Vital signs are essential markers of a patient’s physiological state, and these include heart rate, temperature, blood pressure, oxygen saturation, respiration rate and level of consciousness. Consequently, accurate assessment, documentation and interpretation of these markers are vital for early detection of patients’ deterioration and timely intervention.1 2

Shortages in the nursing workforce impact on the quality of patient care and pose a complex challenge for governments and healthcare organisations across the globe. There are estimated to be approximately 29 million nurses worldwide as of 2020, with a shortage of approximately 7 million against required levels. Despite growth in the workforce over the coming years, the nursing shortage is still projected to be 4.5M by 2030.1

One approach to addressing...

Diabetes is a widespread chronic disease, with steadily rising prevalence in most countries. In 2019, the global prevalence of diabetes was estimated at 9.3%, affecting 463 million people. This figure is projected to rise to 10.2% by 2030 and 10.9% by 2045.2 All people with type 1 diabetes and many people...

Interpretative phenomenological analysis (IPA) is a widely recognised and well-established method of qualitative inquiry designed to explore personal experience in detail, focusing on participants’ understandings and sense-making.1 In this article, we explain what distinguishes an IPA case study from a typical IPA study and highlight the strengths and limitations of this approach. While IPA is frequently used with small samples, single-participant IPA case studies can offer unique insights into deeply personal or rare experiences.

The ‘time-limited trial’ for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient’s response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.

We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials’ conceptual formulation and their heterogeneous, real-world use.

This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.

NCT06042621.

To explore why there is variation in implementation of multifactorial falls prevention practices that are recommended to reduce falls risks for older patients in hospital.

Mixed method, realist evaluation.

Three older persons and three orthopaedic wards in acute hospitals in England.

Healthcare professionals, including nurses, therapists and doctors (n=40), and patients aged 65 and over, and carers (n=31).

We examined mechanisms hypothesised to underpin the implementation of multifactorial falls risk assessment and multidomain, personalised prevention plans.

We developed an explanation detailing that how contextual factors supported or constrained implementation of recommended falls prevention practices.

Nurses led delivery of falls risk assessment and prevention planning using their organisation’s electronic health records (EHR) to guide and document these practices. Implementation of recommended practices was influenced by (1) organisational EHR systems that differed in falls risk assessment items they included, (2) competing priorities on nurse time that could reduce falls risk assessment to a tick box exercise, encourage ‘blanket’ rather than tailored interventions and that constrained nurse time with patients to personalise prevention plans and (3) established but not recommended falls prevention practices, such as risk screening, that focused multidisciplinary communication on patients screened as at high risk of falls and that emphasised nursing, rather than Multidisciplinary Team (MDT), responsibility for preventing falls through constant patient supervision.

To promote consistent delivery of multifactorial falls prevention practices, and to help ease the nursing burden, organisations should consider how electronic systems and established ward-based practices can be reconfigured to support greater multidisciplinary staff and patient and carer involvement in modification of individual falls risks.

Adenotonsillectomy is the primary treatment for type 1 obstructive sleep apnoea (OSA1). Although polysomnography (PSG) remains the gold standard for measuring Apnoea-Hypopnoea Index, it is a labour-intensive procedure and does not correlate with improvements in quality of life postadenotonsillectomy. Mouth breathing is associated with poorer quality of life in children. Mandibular movement (MM), which measures mouth opening, is a validated measure of respiratory effort that can be easily and safely assessed in children using the JAWAC technology. This study aims to evaluate the relationship between changes in quality of life and changes in mouth opening in children with OSA1 after undergoing adenotonsillectomy. Secondary objectives include evaluating changes in quality of life, clinical symptoms and other MM and PSG metrics in the same population.

This exploratory, non-randomised, monocentric, prospective cohort study with a non-blinded single arm will include 50 children aged 3–7 years, undergoing adenotonsillectomy at the Clinique Saint Jean, Montpellier, France. Quality of life will be measured using the parent version of the Paediatric Quality of Life Inventory and MM metrics will be measured during PSG using the JAWAC system during the inclusion visit and 3 months after adenotonsillectomy. The primary outcome will be the correlation between the changes in quality of life and mouth opening (1/10 mm) postadenotonsillectomy. Secondary analyses will evaluate changes in clinical symptoms, PSG measures and other MM metrics including respiratory effort, as well as the associations between these measures.

This study was approved by an independent ethics committee (Comité de Protection des Personnes Est) on 24 March 2025 (2024-A02761-46) and will be conducted in accordance with French law, good clinical practice and the guidelines of the Declaration of Helsinki. Study findings will be disseminated through international peer-reviewed journal articles as well as public, academic presentations at national and international conferences.

NCT06973928.

Our primary objectives were (1) to develop and validate an administrative data algorithm for the identification of hand trauma cases using clinical diagnoses documented in medical records as the reference standard and (2) to estimate the incidence of hand trauma in a universal public healthcare system from 1993 to 2023 using a population-based research cohort constructed using a validated case identification algorithm.

A population-based retrospective validation study.

Ontario, Canada, from 2022 to 2023 (validation) and from 1993 to 2023 (estimation).

Our reference standard was the known hand trauma status of 301 patients (N=147 with hand trauma) who presented to an urban tertiary-care hand trauma centre in Toronto, Ontario.

(1) The sensitivity, specificity, positive and negative predictive values of the optimal algorithm to identify hand trauma using provincial health administrative data and (2) age-standardised and sex-standardised incidence rates of hand trauma among men and women, by age, and by area of patient residence.

The optimal algorithm had a sensitivity of 73.8% (95% CI 66.6% to 81.0%), specificity of 80.1% (95% CI 73.8% to 86.5%), positive predictive value of 78.1% (95% CI 71.2% to 85.0%) and negative predictive value of 76.1% (95% CI 69.5% to 82.7%). Over the study period, the age-standardised and sex-standardised incidence of hand trauma increased from 384 to 530 per 100 000. The greatest increase was observed in males and individuals aged 0–19 and 80+, with higher incidence rates in Southern compared with Northern Ontario.

Our algorithm enabled identification of hand trauma cases using health administrative data suitable for population-level surveillance and health services research, revealing a rising burden of hand trauma from 1993 to 2023. These findings can support improved surveillance, resource allocation and care delivery for this public health problem.

An abnormal composition of gut bacteria along with alterations in microbial metabolites and reduced gut barrier integrity has been associated with the pathogenesis of chronic autoimmune and inflammatory rheumatic diseases (AIRDs). The aim of the systematic review, for which this protocol is presented, is to evaluate the clinical benefits and potential harms of therapies targeting the intestinal microbiota and/or gut barrier function in AIRDs to inform clinical practice and future research.

This protocol used the reporting guidelines from the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol. We will search Embase (Ovid), Medline (Ovid) and the Cochrane Library (Central) for reports of randomised controlled trials of patients diagnosed with an AIRD. Eligible interventions are therapies targeting the intestinal microbiota and/or gut barrier function including probiotics, synbiotics, faecal microbiota transplantation, live biotherapeutic products and antibiotics with the intent to modify disease activity in AIRDs. The primary outcome of the evidence synthesis will be based on the primary endpoint of each trial. Secondary efficacy outcomes will be evaluated and selected from the existing core domain sets of the individual diseases and include the following domains: disease control, patient global assessment, physician global assessment, health-related quality of life, fatigue, pain and inflammation. Harms will include the total number of withdrawals, withdrawals due to adverse events, number of patients with serious adverse events, disease flares and deaths. A meta-analysis will be performed for each outcome domain separately. Depending on the type of outcome, the quantitative synthesis will encompass both ORs and standardised mean differences with corresponding 95% CIs.

No ethics approval will be needed for this systematic review. We will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to disseminate the study results through a peer-reviewed publication.

CRD42025644244.

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

NCT06965738.

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

NCT0665050.

To assess how preoperative anaemia affects surgical outcomes in elderly patients within a resource-limited setting.

Prospective cohort study.

Two comprehensive specialised hospitals in Ethiopia.

Participants consisted of 224 patients aged 65 years and older who underwent surgery between 1 December 2024 and 29 March 2025.

Perioperative blood transfusions were the primary outcome. Secondary outcomes included intensive care unit (ICU) admission, risk of postoperative complications, prolonged hospitalisation, poor recovery quality and in-hospital mortality.

The anaemic group required transfusions of three or more units more frequently than the non-anaemic group (10.5% vs 2.6%; absolute risk difference 8.0%). Their perioperative transfusion rates were significantly higher (42.3% vs 18.4%; p

Preoperative anaemia significantly increases the risk of transfusion, poor recovery, ICU admission, prolonged hospitalisation and in-hospital mortality in older patients who underwent surgery. In resource-limited settings, improving perioperative outcomes should prioritise the early detection and treatment of anaemia.

To determine whether a biopsychosocial model of suicidality, specifically sleep, nutrition, physical exercise, mindfulness, social connectedness, lower socioeconomic status (SES) and sex are uniquely associated with increased suicidal ideation, longitudinally over adolescence.

Longitudinal, prospective cohort study.

A structured self-report questionnaire was collected as part of the Longitudinal Adolescent Brain Study at the University of the Sunshine Coast’s Thompson Institute (Queensland, Australia) from July 2018 to January 2024.

159 Australian adolescents (n=91 female; 68 male) aged 12 to 17 years.

Self-reported suicidal ideation was measured longitudinally. Data were also collected on self-reported lifestyle factors (sleep, nutrition, physical exercise, mindfulness and social connectedness), psychological distress, SES and sex. All measures were collected at 4-monthly intervals for each participant for up to 5 years (maximum of 15 time points).

Significant relationships were identified between increased suicidal ideation and poor sleep (OR 2.6, 95% CI 1.4 to 4.6, p=0.002), socioeconomic disadvantage (SES quintile 1: OR 6.3, 95% CI, 1.8 to 21.8, p=0.004; SES quintile 2: OR 8.7, 95% CI 1.4 to 56.2, p=0.022), psychological distress (OR 5.7, 95% CI 2.1 to 15.6, p≤0.001) and eating habits (β –0.08, 95% CI –0.2 to –0.0).

Poor sleep, socioeconomic disadvantage, psychological distress and eating habits were all found to be significantly associated with increased adolescent suicidal ideation over time. These biopsychosocial factors should be considered in targeted interventions and policies for reducing adolescent suicidality. Further research should employ multilevel modelling to examine factor interactions and rigorously evaluate interventions targeting lifestyle factors and socioeconomic inequalities through randomised controlled trials and quasi-experimental designs.

Persistent somatic symptoms and functional disorders are conditions requiring a biopsychosocial approach to care, often from multiple professionals. The fragmentation of care common in most health systems results in unsatisfactory and challenging care experiences. Collaborative care networks form an important route towards improving outcomes and the overall experience of care for patients and professionals. While we have a good idea of what such collaborative care networks can look like, we lack knowledge on the practicalities of implementing change in such networks.

The core objective of this study is to implement change in a collaborative care network for persistent somatic symptoms and functional disorders care. Our questions were twofold: first, what are examples of realistic action processes to improve such collaborative care networks? Second, what are, in our experience, conditions for an effective change process in such a collaborative care network?

Participatory action research approach embedded within an active regional network between May 2023 and May 2024. The process was led by an action group who selected objectives and related actions with the aim of improving the network, leading to better care for people with persistent somatic symptoms and functional disorders as well as improving satisfaction among professionals.

ALK Netwerk Salland, a regional network of professionals and experts-by-experience, focused on care of persistent somatic symptoms. This network is based in the Salland region in the east of the Netherlands, centred around the city of Deventer.

The action group was made up of local stakeholders including experts-by-experience and health and social care professionals, facilitated by a researcher-in-residence. Other participants included members of the regional network who provided input towards the different objectives.

Over the course of a year, three objectives were selected and enacted, including assessing the resources of the network, improving knowledge of treatment options and improving the shared vision of care. The process faced some challenges, such as changes in action group members and a lack of resources and time to enact changes. However, by having a trusted and engaged team, working with an active network, we were able to enact significant changes to the network, which may be sustained and built on through the ongoing action group.

Future participatory action research studies would benefit from a trusted and embedded researcher-in-residence, meaningful involvement early in the process of experts-by-experience, and serious consideration of realistic outcome measures to monitor for evaluation of changes made.

Asthma is a chronic respiratory disorder requiring ongoing medical management. This ecological study investigated the spatial and temporal patterns of notification rates for asthma from clinic visits and hospital discharges and identified demographic, meteorological and environmental factors that drive asthma in Bhutan.

Monthly numbers of asthma notifications from 2016 to 2022 were obtained from the Bhutan Ministry of Health. Climatic variables (rainfall, relative humidity, minimum and maximum temperature) were obtained from the National Centre for Hydrology and Meteorology, Bhutan. The Normalised Difference Vegetation Index (NDVI) and surface particulate matter (PM2.5) were extracted from open sources. A multivariable zero-inflated Poisson regression (ZIP) model was developed in a Bayesian framework to quantify the relationship between risk of asthma and sociodemographic and environmental correlates, while also identifying the underlying spatial structure of the data.

There were 12 696 asthma notifications, with an annual average prevalence of 244/100 000 population between 2016 and 2022. In ZIP analysis, asthma notifications were 3.4 times (relative risk (RR)=3.39; 95% credible interval (CrI) 3.047 to 3.773) more likely in individuals aged >14 years than those aged ≤14 years, and 43% (RR=1.43; 95% CrI 36.5% to 49.2%) more likely for females than males. Asthma notification increased by 0.8% (RR=1.008, 95% CrI 0.2% to 1.5%) for every 10 cm increase in rainfall, and 1.7% (RR=1.017; 95% CrI 1.2% to 2.3%) for a 1°C increase in maximum temperature. An increase in one unit of NDVI and 10 µg/m³ PM2.5 was associated with 27.3% (RR=1.273; 95% CrI 8.7% to 49.2%), and 2.0% (RR=1.02; 95% CrI 1.0% to 4.0%) increase in asthma notification, respectively. The high-risk spatial clusters were identified in the south and southeastern regions of Bhutan, after accounting for covariates.

Environmental risk factors and spatial clusters of asthma notifications were identified. Identification of spatial clusters and environmental risk factors can help develop targeted interventions that maximise impact of limited public health resources for controlling asthma in Bhutan.

Monitoring systems exist for clinical research transparency in high-income countries, but systematic assessment of these practices in global health (GH) research (GHR) is limited. We evaluated methods for monitoring GHR transparency and engagement.

Cross-sectional study.

Three sources were used: (a) ClinicalTrials.gov, (b) publications from 20 journals with ‘international’ or ‘global’ in the title and (c) outputs from selected GH funder websites.

From ClinicalTrials.gov, we selected 200 interventional trials on maternal health and tuberculosis (2008–2019), ensuring two-thirds were from low- and middle-income countries (LMIC). From journals, we included 200 trial publications (2011–2023). From funder websites, we included outputs with sufficient metadata to track trial registration and reporting.

Trials were extracted independently by two reviewers for result publications; journal articles were screened to confirm whether they reported trial results. Across all sources, we assessed registration timing, result reporting, open access and stakeholder engagement.

For 200 trials, 37% were prospectively registered, 65% published results in journals and 15% reported summary results in ClinicalTrials.gov. Only 34% reported results in any format within 24 months of completion. Of 200 publications, 72% were freely accessible, and 23% of the 100-article subsample included stakeholder engagement statements. The funder website sample yielded insufficient metadata for analysis.

Monitoring GHR is feasible using registries and journals, though funder websites provide limited tracking. While open-access rates are encouraging, timely reporting and engagement documentation remain weak. These results highlight opportunities for developing GHR-specific monitoring approaches through collaborative efforts among global stakeholders.

The study aimed to assess the prevalence of financial catastrophe and explore patients’ perceived effectiveness of the government support programme related to chronic kidney disease.

Cross-sectional mixed-method study.

A total of 120 patients receiving free regular haemodialysis under the government’s Deprived Citizen Support Programme for at least 6 months were included in the quantitative study, and 9 patients participated in the qualitative study.

Prevalence of financial catastrophe and factors associated with financial catastrophe among chronic kidney disease patients undergoing haemodialysis.

A convergent parallel mixed-method approach was carried out from 15 June to 15 December 2024, among chronic kidney disease patients undergoing haemodialysis at the National Kidney Center. Quantitative data were collected through face-to-face interviews using a semi-structured questionnaire. Financial catastrophe was defined as out-of-pocket (OOP) healthcare payments ≥40% of a household’s disposable income, following the WHO-recommended threshold for severe financial burden. OOP expenditures were assessed over 6 months, and associations were tested using ² and binary logistic regression at a 95% CI in SPSS V.25.0. For the qualitative arm, in-depth interviews were conducted with nine purposively selected patients, and inductive thematic analysis was applied to explore the perceived effectiveness of the government support programme. The quantitative and qualitative findings were then integrated to achieve convergence and divergence, allowing for a comprehensive understanding of the extent and context of financial hardship among patients.

The prevalence of financial catastrophe was 72.5%. The factors associated with financial catastrophe were the presence of complications (adjusted OR (AOR): 3.67, 95% CI 1.019 to 13.27), patients without financial support (AOR: 2.77, 95% CI 1.016 to 7.56) and reduction in food expenses (AOR: 0.313, 95% CI 0.109 to 0.896). Qualitative findings on awareness regarding government subsidies, financial strain, barriers to receiving treatment and perceived effectiveness of the programme revealed key aspects of utilisation and effectiveness of the government support programme.

The prevalence of financial catastrophe was substantially high, which highlights the importance of addressing economic challenges in chronic kidney disease care. The study emphasised the need to strengthen financial protection through the expansion of government subsidies and improved insurance coverage.

Functional foods have demonstrated potential in preventing gastrointestinal and musculoskeletal (osteo-related) disorders; however, evidence from cross-sectional studies in adults remains limited. This study aimed to examine the relationship between the frequency of functional food consumption and the prevalence of gastrointestinal and osteo-related conditions among adults in Bangladesh.

Cross-sectional study.

A face-to-face interview was conducted in Southern Bangladesh.

A total of 959 adults participated. Socio-demographic characteristics, lifestyle factors, health status and patterns of functional food consumption were collected using a structured questionnaire.

The prevalence of gastrointestinal and musculoskeletal (osteo-related) diseases, as well as their associations with the frequency of functional food consumption, were assessed using binary logistic regression.

Gastrointestinal and musculoskeletal (osteo-related) diseases were reported by 55.4% and 44.1% of participants, respectively. Multivariate logistic regression showed that several functional foods were associated with lower odds of gastrointestinal conditions, including regular seed intake (OR=0.35, p=0.034), weekly fibre-rich foods (OR=0.48, p=0.021), weekly probiotics (OR=0.26, p=0.012), monthly probiotics (OR=0.33, p

The consumption of functional foods, particularly seeds, probiotics, fibre-rich foods, nuts, tea/coffee and natural products were associated with a lower risk of gastrointestinal and musculoskeletal diseases in adults. These findings provide robust evidence to inform future prospective studies and support public health strategies in Bangladesh aimed at promoting the consumption of functional foods to prevent diet-related health conditions.

Health literacy (HL) is essential for making informed health-related decisions, for example enabling parents to reduce their child’s allergy risk. Health literacy does not, however, rely solely on an individual’s capacities, but is strongly influenced by external factors. Midwives provide important health advice to families, particularly since their relationship is close during a time of significant transition. This offers them a unique opportunity to positively influence the HL of parents, which in turn may support the health and well-being of the whole family. The aim of this study is to develop and evaluate an intervention that can support midwives in providing allergy prevention advice in a way that is in line with the concept of HL.

In accordance with the recommendations of the Medical Research Council framework in the first phase of this study, we will survey midwives (target sample size=379) in Germany regarding their practices, the potential barriers they face and enabling factors in providing advice on early childhood allergy prevention in an HL-responsive way. The data will be subjected to descriptive statistical analysis. Two co-design workshops will then be conducted with various stakeholders in two regions (Rhineland-Palatinate and Saxony) of Germany. Following the protocol proposed by the Stanford Design Thinking School, we will use design thinking to collect ideas for the intervention. Based on these ideas and our previous qualitative and quantitative study, we will develop an intervention in collaboration with didactic experts. The intervention will be piloted in three groups (midwives=10–15, midwives working as practice supervisors=5–10, students of midwifery=10–20). For the process evaluation, we will use observation protocols of the intervention conduct and qualitative interviews. For the outcome evaluation, we will use a questionnaire and observations in simulation laboratories with students of midwifery.

This study protocol was approved by the Ethics Committee of the University of Regensburg (ID 23-3441-101) and is in compliance with the Declaration of Helsinki. Participation in the study will only be possible after informed consent has been given. Our results will be presented at national and international conferences and published in scientific journals. Additionally, once it has been finalised, we will make the intervention available to educational institutions for (future) midwives.