Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

To assess the early risk of diabetic foot ulcer (DFU) among adult patients with diabetes and to identify clinical and behavioural correlates associated with DFU risk using Inlow’s 60-Second Screening Tool.

A cross-sectional analytical study.

Conducted at a tertiary-level referral hospital in Southwest Ethiopia.

The study included 164 adult patients with diabetes (aged ≥18 years) who attended routine follow-up visits at the diabetic clinic between February and March 2025. Patients who were critically ill, unable to communicate during data collection or pregnant were excluded. The median age of participants was 55 years (IQR 46–60), and 54.9% were male.

The primary outcome was early DFU risk, categorised as ‘at risk’ or ‘not at risk’ using Inlow’s 60-Second Screening Tool. Secondary outcomes included factors associated with DFU risk, such as glycaemic control, lipid profile and foot care practices.

Of the 164 participants, 32.3% (n=53) were found to be at risk for DFU. Participants who performed foot self-checks infrequently had more than threefold higher odds of DFU risk compared with those who practiced daily foot care (adjusted OR (AOR)=3.35; 95% CI 1.48 to 7.58; p=0.004). Poor glycaemic control (AOR=2.39; 95% CI 1.03 to 5.55; p=0.042) and dyslipidaemia (AOR=2.63; 95% CI 1.18 to 5.85; p=0.018) were also significantly associated with increased DFU risk.

Nearly one-third of patients with diabetes in this Ethiopian hospital setting were at early risk for DFU. Factors such as inadequate foot care, poor glycaemic control and dyslipidaemia were associated with increased risk. Incorporating rapid foot screening tools like Inlow’s 60-Second assessment into routine diabetes care, together with strengthened patient education and metabolic management, may help reduce the risk of DFU in resource-limited settings.

A key part of the patient safety system is how it responds to and learns from safety incidents. To date, there is limited research on understanding system-based approaches to investigating incidents that occur within this complex interacting system.

The aims of this study were to qualitatively explore mental health professionals’ perceptions of patient safety incident investigations; to understand the impact of the transition to systems-based approaches and to explore the influence of different elements of the system on the goals of patient safety.

The qualitative study involved 19 semi-structured interviews with professionals working within the patient safety system across two mental health National Health Service trusts. The data were analysed using thematic analysis.

Those interviewed identified that a change in approach to incident investigation, from root cause analysis to systems-based, would lead to rigorous investigations that are effectively linked to learning. Over time, this was described as a contributory factor to reducing feelings of blame and positively influencing safety culture. There were considerations of potential negative effects from a systems-based approach, such as the shifting rather than elimination of blame, and the possibility of missing individual poor practice. The findings identify the presence of several interdependencies across the system that could have a positive or negative influence on the outcomes of incident responses.

This study demonstrates that the interdependencies within the system and our limited understanding of safety in mental healthcare introduces complexity and uncertainty to incident investigation outcomes. This is likely to impact on safety incident responses and learning, where acknowledging and evaluating this complexity is likely to reduce any potential negative outcomes that exist.

Allergic rhinitis (AR) is a common chronic inflammatory condition that significantly impairs quality of life (QoL) through symptoms such as nasal congestion, rhinorrhoea, sneezing and itching. Conventional treatments often show limitations, prompting interest in complementary therapies like herbal medicine (HM). HM is widely used in East Asian countries and has demonstrated potential in modulating immune responses and reducing AR symptoms. In Korea, a government pilot project expanded in 2024 to include AR under limited insurance coverage for HM, highlighting the need for robust clinical evidence on its safety and effectiveness.

This study is a multicentre, prospective registry conducted in 21 Korean Medicine (KM) clinics across Republic of Korea. The registry systematically collects real-world data on HM treatments for AR, focusing on patient demographics, treatment patterns and clinical outcomes. Participants meeting predefined criteria will receive HM or other KM therapies as part of routine care. Data will be collected bi-weekly for the first 4 weeks, with additional follow-ups at 6 and 12 months. Primary outcomes include changes in Total Nasal Symptom Score, QoL scores and safety evaluations, analysed using descriptive and inferential statistical methods.

This study was approved by the Institutional Review Board of Kyung Hee University on 11 December 2024 (Approval No. KHSIRB-24–631). The study findings will be published in peer-reviewed journals and presented at academic conferences.

KCT0010172.

To evaluate the associations between depressive symptoms, HIV vulnerability factors and oral pre-exposure prophylaxis (PrEP) use and adherence among adolescent girls and young women (AGYW) in Kenya.

Cross-sectional observational study.

Research site in Kisumu, Kenya.

300 AGYW aged 19–24 years (median age 21 years, IQR 20–22), attending follow-up visits in a randomised controlled trial of the efficacy of a single-dose HPV vaccine.

Participants responded to questionnaires assessing their depressive symptoms (Patient Health Questionnaire-9), HIV vulnerability and PrEP use and adherence.

Moderate to severe depressive symptoms were reported by 14.3% (95% CI 10.5% to 18.8%). Factors associated with increased prevalence of depressive symptoms included medium HIV risk perception (adjusted prevalence ratio (aPR) 2.25; 95% CI 1.20 to 4.26) and engaging in transactional sex (aPR 2.51; 95% CI 1.15 to 5.48). The rate of oral PrEP use was 19.3% (n=58, 95% CI 15.0% to 24.0%), with 43.0% reporting adherence (≥5 doses in the past week). Depressive symptoms were not significantly associated with PrEP use (aPR 0.94; 95% CI 0.52 to 1.70).

The high prevalence of depressive symptoms among AGYW highlights the importance of integrating mental health screening into HIV prevention services, particularly for individuals with higher HIV risk perception and those engaging in transactional sex.

An increasing number of adolescents and young adults seek medical care for gender affirmation.1 Approximately 0.6%–2.0% of adolescents and young adults identify as transgender and non-binary (TNB).2 TNB youth and their caregivers need to be engaged in the developmentally appropriate multidisciplinary care that encompasses gender-affirming medical care and support.

A thoracic aortic aneurysm (TAA) is often considered a precursor to an acute type A aortic dissection (ATAAD), a life-threatening condition requiring immediate surgical intervention. While both conditions share histopathological similarities, less is known about their overlap in clinical cardiovascular risk factors. This study aimed to map the cardiovascular disease burden in patients with ATAAD and compare it with patients with TAA.

A multicentre retrospective study.

The data were collected from electronic health records of two academic hospitals located in the Netherlands.

Patients who were treated surgically for ATAAD or TAA between 2000 and 2022 were eligible. This study included 731 patients with ATAAD and 480 patients with TAA.

Hypertension was equally prevalent in both groups (50.9% vs 50.6%, p=0.921). Diabetes was uncommon (3.3% vs 6.7%, p=0.638). Hyperlipidaemia (9.6% vs 20.0%, p=0.001) and peripheral arterial disease (8.8% vs 22.7%, p

This study suggests distinct cardiovascular risk profiles in patients with ATAAD and patients with TAA, highlighting the importance of tailored treatment strategies for aortic disease. Further research is needed to investigate the pathophysiological mechanisms underlying these differences and their impact on thoracic aortopathy.

Adolescents and young adults (AYAs) represent a significant proportion of the global population, yet they face persistent barriers to accessing HIV services. In Sub-Saharan Africa, nearly 90% of AYA HIV cases occur within the region, with young women disproportionately affected. In Chad, while the overall HIV prevalence has declined, the risk remains high among AYA, accounting for 26.3% of all new infections. Stigma, lack of confidentiality, negative provider attitudes and structural barriers continue to hinder service utilisation, underscoring the urgent need for evidence-based, AYA-centred interventions. However, little is known about which attributes of HIV services AYA prioritise when accessing HIV care. This study applies a discrete choice experiment in Chad to systematically quantify AYA preferences for HIV services to inform the design of youth-responsive interventions.

The study employs a D-efficient fractional factorial design, developed through extensive qualitative research and pilot testing. The final design comprises 80 choice scenarios, divided into 10 blocks to reduce participant burden. The study will recruit 1000 AYA living with HIV aged 15–24 years across eight provinces, ensuring geographical and epidemiological representativeness. Participants will be randomly assigned to one of the blocks and complete eight choice tasks. Choice data will be analysed using conditional logit, mixed logit and latent class models to estimate trade-offs and preference heterogeneity.

Ethical approval was obtained from the National Committee on Bioethics of Chad (#010/MESRS/SE/SG/2024). In addition to disseminating findings through scientific publications, policy briefs and stakeholder engagements, the study will incorporate a codesign process with AYA, healthcare providers and policymakers to translate research findings into actionable interventions that align with AYA preferences and improve HIV service delivery.

Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%–7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients’ quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients’ lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting.

This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator’s Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients’ work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients’ relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary^+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients’ life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints.

This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations.

NCT06815380 (Pre-results).