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Digital patient decision aids for endometriosis management: a scoping review protocol

Por: Pittet · O. · Delvallee · M. · Pluchino · N. · Selby · K. J. · Elwyn · G. · Durand · M.-A.
Introduction

Endometriosis is a chronic, oestrogen-dependent condition with a wide range of symptoms and comorbidities that significantly affect physical, emotional and psychological well-being, as well as quality of life. Women with endometriosis often face complex treatment decisions with no universally accepted gold-standard therapy. Shared decision-making, supported by patient decision aids (PtDAs), can enhance patient knowledge and promote informed preferences and decisions. Digital PtDAs, in particular, offer potential for personalised, interactive and accessible decision support. Their characteristics, development process and evaluation in endometriosis care remain underexplored. The objective of this scoping review is to map the existing literature on digital PtDAs developed for women of reproductive age (18–49) with endometriosis, across a range of healthcare and digital health contexts.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute (JBI) methodology for scoping reviews. A comprehensive three-step search, developed with an information specialist, will be conducted across MEDLINE (PubMed), CINAHL, Embase, Web of Science, Cochrane databases and grey literature sources. Citations will be imported into Rayyan for screening. Two independent reviewers will conduct study selection, data extraction and analysis. Data will be summarised using tables and descriptive content analysis to identify key features, development processes and evaluation methods of digital PtDAs. The review will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines.

Ethics and dissemination

This review started off in July 2025, and the anticipated end date is November 2025. We plan to disseminate this research through publications, presentations at relevant national and international conferences and meetings with relevant stakeholders. This scoping review protocol has been registered at Open Science Framework (osf.io/fp86m). As this scoping review will use data from published and publicly available sources, research ethics approval is not required.

Prevalence of limited health literacy in blue-collar workers: a systematic review protocol

Por: Pires Rodrigues · G. A. · Duong · P. · Luthi · F. · Leger · B. · Melly · P. · Durand · M.-A.
Introduction

Health literacy (HL) is defined as the ability to access, understand, evaluate and apply health-related information, which can influence individuals’ health outcomes. Blue-collar workers, who often have lower educational attainment and experience language barriers, are at increased risk of limited HL. This systematic review aims to assess the prevalence of limited HL among blue-collar workers to inform the development of appropriate interventions for its improvement.

Methods and analysis

The systematic review will assess the prevalence of limited HL among blue-collar workers. We will include all quantitative study designs using any instrument for measuring general HL. We will exclude studies that focus on specific types of HL and specific health conditions. We have performed a literature search from inception up to 30 April 2025, in the Medline, Embase, CINAHL, Web of Science and Cochrane Central Register of Controlled Trials (CENTRAL) databases. We will also search eligible articles from Google Scholar and Open Grey as sources of unpublished studies/gray literature. Two independent reviewers will conduct the primary screening of articles, data extraction and quality assessment (using the Cochrane risk-of-bias tool for randomised trials and risk of bias in non-randomised studies of exposure), with a third individual available to resolve conflicts. We will assess heterogeneity using the ² test and I² test. If there is sufficient homogeneity, we will pool studies in a meta-analysis or summarise the findings narratively if heterogeneity is too high. We will use a random effects model for our analysis, and we will use funnel plots to evaluate potential publication bias. The Grading of Recommendations Assessment, Development and Evaluation approach will be used to assess the certainty of findings.

Ethics and dissemination

Ethical approval will not be required for this review as there is no primary data collection involving humans. The results will be published in a peer-reviewed journal and presented at relevant conferences.

PROSPERO registration number

CRD42024597732.

Femoral versus radial arterial pressure monitoring in cardiac surgery patients: protocol for a randomised controlled multicentric superiority trial (FERARI)

Por: Guinot · P.-G. · Bronnert · R. · Grelet · T. · Bouhemad · B. · Nguyen · M. · Besch · G. · FERARI study group · Berthoud · Kabbout · Radhouani · Martin · Constandache · Durand · GrosJean · Bahr · Anciaux · Bernard · Morgant · Jazzayeri · Bernard · Ghalifa · Lubin · Nays · Guilhot · Al
Background

Accurate arterial pressure monitoring is critical in cardiac surgery to guide haemodynamic management and vasopressor therapy. Radial arterial pressure monitoring may systematically underestimate central aortic pressure compared with femoral monitoring, potentially leading to inappropriate vasopressor escalation and associated complications. Recent evidence demonstrates that excessive norepinephrine exposure is associated with acute kidney injury and increased mortality in cardiac surgery patients.

Objective

To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.

Methods and analysis

This is a prospective, randomised, controlled, single-blind, superiority trial conducted at two French university hospitals (CHU Besancon and CHU Dijon). Adult patients undergoing cardiac surgery with cardiopulmonary bypass will be randomised 1:1 to receive either femoral or radial arterial pressure monitoring. The primary endpoint is the proportion of patients treated with norepinephrine from anaesthetic induction to postoperative day 7. Secondary endpoints include acute kidney injury according to KDIGO criteria, cardiac complications, vasoactive-inotropic scores, duration of vasopressor therapy, vascular complications, and 7-day and 30-day mortality. Sample size calculation indicates 340 patients (170 per group) are needed to detect a 15% absolute reduction in norepinephrine use with 90% power and α=0.05, and an anticipated loss to follow-up rate of 5%.

Ethics and dissemination

The study has been approved by the French Ethics Committee (Comité de Protection des Personnes Nord-Ouest II, no. 2024/897) and will be conducted according to the Declaration of Helsinki and Good Clinical Practice guidelines. Results will be submitted for publication in peer-reviewed journals and presented at international conferences.

Trial registration number

NCT06952907.

Prevention of secondary infections by interferon-gamma in ICU-acquired sustained immune suppression in France: study protocol of the PLATINIUM randomised trial

Por: Hernandez Padilla · A. C. · Daix · T. · Hotchkiss · R. S. · Monneret · G. · Tadie · J. M. · Jeannet · R. · Plateker · O. · Vaidie · J. · Durand-Zaleski · I. · Magne · J. · Giraudeau · B. · Francois · B.
Introduction

Some intensive care unit (ICU) patients develop an extremely deep and sustained immunosuppression that increases the risk of secondary infections and can ultimately compromise survival. Thanks to an easily accessible and simplified immune monitoring to identify immunological failure, a personalised immune restoration approach is now feasible. Among the different therapeutic strategies in this field, interferon gamma (IFN-) is probably the most interesting drug to reduce the burden of secondary infections in the ICU.

Methods and analysis

This is a two parallel group multicentre blinded add-on randomised trial comparing immunorestoration by subcutaneous injection of IFN- to standard of care in targeted ICU patients. The study will be performed in 23 ICUs in France. Patients hospitalised in the ICU for a week, with multiple organ failure defined by a sequential organ failure assessment score ≥6 during this first week, will be enrolled. If within 96 hours after inclusion, these patients express immunosuppressed features defined by a low absolute lymphocyte count (x109/L) and low expression of human leucocyte antigen-DR (HLA-DR) on monocytes (13 500 antibodies bound per cell and an absolute lymphocyte count >1200 x109/L) at day 10, healthcare costs at day 90 and rate of serious adverse reactions and suspected unexpected serious adverse reaction at day 90. We plan to randomise 326 patients.

Ethics and dissemination

The study will be implemented in accordance with European regulations and was independently reviewed and approved by the French Ethics Committee Comité de Protection des Personnes Ile de France III (EUCT number: 2024-516780-93-00). The results will be reported in international peer-reviewed journals and presented at international and national conferences.

Trial registration number

NCT06774235.

Ambulatory management of primary spontaneous pneumothorax in the emergency department: EFFI-PNO protocol - a multicentre, cluster-controlled, stepped-wedge, randomised interventional study

Por: Kepka · S. · Wilme · V. · Duracinsky · M. · Matau · C. · Nze Ossima · A. · Gil Jardine · C. · Le Borgne · P. · Marjanovic · N. · Marx · T. · Ohana · M. · Peyrony · O. · Philippon · A.-L. · Viglino · D. · Chenou · A. · Clere-Jehl · R. · Bilbault · P. · Durand-Zaleski · I. · Sauleau · E. A.
Introduction

For large primary spontaneous pneumothorax (PSP), drainage or simple aspiration are the two first-line treatment options. Outpatient ambulatory strategies have a success rate of almost 80% with few complications. New French recommendations suggest that an outpatient strategy should be preferred if an appropriate care network is in place. However, establishing this care network remains the main obstacle to the use of this strategy. Thus, outpatient management of PSP remains rare, which is neither optimal for the patient, with a likely impact on quality of life (QOL) and satisfaction with care, nor for the healthcare system, with increased costs. We hypothesise that outpatient treatment of PSP compared with usual inpatient management could improve quality of care and represent a more efficient, generalisable and sustainable strategy.

Methods and analysis

In this multicentre, cluster-controlled, randomised interventional study with stepped wedge implementation, patients aged 18–50 presenting to the emergency department (ED) with a first episode of large PSP will be enrolled in seven university hospitals in France. The main objective of this study is to evaluate the impact on changes in QOL of an ambulatory strategy for the management of large PSP in the ED compared with usual inpatient management. The primary outcome is the difference in QOL as measured by SF-36 score, between drain placement and 6 months. Clinical criteria (pulmonary expansion at 6 days, pain, dyspnoea, complications, recurrence), perceived quality of care (satisfaction, patient preference, anxiety) and ease of implementation of the care pathway will also be assessed. A cost-utility analysis will be carried out to evaluate the incremental cost-utility ratio at 1 year, defined as the difference in costs divided by the difference in utility estimated by the EQ-5D scores.

Ethics and dissemination

Ethics approval has been obtained by the Comité de Protection des Personnes Nord Ouest III N° 2024-36. Study findings will be disseminated by publication in a high-impact international journal. Results will be presented at national and international emergency healthcare meetings, and participating patients notified of the main conclusions.

Trial registration number

This trial is registered with Clinical Trials Registry NCT06471608. The trial protocol and statistical design are fully described in this study protocol. Additional data can be provided on reasonable request to the sponsor. Protocol version: V2.1 - 21/11/2024.

Antenatal care interventions in Afghanistan from 2000 to 2024: a rapid realist review

Por: Naseri · S. · Durand · M.-A. · Arifi · F. · Manochehr · M. H. · Safi · N. · Hadad · A. S. · Rahmanzai · A. J. · Sadeq Yaqubi · G. · Ridde · V.
Introduction

In response to the high maternal mortality in Afghanistan, the government emphasised enhancing antenatal care (ANC) coverage to improve skilled birth attendance and reduce maternal mortality. This study aimed to explain how and why ANC interventions worked, for whom, and under what circumstances in Afghanistan between 2000 and 2024.

Methods

A rapid realist review was conducted to identify underlying programme theories and examine contextual factors and key mechanisms influencing ANC outcomes, with input from a panel of national experts. Data were extracted using context–mechanism–outcome (CMO) configurations to develop and refine theories for policy recommendations.

Results

From 3502 papers, 1860 duplicates were removed, 63 were screened for full text and 25 were included in the final review. In total, 29 CMOs were inferred across nine interventions, classified at individual, interpersonal, community and institutional levels. We found that ANC interventions could work best by empowering women and healthcare workers (HCWs), involving husbands, hiring female community health workers (CHWs), ensuring regular contact with the same HCWs, endorsing health messages by the government, incentivising CHWs and designing and implementing interventions using participatory approaches. Interventions are less successful when there is a lack of community trust in service quality or HCW qualifications, low decision-making ability among women, discomfort during travel to health facilities, adherence to traditional practices and beliefs, hiring CHWs from outside the community, chronic stress and lack of support among HCWs and unrecognised incentives.

Conclusion

Our evidence synthesis can inform donors, policymakers and implementers on how to design more effective ANC interventions to achieve better health outcomes in Afghanistan. By emphasising intervention evaluation and ANC quality improvement, it highlights the importance of key social elements, such as cultural norms, power dynamics, relationships, beliefs and trust, which are likely to maximise impact. Community involvement is essential for designing and implementing effective and sustainable ANC interventions.

Factors affecting healthcare access for dysmenorrhoea: a scoping review protocol

Por: Ni Cheileachair · F. · Caes · L. · Belfield · S. · Bartl · M. · Durand · H.
Introduction

Dysmenorrhoea (period pain) is a global public health issue affecting up to 91% of the 1.8 billion individuals who menstruate. While research has emphasised the improvement of menstrual health in low-middle-income countries, undertreated dysmenorrhoea remains an issue in high-income countries (HICs), where individuals often assume their pain experiences are normal. Studies report that individuals with dysmenorrhoea delay seeking medical care, avoid it entirely or are subjected to diagnostic and treatment delays. Difficulties accessing care are troubling, as individuals may suffer without access to evidence-based techniques, as well as the potential for underlying pathologies (eg, endometriosis, pelvic inflammatory disease) to go undiagnosed.

Many HICs have launched strategies for women’s health to address gaps in care access and knowledge around menstruation. Guided by Levesque and colleagues' (2013) Conceptual Framework of Access to Healthcare, this review will contribute to these strategies by providing an overview of factors affecting healthcare access for dysmenorrhoea in HICs from the point of perceiving a healthcare need to engaging with care, as well as factors affecting perceived quality of care.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute’s (JBI) guidance for scoping reviews and will be conducted with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist extension for Scoping Reviews. Guided by Levesque and colleagues’ (2013) Conceptual Framework of Access to Healthcare, searching will seek to locate both peer-reviewed studies across PubMed, CINAHL, PsycINFO and Web of Science databases, as well as using web scraping to locate relevant grey literature. Results will be synthesised and mapped to construct a pathway to care, highlighting factors affecting the healthcare access for dysmenorrhoea, as well as factors related to the quality of healthcare interactions.

Ethics and dissemination

This review does not require ethical approval, as only existing data will be analysed. Results will be shared using peer-reviewed publications and conference presentations. Datasets emerging from the study will be made available on Open Science Framework.

Registration

This review was initially registered on Open Science Framework (https://osf.io/2dsrc/) in February 2024, with an updated protocol registered in February 2025.

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