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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT06922630.

Prevalence of undernutrition and associated factors among children aged 6-59 months in rural model households in the Central Zone of Sidama regional state, Ethiopia: a community-based cross-sectional study using robust Poisson regression analysis

Por: Gujo · A. A. · Amare · H. H. · Estifanos · M. B. · Aregu · M. B.
Objective

Undernutrition remains a public health challenge in Ethiopia, despite several nutrition programmes. Therefore, the aim of this study was to assess the prevalence of undernutrition and its associated factors among children aged 6–59 months in rural model households in the Central Zone of the Sidama regional state.

Design

This study employed a community-based cross-sectional design between 4 July and 4 August 2024.

Setting

The study was conducted in selected woredas of the Central Zone of the Sidama regional state.

Participants

A multi-stage sampling technique was used to select 627 children aged 6–59 months in the model households. Model households, defined as those that attended at least 75% of the 96-hour training sessions and successfully implemented 75% of the Health Extension Program (HEP) packages, were awarded certificates.

Primary outcome

The primary outcomes of this study were undernutrition, specifically stunting, underweight and wasting.

Secondary outcome

The secondary outcome focused on factors associated with stunting, underweight and wasting. Bivariable and multivariable robust Poisson regression analyses were used to identify the associations between outcome and risk factors. The strength and significance of associations were assessed using adjusted prevalence ratios (APRs) with 95% CIs and p

Results

Although multilevel analysis was performed to account for woreda and kebele clustering, no significant effects were found. Simple robust Poisson regression findings are therefore presented. Stunting prevalence was 37.6%, underweight 13.9% and wasting 9.4%. Being male is linked to a higher prevalence of stunting (APR 1.37, 95% CI 1.11 to 1.69), underweight (APR 1.72, 95% CI 1.12 to 2.65) and wasting (APR 1.73, 95% CI 1.003 to 2.98). Conversely, spoon-feeding (APR 0.61, 95% CI 0.39 to 0.95), mothers as housewives (APR 0.56, 95% CI 0.42 to 0.76) versus farmers and maternal household decision-making (APR 0.29, 95% CI 0.12 to 0.70) were associated with lower prevalence of stunting. Additionally, larger households (≥5 members) were also associated with higher prevalence of underweight (APR 1.61, 95% CI 1.04 to 2.52) and wasting (APR 1.88, 95% CI 1.09 to 3.24).

Conclusions

Our findings indicate a higher prevalence of stunting, accompanied by moderate rates of wasting, among children residing in rural model households in the Sidama region. Notably, practices such as spoon-feeding and maternal involvement in decision-making were associated with a lower prevalence of stunting. Conversely, larger family size was linked with a higher prevalence of underweight and wasting among children. To address these challenges, it is essential to promote hygienic feeding practices via the HEP, empower women in their communities, advocate for family planning to manage family size and strengthen community-based nutrition programmes. These measures could help combat undernutrition in rural areas.

Primary caregivers practices and perceptions on antibiotic use and resistance: a one health qualitative study in rural South India

Por: Charan · K. · Lakshmi Kandhan · V. · Rishika · R. S. · Kalimuthu · P. · Pon Ruban · A. C. · Karthikeyan · M. B. · Sahoo · K. C. · Ponnaiah · M. · Chethrapilly Purushothaman · G. K. · Diwan · V.
Objectives

Antimicrobial resistance is a growing global public health threat driven by interactions between human, animal and environmental factors. Rural settings in low- and middle-income countries may face increased risk due to unregulated antibiotic use, close human–animal interactions, and environmental contamination. This study explored community-level knowledge, attitudes and practices related to antibiotic use and resistance among caregivers of children in rural South India using a One Health perspective.

Design

Qualitative study using focus group discussions and thematic analysis.

Setting

Four rural villages in Tirunelveli district, Tamil Nadu, India.

Participants

Seventy-seven primary caregivers of children aged 2–12 years from households with backyard animals, purposively selected from a rural cohort study.

Results

Three themes emerged. First, human health practices included reliance on home remedies, reuse of prescriptions, self-medication and incomplete antibiotic courses alongside misconceptions about antibiotics. Second, environmental factors such as untreated water consumption, open defecation, poor drainage and improper waste disposal were perceived to increase infection risks. Third, animal-related pathways included close child–animal contact, antibiotic use in livestock and unsafe disposal of animal waste. Limited healthcare access and transport costs influenced treatment-seeking behaviour.

Conclusions

Interconnected caregiver practices, environmental conditions and animal husbandry behaviours create multiple pathways for antimicrobial resistance transmission. Integrated, community-based interventions addressing behaviour change, healthcare access and environmental management are essential to support antibiotic stewardship within a One Health framework.

Adipose-derived stem cell uses in orthopaedic surgeries: a scoping review protocol

Por: Cartuliares · M. B. · Andkjaer · S. W. · Kildall Hejbol · E. · Moos · C. · Henrik Frich · L.
Background

Musculoskeletal disorders represent a significant global health burden, frequently leading to chronic pain, functional impairment and disability. Conventional treatment modalities, including rehabilitation, pharmacotherapy and surgical intervention, are often associated with suboptimal outcomes and prolonged recovery. Adipose-derived stem cells (ADSCs) have gained considerable attention due to their regenerative capacity, accessibility and immunomodulatory properties. Preclinical studies of ADSCs have demonstrated promising effects in skeletal muscle regeneration. However, the evidence from human orthopaedic shoulder surgery remains inconclusive. This scoping review aims to map the process of adipose tissue-derived treatments in orthopaedic surgery, especially shoulder surgery.

Methods and analysis

A scoping review will be conducted using the Joanna Briggs Institute methodology to systematically map existing evidence on the clinical use of ADSCs in orthopaedic shoulder surgery. The search strategy will use the Population–Concept–Context framework and will be applied across four bibliographic databases (Embase, MEDLINE, CENTRAL and Scopus) and ClinicalTrials.gov, with additional grey literature searches. Studies will be limited to adults (≥18 years) undergoing shoulder surgery. Both clinical and patient-reported outcomes will be extracted. Article screening and data extraction will be performed independently by two reviewers using Covidence software, with discrepancies resolved through consensus or third-party arbitration.

Discussion

The extensive mapping will provide a comprehensive synthesis of current evidence on the application of ADSCs in orthopaedic surgery, including preparation methods, intraoperative techniques, postoperative follow-up and outcome measures. Special attention will be paid to heterogeneity in clinical practice, methodological limitations and reported patient-centred outcomes. This review will also identify gaps in the literature and inform future research priorities.

Ethics and dissemination

This scoping review does not require ethics approval, as we will only include information from previously conducted studies and will not involve human participants.

Prevalence and types of anxiety disorders among patients with cardiac conditions and elevated HADS-A scores: findings from the initial screening phase of the Heart and Mind trial in Denmark

Por: Berg · S. K. · Rasmussen · L. R. · Thorup · C. B. · Rasmussen · T. B. · Christensen · A. V. · Hammer · C. B. · Jorgensen · M. B. · Svendsen · J. H. · Risom · S. S. · Juul · C. · Schjodt · I.
Objectives

To identify whether patients with arrhythmia, heart failure or ischaemic heart disease presenting with anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS) have identifiable anxiety according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) and, if so, which type of anxiety disorder based on the SCID.

Design

Initial screening data from the Heart and Mind randomised clinical trial.

Setting

Patients with arrhythmia, heart failure or ischaemic heart disease were screened using HADS, and patients with a HADS-anxiety (HADS-A) score≥8 were invited to participate. Participants were interviewed by trained cardiac nurses using the SCID to determine whether they met the criteria for anxiety and, if so, the type of anxiety disorder.

Results

Of the 7816 patients who completed the HADS questionnaire, 1803 (23%) had a HADS-A score≥8. Among these, 398 (22%) agreed to the SCID interview, and 336 (84%) met the diagnostic criteria for an anxiety disorder. The mean age was 61 years, with 40% being female. The mean HADS-A score was 11.3 (SD=2.7). The most common types of anxiety were generalised anxiety disorder (61%), panic disorder (23%) and specific phobia (8%).

Conclusions

The majority of individuals identified by the instrument also met the diagnostic criteria for an anxiety disorder. Generalised anxiety disorder and panic disorder were the most prevalent subtypes. Anxiety was common across the cardiac population, underscoring the need for routine assessment and targeted intervention in clinical practice.

Trial registration number

NCT04582734.

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.

Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial

Por: McCaughey · E. J. · McLachlan · A. J. · Cai · J. · Cohen Freue · G. · Demoule · A. · Gotur · D. B. · Hill · N. S. · Dimatteo · C. · Oliva · S. P. · Patel · M. B. · Girard · T. D. · Heunks · L.
Introduction

Nearly half of patients who receive invasive mechanical ventilation for acute respiratory failure require over 4 days of ventilator support, each day of which is associated with increased morbidity, mortality and cost. Many of these patients develop expiratory muscle atrophy and weakness, which are linked to failed extubation and weaning. We seek to test the hypothesis that exhalation synchronised abdominal functional electrical stimulation reduces mechanical ventilation duration.

Methods and analysis

This pivotal superiority trial will be performed in up to 30 intensive care units (ICUs) in the USA, France, the Netherlands and Australia. Adults (≥22 years old) who have been mechanically ventilated for 24–96 hours and are expected to remain ventilated for another 24+ hours are potentially eligible. We will recruit participants until 150 successful liberations from mechanical ventilation occur. To achieve this, we estimate that a maximum of 272 participants will be randomised in a 1:1 ratio to receive 30 min of active exhalation synchronised abdominal functional electrical stimulation (vs sham). The intervention will be applied using the VentFree Respiratory Muscle Stimulator two times per day, a minimum of 5 days per week, for a maximum of 28 days or until ICU discharge. The primary outcome is time from first intervention to successful liberation from mechanical ventilation. Secondary outcomes include cough peak flow (CPF) and maximum expiratory pressure (MEP) at 24 hours post-extubation, hospital and ICU length of stay, reintubations, complications, ICU readmissions, 90-day mortality and quality of life. The participant, clinical team and outcome assessor are blinded to group allocation. A positive outcome has the potential to improve patient-centred outcomes in ICUs.

Ethics and dissemination

This study was approved by local ethics institutions in the USA, Australia, France and the Netherlands. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. The results will be disseminated through peer-reviewed journal publications, conference presentations and clinicaltrials.gov updates. Individual country-level approvals are as follows:

France:

  • Ethics committee: Comité de Protection des Personnes Ile-de-France X.

  • Reference numbers: CPP 27-2024; RCB 2024-A00559-38.

  • Initial approval date: 14 May 2024.

  • Australia:

  • Ethics committee: South Eastern Sydney Local Health District Human Research Ethics Committee.

  • Reference number: 2022/ETH02724.

  • Initial approval date: 21 March 2023.

  • Netherlands:

  • Ethics committee: Medisch Ethische Toetsings Commissie Erasmus MC.

  • Reference numbers: MEC-2023-0364; NL84195.000.23.

  • Initial approval date: 30 April 2024.

  • USA:

  • Ethics committee: WCG IRB.

  • IRB tracking number: 20214073.

  • Initial approval date: 13 March 2023.

  • All participating sites are currently approved and operating under protocol version 09 or later.

    Trial registration number

    NCT05759013. Registered 8 March 2023.

    Report cards and outcome measurements to improve the safety of surgical care (North America): an updated systematic review from Making Healthcare Safer IV

    Por: Huy · T. · Blegen · M. B. · Tupper · H. · Premji · A. · Motala · A. · Lawson · E. · Shekelle · P. G. · Girgis · M. · Maggard-Gibbons · M.
    Objectives

    In the USA, an estimated 40–50 million operations are performed annually, with high rates of adverse events. Since the 1980s, report cards have been used for outcome measures and to improve safety of surgical care. As part of Making Healthcare Safer IV—an initiative aimed at publishing evidence-based reviews as they are completed to help healthcare leaders, researchers and policymakers act more quickly on evidence-supported practices—we performed an updated review on the certainty of evidence on patient safety practices related to the use of surgical report cards and outcome measurements.

    Design

    Systematic review using the Grade of Recommendations Assessment, Development and Evaluation (GRADE) approach.

    Data sources

    PubMed, Web of Science, Scopus and the Cochrane Library were searched from November 2011 to May 2023.

    Eligibility criteria for selecting studies

    We included primary research studies (randomised control trials or observational studies with a comparison group, including pre–post studies) or observational studies that investigated a surgical report card in adult or paediatric surgical patients at the hospital or surgeon level in inpatient or outpatient settings. Excluded studies included: narrative reviews, scoping reviews, editorials, commentaries, abstracts, studies that measured only patient knowledge or levels of engagement or studies using local surgical dashboard data.

    Data extraction and synthesis

    Screening and eligibility were done in duplicate, while data extraction was done by one reviewer and checked by a second reviewer. Specific items in the Risk Of Bias In Non-randomised Studies - of Interventions tool and a modification of the National Institutes of Health Tool were used to assess for bias in studies. Two reviewers assessed each study for risk of bias. A modified version of the GRADE framework was used to assess the certainty of evidence.

    Results

    We identified 19 studies that met the inclusion criteria: 13 primary research studies and 6 descriptive studies of surgical collaboratives. Of the primary studies, nine used a pre–post or longitudinal study design and four used a regression discontinuity or concurrent controlled design. Seven of the studies were about the American College of Surgeons National Surgical Quality Improvement Project. Five studies were from single institutions and the remainder included nine to greater than 700 hospitals. Pre–post studies of report cards that prompted quality improvement (QI) programmes all reported improvements in outcomes, longitudinal studies reported benefits in some but not all outcomes and one in four controlled before-and-after studies reported a statistically significant mortality benefit. All studies, except for one, were at moderate or high risk of bias. Six collaboratives were identified with preliminary data.

    Conclusions

    Based on the above evidence, the theoretical rationale and parallel evidence in other settings, we judged that it was moderate certainty that report cards and outcomes measurements can improve surgical outcomes. However, given the evidence from studies where report cards were actively linked to institutional QI initiatives, we recommend that outcome data must be paired with actionable QI efforts to meaningfully improve patient outcomes.

    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).

    Prospective cohort study of TIMP-1 and myocardial fibrosis in Chagas disease at a reference clinic in Pernambuco, Brazil: PTICH trial protocol

    Por: Martins · S. M. · Macedo · C. T. · Meira · C. S. · Paim Santos · L. H. · Larocca · T. F. · Cavalcanti da Silva · F. F. · Leandro Lira · C. N. · da Silva · I. P. M. · De Araujo · L. T. · Soares · M. B. P.
    Background

    Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

    Methods and analysis

    Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

    Ethics and dissemination

    The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

    Trial registration number

    RBR-3dcrj98.

    Postmarketing safety surveillance for GSKs AS01E-adjuvanted respiratory syncytial virus prefusion F protein-based vaccine in the USA: protocol for a non-interventional postauthorisation safety study

    Por: Adimadhyam · S. · Luyts · D. · Oraichi · D. · Deraedt · Q. · Pircon · J.-Y. · Bilker · W. B. · Agan · A. A. · Rajbhandari · R. · Carbonari · D. M. · Djibo · D. A. · Wang · X. · Nolan · M. B. · DeVries · A. · Selvan · M. · Ma · Q. · Wentz · A. E. · Daniels · K. · Platt · R. · Lo Re · V. · Coc
    Introduction

    In May 2023, the US Food and Drug Administration (FDA) initially approved an AS01E-adjuvanted respiratory syncytial virus (RSV) prefusion F protein-based vaccine (adjuvanted RSVPreF3) for adults aged ≥60 years. The approval was expanded in June 2024 to include adults 50–59 years of age at increased risk for RSV-associated lower respiratory tract disease. In this paper, we describe the protocol of a postmarketing safety study evaluating the association between adjuvanted RSVPreF3 and new-onset Guillain-Barré syndrome (GBS), acute disseminated encephalomyelitis (ADEM) and atrial fibrillation (AF) among adults ≥50 years of age in the USA and provide our rationale for key methodological decisions.

    Methods and analysis

    The potential associations between adjuvanted RSVPreF3 and GBS, ADEM and AF will be evaluated using secondary healthcare data and the self-controlled risk interval (SCRI) design. Data from five research partners in the USA spanning August 2023 through June 2030 will be used for the conduct of yearly monitoring queries and, sample size permitting, SCRI analyses. Claims-based definitions for new-onset outcomes (first diagnosis in 365 days) are: ≥1 inpatient diagnosis for GBS and ADEM; ≥1 inpatient or ≥2 ambulatory/emergency diagnoses for AF. The primary risk and control windows are 1–42 and 43–84 days, respectively, for GBS and ADEM; and 1–8 and 9–16 days for AF. SCRI analyses for GBS and ADEM will include chart-confirmed cases. SCRI analyses for AF will adjust for the positive predictive value obtained from validation against charts. Conditional Poisson regression will be used to calculate incidence rate ratios.

    Ethics and dissemination

    This study was approved by the Institutional Review Boards (IRB) of Harvard Pilgrim Health Care Institute; WIRB-Copernicus Group, Inc and its affiliates (collectively, ‘WCG’); WCG IRB, Inc; and Sterling IRB, with Federal Wide Assurance (FWA) numbers FWA00000100, FWA00033319 and FWA00025632, respectively, for all participating research partners. Study results will be shared with the US FDA and publicly disseminated through national or international clinical or scientific conferences and peer-reviewed publications.

    Registration

    This protocol has been registered in the Heads of Medicines Agencies–European Medicines Agency Real World Data Catalogues (EUPAS1000000486).

    Breast cancer screening best practices: a Canadian multidisciplinary consensus-based approach for primary care providers

    Por: Pathak · N. · Corrado · A. M. · Seely · J. M. · Heisey · R. · Lofters · A. · Cil · T. · Sussman · J. · Zhong · T. · Amir · E. · Isenberg · A. · Nadler · M. B.
    Objectives

    International guidelines on breast cancer (BC) screening have differing recommendations leading to uncertainty on best practices for primary care providers. The purpose of this study was to create a Canadian best practices document on BC health and screening for primary healthcare providers through multidisciplinary consensus using Nominal Group Technique and Delphi method.

    Participants

    A 9-member multidisciplinary expert group and a patient advocate participated in the consensus methods and voting. Experts included those involved in BC management and two primary care physicians. Twenty-nine experts across BC disciplines participated in external review.

    Primary and secondary outcomes

    Two study objectives included (1) building consensus on key ‘best practice’ behaviours related to BC-related health and screening and (2) building consensus on specific definitions related to BC screening.

    Results

    The final consensus document consists of 65 statements grouped in five categories with companion resources to support uptake of all best practices. Categories include identification and work-up for diagnostic imaging, risk factors and identifying individuals eligible for high-risk screening, shared decision-making, decisions and referrals for BC screening and screening outcomes. Special areas of focus were shared decision-making, age to initiate screening, and BC screening in special populations.

    Conclusions

    We created a comprehensive consensus document distilling the latest evidence to provide practical Canadian consensus-based advice on specific ‘best practice behaviours’ related to BC health and screening to serve as a resource for providers.

    Benefits and challenges in everyday life for patients performing subcutaneous immunoglobulin treatment at home: a qualitative interview study

    Por: Johansen · M. B. · Kass · E. D. · Christensen · J.
    Objective

    Across medicine, new therapies are shifting treatment from clinic to home settings. At-home subcutaneous immunoglobulin treatment for immunodeficiency is an example of one such therapy. In this qualitative interview study, we investigated experiences of patients living an everyday life with subcutaneous immunoglobulin at-home treatment.

    Study design, setting and participants

    24 Danish patients participated in semistructured interviews. Six patients were interviewed in individual home-visit interviews, while the remaining 18 participated in one of six subsequent group interviews using an online video format. Participants represented three patient groups: patients with primary immunodeficiency, patients with secondary immunodeficiency, and patients with chronic inflammatory demyelinating polyneuropathy or multifocal motor neuropathy.

    Results

    According to the interviewed patients, at-home treatment provided a high degree of flexibility and freedom in everyday life. When transitioning to at-home treatment, a sense of security had been achieved through individualised training and access to healthcare professionals. Some patients experienced uncertainty or insecurity during the initial period of administering treatment at home; however, this typically receded over time. For the patients, at-home treatment had become embedded in everyday life either through incorporation into existing everyday routines or through the development of new routines. The time-related and place-related flexibility of the at-home treatment had benefits for several arenas of everyday life: work, family, and leisure. Patients associated at-home treatment with a sense of freedom, which they ascribed both to independence from the hospital and to not being confronted with medical conditions and other patients in the hospital setting. A small minority of the patients viewed the reduced contact with healthcare professionals as a disadvantage, describing feelings of being alone and responsible for their treatment.

    Conclusions

    Patients who had established at-home treatment routines in their everyday lives found the benefits of at-home treatment to outweigh the challenges.

    Internal Regulation Core as a hub of disruptive innovation in hospital management: a scoping review protocol

    Por: Gomes · L. M. · Moreira · F. d. M. B. · Junior · G. F. X. · Duani · H. · Andrade · M. V. M. d. · Ferrari · T. C. A.
    Introduction

    This scoping review protocol aims to examine the role of the Internal Regulation Core (IRC) as an intra-hospital governance structure that coordinates capacity and patient flow and may function as a strategic hub for disruptive innovation in hospital management. By integrating organisational routines, rules and, when available, enabling technologies, IRCs may strengthen operational efficiency and contribute to higher-quality care delivery. As hospitals face increasing operational complexity and constrained resources, clarifying what IRCs are, how they are implemented across settings, and what innovations and impacts are reported has become a priority.

    Methods and analysis

    This scoping review will follow the Joanna Briggs Institute guidance and Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. A comprehensive search will be conducted across five databases (MEDLINE/PubMed, Embase, Scopus, Web of Science and LILACS) and grey literature sources, without language or date restrictions. The searches were conducted up to 6 July 2025. Two reviewers will independently screen studies and extract data using a standardised form; disagreements will be resolved by consensus or a third reviewer. Findings will be synthesised descriptively and thematically, with results presented in tables and narrative summaries, including innovation streams.

    Trial registration number

    Open Science Framework (10.17605/OSF.IO/HWZJS).

    Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol

    Por: Douin · D. J. · Rice · J. D. · Xiao · M. · Beaty · L. · Guo · C. · Withers · C. · Sullivan · A. · Anderson · E. L. · Cheng · A. C. · Banasiewicz · M. K. · Semler · M. W. · Lloyd · B. D. · Maiga · A. · Gibbs · K. W. · Stettler · G. R. · Khan · A. · Sally · M. B. · Wright · F. L. · Aggarwal
    Introduction

    Administering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO2) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO2 90%–96%) compared with usual care.

    Methods and analysis

    The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO2 90%–96%) as measured by continuous non-invasive pulse oximetry, during the first 72 hours after randomisation. Secondary outcomes include the amount of supplemental oxygen administered and the proportion of time spent in hypoxaemia (SpO22 >96%). Specifying the protocol and statistical analysis plan before the conclusion of enrolment increases the rigour, reproducibility and interpretability of the trial. Enrolment began on 6 May 2024.

    Ethics and dissemination

    The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal.

    Trial registration number

    NCT06374225.

    Treatment of bulbar urethral strictures with Optilume drug-coated balloons in a previously untreated population (FIRST-CARE): protocol for a single-blind multicentre randomised controlled trial

    Por: Mahdi · M. B. · Haase · R. N. · Sander · L. · Tuckus · G. · Liltorp · D. L. · Jorgensen · L. · Graugaard-Jensen · C. H. · Weinreich · H. · Pennisi · C. P. · Nielsen · T. K.
    Introduction

    Minimally invasive endoscopic procedures constitute the cornerstone of first-line treatment for bulbar urethral strictures, although their long-term effectiveness is limited by high recurrence rates. The Optilume drug-coated balloon (DCB) is a novel intervention combining mechanical dilation with localised delivery of paclitaxel to reduce recurrence by inhibiting scar tissue formation. While its efficacy has been demonstrated in patients with recurrent strictures, its potential as a first-line option in treatment-naïve patients remains unexplored. The FIRST-CARE trial aims to assess the efficacy and safety of Optilume DCB compared with standard endoscopic treatment in treatment-naïve patients with bulbar urethral strictures.

    Methods and analysis

    Design: Two-arm, randomised, single-blind (participant), investigator-initiated, parallel-group, multicentre clinical trial. Patients: The study will enrol 140 adult male patients with treatment-naïve, single bulbar urethral strictures ≤3 cm in length. Interventions: All patients will undergo the assigned procedure under general anaesthesia with 1.5 g intravenous cefuroxime. Optilume group patients will receive ≥5 min balloon dilation with localised paclitaxel delivery. The control group will receive standard endoscopic treatment (eg, direct visual internal urethrotomy, laser or dilatation). In both groups, a 12–14 French Foley catheter will be left in place for 3–5 days. Primary outcome: Freedom from repeat intervention within 12 months of follow-up. Primary analysis: Time-to-event will be defined from the date of intervention to the date a repeat intervention is decided (indicated and planned) due to confirmed recurrence, with censoring at 12 months. Groups will be compared using Kaplan-Meier survival analysis and the log-rank test. Cox regression and modified Poisson regression will be used to estimate HRs and relative risks.

    Ethics and dissemination

    The trial is approved by the Danish National Committee on Health Research Ethics (2401370) and will be conducted in accordance with the Declaration of Helsinki and principles of Good Clinical Practice. In line with national guidelines, all eligible patients are counselled regarding available treatment options prior to enrolment. Results will be disseminated via peer-reviewed publications and scientific presentations.

    Trial registration number

    NCT06827210.

    Physician beliefs regarding venous thromboembolism prophylaxis at a large multihospital US healthcare system: a cross-sectional survey study

    Por: Moss · S. R. · Bhattacharyya · O. · Mittman · B. G. · Gunaratne · T. · Campoamor · N. B. · Bridges · J. F. · Rothberg · M. B.
    Background

    Venous thromboembolism (VTE) contributes to hospitalisation-associated morbidity. Although guidelines recommend limiting VTE prophylaxis to high-risk patients, some physicians prescribe it broadly. We compared beliefs of low and high prescribing physicians.

    Methods

    We surveyed hospitalists and medical residents who had the opportunity to prescribe prophylaxis ≥50 times. Best-worst scaling was used to assess their beliefs. Using a balanced incomplete block design, we created seven choice tasks with seven statements regarding prophylaxis beliefs each presented four times. For each task, physicians selected the statement that most and least reflected their beliefs. We used a count method to calculate best-worst scores and a conditional logistic regression choice model to compare low and high prescribers.

    Results

    Of 434 invitees, 172 (40%) completed all survey questions between June and November 2023. Low (n=86, ≤62.5% prescribing rate) and high (n=86, >62.5 prescribing rate) prescribers endorsed similar beliefs with differing levels of agreement. All felt confident to prescribe prophylaxis appropriately (low: +1.13, high: +1.10, p=0.81). High prescribers expressed more concern about VTE without prophylaxis (+1.02 vs +0.65, p=0.002). Low prescribers disagreed more that prophylaxis had no downside (–1.03 vs –0.73, p=0.01). High prescribers worried less about prophylaxis risks (–0.49 vs –0.22, p=0.01), and overuse (–0.61 vs –0.34, p=0.02).

    Conclusions

    Compared with low prescribers, high prescribers were more concerned about VTE without prophylaxis and less about harms. These differences in beliefs may underlie physician behaviour and could be targets for interventions to reduce inappropriate prophylaxis.

    Associations between sociodemographic characteristics and knowledge about antibiotics and antibiotic resistance and usage of antibiotics from a One Health perspective in rural Bangladesh: a descriptive cross-sectional study

    Por: Hicks · J. P. · Huque · R. · Fieroze · F. · Saify · M. B. · Ensor · T. · Islam · K. · Latham · S. · Mitchell · J. · Rahman · A. · Islam · M. N. · King · R.
    Objectives

    We explored how key sociodemographic characteristics were associated with correct knowledge about antibiotics and antibiotic resistance (ABR) and appropriate usage of antibiotics from a One Health perspective among rural community members in Bangladesh.

    Design

    Cross-sectional single-period survey.

    Setting

    Rural villages in Cumilla district, Bangladesh.

    Participants

    Eligibility criteria: aged ≥18. Across 50 clusters of villages, we approached 2160 community members and 2187 (98.8%) agreed to participate.

    Primary and secondary outcome measures

    Primary outcomes: we collected two knowledge outcomes measuring the number of correctly answered binary/multiple-choice questions about (1) antibiotics and ABR and appropriate usage of antibiotics in relation to human illness and (2) antibiotics and ABR and appropriate usage of antibiotics in relation to animal health and the environment. Secondary outcomes: self-reported awareness of (1) antibiotics and (2) ABR.

    Results

    Several sociodemographic characteristics were associated with variation in both knowledge outcomes. Education showed the strongest associations, with higher education levels associated with higher knowledge scores. For example, compared with having no formal/incomplete primary education, having higher education was associated with 10 percentage points (95% CI 8 to 12) and 6 percentage points (95% CI 3 to 8) higher mean knowledge scores for the knowledge outcomes 1 and 2, respectively. Having worked in the last month compared with not having worked was also weakly positively associated with both knowledge outcomes, and being female compared with being male was also weakly negatively associated with both knowledge outcomes.

    Conclusions

    Better public education is required to tackle ABR in Bangladesh but correct knowledge about antibiotics and ABR and appropriate usage of antibiotics in relation to humans, animals and the environment varies in relation to individuals’ education level, sex and working status. To maximise their effectiveness, interventions to tackle ABR must be flexible given recipients’ sociodemographic characteristics and pre-existing knowledge levels.

    Prevalence of depression or depressive symptoms among engineering students: a systematic review and meta-analysis

    Por: Gabriel · F. C. · Humes · E. d. C. · Wagner · M. B. · Fraguas · R.
    Objectives

    To assess the prevalence of depression or depressive symptoms among engineering students.

    Design

    Systematic review and meta-analysis of prevalence surveys using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

    Data sources

    PubMed, Index Medicus Global, EMBASE, Web of Science, Scopus and PsycINFO were searched from 1 January 2003 to 28 June 2024.

    Eligibility criteria

    Studies were included if they: (1) reported the prevalence of depression or depressive symptoms among engineering students, (2) used a validated instrument with defined cut-off points to assess depression or depressive symptoms and (3) were published in a peer-reviewed journal.

    Data extraction and synthesis

    Two researchers independently extracted data using a standardised spreadsheet, collecting information on country of data collection, survey years, year of training, sample size, mean age of participants, number and percentage of male participants, assessment instrument, cut-off points and prevalence estimates. Discrepancies were resolved by a third researcher. Risk of bias was assessed with the Risk of Bias for Studies of the Prevalence of Mental Health Disorders tool. Prevalence estimates were synthesised using random-effects meta-analysis. Between-study heterogeneity was assessed with ² tests and the I² statistic. Subgroup analyses were conducted according to severity cut-off points, and meta-regression was used to explore the influence of study-level characteristics on prevalence estimates.

    Results

    23 studies involving 12 758 students across 11 countries were analysed. All studies used validated scales with cut-off points to assess depression or depressive symptoms. The overall pooled prevalence was 42.6% (95% CI 32.7 to 53.1) for studies using symptom severity cut-off points at mild or above, and 33.1% (95% CI 25.2 to 42.0) for studies using symptom severity cut-off points at moderate or above. Meta-regression indicated a progressive annual increase in prevalence (OR 1.14, 95% CI 1.01 to 1.28, p=0.034) across studies conducted from 2014 to 2024.

    Conclusions

    Prevalence of depression and depressive symptoms is high among engineering students, at levels comparable to medical students. Given the substantial impact, further research should investigate risk factors and evaluate preventive, early detection and treatment strategies tailored to engineering students.

    PROSPERO registration number

    CRD42024571131.

    Obstetric violence across the maternal care continuum and its impact on womens perinatal mental health in low- and middle-income countries: a systematic review and meta-analysis protocol

    Por: Mengesha · M. B. · Kidanemariam Berhe · A. · Oyetunji · T. P. · Teka · H.
    Introduction

    Mistreatment and obstetric violence constitute significant human rights violations with profound implications for maternal mental health. These detrimental practices persist globally, particularly in contexts where underfunded health systems, workforce shortages and entrenched gender inequalities intersect, depriving women of adequate psychosocial support and culturally sensitive mental healthcare. Although awareness of the immediate harms of mistreatment is increasing, its cumulative effects throughout the maternal care continuum remain insufficiently understood. This review will synthesise evidence on the impact of mistreatment on perinatal mental health, identify critical gaps and advocate for systemic change.

    Methods and analysis

    This systematic review and meta-analysis protocol complies with the guidelines set forth by the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. A thorough literature search will be executed across multiple electronic databases, including CINAHL—Cumulative Index to Nursing and Allied Health Literature, Embase via Ovid, MEDLINE, PsycInfo, PubMed, Scopus, as well as other significant or specialised databases and grey literature. The review will incorporate only non-randomised study types and observational studies (cohort, cross-sectional, case-control), along with mixed-method and qualitative studies. Abstract and full-text screening will be performed by two reviewers using Covidence. The methodological quality of the included studies will be assessed using the Newcastle-Ottawa Scale for observational studies, the Risk of Bias in Non-Randomised Studies of Interventions, the Critical Appraisal Skills Programme and the Mixed Methods Appraisal Tool. Statistical heterogeneity will be evaluated using the Higgins test. Meta-analysis will be conducted using R statistical software V.4.4.4, employing random effects models to determine the weights. The study results will be reported sequentially, beginning with primary outcomes, followed by secondary outcomes and significant subgroup outcome analyses.

    Ethics and dissemination

    Ethical approval is not required as no original data will be collected. The findings of this review will be disseminated through publication and conference presentations.

    PROSPERO registration number

    CRD420251044379.

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