To explore patients’ perceptions of managing adverse events (AEs) from anticancer drugs for gynaecological cancer, focusing on AEs they want to avoid, views on dose adjustments and communication with healthcare professionals.

Observational study using a web-based questionnaire.

Women in Japan who had received chemotherapy for endometrial or ovarian/fallopian tube cancer were enrolled. Healthcare professionals, including obstetrics and gynaecology physicians, nurses and pharmacists, who administered chemotherapy to these patients, were also enrolled.

AEs that patients wished to avoid or found distressing; varied perceptions of AEs before and after treatment; discrepancies in the communication of AEs between patients and healthcare professionals; administration time and intervals between hospital visits patients found distressing; patient awareness of dose adjustment (reduction, interruption or discontinuation) to suppress AEs.

Participants comprised 153 physicians, 166 nurses, 154 pharmacists and 154 patients. Nausea/vomiting (28.6%), alopecia (18.2%) and peripheral neuropathy (9.1%) were the most distressing AEs overall. Physicians rated nausea/vomiting lower (15.4%) and alopecia higher (38.2%) than patients, while pharmacists emphasised peripheral neuropathy (25.7%). Many patients found AEs, including peripheral neuropathy (53/99), fatigue (52/105) and alopecia (46/120), to be more severe than expected. Communication patterns revealed that 49.4% of patients reported all symptoms, even uncertain ones, but younger patients tended to communicate fewer symptoms. Physicians (54.2%), nurses (92.2%) and pharmacists (85.7%) preferred full disclosure of symptoms. While 28.6% of patients wished to avoid dose reductions because of fears of disease progression, 18.2% preferred dose reduction or discontinuation when AEs became intolerable. Drug administration times and visit intervals influenced patient distress. Treatment administration of over 3 hours (19.5%) and visits occurring more frequently than once every 3 weeks (27.3%) were the most distressing.

This study highlights discrepancies in AE perceptions and communication between patients and healthcare professionals, emphasising the need for tailored communication strategies and shared decision-making to improve cancer treatment experiences and outcomes.

jRCT1040220088, Japan Registry of Clinical Trials (jRCT).

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.

Rising patient numbers and limited resources are creating a challenging environment for healthcare providers recently. Anaesthesiologists are also increasingly faced with complex situations, requiring high adaptability in the operating room. To enhance team adaptability during emergencies, effective communication methods are essential. This study aimed to compare the impact of mobile phones and intercoms on the response time and effectiveness of anaesthesiologist teams in emergency situations.

Prospective, observational and simulation study.

Anaesthesiology and Critical Care, Yokohama City University Medical Center, Yokohama, Japan.

This study, conducted at Yokohama City University Medical Center (Yokohama, Japan), evaluated how communication methods (intercoms vs mobile phones) impact the efficiency of anaesthesiologists in the simulation setting. Two scenarios were tested: (1) retrieving a video laryngoscope during a difficult intubation and (2) gathering support during cardiac arrest.

Outcomes measured included time to secure equipment, time for assistance to arrive and staff numbers gathered. The Wilcoxon signed-rank test was used to compare the outcomes between the intercom and mobile phone groups.

In scenario 1, the time to secure the video laryngoscope was significantly shorter with intercom use compared with mobile phones (intercom vs mobile phone, median (IQR): 29 (25–33) s vs 50 (39–62) s; p=0.013, effect size 20 (95% CI 7 to 31)). In scenario 2, the time from the request for assistance until the first supporting staff member reached the operating room was significantly shorter in using the intercoms (intercom vs mobile phone, median (IQR): 16 (14–18) s vs 35 (31–38) s; p=0.04, effect size 17 (95% CI 6 to 24)), and more personnel were available in the intercom group (intercom vs mobile phone, median (IQR): 3 (3–3.5) persons vs 2 (1–2) persons; p=0.04, effect size 1.5 (95% CI 1 to 3)).

Real-time information sharing through intercoms improved the ability of the anaesthesiologist team to respond more rapidly and effectively in emergency situations, enhancing overall team adaptability. This approach may improve patients’ outcomes by shortening response times and increasing team coordination.

The second phase of the Chiba Study of Mother and Child Health (C-MACH) was initiated to investigate how environmental exposures from the fetal period to early childhood influence maternal and child health outcomes. The sub-cohort focuses specifically on detailed assessments of indoor environmental factors and neighbourhood-built and social environments. By integrating environmental metrics with biological, behavioural and sociodemographic data, the study aims to elucidate their role in the development of allergies, neurodevelopmental disorders and other non-communicable diseases in early life.

Between June 2021 and April 2023, 505 pregnant women were enrolled in the second phase of the C-MACH main study. Of these, 298 participants consented to join the sub-cohort study, including 258 in the sleep and physical activity monitoring option (Option 1) and 148 in the indoor allergen exposure sub-study (Option 2). The study includes biological sampling, environmental monitoring and repeated questionnaire surveys. At baseline, 253 live births were recorded from 251 pregnancies.

Of the 298 women, 272 completed early pregnancy questionnaires. The mean maternal age was 33.1 years (SD 4.6); 97.8% were married. University-level education was reported by 51.0% of mothers and 53.7% of fathers. Most households had an annual income of 6 to

Longitudinal follow-up will continue until the children reach age 15. Future analyses will examine associations between environmental exposures and allergic, developmental, endocrine/metabolic and obesity-related outcomes.

Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.

This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.

The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.

jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).

Venous leg ulcers (VLUs) are complex, chronic wounds that often recur after healing. The ongoing use of compression hosiery is the primary strategy to reduce the risk of VLU recurrence. However, adherence to this prophylactic treatment is low, undermining treatment effectiveness and placing a substantial burden on individuals with a history of VLUs and on healthcare systems. Understanding the factors influencing people’s adherence to compression hosiery for secondary VLU prevention is essential to support approaches to promote uptake.

The study aimed to (1) draw on the Capabilities, Opportunities and Motivations of Behaviour (COM-B) model and the Theoretical Domains Framework (TDF) to explore factors influencing individuals’ use of prophylactic compression hosiery for the secondary prevention of VLUs and (2) use the behaviour change wheel to identify intervention strategies to support the ongoing use of prophylactic compression hosiery by individuals after VLU healing.

A descriptive, interpretive qualitative study involving individuals with a history of healed VLUs. Semistructured interviews were conducted with people who had experienced healed VLUs. The interviews were guided by the COM-B model. Framework analysis was conducted using deductive coding informed by the TDF and inductive coding to capture emerging themes linked to barriers to and enablers of the target behaviour (ongoing compression use). Data management was aided by NVivo software, and coding was conducted by two researchers.

Interventions were conducted in person, by telephone or online, based on participants’ preferences, at community leg clubs or in their homes, from April 2024 to January 2025.

Participants with experience of healed VLUs were recruited from three National Health Service (NHS) trusts and community leg clubs in the North of England.

A total of 15 participants were interviewed, comprising 4 males and 11 females aged between 49 and 89 years. Our analysis identified six factors that may influence individuals’ use of prophylactic compression hosiery following VLU healing: knowledge, skills, environmental context and resources, emotion, social influences and beliefs about consequences. Deficits in knowledge, skills and resources, such as limited availability of prophylactic compression sizes, delays in prophylactic compression delivery and limited access to NHS services after healing, were primary barriers to people’s use of compression hosiery in this context. Conversely, positive beliefs about the benefits of ongoing use of prophylactic compression hosiery were a strong enabler. Emotion and social influences were identified as both barriers and enablers: fear of recurrence and social support encouraged adherence, while stigma and negative feelings hindered it. We identified six intervention functions (education, training, persuasion, environmental restructuring, modelling and enablement) and eight linked behaviour change techniques that could be explored further to support people’s ongoing use of prophylactic compression therapy. These techniques include providing information about antecedents, discussing health and emotional consequences, instruction, demonstration, rehearsal, social support, framing/reframing and vicarious reinforcement.

The identified intervention functions and behaviour change techniques provide theoretically informed insights for designing interventions to support sustained use of prophylactic compression hosiery following VLU healing. Key barriers to address include addressing gaps in individuals’ knowledge about prophylactic compression therapy, prioritising posthealing VLU services, ensuring timely access to appropriately fitted compression and enhancing social support networks.

The literature examining direct-to-consumer (DTC) commercial virtual care has expanded rapidly over the past decade. Our objective was to synthesise the nature and range of evidence on DTC commercial virtual care.

Scoping review.

MEDLINE ALL, EMBASE Classic+Embase, CINAHL, HealthSTAR, PsycINFO, CENTRAL and grey literature sources.

We included original research studies published in English or French between 1 January 2016 and 30 April 2025 that assessed DTC commercial virtual care in all contexts and in all populations.

Screening titles and abstracts, and full-text manuscripts, and extracting data was done in duplicate. We analysed quantitative data using descriptive statistics and reported findings in tables. We provided a narrative summary of textual data.

After excluding duplicates, we identified 8055 studies for title and abstract screening; 691 articles for full-text screening; and 103 studies meeting our inclusion criteria. 32 studies (31.1%) reported financial ties to the virtual care industry. 67 (65.0%) studies were conducted in the USA. Studies were largely quantitative (87/103 (84.5%)) or mixed methods (8/103 (7.8%)) studies and used cross-sectional (85/95 (89.5%)) designs. Most quantitative studies were descriptive, reporting on quality of care, health outcomes, platform characteristics and patient views, with only 24 of the 95 quantitative studies (25.3%) including a control or comparison group. 18 of these 24 studies (75.0%) compared the quality of care, costs and/or utilisation to other models of care and reported variable findings. The rest compared patient characteristics. Few studies assessed clinician perspectives or addressed privacy-related ethical concerns.

Despite a large number of studies assessing DTC commercial virtual care, we have little insight into impacts on quality of care, health outcomes, health system utilisation and privacy-related ethical concerns. The financial ties with industry suggest that there may be bias in the body of research literature.

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

Haemoglobin vesicles (HbVs) (product name, NMU-HbVs [Nara Medical University-Haemoglobin Vesicles]), which contain purified human haemoglobin encapsulated within liposomes, have been developed as a potential alternative to blood transfusions in emergency situations. A previous phase I study examined doses up to 100 mL in 11 healthy volunteers. Here, we describe the protocol for a phase Ib study, wherein we will evaluate the safety and pharmacokinetics of NMU-HbV in healthy Japanese adults.

This single-centre, open-label, dose-escalation study will enrol 16 healthy volunteers divided into four cohorts. Planned doses are 100 mL for cohorts 1 and 2, 200 mL for cohort 3 and 400 mL for cohort 4, with infusion rates gradually increasing to a maximum of 5.0 mL/min. The primary endpoint will be safety, which will be assessed as the incidence of adverse events within 14 days and significant clinical changes within 72 hours after administration. Safety evaluations will include subjective symptoms, vital signs, electrocardiograms and laboratory test results compared with the baseline. The secondary endpoint will be pharmacokinetics, which will be assessed as changes in NMU-HbV concentration immediately after infusion until day 4 to determine the maximum blood concentration, time to reach the maximum blood concentration, area under the blood concentration-time curve and elimination half-life. This study will provide data on the safety and pharmacokinetic profiles of NMU-HbV at doses up to 400 mL. The findings are expected to support the further development of NMU-HbV as a viable alternative to emergency transfusions.

The study protocol was approved by the Institutional Review Board of Nara Medical University on 10 December 2024. Dissemination plans include publishing in peer-reviewed scientific journals and presentation at international conferences.

Japan Registry of Clinical Trials (jRCT2051240249). Registered on 27 January 2025 (https://jrct.mhlw.go.jp/en-latest-detail/jRCT2051240249).

Published clinical trials offer valuable insights into the clinical research landscape in Portuguese-speaking African countries (PSAC)—Angola, Cabo Verde, Guinea-Bissau, São Tomé and Príncipe and Mozambique. The objective of this comprehensive scoping review is to systematically map and analyse randomised clinical trials (RCTs) evaluating pharmacological interventions conducted in PSAC from 1995 to 2024, in order to identify research trends, targeted diseases, geographic distribution and evidence gaps to better understand the development and evolution of clinical trials in the region. This is the first comprehensive scoping review to examine the clinical trials landscape in PSAC.

This scoping review adheres to the Joanna Briggs Institute methodology for scoping reviews, which builds on the Arksey and O’Malley methodological framework (refined by Levac et al) and will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews guidelines. A dual-search strategy will be used, consulting 4 electronic databases (MEDLINE, EMBASE, African Index Medicus, Cochrane Central Register of Clinical Trials) and 3 clinical trials registries platforms (Clinicaltrials.gov, International Clinical Trials Registry Platform, Pan African Clinical Trials Registry). Eligible studies will include RCTs conducted in at least one of the PSAC. Extracted data will include trial characteristics, targeted diseases, phases and designs, funding and ethical compliance. Risk of bias (RoB) will be assessed using the Cochrane RoB tool V.2.0 to evaluate the quality of the evidence included in the scoping review. Conclusions will be drawn upon the comparison between countries and their scope of clinical research, together with comparison with countries from other geographies, considering disease profiles.

Ethical approval is not required. Results will be disseminated through a peer-reviewed publication, conference presentation and in plain language in social media, both in Portuguese and in English.

This protocol is registered in the Open Science Framework https://osf.io/5nhc9.

Strengthening research capacity in Africa is vital for tackling pressing health, educational and socioeconomic challenges facing the continent. At the core of this effort is the cultivation of innovative research leaders through postgraduate training programmes that incorporate mentorship-infused supervision. Such models have demonstrated potential in improving research skills, boosting academic productivity and fostering leadership development among emerging scholars. This systematic review and meta-synthesis protocol aims to examine existing mentorship-infused supervision practices across African higher education institutions. The review seeks to identify effective models, uncover common challenges and barriers, and generate evidence-based recommendations to develop sustainable, contextually relevant strategies. Insights from this work will inform policies and practices to enhance postgraduate research training, advance research leadership and contribute to the broader goal of strengthening research ecosystems across Africa.

A systematic review and thematic meta-synthesis will be undertaken, focusing on qualitative research studies as well as the qualitative components of mixed-methods studies. Relevant studies published in English will be identified through a comprehensive search strategy. The electronic databases, including Medline/PubMed, Scopus, Web of Science, African Journals Online, EMBASE and CINAHL, will be searched to capture a wide range of peer-reviewed articles and grey literature. Databases will be searched from March 2026. Two reviewers will independently perform study selection, data extraction, quality assessment and evaluation of risk of bias, using the Critical Appraisal Skills Programme checklist.

This systematic review and meta-synthesis will analyse publicly available literature and does not require ethical approval, as it involves no primary data collection. It will adhere to established ethical and methodological standards, including proper citation and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The findings will be widely disseminated through open-access journal publication, conference presentations and targeted reports for universities, research institutions and policymakers to inform and support mentorship-based postgraduate research supervision across Africa.

CDR420251049878. Available from https://www.crd.york.ac.uk/PROSPERO/view/CRD420251049878.

Accumulating evidence suggests that glucagon-like peptide-1 (GLP-1) receptor agonists may have therapeutic effects against Parkinson’s disease (PD); however, clinical evidence has not yet been established and remains controversial. This clinical study aims to assess the efficacy, disease-modifying effects, safety and optimal dose of oral semaglutide tablets, a GLP-1 receptor agonist, in idiopathic patients with PD.

The MOST-ABLE study is a phase 2, multicentre, double-blind, randomised, placebo-controlled trial of oral semaglutide tablets in 99 participants with PD. Patients with PD (Hoehn & Yahr stages 1–2.5) at eight sites in Japan will be randomly assigned in a 1:1:1 ratio to one of three groups: oral semaglutide tablets (7 mg or 14 mg) or placebo. The study drugs will be administered once daily as an add-on to conventional medical treatment for PD. After 36 weeks of treatment, the participants will be treated without the study drugs for 12 weeks. The efficacy outcomes include Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Questionnaire-39, cognitive tests and dopamine transporter imaging. The primary endpoint is the change in the MDS-UPDRS part 3 score in the practically defined off-medication state from baseline at 48 weeks between the treatment allocation groups. The safety and tolerability will also be evaluated.

The study protocol was approved by the Pharmaceuticals and Medical Devices Agency of Japan and the study was approved by the institutional review boards at the University of Osaka Hospital and each study site. All participants are required to provide informed consent. The results will be disseminated in peer-reviewed journals, presented at scientific meetings and presented to patients in a lay summary format.

jRCT2051230090 (https://jrct.mhlw.go.jp/latest-detail/jRCT2051230090), universal trial number U1111-1271-3794.

Declined donor organs and explanted recipient organs may hold considerable value for biomedical research, particularly in advancing knowledge of disease mechanisms and supporting drug development. However, public perceptions of such use, and preferences for how consent should be obtained, remain underexplored.

Four workshops were held across the UK to examine the views of organ donor families and transplant recipients regarding the use of human organs in research, with a focus on myocardial regeneration. Each workshop included three brief presentations on transplantation and cardiac regeneration, followed by facilitated small-group discussions. Observational notes were taken to capture participants’ perspectives on the use of organs unsuitable for transplantation. A follow-up survey generated both quantitative and qualitative data, the latter analysed using thematic analysis.

Participants expressed strong support for the use of declined donor and explanted recipient organs in research. Transplant recipients frequently cited a desire to give back to the National Health Service (NHS), while donor families viewed research use as a meaningful way to honour their loved ones when transplantation was not possible.

This exploratory study highlights widespread support for using non-transplantable organs in research among individuals with personal experience of transplantation. The findings suggest a need for further research into how best to support and inform potential donors and families. Participants emphasised the importance of sensitive communication, clear consent processes and transparency regarding the use of donated organs.

To characterise patient and medication-related patterns observed in drug-related pressure ulcers (DRPUs) and provide descriptive findings that may support future consensus-building.

Multicentre retrospective observational study.

20 hospitals across Japan participated in the study with hospital pharmacists specialised in PU care.

A total of 1113 hospitalised patients with existing PUs were included and classified into three groups (definite, probable and no-possibility of DRPUs) based on predefined criteria.

The primary outcome was the description of medication-related characteristics observed in each DRPU classification group, including polypharmacy, initiation of new medications and dose adjustments. Secondary outcomes included differences in ulcer characteristics and functional status across DRPU categories.

The definite group (n=128, 11.5%) showed a significantly higher prevalence of polypharmacy (83.6% vs 71.1% in the no-possibility group, p

Medication-related characteristics such as polypharmacy, initiation of new medications, dose modifications and use of antipsychotics were more frequently observed in the definite DRPU group. These descriptive findings may help characterise the clinical patterns of DRPUs and may inform future hypothesis generation.

Non-occupational post-exposure prophylaxis (nPEP) and pre-exposure prophylaxis (PrEP) are effective HIV prevention methods, but their use is low in Sub-Saharan Africa (SSA). Mobile applications (apps) could increase uptake and adherence to these interventions, yet research on their use in communities is limited. Furthermore, there is limited information on the design and development of these apps, impacting their implementation. This scoping review aims to identify, analyse and evaluate mobile apps designed to improve nPEP uptake, adherence and linkage to PrEP services focusing on key features, barriers and facilitators. It also seeks to address gaps in studies assessing the feasibility, usability and acceptability of these apps, with the goal of informing future research, healthcare policies and public health strategies to reduce the HIV burden in Sub-Saharan Africa.

This review will follow the Arksey and O'Malley framework and search databases such as PubMed, Scopus and Web of Science for relevant studies. Two independent reviewers will screen and assess full-text studies. Primarily, the review will include studies on digital interventions for nPEP and PrEP, excluding opinion papers, narrative reviews and sub-studies. Grey literature from sources like Google Scholar will also be considered. Data will be captured using a charting form, and results will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Reviews framework. Completion is expected in December 2025.

No ethical approval is required as publicly available materials will be used. Results will be shared through peer-reviewed journals, conferences and with policymakers to inform HIV prevention strategies.

To evaluate the cost-effectiveness of implementing a penicillin allergy assessment pathway (PAAP) versus usual care within the NHS.

A decision tree analysis over a 5-year time-period, informed by a randomised controlled trial (RCT) of PAAP and systematic review. Value of information analysis was also conducted to estimate the value of conducting a new trial.

Model inputs were informed by the ALABAMA RCT participants included in the primary analysis, 811 adults with penicillin allergy labels and recent antibiotic prescriptions, and data from published literature.

Participants in the ALABAMA trial included in the primary analysis: PAAP (n=401) and usual care (n=410).

Costs are presented in GBP (£) at 2022–2023 prices, quality-adjusted life years (QALYs), incremental cost-effectiveness ratio, incremental net monetary benefit (INMB), the probability of cost-effectiveness at the £20,000 and £30,000 per QALY threshold, and the cost effectiveness of a new follow-on trial.

PAAP had incremental costs of £–83 (probability of cost saving 47.5%) and incremental QALYs of 0.036 (probability of positive benefits 47.5%). The INMBs (probability of cost-effectiveness) were £806 (48%) and £1167 (48%) under the decision thresholds of £20,000 and £30,000 per QALY, respectively. PAAP was more cost-effective among females, people aged >65 years, and more frequent antibiotic users. A new follow-on trial involving 1267 participants was estimated to cost £2.4 million and, by reducing uncertainty in the evidence, would avoid £19.6 million in costs of incorrect management decisions for eligible patients over the next 10 years.

The PAAP was considered cost-effective, but significant uncertainty remained. Future trials with adequate power and longer follow-up are needed to determine the most cost-effective models for penicillin allergy testing.

ISRCTN20579216.