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☐ ☆ ✇ BMJ Open

Longitudinal investigation of psychological outcomes associated with screen use in Danish preschool children: study protocol for The Digital Child

Por: Nygaard · M. · Olsen · M. F. · Thomsen · M. M. W. · Hadi · N. H. A. · Trans · K. L. · Horwood · S. · Flensborg-Madsen · T. — Septiembre 3rd 2025 at 13:33
Introduction

Despite an increasing use of screens among preschool children and evidence suggesting potential adverse effects, there is a paucity of longitudinal research that aims to disentangle the multifaceted components of screen use and their unique associations with development. We present a protocol for a large-scale national longitudinal study with repeated measurements in Danish preschool children, with the aim of investigating the cross-sectional and cross-lagged longitudinal associations between screen use and psychological outcomes.

Methods and analysis

The Digital Child Study is a national prospective observational cohort of Danish preschool children. Baseline parent-report data collection commenced in 2024 via online questionnaires, and in total will include three time points over 1 year: baseline (age 4 years), and follow-ups at 6 and 12 months (ages 4.5 and 5 years). Participants were divided into two waves based on birth dates, starting in March and September 2024. Recruitment targeted parents and primary caregivers of all Danish children born between specific dates in 2020. Of 30 235 children whose parents were sent invitations, baseline questionnaire data were available for 11 690 (39%).

Children’s screen use was measured by detailed information of amount, content and timing of children’s screen use, and the broader context, incorporating parental mediation strategies, attitudes, motivations and practices. Cognitive and socioemotional developmental outcomes were measured using validated tools such as the Strengths and Difficulties Questionnaire, the Nordic Five-to-Fifteen parent questionnaire and the Behaviour Rating Inventory of Executive Function—Preschool Version. Questionnaire data will be linked to national social and health registries to enable long-term follow-up. Statistical analyses will include longitudinal modelling to explore associations between screen use and developmental outcomes, with sensitivity analyses for robustness. The study’s large sample size provides high statistical power to detect meaningful effects.

Ethics and dissemination

The study adheres to ethical research guidelines, ensuring voluntary participation, confidentiality and compliance with data protection laws, with approvals from relevant authorities. Findings will be disseminated through peer-reviewed publications, conferences and plain-language summaries to engage stakeholders and the broader community.

☐ ☆ ✇ BMJ Open

Pragmatic, multicentre, factorial, randomised controlled trial of sepsis electronic prompting for timely intervention and care (SEPTIC trial): a protocol

Por: Ranard · B. L. · Qian · M. · Cummings · M. J. · Zhang · D. Y. · Lee · S. M. · Beitler · J. R. · Applebaum · J. R. · Schenck · E. J. · Mohamed · H. · Trepp · R. · Hsu · H. · Scofi · J. · Southern · W. N. · Rossetti · S. C. · Yip · N. H. · Brodie · D. · Sharma · M. · Fertel · B. S. · Adelman — Agosto 12th 2025 at 03:13
Introduction

Sepsis is a major cause of death both globally and in the United States. Early identification and treatment of sepsis are crucial for improving patient outcomes. International guidelines recommend hospital sepsis screening programmes, which are commonly implemented in the electronic health record (EHR) as an interruptive sepsis screening alert based on systemic inflammatory response syndrome (SIRS) criteria. Despite widespread use, it is unknown whether these sepsis screening and alert tools improve the delivery of high-quality sepsis care.

Methods and analysis

The Sepsis Electronic Prompting for Timely Intervention and Care (SEPTIC) master protocol will study two distinct populations in separate trials: emergency department (ED) patients (SEPTIC-ED) and inpatients (SEPTIC-IP). The SEPTIC trials are pragmatic, multicentre, blinded, randomised controlled trials, with equal allocation to compare four SIRS-based sepsis screening alert groups: no alerts (control), nurse alerts only, prescribing clinician alerts only, or nurse and prescribing clinician alerts. Randomisation will be at the patient level. SEPTIC will be performed at eight acute-care hospitals in the greater New York City area and enrol patients at least 18 years old. The primary outcome is the percentage of patients with completion of a modified Surviving Sepsis Campaign (SSC) hour-1 bundle within 3 hours of the first SIRS alert. Secondary outcomes include time from first alert to completion of a modified SSC hour-1 bundle, time from first alert to individual bundle component order and completion, intensive care unit (ICU) transfer, hospital discharge disposition, inpatient mortality at 90 days, positive blood cultures (bacteraemia), adverse antibiotic events, sepsis diagnoses and septic shock diagnoses.

Ethics and dissemination

Ethics approval was obtained from the Columbia University Institutional Review Board (IRB) serving as a single IRB. Results will be disseminated in peer-reviewed journal(s), scientific meeting(s) and via social media.

Trial registration number

ClinicalTrials.gov: NCT06117605 and NCT06117618.

☐ ☆ ✇ BMJ Open

Food environment of traditional peoples and communities: a scoping review protocol

Por: Barbosa · B. B. · Tavares · N. H. C. · Adriano · L. S. · Mendes · L. L. · Carioca · A. A. F. — Julio 30th 2025 at 11:57
Introduction

Traditional peoples and communities (TPCs), such as indigenous peoples and quilombolas (communities descended from escaped African slaves), face challenges related to food security and the impact of the food environment on their health. Changes in food systems, urbanisation and loss of territorial rights have contributed to less healthy eating patterns, with increased consumption of ultra-processed foods and a higher prevalence of chronic non-communicable diseases. Despite this, there are gaps in knowledge about how the food environments of these communities are investigated, especially in relation to the physical, economic, political and sociocultural dimensions.

Methods and analysis

This scoping review will be conducted following the methodological framework developed by the Joanna Briggs Institute for scoping reviews, and its reporting will adhere to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Extension for Scoping Reviews checklist. A systematic search will be carried out in the following databases: PubMed, SciELO, Web of Science, Embase and EBSCO, using terms related to traditional populations and food environments. The studies to be included will be selected according to the inclusion and exclusion criteria defined based on the population, concept and context technique. The study population will include TPCs, such as indigenous peoples and quilombolas; the concept will address the food environment in its physical, economic, political and sociocultural dimensions; and the context will encompass studies conducted at a global level, without any restrictions on geographic location. The study type will include original articles and grey literature. The screening of studies will involve independent reviewers and predefined inclusion and exclusion criteria. Data synthesis will be presented in tables, including information on focus, geographic scope and methodology of the selected studies. The risk of bias will be assessed using the Risk of Bias in Non-randomised Studies of Exposure tool.

Ethics and dissemination

As the study does not involve the collection of primary data or human participants, it does not require ethical approval. The results will be submitted to peer-reviewed journals and presented at public health and nutrition conferences, contributing to the advancement of knowledge on food environments of TPCs.

☐ ☆ ✇ BMJ Open

Effect of nature-based health interventions for individuals diagnosed with anxiety, depression and/or experiencing stress--a systematic review and meta-analysis

Por: Jessen · N. H. · Lovschall · C. · Skejo · S. D. · Madsen · L. S. S. · Corazon · S. S. · Maribo · T. · Poulsen · D. V. — Julio 24th 2025 at 09:15
Objectives

The use of natural environments and nature activities as elements in the treatment and rehabilitation of mental health challenges is gaining international attention. The objective of the present review was to summarise the knowledge on the effects of nature-based health interventions (NBHIs) targeting individuals diagnosed with anxiety, depression and/or experiencing stress.

Design

Systematic review and meta-analyses. The quality and certainty of evidence were assessed using the SIGN and GRADE.

Data sources

Searches were performed in Embase, MEDLINE, PsycINFO, CINAHL, Cochrane and Web of Science.

Eligibility criteria

(1) NBHIs, (2) Individuals with a diagnosis of mild to moderate anxiety, depression and/or experiencing stress, (3) Age of participating individuals: 18–84 years, (4) Study designs: randomised controlled trials, cohort studies, case-control studies and case-series studies and (5) Publication date: 2000–2024.

Data extraction and synthesis

Screening, quality appraisal and certainty of evidence, assessed using SIGN and GRADE, were performed by two independent reviewers, except title screening. Meta-analyses were performed using random-effect models.

Results

Nineteen articles were included, of which 14 were included in the meta-analyses. The articles showed substantial variation in design, interventions, settings and risk of bias, limiting the certainty of evidence according to GRADE. Participating in NBHIs led to a small to large effect in mental health with standardised mean changes of –0.80 (95% CI= (–1.56; –0.04)), –0.87 (95% CI= (–1.18; –0.56)), –0.32 (95% CI= (–0.74; 0.09)) and 0.58 (95% CI= (0.39; 0.77)) for anxiety, depression and stress scores and overall mental health scores, respectively.

Conclusions

This is the first systematic review examining the effect of NBHIs exclusively on individuals diagnosed with anxiety, depression and/or experiencing stress. Our findings suggest small to large improvements after participating in NBHIs. However, methodological limitations to the included articles necessitate cautious interpretation.

PROSPERO registration number

CRD42024516270.

☐ ☆ ✇ BMJ Open

Implementation and effectiveness of a nurse-enabled, shared-care follow-up model for early breast cancer survivors (The IBIS-Survivorship Study): protocol for a stepped-wedge cluster randomised trial

Por: Chan · R. J. · Crawford-Williams · F. · Koczwara · B. · Mann · G. B. · Eakin · E. · Turner · J. · Krishnasamy · M. · Collins · L. G. · Skerman · H. · Hemming · K. · Hart · N. H. · Emery · J. · Crowe · B. · Patford · K. · Mahony · J. · Kristunas · C. · Blanchard · G. · Healey · L. · Sanmuga — Junio 19th 2025 at 11:29
Introduction

Breast cancer is the most commonly diagnosed cancer among women worldwide. Survivors often experience physical and psychological effects arising from breast cancer and its treatment, which can last months and years, adversely impacting quality of life. As the number of early breast cancer survivors increases, models of specialist-led follow-up care in hospital settings are not sustainable and evidence suggests that they may not meet survivors’ needs. Nurse-enabled, shared-care, follow-up models between cancer specialist and primary care teams have potential to address this need.

Methods and analysis

The proposed research is a multicentre, prospective, pragmatic, stepped-wedge cluster-randomised trial designed to test the effectiveness and implementation of IBIS-Survivorship, a follow-up care model for patients with early breast cancer who have completed primary treatment. The IBIS-Survivorship intervention involves a nurse-led consultation, development of a Survivorship Care Plan and case-conferencing between a breast care nurse and the patient’s primary care provider. This study seeks to recruit 1079 breast cancer survivors across six cancer centres (clusters) in Australia. Health-related quality of life at 12 months assessed by the Functional Assessment of Cancer Therapy - Breast Cancer questionnaire will be the primary endpoint, along with a range of patient-reported outcomes, safety indicators and cost-effectiveness measures as secondary endpoints. General and generalised linear mixed models will be used to assess the effectiveness of the intervention versus usual care. Implementation and process outcomes will be assessed using the Reach Effectiveness Adoption Implementation Maintenance framework.

Ethics and dissemination

Ethical approval was provided by the Metro South Hospital and Health Service Human Research Ethics Committee (HREC/2020/QMS/59892) and reciprocally across the other five trial sites under National Mutual Acceptance arrangements. Results will be disseminated through peer-reviewed academic journal publications and presentations at national and international conferences.

Trial registration

Australia and New Zealand Clinical Trials Registry (ANZCTR) Trial ID: ACTRN12621000188831.

☐ ☆ ✇ BMJ Open

Efficacy of oral nutrition supplementation enriched with hydroxymethylbutyrate (HMB) and undenatured type-II collagen (UC-II) combined with exercise training on osteoarthritis-related outcomes among adults with knee osteoarthritis in Klang Valley of Malay

Por: Yap · A. X. W. · You · Y. X. · Ajit Singh · D. K. · Mat · S. · Chong · C. P. · Mohamad Yahaya · N. H. · Maktar · J. F. · Abdul Rani · R. · Ooi · T. C. · Ismail · M. · Shahar · S. · Han · W. C. · Kwan · L. K. · Centhyea · C. — Junio 19th 2025 at 11:29
Introduction

Knee osteoarthritis (OA) is a serious public health problem since it is linked to loss of muscular function and independence, especially in older adults. In this study, the researchers have proposed a randomised controlled trial with a three-arm study strategy to explore the effectiveness of an oral nutritional supplementation containing hydroxymethylbutyrate and undenatured type-II collagen combined with exercise training (ET) on the OA-related symptoms and biomarkers among adults with knee OA.

Methods and analysis

Adults with knee OA aged between 50 years and 75 years will be invited to participate in the study and thereafter will be randomly assigned to either one of three groups: oral nutrition supplementation+ET, ET or usual care. The primary outcomes include changes in OA-related symptoms and biomarkers. The secondary outcomes include changes in body composition, blood profiles, physical fitness, quality of life, dietary intake, disability, psychology status and morphological changes of the knee.

Ethics and dissemination

Ethics approval was granted by the Medical Research Ethics Committee of the National University of Malaysia (reference number JEP-2024–264). Findings of this study will be disseminated via peer-reviewed presentations at scientific conferences as well as open access publications.

Trial registration number

ISRCTN14284561.

☐ ☆ ✇ International Wound Journal

Local wound care management for pyoderma gangrenosum

Abstract

Pyoderma gangrenosum (PG) is a rare, painful neutrophilic dermatosis characterized by rapidly progressing skin ulcers. Despite the importance of local wound care in managing PG, there is no consensus or evidence-based guidelines. This systematic review aimed to investigate local wound care strategies for PG. A comprehensive search of Embase, MEDLINE, and the Cochrane Library yielded 1213 references, from which 269 studies were included, covering 351 patients. The most reported treatment methods included sharp debridement (11%), topical corticosteroids (27%) and non-adherent dressings (12%). However, no clear correlation between these treatments and healing outcomes was found likely due to confounding factors such as varied wound sizes, superinfection and inconsistent reporting. Additionally, directed wound care regimens have not been able to show statistical significance for healing outcomes. Our study describes the current local wound care landscape and underscores a critical gap in the current literature regarding standardized treatment protocols for PG.

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