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Wound care in calciphylaxis remains poorly defined without evidence-based consensus on timing and technique of surgical intervention. We demonstrate that surgical debridement and subsequent wound closure are safe and effective in calciphylaxis and describe a systematic multidisciplinary approach to intervention. We retrospectively reviewed a cohort of patients with calciphylaxis at our institution. Those who underwent surgical debridement and wound closure were analysed with emphasis on wound healing, progression to amputation and mortality. Sixty-two patients with calciphylaxis underwent surgical debridement. Twenty patients had wound closure by skin grafting, five were excised with primary wound closure, and 37 were debrided and allowed to heal by secondary intention. There were excellent rates of healing in all groups, and no patients demonstrated wound progression or new lesions following operative intervention. Surgical debridement and wound closure are safe and effective in treating wounds related to calciphylaxis.
by Jimmy Andreyvan Cainamarks-Alejandro, Liliana Cruz-Ausejo, Miguel Angel Burgos-Flores, Jaime Rosales-Rimache, Jonh Astete-Cornejo, David Villarreal-Zegarra
BackgroundThe COVID-19 pandemic marked an increase in depressive, anxiety, and post-traumatic stress disorder symptoms, more specifically among healthcare workers, teachers, and police officers. These workers face external and occupational factors which had a significant impact on mental health, significant increase in workload and direct exposure to the virus, shortage of personnel protective equipment, and instances of abuse, including discrimination. Mental health care in primary care requires a process of early identification and timely referral of complex cases. Telehealth emerges as an effective alternative for addressing challenges in mental health care, although its implementation encounters obstacles.
ObjectiveTo design a telehealth service that facilitates screening, initial management, and timely referral for mental health diagnoses in workers with prior SARS-CoV-2 infection, and to evaluate usability, acceptability, and user satisfaction.
MethodsMixed-method study with a user-centered design approach involving key external and internal service users in three sequential stages (pre-design, co-design, and post-design). The study phases lasted 6 months, involving a total of 23 participants in the pre-design phase (contextual inquiry and preparation and training), 12 participants in the co-design phase (framing the issue, generative design, and sharing design), and in the post-design phase, 4 participants were involved in service implementation, and 81 participants—drawn from the subgroup of 134 users who received psychoeducation—were included in the efficacy assessment.
ResultsThe proposal included the development and evaluation of a service model guide and a telehealth software platform. First, the participants took part in a series of workshops (Pre-design, Co-design) where they provided ideas for meeting the product requirements, based on the Design Thinking methodology framework. The telehealth service model was named TelePsico CENSOPAS. It comprised four processes: a) Service promotion; b) User pre-identification; c) Appointment management; d) Psychoeducation counseling and referral. The Telehealth platform was designed through three cycles of an iterative process and integrated a proprietary development platform with third-party service technologies for communication support and information exchange. During post-design, the pilot test involved 698 screened patients; 193 were identified with mental health risks, and 134 of them received psychoeducation sessions. In addition to user acceptance, the usability score of the platform was 86.1 ± 16.9 SD, satisfaction dimensions of the service was 45.1 ± 7.2 SD for satisfaction with care processes, and 36.7 ± 5.2 SD satisfaction with psychological care.
ConclusionThe proposal for mental health telehealth services and its supporting platform was successfully developed and accepted by both internal and external users, particularly within well-structured occupational health services in workplaces serving vulnerable occupational groups. In addition, it achieved higher satisfaction and usability scores than Peru’s outpatient care services. These findings support the replicability of user-centered design frameworks—such as design thinking—within the occupational health sphere.
The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.
A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.
Secondary care NHS perinatal health services across multiple centres in England.
A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.
Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.
The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.
Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.
On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.
SRCTN18308962.
To translate, culturally adapt and validate the first Spanish version of the Person-centred Practice Inventory-Care (PCPI-C) instrument.
Cross-cultural adaptation and psychometric validation.
Two-phase research design: (1) the PCPI-C's translation and cultural adaptation from English to Spanish following the ‘Translation and Cultural Adaptation of Patient-Reported Outcomes Measures-Principles Guide of Good Practice’ tool; and (2) a cross-sectional quantitative survey to assess the Spanish version's psychometric properties.
A sample of 200 patients participated to obtain the PCPI-C's Spanish version. No significant issues arose during the translation process or the consulting sessions. No item exhibited an inadequate value following adjustment via the weighted kappa index (−scale-level content validity average of 0.95 for clarity and 0.97 for relevance). Psychometric evaluation revealed acceptable internal consistency (Cronbach's alpha from 0.67 to 0.84) and strong construct validity. Exploratory and confirmatory factor analyses supported a five-dimensional structure consistent with the domain Person-Centred Processes. Fit indices improved after model refinements, achieving CFI = 0.92, SRMR = 0.05 and RMSEA = 0.07. This study's observed psychometric properties confirm that the PCPI-C's Spanish version retains the original instrument's theoretical integrity, while showing strong reliability and validity in the new context.
The PCPI-C's Spanish translation was psychometrically valid when tested with Spanish patients, thus providing a culturally appropriate, psychometrically sound tool to evaluate Spanish-speaking patients' perception of person-centred care.
This study provides a validated instrument that allows for the assessment of person-centred practice in Spanish-speaking clinical environments. It enables healthcare professionals to measure patients' perceptions, track the implementation of person-centred principles and supports international comparative studies, contributing to the development of more ethical and responsive models of care.
Patients participated in cognitive consultations and completed the survey for psychometric testing, ensuring that the translated items were understandable, culturally appropriate and reflective of their experiences of person-centred care.
To describe the clinical profile, comorbidity burden, follow-up and healthcare utilisation in patients labelled as having Chronic Obstructive Pulmonary Disease (COPD) in Primary Care (PC) nursing consultations.
Real-world data COPD, retrospective, observational study using routinely collected data in electronic health records (EHR). This study adheres to the STROBE reporting guidelines for cross-sectional studies.
Three Primary Care centres in Catalonia, Spain, belong to the Catalan Health Service.
All patients aged ≥ 15 years with a recorded diagnosis of COPD in their EHR, excluding institutionalised individuals and those deceased before study onset. Final sample: 474 patients (105 women, 369 men; mean age 70 years) from a reference population of 28,000 individuals.
Data included socio-demographics, smoking/alcohol, mMRC dyspnea, inhaled therapy/adherence, spirometry, comorbidities, Adjusted Morbidity Groups (GMA), active COPD care plans and 12-month healthcare use.
EHR showed a high rate of missing data in follow-up variables (inhaler adherence 28.5%; dyspnea 17%–20%). Despite that, all participants were ‘labelled’ as COPD, most of them lacked spirometric confirmation. Active smoking was highly prevalent (52.3% women, 45.0% men). Hypertension, obesity and osteoarthritis were the most common comorbidities; anxiety, depression, osteoporosis and thyroid disorders were more frequent in women. Higher GMA complexity correlated with more Primary Care visits, especially nursing consultations, particularly in patients with cardiovascular disease and diabetes (p < 0.001) for 12 months follow-up. No significant differences between groups were found in urgent or hospital care use.
EHR-labelled COPD patients with cardiometabolic comorbidity received more structured nursing follow-up and more annual visits than without. Improving EHR recording, integrating spirometry with the EHR, and prioritising high-complexity profiles could enhance monitoring, treatment optimisation and equity—nursing consultations are a key lever.
No patients or members of the public were directly engaged in the study design or data analysis. Nevertheless, the research was motivated by patient needs and aims to improve healthcare services.
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)
A lo largo de la historia, el feminismo ha sido clave para el desarrollo de los derechos de las mujeres hacia la igualdad. A principios del siglo XX, las mujeres obtuvieron el derecho al voto en muchos países, un hito significativo en la reivindicación por la igualdad política. Además, lograron la promoción educativa y el derecho a ejercer profesiones liberales, accediendo a la educación en igualdad de condiciones que los hombres, lo que les permitió desarrollar sus capacidades y aspirar a mejores oportunidades laborales. Las mujeres también han luchado por el reconocimiento de sus derechos sexuales y reproductivos, incluyendo el acceso a métodos anticonceptivos y la libertad de decidir sobre su propio cuerpo. Este articulo hace un recorido por las demandas claves que las enfermeras deben plantear en el Día Internacional de las Mujeres y las Niñas, enfocándose en educación de calidad, empoderamiento económico, erradicación de la violencia de género, promoción de la igualdad de género y participación global en sostenibilidad. Estas acciones son esenciales para avanzar hacia una sociedad más justa e igualitaria.
Evidence-based practice (EBP) is widely endorsed as a cornerstone for high-quality, patient-centered care. However, its integration into daily clinical routines remains inconsistent, particularly in settings where cultural, educational, and organizational challenges persist. Reliable, contextually adapted tools are essential to measure EBP implementation and guide improvement efforts.
This study aimed to validate the Italian versions of the EBP Implementation Scale and its short-form (3-item) version.
A cross-sectional survey design was adopted. Both versions of the EBP Implementation Scale were translated and culturally adapted in accordance with internationally recognized guidelines. Data were gathered from a national sample of 405 nurses through a combination of convenience and snowball sampling. Psychometric assessment encompassed confirmatory and Bayesian factor analyses, evaluation of internal consistency and test–retest reliability, and measurement invariance testing. All analyses were performed in R Studio.
Confirmatory factor analyses confirmed that both versions (long and short) of the scale measure a single underlying construct. The instruments demonstrated high reliability (ω = 0.96 and 0.87 respectively). Measurement invariance across educational groups was partially established, as the partial scalar invariance model demonstrated acceptable fit (CFI = 0.991, RMSEA = 0.045), suggesting consistent interpretation of the scale across different levels of EBP training. Latent profile analysis revealed distinct subgroups of EBP implementers, with notable differences in latent means (p < 0.001) associated with previous education in evidence-based practice.
The Italian EBP Implementation Scales are valid and reliable tools for assessing EBP implementation behaviors. They can support education planning, monitor practice changes over time, and inform interventions aimed at enhancing evidence-based care.
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.
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