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Impact of the COVID-19 pandemic on obesity: a prospective cohort study of the Canadian Longitudinal Study on Aging (CLSA)

Por: Sakib · M. N. · Griffith · L. E. · Erbas Oz · U. · Basta · N. E. · Gerstein · H. C. · Morgenstern · J. D. · Kirkland · S. · Thabane · L. · Smith · B. T. · Balion · C. · McMillan · J. M. · Raina · P. · Anderson · L. N.
Objectives

To examine the impact of the COVID-19 pandemic on body mass index (BMI) and obesity status among Canadian residents and explore how this association varied by sociodemographic and health status.

Design

Prospective cohort study.

Setting

Canada.

Participants

41 302 adults, aged 45–85 at baseline, participating in the Canadian Longitudinal Study on Aging.

Primary and secondary outcomes

BMI and BMI-defined obesity were measured at baseline, follow-up 1 and follow-up 2 (FUP2), with 33% of FUP2 data (n=13 444) gathered after 16 March 2020, when COVID-19 restrictions began. Correction factors were applied for self-reported BMI and weighted generalised estimating equations assessed BMI changes before and during the pandemic.

Results

We found a significant interaction between follow-up time and timing of FUP2 data collection (before or during the pandemic). Participants measured during the pandemic had an excess BMI increase of 0.21 kg/m² (95% CI 0.15 to 0.28) and 1.06 times higher odds of obesity (95% CI 1.03 to 1.09) compared with prepandemic trends. Increases were more pronounced among females, middle-aged adults and those without diabetes.

Conclusions

The COVID-19 pandemic was associated with a modest increase in BMI and obesity among Canadian adults. Ongoing research is needed to assess long-term trends.

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.

Determinants of treatment outcomes among hospitalised patients with skin and soft tissue infections: a prospective observational study

Por: Biyazin · A. A. · Mekonnen · G. B. · Anberbr · S. S. · Tarekegn · G. Y. · Zerihun · T. E. · Getahun · A. D. · Abebe · R. B.
Objectives

The study aimed to determine treatment outcome and factors affecting treatment outcomes among hospitalised patients with skin and soft tissue infections (SSTIs) at the University of Gondar Comprehensive Specialised Hospital (UOGCSH) in Ethiopia.

Design

An institution-based prospective observational study.

Setting

UOGCSH, Northwest Ethiopia.

Participants

423 patients from all age groups with clinically diagnosed SSTIs from 25 June to 25 December 2023 at the UOGCSH were included.

Outcome measures

Primary treatment outcomes were early apparent clinical response within 48–72 hours and treatment failure after 72 hours of optimal antibiotic therapy. Secondary treatment outcomes included hospital length of stay (HLOS) and in-hospital mortality. Multiple linear regression assessed factors influencing the HLOS, and multivariable logistic regression identified predictors of treatment failure.

Results

The average HLOS was 13.46±3.01 days. Of the patients, 39.3% had an early clinical response within 48–72 hours, whereas 34.4% had treatment failure. At 0.7%, the in-hospital death rate was modest. Living in a rural area (adjusted OR (AOR) 5.54, 95% CI 2.67 to 11.37), having concurrent illnesses (AOR 2.11, 95% CI 1.10 to 4.07) and starting antibiotics later than 12 hours (AOR 0.08, 95% CI 0.04 to 0.17) were significantly associated with treatment failure. Concomitant disorders and complex comorbidities were also associated with longer HLOS, whereas higher socioeconomic level, oral step-down therapy, early antibiotic initiation and early clinical response were linked to better results and shorter hospital stays.

Conclusion

Timely antibiotic initiation, efficient source control, patient comorbidities and socio-economic considerations affect the treatment course for SSTIs. Prolonged treatment and the frequent use of ‘watch’ and ‘reserve’ antibiotics underscore the need for improved antimicrobial stewardship. In this situation, optimising clinical results and minimising HLOS requires prompt clinical evaluation and customised antibiotic therapy. However, the single-centre design and potential residual confounding may introduce bias.

ODIN Biobank: a Danish cohort for dementia research- cohort profile

Por: Laugesen · K. · Skjaerbaek · C. · Okkels · N. · Moller · H. J. · Borghammer · P. · Gottrup · H. · Parkner · T.
Purpose

Biomarkers related to the diagnosis, prognosis and treatment of dementia will play a key role in future clinical practice. The overarching aim of the ODIN (blood and cerebrospinal fluid) Biobank is to study biomarkers for dementia and contribute to the transition from cerebrospinal fluid to blood-based biomarkers.

Participants

ODIN recruited 451 patients (median age 74 years, 53% females) referred to the Department of Neurology at Aarhus University Hospital, Denmark, for diagnostic assessment of dementia. Enrolment started in March 2020 and ended in July 2025. Patients referred for a lumbar puncture were eligible for inclusion. Cerebrospinal fluid and blood samples (plasma, serum and buffy coat) were stored at –80°C. Information about sociodemographic, educational level, dementia subtype, cognitive test scores, neuroimaging results, hypertension, diabetes, height, weight, alcohol consumption and smoking was collected.

Findings to date

The most frequent diagnoses were Alzheimer’s disease (n=268, 59%), frontotemporal dementia (n=26, 5.8%) and mixed Alzheimer’s and vascular disease (n=23, 5.1%). N=82 (18%) were cognitively unimpaired or had mild cognitive impairment but not dementia. The median Mini–Mental State Examination score was 23 (IQR: 20–26) and the median Addenbrooke’s Cognitive Examination score was 68 (IQR: 58–77).

Future plans

ODIN will contribute to the development, validation and implementation of new biomarkers related to diagnosis, prognosis and treatment of dementia. Furthermore, the cohort will assist the transition from cerebrospinal fluid to blood-based biomarkers.

Dose dE-eScalaTion IN prostATe radIOtherapy usiNg an MR-Linac in 2 Fractions (DESTINATION 2): protocol for a randomised, phase II/R-IDEAL2b trial

Por: Cooper · S. · Alexander · S. · Breitkreutz · D. · Casey · F. · Christodouleas · J. · Dassen · M. G. · Dellacqua · V. · Dunlop · A. · Herbert · T. · Kolias · P. · Mitchell · A. · Pos · F. J. · Westley · R. · Tree · A. C. · Van Der Heide · U. A. · Vesprini · D.
Introduction

Stereotactic body radiotherapy (SBRT) delivered on an MRI-guided linear accelerator (MR-linac) enables highly conformal prostate cancer irradiation. The DESTINATION 2 trial is a federated, randomised phase II/R-IDEAL 2b study evaluating whether de-escalating the dose to prostate tissue, while maintaining a high dose to MRI-visible tumour(s) in two fractions, reduces genitourinary (GU) treatment-related adverse events (AE) without compromising disease control in men with localised prostate cancer.

Methods

200 men worldwide with localised, MRI-visible prostate cancer will be randomised 1:1 to receive either (1) prescribed uniform dose MR-linac SBRT (27 Gy in two fractions to the whole prostate and seminal vesicles with 0 mm CTV-PTV margin) or (2) de-escalated SBRT (20 Gy in two fractions to whole prostate with 0 mm CTV-PTV margin and 27 Gy in two fractions to MRI-visible tumour(s) with a 4 mm intraprostatic margin applied to the GTV. All treatments are delivered using MRI-guided adaptive Radiotherapy (MRIgRT). The primary endpoint is the absolute and relative risk reduction in acute grade 2+GU AE (CTCAE v5) within 12 weeks of completing radiotherapy. Secondary endpoints include late GU AE, acute and late gastrointestinal (GI) AE, sexual AE, patient-reported outcomes, dosimetry, technical feasibility and 2-year biochemical relapse-free survival.

Ethics and dissemination

This is a federated trial design in which each centre operates independently with its own sponsor, ethics committee approval and regulatory oversight. Each centre is responsible for obtaining and maintaining local ethics approval in accordance with their national and institutional requirements. The UK centre (The Royal Marsden NHS Foundation Trust) has received ethical approval from the East of England–Cambridge South Research Ethics Committee (REC reference: 24/EE/0163; IRAS: 338368). Results will be disseminated via peer-reviewed publications and conference presentations.

Trial registration number

NCT06638541.

Influence of general practice education on medical students attitude towards this discipline: a mixed studies scoping review protocol

Por: Schürmann · L. · Höft · L.-M. · Karpfinger · J. · Gerbaulet · S. · Sternal · J. · Muth · C. · Puzhko · S. · Leeuw · B. · Peters · T.
Introduction

The shortage of general practitioners in many countries remains a persistent issue and is likely to become more severe in the future. Multiple factors influencing the attitude of medical students towards general practice have been identified. The aim of this scoping review is to describe the scope of the evidence on the influence of teaching general practice in medical school (eg, lectures, seminars, internships) on medical students’ attitude towards this discipline and to identify knowledge gaps.

Methods and analysis

We will apply a mixed studies scoping review design. Quantitative, qualitative and mixed-methods studies exploring the influence of general practice education in medical school (exposure) on the attitudes (outcome) of medical students (population) will be included. The outcome will be any measured or reported change in medical students’ attitude towards general practice as a discipline. A systematic search in MEDLINE through PubMed, Cochrane, Embase, the Education Resources Information Centre and PsycInfo, as well as forward and backward citation tracking, will be conducted starting from 2015, published in English or German. Titles, abstracts and full texts will be screened and data will be extracted independently by two reviewers. Results will be tabulated and summarised narratively and interpreted according to the framework of the affective domain.

Discussion and conclusion

By identifying and linking educational formats with levels of the affective domain, this approach may help educators understand how medical training can influence the attitude towards and interest in primary care and improve the development of professional identity formation and general practice focused curricula.

Ethics and dissemination

This scoping review does not require ethical approval. The results will be disseminated through publications in peer-reviewed journals and presentations at national and international conferences.

Trial registration number

The protocol of this scoping review has been registered on OSF (DOI: 10.17605/OSF.IO/UFJCR).

Negative Pressure Wound Therapy as a Key Strategy in the Management of Severe Diabetic Foot Ulcers in Septic Frail Patients: A Case Series

ABSTRACT

Diabetes mellitus represents a major global health challenge, with over 537 million adults currently affected worldwide. Among its complications, diabetic foot ulcers remain a leading cause of morbidity, hospitalization and amputation, imposing a significant socioeconomic burden. Effective management requires a multidisciplinary approach integrating surgical, medical and rehabilitative expertise. Negative pressure wound therapy has demonstrated clinical efficacy in promoting granulation tissue formation, accelerating wound healing, and reducing infection rates compared with conventional dressings. This case series presents the management of four frail, septic patients with severe diabetic foot ulcers treated between 2023 and 2025 in an academic surgical department. All patients required surgical intervention, including debridement or partial amputation, combined with negative pressure wound therapy and, in selected cases, revascularization or skin grafting. One case utilized an electrospun nanofiber dressing which enhanced wound granulation and shortened healing time. Outcomes varied according to systemic comorbidities, vascular status and glycemic control; however, NPWT consistently supported wound stabilization and preparation for definitive closure. These findings reinforce the essential role of interdisciplinary collaboration and advanced wound technologies in the treatment of complex diabetic foot infections, particularly in frail or septic patients, and highlight the potential of nanofiber-based dressings as adjunctive therapies in comprehensive diabetic foot care.

Incidence and associated factors of inadequate emergence in elderly patients undergoing elective major abdominal surgery: a prospective cohort study in Northwest Ethiopia

Por: Bayable · S. D. · Debas · S. A. · Aligaz · E. M. · Endeshaw · A. S. · Ale · Y. F. · Amberbir · W. D. · Fetene · M. B. · Yetneberk · T. · Zegeye · S. T.
Background

Inadequate emergence is a common postoperative complication in elderly patients following major abdominal surgery. This study was designed to determine its incidence, identify associated risk factors and characterise its clinical subtypes within this high-risk cohort.

Design and setting

This prospective single-centre cohort study was conducted at a comprehensive specialised tertiary care hospital in Northwest Ethiopia. Consecutive patients aged 65 years and older scheduled for elective major abdominal surgery under general anaesthesia were enrolled.

Primary outcome measure

The primary outcome was the proportion of patients experiencing inadequate emergence.

Results

A total of 388 patients were analysed. Inadequate emergence occurred in 21.9% of participants (95% CI 14.3% to 31.6%), with hypoactive emergence observed in 10.7% and emergence delirium in 11.2%. Multivariable logistic regression identified several independent predictors, including advanced age (adjusted OR (AOR)=1.9; 95% CI 1.5 to 8.2), preoperative anxiety (AOR=2.7; 95% CI 1.2 to 7.2), prolonged preoperative fasting (AOR=2.1; 95% CI 1.8 to 9.1), non-ketofol-based induction (AOR=3.4; 95% CI 1.6 to 6.3), absence of abdominal field block (AOR=4.2; 95% CI 4.0 to 9.6), substantial intraoperative blood loss (>1000 mL; AOR=1.9; 95% CI 1.2 to 7.6), postoperative nausea and vomiting requiring antiemetics (AOR=2.2; 95% CI 2.1 to 7.1) and presence of an indwelling urinary catheter (AOR=2.4; 95% CI 1.8 to 7.9).

Conclusions

Inadequate emergence occurred in approximately one in five elderly patients undergoing elective major abdominal surgery. Independent predictors included advanced age, major intraoperative blood loss, postoperative nausea/vomiting requiring antiemetics, non-ketofol-based induction, preoperative anxiety, absence of abdominal field block, presence of an indwelling urinary catheter and prolonged preoperative fasting.

Development and Psychometric Evaluation of a Medical Device–Related Pressure Injury Risk Assessment Scale

ABSTRACT

Medical device–related pressure injuries are a significant and largely preventable patient safety problem, yet existing pressure injury risk scales do not adequately capture device-specific risk factors in adults. This methodological study developed and psychometrically evaluated a standardized risk assessment scale to identify medical device–related pressure injury risk in hospitalized adult patients. An initial item pool was generated from an extensive literature review and clinical expertise, and content validity was assessed by seven experts using the Davis technique (content validity index = 0.96). The scale was administered to 160 adults receiving at least one medical device in medical, surgical and oncology wards and intensive care units of a university hospital. Construct validity was evaluated using binary logistic regression, exploratory factor analysis, and receiver operating characteristic curve analysis, demonstrating strong discrimination (area under the curve = 0.844, 95% confidence interval 0.728–0.961) with an optimal cut-off score of 14.5 (sensitivity 70.6%, specificity 88.8%). Exploratory factor analysis of the final version of the MedRAS (Kaiser-Meyer-Olkin = 0.792) revealed a two-factor structure (Device and Mechanical Factors; Patient and Tissue Factors) explaining 50.92% of the total variance, with all factor loadings above 0.30. The scale showed good internal consistency (Cronbach's alpha = 0.80) and very good inter-rater reliability (Cohen's kappa = 0.806, p < 0.001). This device-focused scale may support early risk identification and targeted preventive nursing interventions, with potential to improve patient safety and quality of care in inpatient/critical care settings.

Exploring collaboration preferences of health care professionals and patients regarding treatment decision making in severe asthma: a qualitative study in The Netherlands

Por: Achterbosch · M. · van der Werf · H. M. · Mortelmans · L. · Dilles · T. · Dierick · B. J. H. · van Dijk · L. · van Boven · J. F. M.
Background

Shared decision making (SDM) is advocated as an approach for patient-centred asthma care. However, this approach may not always be feasible or preferred by patients and/or healthcare professionals (HCPs). Knowledge and insights into whether and how the preferred collaboration style in medical decision making is discussed and managed during consultations for severe asthma are limited.

Objectives

To investigate how HCPs’ and patients’ preferred collaboration styles in treatment decision making are experienced, discussed and managed during consultations.

Methods

Qualitative research using semi-structured interviews with HCPs specialised in severe asthma and a focus group with severe asthma patients in The Netherlands. Inductive thematic analysis was used, with results reported according to the COREQ checklist.

Results

Four themes concerning HCPs’ and patients’ experiences were identified: (1) overall preference for SDM, yet (2) ambiguity of SDM’s content, (3) variation in application of SDM and (4) friction between medical focus and patient autonomy in SDM. A fifth theme concerned the discussion and management of collaboration style preferences: limited metacommunication. HCPs and patients seem unable to identify each other’s preferences in collaboration styles. Overall, a lack of communication regarding how to collaborate in making treatment decisions was found. Varying views on meaning and content of collaboration styles, especially SDM, and HCPs’ medical focus seemed to contribute to the lack of communication.

Conclusion

With the lack of communication regarding preferences in collaborating, HCPs and patients are likely to miss out on effective collaboration. Future studies should explore how views and preferences regarding HCP-patient collaboration can be bridged.

Position, Responsibilities and Practice Interventions Relevant for Danish Transitional Care Nurses to Perform During Discharge of Older People: Delphi Survey

ABSTRACT

Aim

To determine expert clinicians' consensus opinion on the position, responsibilities and practice interventions relevant for hospital-employed Transitional Care Nurses (TCNs) to perform a successful discharge process of older people with multi-morbidity and transition to home.

Design

A two-round Delphi survey.

Methods

An expert panel of 54 TCNs from five hospitals and 11 municipalities in a rural Danish region was invited to participate in the two Delphi rounds. The Delphi survey was developed using four key sources of data. The final questionnaire consisted of 120 items. The experts evaluated the relevance of the items in two rounds performed in September 2024.

Results

In the first Delphi round, 40 (74.1%) of the 54 experts replied to the questionnaire. Consensus agreement of ≥ 75% relevance (4–5 Likert) was found in 60 of the 120 items. In the second Delphi round, 57.4% of the 54 experts responded. Of the remaining 60 items, four items were evaluated as less relevant and were therefore excluded. The experts consented on the final relevance of 56 items.

Conclusion

Coordination and continuity of the discharge process combined with a high level of teamwork and collaboration with the patients, their relatives, and interdisciplinary colleagues at the hospital and in the municipality were rated as the most relevant responsibilities and practice interventions for the TCNs.

Implications and Impact

Inadequate description of Danish TCN's function may affect the planning and safety of older patients' transition. Consensus agreement was reached on 56 items addressing TCNs' position, responsibilities and practice interventions essential for older patients' transition. Knowledge will be used further to strengthen the Danish TCN's function.

Reporting Method

We have adhered to the ‘Guidance of Conducting and REporting of DElphi Studies’ (CREDES).

Patient or Public Contribution

No patient or public contribution.

[89Zr]bevacizumab PET/CT imaging of vestibular schwannomas for the prediction of bevacizumab treatment effect in patients with symptomatic NF2-related schwannomatosis: a study protocol for a phase II single centre, prospective, feasibility trial

Por: Douwes · J. P. J. · Tops · A. L. · Dibbets-Schneider · P. · Verbist · B. M. · Fuentealba Bassaletti · C. A. · Jansen · J. C. · Koetsier · K. S. · van Dam · V. S. · Koot · R. W. · van Velden · F. H. P. · Pool · M. · Vugts · D. · Schopman · J. E. · Goeman · J. J. · De Geus-Oei · L.-F.
Introduction

Treatment with bevacizumab achieves both tumour stabilisation or regression and preservation or improvement of hearing. However, the efficacy of bevacizumab varies between patients and within patients. Side effects due to bevacizumab treatment are also common. It would be of value to predict therapeutic response prior to initiating therapy to prevent unnecessary exposure in patients unlikely to benefit.

Methods and analysis

We aim to recruit 25 patients with NF2-related schwannomatosis (NF2) with bilateral vestibular schwannomas. Patients will receive an intravenous injection of 37 MBq [89Zr]bevacizumab followed by positron emission tomography (PET)/CT imaging 4 days later. After clinical evaluation at baseline, patients undergo bevacizumab treatment and are followed up at 3 and 6 months. The primary objective is to examine associations between pretreatment [89Zr]bevacizumab uptake on PET/CT and changes in multiple hearing outcomes and radiological characteristics of the target tumour following treatment. Secondary outcome measures include vestibular functioning, patient reported outcome measures, cranial nerve functionality, peripheral neurology, non-target schwannoma response and renal function. Given the explorative nature of the study, associations between PET-derived metrics and clinical and radiological outcomes will be examined without formal hypothesis testing, using generalised estimating equations to account for within-patient correlation. Pairwise associations will be summarised in an association matrix with multiplicity addressed using an all-resolutions inference approach, and findings will be considered hypothesis generating.

Ethics and dissemination

This study was submitted via the Clinical Trials Information System reviewed and approved by the Medical Research Ethics Committee Leiden–The Hague–Delft Delft. The study findings will be disseminated through publication in peer-reviewed scientific journals and by presentation at national and international conferences.

Trial registration number

The trial is registered at ClinicalTrials.gov Protocol Registration and Results System under the registration ID: NCT05685836.

Correlates of Patient and Nurse Missed Care: A Multi‐Hospital Cross‐Sectional Study

ABSTRACT

Aim

To determine the prevalence of missed care in inpatient surgical wards and to examine the causes and consequences of missed care from the perspectives of patients and nurses.

Design

This study employed a descriptive, correlational, cross-sectional design.

Methods

This study was conducted over 3 days in November 2023 and included 354 patients and 89 nurses working in surgical wards of city hospitals. Data were collected using the Patient and Nurse Identifying Information Form, the MISSCARE Survey-Patient, and the MISSCARE Survey-Nurse. The data were analysed using SPSS. The study was reported in accordance with the STROBE checklist.

Results

Patients reported that oral care, body care and mobilization were care activities that were most frequently not performed. Patients' educational level and age did not affect the MISSCARE Survey-Patient scores, whereas duration of hospitalization and gender had a significant effect on the scores. According to nurses, the most frequently missed nursing care need was turning the patient every 2 h. Nurses also reported that an insufficient number of auxiliary and technical personnel, as well as unexpected increases in patient numbers and workload intensity in the unit, were major reasons for missed care. Gender, educational level, job satisfaction, age, years of employment, and weekly working hours did not significantly affect the MISSCARE Survey-Nurse scores of the nurses.

Conclusion

The results indicate that missed nursing care is a significant problem from both patient and nurse perspectives. Communication deficiencies and insufficient staffing negatively affect the quality of care. Health institutions should focus on improving communication, staffing levels, and teamwork to enhance care quality.

Implications for Clinical Nursing Practice and Patient Care

This study highlights the persistent issue of missed care from both patient and nurse perspectives. The findings demonstrate that basic care needs, such as oral hygiene, mobilization, and personal care, are frequently unmet. Contributing factors including communication breakdowns, insufficient staffing, and workload imbalance were identified. These results underscore the need for nursing managers to reassess resource allocation, strengthen interdisciplinary communication, and support care planning strategies that prioritize fundamental care. The study offers valuable guidance for clinical nurses and nurse leaders aiming to enhance patient safety and improve the quality of care in surgical wards.

Impact Statement

The findings of this multi-centre study may inform nursing management practices in acute surgical settings, particularly in middle- and low-resource health systems where staffing shortages are common. The dual-perspective approach, incorporating both patient and nurse views, provides a more comprehensive understanding of care gaps. This perspective may influence policy decisions, staff allocation and training programs. The results may also guide future interventions aimed at reducing adverse patient outcomes associated with missed care.

Patient or Public Involvement

Patients participated in this study by completing the MISSCARE Survey-Patient tool and sharing their experiences of missed care needs during hospitalization. Their perspectives were essential in identifying gaps in basic nursing care and potential adverse events associated with care omissions. Although patients were not involved in the study design or data analysis, their contributions informed the interpretation of the findings and supported the development of practice recommendations aimed at improving person-centred care in surgical wards.

Reporting Method

This study was reported in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist for cross-sectional studies.

Maternal Zika virus exposure and neurodevelopmental outcomes: A longitudinal study of preschool children in the ZIKAlliance Colombian Cohort

by Víctor Herrera, María Consuelo Miranda, Anyela Lozano-Parra, Diana Niño, Luis Ángel Villar, Rosa Margarita Gélvez Ramírez, Thomas Jaenisch, Laura Pezzi, Claudia Acevedo, Jürg Niederbacher

Background

Zika virus (ZIKV) infection has been inconsistently associated with neurodevelopmental delay (ND). We aimed to compare the incidence of ND between ZIKV-exposed and ZIKV-unexposed children within the ZIKAlliance (ZA) cohort, in Colombia, assessed 2 years after birth (2018–2021).

Methods

We performed a neurodevelopmental evaluation on normocephalic children (aged 40–72 months) from the ZIKAlliance cohort. Children were classified as ZIKV-exposed (maternal positive RT-qPCR or virus neutralization test – VNT) or unexposed (maternal negative IgG ELISA or VNT in paired antenatal samples). A trained psychologist, blinded to exposure status, administered the Denver Developmental Screening Test II (DDST-II). Children were considered at ND risk if they presented ≥1 delay or ≥2 cautions in one or more areas, within their age range in the DDST-II scale. Inconclusive initial tests were re-evaluated. Adjusted odds ratios were estimated using logistic regression.

Results

We analyzed conclusive DDST-II results from 153 children (mean age: 4.7 years; 53.8% male). Overall, 57.2% (n = 83) were classified as cases of ND. Children with ND were more likely to be male (61.4% versus 43.5%) and less likely to attend daycare or school (42.2% versus 11.3%) than children with normal development. After adjusting for child age, sex, household size, and education, the association between in utero ZIKV exposure and ND was not statistically significant (OR = 0.71; 95% CI: 0.32–1.59, p = 0.320). However, children attending daycare or school had a significantly lower risk of ND compared to those who stayed at home.

Conclusions

Prenatal ZIKV exposure was not associated with ND in this cohort of normocephalic preschool children. Instead, attending a community daycare or school emerged as a significant protective factor against developmental delays.

Primary cilia in osteoblasts and osteocytes are required for skeletal development and mechano-adaptation

by Mariana Moraes de Lima Perini, Alyssa F. Fayemi, Julie N. Pugh, Elizabeth M. Scott, Karan Bhula, Austin Chirgwin, Olivia N. White, Nicolas F. Berbari, Jiliang Li

Primary cilia play a crucial role in the development and mechanosensation of various tissue types, including bone. In this study, we investigated their role in bone growth and adaptation by targeting two cilia specific genes, IFT88 and MKS5. Conditional knockout (cKO) of IFT88 in osteoblasts significantly reduced body weight and femur length in mice compared to the littermate controls. Additionally, female IFT88 cKO mice exhibited a significant suppression of bone formation rate compared to the littermate controls. To further explore the role of primary cilia in osteocytes, osteocytes specific MKS5 cKO mice underwent axial ulnar loading at a peak force of 2.9N for females and 3.2N for males with 120 cycles per day for three consecutive days. Load induced bone formation rate was significantly decreased by 48% in males and 42% in females compared to the littermate control mice. These findings underscore the critical role of primary cilia in bone development and mechano-adaptation. They suggest that functional primary cilia in osteoblasts are essential for skeletal development, while those in osteocytes mediates mechanically induced bone formation, highlighting its potential as therapeutic targets for bone loss prevention.

Sick leave and engagement as workforce well-being proxies in hospital departments: a cross-sectional study of routinely collected organisational data in a Dutch academic hospital

Por: Bazuin · T. · Oerbekke · M. S. · Bontjer · S. · Reijmerink · I. M. · Dongelmans · D. A. · Franx · A. · Wietasch · J. K. G. · Hooft · L. · van der Laan · M. J.
Objectives

Well-being of healthcare professionals (HCPs) is vital for care quality, staff retention and overall healthcare system effectiveness. This study aims to identify the organisational and workplace variables associated with sick leave and measures of engagement of HCPs on department level within a single Dutch academic hospital.

Design

Cross-sectional study using routinely collected organisational data.

Setting

A tertiary-care academic hospital in the Netherlands.

Participants

25 clinical departments were included. Department level variables were derived from routinely collected hospital databases. Availability of data varied across variables. Analysis included information on patient population, human resources, care processes, quality of care and employee and patient experiences to assess differences, correlations and predictors for sick leave and engagement.

Primary and secondary outcome measures

Primary outcome measures were (1) sick leave (%) and (2) engagement, assessed through two staff-survey items (vitality and connectedness; 0–10 Numeric Rating Scale). Both outcomes were analysed at department level.

Results

Employee population data showed the most consistent patterns across analyses. Departments with higher staffing capacity had higher sick leave and lower engagement in group comparisons (p=0.009, p=0.030, respectively). In multivariable models, higher staffing capacity remained associated with increased sick leave (B=1.38, 95% CI 0.53 to 2.23, p=0.003). Engagement was positively associated with higher inflow (B=0.92, 95% CI 0.06 to 1.77, p=0.037) and negatively associated with outflow (B = –1.36, 95% CI –2.08 to –0.63, p=0.001). No consistent associations were found with patient population and patient experience measures.

Conclusions

Workforce-related factors, particularly staffing capacity and inflow and outflow, are strongly linked to sick leave and engagement. Routinely collected hospital data can be used to identify at-risk departments and inform targeted strategies for improving workforce sustainability. Future studies should explore more granular, team-level data to better support staff well-being and care quality.

Efficacy, moderators and mediators of cognitive behavioural analysis system of psychotherapy (CBASP) versus behavioural activation (BA) in persistently depressed treatment-resistant inpatients: study protocol for the multicentre, randomised controlled cha

Por: Brakemeier · E.-L. · Klein · J. P. · Zimmermann · J. · Hollandt · M. · Reinhard · M. A. · Boger · S. · Daldrup · L. · Eldem · L. · Gebhardt · P. · Heinrich · S. · Hirsmueller · M. · Millerowski · J. · Richter · M. · Ridderbusch · I. C. · Suerig · S. · Schroeter · L. · Velten-Schurian
Introduction

Up to 30% of individuals with depression develop persistent depressive disorder (PDD), an often disabling and difficult to treat condition. The Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is the only psychotherapy developed specifically for treating individuals with PDD. While several randomised controlled trials (RCTs) have demonstrated its efficacy in outpatient settings, evidence for its use in inpatient settings remains limited. Pilot studies of CBASP inpatient programmes in Germany have shown promising feasibility and effectiveness; however, no RCTs to date have systematically evaluated their outcomes. This study represents the first RCT to compare the short- and long-term efficacy and safety of CBASP with Behavioural Activation (BA), a first-line psychotherapy for depression, within an intensive multimodal inpatient setting.

Methods and analysis

In this prospective, multicentre, rater-blinded RCT with an active control group, we aim to recruit 396 adults (aged 18–70 years) with treatment-resistant PDD at eight German university hospitals. Participants will be randomly assigned to receive either (1) CBASP or (2) BA within an intensive treatment programme consisting of 10 weeks acute treatment in an inpatient and/or day clinic setting, followed by 6 weeks of outpatient continuation treatment. Primary and secondary outcome assessments will be conducted at multiple time points: baseline (T0), treatment onset (T1), after 5 and 10 weeks of acute treatment (T2, T3), at the end of continuation treatment (T4, week 16) and every 2 months up to week 64 (T5, naturalistic follow-up).

The primary outcome measure will be the change in depression severity, as assessed by the Hamilton Depression Rating Scale (24-item version), after 16 weeks of treatment (from T0 to T4). Secondary outcomes will include response, remission, deterioration and relapse rates, self-reported depression and anxiety symptoms and additional psychological variables. A cost-benefit analysis will evaluate the health-economic benefits of both interventions. Additionally, this RCT will explore personalised treatment selection and mechanisms of change, including potential moderators and mediators of treatment effects. The findings from this trial are expected to provide clinicians with evidence-based guidance on choosing CBASP versus BA for inpatients with treatment-resistant PDD.

Ethics and dissemination

This study has received ethical approval from the ethics committees of all participating university hospitals. All participants will provide written informed consent before enrolment. Study findings will be published in peer-reviewed journals and presented at national and international conferences. We have involved people with lived experience from the earliest pilots onward, using their feedback to refine our study design. Ongoing consultation at conferences and public events has further ensured that our research remains grounded in patient perspectives.

Trial registration number

NCT04996433.

PRECISION study: impact of personalised cardiac anaesthesia and cerebral autoregulation on neurological outcomes in patients undergoing cardiac surgery - protocol for an international, multicentre, prospective cohort study

Por: Gomes · N. V. · Edgar-Whelan · H. · Beqiri · E. · Young · J. · Schindler · C. · Gregor · M. · Erb · J. M. · Siegemund · M. · Kuhle · J. · Maleska Maceski · A. · Needham · E. · Cichon · S. · Burger · B. · Monsch · A. U. · Hasemann · W. · Wüest · A. · Fassl · J. · Kaiser · H. A. · Hight · D
Introduction

Adverse neurological complications, including postoperative delirium (POD) and stroke, remain one of the major risks after cardiac surgery. A lack of comprehensive knowledge about their causes and neuroprotective strategies has hindered the development of effective interventions to reduce these events. Personalised cerebral autoregulation (CA)-oriented blood pressure monitoring aims to identify blood pressure targets tailored to each individual patient, thereby reducing brain injury. The PRECISION study aims to assess whether perioperative duration and magnitude of mean arterial pressure (MAP) deviation from an individual’s CA limits are associated with adverse neurological complications.

Methods and analysis

This international, multicentre, prospective cohort study is conducted at two Swiss and one British hospital. Patients aged 65 years or older undergoing elective primary or re-operative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass are included. Preoperatively, the patient’s baseline of physical, cognitive and mental status is established. Intraoperatively, near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are recorded in real-time to generate NIRS-derived and TCD-derived CA indices. The primary endpoint is POD, assessed daily on postoperative days 0 to 7 or up to discharge, whichever occurs earlier with the 3D-Confusion Assessment Method (3D-CAM) or CAM-Intensive Care Unit. Secondary endpoints include a composite neurological outcome of POD and overt stroke, postoperative neurocognitive disorders, major morbidity and mortality. Associations between neurologic outcomes, neurobiomarkers and genetic variation will be explored.

A total of 500 participants is required to achieve 90% power to find a statistically significant effect of the area under the curve MAP

Ethics and dissemination

Ethical approval has been obtained from all responsible ethics committees (Swiss lead ethics committee EKNZ 2022-01457 and Health Research Authority and Health and Care Research Wales, UK, REC 23/SW/0076). Results will be disseminated at national and international conferences and published in peer-reviewed journals.

Trial registration number

NCT05595954.

Effectiveness of a web-based preventive postpartum depression programme in pregnancy, with/without telephone support: a randomised control trial

Por: Dessy · T. · Montreuil · T. C. · St-Andre · M. · Herba · C. M. · MacKinnon · A. L. · Clement · M. · Boucoiran · I. · Dinello-Goupil · C. · Beland · J. · Samson · V. · Tchouangue-Dinkou · G.-D. · Berard · A. · Morin · L. · Amirali · L. · Dennis · C.-L. · Masse · B. · Cote · S. M.
Objective

To evaluate the effectiveness of a web-based secondary prevention programme for postpartum depression, delivered with or without telephone support, compared with usual care.

Design

We first conducted a randomised controlled superiority trial to test whether the web-based Parents and Babies programme (Toi, Moi, Bébé; TMB) delivered with motivational telephone support (ie, coaching) was superior to the fully automated programme (ie, self-help). TMB incorporated classic and third-wave cognitive–behavioural therapy components and psychoeducation. Then, we tested whether TMB (both treatment modalities combined) was superior to usual care. The usual care comparison group was drawn from the CONCEPTION prospective pan-Canadian perinatal cohort (N=592).

Setting

A remote study based at Sainte-Justine Hospital Centre, Quebec, Canada.

Participants

Web-based intervention programme participants were women aged ≥14 years at 12–25 weeks’ gestation, with subclinical to moderate clinical Edinburgh Postnatal Depression Scale (EPDS) scores: 9–16. Exclusion criteria were psychosis and self-reported substance abuse. The usual care comparison group was pregnant women ≥18 years old. All participants were living in Canada at study inception.

Main outcome measures

The primary outcome was EPDS scores at 3 months post partum, accounting for baseline EPDS scores and depression events defined as EPDS ≥13 at 3 months post partum. The secondary outcomes were EPDS scores at 6 months post partum, depression events (EPDS≥13) at 6 months post partum, anxiety symptoms (Generalised Anxiety Disorder 7-item Scale, GAD-7) at 3 and 6 months post partum, accounting for baseline scores for the continuous outcomes; as well as the number of completed intervention modules and well-being scores (WHO 5-Item Well-being Index) at 3 months post partum.

Results

We randomised 510 participants to TMB self-help (n=255) or TMB with coaching (n=255); 211 and 214 participants, respectively, were included in the complete-case intention-to-treat analyses. At baseline, 91% lived with a partner, 71% were university graduates and 42% self-reported GAD-7≥10. Randomisation was successful. First, TMB with coaching was not superior to TMB self-help: at 3 months post partum, EPDS scores were TMB self-help (mean 8.0±4.3) vs TMB with coaching (mean 8.6±4.5); effect size was 0.01 (95% CI 0.00 to 0.03; p=0.16). Second, TMB (regardless of intervention arm) was superior to usual care: in adjusted regression models, EPDS scores were 6.2 units lower (per SD, 95% CI –8.2 to –4.3) in TMB (both treatment modalities combined) than in usual care; and proportions of depression events were 4.7 units lower (per SD on the logit scale, 95% CI –6.6 to –2.7) in TMB (combined) than in usual care. No other group differences were observed.

Conclusions

Our findings suggest that, in women with subclinical to moderate clinical antenatal depressive symptoms, receiving a web-based cognitive–behavioural therapy-based programme in addition to usual care can reduce depression postnatally.

Trial registration number

NCT05110456.

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