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Preventable intraoperative adverse events (iAEs) are common despite widespread implementation of surgical quality improvement initiatives. These events often result from the interaction of multiple system-based factors (safety threats, STs) that coalesce to compromise safety. Existing research does not fully capture how STs vary across institutions, and how surgical teams either recover from or anticipate challenges (resilience supports, RSs). Consequently, efforts to design and align interventions are hindered by an incomplete understanding of the system-level contributors to patient safety risks. This study uses a human factors approach to gain a comprehensive understanding of STs and RSs across four hospitals by analysing operating room (OR) video recordings and conducting interviews with clinical teams to contextualise STs and RSs.
This mixed-method study will analyse 120 surgical video recordings from four hospitals, using a comprehensive multimodal data capture platform, called OR Black Box (ORBB, Surgical Safety Technologies New York City, USA). All ORBB videos will be coded for case information, surgical phase, iAE type and severity. Human factor researchers will then retrospectively identify and code STs and RSs, applying a combined deductive (Systems Engineering Initiative for Patient Safety components: person, tasks, tools/technology, environment, organisation) and inductive approach. Detailed qualitative observations of STs and RSs will be transcribed, with the roles of the involved individuals noted. Quantitative and qualitative cross-institutional comparisons will highlight potential effective interventions (eg, radiofrequency sponge detection wands used during surgical counts) at specific sites, offering insights that could inform potential improvements at other institutions. Additionally, interviews with clinicians at each site will provide contextual insights into the prevalent STs and RSs.
Ethics approval was obtained from the research ethics boards of: North York General Hospital (REB #2024-0174-993), a large Canadian community academic hospital; Sunnybrook Health Sciences Centre (REB #5779; REB #6688) and Unity Health Toronto (REB #16243), large Canadian academic hospitals and the Panel on Human Subjects Medical Research of Stanford University (IRB #6208), for its large American academic hospital. Results will be published in peer-reviewed journals, presented at conferences and to stakeholders.
This study reports on the implementation of a registered advanced nurse practitioner intervention. Aims include improving access, service user outcomes and integration between primary and secondary care.
This paper reports the quantitative results of a mixed methods implementation study. Qualitative data are reported separately. The PARiHS framework informs the implementation process itself, with considerations for nurses and other healthcare professionals explored.
The CORE-OM 34 item rating scale was administered both pre- and post-intervention. Service user attendances in secondary care was monitored.
Findings suggest that the intervention was associated with clinically significant improvements in global or generic distress, reported by service users, as evidenced by changes in the CORE-OM scores. Access to care was recorded at an average of 3.6 days. Implementation science supported effective and safe implementation with clear governance structures.
Registered advanced nurse practice in mental health clinics which provide full episodes of care results in improved integration and may be associated with positive patient outcomes. Implementation science is taught on Irish nursing programmes and this is important if innovative services are to be embedded in the healthcare system.
The development of a model of care for mental health Registered Advanced Nurse Practitioners at the interface of primary and secondary care settings may be merited. Positive Advanced Recovery Connections may be associated with improving mental health outcomes and bolstering integration of primary and secondary care services. The utilisation of implementation science highlights the need for collaboration with all stakeholders to overcome barriers and recognise facilitators to attain the necessary model of integrated care.
Peer recovery input was provided by members of the service Recovery College, with participation evident in all stages of the project. The psychosocial assessment template was also co-designed.
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.
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.
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