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Association of 24-hour movement guideline adherence with mental health symptoms among Colombian university students: a cross-sectional study

Objective

This study aimed to determine the associations between adherence to the 24-hour movement guidelines and symptoms of anxiety and depression among Colombian university students.

Study design

Cross-sectional study.

Participants

1125 individuals (mean age 20.2±2.5 years; 56.7% female).

Setting

Students sampled from a single public university.

Primary and secondary outcome measures

Participants completed validated self-report instruments: the International Physical Activity Questionnaire-Short Form to assess physical activity (PA), sedentary behaviour (SB) and the Pittsburgh Sleep Quality Index to assess sleep duration. Symptoms of depression and anxiety were measured using the Hospital Anxiety and Depression Scale, with a score of ≥11 used to classify elevated symptoms. Binary logistic regression models were used to estimate associations between adherence to the 24-hour movement guidelines (meeting all three, two, one or none) and mental health outcomes, adjusting for potential confounders.

Results

Only 15.5% of students met all three components of the 24-hour movement guidelines. Meeting a greater number of components was significantly associated with lower odds of depressive and anxiety symptoms. In fully adjusted analyses, students who met all three guidelines were less likely to report anxiety symptoms (OR=0.26; 95%CI 0.13 to 0.54) and depressive symptoms (OR=0.42; 95%CI 0.22 to 0.79) compared with those who met none. Among individual behaviours, sufficient PA and adequate sleep were independently associated with lower odds of both outcomes, whereas high SB was associated with higher odds of elevated symptoms.

Conclusions

In this cross-sectional study, adherence to a greater number of 24-hour movement guideline components was associated with lower levels of anxiety and depressive symptoms in a graded manner. However, the cross-sectional design precludes inference regarding directionality or causality, and bidirectional associations or residual confounding remain possible. Longitudinal and interventional studies are needed to determine whether integrated daily movement behaviours influence mental health outcomes in young adults, particularly in Latin American populations.

Translation and validation of the Norwegian ABCD Risk Questionnaire to assess cardiovascular disease knowledge and risk perception prior to myocardial infarction

Por: De Martin Topranin · V. · Brors · G. · Saether · J. C. · Gerdts · E. · Vangen · S. · Bye · A.
Objectives

The aim of this study was to translate the Attitudes and Beliefs about Cardiovascular Disease (ABCD) Risk Questionnaire into Norwegian and assess its psychometric properties among individuals with a history of myocardial infarction.

Design

The study adopted a cross-sectional design. The original questionnaire was translated into Norwegian and adapted for use in the target population. The Norwegian version was pilot tested in a sample of patients and then validated in the target population.

Setting

Norway, using a web-based solution to collect data.

Patients

A random sample of Norwegian individuals

Main outcome measures

Internal consistency was tested using Cronbach’s α and test–retest reliability using intraclass correlation coefficient (ICC). Difficulty and discrimination indices were determined for the Knowledge scale. Confirmatory factor analysis (CFA) was used to assess structural validity of the Risk scale.

Results

Data for 746 participants (mean age, SD: 66.4, 10.3 years), of which 26.9% females were analysed. The Norwegian version showed satisfactory internal consistency (Cronbach’s α 0.73–0.79) but modest test–retest reliability (ICC 0.35–0.64). The Knowledge scale showed moderate difficulty (0.39–0.84) and good discrimination power (0.44–0.60). The one-factor model CFA for each scale achieved acceptable fit, and the four-factor model showed moderate fit (root mean square error of approximation=0.05, standardised root mean squared residual=0.07, Comparative Fit Index=0.91, Tucker-Lewis Index=0.88).

Conclusions

The Norwegian translated ABCD Risk Questionnaire demonstrated satisfactory psychometric properties and can be considered a useful instrument for assessing knowledge and risk perception among individuals with a history of myocardial infarction.

WeCare intervention to improve breast cancer screening and research preparedness in rural and low-socioeconomic women: study protocol for a community-engaged feasibility trial

Por: Sharma · P. · Imsande · K. G. · Vitriago · A. · Seibel · M. · Pritchett · J. C. · Rudder · B. · Watson · D. · Beenken · M. J. · Tran · L. T. · Larson · S. L. · Flock · C. · Murphy · C. M. · Puljas · T. L. · Patten · C. A. · Asiedu · G. B. · Odedina · F. T. · Lynch · B. A. · Haddad · T. C.
Introduction

Women residing in rural areas or belonging to lower socioeconomic status (SES) strata experience disproportionately low rates of breast cancer screening, contributing to delayed diagnoses and poorer prognoses. In addition, their participation in clinical trials remains markedly limited, reducing opportunities to access preventive and screening interventions. Promoting research preparedness among women before disease onset may empower them to make informed decisions regarding their health and willingness to participate in clinical research with fewer emotional and logistical barriers.

Methods and analysis

This project applies a community-based participatory research approach to develop and refine the WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention for women aged 50–74 years who have either never undergone breast cancer screening or have not received screening in the past 5 years and who reside in rural areas or belong to low SES groups. The intervention consists of two components. Component 1 is a single-day, in-person community forum that includes (a) an educational seminar led by an oncologist to address breast cancer risk and screening guidelines, (b) survivor storytelling to enhance emotional engagement and cultural resonance and (c) facilitated navigation to breast cancer screening and future research participation. Component 2 involves structured post-forum follow-up through multiple touchpoints (phone calls and mailed boosters) to reinforce knowledge, address barriers and support screening completion and research enrolment. Quantitative data (eg, screening completion, satisfaction and follow-up engagement) will be summarised using descriptive statistics to assess feasibility and reach on 50 participants. Qualitative feedback from participants will undergo thematic analysis to identify barriers, facilitators and perceived cultural relevance. Integrated mixed-method interpretation will inform iterative refinement of the WeCARE intervention and guide design of subsequent larger trials.

Ethics and dissemination

Approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent. Procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be stored in REDCap and disseminated through publications, conferences, local town halls and community reports.

Clinician experiences of organisational compassion in healthcare: a qualitative study

Por: Pestian · T. · Ellakula · J. C. · Awtrey · E. · Carle · A. C. · Winick · N. · Kanov · J. · Thienprayoon · R.
Background

While compassion is widely recognised as an essential component of high-quality patient care, the compassion needs of clinicians often go unrecognised and unmet. Clinicians face multifaceted sources of workplace suffering, both sources inherent to working with the sick and avoidable sources due to healthcare systems and leadership challenges. Organisational compassion, defined as the continuous and systematic identification, prevention and alleviation of sources of suffering for healthcare workers, offers a paradigm shift in mitigating and preventing clinician suffering and burnout. Yet little is known about how clinicians experience suffering and compassion from their organisations, teams and leaders.

Objective

Our overarching goal is to develop a clinician-reported experience measure of organisational compassion. The purpose of this study was to explore how clinicians experience suffering and compassion in healthcare organisations.

Design and participants

This qualitative study used semistructured interviews of interdisciplinary paediatric hospice and palliative care clinicians from across the USA. A moderator’s guide was developed based on the literature of organisational compassion in management and healthcare and validated through practice interviews with clinicians. 22 participants were recruited via national paediatric hospice and palliative care email list serves. Video interviews were conducted via Zoom. Transcripts were analysed using a hybrid grounded theory-thematic analysis methodology to identify themes and to construct a theoretical framework of compassion experiences.

Results

Five major themes of experiencing compassion emerged: (1) Feeling cared about, characterised by authentic, empathetic responses to clinician distress; (2) Dignity, encompassing being valued, respected and recognised as a whole person and professional; (3) Proximal (team) compassion, including camaraderie, shared workload and mutual support within teams; (4) Structural (organisational) compassion, reflecting policies, practices and benefits that alleviate or exacerbate suffering and (5) Compassionate leadership behaviours, such as presence, empathy and connection to frontline staff needs.

Conclusions

Healthcare work includes sources of both inherent and avoidable suffering for clinicians. In this study, we sought to understand how clinicians experience compassion from their organisations, leaders and team members during times of distress. We found five themes of experiencing compassion in healthcare organisations: feeling cared about; dignity; proximal (team) compassion; structural (organisational) compassion and compassionate leadership behaviours. These qualitative data and results will provide an empiric foundation for the development of a clinician-reported experience measure of compassion for use in healthcare settings. Such a measure will enable future research examining how compassion experiences in healthcare may predict workforce outcomes such as burnout, satisfaction, engagement and thriving. Ultimately, this work may support the design of interventions aimed at strengthening compassionate organisational cultures and improving conditions for the healthcare workforce and both experiences and outcomes of the patients they serve.

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.

Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a systematic review with meta-analysis and trial sequential analysis

Por: Petersen · J. J. · Faltermeier · P. · Juul · S. · Kamp · C. B. · Sillassen · C. D. B. · Dos Santos · T. J. · Jakobsen · J. C.
Objectives

To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes.

Design

Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis.

Data sources

CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026.

Study selection

Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes.

Analyses

Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Primary outcomes

Severe hypoglycaemia, ketoacidosis and serious adverse events.

Results

10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I2=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I2=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I2=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered.

Conclusions

Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain.

PROSPERO registration number

CRD42024508625.

Seasonality of scabies and its association with climatic factors in Rohingya refugee camps, Coxs Bazar: a retrospective observational study, 2021-2023

Por: Halder · C. E. · Hasan · M. A. · Okello · J. C. · Khan · M. F. · Soma · E. R. · Poly · J. T. · Tassdik · H. · Hosen · M. S. · Prue · U. M. · Hannan · A.
Background

Scabies is a common skin condition and poses a substantial disease burden in resource-poor tropical settings. The Rohingya refugee camps in Cox’s Bazar, Bangladesh represent one of the world’s largest and most protracted humanitarian crises. Using 3 years of data from 2021 to 2023, this study analysed the seasonality of scabies and examined its association with climatic factors.

Methods

This is a retrospective observational study conducted in the Rohingya refugee camps and adjacent host communities in Ukhiya and Teknaf, Cox’s Bazar. All patients clinically diagnosed with scabies and who received treatment at 35 International Organization for Migration (IOM)-supported health facilities between 1 January 2021 and 31 December 2023 were included. Climate data, including daily mean, minimum and maximum temperature and total and maximum rainfall, were obtained from the Bangladesh Meteorological Department. Seasonal–Trend decomposition using LOESS (locally estimated scatterplot smoothing) (STL) was applied. Associations between climatic variables and the decomposed seasonal component of scabies cases and corresponding attack rate, as well as overall scabies case counts and overall attack rate, were assessed using Pearson’s correlation tests.

Results

A total of 323 106 new scabies cases were reported from IOM-supported health facilities between January 2021 and December 2023. Children aged under 5 years and 6–18 years accounted for the highest proportion of cases (32.08% and 38.95%, respectively). The average monthly number of scabies cases was highest in November (12 625) and lowest in May (5862). Case numbers increased from November to February (high season), with a peak between October and November, and declined between April and June (low season). An inverse relationship was observed between temperature and scabies incidence, with higher case numbers during cooler months and lower numbers during warmer months. Pearson’s correlation analysis demonstrated a strong and significant negative correlation between the seasonal components of both scabies cases and attack rate and temperature variables, including maximum (cases: r=–0.492, p=0.002; attack rate: r=–0.484, p=0.003), minimum (cases: r=–0.506, p=0.002; attack rate: r=–0.489, p=0.002) and mean temperature (cases: r=–0.525, p=0.001; attack rate: r=–0.511, p=0.001). No significant association was observed between the seasonal component of scabies cases or attack rate and humidity or rainfall.

Conclusion

This study identified a distinct seasonal pattern of scabies, with higher caseloads and attack rate during late autumn and winter (October to February) and lower caseloads and attack rate during summer months (April to June). Temperature showed a strong negative association with the seasonal component of scabies burden. These findings may inform the timing of public health strategies, including mass drug administration, intensified case management and social and behavioural change communication, in humanitarian settings.

Patient engagement, shared decision-making and equity, diversity and inclusion considerations in research ethics board application forms and templates in Canada: a mixed methods study

Por: Morgan · T. L. · Carroll · K. · Mosa · M. · Hudek · N. · Richards · D. P. · Marlin · S. · Meeking · K. · Etherington · C. · Presseau · J. · Brehaut · J. C.
Objectives

Equity, diversity and inclusion (EDI), patient engagement and shared decision-making are important considerations throughout clinical trials, including the research ethics review stage. Meaningfully integrating these considerations can enhance the relevance and generalisability of trial results and reduce participation barriers among equity-deserving populations. Presently, it is unclear to what extent such guidance is provided at the ethics application stage for clinical trials. This study aimed to report the degree of guidance on EDI, patient engagement and shared decision-making in clinical trial research ethics documents.

Design

This was an embedded mixed methods study conducted in collaboration with Clinical Trials Ontario.

Setting

This study analysed research ethics board (REB) forms and templates from 17 institutions across seven provinces in Canada.

Participants and methods

15 REB application forms, 9 protocol templates and 17 informed consent document (ICD) templates were assessed for guidance related to EDI, patient engagement and shared decision-making. The Place of residence, Race, ethnicity, culture and language, Occupation, Gender and sex, Religion, Education, Socio-economic status, Social capital (PROGRESS)-Plus framework, International Association for Public Participation Spectrum of Public Participation, Patient-Oriented Research Level of Engagement Tool, Indigenous Research Level of Engagement Tool and shared decision-making standards guided our coding. We engaged with patients and persons with lived experience to inform interpretation, reporting and dissemination.

Results

EDI guidance from 15 ethics application forms and 9 protocol templates predominantly covered the ‘Race, ethnicity, culture, language’ (n=14; 93.3%), ‘Age’ (n=13; 86.7%) and ‘Gender and sex’ (n=12; 80%) categories of PROGRESS-Plus but lacked nuance on diverse gender identities (n=1; 6.7%). Patient engagement guidance mostly covered the ‘inform’ level (n=7; 46.7%) and applying ‘knowledge in practice’ with non-Indigenous (n=7; 46.7%) or Indigenous communities (n=13; 86.7%). All 17 (100%) ICD templates included guidance on information about options, disclosures, key elements, ethical issues and study design. No guidance was available on time-dependent relationships, empowering patients and communities in co-leading trials or providing structured guidance in making trial participation decisions (all n=0; 0%).

Conclusions

We provided a comprehensive view of EDI, patient engagement and shared decision-making guidance in trial ethics applications in Canada. REB guidance may be strengthened in several areas to support the inclusion of equity-deserving populations in trials, meaningful engagement with patients and Indigenous communities and evidence-informed, values-aligned decisions about trial participation.

Outcome 50 years after surgical repair of pulmonary valve stenosis: a longitudinal cohort study

Por: Ünlütürk · S. · Kauling · R. M. · Cuypers · J. A. A. E. · van den Bosch · A. E. · Hirsch · A. · Pelosi · C. · Bowen · D. J. · Bogers · A. J. J. C. · Helbing · W. A. · Kardys · I. · Roos-Hesselink · J. W.
Objectives

Data on long-term outcomes after surgical repair of pulmonary valve stenosis are limited. This study evaluated survival, clinical outcomes and quality of life (QoL) after surgery during childhood.

Methods

Single centre, longitudinal cohort study evaluating consecutive patients with pulmonary valve stenosis who underwent surgical repair between 1968–1980 and were evaluated every decade since 1990.

Results

Of the original cohort of 89 operated patients, 11 died (12%), including 2 who died within 30 days postsurgery (2%), and 7 (8%) were lost to follow-up. Survival at 50 years follow-up was 87%, which was not significantly different from the GDP. Of the remaining 71 survivors, 32 refrained earlier from participating in this cohort study, leaving 39 eligible, of whom 34 (87%) participated again (50% male, median age 48 years) with a median follow-up of 45 (range 40–52) years. Event-free survival was 50%, with supraventricular tachycardia (14%) and reintervention (13%) being the most frequent events, although less frequently in the last 10 years. At last follow-up, biventricular function was preserved in most patients. Reduced right and left ventricular ejection fraction (EF) was found in 33% and 13%, respectively. Exercise capacity and maximum rate of oxygen consumption were mildly impaired in 14% and 32% of patients. Patients who underwent an infundibulectomy during initial surgery were significantly more likely to undergo reintervention (HR=8.32, p=0.003). Patient-reported QoL scores remained stable over time and consistently exceeded those of the age-matched GDP.

Conclusion

Fifty-year survival after surgery for pulmonary valve stenosis was excellent and comparable to the GDP. Most patients maintained preserved ventricular function, functional capacity and excellent QoL. Routine lifelong follow-up may not be necessary for all patients, but should be considered for those who underwent an infundibulectomy or have residual lesions.

From legalisation to practice: implementation of newly legalised health interventions in healthcare settings - a systematic review

Por: Vizheh · M. · Lamprell · K. · Sheriff · S. · Cormack · M. · Braithwaite · J. · Ludlow · K. · Mills · C. · Long · J. C.
Objectives

Over the last decade, a growing number of health interventions (eg, medical assistance in dying and mitochondrial donation) have become legalised or decriminalised globally. Newly legalised health interventions share characteristics that are distinct from other health interventions, making their implementation more challenging. They are often highly emotive, controversial and associated with strong opinions and ethical dilemmas, with some of them being high-stake and irreversible. This study aimed to identify, systematise and map the factors that affect the implementation of health interventions that have recently been legalised.

Design

A systematically conducted review.

Data sources

PubMed, Scopus, EMBASE and CINAHL were searched to identify studies published between 2014 and 2024.

Eligibility criteria for selecting studies

We included studies if they evaluated the implementation of health interventions that were newly legalised or newly decriminalised.

Data extraction and synthesis

Data were extracted and synthesised through descriptive analysis. Both deductive and inductive thematic analyses were applied to map the barriers, facilitators and implementing strategies that influence the implementation of newly legalised health interventions in healthcare settings.

Results

The search strategy yielded 1510 publications, of which 78 were included in this review. Findings showed that several newly legalised health interventions, including medical assistance in dying (n=56 studies); medical abortion (n=13); assisted human reproduction (n=3); psychedelic-assisted therapies (n=3); use of medical cannabis (n=2) and use of biosimilars (n=1) were addressed. The analysis identified a total of 880 diverse barriers, facilitators and strategies in five domains across system, organisational and individual levels: (1) patients/service users/consumers; (2) healthcare providers; (3) healthcare organisation; (4) legal processes and (5) system. These were further divided into 27 themes of barriers, 18 themes of facilitators and 17 themes of strategies.

Conclusions

Implementing newly legalised health interventions is complex. Our findings can support the development of an implementation plan for the spread and scaling of future health interventions, maximising the impact of interventions and making them accessible to more people and health organisations.

N-terminal proBNP adds prognostic value to high-sensitivity cardiac troponin I in elective thoracic surgery: an observational cohort study

Por: Alonso · M. · Popova · E. · De Miguel · M. · Garcia-Osuna · A. · Gonzalez-Tallada · A. · Ordonez-Llanos · J. · Jauregui · A. · Trujillo · J. C. · Martin Grande · A. · Martinez-Tellez · E. · Parera · A. · Planas · G. · Trujillo · L. · Butron · D. · Sola-Roca · J. · De Nadal · M.
Background

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

Objective

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Design

Multicentre observational cohort study.

Setting

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Participants

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Main outcome measures

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Results

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Conclusions

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

Trial registration number

NCT04749212

[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.

Marburg Heart Score and INTERCHEST score for telephone triage of acute chest pain: a prospective, diagnostic accuracy study in out-of-hours primary care

Objectives

To assess whether the Marburg Heart Score (MHS) and INTERCHEST score may improve telephone triage of chest pain by providing better diagnostic discrimination compared with the triage protocol from the Netherlands Triage Standard (NTS).

Design

Prospective diagnostic accuracy study.

Setting

Large regional out-of-hours primary care (OOH-PC) facility in Alkmaar, the Netherlands.

Participants

A total of 1254 eligible patients contacted the OOH-PC facility (median age 56.0 years, 57.9% female) between December 2022 and May 2023. The study was completed and verbal informed consent obtained in 280 (22.3%) patients.

Interventions

Triage assistants asked study questions in addition to the NTS protocol to complete the MHS and INTERCHEST score.

Primary and secondary outcome measures

Discrimination (C-statistics) and diagnostic test properties (eg, sensitivity/specificity) were used; the reference standard was the occurrence of a major event (ie, composite of all-cause mortality, and urgent cardiovascular and non-cardiovascular conditions) or acute coronary syndrome (ACS) within 6 weeks.

Results

A major event occurred in 36 patients (12.9%), including 13 (4.6%) ACS cases. For predicting major events, the MHS and INTERCHEST scores showed C-statistics of 0.67 (95% CI 0.57 to 0.77) and 0.64 (95% CI 0.54 to 0.74), respectively, compared with 0.62 (95% CI 0.53 to 0.71) for the NTS protocol. For ACS, C-statistics were 0.62 (95% CI 0.45 to 0.79), 0.59 (95% CI 0.43 to 0.75), and 0.62 (95% CI 0.49 to 0.75) for MHS, INTERCHEST and NTS, respectively. Regarding test characteristics, the MHS and INTERCHEST score showed higher point estimates for specificity (27.9% and 26.6%) vs the NTS (19.7%), but at the expense of lower sensitivity (88.9% and 86.1% versus 97.2%) for major events. For ACS, a similar pattern was observed (specificity 26.2% and 25.5% vs 18.4; sensitivity 84.6% and 84.6% vs 100.0%).

Conclusions

Simple clinical decision rules (MHS and INTERCHEST) have comparable, modest discriminative ability and diagnostic properties compared with the current protocol for telephone triage of acute chest pain in Dutch OOH-PC.

Trial registration number

Netherlands Trial Register (TRACE – NL-OMON20102).

What do patients value? A retrospective study of compliment letters from a single institution

Por: Kwon · Y. G. · Namgung · M. · Kim · M. K. · Choi · J. C. · Jeong · D. · Kim · C. W.
Objectives

This study aimed to analyse patient-initiated compliment letters from a single institution, identify the key elements that patients value and offer actionable insights to enhance patient-centred care.

Design

A retrospective, single-institution study using the Healthcare Complaints Analysis Tool (HCAT), text network analysis and latent Dirichlet allocation (LDA) topic modelling on patient compliment letters to pinpoint key valued care elements.

Setting

A newly established general hospital in Gwangmyeong, South Korea, opened on 22 March 2022.

Participants

A total of 1213 compliment letters were collected through the hospital’s feedback system, which accepted both online and on-site submissions between 25 March 2022 and 28 June 2024. Letters lacking substantive descriptive content and those containing purely administrative requests were excluded.

Primary and secondary outcome measures

The HCAT was adapted to categorise positive statements into clinical, management and relationship domains, along with six stages of care. Inter-rater reliability was evaluated using Gwet’s AC1 statistic. A text network analysis, applying a term frequency–inverse document frequency approach, was conducted to identify prominent keywords. Subsequently, LDA was performed to extract thematic topics.

Results

Most compliments concerned the ‘relationship’ domain (62%), particularly during the care in the ward stage (56%). Keyword analysis indicated that the most frequently mentioned terms were ‘gratitude’, ‘kindness’, ‘nurse’, ‘doctor’ and ‘heart/mind’, underscoring patients’ high valuation of positive interactions, professional competence and compassionate communication with medical staff. Topic modelling identified three primary topics, namely, ‘appreciation of nursing care’ (39%), ‘professionalism in surgery and treatment’ (35%) and ‘effective communication during consultations’ (26%).

Conclusions

Positive relationships with medical staff, particularly kindness, professionalism and effective communication, influence patient satisfaction. Patient compliment letters serve as important indicators of exceptional care and can inform quality improvement initiatives. Healthcare institutions should leverage these insights to enhance patient-centred services by strengthening patient–provider relationships and promoting a culture of excellence.

Protocol for the development of the Asian consensus recommendations on the standardised diagnosis and imaging of intracranial atherosclerotic stenosis applying a modified Delphi approach

Por: Navarro · J. C. · Pedregosa · B. C. · Belen · A. A. · Gan · R. N.
Introduction

Intracranial atherosclerotic stenosis (ICAS) is a leading cause of ischaemic stroke, particularly among Asian populations, and continues to impose a significant burden across the region. Despite this, evidence from Asia remains fragmented. Findings from our previously conducted scoping review revealed an absence of standardised diagnostic criteria and imaging protocols. This resulted in marked methodological inconsistencies in regional ICAS research, thereby limiting the validity and interpretability of existing data. To address this, we have initiated a consensus process that aims to establish standardised definitions, develop harmonised diagnostic protocols and outline research standards and priorities for ICAS across Asia.

Methods and analysis

A modified Delphi approach will be employed to formulate consensus-based recommendations through a structured, iterative, multistage process. Draft Delphi statements will be informed by targeted literature reviews and formatted into five-point Likert scale questionnaires with fields allowing for qualitative feedback. An expert core group was selected based on their established clinical and research expertise in intracranial atherosclerosis, cerebrovascular imaging and stroke, with deliberate consideration for geographic and disciplinary diversity. This group will serve as the formal voting panel. The process will comprise three to four anonymous online rounds, with a predefined consensus threshold of ≥80% agreement. Statements that do not reach consensus will be revised based on aggregated feedback and re-evaluated in subsequent rounds. A non-voting hybrid conference, open to the public, will follow the second round to facilitate broader engagement and discussion; relevant points will be incorporated into the subsequent round. Consensus on research standards and priorities will follow the finalisation of recommendations on standardised definitions and harmonised diagnostic protocols to ensure alignment with preceding outcomes.

Ethics and dissemination

This consensus was granted exemption by the Jose R. Reyes Memorial Medical Center Institutional Review Board (No. 2025–221). Resulting recommendations will be disseminated through peer-reviewed publication and presentation at scientific fora.

Registration number

https://doi.org/10.17605/OSF.IO/MB6GP.

Imaging the choroidal microvasculature in intensive and high dependency care unit patients: a pilot study

Por: Cooper · G. M. · Burke · J. · Hamid · C. · Godden · E. · Dhaun · N. · King · S. · MacGillivray · T. · Baillie · K. · Griffith · D. M. · MacCormick · I. J. C.
Objectives

Microcirculatory dysfunction drives the end-organ pathophysiology of circulatory shock but is not reflected within existing clinical indices of perfusion, such as blood pressure. The choroidal vasculature of the retina can be measured non-invasively and we hypothesised that this may reflect dysfunction in other organs. We tested the feasibility of measuring the choroid in intensive care and explored associations between choroidal measurements and clinical parameters.

Design

A pilot study of optical coherence tomography conducted in a sample of general intensive care unit (ICU) patients.

Setting

A tertiary mixed ICU within the UK.

Participants

15 patients were recruited. One patient was excluded following withdrawal of active treatment. 12/14 (86%) of the remaining patients had successful baseline imaging and 6 (40%) of these had follow-up imaging within intensive care. These patients had a mean age of 56.3 years, were 71% (10/14) male and mean Acute Physiology and Chronic Health Evaluation 2 (APACHE2) score on ICU admission was 20.4.

Outcome measures

Choroidal anatomy, including choroidal and suprachoroidal thickness, as well as volumetric analysis of intrachoroidal blood vessels, was assessed using automated image segmentation along with clinical, physiological and biochemical data at ICU admission and after an interval of 12–72 hours. Feasibility and safety data were assessed throughout ICU admission.

Results

Baseline choroidal vascular index and choroidal thickness were positively associated with fluid balance, and negatively with APACHE2 score, haematocrit and albumin content. A measurable suprachoroidal space was seen in nine (75%) patients (range 25.0–110.0 microns) and was inversely associated with heart rate. There was substantial intraindividual variation in choroidal measurements over time. There were no safety concerns.

Conclusions

Measuring the choroid is feasible in patients with Intensive Care Society Level 2 or Level 3 requirements. The suprachoroidal space may be markedly enlarged in these patients. Exploratory associations with systemic variables suggest that the choroid may provide information about the microvascular function of other major organs. Size and change of choroidal measurements may reflect perfusion pressure and vascular leakage.

Disaster preparedness of Australian hospital networks: a qualitative study with key actors

Por: Naru · F. S. · Churruca · K. · Long · J. C. · Sarkies · M. N. · Braithwaite · J.
Objective

Disasters can have a disproportionate impact on highly vulnerable hospitalised patients. Managers preparing hospital networks for disasters play an important role in enhancing networks’ readiness by creating disaster plans and imparting that knowledge through training and simulation exercises. The objective of this research was to uncover how those working in disaster preparedness roles in Australian hospital networks perceived the challenges that they face while ensuring adequate preparation for disasters.

Design

A qualitative study design was employed which involved purposive sampling of Australian hospital network professionals responsible for disaster preparedness. Thematic analysis of data collected through individual online interviews generated prominent challenges of disaster preparedness in Australian hospital networks.

Setting

Local hospital networks across Australia

Participants

Twenty-six disaster preparedness managers, including hospital executives, disaster managers, emergency management coordinators and business continuity managers from 23 hospital networks located in five Australian states and one territory, participated in semi-structured online interviews. Interview transcripts were coded through an iterative inductive thematic analysis process to synthesise the predominant challenges faced by these participants when preparing their hospital networks for disasters.

Results

Participants reported four challenges: staff’s limited interest in preparedness, budgetary constraints, staffing issues and ambiguous relationships with state and national health departments. They also presented four related solutions: capitalising on interest after disasters, attracting funding with evidence from prior disasters, facilitating staff’s availability for disaster training and specifying network-government relationships for accountability.

Conclusion

Disasters, although infrequent, are known to occur and can be catastrophic, yet those working in hospital network disaster preparedness roles encounter limited availability of wider staff for training and low interest in disaster planning. The sudden onset of a disaster can take a heavy toll on patients if hospitals’ staff are not sufficiently trained in disaster response or are not aware of the disaster plan. By identifying the perceptions of managers to disaster preparedness, this research presents specific challenges that hospital networks can address to improve awareness and preparation.

Epidemiological investigation of perinatal depression among pregnant and postpartum women: findings from a cross-sectional survey in the Philippines

Por: Filoteo · J. A. · Maravilla · J. C. · Mamaat · J. E. · Flores · A. D. · Jumamil · A. N. · Cardenas · R. L. · Quijencio · W. · Bayani · M. A. · Santos · N. · Acena · J. L. · Alfonso · A. L. · Rivera · M. · Guarino · R. · Sarmiento · R. · Flenady · V. · Boyle · F. M. · Loughnan · S. A. · T
Objective

This study investigated perinatal depressive symptoms among pregnant and postpartum Filipino women.

Design

Cross-sectional survey.

Setting

The Philippines.

Participants

Participants were recruited online and face-to-face from maternal care facilities.

Primary outcome measure

Perinatal depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS) score, with prevalence calculated based on ≥13 cut-off, indicating clinically significant symptoms of depression. Patterns of depressive symptoms were examined by demographics, perinatal time period and other obstetric information using adjusted regression coefficients (ab) and risk ratios (aRR).

Results

A total of 856 women participated in the study, comprising 356 pregnant and 500 postpartum women. EPDS scores were, on average, similar between pregnant (14.4) and postpartum women (14.1). Using the locally validated cut-off of ≥13 revealed that 69.1% of pregnant and 62.0% of postpartum women reported clinically significant depressive symptoms. Consistent EPDS scores and prevalence were observed across pregnancy trimesters and within 12 months postpartum and beyond. Women who received adequate prenatal care were less likely to experience antenatal (ab=–1.59, 95% CI –3.13 to –0.05) and postpartum (ab=–1.30, 95% CI –2.48 to –0.12) depressive symptoms. Postpartum EPDS scores and depressive symptom prevalence (EPDS score ≥13) were higher among 18–24-year olds (ab=1.96, 95% CI 0.30 to 3.61; aRR=1.23, 95% CI 1.03 to 1.47) and single mothers (ab=3.46, 95% CI 0.22 to 6.71; aRR=1.42, 95% CI 1.07 to 1.90), compared with older and married mothers, respectively.

Conclusions

At least 60% Filipino mothers experienced clinically significant perinatal depressive symptoms, which exceeds the established global average of 25%. Younger and single postpartum women were at greater risk, while pregnant and postpartum women who attended adequate prenatal visits were less likely to report depressive symptoms. Our study underscores the need for further research to uncover the true burden of poor perinatal mental health and calls for targeted early interventions and integrative public health strategies to support at-risk mothers, particularly those from socially disadvantaged backgrounds.

Cognitive and physical exercise to improve outcomes after surgery (COPE-iOS) study: protocol for a randomised, controlled trial in the USA examining the efficacy of a combined cognitive and physical exercise programme performed before and after major surg

Por: Rengel · K. F. · Archer · K. R. · Jackson · J. C. · Raman · R. · Orun · O. M. · Ellison · T. · Vanston · S. W. · Ervin · H. · Lauck · A. · Provin · M. · Pandharipande · P. P. · Hughes · C. G.
Introduction

Surgery and its resulting hospitalisation are associated with subsequent cognitive and functional decline. Interventions to reduce this decline have exhibited limited success. Prehabilitation is the process of enhancing capacity and reserve before an acute stressor to improve tolerance of the acute physiologic insult. Older adults requiring major surgery are an ideal population for prehabilitation. Prehabilitation exercise studies have mostly focused on physical training to improve physical outcomes after specific surgery types, and data on cognitive outcomes and in broader surgical populations are needed. Computerised cognitive training (CCT) has been shown to enhance memory, processing speed, attention and multitasking. Combining CCT with a physical exercise may be most effective in reducing cognitive and functional decline in older patients undergoing major surgery, but has yet to be evaluated.

Methods and analysis

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is a randomised, controlled, participant and assessor blinded clinical trial testing the hypothesis that a pragmatic programme combining CCT and physical exercise throughout the perioperative (ie, preoperative and postoperative) period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. The trial aims to randomise 250 patients who undergo major surgery for a treatment period of approximately 1 month prior to surgery and 3 months after surgery, with a follow-up period of 12 months after surgery. The primary outcome is global cognition at 3 months after surgery. Key secondary outcomes include global cognition at 12 months after surgery and disability in activities of daily living and depression at 3 and 12 months after surgery.

Ethics and dissemination

Trial protocol has been approved by Vanderbilt Human Research Protections Programme (#202496) and an independent Data Safety Monitoring Board. Results will be presented at scientific conferences and submitted for publication.

Trial registration number

ClinicalTrials.gov Registry NCT04889417.

Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study

Por: Gunning · S. G. S. · Page · J. · Rossdale · J. · Charters · P. F. P. · Hudson · B. · Lyen · S. · Mackenzie Ross · R. · Seatter · A. · Bartlett · J. W. · Austin · L. · Myring · G. · McLeod · H. · Mitchell · P. · Stimpson · D. · Cookson · A. · Suntharalingam · J. · Rodrigues · J. C. L.
Introduction

Pulmonary embolism (PE) is a potentially fatal condition requiring timely diagnosis and treatment. CT pulmonary angiography (CTPA) is the gold standard for diagnosis and indicates PE severity through radiological markers of right heart strain. However, accurate interpretation and communication of these findings is often suboptimal in real-world practice. Artificial intelligence (AI) could alleviate pressure on radiology services by supporting PE identification, risk stratification and worklist prioritisation. Before widespread adoption, AI tools must be rigorously validated for diagnostic accuracy, safety and clinical impact.

Methods and analysis

This pragmatic single-centre, non-randomised quasi-experimental study will evaluate the diagnostic accuracy, feasibility, and clinical-cost impact of AI-assisted PE detection and risk stratification using AIDOC and IMBIO software. We will recruit two consecutive cohorts of adult patients undergoing CTPAs for suspected PE: a comparator cohort (12 months pre-AI implementation) and an intervention cohort (12 months post-AI implementation). AI will be applied retrospectively to the comparator cohort, while in the intervention cohort, radiologists will have contemporaneous access to the AI’s interpretation of CTPA images.

A subset of retrospective scans, both PE-positive and PE-negative, will undergo expert thoracic radiologist review to establish a reference standard. Data on patient demographics, clinical management and outcomes will be collected. Clinical management pathways and patient outcomes will be compared between cohorts to assess AI’s influence on acute PE management. Health economic modelling will assess the cost-effectiveness of integrating AI technology within the diagnostic workflow of acute PE.

Ethics and dissemination

This study was approved by the UK Healthcare Research authority (IRAS 311735, 10 May 2023). Ethical approval was granted by West of Scotland Research Ethics Service (23/WS/0067, 3 May 2023). Results will be shared with stakeholders, presented at national and international conferences, and published in open-access peer-reviewed journals.

Trial registration number

NCT06093217.

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