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☐ ☆ ✇ BMJ Open

Factors associated with low levels of resilience among French university students during COVID-19 lockdown: results of the cross-sectional PIMS-CoV19 survey

Por: Todorovic · A. · Baumann · C. · Tarquinio · C. · Rotonda · C. · Rousseau · H. · Bourion-Bedes · S. — Febrero 26th 2026 at 13:47
Objectives

To identify the factors associated with low psychological resilience among university students in the Grand Est region of France at the end of the first national COVID-19 lockdown.

Design

A cross-sectional online survey was conducted (May 2020) among students at the University of Lorraine using the LimeSurvey platform and institutional mailing lists.

Setting

Higher education setting in north-eastern France, involving students from the University of Lorraine (multicampus public university) and Sciences Po Nancy, a political science institute in the same region.

Participants

A total of 3708 students fully completed the online questionnaire, including the Brief Resilience Scale (BRS), resulting in an estimated response rate of 7.1%. All students enrolled at the University of Lorraine and Sciences Po Nancy during the 2019–2020 academic year were eligible to participate.

Primary and secondary outcome measures

The primary outcome was psychological resilience, measured using the BRS. Secondary measures included perceived social support assessed with the Multidimensional Scale of Perceived Social Support, quality of interpersonal relationships evaluated using the Quality of Interpersonal Relationships Scale (Échelle de la Qualité des Relations Interpersonnelles, EQRI) and frequency of positive and negative thoughts measured with the Thermometer of Thoughts Tool. Factors associated with low resilience were analysed using bivariable and multivariable logistic regression.

Results

Among 3708 students included in the sample, corresponding to a response rate of approximately 7.1%, 50.6% had normal resilience, while 37.3% reported low resilience. Female gender (OR=2.1, 95% CI: 1.8 to 2.6) and low social support (OR=1.7, 95% CI: 1.1 to 2.6) were the factors associated most strongly with low resilience. Negative thoughts (OR=1.4, 95% CI: 1.4 to 1.5), lower quality of relationships with people in general (OR=1.5, 95% CI: 1.3 to 1.8) and studying arts, humanities or languages (OR=1.4, 95% CI: 1.0 to 1.8) were identified as factors associated with low resilience. Increased age (OR=0.9, 95% CI: 0.9 to 1.0) and flat sharing (OR=0.6, 95% CI: 0.4 to 0.9) were inversely associated with low resilience levels.

Conclusions

Resilience seems to be impacted primarily by internal and micro-environmental factors. Consolidating levels of individual resilience of at-risk populations by acting on these factors could be the key to improving their mental health.

☐ ☆ ✇ BMJ Open

Relationships between alcohol use and dementia: protocol for an observational study in the UK Clinical Practice Research Datalink

Por: Fatih · N. · Bhaskaran · K. · Kwok · A. C. H. · Ebmeier · K. P. · Nichols · T. · Gelernter · J. · Christodoulou · M. D. · Topiwala · A. — Febrero 12th 2026 at 19:06
Introduction

Alcohol consumption is an increasingly recognised modifiable risk factor for dementia, yet whether it has differential impacts on dementia subtypes and its role in disease progression remains unclear. This study aims to: (1) quantify the association between alcohol intake and incidence of dementia subtypes and (2) examine whether individuals who drink heavily and develop dementia referred to hereafter as ‘alcohol-related’—have poorer post-diagnosis outcomes compared with other dementia cases. Clarifying these relationships will determine whether alcohol selectively increases risk for specific dementia phenotypes or broadly heightens neurodegenerative vulnerability, with implications for prevention, clinical counselling and therapeutic targeting.

Methods and analysis

This population-based cohort study of alcohol and dementia will use linked UK electronic health records from Clinical Practice Research Datalink, Hospital Episode Statistics and Office for National Statistics (ONS). Participants will be eligible if they have available linked data from January 1998, when ONS death registrations became available, until the end of follow-up. Alcohol exposure will be defined through self-reported recorded weekly alcohol units and diagnostic codes for harmful or dependent alcohol use. Primary outcomes including incident all-cause and subtype-specific dementia (eg, Alzheimer’s, vascular, Lewy body, Parkinson’s, frontotemporal) as well as secondary outcomes (ie, mortality, care-home entry and neuropsychiatric symptoms). Key covariates encompassing socio-demographic factors, smoking and relevant comorbidities will be adjusted for. Multivariable Cox proportional hazards and Fine-Gray competing risk models will estimate associations with dementia incidence. Post-diagnosis prognosis will be compared for dementia in individuals with a history of heavy alcohol use (‘alcohol-related’) and dementia in individuals with minimal alcohol exposure (‘non-alcohol-related’) cases using survival and logistic regression models. Multiple testing correction will be applied across dementia subtype comparisons. Alcohol exposure will be modelled continuously and non-linearly using restricted cubic splines and categorically using binary indicators of harmful/dependent use. Missing covariate data will be assessed and addressed using appropriate methods, including multiple imputation and complete-case analysis. Data extraction and analysis are scheduled from October 2025 to October 2026.

Ethics and dissemination

Use of de-identified routine data will proceed under existing Research Ethics Committee and data governance approvals. Findings will be disseminated via open-access peer-reviewed journals, academic conferences and summaries targeted at patient, public and policy audiences. The results of this study will be reported according to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) guidelines.

☐ ☆ ✇ Journal of Clinical Nursing

Assessing the Impact of Supplemental Oxygen Use on Deterioration Detection in the General Care Setting With Pulse Oximetry‐Based Continuous Monitoring

ABSTRACT

Aims

Continuous pulse oximetry monitoring has been used in patient deterioration recognition systems for decades. For patients on supplemental O2, questions related to the effectiveness of this approach have been raised due to elevation of SpO2 from O2 therapy. We examine this issue in the context of a stable inpatient continuous pulse oximetry-based rescue system with the aim of ascertaining if patients receiving supplemental oxygen are at risk of experiencing clinically meaningful delays in deterioration recognition as compared to patients on room air.

Design

Retrospective observational analysis.

Methods

Clinical markers of deterioration recognition timeliness and impact were compared for patients receiving various levels of supplemental oxygen and those on room air over 6 years. Chart review was conducted to assess cause and likelihood of preventability and improvement in detection with other monitoring modalities for emergent cases.

Results

Analysis adjusted for patient characteristics, and population level supplemental oxygen use showed no difference between patients on supplemental oxygen vs. room air for transfer rate, emergent transfer rate, or death after rescue or transfer. Analysis excluding population supplemental oxygen modeling showed limited increases in event likelihood, but not for emergent transfers. Chart review of emergent transfers revealed no pattern of delay in recognition of deterioration for patients on supplemental oxygen.

Conclusions

This study found no evidence that pulse oximetry-based continuous monitoring significantly degrades or delays detection of severe deterioration episodes for patients receiving supplemental oxygen. These findings challenge arguments suggesting pulse oximetry is not an appropriate continuous monitoring modality for general care patients receiving oxygen.

Implications for the Profession and/or Patient Care

This study provides clinical nurses with information about using continuous monitoring when caring for patients who are receiving supplemental oxygen in the general care setting. The study also assesses patient safety of the practice of using pulse oximetry for monitoring in this patient population.

Impact

This study addresses concerns related to using continuous pulse oximetry monitoring for deterioration detection when patients are receiving supplemental oxygen. This study found no evidence that pulse oximetry-based continuous monitoring significantly degrades or delays detection of severe deterioration episodes for patients receiving supplemental oxygen. The results can be used by the inpatient nursing community to ensure safe practices are in place for patient care.

Reporting Method

This study adheres to the STROBE reporting method.

No Patient or Public Contribution

Patient and/or public contribution was not deemed applicable for the rigorous design and execution of this study.

☐ ☆ ✇ BMJ Open

Factors influencing the decision to accept or decline aortic valve replacement for asymptomatic aortic stenosis: a nested longitudinal qualitative substudy of the EASY-AS randomised trial

Por: Allmark · P. · Taylor · B. · Tod · A. M. · Ryan · T. · Dweck · M. · McCann · G. P. · Singh · A. — Enero 22nd 2026 at 13:48
Objective

To examine how patients and family members decide whether to accept a highly invasive intervention (aortic valve replacement (AVR)) when their condition (aortic stenosis (AS)) is asymptomatic and its course uncertain.

Design

Nested, longitudinal, qualitative substudy of an ongoing randomised controlled trial (RCT) (NCT04204915) testing early intervention (EI) versus watchful waiting (WW) in patients with asymptomatic severe AS.

Setting

Six select UK sites of the RCT.

Participants

Select participants of the RCT, their next-of-kin and some who declined RCT participation.

Results

73 interviews were conducted, with 41 participants.

Few knew much about AS before diagnosis. Uncertainty and the need for reliable information regarding symptoms and progress was a significant problem.

While some expressed unease at a major intervention for an asymptomatic condition, there were no outright objections to the idea.

Those who declined participation in the RCT did so for personal reasons, for example, their home circumstances did not permit the required period of recovery or they felt too old to risk intervention.

Reasons for accepting early intervention included the belief that the condition was serious and likely to deteriorate, and so better to have the intervention before such deterioration, as well as avoiding long waiting lists. Trusting clinicians’ judgement played a part in some decisions. Patients also wanted choice in the type of intervention received.

The longitudinal interviews (n=32) showed satisfaction in the early intervention group despite some problems in the the early recovery phase, especially for those undergoing surgical AVR.

Conclusions

Where evidence supports major intervention for an asymptomatic condition, patients are likely to accept the offer, although personal circumstances play an important role in decision-making. Where a condition is not well known to the public, such as AS, patients rely on clinicians and other resources to help decide. Liaison with patient groups in developing shared decision-making resources may help with complex decisions.

Trial registration number

NCT04204915

☐ ☆ ✇ Journal of Advanced Nursing

Nursing Perspectives on Factors That Influence Provision of Patient‐Centered Care for Autistic Patients in a Large Urban Hospital System: A Qualitative Study

ABSTRACT

Aim

To characterise nurses' perspectives on factors that influence their ability to provide patient-centered nursing care for autistic patients in a large urban hospital setting.

Design

Qualitative exploratory study.

Methods

We conducted semi-structured interviews via Zoom with nurses from a large urban hospital serving primarily adult patients. We analysed interviews using codebook/template analysis. Two researchers coded each interview and resolved discrepancies through discussion.

Results

Twelve nurses (3 males) with 2–20 years of professional experience across research, management, and patient care roles were interviewed. Three primary themes were generated: (1) barriers to patient-centered care, including lack of formal autism education, factors related to the hospital setting, and specific nurse characteristics, such as inflexible adherence to care routines; (2) facilitators of patient-centered care, including experiential autism knowledge, caregiver involvement, and specific nurse characteristics, such as showing respect for all patients; and (3) missed opportunities for patient-centered care, including underuse of behavioural care teams, inadequate time for planning and preparation, and reliance upon restraints and security personnel for behaviour management.

Conclusion

Nurses identified several areas where consistent implementation of existing processes could improve care. A key finding was the need to explore more patient-centered alternatives to the use of restraints and security personnel in response to aggressive or self-injurious behaviour. Overall, our results support the need for competency training to facilitate increased nursing comfort and ability to provide patient-centered care for autistic patients.

Implications for the Profession

This work suggests nurses gain much of their autism-related knowledge through patient care experiences. Despite providing the majority of hands-on care, nurses receive little to no formal training about caring for the growing autistic population.

Impact

This work has identified targeted areas to improve education and processes in caring for autistic patients.

Patient or Public Contribution

No patient or public contribution.

☐ ☆ ✇ BMJ Open

Transforming first response through non-police, community safety response programmes: a peer-reviewed and grey literature scoping review protocol

Por: Todd · T. L. · Lappen · H. · Neath · S. · Markham · M. J. · Purtle · J. · Allen · B. · Rouhani · S. · Friedman · B. — Diciembre 5th 2025 at 09:25
Introduction

Police are frequently dispatched to a wide range of 911 calls, including mental and behavioural health crises, despite lacking the training, resources and time to respond effectively. In particular, people with serious mental illness are at elevated risk of experiencing excessive use of force, arrest and continued criminal legal involvement following police contact. Following the murder of George Floyd and other highly publicised police killings, Community Safety Response (CSR) programmes, staffed by unarmed peers, mental health professionals and other trained responders, have proliferated to provide non-police responses to mental and behavioural health and other quality-of-life concerns. CSR programmes have expanded rapidly, yet the evidence base remains fragmented and largely outside the peer-reviewed literature.

Methods and analysis

This scoping review will synthesise peer-reviewed and grey literature from 2020 to present on CSR programmes operating in North America. Guided by Joanna Briggs Institute methodology and reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) standards, we will search multiple databases (Medline, PsycINFO, Embase, SocIndex, Web of Science, Policy Commons) and employ complementary grey literature search strategies, including targeted website searches, reference tracking and review of internal and external reports and evaluations. Inclusion criteria require that programmes provide non-police first response to calls traditionally served by law enforcement and include information on programme operations or outcomes. Two reviewers will independently screen and extract data on process metrics including operational characteristics, dispatch, funding, services provided and outcomes such as populations served, diversion from police, service linkage and use of force.

Ethics and dissemination

No ethical review for this study is required as it will not include human subjects or any identifiable information. Findings will provide the first national synthesis of CSR programme models, operations and outcomes. Results will inform policy-makers, practitioners, researchers and community members. Findings will be disseminated through peer-reviewed publications and public-facing products to support implementation, scale-up and sustainability of CSR programmes.

☐ ☆ ✇ BMJ Open

Stakeholder perceived value of telehealth: a systematic review

Por: Sumanasekera · K. · Todorova · N. — Noviembre 18th 2025 at 06:10
Objective

Telehealth has the potential to address challenges faced by the healthcare industry. To achieve the intended goals of telehealth programmes, stakeholders should engage with these services. Prior research demonstrates that perceived value influences stakeholder engagement in a system-based service. Therefore, this review aims to synthesise the value perceptions of telehealth stakeholders.

Design

The review followed Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.

Data sources

Articles published between 1 January 2013 and 31 December 2024 were identified through SCOPUS, PubMed and Association for Computing Machinery (ACM) digital library database search, and screening relevant article reference and citation lists.

Eligibility criteria for selecting studies

Articles examining a single-specific telehealth application, proving evidence of post-use value by one or more stakeholder groups were selected.

Data extraction and synthesis

Two independent reviewers used standardised methods to search, screen and code included studies. Information was recorded related to telehealth type, stakeholders, reported perceived value from the articles and codes were developed successively from specific perceived outcomes.

Results

140 articles were included in the review. The selected studies assessed various types of telehealth applications with a balanced representation of the types of care, telehealth modality and service. The stakeholders were patients and/or healthcare providers; the majority (82.85%) focusing on patients’ view. The reported perceived value outcomes were diverse and categorised into six themes: access to care, care effectiveness and efficiency, quality of care, affective outcomes and human capital. None of the studies reported all these value dimensions and there wasn’t a single value dimension reported by all studies.

Conclusion

The review demonstrates the diversity and fragmentation in perceived value of telehealth. Within each theme, there were variances in how different stakeholders defined their meaning. These insights highlight the multi-dimensional and context-specific nature of perceived value. This comprehensive view of value can inform the design of telehealth programmes to motivate the engagement of all stakeholders.

☐ ☆ ✇ BMJ Open

Clinical utility and cost-effectiveness of BeginNGS newborn screening by genome sequencing and standard newborn screening for severe childhood genetic diseases: an adaptive, international and comparative clinical trial

Por: Reimers · R. · Bailey · M. · Brown · C. · Chan · K. · Defay · T. · Finkel · T. · Kahn · S. · Protopsaltis · L. · Stoddard · L. · Talati · A. J. · Wigby · K. · Akil · A. S. A.-S. · Wright · M. · Kingsmore · S. F. · BeginNGS Consortium · Kingsmore · Defay · Perez · Reimers · Ponte · Son-Ri — Noviembre 14th 2025 at 06:04
Introduction

In the last 60 years, newborn bloodspot screening (NBS) has expanded as a public health intervention from a single severe childhood genetic disease (SCGD) to up to as many as 80 SCGD and testing of ~40 million newborns/year worldwide. However, the gap between current NBS and its potential to increase the efficiency, effectiveness and global equity of healthcare delivery for SCGD is large and rapidly growing. There are now effective therapeutic interventions—drugs, diets, devices and surgeries—for up to 2000 SCGD. Since almost all SCGD can be identified by bloodspot genome sequencing, it has been a longstanding goal to supplement current NBS with genome sequencing-based NBS (gNBS) for all eligible SCGD. We recently described a novel gNBS platform (named Begin Newborn Genome Sequencing (BeginNGS)) with the potential to overcome several major challenges to gNBS (cost, scalability, false positives and an unprepared healthcare workforce). A pilot clinical trial of BeginNGS for 412 SCGD in a level IV neonatal intensive care unit (NICU) had a true positive rate of 4.2%, sensitivity of 83%, positive predictive value of 100% and clinical utility rate of 4.2%, indicating readiness of the platform for use in a powered, multicentre study.

Methods and analysis

The BeginNGS study is a single group, international, multicentre, adaptive clinical trial to compare utility, acceptability, feasibility and cost-effectiveness of BeginNGS gNBS (experimental intervention) with standard NBS (control). A minimum of 10 000 neonates (aged 50 000 US children per year.

Ethics and dissemination

This study was approved by the WCG Clinical institutional review board on 14 February 2024, and the most recent amendment approved on 7 October 2025 (approval number 20235517). Study findings will be shared through research consortium workshops, national and international conferences, community presentations and peer-reviewed journals.

Trial registration number

NCT06306521.

☐ ☆ ✇ BMJ Open

Validation and cost-effectiveness of an mHealth tool for cognitive impairment detection in Peru: protocol for the IMPACT Salud observational study

Por: Cardenas · M. K. · Anza-Ramirez · C. · Bernabe-Ortiz · A. · Custodio · N. · Montesinos · R. · Miranda · J. J. · Da Re · M. · Belon-Hercilla · M. V. · Lazo-Porras · M. · Hawkins · J. · Diez-Canseco · F. · Moore · G. · Whiteley · W. · Calvo · R. A. · Cuba-Fuentes · M. S. · Landeiro · F. — Noviembre 10th 2025 at 05:24
Introduction

Dementia is a chronic and progressive neurological condition characterised by cognitive and functional impairment. It is often associated with multimorbidity and imposes a significant economic burden on healthcare systems and families, especially in low-income and middle-income countries. In Peru, where dementia cases are increasing rapidly, timely detection and referral for diagnosis is crucial. This protocol is part of the IMPACT Salud project in Peru. Here, we focus on a specific component aimed at validating an mHealth tool for the detection of cognitive and functional impairment and assessing its cost-effectiveness. We will also assess changes in cognitive and functional impairment as well as health economic outcomes over 1 year.

Methods and analysis

This observational study will be conducted in four geographically diverse regions of Peru. Community health workers are expected to contact approximately 32 000 participants (≥60 years) to apply an mHealth-enabled tool that includes cognitive and functional instruments: Ascertain Dementia 8, Peruvian version of Rowland Universal Dementia Assessment Scale and Pfeffer Functional Activities Questionnaire. From this large sample, we aim to find 3600 participants and their study partners to enrol and interview at baseline regarding sociodemographic characteristics, lifestyles, comorbidities and health economic data including resource use, costs and health-related quality of life (HR-QoL). Psychologists, blind to previous results, will assess dementia stage of the participants using an abbreviated Clinical Dementia Rating (CDR) scale. At 6-month follow-up, participants will complete a brief health economics questionnaire on resource use, costs and HR-QoL. To validate the accuracy of the detection tool, a subsample of 600 participants who completed the baseline will undergo a gold-standard clinical neuropsychological assessment. This subsample will participate in a 12-month follow-up, including health economics, cognitive and functional impairment tests and the CDR scale. Results will be analysed and presented by cognitive status, site, sex and multimorbidity profile. Finally, data from all stages and external sources will inform a decision model to implement a cost-effectiveness analysis of the detection tool at the national level.

Ethics and dissemination

The study received ethics approval in Peru (Universidad Peruana Cayetano Heredia: CONSTANCIA-CIEI-378-33-23) and in the UK (Imperial College London: ICREC/SETREC reference number 6647445). Informed consent will be obtained from participants and their study partners, considering the participant’s capacity to consent. For illiterate participants, consent will be obtained through a witnessed procedure involving study partners, with a fingerprint obtained instead of a signature. The results will be disseminated through conferences, published articles, public presentations (particularly to those involved in dementia care) and presentations or meetings with local health authorities.

☐ ☆ ✇ BMJ Open

Trends and factors associated with modern contraceptive use among sexually active female youths in Tanzania, 2004-2022

Por: Ollomy · F. · Msuya · S. E. · Todd · J. · Meku · S. · Samwel · E. L. · Lutobeka · J. · Mboya · E. A. · Ndeki · D. · Mboya · I. B. — Octubre 21st 2025 at 08:30
Objective

The study aimed to assess the trends and factors associated with modern contraceptive use among female youths (15–24 years) in Tanzania from 2004 to 2022.

Design

We performed secondary analysis of cross-sectional data from four consecutive Demographic and Health Surveys (DHS) in Tanzania: 2004, 2010, 2015/2016 and 2022.

Setting

Tanzania.

Participants

Sexually active female youths (n=8659).

Primary outcome

The use of any modern contraceptive method, coded as Yes or No.

Results

The sample had a median age of 21 (IQR 18–22 years), with 63.7% aged 20–24 years. Modern contraceptive use among female youths increased from 24.6% in 2004 to 32.1% in 2022. Consistent across surveys, modern contraceptive use was positively associated with secondary or higher education level, having one or more live births and engaging in sexual activity within the month preceding the survey. Additionally, adolescents (15–19 years) demonstrated a weak protective association, indicating a reduced likelihood of modern contraceptive use compared with young women (20–24 years). In 2015/2016 and 2022 surveys, primiparous, multiparous and married/cohabiting women were more likely to use modern contraceptives than nulliparous women.

Conclusions

Modern contraceptive use among female youths increased gradually in Tanzania between 2004 and 2022 Tanzania DHS. To sustain these upward trends and reduce the risk of unwanted pregnancies and sexually transmitted infections, public health policies should consider the factors positively associated with modern contraceptive use, particularly among young women aged 20–24 years, married/cohabiting, who have initiated childbearing and those with high education levels.

☐ ☆ ✇ BMJ Open

How can citizen science enhance mental health research quality: theory of change development

Por: Todowede · O. · Rennick-Egglestone · S. · Boyd · D. · Moran · S. · Bell · A. · Sweeney · A. · Hart · A. · Tomlin · A. · Robotham · D. · Repper · J. · Rimmer · K. · Brown · M. · Howells · M. · Singh · S. · Lavis · P. · Higton · F. · Hendy · C. · Slade · M. — Septiembre 25th 2025 at 11:09
Objective

Public involvement in mental health research enhances research quality. The use of citizen science methods in mental health research has been described as a conclusion of a movement towards increased public involvement; however, this field is in its early stages of development. Our objective was to create a theory of change (ToC) for how citizen science can be used to enhance mental health research quality.

Design

Iterative consultation with the stakeholders of an existing citizen mental health science study, that is, change for citizen science to achieve co-production at scale (C-STACS: https://www.researchintorecovery.com/research/c-stacs/)

Methods

We co-developed a ToC through an iterative consultation with C-STACS stakeholders who were (a) representatives of mental health community organisations (n=10), individuals with public involvement experience (n=2) and researchers (n=5). In keeping with established ToC practice, entities were identified, including long-term impacts, outcomes needed to create an impact, stakeholder assumptions and indicators for tracking progress.

Results

A desired primary long-term impact of greater co-production of research was identified between researchers and members of the public, which would create a secondary impact of enhancing public capacity to engage in citizen mental health science. We proposed long-term outcomes needed to enable this impact: (1) greater co-production of research objectives and pathways between researcher and the public, (2) greater embedment of citizen mental health science into funder processes (eg, the creation of specific funding calls for citizen mental health science proposals, (3) greater clarity on the boundaries between citizen science and other participatory approaches (eg, so that there is not loss of impact due to conceptual confusion between these, (4) increased knowledge around effective frameworks to enable mass public participation and (5) greater availability of technology platforms, enabling safe and accessible engagement with citizen mental health science projects.

Conclusion

The proposed ToC is grounded in the C-STACS project, but intended to be broadly applicable. It allows the continued formation of a community of practice around citizen mental health science and should be reviewed, as greater knowledge is developed on how citizen mental health science creates change.

☐ ☆ ✇ BMJ Open

Practice of oxygenation and respiratory support during fibreoptic bronchoscopy: the OxyFOB study protocol

Por: Longhini · F. · Crimi · C. · Noto · A. · Pelaia · C. · Karakurt · Z. · Skoczynski · S. · Boleo-Tome · J. P. · Winck · J. C. · Esquinas · A. M. · Melhorn · J. · Corneci · D. · Pobeha · P. · Bosco · V. · Garofalo · E. · Bruni · A. · Cammarota · G. · Todorova · V. · Puci · M. V. · Sotgiu · G. — Septiembre 2nd 2025 at 15:14
Introduction

Flexible bronchoscopy (FB) is widely used for diagnostic and therapeutic procedures in pulmonary medicine. However, FB can cause respiratory and haemodynamic complications, especially in patients with pre-existing lung and/or cardiovascular comorbidities. Despite the range of oxygenation and ventilatory approaches available to prevent these risks, evidence regarding their real-world application and clinical impact is limited. The OxyFOB study aims to assess the prevalence and outcomes of various oxygenation and ventilatory support strategies used during FB across Europe.

Methods and analysis

The OxyFOB study is a large, prospective, international, observational cohort study which aims to involve over 10 000 FB procedures across European centres. Eligible participants include all adults undergoing FB for diagnostic, therapeutic or procedural indications. Data are collected via a standardised electronic case report form and encompass demographic information, procedural details and clinical outcomes. The primary endpoint is the prevalence of oxygenation and ventilatory support strategies: conventional oxygen therapy, high-flow oxygen therapy, continuous positive airway pressure, non-invasive ventilation and invasive mechanical ventilation. Secondary outcomes include periprocedural respiratory and haemodynamic events, patient comfort, dyspnoea and postprocedural complications. Statistical analyses include descriptive statistics, subgroup comparisons and multivariate logistic regression.

Ethics and dissemination

The study has received ethical approval from the coordinating centre (protocol n. 22/2022 on the 20 January 2022, by the ‘Comitato Etico Sezione Area Centro - Regione Calabria’) and all participating sites. Informed consent is given from all patients or their legal representatives. Findings will be disseminated through peer-reviewed publications and presentations at international meetings. Data will be managed and made available on reasonable request to support further research.

Trial registration number

ClinicalTrials.gov ID: NCT05681962. Registered January 2023.

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