Conectar
Burn injuries pose a significant challenge in resource-limited settings, particularly during humanitarian crises. This study examines the epidemiology, management, and outcomes of burn patients at a tertiary hospital in Damascus, Syria, from 2021 to 2024. A single-centre retrospective cohort study was conducted on 500 admitted burn patients. Data on demographics, injury characteristics, management, complications and mortality were analysed using descriptive statistics, chi-square tests, Mann–Whitney U tests and binary logistic regression. The lethal area 50% (LA50) was estimated using the logistic regression equation: LA50=−constant+∑bixibTBSA$$ LA50=-\frac{constant+\sum \left({b}_i{x}_i\right)}{b_{TBSA}} $$. The mean patient age was 20.5 ± 17.9 years, with a male predominance (55%). Flame burns (72.4%) at home (87.6%) were most common. The mean total body surface area burned was 30.99% ± 21.31%, with 68.6% being full-thickness injuries. The complication rate was 91%, with infection being most prevalent. The overall mortality rate was 39%, with sepsis (56.4%) as the leading cause. Logistic regression identified larger burn area (OR = 1.152, p < 0.001), full-thickness depth (ref. partial thickness, OR = 0.281, p < 0.001), older age and female gender as independent predictors of increased mortality. Deceased patients had significantly shorter hospital stays. LA50 was 42.63% for a 40-year-old male with a partial-thickness flame burn and a 10-day hospital stay; for a female with a full-thickness flame burn under the same conditions, it was 27.43%. This study reveals an alarmingly high burden of burn injuries in a crisis-affected setting, with extreme complication and mortality rates. The findings highlight the critical impact of extensive burns and sepsis, underscoring severe systemic constraints on care. Urgent context-specific interventions to strengthen acute burn management, infection control, and prevention strategies are imperative.
The cover image is based on the article by Caring Science as a Mature Solution to Global Healthcare Challenges by Sara Horton-Deutsch et al., https://doi.org/10.1111/jan.70237
Primary care is facing multiple crises, including an increase in health misinformation. Digital health messaging by primary care providers has been shown to reach a diverse patient population. With the uptake of Generative Artificial Intelligence (GenAI) usage in healthcare, there is an important opportunity to rapidly create messages that are tailored to different populations and conditions. However, thoroughly assessing artificial intelligence (AI)-generated content is essential, as GenAI raises concerns regarding its accuracy, understandability, actionability and bias perpetuation. We aim to investigate whether digital health messages created by GenAI are evaluated as non-inferior compared with those created by human experts.
The AI-CARE (AI to Create Accessible and Reliable patient Education materials) study is a double-blind, crossover, non-inferiority randomised controlled trial. Data collection began on 30 May 2025, and is expected to be completed at the end of May 2026. Over 12 months, 192 messages on 48 topics will be written: half by primary care and public health experts and half by a GenAI tool (OpenAI’s ChatGPT). Review Panels composed of 24 primary care providers and 24 patients will evaluate these messages using an Evaluation Grid developed to assess the messages’ quality of information, adaptation to the target audience, relevance and usefulness, and readiness to be shared with patients. Evaluations will be completed via online REDCap (Research Electronic Data Capture) surveys and the order in which the 192 messages appear will be randomised and will vary between individuals. Participants and analysts will be blinded to the generation source. The primary outcome will be the Clarity and Understandability score.
The Research Ethics Boards of the Hôpital Montfort (24-25-11-038) and the University of Ottawa (S-12-24-11153) formally approved this study in December 2024. Reported data will be grouped and anonymised for dissemination in peer-reviewed scientific journals and conferences.
To explore how nursing teams (co)organise their work environment by going beyond caregiving.
A descriptive qualitative study with a phenomenological approach.
Semi-structured group interviews were conducted in 2022 with nurses and managers from 18 nursing teams in a general hospital located in the Netherlands. In each group interview, 2–3 participants per team took part. The interviews were audio-recorded, transcribed verbatim, and analysed using thematic analysis.
The analysis identified four main themes contributing to a more supportive work environment: (1) embracing diversity, (2) stretching nursing roles, (3) raising voices, and (4) aligning nurses and managers. These themes show how nursing teams go beyond caregiving and actively shape and co–organise their work environment.
Teams that extend their roles create more supportive work environments, enhancing patient care and professional development. These findings contribute to the understanding of organising professionalism in nursing and provide insights for nursing teams striving to improve their work environments.
Nursing teams can use the four themes—as team features—to reflect upon their organising roles and engagement with their work environment. Our findings offer practical insights for nurses with responsibilities in areas such as team development and leadership. They can focus on team diversity, voicing, stretching roles, and organisational alignment, and facilitate their teams to become more assertive.
The Consolidated criteria for Reporting Qualitative research guideline was followed.
No patient or public involvement.
by Clarisse Kagoyire, Albert Ndagijimana, Gilbert Nduwayezu, Jean Nepo Utumatwishima, Jean Pierre Mpatswenumugabo, Marie Anne Mukasafari, Diane Rinda, Vedaste Ndahindwa, Kristina Elfving, Gunilla Krantz, Torbjörn Lind, Ali Mansourian, Renée Båge, Ewa Wredle, Elias Nyandwi, Aline Umubyeyi, Jean Baptiste Ndahetuye, Petter Pilesjö
Despite national progress, stunting remains prevalent in specific regions of Rwanda, highlighting the limitations of coarse-resolution data for effective mapping and intervention planning. This study explored optimal spatial resolution and analytical approach to capture localised dynamics and the multifactorial nature of stunting. A cross-sectional, population-based study was conducted in the Northern Province of Rwanda, focusing on children aged 1–36 months. Data were collected using structured questionnaires covering socio-demographic, economic, health, childcare, livestock factors and anthropometric measurements. Environmental characteristics were obtained from national datasets, while household geographic coordinates were captured using a customized mobile geodata platform (emGeo). After data cleaning, predictors were analysed using univariable and multivariable logistic regression as well as geographically weighted logistic regression (GWLR) to account for spatial heterogeneity. Among 601 children, stunting prevalence was 27% (boys 33.8%; girls 20.9%). GWLR improved model fit, increasing adjusted deviance explained from 34% to 39%. Significant predictors included child age (adjusted OR = 2.46; 95% CI: 1.78–3.39), male sex (OR = 2.83; 95% CI: 1.65–4.86), birthweight (OR = 0.71; 95% CI: 0.54–0.94), maternal autonomy (ability to refuse sexual intercourse; OR = 0.48; 95% CI: 0.27–0.86), inconsistent maternal social support (OR = 2.30; 95% CI: 1.20–4.42), household electricity access (OR = 0.48; 95% CI: 0.27–0.84) and handwashing facilities (OR = 0.21; 95% CI: 0.07–0.67). GWLR revealed substantial spatial heterogeneity in these factors, delineating areas where each factor matters most. This household-level, spatially explicit analysis reveals localised risk patterns often masked by aggregated national data. Prioritising context-specific interventions (such as electrification, hygiene promotion, and enhanced maternal social support), can enhance effectiveness. The proposed analytical workflow provides a model for addressing persistent stunting in other resource-limited settings.Adnexal torsion is a gynaecological emergency in which prompt diagnosis and management are critical to preserving ovarian function. However, the clinical presentation is often non-specific, and diagnosis primarily relies on pelvic ultrasound, a modality with limited sensitivity that can lead to misdiagnosis and unnecessary surgery. Contrast-enhanced ultrasound (CEUS) has emerged as a promising imaging technique that may enhance diagnostic accuracy by better characterising adnexal vascularisation.
The aim of this study is to assess whether the addition of CEUS to standard diagnostic procedures can reduce the rate of unnecessary emergency surgeries. Specifically, we compare two diagnostic strategies in cases of high clinical suspicion of adnexal torsion: the current standard approach versus an experimental strategy incorporating CEUS. The primary outcome is the rate of inappropriate surgical interventions, defined as emergency surgery performed within 6 hours without intraoperative confirmation of torsion.
This is a prospective, open-label, multicentre, randomised (1:1), controlled, superiority trial. A total of 256 women presenting with a high clinical suspicion of adnexal torsion will be enrolled over a period of 36 months. Participants will be randomly assigned to either the standard diagnostic strategy or an experimental strategy that includes CEUS. The primary endpoint is the proportion of emergency surgical procedures (performed within 6 hours of hospital admission) in which adnexal torsion is not confirmed.
The study was approved by the French Ethics Committee, the CPP (Comité de Protection des Personnes) on 28 October 2024. The results of this study will be published in peer-reviewed journals and presented at relevant national and international conferences. The ethical approval number from the CPP is 6115.
NCT06677554; 2024-511720-13-00.
by Jeanette Alcaraz, Charlotte Keyse, Charles Hall, David W. Walker, David P. Doupé, Rebecca I. Clark
Inflammaging is considered a driver of age-associated pathology across tissues. Similarly, intestinal permeability is a feature of ageing and underlies a range of inflammatory and age-related diseases. Increased intestinal permeability has been described as both a cause and a consequence of inflammation. Both intestinal permeability and inflammation are closely associated with microbial dysbiosis, epithelial dysplasia and mortality but dissecting the complex interplay between these phenotypes remains challenging. Here we genetically induce intestinal immune activation in Drosophila and stratify animals by their intestinal barrier status using the Smurf assay. We demonstrate that intestinal barrier failure has a distinct impact on the microbiota. Further, immune activation, both within the intestine and systemically, drives intestinal barrier failure and mortality even in the absence of the microbiota. Importantly, immune-induced intestinal barrier failure takes time to develop and is closely associated with the onset of mortality. Our work adds to building evidence that the impact of intestinal permeability on the microbiota and on animal health needs to be considered independently of its relationship with inflammation.To combine qualitative and quantitative data to evaluate the feasibility, participant satisfaction and effectiveness of a hybrid pulmonary rehabilitation programme following hospital discharge for an exacerbation of chronic obstructive pulmonary disease (COPD).
Convergent parallel mixed method study nested in a larger ongoing prospective study; this report includes a subset of 21 participants who complete the qualitative and quantitative assessments between May 2023 and January 2024.
Semi structured interviews using open-ended questions were conducted and analysed using a thematic analysis approach. Participants were interviewed after completing an 8-week hybrid home-based rehabilitation programme, including four face-to-face and four remote sessions. Quantitative assessments—covering disease impact, anxiety and depressive symptoms, and exercise tolerance—were conducted at the beginning and end of the intervention in the same participants who took part in the interviews, and a 10-item satisfaction questionnaire was also completed after the programme.
May 2023 to January 2024.
GRAMMS checklist was followed.
21 people with chronic obstructive pulmonary disease (11 females; mean age 62 ± 7 years; mean FEV1 30% ± 10% of predicted) were interviewed. Five major themes were identified: (i) accessibility and adaptation to individual needs; (ii) confidence in the transdisciplinary care manager model, confirmed by high satisfaction score (95/100); (iii) integration of informal carers; (iv) perceived benefits supporting maintenance of health behaviour, consistent with the statistically and clinically significant improvements observed across all quantitative outcomes; and (v) hybrid programme challenges (technical issues and preference for face-to-face visits).
The hybrid programme resulted in significant improvements in physical and psychological outcomes, and participants reported high levels of satisfaction. Qualitative findings highlighted the value of home-based delivery, supervision by a single care manager, informal carer involvement and emotional support in shaping feasibility and satisfaction. However, challenges related to remote sessions indicate that telerehabilitation may not be suitable for all patients and should not be used as a standalone PR option.
Given the strong preference of participants for face-to-face visits over remote visits, telerehabilitation should always include a minimum of individual or group face-to-face supervised sessions. The balance between supervision modalities should be personalised according to participants' needs and progress.
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.
To determine whether femoral arterial pressure monitoring reduces norepinephrine use compared with radial monitoring in cardiac surgery patients.
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%.
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.
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.
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.
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.
To identify key communication skills for Canadian nursing practice.
Quantitative research using a nationwide survey.
Exploratory confirmatory factor analysis was used to identify factors underlying key communication skills required for nursing practice. Multiple regression analyses were used to examine differences across demographic variables, designations, roles and settings.
Dimensions of effective communication skills were identified. Demographic and contextual variables showed some impact on the perceived importance of communication skills, but low variance suggested that language demands are relatively consistent across roles and settings.
A framework describing the communication demands for Canadian nursing practice is described, contributing to the development of tailored curricula, assessments and policies.
Focusing on communication skills ensures that nurses are equipped to deliver safe healthcare and interact effectively with patients and colleagues, potentially leading to improved health outcomes.
To our knowledge, this study is the first to develop a framework for communication skills and identify key language skill factors across nursing professional designations and practice settings. The research provides a framework for developing curricula and training programmes that focus on essential communication skills.
No patient or public contribution.
To evaluate the available virtual reality (VR) applications for treating perinatal mental health disorders, focusing on their effectiveness in reducing symptoms such as anxiety and depression, which are common during the perinatal period.
Rapid scoping review adhering to the Joanna Briggs Institute guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Review (PRISMA-ScR), with adjustments based on the Cochrane Rapid Reviews guidelines.
Medline, PsychInfo, Embase, Evidence-Based Medicine (EBM) Reviews using Ovid and Web of Science were searched through 20 February 2024.
Studies were included if they were written in English or French, provided details on the VR technology, described the assessment of perinatal mood disorders and specified the outcomes measured and the methodological approach used. Review and editorial articles were excluded as well as abstracts and posters.
One reviewer extracted study characteristics (eg, design, participants, VR components, outcomes) and a second reviewer verified accuracy; study quality was assessed using the National Institute of Health (NIH) Quality Assessment of Controlled Intervention Studies tool, and findings were synthesised narratively and in tabular form.
A total of 425 records were identified. After removing duplicates, 308 records were screened by title and abstract. Of these, 74 full texts were assessed for eligibility, resulting in 10 studies being included for data extraction. These final studies were primarily conducted in high-income countries from 2019 to 2024. 8 of 10 (80%) were randomised controlled trials, employing VR through head-mounted displays. Studies predominantly targeted non-severe cases of anxiety and depression, with VR environments ranging from nature scenes to therapeutic content. Results suggest a positive impact of VR interventions on reducing anxiety and depression levels among participants.
Studying VR appears to be a promising avenue for developing options to manage perinatal mental health. The immersive nature of VR may provide opportunities for emotional relief and support during this critical period through engaging experiences which can reduce symptoms of anxiety and depression. However, the body of research remains limited, indicating a need for further studies to explore the long-term benefits and potential integration of VR into perinatal healthcare practices. The promising results from initial studies encourage continued exploration and development within this innovative therapeutic field.
by Jarad A. Lewellen, Cami A. Barnes, Aidan Forget, Jeanette M. Garcia, D. Jake Follmer, Guy Hornsby, Hannah L. Silva-Breen, Peter R. Giacobbi Jr.
Research has supported the use of virtual reality (VR) in sport to train skills such as decision-making and anticipation, as well as aid in injury rehabilitation. Despite this, VR is not commonly used as a training tool in sport. Barriers to its adoption include a lack of understanding, low awareness, risk of cybersickness, and cost. As such, there is a critical need to address these barriers and promote acceptance of VR in sport. The purpose of this single-arm, non-randomized, mixed-methods feasibility trial was to examine the feasibility of the Virtual Reality Education and Acceptance Protocol (VREAP), which was designed by the study’s authors to address barriers to VR adoption. While the VREAP is intended to be used in multiple domains, we assessed its feasibility among baseball and softball players. Specifically, we assessed pre- and post-training attitudes toward VR using the Attitudes toward Virtual Reality Technology Scale (AVRTS), which uses the Technology Acceptance Model (TAM) as a guiding framework. Participants (n = 18) completed the VREAP, which includes stages of education, acclimation, and application. Exit interviews provided further insights into participant experiences. Results from quantitative and reflexive content analyses demonstrated feasibility of the VREAP based on recruitment and adherence, acceptability, demand, implementation, and practicality. Statistical analyses from the AVRTS revealed significant pre- to post-training increases in overall attitudes toward VR as well as increases in enjoyment, perceived usefulness, and ease of use. Minimal cybersickness was reported. Our findings demonstrate the feasibility of the VREAP among baseball and softball players and show promise for its future research and application.by Nathanael J. Kuzio, Marco Tonelli, Jasna Fejzo, Jeanne A. Hardy
Proteases represent a difficult family of proteins to purify, concentrate and store at homogeneity due to their toxicity during overexpression and their propensity to self-cleave, leading to the loss of sample stability and function. A protease of interest, caspase-6, is a member of the apoptotic family of caspases, and has been shown to be involved in human neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s disease. Previous studies have elucidated key structural aspects and potential inhibition mechanisms of caspase-6 through various structural biology techniques such as x-ray crystallography and hydrogen-deuterium exchange mass spectrometry. However, caspase-6 undergoes a structural transition that requires atomic-resolution insight in solution to understand the conformational transitions and ensemble. This can be most optimally achieved using multi-dimensional biomolecular NMR. Prior attempts to study caspase-6 by NMR have failed due to challenges in sample preparation and insufficient protein concentration. Here, we document our exploratory strategy, which ultimately led to the refinement of crucial sample preparation steps and enabled us to obtain isotopically-labeled caspase-6 in yields suitable for heteronuclear NMR studies. We present this work in the hope that it will assist others in the preparation of difficult protein samples, particularly proteases.by Claude Emmanuel Koutouan, Marie Louisa Ramaroson, Angelina El Ghaziri, Laurent Ogé, Abdelhamid Kebieche, Raymonde Baltenweck, Patricia Claudel, Philippe Hugueney, Anita Suel, Sébastien Huet, Linda Voisine, Mathilde Briard, Jean Jacques Helesbeux, Latifa Hamama, Valérie Le Clerc, Emmanuel Geoffriau
Resistance of carrot to Alternaria leaf blight (ALB) caused by Alternaria dauci is a complex and quantitative trait. Numerous QTL for resistance (rQTLs) to ALB have been identified but the underlying mechanisms remain largely unknown. Some rQTLs have been recently proposed to be linked to the flavonoid content of carrot leaves. In this study, we performed a metabolic QTL analysis and shed light on the potential mechanisms underlying the most significant rQTL, located on carrot chromosome 6 and accounting for a large proportion of the resistance variation. The flavonoids apigenin 7-O-rutinoside, chrysoeriol 7-O-rutinoside and luteolin 7-O-rutinoside were identified as strongly correlated with resistance. The combination of genetic, metabolomic and transcriptomic approaches led to the identification of a gene encoding a bHLH162-like transcription factor, which may be responsible for the accumulation of these rutinosylated flavonoids. Transgenic expression of this bHLH transcription factor led to an over-accumulation of flavonoids in carrot calli, together with significant increase in the antifungal properties of the corresponding calli extracts. Altogether, the bHLH162-like transcription factor identified in this work is a strong candidate for explaining the flavonoid-based resistance to ALB in carrot.Healthcare systems face a growing challenge: as technology advances, patients increasingly feel like data points in systems that prioritise efficiency over empathy. This paper addresses the global healthcare crisis of disconnection, arguing that fundamental change requires putting human experience at the centre through Caring Science principles in nursing.
COVID-19 clearly revealed this disconnect. While showcasing scientific advances, it exposed gaps in compassionate care and fair access globally. Nurses struggled to maintain human connection while dealing with resource shortages and isolation protocols, proving that advanced medical treatments alone cannot address the physical, emotional, spiritual, and social factors that influence health.
This work draws on peer-reviewed studies, contemporary research, and theories of human caring to demonstrate the global responsibility and urgent need for integrating caring practices into healthcare systems. Collectively, this evidence underscores both the necessity of intervention and the effectiveness of Caring Science as a strategy for transforming organisational practices while highlighting a pressing truth: healthcare systems worldwide must move beyond efficiency alone and intentionally weave caring practices into their structures.
This analysis examines Caring Science through three key areas: Relational, Organisational, and Global. Using Watson's Theory of Human Caring and current research, the paper shows how caring relationships can improve through thoughtful use of innovation. Recent healthcare improvements demonstrate promising results when technology integration enhances both nurse empowerment and patient outcomes within frameworks that prioritise human connection.
Future directions position Caring Science as a mature, evidence-informed framework for addressing healthcare's complex challenges. The paper calls for ‘sacred activism’—a commitment to protecting caring's essential dimensions while embracing beneficial innovation, positioning nursing to lead healthcare transformation through both the art and science of nursing that honours human dignity.
Current guideline-recommended antibiotic treatment durations for ventilator-associated pneumonia (VAP) are largely standardised, with limited consideration of individual patient characteristics, pathogens or clinical context. This one-size-fits-all approach risks both overtreatment—promoting antimicrobial resistance and adverse drug events—as well as undertreatment, increasing the likelihood of pneumonia recurrence and sepsis-related complications. There is a critical need for VAP-specific biomarkers to enable individualised treatment strategies. The Ventilator-associated pneumonia Biomarker Evaluation (VIBE) study aims to identify a dynamic alveolar biomarker signature associated with treatment response, with the goal of informing personalised antibiotic duration in future clinical trials.
VIBE is a prospective, observational, case-cohort study of 125 adult patients with VAP in Michigan Medicine University Hospital intensive care units. Study subjects will undergo non-bronchoscopic bronchoalveolar lavage on the day of VAP diagnosis (Day 1) and then on Days 3 and 5. Alveolar biomarkers (quantitative respiratory culture bioburden, alveolar neutrophil percentage and pathogen genomic load assessed via BioFire FilmArray polymerase chain reaction) will be assessed. An expert panel of intensivists, blinded to biomarker data, will adjudicate each patient’s Day 10 outcome as VAP clinical cure (control) or treatment failure (case). Absolute biomarker levels and mean-fold changes in biomarker levels will be compared between groups. Data will be used to derive a composite temporal alveolar biomarker signature predictive of VAP treatment failure.
Ethical approval was obtained from the University of Michigan Institutional Review Board (IRB #HUM00251780). Informed consent will be obtained from all study participants or their legally authorised representatives. Findings will be disseminated through peer-reviewed publications, conferences and feedback into clinical guidelines committees.
The standard treatment of oral cavity cancers (OCC) relies on surgery and postoperative radiotherapy (poRT) for advanced stages or poor factors. In more than 75% of cases, reconstructive surgery with a flap aims to restore the function lost with tumour resection. Current poRT planning and delineation guidelines omit the presence of a flap. It may be assumed that poRT with flap sparing may allow for reducing radio-induced toxicities and improving functional outcomes, without impairing local primary control. The OPTIFLAP trial assesses non-inferior locoregional control using flap sparing compared with conventional flap-agnostic radiotherapy in patients with OCC, while reducing treatment-related toxicity and improving functional outcomes.
The OPTIFLAP study is a French, multicentre, 1:1 randomised, phase III, controlled trial. It will recruit 348 patients with OCC with a flap. Recruitment is active with the first enrolment on 2 July 2025 and is planned over 48 months. The primary outcome is non-inferior 2-year locoregional control rate using flap sparing compared with flap-agnostic radiotherapy (as per standard routine practice) in completely resected OCCs undergoing poRT. Key secondary outcomes include rates of toxicities, locoregional relapse-free survival, progression-free survival, overall survival, quality of life, functional outcomes (assessed by the Performance Status Scales for Head and Neck Cancer, the MD Anderson Dysphagia Inventory (self-questionnaire) and the Phonation Handicap Index (self-questionnaire)), flap doses and outcomes between arms depending on dosimetric parameters. The trial incorporates translational ancillary studies addressing individual radiosensitivity, salivary microbiome evolution, radiomics and dosiomics of flap changes, as well as medico-economic evaluation.
The study protocol has been approved by the Medical Ethics Committee East III (January 2025; Ref 24.05832.000442) and the French Agency for Medical and Health Products Safety (December 2024; ID-RCB: 2024-A01764-43) and was validated by review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences.
FreshRSS 