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.
Providing care management, treatment and support to patients with Alzheimer’s Disease and Related Dementias (ADRD) is a difficult task for health systems. Over the past 20 years, interventions designed to improve outcomes for patients living in the community with dementia and their care partners have moved progressively, but separately, from large scale trials and pragmatic models of collaborative care. Given the projected increase in the number of people living with dementia coupled with the realignment of payment for services to be value-based and provided in the community, system-level approaches are needed to address the complex needs of patients with a dementia diagnosis and their care partners. We designed a statewide, pragmatic trial to evaluate virtual delivery of an evidence-based dementia collaborative care program on patient healthcare utilization and medication use.
The Aging Brain Care Virtual (ABCV) program is a 12-month embedded, cluster randomized, usual care controlled trial designed to test the effectiveness of a virtual dementia collaborative care program in 24 Indiana University Health primary care clinics (12 intervention, 12 control) across the state of Indiana, enrolling 860 persons living with dementia (430 intervention, 430 control) and their care partners. ABCV relies on a tailored approach in which dyad needs are identified during virtual visits and addressed with standardized protocols previously tested in a randomized controlled trial delivered in person. The ABCV trial will measure emergency department utilization (primary outcome) and appropriate medication use (secondary outcome) at 12 months using electronic medical record data. Additionally, this study will use semi-structured interviews with care partners and clinicians to explore the implementation context, process and outcomes of the ABCV program.
Ethics approval was obtained from the Indiana University Institutional Review Board (20249). Research findings will be published in peer-reviewed journals and presented at scientific conferences.
Globally, the circulation of influenza and other seasonal respiratory viruses changed dramatically during the COVID-19 pandemic. This study aims to determine the trends of acute respiratory infections (ARIs) caused by SARS-CoV-2, influenza A, influenza B and respiratory syncytial viruses (RSVs) in patients presenting to hospitals in the Lao People’s Democratic Republic (PDR) (Laos).
Prospective surveillance study.
Four provincial hospitals across Laos between March 2021 and July 2023.
Participants of all ages who met our case definition for an ARI (axillary temperature ≥37.5°C or history of fever AND cough or other respiratory symptoms/signs OR loss of smell and/or taste) presenting to the hospital less than 10 days after symptom onset were eligible to be enrolled in the study. Combined nasopharyngeal and throat swabs were tested for SARS-CoV-2, influenza A, influenza B and human RSV (hRSV) using probe-based real-time RT (Reverse transcription)-PCR assays.
The proportion of patients in whom SARS-CoV-2, influenza A, influenza B and hRSV was detected.
There were 4203 patients recruited, of whom 898 (21%) were children aged under 5 years. SARS-CoV-2 was detected in 16.9% of patients, followed by influenza A, influenza B and hRSV (8.4%, 7.2% and 4.7%, respectively). 98 patients (2.3%) were diagnosed with probable co-infection, with at least two viruses detected. After May 2022, the number of cases of influenza A, influenza B and hRSV increased rapidly. Six per cent of patients (263) had a quick Sequential Organ Failure Assessment score of ≥2, and 34 (0.8%) patients died, of whom 11 tested positive for a respiratory virus.
During the COVID-19 pandemic in Laos, few respiratory viruses were detected by passive surveillance until the relaxation of non-pharmaceutical interventions implemented for infection control. After restrictions were lifted, influenza A, influenza B and hRSV emerged rapidly, showing the importance of continuous surveillance.