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Targeted biologic therapies have transformed outcomes for individuals with psoriasis, a common immune-mediated inflammatory skin disease. The widespread use of these highly effective treatments has led to a growing number of individuals with clear or nearly clear skin remaining on continuous, long-term treatment. Personalised strategies to minimise drug exposure may sustain long-term disease control while reducing treatment burden, associated risks and healthcare costs. This study aims to evaluate the feasibility of a definitive pragmatic effectiveness trial of two personalised dose minimisation strategies compared with continuous treatment (standard care) in adults with well-controlled psoriasis receiving the exemplar biologic risankizumab.
This is a multicentre, assessor-blind, parallel group, open-label randomised controlled feasibility trial in the UK, evaluating two personalised biologic dose minimisation strategies for psoriasis. 90 adults with both physician-assessed and patient-assessed clear or nearly clear skin on risankizumab monotherapy for ≥12 months will be randomised in a 1:1:1 ratio to (1) patient-led ‘as-needed’ treatment, where risankizumab is administered at the first sign of self-assessed psoriasis recurrence, (2) therapeutic drug monitoring-guided treatment, with personalised dosing intervals determined using a pharmacokinetic model or (3) continuous treatment as per standard care, for 12 months. Participants will be invited to submit self-reported outcomes and self-taken photographs every 3 months using a bespoke remote monitoring system (mySkin app) and will attend an in-person assessment at 12 months. They may also request additional patient-initiated follow-up appointments during the trial if needed. The primary outcome is the practicality and acceptability of the two personalised biologic dose minimisation strategies, assessed as a composite measure including recruitment and retention rates, adherence to the assigned strategies and acceptability to both patients and clinicians. The feasibility of collecting healthcare cost and resource utilisation data will also be evaluated to inform a future cost-effectiveness analysis. A nested qualitative study, involving semistructured interviews with patients and clinicians, will explore perspectives on the personalised biologic dose minimisation strategies. These findings will inform the design of a future definitive trial.
This study received ethical approval from the Seasonal Research Ethics Committee (reference 24/LO/0089). Results will be disseminated through scientific conferences, peer-reviewed publications and patient/public engagement events. Lay summaries and infographics will be codeveloped with patient partners to ensure the findings are accessible for the wider public.
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.
To identify strategies and mechanisms of interventions between caregivers and people with dementia that contribute to reducing refusals of care and determine how they work, in which contexts, why and for whom.
Realist synthesis.
There were three stages: (1) initial programme theory development and prioritisation through assessing video-recorded personal care interactions and interview transcripts; scoping the literature and team discussions, (2) literature search, review and synthesis and (3) realist interviews with stakeholders and refinement of evidence-based programme theories.
Searches were conducted in MEDLINE, EMBASE, PsycINFO, CINAHL Ultimate, Cochrane CENTRAL Register of Controlled Trials and Web of Science; date range: 2000–2024.
A total of 71 sources were included in the synthesis, and interviews with 15 stakeholders. Eight programme theories were generated, evidenced and refined, each incorporating multiple caregiver strategies. The overarching mechanism which made people with dementia more likely to accept assistance with personal care was trusting the caregiver and feeling safe. Seven mechanisms fed into this: a sense of control, positive connection, care feeling manageable, working together, engaging with the care activity (or something non-care related), comfort and needs being known and addressed.
Refusals of care from people with dementia can be reduced by multiple caregiver strategies related to communication, approach, the type of care offered and the care interaction process. Mechanisms reflect relational aspects: the quality of the caregiver/person partnership and making the person with dementia feel safe.
Our findings provide programme theories and practical care strategies which could be helpful for those, such as nurses, working to improve personal care practices for people with dementia.
Public representatives advised the study throughout, providing advice on initial programme theories, evidence-based programme theories and synthesised stakeholder evidence.
This synthesis uses the publication standards for realist synthesis (RAMESES 1).
PROSPERO: 2024 CRD42024496072
Health advocacy (HA) is acknowledged as a core competence in medical education. However, varying and sometimes conflicting conceptualisations of HA exist, making it challenging to integrate the competence consistently. While this diversity highlights the need for a deeper understanding of HA conceptualisations, a comprehensive analysis across the continuum of medical education is absent in the literature. This protocol has been developed to clarify the conceptual dimensions of the HA competence in literature as applied to medical education.
The review will be conducted in line with the JBI (formerly Joanna Briggs Institute) methodology for scoping reviews. A comprehensive literature search was developed and already carried out in eight academic databases and Google Scholar, without restrictions on publication date, geography or language. Articles that describe the HA role among students and physicians who receive or provide medical education will be eligible for inclusion. Two independent reviewers will independently complete title and abstract screening prior to full-text review of selected articles and data extraction on the final set. A descriptive-analytical approach will be applied for summarising the data.
This scoping review does not involve human participants, as all evidence is sourced from publicly available databases. Therefore, ethical approval is not required for this study. The findings from this scoping review will be disseminated through submission to a high-quality peer-reviewed journal and presented at academic conferences. By clarifying the conceptualisations of HA, this review aims to contribute to a shared narrative that will strengthen the foundation for integrating the HA role into medical education.
A preliminary version of this protocol was registered on the Open Science Framework on 9 December 2024, and can be accessed at the following link: https://osf.io/ed2br. We have also registered our scoping review protocol as a preprint at medRxiv:
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