Clinical psychology interventions for reducing obesity have developed alongside pharmacological and surgical treatments, but usually as interventions for individual patients. Any healthcare intervention rests on a logic model: assumptions that through specific physical and social mechanisms, it will produce certain intended outcomes, provided that conducive background conditions (‘contexts’) exist. Using evidence from the feasibility trial preceding a full randomised controlled trial (RCT), this paper assesses the empirical validity of the initial logic model of a new group-based weight management intervention: PROGROUP, designed for patients with body mass index (BMI) ≥40 kg/m² or ≥35 kg/m² with comorbidities. We aimed to test whether:

Multimethod proof-of-concept study by means of realist evaluation of the initial PROGROUP logic model. We:

Specialised ambulatory mental health services in the English NHS.

Adults with severe obesity (BMI ≥40 kg/m² or ≥35 kg/m² with comorbidities).

Group-building techniques to enhance group members’ adoption of evidence-based methods of behaviour change affecting their dietary behaviour and physical activity.

Qualitative outcomes. What kinds of:

Quantitative measures not used.

The initial logic model assumed that the following sequence of mechanisms would produce weight loss: referral from GP to specialist weight management services; further referral to PROGROUP; preparatory individual consultation; facilitated group sessions produce a group identity; group identity reinforces weight management capability and motivation; further individual consultations adjust for individual circumstances; behaviour change outside the treatment setting, producing weight loss. Contexts necessary for these mechanisms to work included: sufficient catchment population; group size, continuity and membership retention; suitable location; facilitator training; and practical support outside the treatment setting.

The findings suggested revisions to the logic model, but more in the delivery components and contextual assumptions than the core therapeutic mechanisms. There was scope to simplify the referral mechanisms. Different professions could implement the model. A realist evaluation of a pre-RCT feasibility study can be used to make the intervention’s logic model more securely evidence-based, serving as a proof-of-concept test for the intervention. It indicated the conditions under which such group psychological interventions might be more widely used.

ISRCTN22088800.

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.

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.

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.

ISRCTN11667770.