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☐ ☆ ✇ PLOS ONE Medicine&Health

Exploratory study on the impact of <i>Ganoderma australe</i> extract on gut microbiota and immune gene expression in honey bees exposed to <i>Vairimorpha ceranae</i>

by Sarah Zuern, Bella Romero, Carlos Spichiger, Leandro Ortiz, Alejandro Jerez, Esteban Basoalto, Max Emil Schön, Sigisfredo Garnica

The microsporidium Vairimorpha (Nosema) ceranae is an emerging threat to honey bees (Apis mellifera), known to disrupt gut microbiota and suppress immune responses, potentially contributing to colony losses. Fungal extracts have recently gained interest as sources of bioactive compounds with antimicrobial and immunomodulatory potential. In this study, we explored the effects of different dietary supplements—sugar syrup, HiveAlive™, and a novel Ganoderma australe extract (GanoBee)—on gut bacterial composition and immune-related gene expression in honey bees subjected to experimental exposure to V. ceranae 1 x 104 spores per bee. The GanoBee diet altered the gut microbiota, notably reducing the relative abundance of Rhizobiaceae (Bartonella apis) and increasing Frischella compared to other treatments. While alpha diversity was not significantly affected by diet or exposure to V. ceranae, beta diversity differed significantly in bees fed with GanoBee. Additionally, the expression of the antimicrobial peptide genes abaecin and hymenoptaecin was elevated in both exposed and unexposed bees fed with GanoBee, depending on the sampling day. However, the establishment of V. ceranae infection appeared limited, likely due to low spore viability, and mortality in control bees was higher than expected. The low Vairimorpha ceranae infection levels observed in this study are likely attributable to reduced spore viability caused by storage conditions and/or suboptimal environmental conditions within the laboratory cages. Post hoc analyses indicated that the high viscosity of GanoBee-supplemented diets likely contributed to the elevated bee mortality observed, underscoring a critical limitation of the experimental design related to diet formulation and delivery method. These physical factors complicate the interpretation of treatment efficacy and highlight the importance of optimizing feeding protocols to avoid confounding effects. Despite these constraints, GanoBee demonstrated promising potential as a modulator of gut microbiota composition and immune-related gene expression, supporting the need for further research under improved and carefully controlled experimental conditions.
☐ ☆ ✇ International Wound Journal

Necrotising Soft Tissue Infections: A Single Center's Case Series

ABSTRACT

Necrotising soft tissue infection (NSTI) is a progressive disease with a time-dependent prognosis; if not promptly treated, it can lead to significant morbidity as well as mortality. Early and aggressive surgical treatment is mandatory for appropriate management. This study reports the diagnostic and therapeutic pathway, surgical treatment and outcomes in a single-centre series. Data from 40 patients with NSTI treated between 2015 and 2024 were retrospectively analysed for demographic and social information, microbiological results, therapeutic course, clinical outcome and mortality. TC Indication and timing, the role of limb amputation in critical patient survival and reconstruction technique were also reviewed. Fourteen patients (35%) were referred at an advanced stage due to avoidable delay. The mean number of surgical interventions for a single patient was 4. Eight patients (20%) underwent limb amputation. Skin grafts were the most used reconstruction procedure. Seven patients (17.5%) died in the hospitalisation. NSTI is a life-threatening disease requiring prompt diagnosis and treatment within dedicated clinical pathways. Our series highlights the fundamental role of TC in critical patients or unclear diagnosis, and limb amputation as a life-saving procedure even at admission in severe cases.

☐ ☆ ✇ BMJ Open

Exploring stress and coping among black women in early midlife with elevated blood pressure in a safety-net health system: a qualitative focus group protocol

Por: Sprague · B. N. · Beverly · A. R. — Febrero 26th 2026 at 13:47
Introduction

Black women in early midlife experience disproportionate exposure to stress and elevated cardiovascular risk, including hypertension. Despite this, few stress management interventions are designed with and for this population. This study aims to explore the lived experiences of stress and coping among black women in early midlife with elevated blood pressure to inform the codesign of a culturally relevant, multilevel stress management intervention.

Methods and analysis

We will conduct one-time, semistructured focus groups with black women aged 35–50 who have elevated blood pressure, recruited from a large safety-net health system. Data will be analysed using a constructivist grounded theory approach, with inductive theme development supported by line-by-line, focused and theoretical coding. The Social Determinants of Cardiovascular Disease framework will serve as a sensitising guide to multilevel contextual factors rather than a prescriptive coding structure. An artificial intelligence (AI)-assisted analytic component will complement human-led analysis by supporting preliminary theme exploration and enhancing transparency.

Ethics and dissemination

Approved by the Indiana University Institutional Review Board (Protocol #21785). All participants will provide written informed consent. Findings will be shared via peer-reviewed publications, conference presentations and lay summaries for stakeholders.

☐ ☆ ✇ BMJ Open

Acceptability and adoption of a multiparameter point-of-care testing (POCT) device in primary healthcare for non-communicable diseases in resourced-limited communities in Peru

Por: Huayanay-Espinoza · C. A. · Moran · D. · Albitres-Flores · L. · Bernabe-Ortiz · A. · Cahuana-Hurtado · L. · Vetter · B. · Safary · E. · Lazo-Porras · M. — Febrero 26th 2026 at 13:47
Objectives

To assess the acceptability and adoption of multiparameter point-of-care testing (POCT) devices for the diagnosis and management of non-communicable diseases (NCDs) at the primary healthcare level in a resource-limited region of Peru.

Design

Qualitative case-control process evaluation.

Setting

Eight primary healthcare facilities in northern Peru, including both urban and rural centres, where routine chronic care and laboratory services are provided.

Participants

Sixty-three participants: 36 patients, 12 laboratory technicians, 10 healthcare professionals and five facility heads. Eligible patients were ≥18 years, residing in the catchment area, with or without prior NCD diagnoses. Healthcare workers, including physicians, nurses, laboratory staff and facility managers.

Interventions

Multiparameter POCT devices were installed in four intervention facilities, accompanied by staff training and community awareness activities, while four control facilities continued with conventional laboratory diagnostics.

Primary and secondary outcome measures

Primary outcome: perceptions of patients and healthcare workers regarding the acceptability and adoption of POCT devices. Secondary outcomes: identification of facilitators and barriers to implementation, including infrastructure, supply chains and training gaps.

Results

(1) Individuals: POCT was valued for speed and comfort, but concerns over accuracy were mentioned. (2) Intervention characteristics: laboratory staff valued POCT’s practicality in emergencies, but noted limitations in handling multiple samples. (3) Outer setting: urban centres outperformed rural facilities, with more staff and longer operating hours. (4) Inner setting: calibration gaps impacted POCT and conventional test reliability, requiring quality control and training. (5) Process: clear staff communication boosted patient confidence in POCT, but inconsistent training could lead to reliability doubts.

Conclusions

Multiparameter POCT devices show promise for enhancing NCD care in resource-limited primary healthcare settings, particularly in rural areas. However, their sustainability depends on broader health system reforms, including reliable supply chains, expanded training and stronger quality assurance mechanisms. Further research should examine strategies for embedding POCT within national regulatory and policy frameworks.

☐ ☆ ✇ BMJ Open

Mechanisms of SGLT inhibitor action and physiological mediators: systematic review and protocol for the MOSAIC collaborative meta-analysis

Por: Kugathasan · L. · Nardone · M. · Muskiet · M. · Diaz Martinez · J. P. · Lovblom · L. E. · Orchanian-Cheff · A. · Nielsen · S. · Rotbain · V. · Kazup · A. · Cersosimo · E. · Gullaksen · S. · Vernstrom · L. · van Baar · M. J. B. · van Bommel · E. · Kannenkeril · D. · Scholtes · R. · Hesp — Febrero 26th 2026 at 04:41
Introduction

Sodium-glucose cotransporter (SGLT) inhibitors have shown substantial benefit in reducing cardiovascular and kidney events across diverse clinical populations, but the underlying physiological mechanisms remain unclear. However, existing mechanistic studies on renal and cardiovascular haemodynamics show variability in design, have limited statistical power and yield inconsistent outcomes, thus limiting the ability to draw generalisable conclusions. To address this gap, we conducted a systematic review and proposed the first meta-analysis to aggregate individual participant-level data from mechanistic studies to identify consistent physiological patterns and enhance understanding of the therapeutic effects of SGLT inhibition.

Methods and analysis

Gold-standard measured glomerular filtration rate (mGFR) was selected as the primary outcome for this systematic review, which aimed to identify all completed mechanistic studies investigating the effects of SGLT inhibition. Electronic databases including Ovid MEDLINE; Ovid Embase; Cochrane Database of Systematic Reviews; and Cochrane Central Register of Controlled Trials were searched using a detailed search strategy. In total, 24 studies (n=1296) were identified. This systematic review was reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Key variables including demographics, medical history, concomitant medications, vital signs, mGFR, renal haemodynamics, urine and plasma biochemistry, tubular sodium handling, echocardiography, cardiac output monitoring, arterial stiffness and fluid volume will be extracted. A one-stage individual participant data meta-analysis under a Bayesian framework will be conducted, using hierarchical models to simultaneously analyse data from all eligible studies. The risk of bias due to missing results will be assessed. Sensitivity analyses and subgroup evaluations will be incorporated to explore sources of heterogeneity and assess robustness of findings.

Ethics and dissemination

Ethics approval was obtained from University Health Network, Toronto, Canada. Findings from the Mechanisms of SGLT Inhibitor Action and Physiological Mediators (MOSAIC) meta-analysis will be published in peer-reviewed journals and results will be disseminated at scientific conferences.

PROSPERO registration number

CRD420251001413.

☐ ☆ ✇ BMJ Open

Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial

Por: Coudroy · R. · Telias · I. · Jonkman · A. · Thille · A. W. · Diehl · J.-L. · Peron · N. · Ko · M. · Bourion · A.-A. · Tiribelli · N. · Fredes · S. · Gutierrez · M. · Manchado Bruno · A. · Vasquez · D. N. · Pratto · R. A. · Plotnikow · G. A. · Bianchini · F. · Accoce · M. · Dorado · J. · Sp — Febrero 23rd 2026 at 12:58
Introduction

Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

Methods and analysis

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics and dissemination

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

Trial registration number

NCT03963622.

☐ ☆ ✇ BMJ Open

Analgesic efficacy of peri-operative methadone in orthopaedic surgery: protocol for a systematic review of randomised controlled trials

Por: Evaldsson · B. B. · Nygaard · K. H. · Petersen · S. R. · Moos · C. M. · Stroem · T. · Specht · K. · Schonnemann · J. O. — Febrero 22nd 2026 at 18:08
Introduction

Optimising post-operative pain management is crucial for recovery in orthopaedic surgery. Methadone has attracted interest due to its long half-life, N-methyl-D-aspartate -receptor antagonism and potential to reduce post-operative opioid consumption. Existing reviews combine multiple surgical populations, limiting applicability to orthopaedic settings. This protocol outlines a systematic review assessing the analgesic efficacy and safety of peri-operative methadone in adult and adolescent orthopaedic patients.

Methods and analysis

This review will include randomised controlled trials evaluating intravenous peri-operative methadone vs placebo or standard analgesic regimens in orthopaedic surgery. Primary outcomes are post-operative rescue opioid consumption and pain intensity within 72 hours. Secondary outcomes include adverse events, mobility scores and the length of hospital stay. If available data permit, a methadone dose–response pattern may be investigated. Searches will be conducted in MEDLINE (Ovid), Embase (Ovid), CINAHL, CENTRAL, Web of Science and ClinicalTrials.gov without date restrictions. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane risk-of-bias tool for randomised trials. When appropriate, random-effects meta-analysis methods will be performed. Certainty of evidence will be assessed using Grading of recommendations assesment, development and Evaluation (GRADE).

Ethics and dissemination

As this study uses previously published data, ethical approval is not required. Findings will be disseminated through a peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD42025616291.

☐ ☆ ✇ Journal of Clinical Nursing

Nursing Professional Organisations as Human Rights Intermediaries: Towards an Integrated Framework of Stakeholdership for Healthcare AI Governance

Por: Jerome Visperas Cleofas — Febrero 19th 2026 at 17:11

ABSTRACT

Aim

To propose a normative framework that guides nursing professional organisations to act as human rights intermediaries in the governance of artificial intelligence in healthcare.

Design

Discursive paper.

Results

The paper presents a triaxial framework that conceptualises the role of nursing professional organisations in artificial intelligence governance. The framework consists of a domain axis, which identifies key areas of engagement; a modality axis, which aligns actions with the specific functions of these organisations; and a human rights axis, which defines their role towards rights claimants and duty bearers.

Conclusion

The proposed framework provides a practical tool for nursing professional organisations to strategically plan and implement initiatives to influence the advancement and regulation of artificial intelligence. Its application can help ensure that healthcare innovation is equitable and rights-based.

Implications for the Profession

This paper provides a blueprint for nursing leaders and policymakers to engage proactively with the ethical dimensions of artificial intelligence. It emphasises the salient roles of nursing professional organisations in advocating for the human right to health in a technologically driven healthcare landscape.

Impact

This paper addresses the gap in how the nursing profession can systematically engage with artificial intelligence governance. The main finding is a novel framework that provides a structured way for nursing professional organisations to act as human rights intermediaries. This research will have a significant impact on nursing leadership, patient advocacy groups, and policymakers involved in healthcare technology and ethics.

Patient or Public Contribution

Initial parts of this paper were presented to allied health practitioners via a webinar, providing early feedback and dialogue that informed its development.

☐ ☆ ✇ BMJ Open

Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) study: rationale and design for a sequential, repeated crossover trial

Por: Stallings · E. G. · Wanderer · J. P. · Balavage · M. · Henson · C. P. · Fowler · L. · Eden · S. · Shotwell · M. S. · Gruss · C. · Neuhafen · K. R. · Gelfand · B. J. · Kertai · M. D. · for the ASPIRE-PONV Investigators — Febrero 10th 2026 at 14:17
Introduction

This project, in adult surgical patients, will evaluate whether the creation of a customised checklist, driven by a clinical decision support tool, is able to improve anaesthesia providers’ adherence to consensus guidelines and standardised practice recommendations for the prevention of postoperative nausea and vomiting (PONV).

Methods and analysis

The intervention will be evaluated using a sequential, repeated crossover design at the institutional level, with designated washout, control and intervention periods. The surgical case will serve as the unit of analysis. The primary outcome is adherence to appropriate PONV prophylaxis administration guidelines. Secondary outcomes include the incidence of PONV and length of stay in the postanaesthesia care unit (PACU).

Ethics and dissemination

This protocol and statistical analysis plan provide an outline of the study design, primary and secondary end points and analytic approach. The Advancing Strategies to Optimise the PerIopeRativE Management of PostOperative Nausea and Vomiting trial has received approval from the Vanderbilt University Institutional Review Board (IRB: 250773). The results will be disseminated through peer-reviewed publications and presentations at national conferences. Findings from this trial will inform best practices for timely antiemetic prophylaxis, with the goal of reducing PONV incidence and shortening PACU stay.

Trial registration number

NCT07152249.

☐ ☆ ✇ BMJ Open

Differences in sexual risk behaviours, HIV care utilisation and experiences of stigma between transgender women and cisgender men who have sex with men: findings from integrated biobehavioural surveys in Ukraine 2013-2018

Por: Aijaz · S. · Vickerman · P. · Saliuk · T. · Nicholls · J. · Gillespie · D. · Hood · K. · Stone · J. — Febrero 10th 2026 at 14:17
Objectives

To assess whether transgender women who have sex with men (TGWSM) sampled in men who have sex with men (MSM) biobehavioural surveys in Ukraine experience different levels of sexual risk, stigma, HIV prevalence and engagement in the HIV care than cisgender MSM (CMSM).

Design

Analysis of secondary data from three population-level cross-sectional surveys.

Setting

The analysis was conducted on data from three rounds of integrated biobehavioural surveys of MSM in 27 cities of Ukraine from 2013 to 2018.

Participants

Data from n=18 621 MSM with n=18 102 CMSM and n=503 TGWSM.

Primary and secondary outcome measures

The primary outcomes were differences in sexual risk behaviours, HIV testing and treatment uptake, and the secondary outcomes were differences in lifetime experiences of stigma, coercive sex and physical assault (in the 2018 survey only) between CMSM and TGWSM.

Results

Compared with CMSM, TGWSM were more likely to be clients of non-governmental organisations (adjusted OR, aOR: 1.39, 95% CI 1.15 to 1.67), engage in commercial sex (last month; aOR: 1.28, 95% CI 1.01 to 1.61), have group sex (aOR: 1.31, 95% CI 1.06 to 1.61), more long-term sex partners (last month; adjusted incidence rate ratio: 1.14, 95% CI 1.03 to 1.27), history of imprisonment (aOR: 1.51, 95% CI 1.00 to 2.31) and engage in chemsex (last month, aOR: 1.58, 95% CI 1.12 to 2.23). We found no difference in HIV prevalence (5.17% in TGWSM vs 5.43% in CMSM, p=0.065). In 2018, more TGWSM reported lifetime experience of stigma from family and friends (aOR: 3.58, 95% CI 2.54 to 5.04), general social stigma (aOR: 3.13, 95% CI 2.22 to 4.41), anticipated healthcare stigma (aOR: 3.63, 95% CI 2.53 to 5.16), physical assault (aOR: 2.73, 95% CI 1.85 to 4.03) and coercive sex (aOR: 3.01, 95% CI 1.99 to 4.55) than CMSM.

Conclusions

TGWSM in Ukraine may be at increased risk of HIV acquisition compared to CMSM due to many factors including elevated levels of stigma and violence. Services specifically tailored for transgender people are needed to help reduce these high-risk behaviours.

☐ ☆ ✇ BMJ Open

Adolescent community reinforcement approach in secure care for adolescents with substance use and serious norm-violating behaviour: a randomised feasibility trial

Por: Mälarstig · I. · Tyrberg · M. · Spännargard · A. · Garke · M. A. · Lundgren · T. · Alfonsson · S. — Febrero 9th 2026 at 15:19
Background

Adolescents placed in state-run secure youth homes (by the Swedish National Board of Institutional Care) due to substance misuse and serious norm-violating behaviour (including offending) are in pressing need of effective help, yet available treatments lack scientific support. The treatment Adolescent Community Reinforcement Approach (A-CRA) supports abstinence and improves social functioning in outpatient settings, but has not been evaluated in secure youth homes.

Objective

To evaluate the feasibility, acceptability and preliminary effects of A-CRA in Swedish secure youth homes, and assess the feasibility of study procedures before a multicentre randomised controlled trial (RCT).

Methods

In a randomised feasibility trial, 42 adolescents (16–20 years) at four secure youth homes were allocated to A-CRA plus treatment as usual (A-CRA+TAU; n=22) or TAU alone (n=20). Substance use was measured with self-reports and registry data at baseline, post-treatment and up to 24 months after treatment; participants were also interviewed about acceptability and satisfaction.

Results

Feasibility was demonstrated: 77% reached the predefined exposure threshold (≥12 A-CRA procedures). Adolescents found the intervention acceptable and helpful in secure care. Study procedures were largely workable, though questionnaire data showed substantial missingness. Preliminary effects were favourable, with no evidence of harm.

Conclusions

A-CRA appears feasible in secure youth care, with minor adjustments, and is perceived as helpful and acceptable by adolescents. Treatment effects will be evaluated in an upcoming multicentre RCT.

Trial registration number

NCT05081934.

☐ ☆ ✇ PLOS ONE Medicine&Health

Association between hospital frailty risk score, risk of sepsis and adverse outcomes across all adult ages

Por: Huda Kutrani · Jim Briggs · David Prytherch · Claire Spice — Febrero 13th 2026 at 15:00

by Huda Kutrani, Jim Briggs, David Prytherch, Claire Spice

Background

Hospital Frailty Risk Score (HFRS) is commonly used to identify frailty risk and predict poor outcomes. Frailty and sepsis are associated with poor outcomes. This study aimed to evaluate the association between HFRS, risk of sepsis and poor health outcomes across all adult ages.

Methods

A retrospective cohort study analysed data from Queen Alexandra Hospital, a major acute hospital in the UK, covering the period from January 1, 2010, to December 31, 2019. It included patients aged 16 and older. The Hospital Frailty Risk Score (HFRS) was used to identify patients at risk of frailty. The Suspicion of Sepsis (SOS) codes and the National Early Warning Score (NEWS) were used to identify patients at risk of sepsis. Logistic Regression with interaction models were developed to examine the associations between HFRS, risk of sepsis and poor outcomes (length of stay and in-hospital mortality) across all adult ages.

Results

Patients with higher frailty risk and sepsis-risk-positive groups had longer length of stay and higher risk of in-hospital mortality compared to the sepsis-risk-negative groups. Interaction between intermediate or high frailty risk and sepsis-risk-positive (SOS codes present, NEWS≥7, and SOS codes present with NEWS≥7 groups) was significant for all periods of length of stay and all periods of in-hospital mortality (P  Conclusion

This study concluded that there is a strong association between risk of frailty (identified with HFRS), risk of sepsis, and poor outcomes in urgently hospitalised adults of all ages.

☐ ☆ ✇ BMJ Open

FoodCHOMP (Food Challenge--at HOme or in Medical Practice): a pilot multicentre randomised controlled trial evaluating home versus clinic-based food allergy challenges in low-risk adults-study protocol

Por: Godsell · J. · Vogrin · S. · Chan · S. · Henri · M. · Ng · I. · Andrews · E. · Spriggs · K. · Perrett · K. P. · Trubiano · J. — Febrero 6th 2026 at 14:29
Introduction

Approximately 6%–10% of adults carry food allergy labels. Many such labels are unverified and may be incorrect, contributing to delays in appropriate care, significant dietary restriction, anxiety and unnecessary use of emergency medications. Oral food challenges (OFCs) are the gold standard for confirming or excluding food allergy, but the current model of clinic-based challenges often has long wait times and logistical barriers. This study aims to investigate the feasibility and safety of home-based OFCs compared with standard in-clinic challenges in adults with negative skin-prick testing.

Methods and analysis

Food Challenge at HOme or in Medical Practice is a pilot multicentre randomised controlled trial enrolling 120 adults with reported food allergy labels and negative skin prick testing to the implicated food. Participants will be randomised 1:1 to undergo an OFC either at home or in-clinic. The study is designed to generate feasibility and preliminary safety data for home-based OFC, measured by the proportion of participants experiencing immune-mediated adverse events (AEs), compared with clinic-based OFC. Feasibility metrics (screening to recruitment ratio, protocol completion), non-immune AEs, protocol adherence and quality of life assessed using the Food Allergy Quality of Life Questionnaire-12 at baseline prior to OFC and 6 months post OFC will also be collected. Statistical analysis will include descriptive statistics, with comparisons between arms using risk differences and relative risks with 95% CIs.

Ethics and dissemination

The trial has received ethics approval from the Austin Health Human Research Ethics Committee (HREC/111750/Austin-2024). Findings will be disseminated through peer-reviewed publications and scientific meetings. Data will be presented in aggregated, de-identified form.

Trial registration number

NCT06916819.

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