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Weight-Neutral Health Intervention (WIN) for adults with BMI >=30 kg/m2: protocol for a single-arm feasibility study

Por: Sigurdardottir · G. A. · Koster-Rasmussen · R. · Meyer · L. B. · Sandholdt · C. T. · Christiansen · A.-K. L. · Specht · I. O. · Lindschou · J. · Engstrom · J. · Heitmann · B. L. · Bojsen-Moller · K. N. · Overbeck · G. · Kousgaard · M. B. · Reventlow · S. · Jebb · S. · Dirksen · C.
Introduction

Weight stigma and internalised weight bias are associated with poor mental, social and physical health. Weight-neutral approaches prioritise well-being and sustainable health behaviours. However, the feasibility and acceptability of weight-neutral interventions remain uncertain.

Methods and analysis

Weight-Neutral Health Intervention (WIN) is an investigator-initiated single-arm feasibility study enrolling 56 adults with body mass index ≥30 kg/m2 in the Capital Region of Denmark. The study investigates a codesigned weight-neutral health intervention. The 6-month intervention comprises 1 preparatory session and 11 group sessions led by trained practitioners, focusing on intuitive eating, body acceptance and self-compassion; optional components include support-network events, up to three individual online sessions and access to ‘size-inclusive yoga’ and ‘body competence’ courses. The primary feasibility outcome is follow-up completion. Recruitment proportion and adherence are secondary feasibility outcomes. These will be assessed using a set of predefined ‘traffic-light’ stop/go progression criteria. Exploratory feasibility outcomes include data completeness for other outcomes and participant engagement with the intervention. Exploratory clinical outcomes include questionnaire data (quality of life, depression, weight bias internalisation, eating behaviours, self-esteem, body image, stress and life satisfaction), clinical measures (weight, heart rate and blood pressure), biomarkers (blood samples and hair cortisol), 7-day actigraphy (physical activity and sleep) and serious adverse events. Qualitative interviews, focus groups and fieldnotes will be used to explore acceptability and contextual factors. If progression criteria are met, the study will inform the design of a pragmatic, multicentre, randomised trial. The exploratory outcomes will inform outcome selection, setting, sample size and procedures.

Ethics and dissemination

Approved by the Regional Ethics Committee of the Capital Region of Denmark (H-25013213). Results will be disseminated through peer-reviewed publications, conferences and public platforms.

Trial registration number

NCT06922630.

Intensive weight loss intervention versus usual care for adults with severe and complex obesity: the LightWAY randomised trial protocol

Por: Wane · S. · Aveyard · P. · Wielsoe · S. · Larsen · S. C. · Scragg · J. · Lindschou · J. · Jakobsen · J. C. · Engstrom · J. · Specht · I. O. · Christiansen · A.-K. L. · Jensen · A. K. G. · Bandholm · T. · Albury · C. · Overbeck · G. · Reventlow · S. · Olsen · K. R. · Farr · P. · Bojsen-Mo
Introduction

Effective treatment for clinical obesity is available but is rarely offered by healthcare systems, which often treat complications without treating the underlying cause. The LightWAY trial will investigate the clinical benefits and harms as well as cost-effectiveness of an intensive weight loss intervention compared with existing weight management programmes for people with clinical obesity.

Methods and analysis

LightWAY is an investigator-initiated, international, randomised, parallel-group clinical superiority trial with blinded outcome assessment. Six hundred people seeking treatment for clinical obesity (body mass index ≥35 kg/m2 with comorbidities) will be recruited in centres in the UK and Denmark and randomised 1:1 to one of two groups. The experimental group will be offered a 2-year intensive weight loss programme providing support and advice to follow a total diet replacement programme, followed by gradual transition to an energy-reduced diet in combination with increased physical activity and if needed, prescription of weight loss medication. The control group will receive usual care, typically comprising brief behavioural support for weight loss and treatment of the complications of obesity or occasionally referral to specialist weight management services. The two co-primary outcomes are cardiometabolic risk, assessed with metabolic syndrome severity Z-score, and body weight assessed at 2 years. The secondary outcomes include the Short Form-36 mental component scale, 4-metre gait speed and proportion of participants achieving ≥20% weight loss. The key adverse effects will be the proportion of participants with at least one serious adverse event, incidence of eating disorders and disproportional loss of bone mass. Incremental cost-effectiveness will be assessed over the trial period and over the lifetime through modelling.

Ethics and dissemination

Ethical approval was granted in the UK (August 2024, 24/SC/0211) and Denmark (December 2023, H-23065222). Findings will be disseminated through peer-reviewed journals and scientific conferences and to participants in the trial and clinicians.

Trial registration number

NCT06321458.

Systemic iron availability differentially shapes tumor and brain iron handling in a sex-dependent manner in glioblastoma

by Emily Tufano, Kondaiah Palsa, Rebecka O. Serpa, Timothy B. Helmuth, Gabriela Remit-Berthet, Sara Mills-Huffnagle, Mathias Kant, Aurosman Sahu, James R. Connor

Iron is essential for normal physiological function, yet dysregulation of iron metabolism is increasingly recognized as a hallmark of cancers such as glioblastoma (GBM). Recent clinical evidence suggests that systemic iron deficiency anemia (IDA) negatively impacts GBM outcomes in a sex-dependent manner, but the mechanisms linking systemic iron availability to tumor iron metabolism remain poorly understood. Here, we interrogate the impact of systemic iron through dietary modulation (control, iron deficiency (ID), and high iron diets), stratified by sex, on tumor iron handling and GBM outcomes utilizing an immune competent (C57BL/6) GBM (GL261) mouse model. Subsequently, we analyzed clinical samples to evaluate translational value. In the preclinical study, we show that iron deficiency decreased survival in males but conferred a slight survival advantage in females, consistent with prior clinical trends. Among circulating iron markers, only ferritin light chain (FTL), but not ferritin heavy chain (FTH) or serum iron, positively correlated with survival in males but not females. In the brain, contralateral iron levels reflected dietary iron status in males but not females, further supporting sex-dependent regulation of local and circulating iron. Notably, tumor iron content remained unchanged in males but was significantly elevated in ID female tumors, complemented by increased transferrin receptor (TfR1) and FTH expression. In clinical GBM samples, we observed non-statistically significant but similar survival trends across varying iron and ferritin levels, suggesting potential translational relevance of our exploratory model. These findings demonstrate that systemic iron availability exerts a sex-specific effect on tumor iron handling, highlighting a critical relationship between systemic and tumor iron regulation in GBM.

Longitudinal Mediating Role of Cancer‐Coping Self‐Efficacy Between Symptom Occurrence and Quality of Life Among Cancer Patients: A Cross‐Lagged Panel Model

ABSTRACT

Purpose

Although the positive correlation between self-efficacy and quality of life and the negative correlation between symptom occurrence and self-efficacy are well established in the cancer literature, the underlying mechanism, whether self-efficacy mediates the effect of symptoms on quality of life, remains unclear due to the cross-sectional design of prior studies. Longitudinal investigation is crucial for establishing the causal mechanism of self-efficacy in mitigating the adverse impact of cancer-related symptoms on quality of life.

Aim

To examine the longitudinal mediating effect of self-efficacy on the relationship between symptom occurrence and quality of life among 534 cancer patients on treatment with moderate to high symptoms.

Methods

This is a secondary data analysis of the longitudinal mediating effect. A sample of patients with moderate to high symptoms on cancer treatments (N = 534) from a randomised controlled trial was used. We adopted a cross-lagged panel model (CLPM) approach to test the longitudinal mediating effect with three waves. The longitudinal invariance of the measurement was previously tested.

Results

The results showed that cancer-coping self-efficacy predicted the following assessment of symptom occurrence, but not vice versa. Also, cancer-coping self-efficacy had an immediate direct impact on quality of life and the influence sustained to the following assessment. Our mediating analysis showed that cancer-coping self-efficacy totally mediated the relationship between symptom occurrence and quality of life (unstandardized β = −0.008, standardised B = −0.036, p = 0.036, CI95 = [−0.001, −0.016]).

Conclusion

Our findings provide initial evidence supporting the causal mechanism of cancer-coping self-efficacy in interventions that aim for symptom management and quality of life improvement.

Implications

This study is the first to test the longitudinal mediating mechanism of cancer-coping self-efficacy in the relationship between symptom occurrence and quality of life among the cancer population. Further testing using a randomised controlled trial of a specifically designed self-efficacy-enhancing intervention is needed.

Patient or Public Contribution

No patient or public contribution.

The Power of a Ricoeur‐Inspired Phenomenological‐Hermeneutic Approach to Focus Group Interviews

ABSTRACT

Aim

To justify the use of focus group interviews with patients and healthcare professionals within a phenomenological-hermeneutic approach inspired by the theory of the French philosopher Paul Gustave Ricoeur.

Design and Methods

Methodological guidance and discussion grounded in Ricoeur's theory on narrative, dialogue, threefold mimesis and interpretation.

Results

This phenomenological-hermeneutical approach to focus group interviews yields significant, in-depth understandings of lived experiences from both patients and healthcare professionals.

Conclusions

Ricoeur-inspired phenomenological-hermeneutical focus group interviews with patients and healthcare professionals offer a promising approach for exploring and generating new, valuable insights into the complexities of clinical nursing practice. Thus, this paper argues for an integration of focus group interviews and a phenomenological-hermeneutical approach within nursing science.

Implications for the Profession

The approach has significant implications for nursing practice. By incorporating Ricoeur-inspired dialogue-based collective voices of patients and healthcare professionals in focus group interviews, nursing practices can be refined, leading to improved patient care and more effective clinical interventions. Thus, this approach advocates for a broader adoption of Ricoeur-inspired focus group interviews in nursing research and in health research in general to enhance the understanding and development of clinical models.

Reporting Method

No available EQUATOR guidelines were applicable to this methodological paper, as no new data were created or analysed.

Patient or Public Contribution

As this is a methodological paper, no new patient or public contributions are included.

Transforming Hospital Care: Impact of an Evidence‐Based Practice Course on Healthcare Professionals' Competencies in a Randomized Clinical Trial

ABSTRACT

Introduction

Evidence-Based Practice (EBP) is essential to healthcare quality and safety, integrating scientific evidence with clinical expertise and patient preferences. Despite its importance, EBP implementation still faces major challenges. Educational interventions have proven effective in strengthening EBP competencies among healthcare.

Main

To evaluate the impact of a personalized educational intervention on EBP competencies among healthcare professionals. Working at a private tertiary general hospital, comparing performance before and after the intervention.

Methods

A randomized controlled trial involving healthcare professionals was conducted. Eligible and consented participants were randomly assigned to either an Intervention Group (IG) receiving an Evidence-Based Practice (EBP) course or a Control Group (CG) not receiving the course, stratified by job level, role, and work shift. From the completers, 18 participants were randomly selected for the IG, and all 7 available CG participants were included in the final sample for analysis. All study participants completed two validated instruments: the Assessing Competencies in Evidence-Based Medicine (ACE) and the Fresno Test. The educational intervention consisted of a seven-week course with weekly three-hour sessions, for a total of 21 h. Comparative analyses were conducted using a Linear Mixed Model, adjusted for educational level, job level, time working at the hospital, and weekly workload.

Results

A statistically significant increase in general EBP knowledge was observed in the IG following the intervention, with a mean gain of 19.1%. Separate analysis showed improvements of 10.8% in ACE and 24.2% in Fresno Test scores. No statistically significant changes were observed in the CG. Furthermore, after the intervention, the IG outperformed the CG for both general EBP knowledge and Fresno Test scores on both pre- and post-intervention comparisons.

Conclusion

The educational intervention had a positive statistically significant impact on EBP knowledge and skills among healthcare professionals in the IG compared to the CG. These findings underscore the potential of structured educational initiatives to enhance the quality of clinical practice through improved EBP competencies.

Trial Registration

UTN U1111-1322-8443

Disciplinary removal patterns among students with other health impairments and emotional disturbance: A three-year descriptive analysis of IDEA Part B data

by Melissa Beck Wells

Students classified under Other Health Impairment (OHI), a category that includes Attention-Deficit/Hyperactivity Disorder (ADHD), are frequently disciplined in school settings despite ADHD being classified as a neurodevelopmental rather than a behavioral disorder. This study examined patterns of disciplinary removal among students served under the Individuals with Disabilities Education Act (IDEA), Part B, focusing on comparisons between OHI and Emotional Disturbance (ED). Using publicly available IDEA Part B discipline data, a descriptive longitudinal analysis was conducted across three academic years (2019–2020, 2020–2021, and 2021–2022). Percentage-based indicators were analyzed to examine the proportion of students ages 3–21 subject to disciplinary removal by disability category and state. Across all three years, students classified under OHI experienced disciplinary removal at rates comparable to, and in many states exceeding, those of students classified under ED. These patterns persisted despite year-to-year variation associated with the COVID-19 pandemic. Findings are interpreted through IDEA procedural safeguards and DSM-5 diagnostic frameworks, highlighting a potential misalignment between neurodevelopmental disability classification and behavioral support provision. The study discusses how Universal Design for Learning (UDL) may reduce disciplinary risk through proactive design, while emphasizing that individualized behavioral interventions, including Functional Behavioral Assessments and Behavior Intervention Plans, remain legally required when behavior is a manifestation of disability.

Barriers and facilitators to implementing a shared decision-making tool for anticoagulant-related drug-drug interactions: a qualitative study across three academic medical centres in the USA

Por: Becker · R. A. · Bonnet · K. · Shah · M. V. · Dang · E. · Ancker · J. S. · Malone · D. C. · Trinkley · K. E. · Gomez-Lumbreras · A. · Del Fiol · G. · Kawamoto · K. · Tawfik · A. G. · Cornia · R. · Jones · A. E. · Mitchell · J. · Reese · T. J.
Objectives

To identify barriers and facilitators to implementing an electronic shared decision-making tool for managing anticoagulant-related drug-drug interactions that affect bleeding risk in routine clinical care.

Design

Preimplementation qualitative study using semistructured interviews.

Setting

Three academic medical centres in the southeastern and western USA. Interviews were conducted between 27 March and 25 September 2024.

Participants

36 participants, including 19 clinicians involved in prescribing or managing anticoagulants and seventeen patients prescribed anticoagulants, were recruited using purposive and convenience sampling.

Results

Participants identified multiple barriers and facilitators to tool implementation. Common barriers included limited visit time, challenges integrating the tool into existing workflows, role and scope-of-practice constraints, and variation in patient digital literacy. Facilitators included clear visualisation of bleeding risk, access to supporting evidence, familiar interface design and perceived potential to support patient engagement and shared decision-making. Several determinants functioned as both barriers and facilitators, depending on clinical context and user role.

Conclusions

This preimplementation qualitative study identified context-specific determinants that influence the adoption of an electronic shared decision-making tool for anticoagulant-related drug–drug interactions. Findings highlight the importance of early attention to workflow integration, role alignment and usability to support uptake in routine care. Addressing these factors during design and implementation may inform strategies to support adoption and future evaluation in real-world clinical settings.

Adapting substance use treatment for black adolescents in the US legal system: protocol for a mixed-method, exploratory, feasibility and acceptability study using the eight-step ADAPT-ITT framework

Por: Bryant · B. E. · Tolou-Shams · M. · Ezimora · I. · Zapolski · T. C. · DiClemente · R. · Jordan · A. · Becker · S. J. · Squeglia · L. M.
Introduction

This community-led research study protocol emphasises placing black youth impacted by the legal system, their families and their communities at the forefront of substance use treatment development research and decision-making. The study, the Cultural Adaptation of a Substance Use Treatment (CAST) Project, challenges traditional top-down approaches to treatment creation, advocating for a grassroots model that centres community knowledge, values and active participation.

Methods and analysis

The CAST project is a US-based mixed-methods study with an exploratory design that examines the impact of racial discrimination on substance use in black youth impacted by the legal system. The study participants are black youth impacted by the legal system (N=15), parents of black youth impacted by the legal system (N=10) and community members who serve black youth (N=10) (total N=35 study participants). Study participants from each group (youth, parents and community members) will participate in three separate focus groups, respectively, to provide feedback on the culturally responsive content needed to best support black youth impacted by the legal system around substance use and mental health. The eight-step Assess, Decision, Adaptation, Production, Topical Expert, Integration, Training, Testing framework will be used as a guide to inform adaptations to the Motivational Enhancement Therapy and Cognitive Behavioural Therapy (MET/CBT12) for black youth impacted by the legal system. Once the cultural adaptation process has been completed, the study will conclude with an open feasibility and accessibility trial of the culturally adapted MET/CBT12 manual. The primary outcomes of this study are the feasibility and acceptability of the culturally adapted manual, measured by treatment attendance and participant feedback. Secondary outcomes include reductions in substance use and discrimination distress, and improvements in mental health symptoms.

Ethics and dissemination

This study was approved by the Institutional Review Board (IRB) at the University of California, San Francisco (IRB Protocol Number: 23-40126). All study procedures will be conducted in accordance with the ethical standards outlined by the institutional review board. The results from this study will be shared through peer-reviewed publications, academic conferences, community forums and policy briefs to support broader implementation of culturally adapted adolescent substance use interventions that address discrimination-related stress and substance use among black individuals impacted by the legal system.

Trial registration number

NCT06003725.

Success by Design: Senior Leadership Perspectives on Optimising the Role of Clinical Nurse Specialists

ABSTRACT

Aims

To report on the unique perspectives of senior nursing leaders on the value proposition of the Clinical Nurse Specialist (CNS) role, their organisational experience and the barriers and facilitators to optimise and promote the long-term sustainability.

Design

A qualitative sub-study of a larger multi-method study focused on informing policy recommendations to optimise the CNS workforce, informed by integrated knowledge translation.

Methods

Chief Nursing Officers (CNOs) and other senior leaders in all health authorities in British Columbia, Canada, were invited to participate in semi-structured interviews via video call between August–December 2023. We recruited 13 participants from diverse health regions, including 5 CNOs.

Results

Leaders collectively conveyed a renewed interest in the CNS role to support nursing and multidisciplinary teams to better meet patient and system needs, and a sense of urgency to optimise the role in diverse settings. The overarching theme of “success by design” was supported by three thematic priorities: (1) understanding the CNS role, (2) a role that needs protection and connections and (3) moving forward together. Views were aligned to co-construct implementation-ready policy recommendations to guide provincial strategies.

Conclusion

Senior leaders reported a common understanding of the value-add of the CNS workforce and had a shared experience of barriers to optimisation. Contemporary policy guidance is needed to equip health systems to address this gap.

Impact

Across international regions, the role of CNSs is not fully optimised. This is a wasted opportunity to address the pressing need for nursing practice leaders to transform health systems and improve outcomes. This study provides new knowledge about the perspectives of Chief Nursing Officers and other nursing leaders to shape comprehensive and targeted policy recommendations and address enduring and new challenges to realise the full impact of the CNS workforce.

Reporting Methods

We have adhered to COREQ reporting guidelines (See supplemental file).

Patient and Public Involvement

This study did not include patient or public involvement in its design, conduct, or reporting.

Thriving in Nursing Work: The Association Between Self‐Reports and Biomarkers of Stress, Inflammation and Neuroplasticity

ABSTRACT

Aim

To examine whether self-reported thriving at work is associated with biomarkers of stress, inflammation, neuroplasticity and neurodegeneration in nurses.

Design

A cross-sectional study.

Methods

An online questionnaire measuring thriving at work was administered to nurses in a teaching hospital in Michigan, U.S. over 5 weeks in 2024. A subsample of 100 questionnaire respondents provided blood samples for biomarker analysis. Multiple regression was used to identify self-reported and biomarker predictors of nurse thriving. Cluster analysis was used to distinguish between nurses with high and low levels of thriving based on a combination of self-report and biomarker data.

Results

Higher self-reports of individual and work-related resources predicted higher thriving. Cortisol, a stress hormone, was significantly and inversely associated with thriving. No blood-based biomarkers of inflammation or neuroplasticity predicted thriving. Neurofilament light chain, a marker of neurodegeneration, was not a direct predictor but modified the effects of interpersonal and work resources on thriving.

Conclusion

Biological markers do play a role in nurses' thriving at work and may contribute important complementary information to that provided by nurse self-reports.

Implications for the Profession and/or Patient Care

Nurses thrive in a work situation characterised by positive reports of individual, interpersonal and work resources and lower levels of stress. Efforts to enhance thriving could positively impact nurses' well-being and conditions for providing high-quality patient care.

Impact

This study addressed the question of whether self-reported thriving at work among nurses is reflected in biomarkers of stress, inflammation, and neurocognitive health. A profile of high self-reported work-related resources and low cortisol distinguished higher levels of nurses' thriving from lower levels. Organisational efforts to enhance nurses' thriving can positively impact nurses' health, their work environment, and patient care.

Reporting Method

We followed the STROBE checklist in reporting this study.

Patient or Public Contribution

No Patient or public contribution.

Transcorneal electrical stimulation for the treatment of visual field defects in patients with open-angle glaucoma: a monocentric, randomised, double-masked, sham-controlled pilot study: the TES-GPS study protocol

Por: Lorenz · K. · Schuster · A. · Michel · H. M. · Ruckes · C. · Kronfeld · K. · Schippert · R. · Stett · A. · Beck · A.
Introduction

Glaucoma is one of the leading causes of irreversible blindness and is characterised by progressive loss of retinal ganglion cells. While therapies to lower intraocular pressure slow the progression of the disease in most patients, a significant subset still shows progression despite treatment. Transcorneal electrical stimulation (TES) may potentially activate neuroprotective pathways and slow the progression of visual field defects. The OkuStim 2 System is a medical device for TES which was originally developed for the treatment of retinitis pigmentosa and similar retinal dystrophies and shall now be tested for the treatment of glaucoma. Stimulation of the diseased retina with weak currents can activate signalling pathways and the release of substances that have a protective effect on the retinal cells. This neuroprotective effect might preserve physiological functions of the retina for longer and slow down its gradual degeneration. Long-term use is required to maintain this effect. The TES-GPS study is investigating the safety and efficacy of TES in open-angle glaucoma.

Methods and analysis

TES-GPS (short title for glaucoma pilot study) is a prospective, randomised, double-blind, sham-controlled, single-centre pilot study at the University Medical Center Mainz. 50 patients with progressive visual field loss due to open-angle glaucoma will be randomised 1:1 to receive either TES with the OkuStim 2 System or sham stimulation. The primary endpoint is the change in visual field sensitivity (Humphrey mean deviation) after 18 months. Secondary endpoints include changes in visual acuity, intraocular pressure, optical coherence tomography (OCT) parameters and quality of life (National Eye Institute Visual Function Questionnaire 25, NEI-VFQ 25). The intervention consists of weekly 30 min TES sessions, which are conducted in the patient’s home after initial training in the clinic. The study comprises up to 13 scheduled visits over 18 months.

Ethics and dissemination

The study is conducted in accordance with ISO14155, Medical Device Regulation (EU) 2017/745, International Council for Harmonisation Good Clinical Practice and the Declaration of Helsinki. Approval was obtained from the Ethics Committee of the Landesaerztekammer Rheinland-Pfalz in Mainz and from Bundesinstitut fuer Arzneimittel und Medizinprodukte. Results will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

NCT06682962.

Protocol for the PROSECCA study: a new approach for predicting radiotherapy outcome using artificial intelligence and electronic population-based healthcare data

Por: Nailon · W. H. · Noble · D. J. · Harrison · E. · Yang · Z. · Elliot · S. · MacNair · A. · Beckett · G. · Hallam · A. · Sheikh · A. · Mills · N. · Halliday · R. · Morrison · D. · Chalmers · A. · Cameron · D. · Gourley · C. · Hall · P. · Lilley · C. · Carruthers · L. J. · Trainer · M. · Burns
Introduction

Within the UK there are 33 deaths every day from prostate cancer, second only to lung cancer as the most common cause of cancer death in males in the UK. Of the 55 000 new cases each year, up to 50% of these patients will receive radiotherapy either alone or after prostatectomy. Although there have been significant improvements in the accuracy of radiotherapy delivery leading to better tumour targeting and a reduction in dose to normal tissues, significant permanent genito-urinary or gastrointestinal-related side effects are all too common. With nearly 80% of patients with prostate cancer surviving for 10 years or more, minimising life-limiting radiation damage to normal tissues is vitally important. However, at present, it is not possible to identify which patients will suffer a poorer outcome after radiotherapy. The aim of this study, improving radiotherapy in PROState cancer using EleCtronic population-based healthCAre data (PROSECCA), is to do this by using the existing information in a patient’s digital healthcare record. By linking primary, secondary and tertiary clinical data, including digital image information, with radiotherapy treatment plans and outcome data, the PROSECCA study will identify de novo predictive biomarkers of radiation response and provide clinicians with a tool to individualise a radiotherapy dose and plan to maximise cure and minimise toxicity.

Methods and analysis

The PROSECCA study is a large multidisciplinary project, the purpose of which is to analyse healthcare records from up to 15 000 patients with prostate cancer who underwent radiotherapy in the treatment of their cancer in Scotland between 2010 and 2022. Through the linkage of data obtained specifically for radiotherapy and data held within each patient’s unique electronic health record (EHR), the factors that indicate why some patients have a poor response to treatment, or an increased risk of side effects from radiation, will be identified. This will be made possible by the use of artificial intelligence and machine learning (AL/ML), which will help to identify at-risk patients earlier and allow adaptation of their treatment accordingly.

Ethics and dissemination

The study is being conducted in accordance with the ethical principles set out in the Declaration of Helsinki and Good Clinical Practice that respects and protects the rights, and maintains confidentiality, of all trial participants. The study protocol (V.1.0) was reviewed by the South Central Oxford A Research Ethics Committee (REC) on 13 December 2021 and received a favourable opinion subject to each National Health Service (NHS) organisation confirming permission for patients treated within their area. Approval for the use of unconsented healthcare record data for patients included in the study and treated at one of the five Scottish Cancer Centres required an application to the NHS Scotland Public Benefit and Privacy Panel for Health and Social Care (HSC-PBPP). Full approval from the HSC-PBPP panel was received on 1 July 2024, which covered the use of pseudoanonymised EHR data for all patients participating in the study. The study is publicly listed on the NHS Health Research Authority site, with IRAS ID 306245 and REC reference 21/SC/0402. Dissemination of the study findings will take place through field-leading cancer, radiation oncology and medical physics journals. All manuscripts will be approved by the main study team and authorship determined by mutual agreement.

Trial registration number

NCT06714630.

Factor Structure and Longitudinal Invariance of the Cancer Behaviour Inventory: Assessing Cancer‐Coping Self‐Efficacy in Patients With Moderate‐to‐High Symptoms

ABSTRACT

Background

The Cancer Behaviour Inventory–Brief Version was designed to assess cancer-coping self-efficacy in clinical and research settings where minimising patient burden is essential. However, there is no evidence of its longitudinal validity. Although widely used in cancer research, the lack of evidence for longitudinal invariance significantly undermines its validity in studies spanning multiple time points. Establishing longitudinal invariance enables valid comparisons over time, enhancing our confidence in applying it in longitudinal research.

Aim

To examine the factor structure of the measurement and test its longitudinal invariance across four time points in cancer patients experiencing moderate-to-high symptoms during curative cancer treatment.

Design

A longitudinal psychometric evaluation.

Methods

This is a secondary data analysis of a randomised controlled trial in patients with moderate-to-high symptoms undergoing cancer treatment (N = 534). We conducted longitudinal invariance tests for the measurement using four time points. Other psychometric tests included confirmatory factor analysis, reliability analyses and correlations.

Results

Our confirmatory factor analysis supported the four-factor, 12-item structure for the Cancer Behaviour Inventory–Brief Version. Items 1 and 6 were found to be moderately correlated. The resulting 12-item measure demonstrated good internal consistency, with convergent and divergent validity supported by correlations with selected instruments. Finally, longitudinal invariance was tested, which revealed strict measurement invariance across four time points (CFI = 0.930, RMSEA = 0.045, SRMA = 0.056).

Conclusion

We found that the factor structure of the Cancer Behaviour Inventory–Brief Version remained stable over four time points in a sample of patients having moderate to high symptoms under cancer treatment. This supports its accountability for examining the changes in cancer-coping self-efficacy among cancer patients over time in longitudinal studies.

Implications

This study confirms that Cancer Behaviour Inventory–Brief Version has adequate internal consistency and demonstrated evidence of construct validity. Our conclusion of strict longitudinal invariance supports its credibility for continuous assessment of cancer-coping self-efficacy to evaluate patient outcomes and intervention processes over time in clinical and research settings.

Patient or Public Contribution

No patient or public contribution.

Achieving Quality Through Evidence‐Based Practice and Process Improvement Synergy: The EQUiPP Framework

ABSTRACT

Background

Quality improvement is a well-known and commonly utilized approach to improving care and outcomes that is built on process improvement methods but not practice improvement methods. Because quality care includes both process and practice elements, process improvement alone cannot ensure quality outcomes will be achieved. This calls for a new approach.

Purpose

To share an innovative, synergistic, and collaborative quality framework: Evidence-based Quality in Practice and Process: The EQUiPP Framework.

Importance/Relevance to Healthcare Quality

The EQUiPP Framework's intent is to provide structure for collaborative efforts to effectively identify best practices/processes, implement and sustain change, and improve outcomes. The framework provides guidance to decrease the frequency of implementing ineffective changes by deriving effective solutions … the first time, every time.

Methods

A team of experts used a consensus approach to develop the framework.

Framework Development

A precursor to this framework, the Practice and Process Improvement = Quality (PPQ) Model, was evaluated by individual expert review and a two-day beta test workshop. Feedback was obtained during the workshop when participants applied the model in activities reflecting real-world healthcare scenarios. When used in both DNP student work and real-world health systems, fundamental flaws were identified which resulted in the necessity to develop a different conceptualization. The framework described here is a new approach to improving quality care.

Conclusion

The EQUiPP Framework is a tool that provides the synergistic integration of both practice improvement (EBP) and process improvement methodologies to successfully implement and sustain best practices to achieve and sustain quality outcomes.

Implications for Practice

The EQUiPP Framework aligns EBP and process improvement, allowing clinicians and students to work collaboratively to identify and effectively, as well as efficiently, implement and sustain best practices to deliver quality outcomes.

Predictors of Patient Participation in Pressure Injury Prevention: An Observational Substudy

ABSTRACT

Patient participation improves patient outcomes, but factors that predict participation in pressure injury prevention (PIP) are relatively unknown. This study aimed to identify patient-related factors predictive of patient participation in pressure injury prevention (PPPIP) in hospitalised medical and surgical patients and to assess the psychometric properties of the PPPIP scale. This observational substudy recruited consenting adults at risk of pressure who participated in a parent trial. The seven-item PPPIP scale was administered within 48 h of recruitment, with higher scores reflecting more participation. Multiple regression was used to identify patient-related factors predictive of patient participation. The scale's psychometric properties were assessed using confirmatory factor analysis and Cronbach's alpha. In total, usable data were obtained from 856 patients. Mean PPPIP scale scores were relatively high, with 571 (66.7%) scores reflecting agreement or strong agreement. The Cronbach's alpha was 0.81, and most confirmatory factor analysis criteria for construct validity were met. Only the use of mobility aids was statistically significant in the model, but it predicted a small amount of variability in PPPIP score (adjusted R 2 = 0.017; p < 0.001). Targeting patients with limited mobility may be a useful strategy when trying to engage patients in PIP if resources are limited.

Study protocol for a pilot randomised controlled trial assessing prehospital whole blood versus component therapy in traumatic haemorrhage: SWiFT Canada (study of whole blood in frontline trauma)

Por: Lin · Y. · Peddle · M. · Callum · J. · Beckett · A. · da Luz · L. T. · Drennan · I. · Pavenski · K. · Mack · J. · McGowan · M. · Ahghari · M. · Smith · J. · Green · L. · Keown-Stoneman · C. D. G. · Nolan · B. · on behalf of the SWiFT Canada Investigators
Introduction

Major haemorrhage is the leading cause of preventable death in trauma, and prehospital blood transfusion may improve survival and outcomes for patients with prolonged out-of-hospital times. Globally, there is increasing interest in the use of whole blood in the prehospital environment, with randomised controlled trials ongoing. However, the results of these studies may not be generalisable to the longer out-of-hospital times seen in the Canadian trauma environment. The aim of this trial is to determine the feasibility of performing a randomised clinical trial evaluating the use of leukocyte-reduced whole blood transfusion compared with component blood transfusion in the Canadian prehospital environment. The secondary objective is to explore whether whole blood transfusion is better in reducing the proportion of patients who die or require massive transfusion within 24 hours.

Methods and analysis

This is a multi-centre, open-label, randomised controlled feasibility trial. Patients aged 16 years or older will be eligible if they have suffered a major traumatic haemorrhage, are attended by the provincial air ambulance service and require a prehospital blood transfusion. The primary outcome is feasibility as measured by the following metrics: proportion of patients enrolled with full data collection, proportion of patients who received at least one prehospital transfusion prior to arriving at the receiving trauma centre, proportion of patients who completed transfusion of all assigned blood units, number of patients unable to be enrolled due to lack of whole blood availability and number of whole blood units produced for the study that were wasted or expired. The secondary outcome is a composite outcome of death (all-cause mortality) or receipt of massive transfusion (receipt of 10 units of blood or more) within the first 24 hours from randomisation. We plan to recruit 60 patients, with an anticipated post-randomisation exclusion of ~10 patients for traumatic cardiac arrest or who do not meet eligibility criteria.

Ethics and dissemination

Provincial ethics approval was obtained (Clinical Trials Ontario REB ID: CTO-4921). An opt-out consent model will be employed for participants. The SWiFT Canada trial will recruit 60 patients through the provincial air ambulance organisation in Ontario who are transported to one of the six participating lead trauma centres. It will investigate the feasibility of a pre-hospital transfusion clinical trial in Canada to compare the effectiveness of whole blood compared with component blood therapy in a future definitive trial.

Trial registration number

ClinicalTrials.gov: NCT06495294 (https://clinicaltrials.gov/study/NCT06495294), Clinical Trials Ontario: CTO-4921.

Evaluating Nurses' Perspectives on the Acceptability and Practicality of Comfort Rounding for Personalised Nutritional and Mobility Care in Surgical Wards: A Mixed‐Methods Feasibility Study

ABSTRACT

Aim

To evaluate nurses' perspectives on factors influencing the acceptability and practicality of comfort rounding, focussing on personalised nutritional and mobility care.

Design

Mixed-methods feasibility study.

Methods

Focus group interviews with nurses were conducted before, during and at the end of the implementation period (2022–2023). A questionnaire assessed acceptability and practicality among nurses at the end of the implementation. Data were analysed using directed content analyses and descriptive statistics.

Results

Comfort rounding's acceptability and practicality were influenced by nurses' attitudes, knowledge and skills, patient characteristics and the nurse–patient relationship. Barriers included workload, time pressure, team culture and the extensive, rigid design of comfort rounding. Questionnaire responses demonstrated nurses perceived added value of comfort rounding and frequently engaged patients in activities related to nutrition and mobility. However, it was not performed as originally intended.

Conclusion

Nurses considered personalised nutritional and mobility care important and frequently provided it during ‘usual care’. However, nurses were critical of comfort rounding's acceptability and practicality and did not perform it as intended.

Implications for the Profession and/or Patient Care

Comfort rounding's concept does not align well with current nursing practice. Greater tailoring to nurses' preferences or alternative approaches to structuring personalised nutritional and mobility care are recommended.

Impact

What problem did the study address: Hospitalised patients often receive suboptimal nutritional care and are largely inactive. The challenge is to integrate personalised nutritional and mobility care effectively into standard nursing practice to enhance patient safety and well-being. Comfort rounding could improve patient safety and satisfaction; however, there is no research evaluating the feasibility of comfort rounding in relation to personalised nutritional and mobility care. What were the main findings: Comfort rounding was generally perceived as valuable and aligned with existing care routines, but its rigid structure was often considered impractical. Comfort rounding was not performed as originally intended due to the influence of individual, social and organisational factors. Flexibility in execution emerged as a critical factor for successful integration. Where and on whom will the research have an impact?: Comfort rounding can enhance attention to nutrition, mobility and patient participation when adapted to local contexts and delivered with flexibility. Policymakers and nurse leaders should avoid rigid protocols and instead support tailored implementation strategies alongside the practical delivery of locally tailored interventions.

Reporting Method

Consolidated criteria for reporting qualitative research and Checklist for Reporting of Survey studies.

Patient or Public Contribution

Nurses were involved in all stages of the study, contributing through focus group interviews and completing a questionnaire to help develop and evaluate comfort rounding.

Trial Registration

PaNaMa Research Management System, number 112832

Prevalence of sexually transmitted infections among military personnel: a systematic review protocol

Por: Shoemaker · E. S. · Sandstrom · E. · Dangerfield · C. D. · Linton · J. · Cholette · F. · McClarty · L. M. · Lazarus · L. · Herpai · N. · Pavlova · D. · Pickles · M. · Becker · M.
Introduction

Military personnel are a unique population with heightened vulnerability to sexually transmitted infections (STIs), often exhibiting higher prevalence rates than civilians due to demographic, environmental and occupational factors. These vulnerabilities underscore the need for global prevalence estimates to guide effective, evidence-based interventions. This study aims to quantify the global burden of STIs among military personnel, providing a comprehensive and up-to-date assessment.

Methods and analysis

This systematic review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Guidelines (2020). Using the CoCoPop (Condition, Context, and Population) framework, a comprehensive search strategy will be conducted in MEDLINE, Embase, Global Health and Scopus to retrieve peer-reviewed records published between January 2010 and June 2025. Eligible studies will report numerical STI prevalence data among military personnel. Studies with insufficient information to calculate prevalence or those relying on self-reported STI data will be excluded. Data extraction will include study details, military descriptors, STI prevalence and diagnostic methods. Risk of bias will be assessed using the Joanna Briggs Institute critical assessment tool for prevalence and incidence studies. Prevalence estimates with 95% CIs will be reported for each STI and, where appropriate, pooled for curable STIs. Subgroup analyses will stratify prevalence by geographic region, service status, deployment status and socioeconomic factors. Heterogeneity will be evaluated within predefined subgroups using the I² statistic. Data will be presented in comprehensive tables and visualised with graphical tools, including forest plots for subgroup analyses and pooled estimates.

Ethics and dissemination

Ethical approval is not required for this review. The results will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42023472113.

Methods and baseline results of the Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice in Denmark (CHRONIC-GP)

Por: Larsen · H. H. · Willadsen · T. G. · Prior · A. · Lyhnebeck · A. B. · Waldorff · F. B. · Holm · A.
Purpose

The Cohort of Health-Related Outcomes in Chronic Illness Care in General Practice was established using data collected as part of a cluster-randomised trial. This aims to support the trial’s follow-up and enable further examination of the interplay between chronic disease, multimorbidity (MM), polypharmacy (PP) and quality of life (QoL) in a Danish general practice setting.

Participants

The cohort comprises 35 977 adult patients from 250 general practices participating in a cluster-randomised trial and had a response rate of 22.4%. Participants were either registered as chronic care patients or had attended an annual chronic disease consultation. They completed a comprehensive questionnaire on self-reported chronic conditions, medication use, QoL, treatment burden and patient-centred care. Additionally, 431 general practitioners (GPs) from the participating practices completed a questionnaire about managing patients with complex MM.

Findings to date

Among participants, 51.9% were female, the mean age was 65.6 (SD 12.9) years, 93.1% had education beyond basic schooling, and half were retired. Conditions from more than one organ system-based disease group were reported by 82.2%, and 94.6% used one or more prescription medications. The main challenges reported by the participating GPs in managing patients with complex MM were keeping time and obtaining an overview of the patient’s health status.

Future plans

Cohort data will be linked with Danish registries to improve the detection and treatment of chronic conditions and PP in general practice.

Registration

The cluster randomised trial (MM600) is registered with ClinicalTrials.gov ID: NCT05676541.

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