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Add-on tocilizumab versus placebo for resistant major depression in psychiatric outpatients with low-grade inflammation in a tertiary public hospital in Southern Brazil: randomised triple-blind clinical trial protocol

Por: Portal · P. H. G. · Peixoto · G. N. · de Matos · M. R. · da Silva · L. C. N. · Alexandrino · G. B. · Dutra · P. H. G. · Carniel · B. P. · da Rocha · N. S.
Introduction

Emerging evidence supports a role for interleukin 6 (IL-6), a pro-inflammatory cytokine, in the pathogenesis of treatment-resistant major depressive disorder (TRD). However, interventional studies targeting IL-6 in this population remain scarce. Tocilizumab is a humanised monoclonal antibody that inhibits IL-6 signalling and is approved for the treatment of autoimmune conditions such as rheumatoid arthritis. The primary objective of this study is to examine whether IL-6 inhibition via tocilizumab can impact depressive symptoms, inflammation-related biomarkers and cognition in patients with TRD. A secondary objective is to compare the biological profiles of patients with TRD with elevated inflammation to those of healthy controls.

Methods and analysis

This is a proof-of-concept, randomised, parallel-group, triple-blind, placebo-controlled clinical trial. 22 adult outpatients diagnosed with TRD and evidence of low-grade inflammation (serum C reactive protein≥3 mg/L) will be randomised (1:1) to receive either one intravenous infusion of tocilizumab (8 mg/kg; maximum 800 mg) or normal saline, administered as an add-on to their ongoing treatment. Psychiatric, cognitive and biomarker assessments will be performed at baseline and at follow-up visits on days 7, 14 and 28 post-infusion. Additionally, 10 healthy controls with no psychiatric history will undergo the same baseline assessments for biomarker comparison.

Ethics and dissemination

The study has been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre (Project number: 2025-0245, CAAE: 88904825.7.0000.5327). Findings will be disseminated through peer-reviewed publications, scientific meetings and, on request, lay summaries for participants.

Trial registration number

NCT07052058.

Determinants of pain, anxiety and patient satisfaction during intravenous injection: a cross-sectional study

Por: Yıldız · G. N. · Yüce Basaran · H. D. · Yavuz · B. · Kocyigit · D. · Koc · G. · Ciftci · B.
Background

Intravenous injection is one of the most frequently performed invasive nursing procedures in hospitals. However, patients may experience pain and anxiety during this procedure, which can affect patient satisfaction.

Objective

The aim of this study was to determine the levels of pain, anxiety and satisfaction in patients undergoing intravenous injection and to examine the sociodemographic, clinical and procedural factors affecting these levels.

Methods

A descriptive, cross-sectional study was conducted between August and November 2025 in the emergency departments of Atatürk University Research Hospital, a large tertiary care university hospital. This single-centre study was carried out in a high-volume emergency department that provides 24-hour services to a diverse patient population. A total of 405 patients who received intravenous injections and agreed to participate in the study were included. Data were collected using an Information Form, Visual Analogue Scale (VAS) for pain, VAS for anxiety and Post-Injection Satisfaction Scale. Descriptive statistics, t-tests, analysis of variance, correlation analyses and multiple regression analyses were used to analyse the data.

Results

The mean pain VAS score for patients was 4.39±2.33, the mean anxiety VAS score was 4.42±2.14 and the mean Post-Injection Satisfaction Scale score was 3.51±0.77, indicating moderate levels of pain and anxiety on a 0–10 VAS. Women were found to have significantly higher levels of pain and anxiety than men (p

Conclusion

It was found that patients experienced moderate pain and anxiety during intravenous injection and that this situation negatively affected patient satisfaction. The results indicate that individualised nursing approaches in intravenous injection practices and the implementation of pharmacological and non-pharmacological interventions aimed at reducing pain and anxiety may increase patient satisfaction.

Barriers and enablers to scaling implementation of Trauma Recovery Center model of care: a protocol for scoping review

Por: Varyvoda · Y. · Yurika · R. · Chukwuonye · G. N. · Soto · S. · Manygoats · T. · Ehiri · J.
Introduction

The Trauma Recovery Center (TRC) is an evidence-based model of care designed to meet the needs of underserved survivors of violent crime through the provision of comprehensive mental health and psychosocial services. Originally developed in the USA, the TRC model has been adopted by 53 hospitals and outpatient settings nationwide. Its demonstrated effectiveness supports its potential for international scale-up, particularly in countries seeking to improve their responses to interpersonal violence and trauma. While the core principles of the model remain universally consistent, there is a striking paucity of synthesised evidence on implementation barriers and enablers, necessary to guide effective scale-up and adaptation across diverse systems of care. The objective of this scoping review is to identify and map barriers and facilitators that influence implementation of the TRC model of care.

Methods and analysis

The scoping review was initiated in May 2025 and is expected to be completed in May 2026. The review will be conducted following the Joanna Briggs Institute methodology for scoping reviews. Results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews. The initial PubMed search was conducted in June 2025. The finalised search strategy will subsequently be applied to PubMed, Embase, PsycINFO, CINAHL and Scopus databases. A two-stage screening process using Covidence software will be used to determine study eligibility. To be included, studies will be required to have examined implementation-related barriers or facilitators associated with at least one core element of the TRC model or analogous psychosocial support programmes within the context of comprehensive, trauma-informed care for survivors of violent crime. Studies conducted within the USA and published in English between 2001 and 2026 will be included.

All studies will be independently assessed for eligibility. Data will be extracted and mapped using the Consolidated Framework for Implementation Research (CFIR). Extracted data will be analysed and synthesised narratively across the five CFIR domains, accompanied by summary tables that describe how the findings relate to the review objective. Existing knowledge gaps will be identified and discussed.

Ethics and dissemination

Ethics approval is not required for this scoping review. Experts from the National Alliance of Trauma Recovery Centers (NATRC) will be engaged to provide feedback on the study findings and support the dissemination of results. Dissemination activities will include peer-reviewed publications and presentations at academic conferences and professional events, such as NATRC’s technical assistance and learning community training sessions.

Surgical approaches, choice and positioning of implants in the surgical treatment of proximal tibia fractures in adults: a scoping review protocol

Por: Zierke · J. N. · Kröpelin · A. · Heyland · M. · Duda · G. N. · Tzschätzsch · H. · Bejaoui · A. · Agha-Mir-Salim · L. · Zhou · H. · Back · D. A. · Hölzl · S. · Tuttle · N.
Introduction

Tibial plateau fractures present a complex orthopaedic challenge and usually require surgical intervention to restore joint alignment and stability as well as to prevent complications. In practice, determining the most appropriate surgical approach, implant selection and positioning remains a challenge and depends on the surgeon’s experience and patient-specific factors. Therefore, this scoping review aims to map the current evidence on surgical fixation methods for proximal tibia fractures in adults. In particular, we seek to first assess study types and their distribution across levels of evidence and second to identify knowledge gaps to support evidence-based surgical planning.

Methods and analysis

The proposed scoping review will be conducted in accordance with the JBI methodology for scoping reviews and will be reported as per the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. Information for this study will be gathered from Medline, Cochrane and Embase. Data analysis will involve categorising the studies by their level of evidence and extracting predefined parameters, including fracture characteristics, surgical approach, implant type and key findings relevant to the review question. The study focuses on surgically stabilised intra-articular proximal tibia fractures in adults. Only English- and German-language studies that are available in full text and published after 1995 will be included.

Ethics and dissemination

No ethical approval is required. The findings of the proposed review will be disseminated through publications in peer-reviewed journals.

Review registration

Open Science Framework, osf.io/g9zfu.

Student paramedic experiences of group-based simulation activities used in assessment: a qualitative UK study

Por: Colthup · R. A. · Johnson · G. N. · Jenkins · R. J. · Runacres · J.
Objectives

This research aimed to explore student paramedics’ experiences of participating in group-based simulation activities used as part of their summative assessment. It sought to understand their perceptions of the effectiveness of group-based simulation in fostering learning and informing future assessment design.

Design

A qualitative questionnaire-based study.

Setting

A UK higher education institution.

Participants

A total of 34 first-year (level 4) student paramedics from the September 2022 to September 2023 cohorts.

Intervention

Following the completion of a summative assessment for the introduction to non-technical skills and simulation module, students were invited to reflect on their experiences of group-based simulation through an online questionnaire. The assessment incorporated team-based simulation scenarios intended to evaluate non-technical competencies within a realistic and supportive environment.

Results

Four key themes emerged through thematic analysis of the responses: experiential learning; autonomous learning; reflective learning; and support and learning. These themes provide insights into the pedagogical value of group-based simulation, with students identifying both individual and collective benefits in developing non-technical skills within a group assessment framework.

Conclusion

Group-based simulation assessments enhance student engagement and promote collaborative decision-making in a context that mimics real paramedic practice. While students often associate realism with increased confidence, their experiences highlight complex interactions between perceived fidelity, assessment pressure and learning. This underscores the need to further investigate how group dynamics and authenticity influence learning outcomes in assessment-focused simulations.

Development, content and planned evaluation of a behavioural support intervention to reduce ultraprocessed food intake and increase physical activity in UK healthcare workers: UPDATE trial stage 2 study protocol

Por: Heuchan · G. N. · Buck · C. · Conway · R. · Dicken · S. · Brown · A. C. · Jassil · F. C. · Makaronidis · J. · Van Tulleken · C. · Gandini Wheeler-Kingshott · C. A. · Batterham · R. · Fisher · A.
Introduction

Diets high in ultraprocessed food (UPF) are associated with poor health outcomes and weight gain. Healthcare workers are particularly at risk of consuming diets high in UPF due to erratic work patterns, high stress and limited access to fresh food at work. Despite this, no interventions to date have specifically targeted a reduction in UPF intake in healthcare workers.

Methods and analysis

This article describes the development and content of a 6-month behavioural support intervention targeting a reduction in UPF intake in UK healthcare workers. The intervention was offered to all participants who took part in the UltraProcessed versus minimally processed Diets following UK dietAry guidance on healTh outcomEs trial—a two-stage study in which Stage 1 was a controlled-feeding crossover randomised controlled trial of provided UPF versus minimally processed food (MPF) diets (published previously) and was completed before the start of Stage 2. Stage 2, reported here, aimed to support participants to reduce their UPF consumption, increase MPF and increase physical activity in real-world settings. The intervention was developed using the behaviour change wheel framework, which systematically links behavioural diagnoses to intervention functions, incorporating the capability, opportunity and motivation model for behaviour change. It included tailored one-to-one and group support sessions, bespoke digital and print resources and a mobile-optimised website. The detailed description is intended to support future replication and adaptation. The acceptability and feasibility of the intervention will be assessed using quantitative and qualitative data in a future paper.

Ethics and dissemination

Sheffield Research Ethics Committee approved the trial (22/YH/0281). Findings will be disseminated through peer-reviewed publications, conference presentations and summaries shared with participants and stakeholders.

Trial registration number

NCT05627570.

Adverse pregnancy outcomes and associated factors among mothers who had operative vaginal delivery in Amhara Region Comprehensive Specialized Hospitals: multicentre cross-sectional study

Por: Misker · A. D. · Melesew · A. A. · Gobezie · N. Z. · Wubet · H. B. · Diress · G. M. · Abuhay · A. G. · Demite · D. G. · Tadesse · M. A. · Mihretie · G. N. · Abate · A. T. · Asmare · T. B. · Goshu · Y. A. · Siyoum · T. M. · Mekuriaw · B. Y. · Gedefaw · G. D. · Kebede · S. D. · Demissie
Objective

Assess the magnitude of adverse pregnancy outcomes and associated factors among mothers who had operative vaginal delivery in Amhara Region Comprehensive Specialized Hospitals, 2024.

Study design

A cross-sectional study was conducted from 1 November 2024 to 20 February 2025.

Study setting

Seven comprehensive specialised hospitals were included in the study.

Participants

The study was employed on 389 mothers who had operative vaginal delivery.

Methods

Systematic sampling was used. Data were collected via questionnaires, chart reviews and observation. Data were entered into Epi Data V.4.6 and analysed using V.25 statistical package of social sciences. Variables with p

Outcome

Adverse pregnancy outcomes of operative vaginal delivery.

Results

Adverse pregnancy outcomes of operative vaginal delivery were 42.2%. Among them, 46 (11.8%) had only maternal complications, 55 (14.1%) had only neonatal complications and 63 (16.2%) had both maternal and neonatal complications. Perineal tear 29 (7.5%) and episiotomy extension 31 (8%) were the most common maternal complications, while caput succedaneum 45 (11.6%) was the most neonatal complication. The most common indication of operative vaginal delivery was prolonged second stage 203 (52.2%). Vacuum-assisted delivery (AOR 0.53; 95% CI 0.29 to 0.96), two tractions (AOR 2.19; 95% CI 1.23 to 3.90), birth weight less than 2.5 kg (AOR 1.85; 95% CI 1.21 to 2.83) and mid fetal station (AOR 2.9; 95% CI 1.49 to 5.64) were significantly associated with adverse pregnancy outcomes.

Conclusions

Adverse pregnancy outcomes following operative vaginal delivery were high. Type of instrumental vaginal delivery, number of tractions, fetal birth weight and fetal station were significantly increased risks. Therefore, operators should minimise traction attempts during operative vaginal delivery to reduce adverse outcomes.

Predictive machine-learning model for screening iron deficiency without anaemia: a retrospective cohort study

Por: Efros · O. · Soffer · S. · Mudrik · A. · Robinson · R. · Kenet · G. · Nadkarni · G. N. · Klang · E.
Objectives

This study aimed to develop and validate a machine-learning (ML) model to predict iron deficiency without anaemia (IDWA) using routinely collected electronic health record (EHR) data. The primary hypothesis was that an ML model could achieve better accuracy in identifying low ferritin levels (

Design

A retrospective cohort study.

Setting

Data were derived from secondary and tertiary care facilities within the eight-hospital Mount Sinai Health System, an urban academic health system.

Participants

The study included 211 486 adult patients (aged ≥18 years) with normal haemoglobin levels (≥130 g/L for men and ≥120 g/L for women) and recorded ferritin measurements.

Primary and secondary outcome measures

The primary outcome was the prediction of low ferritin levels (

Data from 211 486 Mount Sinai Health System patients with normal haemoglobin levels and ferritin testing were analysed. The model used demographic data, blood count indices and chemistry results to identify low ferritin levels (

Results

Of the 211 486 patients analysed, 19.56% (n=41 368) of the patients had low ferritin levels. In the low ferritin group, the mean age was 41.28 years with 89.64% females. In contrast, the normal ferritin group had a mean age of 50.14 years with 62.02% females. The model achieved an area under the curve (AUC) of 0.814. At a sensitivity threshold of 70%, the model had a specificity of 75.85%, with a positive predictive value of 37.6% and a negative predictive value of 92.41%. The model outperformed an alternative model based only on complete blood count indices (AUC 0.814 vs 0.741). Subgroup analysis showed that model accuracy varied by sex and age, with lower performance in premenopausal women (AUC 0.736) compared with postmenopausal women (AUC 0.793) and men (AUC of 0.832 in those under 60 years and 0.806 in those aged 60 and above).

Conclusions

The ML model provides an effective approach to screening for IDWA using readily available EHR data. Implementing this tool in clinical settings may facilitate early diagnosis of IDWA.

What factors influence nutrition-related information-seeking behaviour among pregnant women attending antenatal care at public hospitals in Bahir Dar City, northwest Ethiopia: a cross-sectional study

Por: Bitacha · G. K. · Asemahagn · M. A. · Mekonnen · Z. A. · Chekol · T. M. · Ahmed · M. H. · Meshesha · N. A. · Guadie · H. A. · Dube · G. N.
Objective

This study aimed to assess the proportion of nutrition-related information-seeking behaviour and its associated factors among pregnant women attending antenatal care at public hospitals in Bahir Dar City, northwest Ethiopia, 2023.

Method

A cross-sectional quantitative supplemented with qualitative study design was conducted from March to April 2023 among 406 pregnant women. Pre-tested structured interviewer-administered and semistructured open-ended questionnaires were used to collect quantitative and qualitative data, respectively. Data were collected using the Kobo toolbox, and SPSS V.25 was used for analysis. Descriptive statistics were used to describe study subjects, and multivariate logistic regression analysis was employed to investigate the associated factors. The strength of associations was described using the OR with the corresponding 95% CI.

Result

The study included 406 pregnant mothers with a median age of 28 with an IQR of 8 and 212 (52.2%) from rural settings. Of the total respondents, 173 (42.6%; 95% CI 37.7 to 47.6) of pregnant mothers were nutrition-related information seekers. Educational status, residence, monthly income and nutrition information literacy were significantly associated with nutrition-related information-seeking behaviour.

Conclusion

The proportion of nutrition information seeking among pregnant mothers in Bahir Dar City public hospitals was low. Lower educational status, low nutrition information literacy level, being from a rural residence and low monthly income are significantly associated factors.

Recommendation

Awareness creation for pregnant mothers from rural areas and with low educational status and improving nutrition information literacy of pregnant mothers are important activities to improve their nutrition information-seeking behaviour.

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