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AnteayerInterdisciplinares

Determinants and implementation strategies to implement a reflection method for guideline-based informal caregiving in community nursing in the Netherlands: a mixed-method study

Por: Vullings · N. · Maas · M. · Adriaansen · M. · Vermeulen · H. · Van der Wees · P. · Heinen · M.
Aim

This study aims to identify key determinants and strategies for effectively implementing a reflection method to support adequate use of the ‘Informal Care’ guideline within community nursing. The SPARK (Self & Peer Assessment to Reflect on Quality Standards) reflection method, developed in an earlier participatory design-based study, is a structured group reflection approach designed to help nurses and nursing assistants reflect on and apply guideline recommendations in daily practice.

Design

A mixed method study.

Setting

Six community care organisations in the Netherlands.

Participants and interventions

This mixed-method study collected qualitative data through observations and video recordings of group meetings with community nurses, nursing assistants and a patient representative, alongside quantitative questionnaires. This project included design and test group meetings to develop and evaluate prototypes of the reflection method. Observations were discussed, and video recordings were thematically analysed. The Measurement Instrument for Determinants of Innovations questionnaire was used to identify key determinants for effective implementation. The questionnaire results were analysed descriptively, using the Tailored Implementation in Chronic Diseases (TICD) framework to present preliminary determinants for validation. Implementation strategies were then selected in a group meeting. Based on this input, the research group operationalised the selected implementation strategies.

Results

Twenty-nine determinants for implementing the reflection method were identified across seven TICD domains, including barriers such as limited support, knowledge and time, and facilitators such as team collaboration and prevention of caregiver overload. Based on these findings, three implementation strategies, namely knowledge enhancement, coaching development and leadership strengthening, were formulated to support integration into community nursing practice.

Conclusion

This study identified key determinants and strategies for implementing a reflection method in community nursing. While several determinants align with existing literature, context-specific determinants related to the heterogeneous group of registered nurses and certified nursing assistants also emerged. Strengthening guideline knowledge, coaching competencies and leadership is essential for sustainable, guideline-based reflection in practice.

Using participatory methods to develop a narrative intervention to alleviate distress in children hospitalised with TB in South Africa: The DIMPle project

by Caitlin D. October, Dzunisani P. Baloyi, Lario Viljoen, Rene Raad, Dillon T. Wademan, Megan Palmer, Juli Switala, Michaile G. Anthony, Karen Du Preez, Petra De Koker, Anneke C. Hesseling, Bronwyne Coetzee, Graeme Hoddinott

Children who are hospitalised for tuberculosis (TB) experience challenges that put them at risk of developing emotional, behavioural, and social difficulties. In this methodological paper, we showcase the development of a narrative intervention toolkit with key components of the resulting version 1.0 tool. The study design was participatory and pragmatic, with researchers working with the routine staff of TB hospital wards, children admitted and their caregivers, to iteratively understand and improve children’s experiences of hospitalisation. The project included three phases: (1) a situational analysis to map children and healthcare providers’ perspectives on priorities and potential intervention components, (2) co-development of a beta-version of the intervention, and (3) piloting and incremental refinement toward a version 1.0 of the intervention. The intervention toolkit combined a series of activities alongside the story of ‘Courageous Curly’ to facilitate children’s engagement with their own experiences of hospitalisation, including psychosocial and treatment challenges, captured, and described throughout data collection. We found that dividing the story into short chapters facilitated children’s engagement with the section of story that is being told on a specific day. Each chapter of the story follows/mimics a different stage children can expect during their treatment journey while hospitalised for TB care. Implementation and evaluation of such interventions can mitigate the psychosocial impact of TB in children and inform policies to improve their overall TB care.

Interventions to enhance medication therapy safety in older patients with cognitive impairment--protocol of a systematic review with public involvement

Por: Jungreithmayr · V. · Terstegen · T. · Eidam · A. · Rastätter · S. · Benzinger · P. · Seidling · H. M.
Introduction

Cognitive impairment is considered a challenge in medication management for both the affected patient as well as their caregiver. Numerous studies have investigated interventions aiming to improve medication therapy safety in this population; however, there is insufficient knowledge on interventions which support patients and caregivers effectively. The aim of this systematic review is to (1) identify interventions to improve medication therapy safety in older patients with cognitive impairment, and (2) to evaluate their effectiveness.

Methods and analysis

We will conduct a systematic review of literature with participatory elements of public involvement in every step of the process. Five literature databases (PubMed, CENTRAL, Embase, PsycINFO and CINAHL) will be screened to identify interventions to improve medication therapy safety in older (≥65 years of age) adults with cognitive impairment. To support methodology and evidence synthesis, we will conduct expert panel discussions as well as focus group discussions of caregivers and healthcare professionals. Study selection, data extraction and bias assessment will be conducted independently by two reviewers. For data synthesis, studies will be organised by setting (eg, community setting, hospital setting, nursing home setting).

Ethics and dissemination

The responsible Ethics Committee of the Medical Faculty of Heidelberg granted approval for the public involvement strategies in this project (S-562/2024). Results will be presented by publication in an academic journal and at scientific conferences.

PROSPERO registration number

CRD42024623352.

HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to study the (cost-)effectiveness of laparoscopic hernia repair compared to open hernia repair in children 0-16 years

Por: Maat · S. C. · de Vreeze · L. E. · Eurlings · R. · Anema · J. · Van Baren · R. · Been · J. V. · van den Broek · F. · Cakir · H. · van Dongen · J. M. · Ferenschild · F. · de Graaf · J. · Nijveldt · R. · Ottenhof · A. · Ploeg · A. J. · Rippen · H. · Ruiterkamp · J. · Twisk · J. W. R. · Ver
Introduction

Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.

Methods and analysis

A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.

Ethics and dissemination

The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.

Trial registration number

ClinicalTrials.gov PRS (ID NCT06451432).

Extracorporeal Shockwave Therapy for Diabetes Related Foot Ulcers: A Pilot Three‐Arm Double‐Blinded Randomised Controlled Trial

ABSTRACT

There is an urgent need for effective interventions to aid diabetes-related foot ulcer (DFU) healing. This study aimed to test the deliverability of a proposed trial of extracorporeal shockwave therapy (ESWT) for DFU healing. A pilot double-blinded randomised controlled trial. Patients with a DFU present for ≥ 4 weeks were randomised to high dose (500 shocks/cm2), low dose (100 shocks/cm2) or sham (0 shocks/cm2) ESWT, plus standard care. Follow-up was for 24 weeks. Primary outcome was deliverability of the trial. Secondary outcomes were healing, quality of life and healthcare resource use. One-hundred and forty-one (15.6%) screened patients were eligible and 74 (52.5%) patients were recruited. Follow-up attendance was 97.3% (72/74), 93.2% (69/74) and 87.8% (65/74) at 6, 12 and 24 weeks. The median DFU healing time was high dose: 54.0 (IQR 119.0), low dose: 78.5 (IQR 61.0) and sham: 83.0 (IQR 85.0) days. The mean EQ-5D-5L utility value at 24 weeks was high dose: 0.621 (95% CI 0.438–0.804), low dose: 0.779 (95% CI 0.683–0.876) and sham: 0.806 (95% CI 0.717–0.895). Healthcare resource use was lowest in the low-dose ESWT arm. The pilot trial has demonstrated that patients with a DFU are willing to engage in the proposed trial and suggest the optimal way to deliver the definitive trial.

Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy--Px7 The study protocol of a multicentre binational randomised controlled trial

Por: Agache · A. · Deding · U. · Kaalby · L. · Kobaek-Larsen · M. · Al-Najami · I. · Ostergaard Hansen · L. · Stryhn · C. · Wilde · D. · Forsberg · A. · Backman · A.-S. · Bates · T. · de Lange · T. · Martling · A. · Baatrup · G.
Introduction

A large bowel cancer chemoprevention potential has been demonstrated by the consumption of carrots, which represent the major dietary source of polyacetylenes. Their interaction with cancer cells and enzyme systems of animals and humans has been systematically investigated over the last 15 years and has now been characterised as anti-inflammatory compounds with antineoplastic effect. Our objective is to investigate whether selected carrot species with a high content of the polyacetylenes falcarinol (FaOH) and falcarindiol (FaDOH) prevent neoplastic transformation and growth in humans, without side effects.

Methods and analysis

We will conduct a multicentre prospective binational (Denmark and Sweden) randomised controlled trial, with the aim to test the clinical effects of adjuvant treatment with carrot juice in patients who had an excision of high-risk colon adenomas. Patients from six centres will be randomised to receive either anti-inflammatory juice made of carrots high in FaOH and FaDOH or placebo. We will compare the proportion of participants with recurrent adenoma and mean size of them, found in the 1-year follow-up colonoscopy between the two randomised groups.

Ethics and dissemination

Informed written consent will be obtained from all participants before randomisation. The study was approved by the regional ethics committee in Denmark (ref. S-20230072) and Sweden (ref. 2024-04732-01). After completion of the trial, we plan to publish two articles in high-impact journals: one article on primary and secondary outcomes, respectively.

Trial registration number

NCT06335420.

Reducing decisional conflict in COVID-19 vaccination in ethnocultural communities through sensemaking: a participatory action mixed-methods study

Objective

To examine how cultural health brokers, as trusted intermediaries between formal systems and diverse ethnocultural communities, help navigate decisional conflict and misinformation regarding COVID-19 vaccination and to identify how their work contributes to system resilience in crisis contexts.

Design

A community-based participatory action sensemaking research project to capture the real-time work of cultural health brokers in helping people navigate decisional conflict for vaccination.

Setting, participants

Multicultural Health Broker Cooperative in Edmonton, Alberta where brokers speak 54 languages and serve more than 10 000 people from diverse ethnolinguistic communities. 28 cultural health brokers (9 male; experience 4–25 years) contributed to data collection and analysis between 16 September 2021 and 16 December 2021.

Data collection and analysis

The brokers captured real-time reflections and self-interpretations in the SenseMaker platform through a theoretically informed, codesigned, mixed-method data collection tool. The team engaged in 13 weekly, 90 minute, audio-recorded and transcribed sessions: seven focused on understanding and action planning and five reflecting on the SenseMaker data, the focus of the thematic analysis. Data were managed in NVivo (QSR International, Version 12, 2018).

Results

Brokers collected 277 narratives and conducted 13 sensemaking sessions. Understanding and purpose were identified in 68% of narratives as key to achieving coherence; 81% of narratives highlighted trust as crucial to what was needed for action; 62% of narratives reflected on a potential risk, with loss of trust a concern in 70% of them. A rich understanding of the sources of decisional conflict and misinformation was achieved and managed through outreach. There were four entwined components to navigation of the evolving complexity of COVID-19 vaccination: (1) building and sustaining trust; (2) strengthening relationships; (3) creating safe spaces for collective sensemaking and solution finding; and (4) leveraging cultural and social capital to address barriers. Through these mechanisms, brokers reduced decisional conflict and misinformation, supporting informed, values-congruent decisions.

Conclusions

Cultural health brokers, embedded within communities and linked to formal systems, play a critical role in crisis response by fostering trust, mobilising resources and enabling collective sensemaking. This study demonstrates how these intermediaries’ contextually and culturally attuned work provides a model for building system resilience for future crisis response.

Barriers and challenges for preventing inpatients falls in tertiary healthcare facilities following the COVID-19 pandemic: a scoping review protocol

Por: Mohd Noor · J. · Jamil · M. F. A. · Abdul Hamid · N. · Chong · E. G. M. · Ling · J. N. · Subramaniam · S. · Lai · W. H. · Muhamad · N. A.
Introduction

Hospital patients are at an increased risk of falls, which are a significant safety concern within healthcare settings.1 Understanding how the COVID-19 pandemic has influenced fall risks is essential for identifying key factors that could inform future fall prevention strategies.2 This scoping review aims to explore the barriers and challenges associated with preventing inpatient falls in the context of the post-COVID-19 environment.

Methods and analysis

The methodology for this scoping review follows the framework established by Arksey and O’Malley. A comprehensive literature search will be conducted using specific keywords to identify relevant published studies. Searches will be performed across selected electronic databases, including PubMed/MEDLINE, CINAHL, Scopus, ProQuest and Web of Science, covering publications from 2014 to 2024. This review will focus on a global perspective. Two authors will independently screen titles and abstracts to identify potential studies for inclusion. Studies meeting the inclusion criteria will be retrieved for full-text review, and their references will be assessed for relevance using the same criteria. The PRISMA flow diagram will guide the review process. Data will be extracted, analysed and charted according to categories from the selected publications.

Ethics and dissemination

This scoping review will provide a comprehensive overview of the barriers and challenges in preventing inpatient falls in the post-pandemic context. The findings will be disseminated through submission for publication in a scientific journal.

Registration details

This scoping review protocol is registered with Open Science Framework (OSF) available at https://osf.io/.

Little ears - Aboriginal programmes for hearing and EAR screening (LEAP - HEAR): a research protocol for co-design workshops to strengthen programmes

Por: Mealings · K. · Halvorsen · L. · Nash · K. · MacQueen · D. · Ward · K. · McMahon · C. M.
Introduction

Multiple well-considered but siloed initiatives and programmes exist in Australia to support ear and hearing screening and assessment for Indigenous children. However, the lack of coordination of these programmes leads to inefficiencies in resource allocation and disrupts opportunities to implement a cost-effective, efficient, and easily navigable system of care. Indigenous children experience high prevalence rates of middle ear disease, as well as earlier onset, increased severity and longer infections compared with non-Indigenous children. The aims of this study are to: (1) Understand current ear and hearing screening programmes in three New South Wales communities and evaluate their strengths and limitations, (2) Strengthen, implement and evaluate ear and hearing screening programmes and (3) Identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

Methods and analysis

A series of desktop searches and co-design workshops will be completed to achieve aim (1) and (2) and the results will be mapped into work-as-done and work-as-imagined using the Functional Resonance Analysis Method. Strengthened screening programmes will be implemented in communities using the criteria from national and international guidance documents and the Practical, Robust, Implementation and Sustainability Model and evaluated. Finally, workshops will be conducted with key stakeholders to identify the barriers and facilitators for scaling strengthened ear and hearing screening programmes nationally and the importance and feasibility of each factor.

Ethics and dissemination

This project has received ethics approval from the Aboriginal Health and Medical Research Council Human Research Ethics Committee (Ref: 2350/24). Results will be disseminated to the community through the CEOs of the Aboriginal Community Controlled Health Organisations as well as published in peer-reviewed journals and presented at conferences. The findings from data collected will be used to inform the co-production of an enhanced system for ear and hearing care.

Barriers and challenges in preventing falls among community-dwelling patients with dementia: a scoping review protocol

Por: Jamil · M. F. A. · Mohd Noor · J. · Abdul Hamid · N. · Chong · E. G. M. · Ling · J. N. · Subramaniam · S. · Lai · W. H. · Muhamad · N. A.
Introduction

Falls are highly prevalent among individuals with dementia, largely due to the cognitive and physical impairments associated with the condition. Understanding the barriers and challenges to fall prevention in community-dwelling individuals with dementia is essential for developing tailored strategies that address their unique risks. Despite the existing evidence on fall prevention in older adults, few reviews specifically examine the obstacles faced by persons with dementia and their caregivers in community settings. This scoping review, therefore, aims to map the barriers and challenges to preventing falls among community-dwelling individuals with dementia.

Methods and analysis

This review will follow Arksey and O’Malley’s five-stage framework and be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews checklist. Six electronic databases (PsycINFO, PubMed, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Scopus and Embase) will be searched for relevant studies published between 2014 and 2024. Grey literature sources, including dissertations and conference proceedings, will also be included. Data will be charted and synthesised thematically to provide an overview of barriers and contextual factors influencing fall prevention. The study commenced in August 2025 and is expected to be completed by February 2026.

Ethics and dissemination

As this review involves the analysis of existing literature, ethical approval is not required. Findings will be disseminated through peer-reviewed publications, conference presentations and summaries tailored for healthcare providers and caregiver groups.

Registration details

The protocol is registered with the Open Science Framework: https://osf.io/gnw47/(dataset).

Short- and long-term complications after slowly resorbable biosynthetic P4HB mesh (Phasix) implantation in European centres: a protocol paper for a multiregistry study

Background

Phasix mesh is a fully resorbable synthetic mesh for use in clean and contaminated ventral incisional hernia repairs. Long-term absorbable Phasix mesh appears to be a safe and promising device in incisional hernia repair, with low recurrence rates; however, data on long-term complications after surgery, particularly after the resorption period of the mesh, are scarce.

Methods and analysis

This protocol describes a study of several European registries on the use of a Phasix mesh in incisional hernia repair. The primary endpoint of the study is long-term complications at 2–5 year follow-up after mesh implantation, with secondary endpoints including hernia recurrence and complications during short-term follow-up.

Ethics and dissemination

Ethical approval was not required for this protocol as the study is based on anonymised registry data collected with prior patient consent in each registry. Each participating registry has its own ethical approval process, and this study will adhere to those regulations. The results will be disseminated through peer-reviewed publications and conference presentations.

Use of electronic point-of-care resources by early-career general practitioners and associations with their use during consultations: A cross-sectional analysis of consultation data.

Por: Mitchell · B. · Magin · P. · van Driel · M. L. · Tapley · A. · Ralston · A. · Davey · A. · Holliday · E. · Dizon · J. · Moad · D. · Fielding · A. · Fisher · K. · Clarke · L. · Spurling · G.
Objectives

To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.

Design

Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.

Setting

Australian training general practices.

Participants

3024 GP trainees in community-based vocational training.

Primary and secondary outcome measures

The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.

Results

A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.

Conclusions

Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.

Global, regional, and national burden of endometriosis among women of reproductive age, 1990–2021: Insights from the global burden of disease study 2021

by Jun Zhang, Mengduan Pang, Ling Li, Chuanjia Guo

Background

Endometriosis is a common gynecological disorder among women of reproductive age worldwide. This study aims to examine global patterns of endometriosis disease burden among reproductive-aged women and to evaluate its correlation with socioeconomic development indices.

Methods

This study conducted a comprehensive analysis of endometriosis disease burden using epidemiological parameters from the Global Burden of Disease (GBD) 2021 database, including incidence rates, prevalence rates, Disability-Adjusted Life Years (DALYs), and corresponding age-standardized rates. Through stratified analyses at global, regional, and national levels, we systematically evaluated the disease burden patterns among reproductive-aged women and performed correlation analysis with socioeconomic development indices.

Results

We found that the highest incidence of endometriosis among women of reproductive age globally occurs in the 20–24 age group, with an incidence rate of 399.49 per 100,000 in 1990 and 304.31 per 100,000 in 2021. The results show that the global disease burden of endometriosis is mainly influenced by population size, followed by epidemiological changes. Compared to countries with a medium Social Development Index (SDI), the disease burden of endometriosis in low and high SDI regions fluctuated significantly from 1990 to 2021. In most countries with SDI values between 0.2 and 0.6, the burden of endometriosis showed a gradual decline.

Conclusion

Endometriosis remains a significant public health issue for women of reproductive age globally. Although the global disease burden of endometriosis among women of reproductive age showed a slight decline from 1990 to 2021, the disease burden continues to fluctuate in certain regions and countries. In light of the differences in the disease burden of endometriosis across regions and countries, regionalized disease management strategies are expected to be developed in the future.

Quantitative proteomic analysis reveals key proteins involved in radiation-induced brain injury

by Jing Liu, Junshuang Wang, Shuang Lv, Hengjiao Wang, Defu Yang, Ying Zhang, Ying Li, Huiling Qu, Ying Xu, Ying Yan

Objective

Radiation-induced brain injury (RIBI) is a significant complication following radiotherapy for brain tumors, leading to neurocognitive deficits and other neurological impairments. This study aims to identify potential biomarkers and therapeutic targets for RIBI by utilizing advanced proteomic techniques to explore the molecular mechanisms underlying RIBI.

Methods

A rat model of RIBI was established and subjected to whole-brain irradiation (30 Gy). Tandem mass tagging (TMT)-based quantitative proteomics, combined with high-resolution mass spectrometry, was used to identify differentially expressed proteins (DEPs) in the brain tissues of irradiated rats. Gene Ontology (GO) enrichment and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway analyses were conducted to identify the biological processes and pathways involved. Protein-protein interaction (PPI) networks were constructed to identify key hub proteins.

Results

A total of 35 DEPs were identified, including PHLDA3, APOE and CPE. GO enrichment analysis revealed that the DEPs were mainly involved in lipid transport, cell adhesion, and metabolic processes. KEGG analysis highlighted the enrichment of pathways related to metabolism, tight junctions, and PPAR signaling. APOE was identified as a key hub protein through PPI network analysis, indicating its potential role in RIBI pathophysiology. Immunohistochemistry further validated the increased expression of PHLDA3, APOE, and CPE in the brain tissue of irradiated rats.

Conclusion

This study provides valuable insights into the molecular mechanisms of RIBI by identifying key proteins and their associated pathways. The findings suggest that these proteins, particularly APOE and PHLDA3, could serve as potential biomarkers and therapeutic targets for clinical intervention in RIBI. These results not only enhance our understanding of RIBI’s molecular pathology but also open new avenues for the development of targeted therapies to mitigate radiation-induced neurotoxicity.

Long-term recovery from post-traumatic neck pain: protocol for a prospective cohort study in the emergency department

Por: Lynaes · C. · Ravn · S. L. · Skou · S. T. · Mogensen · C. B. · Arvig · M. D. · Christensen · S. W. M. · Sterling · M. · Andersen · T. E.
Introduction

Post-traumatic neck pain is common, representing a substantial human and societal burden. About 15%–25% of individuals involved in an accident causing whiplash continue to experience moderate-to-severe symptoms and functional impairment 1 year post-trauma. Factors such as age, high pain intensity, hypersensitivity to pain and early post-traumatic hyperarousal are associated with persistent neck pain. However, multiple questions remain unanswered regarding how best to improve early care. As such, research on recovery patterns (including indicators for health economic burden) and their predictors is still needed, including biomarkers for pre-traumatic and peri-traumatic stress, and the value of early prediction tools.

Methods and analysis

This prospective cohort study will include 100 participants (18 years) suffering from post-traumatic neck pain sustained within 72 hours of an accident. At baseline (a combination of inclusion and 1 week assessment), eligible participants will undergo a thorough evaluation, including assessment of descriptive characteristics, self-reported variables (eg, pain, disability, sleep quality and post-traumatic stress), biomarkers (eg, heart rate variability (HRV) and hair cortisol) and clinical tests (eg, cervical range of motion). Follow-up will be conducted at 3, 6 and 12 months post-trauma. Further, register data (eg, data on labour market attachment) will be added for the period. Among other methods, a receiver operating characteristic (ROC) curve and multivariable regression analyses will be used to evaluate performance and associations of the prediction tools and their associations with measures of HRV.

The sample size calculation is based on previous studies, estimating that 15% of participants will develop moderate-to-severe ongoing symptoms. Using a conservative estimate, 64 participants are needed to achieve a statistical power of 90% with an expected area under the curve of 0.80. Accounting for a 25% loss to follow-up, 80 participants are required. For regression analysis, 100 participants will be included. The prediction tool will be validated using ROC analysis, sensitivity and specificity. Logistic regression models will be performed with and without biomarkers and pain sensitivity. Health economic costs will be compared across groups. Multivariable regression will examine the link between HRV and post-traumatic stress disorder, adjusting for confounders and a moderation analysis will assess hair cortisol as a potential moderator.

Ethics and dissemination

The study is approved by the Regional Committee on Health Research Ethics of Southern Denmark (S-20230037). Due to the acute nature of recruitment, the study design does not allow for a 24-hour reflection period; however, this approach has been approved by the Committee.

Study results will be published in peer-reviewed journals and disseminated through non-scientific outlets, including patient and professional publications, press releases and social media. If effective, workshops for clinicians will be organised. Results will be published regardless of outcome, with coauthorships following ICMJE guidelines.

Trial registration number

NCT06176209.

Integrated knowledge translation (iKT) in preclinical research: A scoping review protocol

by Georgia Black, Reena Besa, Daniel Blumberger, Heather Brooks, Graham Collingridge, John Georgiou, Evelyn K. Lambe, Clement Ma, Bernadette Mdawar, Tarek K. Rajji, Sanjeev Sockalingam, Cara Sullivan, Quincy Vaz, Zhengbang Yao, Branka Agic

Introduction

Integrated knowledge translation (iKT) is a collaborative research approach that emphasizes the meaningful and active participation of knowledge users throughout the research process. Evidence suggests that integrated knowledge translation has the potential to increase the relevance, applicability, and use of research findings. This approach has been increasingly utilized in health research in recent years. However, the extent to which it has been applied in preclinical research and its effectiveness are unknown. To address this gap, we will conduct a scoping review to map the current use, potential benefits, and challenges of iKT in preclinical research.

Methods

Guided by a modified Arksey and O’Malley’s scoping review framework, we will systematically search reference lists and key research databases including Medline, Embase, PsycINFO, Cochrane CENTRAL, Cochrane Database of Systematic Reviews, and Web of Science. Peer-reviewed articles written or translated in English that focus on iKT or approaches that align with iKT within the context of preclinical research will be included. This review will be conducted as part of the Improving Neuroplasticity through Spaced Prefrontal intermittent-Theta-Beta-Stimulation REfinement in Depression (INSPiRE-D) project, which features preclinical research from mouse models to human work (Grant number CAMH File No.22-060). The project’s multidisciplinary team and knowledge user advisory committee will be consulted at key points throughout the scoping review process. A person with lived experience co-chairs the project advisory committee, co-authored this manuscript, and will be routinely included in the decision-making process of the scoping review.

Effects of ascorbic acid on intestinal flora and metabolites of C57 mice exposed to formaldehyde in digestive tract

by Xin Ling, Ziyan Hao, Yixuan Shi, Yuting Li, Kehan Wang, Yunshan Zhang, Yue Wang

The diversity of microbiota and metabolites plays a key role in regulating metabolism, host immune response, neurobehavioral effects and detoxification mechanism in the digestive tract gut. Formaldehyde (FA) affects the gastrointestinal tract and its microbiota, whereas ascorbic acid (VC) improves gut health and selectively promotes microbial growth. In this study, we employed 16S rRNA sequencing and non-targeted metabolomics approaches to investigate these interactions. Our results demonstrated that Lachnospiraceae_NK4A136_group, Lactobacillus, Ligilactobacillus, Clostridiales_unclassified, and other microflora significantly decreased following FA exposure, whereas the intestinal flora changed in the exact opposite way following VC administration. And compared with FA group, the number of 492 ions were regulated, in which 382 feature was up-regulated and 304 feature was down-regulated in FA + 150 mg VC group. In addition, a correlation between gut microbiota and metabolites was observed. These results reveal the effects of FA or VC on the gastrointestinal tract and its microbiota, and our understanding in the treatment of FA-induced damage to the digestive tract.

Long-term effects of psychotherapy in children and adolescents: protocol for database development and a systematic review in the LaKiJu META project

Por: Schäfer · S. K. · Burmeister · C. F. · Lottermoser · E. · Schäfer · C. G. · Cascant Ortolano · L. · Stoffers-Winterling · J. · Flasinksi · T. · Equit · M. · Schneider · S. · Lieb · K. · de Haan · A.
Introduction

Approximately one in every six children and adolescents is affected by mental disorders, which impose significant costs on patients, their families and societies. Psychotherapy is the first-line treatment for many of these disorders, and systematic reviews of post-intervention effects show small to moderate favourable outcomes compared with control groups. However, the long-term effects of psychotherapy remain less well understood.

Methods and analysis

The LaKiJu META project aims to address this gap by developing an open-access database, which will subsequently be used for data synthesis. This database will be established through literature searches in nine databases for (cluster) randomised controlled trials (RCTs) investigating the long-term effects (≥6 months) of any type of psychotherapy in school-aged children and adolescents (ages 6;00 to 17;11 years) with mental disorders. Outcomes will be prioritised based on their relevance to patients, caregivers and clinicians and will encompass a broad range of measures, including symptom changes, response rates and reliable changes. Syntheses will use multilevel meta-analyses to compare intervention and control groups at follow-up assessments, across both transdiagnostic and disorder-specific symptom outcomes. In secondary analyses, we will examine changes within intervention groups over time. Moderator analyses will focus on the effects of study-, intervention- and patient-level characteristics.

Ethics and dissemination

Ethical approval for public involvement was obtained from the ethics committee of the Faculty of Psychology of the Ruhr University Bochum. For dissemination, we will employ tailored strategies to reach researchers, clinicians, patients and their caregivers, with all groups involved in the development of dissemination plans.

PROSPERO registration number

CRD420251003208 (preregistered on 10 March 2025).

Effect of the 'digital plus approach to upscaling early childhood development services in rural China: study protocol for a cluster randomised controlled trial

Por: Wang · B. · Xiao · Y. · Qian · Y. · Li · S. · Zhang · H. · Reiling · K. · Rozelle · S.
Introduction

The high prevalence of developmental delays among young children poses significant barriers to long-term social mobility in low-income and middle-income countries. Digital interventions aimed at early childhood development (ECD) have shown promise in improving developmental outcomes, yet scalable and effective strategies remain under-explored. This study aims to evaluate the effectiveness of a digitally delivered parenting intervention to improve early child development in rural China.

Method and analysis

We design a parallel cluster-randomised controlled trial to evaluate a 12-month digitally delivered ECD intervention in rural China. Key inclusion criteria are households with children aged 6–24 months and without relocation intentions. Key exclusion criteria are children with a severe disability. Participants are masked to treatment assignment. The project implements village-level interventions in three counties in central China, involving 70 villages (clusters). Implementation involves two phases: the preparatory phase and the online phase, in which ‘Parenting the Future’ curriculum will be delivered through a newly developed mobile application. During the preparatory phase, county-level parenting trainers will conduct weekly home visits to each sampled household. In the online phase, caregivers will primarily access weekly parenting training through prerecorded videos on a mobile application. Trainers will conduct short, fortnightly home visits to manage toys and picture books loaned through the same application in accordance with the training. The planned total treatment involves 48 sessions over 1 year. Assessments were conducted via home visits at baseline and endline. The primary outcomes include cognitive development measured with the Bayley Scales of Infant and Toddler Development, third edition and social-emotional development measured with the age and stage questionnaire: social emotional. Secondary outcomes include caregiver engagement and the home learning environment measured by family care indicators and responsive caregiving rating scale. The trial aims to test the effectiveness and scalability of a hybrid ECD intervention.

Ethics and dissemination

Ethical approval for this study has been obtained from the Institutional Review Board of Southwestern University of Finance and Economics. Informed consent will be obtained from all participants, with appropriate measures in place to ensure participant confidentiality. Results from the study will be shared through academic publications, policy briefs and presentations to government stakeholders and international organisations, contributing to policy discussions on the scalability of digital ECD interventions.

Trial registration number

AEA RCT Registry (AEARCTR-0013908); ISRCTN Registry (ISRCTN15854033).

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