternity nurses.
To examine the mediating role of PE and burnout in the associations of WI, JS, and PMC among maternity nurses.
A cross-sectional and correlational study employed consecutive sampling to recruit maternity nurses (n = 312) from five hospitals in Saudi Arabia (three government and two private hospitals in Hail and Makkah regions, respectively). Maternity staff nurses, regardless of their sex, years of professional nursing experience, or nationality, who met inclusion criteria were included in this study. Data was collected from July to September 2024 using four standardized self-report scales. Structural equation modeling was utilized for statistical analyses.
Maternity nurses' WI negatively influenced PE (β = −0.23, p = 0.014), while positively affected PMC (β = 0.15, p = 0.031). The PE positively affected JS (β = 0.24, p = 0.034) but had a negative effect on burnout (β = −0.24, p = 0.007) and PMC (β = −0.21, p = 0.038). Burnout negatively affected JS (β = −0.25, p = 0.028), while positively associated with PMC (β = 0.20, p = 0.022). PE mediated the associations between WI and burnout (β = 0.05, p = 0.019), JS (β = −0.07, p = 0.020), and PMC (β = −0.06, p = 0.008). Meanwhile, burnout mediated between PE and JS (β = 0.05, p = 0.030) and PMC (β = −0.04, p = 0.023).
Understanding the relationships among maternity nurses' burnout, JS, PE, and PMC is key to improving the quality of perinatal care and ensuring the patients' well-being. By focusing on strategies to enhance the PE (e.g., adequate staffing and resources, improved nurse–patient ratio), reduce burnout (e.g., meditation and mindfulness programs, coping intervention programs), and improve JS (e.g., work schedule flexibility, facilitate work-life balance, staff professional development), healthcare organizations can mitigate the occurrence of PMC.
This study aimed to test the psychometric properties of the Self-Care of Chronic Illness Inventory and the Self-Care Self-Efficacy scale in patients with cancer.
A multisite cross-sectional validation study was conducted.
Between November 2022 and July 2023, a convenience sample of 318 patients with cancer were enrolled in five Italian inpatient and outpatient facilities. Confirmatory factor analysis was performed on the three scales of the Self-Care of Chronic Illness Inventory and the Self-Care Self-Efficacy scale. Internal consistency was tested using Cronbach's alpha for unidimensional scales and McDonald's Omega for multidimensional scales. Construct validity was assessed with the global health status by Pearson's correlation. The COnsensus-based Standards for the selection of health Measurement INstruments reporting guidelines were followed for the reporting process.
Three hundred fourteen patients were included (median age: 55.5 years; male: 53.82%). Confirmatory factor analysis showed supportive fit indices for the three Self-Care of Chronic Illness Inventory scales (CFI: 0.977–1.000; SRMR: 0.004–0.78) and the Self-Care Self-Efficacy scale (CFI: 1.000; SRMR: 0.014). All scales demonstrated adequate internal consistency (0.89–0.99) and test–retest reliability (0.85–0.95). Construct validity was confirmed through correlations between Self-Care Self-Efficacy, each Self-Care of Chronic Illness Inventory scale, and global health status.
The Self-Care of Chronic Illness Inventory and Self-Care Self-Efficacy scales demonstrated excellent psychometric qualities and construct validity when administered to patients with cancer. Future research should explore self-care behaviours across different diseases and cultural contexts.
These tools can help develop targeted educational programs, improving patient outcomes.
Currently, there is a lack of knowledge regarding self-care behaviours in patients with cancer. These tools enable healthcare professionals to identify patient needs, design personalised interventions, and monitor their effectiveness over time.
No patient or public contribution.
To observe and compare the environmental impacts of different types of infant feeding, considering the use of formula, infant feeding accessories, potentially increased maternal dietary intake during breastfeeding (BF) and food consumption habits.
An observational cross-sectional multicentre study conducted in the Barcelona Metropolitan Area of the Catalan Institute of Health.
Data were collected from 419 postpartum women on infant feeding type (formula milk and accessories), maternal dietary intake (24-h register) and food consumption habits from November 2022 to April 2023. The environmental impacts (climate change (CC), water consumption and water scarcity) of the infant feeding types and maternal diet were calculated using the IPCC, ReCiPE and AWARE indicators, respectively. The differences in impacts were calculated by Kruskal–Wallis test.
Significant differences for the three environmental impacts were observed. The CC impact of formula milk and feeding accessories was 0.01 kg CO2eq for exclusive BF, 1.55 kg CO2eq for mixed feeding and 4.98 kg CO2eq for formula feeding. While BF mothers consumed an extra 238 kcal, no significant differences were found related to maternal diet across feeding types.
Exclusive BF was the most sustainable type of infant feeding, considering formula and infant feeding accessories. In our study, the difference between the impacts of BF and non-BF mothers' diet was insignificant.
Offer informative and educational support for midwives and other healthcare professionals on BF and a healthy, sustainable diet to transfer this knowledge to the general public.
Raise the general public's awareness about BF and a healthy, sustainable diet. To reduce environmental impacts through behavioural changes.
STROBE.
Patients of the Catalan Health Service reviewed the content of the data collection tools.
Trial Registration: (for the whole GREEN MOTHER project): NCT05729581 (https://clinicaltrials.gov)
To identify interventions and strategies to prevent patient- and visitor-perpetrated violence against nurses working in acute hospital Emergency Departments. Design Scoping review following the Joanna Briggs Institute guidelines.
A comprehensive literature search was conducted in PubMed and CINAHL to identify relevant studies published up to June 2024. The review included primary research studies employing quantitative, qualitative, and mixed-method approaches. Eligibility criteria focused on interventions aimed at preventing physical and verbal violence in acute hospital emergency settings, explicitly targeting nurses. The selection process followed PRISMA-ScR guidelines, with independent screening and data extraction by two reviewer pairs. Data Sources PubMed and CINAHL databases were searched for studies published up to June 2024.
A total of 40 studies were included, covering interventions across 11 countries, mostly from the United States. Interventions were categorised as organisational, environmental, or individual-focused. Training programs were the most common strategy, followed by risk assessment tools, defense strategies, multidisciplinary briefings, and technology-assisted interventions. Most interventions (73%) were implemented before violent incidents, 23% during, and 5% after. Healthcare workers, particularly nurses, were the primary target group, highlighting the need for effective preventive strategies.
Violence prevention interventions in Emergency Departments focus on pre-incident strategies, mainly organisational and individual-focused. Limited attention has been given to environmental interventions despite their role in mitigating workplace violence. Further research is needed to assess the long-term effectiveness of these strategies.
Addressing workplace violence in EDs ensures a safer work environment, improves staff retention, and enhances patient care quality.
This study did not include patient or public involvement in its design, conduct, or reporting.
Distal radius fractures are the most common fractures seen in the emergency department in children in the USA. However, no established or standardised guidelines exist for the optimal management of completely displaced fractures in younger children. The proposed multicentre randomised trial will compare functional outcomes between children treated with fracture reduction under sedation versus children treated with simple immobilisation.
Participants aged 4–10 years presenting to the emergency department with 100% dorsally translated metaphyseal fractures of the radius less than 5 cm from the distal radial physis will be recruited for the study. Those patients with open fractures, other ipsilateral arm fractures (excluding ulna), pathologic fractures, bone diseases, or neuromuscular or metabolic conditions will be excluded. Participants who agree to enrol in the trial will be randomly assigned via a minimal sufficient balance algorithm to either sedated reduction or in situ immobilisation. A sample size of 167 participants per arm will provide at least 90% power to detect a difference in the primary outcome of Patient-Reported Outcomes Measurement Information System Upper Extremity computer adaptive test scores of 4 points at 1 year from treatment. Primary analyses will employ a linear mixed model to estimate the treatment effect at 1 year. Secondary outcomes include additional measures of perceived pain, complications, radiographic angulation, satisfaction and additional procedures (revisions, refractures, reductions and reoperations).
Ethical approval was obtained from the following local Institutional Review Boards: Advarra, serving as the single Institutional Review Board, approved the study (Pro00062090) in April 2022. The Hospital for Sick Children (Toronto, ON, Canada) did not rely on Advarra and received separate approval from their local Research Ethics Board (REB; REB number: 1000079992) on 19 July 2023. Results will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
To analyse the impact of a participatory process of awareness and reflection on compassion, in the face of end-of-life processes, in students aged 12–23 years in six Spanish regions, and to understand how the participatory process can transform their compassion.
Mixed sequential transformative methodology with different phases. In the first phase, a prospective quasi-experimental design with evaluation pre-post in a single group will be adopted. The second phase is the intervention under study, which will consist of a Participatory Action Research with concurrent evaluations.
In the quantitative phase, 1390 students aged 12–23 from a Public University and a Public Secondary Education Institute across six different Spanish regions will be included. A single questionnaire will be administered before and after the Participatory Action Research to contribute to the process evaluation, incorporating four scales (compassion for others' lives, Death Anxiety Scale, basic empathy modified for adolescents and self-compassion). Responses will be recorded in the Research Electronic Data Capture system. For data analysis, comparison groups, change evolution and associations between variables will be examined, along with multivariate logistic regression models. In the qualitative phase of participatory action research, a promoter group will be established in each university and secondary school in every region. Qualitative data will be analysed following the authenticity, transferability, auditability and neutrality criteria. Discourse analysis triangulation will be conducted to achieve data saturation.
Implementing participative action research in the educational environment to improve students' compassion makes them capable of founding compassion communities to help those who have a terminal illness.
This study will adhere to the relevant EQUATOR guidelines, such as the Good Reporting of a Mixed Methods Study guideline, to efficiently report its results through the different steps of this mixed-methods study.
Participatory action research is a method that enables participants to act as researchers of the phenomenon under study, facilitating the immediate application of results within the context. Although students did not participate in the writing of the proposal grant or the research design.
This study registered on Clinical Trials (NCT06310434), was initiated in January 2024, and it will continue up to December 2026.
This multicentre study will contribute to the nursing community with an overview of compassion for those at the end of their lives among young people and provide the knowledge needed to cultivate compassion at universities and schools.
Implementing compassion programmes and death education in the educational environment will empower students to create a compassionate community. The double evaluation of the process will contribute to the qualitative databases.
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.
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.
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