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Health Literacy and Unmet Needs in Patients With Multiple Sclerosis: A Cross‐Sectional Study

ABSTRACT

Aims

To identify a correlation between unmet needs and HL levels in people with Multiple Sclerosis (pwMS) and to evaluate how sociodemographic characteristics influence HL levels and unmet needs.

Design

A cross-sectional study.

Methods

The study was conducted using a questionnaire including the HLS19-Q12 to assess HL and the Long-term Unmet Needs in Multiple Sclerosis tool, which evaluates five domains (neuropsychological, ambulation, physical, interpersonal relationship, and informational) and identifies whether needs are met or unmet and the desire for support.

Results

Among the 116 participants included in the study, the overall HL level was sufficient. Mean scores across unmet needs domains were comparable. A significant difference in HL emerged in the informational domain, where participants reporting informational needs and a desire for support showed higher mean ranks. Although not significant, participants who acknowledged a need and expressed a desire for help showed higher mean ranks in HLS19-Q12 scores across several domains. No significant correlations were found between HL and unmet needs domains.

Conclusion

HL levels may enhance patients' ability to recognize and express needs without necessarily ensuring that these needs are met.

Implications for the Profession and/or Patient Care

Routine assessment of both HL and unmet needs may help healthcare professionals identify patients who recognize problems but lack the structural support to address them.

Impact

The impact of HL on need recognition and communication, together with the complexity and interconnectedness of unmet needs, highlights the need for healthcare systems to implement organizational, systemic, and multidimensional interventions aimed at promoting HL and effectively addressing patients' needs. Such strategies may support better disease management and improve quality of life in pwMS.

Reporting Method

This study was reported according to STROBE checklist.

Patient or Public Contribution

None.

Self‐Efficacy as a Mediator Between Medication Adherence and Self‐Care in Inflammatory Bowel Disease: A Multicenter Cross‐Sectional Study

ABSTRACT

Aims

To examine the role of self-efficacy in the relationship between medication adherence and self-care behaviours in patients with Inflammatory Bowel Disease by describing their levels and exploring the interconnections among these variables.

Design

Multicenter, cross-sectional.

Methods

A total of 452 patients were recruited through consecutive non-probabilistic sampling across nine Italian outpatient Inflammatory Bowel Disease Units. Data were collected using validated tools: the Morisky Medication Adherence Scale-8, the Self-Care Self-Efficacy Scale, and the Self-Care of Chronic Illness Inventory. Descriptive statistics, Pearson correlations, and mediation analyses were performed to explore associations and the mediating role of self-efficacy between medication adherence and self-care behaviours.

Results

Participants had a mean age of 43.49 years; 50.9% were male, 49.2% had Crohn's disease, and 50.8% had ulcerative colitis. Only 10.2% reported high medication adherence, while most showed medium or low adherence. The mean self-efficacy score was 74.82. Medication adherence was positively associated with self-care maintenance, and self-efficacy statistically accounted for part of this association. Lower levels were observed in self-care monitoring and management behaviours.

Conclusions

Medication adherence was positively associated with self-care maintenance, and self-efficacy partially explained this relationship.

Implications for Clinical Practice

Routine assessment of medication adherence and self-efficacy may help identify patients at risk of poor self-care. Interventions aimed at strengthening self-efficacy, such as motivational interviewing, nurse-led counselling, and digital monitoring tools, may improve adherence and self-care maintenance.

Impact

The study addressed low medication adherence and suboptimal self-care in patients with IBD. Findings support integrating self-efficacy-enhancing strategies into multidisciplinary care to improve adherence and self-care behaviours.

Patient or Public Contribution

Patients completed validated self-report questionnaires; however, they were not involved in the study design, conduct, analysis, or manuscript preparation.

Positive psychological intervention to reduce HIV acquisition risk with men who use stimulants: protocol for a randomised controlled trial

Por: Valentin · O. R. · Henderson · C. · Coffin · L. S. · Paredes-Gotamco · J. · Olem · D. · Farrales · W. · Neilands · T. B. · Dilworth · S. E. · Doblecki-Lewis · S. · Page · K. · Moskowitz · J. T. · Anderson · P. L. · Johnson · M. O. · Carrico · A. W.
Introduction

A resurgent methamphetamine epidemic is a major driver of HIV incidence in the USA. Although daily oral pre-exposure prophylaxis (PrEP) is highly effective for preventing HIV acquisition, its effectiveness depends on achieving and maintaining prevention-effective adherence (ie, four or more doses per week). Digital health interventions offer a scalable method to extend the reach of behavioural approaches to HIV prevention, but evidence of their efficacy in improving objectively measured adherence remains limited. Addressing this gap is critical to maximising the clinical and public health benefits of PrEP.

Methods and analysis

From 26 January 2022 through 17 January 2025, this single-blind, parallel-group randomised controlled trial (RCT) enrolled 239 men taking PrEP who reported problematic stimulant use and who resided in California or Florida. Participants were randomised to receive five individually delivered telehealth sessions of a positive psychological intervention (n=119) or an attention-control condition (n=120), both delivered alongside remote contingency management for directly observed PrEP doses using the Spotlight mobile health application. Participants received US$20 per session and up to US$360 for uploading videos of at least four PrEP doses per week over 3 months. Follow-up assessments at 3, 6 and 12 months included surveys and dried blood spot specimens to quantify tenofovir diphosphate (TFV-DP). The primary outcome is biobehavioural HIV acquisition risk, defined as any recent condomless anal sex in the absence of TFV-DP concentrations consistent with prevention-effective adherence.

Ethics and dissemination

This RCT was approved by the University of Miami Institutional Review Board and registered prior to initiation of enrolment. Analyses of primary and secondary outcomes using intent-to-treat principles will be conducted after the completion of TFV-DP assays in June 2026, with results disseminated shortly thereafter through peer-reviewed publications.

Registration

This RCT was registered on www.clinicaltrials.gov (NCT04899024) prior to launching enrolment.

Health Outcomes Led by Advanced Practice Nurses in Patients With Chronic Wounds: A Scoping Review

ABSTRACT

Aim

To examine and map the available literature on outcomes associated with interventions carried out by advanced practice nurses in chronic wound care.

Background

The role of the advanced practice nurses in wound care is identified as a key element in the management of patients with chronic wounds. However, the literature offers fragmented knowledge of the outcomes associated with their practice.

Design

Scoping review.

Methods

This scoping review was conducted following the methodological framework proposed by Arskey and O'Malley, following the Preferred Reporting Item for Systematic Review and Meta-analysis for Scoping Review. PRISMA-ScR Checklist is included in the manuscript. Observational or experimental studies related to patients affected by chronic wounds and cared for by advanced practice nurses in wound care were included.

Data Sources

The following databases were queried: PubMed, CINAHL, Cochrane Library, and Scopus from 01 May 2025 to 31 October 2025.

Results

The search strategy in the consulted databases identified 1956 studies; 31 met the inclusion criteria. Different types of chronic wounds were investigated: diabetic foot ulcers, venous leg ulcers, and pressure injuries. The most frequently measured outcomes were clinical responses (healing, recurrence, complications), organizational efficiency (referrals, resource utilization), and patient-reported outcomes.

Conclusion

Evidence from the included studies suggests that Advanced practice nurses led wound care models may be associated with faster healing, lower recurrence and complication rates, and more efficient care pathways, across different settings. This review highlights the global applicability of APN-led models, showing consistent improvements in clinical, organizational, and patient-reported outcomes through core interventions.

Reporting Method

This scoping review follows Arskey and O'Malley's methodological framework and the Preferred Reporting Item for Systematic Review and Meta-analysis for Scoping Review.

Patient or Public Contribution

No Patient or Public Contribution.

Protocol Registration

The revision protocol was registered on the OSF (https://doi.org/10.17605/OSF.IO/P9TA4).

Factors Influencing Intention to Leave Among Nurse Managers: A Cross‐Sectional Study

ABSTRACT

Aims

To estimate the proportion of Italian nurse managers (NMs) intending to leave (ITL) their positions and to identify associated socio-demographic, job-related, and psychosocial factors.

Design

Cross-sectional study.

Methods

Between September and November 2023, 464 NMs from 19 public hospitals completed a case-report form and the short version of the Copenhagen Psychosocial Questionnaire II (COPSOQ II). Latent Class Analysis (LCA) identified ITL profiles, and multiple logistic regression assessed factors associated with ITL.

Results

284 NMs (61.2%; 95% CI 57–66) reported an intention to leave within 12 months. LCA identified two classes: (1) Low-ITL (54%)—mainly outpatient NMs from Central regions with strong relationships with management, good support, work–life balance, and autonomy (55.9% probability of being unlikely to leave). (2) High-ITL (46%)—mainly surgical or critical-care NMs, often from Northern regions, marked by poor management relations, low support and high work–family conflict (80.9% probability of being likely to leave). Multiple regression confirmed that stronger management relations reduced ITL (OR 0.60, 95% CI 0.46–0.79) whereas high job demands and work–health conflict increased it (OR 1.56, 95% CI 1.19–2.04). Northern location also predicted higher ITL (OR 1.58, 95% CI 1.03–2.44). Demographics, education, and clinical setting were not significantly associated.

Linking Evidence to Action

These findings suggest that healthcare organizations should prioritize managerial and organizational strategies targeting modifiable work-related factors to reduce nurse managers' intention to leave. Interventions aimed at improving organizational support, work environment, and job satisfaction may contribute to workforce retention at the managerial level. Future research should evaluate the effectiveness of targeted organizational interventions in sustaining nurse manager retention.

Neoplastic Foot Ulcers: A Multicentre Retrospective Study

ABSTRACT

Neoplastic foot ulcers are particularly challenging for dermatologists and specialists in hard-to-heal wounds because their location and comorbidities can delay accurate diagnosis. We performed a multicentre, retrospective study analysing clinical and histological data, focusing on neoplastic foot ulcers collected over the past 5 years. We evaluated patients' demographic characteristics, clinical features, histological diagnosis, tumour onset and ulcer site. Statistical analyses were conducted using SPSS software, v.30. In total, 106 patients affected by foot skin ulcers were enrolled in the present protocol (52 women, 54 men). The mean age was 70.15 years. In most cases, the neoplastic ulcer was due to primary tumour ulceration. The dorsum of the foot was the most common site of neoplastic ulcers (66%). From a clinical perspective, most lesions were classified as ulcerated nodules (n = 58), ulcerated plaques (n = 8) or hypergranulating ulcers (n = 25), all with thickened, atypical edges. Histological diagnoses included melanoma (n = 45), non-melanoma skin cancers (n = 34), benign tumours (n = 18) and rarer malignancies (n = 9). A statistically significant correlation was found between histotype and clinical lesion type, and between age and histotype. The study provided preliminary data on the clinical and histological characteristics of neoplastic foot ulcers, warranting further exploration in a prospective, multicentre study.

Measuring Advanced Practice in Health Visiting: Development and Psychometric Testing of the Health Visiting Advanced Practice Scale in Public Health Nursing

ABSTRACT

Background

The debate about whether health visiting, a specialist community public health nursing role, is at the level of advanced practice nurse has gone on for more than a decade. There is little empirical evidence that the role matches the traditional role of an advanced practice nurse, although many of the attributes of advanced practice nursing such as prescribing rights, managing complex cases, caseloads with undifferentiated need and advanced assessment and decision-making are certainly present.

Aim

The current study aimed to develop, refine and test the Health Visiting Advanced Practice Scale to assess the scope of advanced practice of UK health visitors.

Design

A cross-sectional and methodological scale validation design, following classical test theory.

Methods

The design consisted of three phases; the first involved scale development including item generation, phase two assessed the content validity index, and the third phase involved a cross-sectional survey to establish construct validity, content validity, and internal consistency reliability, and conduct exploratory and confirmatory factor analysis.

Results

The initial 44-item scale underwent iterative exploratory and confirmatory factor analyses, leading to a refined 5-factor structure with 29 items covering domains such as family-centred care, leadership, prescribing, diagnostic reasoning, and professional practice. This final version demonstrated strong reliability and construct validity in the EFA but mixed fit indices in the CFA, supporting both internal consistency and validity of the scale.

Conclusion

The final scale offers a rigorously validated tool for assessing advanced practice among UK health visitors, capturing core domains such as family-centred care, leadership, prescribing, and diagnostic reasoning. By bridging theoretical frameworks with real-world practice, it fills a critical gap in evaluating and supporting the professional scope of this public health nursing specialty.

Impact

These findings provide valid and reliable insights for measuring and improving health visitors' advanced practice and developing future professional policies.

Patient or Public Contribution

No patient or public contribution.

Reporting Method

STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies.

Decision Trees for Managing Impaired Physical Mobility in Multiple Trauma Patients

ABSTRACT

Aim

To develop and validate decision trees using conditional probabilities to identify the predictors of mortality and morbidity deterioration in trauma patients.

Design

A quasi-experimental longitudinal study conducted at a Level 1 Trauma Center in São Paulo, Brazil.

Method

The study analysed 201 patient records using standardised nursing documentation (NANDA International and Nursing Outcomes Classification). Decision trees were constructed using the chi-squared automatic interaction detection (CHAID) algorithm and validated through K-fold cross-validation to ensure model reliability.

Results

Decision trees identified key predictors of survival and mobility deterioration. Patients who did not require (NOC 0414) Cardiopulmonary Status but required (NOC 0210) Transfer Performance had a 97.4% survival rate. Conversely, those requiring (NOC 0414) Cardiopulmonary Status had a 25% risk of worsening mobility, compared to 9% for those who did not. K-fold cross-validation confirmed the model's predictive accuracy, reinforcing the robustness of the decision tree approach (Value).

Conclusion

Decision trees demonstrated strong predictive capabilities for mobility outcomes and mortality risk, offering a structured, data-driven framework for clinical decision-making. These findings underscore the importance of early mobilisation, tailored rehabilitation interventions and assistive devices in improving patient recovery. This study is among the first to apply decision trees in this context, highlighting its novelty and potential to enhance trauma critical care practices.

Implications for the Profession and/or Patient Care

This study highlights the potential of decision trees, a supervised machine learning method, in nursing practice by providing clear, evidence-based guidance for clinical decision-making. By enabling early identification of high-risk patients, decision trees facilitate timely interventions, reduce complications and support personalised rehabilitation strategies that enhance patient safety and recovery.

Impact

This research addresses the challenge of improving outcomes for critically ill and trauma patients with impaired mobility by identifying effective strategies for early mobilisation and rehabilitation. The integration of artificial intelligence-driven decision trees strengthens evidence-based nursing practice, enhances patient education and informs scalable interventions that reduce trauma-related complications. These findings have implications for healthcare providers, rehabilitation specialists and policymakers seeking to optimise trauma care and improve long-term patient outcomes.

Patient or Public Contribution

Patients provided authorisation for the collection of their clinical data from medical records during hospitalisation.

Can a digital intervention 'Momentum improve social functioning and transdiagnostic symptoms for Australian youth at ultrahigh risk for psychosis? Protocol for a superiority randomised controlled trial comparing treatment as usual with and without Momentu

Por: Mangelsdorf · S. N. · Cagliarini · D. · Nelson · B. · McEnery · C. · Whiting · J. · Chinnery · G. · Valentine · L. · Lee · Y. Y. · Mihalopoulos · C. · Liu · V. · Bendall · S. · Koval · P. · DAlfonso · S. · Gonzalez-Blanch · C. · Ryan · R. M. · Lederman · R. · H Lim · M. · McGorry · P. · Po
Introduction

Existing psychological and pharmacological interventions for young people at ultra-high risk (UHR) for psychosis have shown benefit in at least delaying the transition to psychosis, but they have limited benefit for comorbid disorders or social dysfunction, which are prominent for those at UHR. We developed a moderated online social therapy platform (named Momentum) including: (1) transdiagnostic therapeutic interventions targeting social functioning, depression, generalised anxiety and social anxiety; (2) a moderated, peer-led online community and (3) specialised human support from clinicians, career consultants and peer workers. The aim of this trial is to determine whether, in addition to treatment as usual (TAU), Momentum, a 12-month digital intervention, informed by the complex intervention framework, is superior to 12 months of TAU in improving social functioning in UHR young people.

Methods and analysis

The study design is a prospective, parallel group, rater-masked randomised controlled trial. We will recruit young people aged 14–27 years, meeting one or more UHR for psychosis criteria. Participants are randomly assigned to the condition using randomly permutated blocks with a 1:1 allocation ratio. Participants are stratified by age (

Ethics and dissemination

Melbourne Health Human Research Ethics Committee (HREC/42964/MH-2018) provided ethics approval for this study. Findings will be made available through scientific journals and forums and to the public via social media and the Orygen website. De-identified individual participant data will be available after publication for 3 years via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. Supplementary material including study protocol, informed consent material and statistical analysis plan will also be available.

Trial registration number

Australian New Zealand Clinical Trial Registry (ANZCTR), ACTRN12619001411134.

The Illness Narratives of Children and Young People With Spinal Muscular Atrophy: A Scoping Review

ABSTRACT

Aim(s)

This review seeks to explore the illness narratives of children and young people focusing on their healthcare trajectories; the right to health; and the kind of stories told about them.

Design

This scoping review adopts a narrative approach to analyse how the illness experience of Spinal Muscular Atrophy is represented in the literature, moving beyond biomedical descriptions to consider sociocultural and historical dimensions. We explore how global and local forces shape everyday life and therapeutic possibilities for people with this condition.

Methods

Four online databases were used to identify papers published between 2014 and 2024 in English and Spanish. The analysis process was guided by the PAGER Framework.

Results

Twenty-one articles met the criteria for the review, mainly published in the Global North. Following organisation of Patterns, findings were categorised into three themes: (1) Parents as storytellers of young people's life trajectories; (2) Tropes about everyday life with Spinal Muscular Atrophy; and (3) The right to health as a narrative terrain. Findings show that access to medical treatment, information, and healthcare coverage poses difficulties when navigating the healthcare system with little institutional support.

Conclusions

The voices of individuals with Spinal Muscular Atrophy are rarely reported, often represented by their parents. There are opportunities to develop strategies that enhance the experiences of children and young people when seeking care, which should have a rights-based, intersectional, and family-centred approach.

Impact

This review highlights the need to listen to children and young people's voices, offer support to caregivers, and further explore the right to health in the Global South.

Patient or Public Contribution

The interpretation of the findings was enriched by the involvement of patients, who participated as advisors for the research team. Their contributions ensured the research remained aligned with concerns and priorities informed by lived experience of the disease.

Profiling Healthcare Professionals' Digital Health Competence and Associated Factors: A Cross‐Sectional Study

ABSTRACT

Aim

To assess healthcare professionals' digital health competence and its associated factors.

Design

Cross-sectional study.

Methods

The study was conducted from October 2023 to April 2024 among healthcare professionals in Italy, using convenience and snowball sampling. The questionnaire included four sections assessing: (i) socio-demographic and work-related characteristics; (ii) use of digital solutions as part of work and in free time, and communication channels to counsel clients in work; and DigiHealthCom and DigiComInf instruments including measurements of (iii) digital health competence and (iv) managerial, organisational and collegiality factors. K-means cluster analysis was employed to identify clusters of digital health competence; descriptive statistics to summarise characteristics and ANOVA and Chi-square tests to assess cluster differences.

Results

Among 301 healthcare professionals, the majority were nurses (n = 287, 95.3%). Three clusters were identified: cluster 1 showing the lowest, cluster 2 moderate and cluster 3 the highest digital health competence. Most participants (n = 193, 64.1%) belonged to cluster 3. Despite their proficiency, clusters 2 and 3 scored significantly lower on ethical competence. Least digitally competent professionals had significantly higher work experience, while the most competent reported stronger support from management, organisation, and colleagues. Communication channels for counselling clients and digital device use, both at work and during free time, were predominantly traditional technologies.

Conclusion

Educational programmes and organisational policies prioritising digital health competence development are needed to advance digital transition and equity in the healthcare workforce.

Implications for the Profession

Greater emphasis should be placed on the ethical aspects, with interventions tailored to healthcare professionals' digital health competence. Training and policies involving managers and colleagues, such as mentoring and distributed leadership, could help bridge the digital divide. Alongside traditional devices, the adoption of advanced technologies should be promoted.

Reporting Method

This study adheres to the STROBE checklist.

Patient or Public Contribution

None.

Validity and Reliability of the Self‐Care of Chronic Illness Inventory and Self‐Care Self‐Efficacy Scale in Patients Living With Cancer

ABSTRACT

Aim

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.

Design

A multisite cross-sectional validation study was conducted.

Methods

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.

Results

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.

Conclusion

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.

Implications For the Profession

These tools can help develop targeted educational programs, improving patient outcomes.

Impact

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.

Patient or Public Contribution

No patient or public contribution.

Design, 3D printing, and preclinical validation of an extraglottic ramp to facilitate blind orotracheal intubation in emergency airway management

by Jorman H. Tejada-Perdomo, Valentina Gutierrez-Perdomo, Juana V. Agudelo-Castro, Jorge A. Pérez-Gamboa, Alejandro Weinstein, Sebastián San Martín, Rodrigo Salas, Jorge A. Ramos-Castaneda

The use of devices that facilitate rapid airway isolation is essential when managing critical patients in emergencies. In recent years, additive manufacturing has emerged as an innovative, versatile, and accessible technology for developing medical devices. This study presents the design, development, and validation of an extraglottic medical device created using computer-aided design tools and stereolithographic 3D printing to facilitate blind intubation by first responders. The device was iteratively modeled and fabricated with biocompatible materials; validation in airway simulators and human cadaveric specimens assessed dimensions, friction, intubation technique, and learning curve, and ease of use was rated with a Likert scale. Ten iterations led to a final design with low friction and minimal cervical manipulation; ramp angle, cup geometry, and distal tip were optimized for tube passage, and BioMed Flex 80A showed high strength and anatomical compatibility. The final version is a safe, reusable, and functional alternative for airway management and blind orotracheal intubation, particularly in emergencies and resource-limited settings; clinical validation in live patients is still needed.

Move to improve: protocol for a single-arm, pragmatic feasibility trial of an individualised physical activity programme for children with chronic conditions

Por: Sivaramakrishnan · H. · Finlay-Jones · A. · Valentine · J. · Wood · F. M. · Naylor · L. H. · Haustead · L. · Davey · E. · Reid · S. · Shetty · V. B. · Graciet · J. · OMeara · D. · Robertson · A. · Davis · E. · Move to Improve Author Group · Elliott · Walwyn · Gottardo · Martin · Long
Introduction

Physical activity improves physical and psychosocial outcomes in healthy children and in children with a range of chronic health conditions. Unfortunately, children with chronic health conditions have lower levels of physical activity compared to their healthy peers due to multiple restrictions in physical activities and therefore tend to have lower levels of physical activity compared with their peers. This paper describes the protocol for Move to Improve, a pragmatic trial of an individualised physical activity intervention for children with chronic health conditions.

Methods and analysis

Using the RE-AIM framework, this study aims to test the feasibility of Move to Improve, an 8-week hospital-based individualised physical activity intervention. We will recruit 100 children aged 5–17 years who are diagnosed with type 1 diabetes, cancer, postburn injuries and cerebral palsy to a single-arm, pragmatic feasibility trial. The primary outcomes (objective moderate to vigorous physical activity, quality of life and goal attainment) and secondary outcomes (including aerobic capacity, body composition, motor function, grip strength and psychosocial outcomes) will be assessed at baseline, post intervention and at 6-month and 12-month follow-ups. We will conduct semistructured interviews with participants and their primary caregiver at a 2-month follow-up to capture aspects of feasibility. Quantitative data will be reported descriptively, and qualitative data will be analysed using thematic analysis. Data gathered from this study will inform service decision-making and future trials.

Ethics and dissemination

The study has received ethics approval from the Government of Western Australia Child and Adolescent Health Service Human Research Ethics Committee (RGS6677). Findings of this research will be communicated to the public through peer-reviewed publications, conference presentations, reports, infographics and information sheets. Modifications to the protocol will be outlined in the trial registry and journal publications. Authorship will be in accordance with the International Committee of Medical Journal Editors.

Trial registration number

Australian and New Zealand Clinical Trials Registry Number: ACTRN12624000836538.

NuPOWER (Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis): protocol for an open-label, single-arm, multicentre study

Por: Srivastava · A. · Kanny · A. · Langer · F. · Kubicek-Hofmann · C. · Alvarez Roman · M. T. · Nunez Vazquez · R. · Boban · A. · Dejanova-Ilijevska · V. · Miljic · P. · Garcia · J. · Halimeh · S. · Drillaud · N. · Valentin · J.-B. · Mancuso · M. E. · Castaman · G. · Santoro · R. C. · Leht
Introduction

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

Methods and analysis

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethics and dissemination

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

Trial registration number

CT EU 2022-502060-21-00; NCT05935358.

Global prioritised indicators for measuring WHOs quality-of-care standards for small and/or sick newborns in health facilities: development, global consultation and expert consensus

Por: Day · L. T. · Vaz · L. M. E. · Semrau · K. E. A. · Moxon · S. · Niermeyer · S. · Khadka · N. · Chitashvili · T. · Valentine · G. C. · Drake · M. · Ehret · D. E. Y. · Sheffel · A. · Sacks · E. · Greenspan · L. · Shaver · T. R. · Kak · L. · Hailegebriel · T. D. · Gupta · G. · Hill · K. · Jac
Objectives

The aim of this study was to prioritise a set of indicators to measure World Health Organization (WHO) quality-of-care standards for small and/or sick newborns (SSNB) in health facilities. The hypothesis is that monitoring prioritised indicators can support accountability mechanisms, assess and drive progress, and compare performance in quality-of-care (QoC) at subnational levels.

Design

Prospective, iterative, deductive, stepwise process to prioritise a list of QoC indicators organised around the WHO Standards for improving the QoC for small and sick newborns in health facilities. A technical working group (TWG) used an iterative four-step deductive process: (1) articulation of conceptual framework and method for indicator development; (2) comprehensive review of existing global SSNB-relevant indicators; (3) development of indicator selection criteria; and (4) selection of indicators through consultations with a wide range of stakeholders at country, regional and global levels.

Setting

The indicators are prioritised for inpatient newborn care (typically called level 2 and 3 care) in high mortality/morbidity settings, where most preventable poor neonatal outcomes occur.

Participants

The TWG included 24 technical experts and leaders in SSNB QoC programming selected by WHO. Global perspectives were synthesised from an online survey of 172 respondents who represented different countries and levels of the health system, and a wide range of perspectives, including ministries of health, research institutions, technical and implementing partners, health workers and independent experts.

Results

The 30 prioritised SSNB QoC indicators include 27 with metadata and 3 requiring further development; together, they cover all eight standard domains of the WHO quality framework. Among the established indicators, 10 were adopted from existing indicators and 17 adapted. The list contains a balance of indicators measuring inputs (n=6), processes (n=12) and outcome/impact (n=9).

Conclusions

The prioritised SSNB QoC indicators can be used at health facility, subnational and national levels, depending on the maturity of a country’s health information system. Their use in implementation, research and evaluation across diverse contexts has the potential to help drive action to improve quality of SSNB care. WHO and others could use this list for further prioritisation of a core set.

Older Adults' Self‐Care and Family Caregiver Contribution in Multiple Chronic Conditions: A Dyadic Qualitative Study

ABSTRACT

Aims

To explore how older adult-family caregiver dyads jointly manage multiple chronic conditions. Specifically, it investigates how dyads (i) prioritise chronic diseases, (ii) make and negotiate decisions related to self-care and (iii) define and distribute self-care tasks and caregiver contributions.

Design

A qualitative descriptive study using dyadic data collection and analysis.

Methods

Semi-structured interviews were conducted separately with chronically ill older adults and their family caregivers between July and December 2024. A hybrid inductive-deductive content analysis was applied. Dyadic analysis compared intra-dyad perspectives to identify patterns of agreement and disagreement.

Results

Thirty-four dyads (n = 68 participants) were interviewed. Older adults had a mean age of 80.09 years (SD = 6.95) and were affected by a median of four chronic conditions. Family caregivers had a mean age of 51.71 years (SD = 14.59), with most being the older adults' children (66.67%) and women (82.35%). Five categories, comprising 25 subcategories, were derived from the data. Disease prioritisation varied within dyads: older adults often focused on conditions with the most disabling symptoms, while caregivers emphasised those with higher risks of complication. Decision-making roles ranged from older adult-led to caregiver-led to shared. Care organisation followed three models: collaborative, older adult-directed, or caregiver-directed. Challenges in managing diseases included treatment adherence, care coordination, emotional burden and addressing multiple symptoms simultaneously. Role distribution in disease management and decision-making was complex and occasionally misaligned, sometimes resulting in conflict. Collaborative dyads reported greater adaptability and balance, while incongruent dyads experienced relational and organisational strain.

Conclusion

Managing multiple chronic conditions in older adults is a relational process shaped by interpersonal dynamics and shared responsibilities with family caregivers. Recognising dyadic relational patterns is essential for designing targeted educational interventions. Nurses should incorporate dyadic assessments into routine care to improve outcomes for older adults and reduce caregiver burden.

Implications for the Profession and/or Patient Care

This study highlights the importance of viewing chronic disease management as a dyadic process, rather than an individual task, involving both the older adult and the family caregiver. Tailored strategies that account for the relational dynamics within dyads, such as decision-making roles and care task distribution, are essential for effective chronic disease management.

Reporting Method

Consolidated criteria for reporting qualitative studies (COREQ).

Patient or Public Contribution

None.

Head-to-head comparison of the RMI and ADNEX models to estimate the risk of ovarian malignancy: a systematic review and meta-analysis of external validation studies

Por: Barrenada · L. · Ledger · A. · Kotlarz · A. · Dhiman · P. · Collins · G. S. · Wynants · L. · Verbakel · J. Y. J. · Valentin · L. · Timmerman · D. · Van Calster · B.
Objectives

Assessment of Different NEoplasias in the adneXa (ADNEX) and Risk of Malignancy Index (RMI) are models that estimate the risk of malignancy in ovarian masses based on clinical and ultrasound information. The aim is to perform a meta-analysis of studies that compared the performance of the two models in the same patients (‘head-to-head comparison’).

Design

Systematic review and meta-analysis.

Data sources

Systematic literature search from publication of ADNEX model (15/10/2014) up to 31/07/2024 in Embase, Web of Science, Scopus, Medline (via PubMed) and EuropePMC.

Eligibility criteria for selecting studies

We included all studies that externally validated the performance of ADNEX (with or without CA125) and RMI on the same data.

Data extraction and synthesis

Two independent reviewers extracted data using a standardised extraction sheet. We assessed risk of bias using PROBAST. We performed random effects meta-analysis of the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and clinical utility (net benefit, relative utility and probability of being useful in a hypothetical new centre) at thresholds commonly used clinically (10% risk of malignancy for ADNEX, 200 for RMI).

Results

We included 11 studies comprising 8271 tumours. Most studies were at high risk of bias. The summary AUC to distinguish benign from malignant tumours in operated patients for ADNEX with CA125 was 0.92 (95% CI 0.90 to 0.94) and for RMI it was 0.85 (0.81 to 0.89). Sensitivity and specificity for ADNEX with CA125 were 0.93 (0.90 to 0.96) and 0.77 (0.71 to 0.81) and for RMI, they were 0.61 (0.56 to 0.67) and 0.92 (0.89 to 0.94). The probability of the test being useful in a hypothetical new centre in operated patients was 96% for ADNEX with CA125 and 15% for RMI at the selected thresholds.

Conclusions

ADNEX has better discrimination and clinical utility than RMI.

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