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AnteayerBMJ Open

Molecular epidemiology of traumatic brain injury outcome amongst individuals of Black racial identity or African ancestry: a scoping review protocol

Por: Wroblewski · T. H. · Ajmal · E. · Roberts · M.-C. · Bigdeli · T. B. · Barthelemy · E. J.
Introduction

Traumatic brain injury (TBI) is a leading cause of mortality and disability worldwide. In the USA, individuals who racially identify as African American or Black experience disproportionately higher rates of TBI and sustain worse prognosis compared with White patients; however, this population continues to be under-represented in contemporary translational research agendas. This protocol aims to comprehensively evaluate and synthesise what is currently known about the molecular epidemiology of TBI outcome among individuals of Black racial identity or African ancestry.

Methods and analysis

This review will use the established scoping review framework from the Joanna Briggs Institute. The search strategy will be implemented in PubMed (MEDLINE) and expanded to Embase and Cochrane CENTRAL Library (Wiley) databases in the final review. The date range will span from database inception to 20 July 2025 (date of final search). A two-stage screening process will be performed first at the title and abstract level before full-text assessment. Screening will be performed by two independent reviewers and discrepancies will be reconciled by a third reviewer. Articles that meet the following inclusion criteria will be considered: we will include human studies that investigate molecular and biochemical markers associated with TBI outcome. Studies must include individuals who are (A) of Black or African American racial identity, (B) of African ancestry and/or (C) performed in Sub-Saharan African countries. There is no eligibility criteria related to participant age, sex or gender. Eligible studies will be limited to English, Spanish or French. Data extracted from will be analysed and presented as written narrative, summary statistics of study characteristics and graphical or tabular displays.

Ethics and dissemination

Ethical approval is not required for this scoping review. The results of this review will be disseminated through peer-reviewed publications and academic conferences.

Flow cytometric lyophilised reagent tube assay for peripheral blood neutrophil myeloperoxidase expression to rule out myelodysplastic neoplasms at a university hospital: a diagnostic accuracy study

Por: Planta · C. · Scheffen · L. · Jacob · M.-C. · Szymanski · G. · Chevalier · S. · Tondeur · S. · Bulabois · B. · Meunier · M. · Lefebvre · C. · Gonnet · N. · Garban · F. · Molina · L. · Paradis · C. · Seigneurin · A. · Chiriac · R. · Merle · R. · Labarere · J. · Park · S. · Raskovalova · T.
Objectives

Although flow cytometric analysis of peripheral blood neutrophil myeloperoxidase expression can accurately rule out myelodysplastic neoplasms (MDS), it lacks reliability and efficiency due to the practical limitations of laboratory-developed liquid reagent-based assays. This study aimed to quantify the agreement and comparative discriminatory accuracy between a single-use flow cytometric lyophilised reagent tube (BD Lyotube Stain 468) and its laboratory-developed liquid reagent counterpart.

Design

Cross-sectional diagnostic accuracy study of two index tests against a reference diagnosis.

Setting

A university hospital in France.

Participants

Consecutive adult patients with an indication for bone marrow aspiration due to suspected MDS and unexplained peripheral blood cytopenia.

Primary outcome

MDS confirmed by cytomorphological evaluation of the bone marrow aspirate performed in duplicate by experienced haematopathologists blinded to the index test.

Results

Of 103 participants enrolled between July 2020 and August 2021, 37 had MDS (prevalence, 36%). The median intra-individual robust coefficient of variation (RCV) for myeloperoxidase expression was 30.9% using the BD Lyotube Stain 468 and 31.2% using the laboratory-developed liquid reagent assay, with an intraclass correlation coefficient of 0.94 (95% CI 0.91 to 0.96). The areas under the receiver operating characteristic curves were 0.83 (95% CI 0.74 to 0.90) and 0.82 (95% CI 0.73 to 0.89), respectively. Using a prespecified threshold of 30.0%, the corresponding sensitivity estimates were 89% (95% CI 75% to 97%) and 95% (95% CI 82% to 99%).

Conclusion

BD Lyotube Stain 468 performs as well as its laboratory-developed liquid reagent counterpart for the quantification of myeloperoxidase expression by peripheral blood neutrophils. It may obviate the need for invasive bone marrow aspiration in up to 40% of patients with suspected MDS.

Trials registration number

NCT04399018.

European, multicentre, prospective observational phase IV clinical study to assess the impact of lebrikizumab on health-related well-being and control of skin manifestations in patients with moderate-to-severe atopic dermatitis (ADTrust): study protocol

Por: Augustin · M. · Bewley · A. · Brüggen · M.-C. · de Bruin-Weller · M. S. · Ezzedine · K. · Ferrucci · S. M. · Gkalpakiotis · S. · Herranz · P. · Johansson · E. K. · Kampe · T. · Lapeere · H. · Legat · F. J. · Rehbinder · E. M. · Szepietowski · J. C. · Torres · T. · Vestergaard · C.
Introduction

Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.

Methods and analysis

This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.

Ethics and dissemination

This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.

Trial registration number

NCT06815380 (Pre-results).

Effect of strategies to improve interhospital transports of critically ill patients on safety and costs: protocol for a systematic review and meta-analysis

Por: Severino · F. · Gallani · M.-C. · Mercier · E. · Ouellet · S. · Tremblay-Roy · J.-S. · Lapierre · A. · Malo · C. · Boivin · A. · Berube · M.
Introduction

Transporting critically ill patients between medical facilities can be hazardous and costly. Whether by road, fixed-wing aircraft or helicopter, many professional associations have proposed strategies to efficiently and safely transport patients at high risk of instability. Although these strategies have been assessed in some studies, no comprehensive synthesis of their benefits has been conducted to date. The aim of this study is to assess the effect of strategies to improve the safety and costs of interhospital transports for critically ill patients.

Methods and analysis

We will conduct a systematic review according to the Cochrane guidelines. The review will include randomised controlled trials (RCTs), cohort studies and case-control studies assessing the effect of interventions to improve interhospital transports of critically ill patients on safety and costs. We will search multiple electronic databases (PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library) from inception to 6 months prior to the submission of the final manuscript. Screening by title and abstract, full-text screening, data extraction and quality assessment will be performed by two independent reviewers. We will assess the risk of bias with the Cochrane revised tool for RCTs and with the risk of bias in non-randomised studies of interventions tool. If possible, we will calculate pooled effect estimates and 95% CIs to assess the effect of the interventions. We will also assess heterogeneity using the I2 index and rate the certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation tool and trial sequential analysis.

Ethics and dissemination

Ethics approval is not required for this review. The results of this systematic review will be shared through publication in a peer-reviewed journal, conference presentations and our network of knowledge user collaborators.

PROSPERO registration number

International Prospective Register of Systematic Reviews (CRD42024595080).

Barriers and facilitators to implementing reusable personal protective equipment in hospitals, and their impacts on environment, care safety, costs, and supply chain resilience: a scoping review protocol

Por: Clavel · N. · Castonguay · F. M. · Laprise · C. · Williams · S. · Ethier · I. · Bernier · M.-C. · Beauharnais · C.
Introduction

Climate degradation poses a significant global health challenge, with healthcare systems paradoxically contributing to this issue while adhering to the principle of ‘do no harm’. Notably, the healthcare sector accounts for a considerable share of greenhouse gas emissions in many industrialised countries, primarily due to the supply chain, including pharmaceuticals, disposable medical devices and personal protective equipment (PPE). The COVID-19 pandemic exacerbated this issue, with millions of tons of CO2 emissions attributed to single-use PPE. In response to the pandemic, some hospitals have begun adopting and implementing reusable PPE as a sustainable alternative to reduce emissions, enhance resilience to supply chain disruptions and achieve cost savings. This scoping review aims to synthesise the available evidence on the adoption, implementation barriers and facilitators, as well as the impacts of reusable PPE in hospital settings.

Methods and analysis

This protocol is based on York’s five-stage framework outlined by Arksey and O’Malley. We will map evidence on the environmental and economic impacts of reusable versus disposable PPE, and the associated infection risks. Using an adapted Consolidated Framework for Implementation Research, our scoping review will identify enablers and barriers to implementation across different clinical settings. The methodology will adhere to the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Review guidelines and will include a comprehensive search of peer-reviewed articles in five databases (Medline, Embase, CINAHL, Web of Science and Global Health) and grey literature. Databases will be searched from inception to December 2024. Two reviewers will independently evaluate the eligibility of all identified titles and abstracts for inclusion in the full-text review, as well as for data extraction. Descriptive data will provide insights into the enablers and facilitators of reusable PPE adoption and implementation, along with its impacts on patient and staff safety, costs, the environment and supply chain resilience to disruptions will be reported.

Ethics and dissemination

We expect the results to both identify research gaps and generate novel ideas for future studies on transitioning to reusable PPE in healthcare settings. This review will offer healthcare decision-makers valuable insights into the factors influencing the shift from disposable to reusable PPE and its associated impacts. By refining PPE management strategies, the findings will enable managers to clearly understand the challenges and anticipated outcomes, thereby guiding effective decision-making and facilitating a smooth transition that minimises operational disruptions while upholding patient and staff safety. Ethics approval was not required for this review. The findings will be shared through conferences on healthcare management and sustainability, and submitted to peer-reviewed journals in healthcare management and implementation science.

Trial registration details

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

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