Palmoplantar pustulosis (PPP) is a rare, debilitating inflammatory skin disease involving painful pustules on the palms and soles. Janus kinase (JAK) inhibitors target pathways relevant to PPP disease biology but also confer a risk of major adverse cardiovascular events and malignancy in certain ‘at risk’ individuals; this includes those with PPP given prevalent smoking and cardiovascular risk factors in the PPP population. The feasibility of JAK inhibitor therapy for PPP requires assessment prior to a randomised controlled trial evaluation of drug efficacy and safety for this indication.
The ‘Janus kinase inhibitors in palmoplantar pustulosis: a mixed-methods feasibility’ trial is an open-label, single-centre, single-arm, mixed-methods feasibility trial of JAK inhibition in PPP (REC reference: 24/NE/0147; ISRCTN61751241). Participants (n=20) will receive 8 weeks of treatment with the JAK inhibitor upadacitinib (‘Rinvoq’, 30 mg, once daily). Qualitative semistructured interviews (up to n=40) will be undertaken with trial participants, trial decliners and healthcare professionals. The primary outcome will be a composite assessment of feasibility across three domains: recruitment, adherence and acceptability, using a mixed-methods analysis approach. Secondary objectives include the identification of trial recruitment optimisation strategies, using the ‘Quintet Recruitment Intervention’, and the generation of an indication of effect size on disease severity (measured using the Palmoplantar Pustulosis Psoriasis Area and Severity Index) to inform future sample size calculations. Historic placebo control data from the Anakinra for Pustular Psoriasis: Response in a Controlled Trial (National Institute of Health and Social Care reference: 13/50/17; Research Ethics Commitee reference: 16/LO/0436) will be used as the effect size comparator. Study recruitment will be undertaken over a 24-month period, commencing in November 2024.
This study has been approved by the Newcastle North Tyneside 2 Research Ethics Committee, 24/NE/0132. Our findings will inform the feasibility of a future adequately powered RCT evaluating the efficacy of JAK inhibitor therapy in PPP.
Congenital heart disease (CHD) is the most common congenital condition, often necessitating complex heart surgeries that require careful planning by multidisciplinary teams. Multidisciplinary meetings (MDMs) in CHD care aim to integrate diverse expertise to optimise surgical planning. However, the lack of standardised protocols for conducting these meetings introduces undesirable variability in decision-making processes, potentially impacting patient outcomes. This study addresses the critical gap in understanding which aspects of MDMs should be standardised to ensure consistent, high-quality decision-making while also identifying areas where flexibility is essential to accommodate individual patient needs. The objective is to characterise current MDM practices in CHD care, identify factors contributing to variability and provide insights into how a balance between standardisation and flexibility can improve decision-making and patient outcomes.
A convergent parallel mixed-methods study design will be used to collect, analyse and interpret quantitative and qualitative data. Data collection will include a blend of naturalistic observations and chart reviews to track patient journeys from surgical planning through to postoperative outcomes. To complement these findings, interviews with healthcare providers will capture subjective perspectives on multidisciplinary decision-making. Additionally, departmental metrics will be collected to contextualise the broader clinical environment. Closed-ended observational and chart review data will be analysed using summary statistics and descriptive analysis (eg, percentages, means) to characterise MDM decision-making. Qualitative data (eg, reflections and learnings) from weekly post-surgical debriefs (called Performance Rounds) and clinician interviews on MDM decision-making will be analysed using a modified Framework Method.
Institutional research ethics approval has been acquired (REB #1000080464). To engage key stakeholders and foster collaborative improvement, study results will be shared in research rounds, where staff attending medical surgical conferences, team huddles, morbidity and mortality reviews, and Performance Rounds will be invited to participate. Targeted meetings with individual clinician groups will further allow for in-depth discussion and valuable feedback on the findings. Finally, the findings from this study are anticipated to make a meaningful contribution to the literature; a manuscript is planned for submission to a peer-reviewed journal.
To determine the proportion of Aboriginal and/or Torres Strait Islander Peoples with diabetes who were monitored according to recommended national guidelines and had their clinical parameters within recommended targets. We also examined trends over time (2013–2022) and compared urban and rural areas.
A repeated cross-sectional study using data from a national general practice database (MedicineInsight, 2013–2022).
De-identified electronic health records (EHR) of people attending 427 mainstream general practices across Australia.
This study included all Aboriginal and/or Torres Strait Islander adults (18+ years) diagnosed with diabetes mellitus who were regular patients (attended at least once a year in three consecutive years) within the MedicineInsight database.
Outcomes measured were (i) monitoring of blood glucose, lipids, blood pressure (BP), renal function and Body Mass Index (BMI)/waist circumference (WC) and (ii) achieving recommended targets: glycosylated haemoglobin (HbA1c) ≤7.0%, fasting glucose 4–7 mmol/L, random glucose 5–10 mmol/L, total cholesterol ≤4.0 mmol/L, low-density lipoprotein 60 mL/min/1.73 m2, urine albumin-creatinine ratio (uACR) 2, WC
Between 70% and 90% of individuals were monitored for the clinical parameters above, except for BMI/WC (55%–75%). Trends in monitoring over time were similar across remoteness areas, increasing slightly in 2013–2014 and declining from 2019. Among those monitored, 53%–86% achieved targets for blood glucose, lipids and renal function; 32%–42% for BP; and
The risk of diabetes complications among Aboriginal and/or Torres Strait Islander Peoples could be reduced by improving management of blood pressure and overweight/obesity in all areas, and blood glucose and lipids in rural areas.
Venous thromboembolism (VTE) occurs when a blood clot forms in a vein. It is comprised of deep vein thrombosis (DVT) and pulmonary embolism and can be potentially life-threatening. Patients undergoing surgery are at increased risk of developing VTE within hospital admission and 90 days after hospital discharge are collectively known as hospital-acquired thrombosis (HAT). Without the use of thromboprophylaxis, the untreated risk of VTE is reported to be as high as 40–60% in those undergoing major orthopaedic procedures and around 15–40% in the general surgical population.
HAT accounts for around 12 000 deaths per year in the UK. For patients undergoing surgery, there is good evidence for the use of thromboprophylaxis to prevent VTE.
Thromboprophylaxis is available in both pharmacological and mechanical forms. While there is a huge body of evidence demonstrating that pharmacological thromboprophylaxis significantly reduces VTE by 30–65%, the benefit of graduated compression stockings (GCS) has been called into question. The GRACE study (Graduated Compression stocking as an adjunct to Extended duration pharmacological thromboprophylaxis for venous thromboembolism prevention) aims to evaluate the adjuvant benefit of GCS in addition to extended duration pharmacological thromboprophylaxis (EDPTP) for elective surgical patients at highest risk of VTE.
GRACE is a pragmatic, multicentre randomised trial of adults undergoing surgery who are at high risk of VTE. Participants are randomised into a 1:1 ratio to either EDPTP and compression stockings (control arm) or EDPTP (intervention arm). Following randomisation, participants will undergo surgery and be followed up centrally at 7, 21–35 and 90 days after their procedure. All participants will be offered a bilateral full lower limb duplex scan at 21–35 days post procedure to capture any asymptomatic DVT.
The trial aims to randomise 8608 participants from around 50 National Health Service (NHS) and non-NHS sites in the UK over a 24-month period. The primary endpoint is any imaging-confirmed incidence of VTE within 90 days of surgery.
On 20 December 2023, GRACE received favourable ethical approval from the Wales Research Ethics Committee 3 Cardiff (23/WA/0350) and the Health Research Authority (IRAS 333539). The results of the study will be disseminated via peer-reviewed publications, presentation at national and international conferences and to study participants via electronic newsletter and social media channels.