Diabetic foot ulcers (DFUs) are highly prevalent and recurrent complications of diabetes mellitus that have significant health and cost implications. Self-care is critical for preventing or delaying DFU and promoting healing, yet adherence to self-care recommendations is low. Interventions using motivational interviewing (MI) have been effective in supporting behaviour change and emotional adjustment, but evidence for DFU is scarce. This study will assess the acceptability, feasibility and preliminary efficacy of an MI-guided programme, Healing DFU through Empowerment and Active Listening (HEALing), and its integration in usual wound care practice.

This single-arm pilot study adopts a mixed-methods approach to assess the feasibility and acceptability of the HEALing intervention. HEALing is a practical, low-intensity, clinic-integrated personalised self-care support intervention, comprising three 30 min face-to-face sessions delivered over 6 weeks by trained wound care nurses, aiming to enhance self-care behaviours and support emotional adjustment in patients with DFU. Data will be collected from a battery of questionnaire-based surveys with patients (n=30), and in-depth individual interviews with both patients (n=30) and wound care nurse facilitators (n=10) from nurse-led wound clinics in a large primary care sector in Singapore.

The primary feasibility outcomes will include enrolment, retention (≥80%), data completion (≥80% of surveys) and participant satisfaction. Secondary outcomes will include self-report measures of illness perceptions, foot care confidence, diabetes distress, foot self-care behaviour, DFU knowledge, autonomy support and health-related quality of life, taken at baseline and post-intervention. Post-intervention interviews with patients and wound care nurse facilitators will be conducted to collect feedback on the programme and its implementation feasibility.

The study protocol has been approved by the local ethics committee, and written informed consent will be obtained from all participants. Findings will be disseminated through the first author’s PhD thesis, peer-reviewed journals, national and international conferences and public events.

NCT06540170; Pre-results.

Undergoing pancreatic surgery represents an exceptional situation for the individual patient who therefore requires appropriate preoperative information. In daily clinical practice, however, there is often a lack of time for adequate patient information and education, which may be associated with stress, fears and worries with potentially negative impact on patient-reported and postoperative outcomes. The aim of the INFORM trial is to evaluate the impact of video-assisted preoperative patient information on patient-reported and surgical outcomes in patients scheduled for elective pancreatic resection.

The INFORM trial is an open-label, randomised controlled pilot trial with two parallel study groups and a planned sample size of 80 patients with any indication for pancreatic resection. The intervention group will receive access to videos providing detailed information on the planned surgery and the perioperative procedures within 2 weeks before surgery in addition to the standard preoperative preparations. The control group will only receive the standard preoperative preparations without video. Quality of life (QLQ), satisfaction with information on disease and treatment as well as disease symptoms will be assessed using the European Organisation For Research and Treatment of Cancer QLQ INFO25, C30 and PAN26 questionnaires. Surgical complications will be assessed according to appropriate classifications by Clavien and Dindo and the International Study Group of Pancreatic Surgery (ISGPS). To account for the potential impact of cancer treatment on the outcome parameters, a subgroup analysis including only patients without malignancy will be performed. In addition, potential influencing factors on QLQ scores will be investigated by comparing QLQ scores among appropriate subsets of patients.

This trial was approved by the institution’s Ethics Committee (reference number 1479/2024). All trial procedures are performed in accordance with the ICH E6 harmonised tripartite guideline on Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Once the study has been completed, the results will be published in due course.

German Clinical Trial Register number: DRKS00035173. Registered 14 October 2024 (https://drks.de/search/de/trial/DRKS00035173/details).

Hospital falls persist as a major threat to patient safety. This study aimed to develop an interprofessional reference standard to prevent, manage and report hospital falls.

A Delphi consensus methodology, informed by the Conducting and Reporting Delphi Studies guideline, was used to design the reference standard. An interprofessional expert panel (n=47) of health professionals, researchers, policymakers and consumers participated in three Delphi rounds. Following the review of clinical guidelines, an e-Delphi survey was developed and piloted to derive 60 initial items for the standard. Two iterative rounds of e-Delphi surveys were distributed via Research Electronic Data Capture and included free-text questions and 9-point Likert scales. An online consensus meeting followed, to ratify the final standard.

In the first Delphi round, there was over 80% agreement for 44/60 items to be included in the reference standard. This increased to 48/60 items in Round 2. At the final consensus meeting, 12 items still did not reach consensus for inclusion and one was added, yielding 49 items. Items that replicated text according to falls with injury/without injury were combined, resulting in 42 items in the final reference standard. Agreed items included: (1) brief screening of falls risk on hospital admission; (2) comprehensive falls assessment for inpatients who are older, frailer or have complex conditions; (3) single interventions (such as environmental adaptations and exercise); (4) multifactorial interventions; (5) education of patients, families and staff; (6) optimising local falls hospital policies, procedures and leadership capability; (7) optimising documentation and reporting; (8) improving accreditation processes; (9) workforce redesign to augment falls education. Items that did not reach agreement (n=12) pertained to alarms, bed rails, grip socks, artificial intelligence, volunteers and care bundles.

This new reference standard provides a checklist for staff, patients, managers and policymakers to reduce unwanted variations in prevention, management and reporting of hospital falls.

ANZCTR 386960

To develop and compare algorithms for identifying gestational diabetes mellitus (GDM) across European electronic healthcare databases and evaluate their impact on the estimated prevalence.

Multi-national cohort study using routinely collected electronic healthcare data

National and regional databases in five European countries (Norway, Finland, Italy, Spain and France), in primary and/or secondary care.

Pregnancy cohorts resulting in stillbirths or live births between 2009 and 2020, comprising 602 897 pregnancies in Norway, 507 904 in Finland, 374 009 in Italy, 193 495 in Spain and 116 762 in France.

The primary outcome was the prevalence of GDM identified using six algorithms: (1) Only diagnosis; (2) Diagnosis or prescription; (3) Two diagnoses or prescriptions (2DxRx); (4) Diagnosis including unspecified diabetes in pregnancy or prescription (DxRx broad); (5) Diagnosis excluding pre-existing diabetes in pregnancy or prescription; (6) Registration of GDM in a birth registry (BR).

The strictest algorithm (2DxRx) resulted in the lowest GDM prevalence, while the broadest (DxRx broad) resulted in the highest, except in France where it was BR. In the Nordic countries, GDM prevalence varied only slightly by algorithm; greater variations were observed in other countries. The prevalence ranged from 3.5% (95% CI: 3.5% to 3.5%) to 4.6% (95% CI: 4.5% to 4.7%) in Norway; 12.1% (95% CI: 12.0% to 12.2%) to 15.8% (95% CI: 15.7% to 15.9%) in Finland, where prevalence was much higher than elsewhere. The prevalence ranged from 1.3% (95% CI: 1.3% to 1.3%) to 5.4% (95% CI: 5.3% to 5.5%) in Italy; 1.6% (95% CI: 1.5% to 1.7%) to 6.2% (95% CI: 6.1% to 6.3%) in Spain; and 1.7% (95% CI: 1.6% to 1.8%) to 5.8% (95% CI: 5.7% to 5.9%) in France.

In this multinational study, GDM prevalence ranged from 1.3% to 15.8% depending on the algorithm and database. Nordic countries showed smaller differences in prevalence between algorithms, while the other countries showed larger variations, likely due to differences in coding practices, healthcare systems and database coverage.

To investigate whether gestational diabetes mellitus (GDM) was associated with survival without bronchopulmonary dysplasia (BPD) in very preterm infants (VPIs).

Retrospective multicentre cohort study.

A total of 79 neonatal intensive care units across China, January 2019 to December 2021.

A total of 23 752 VPIs (

The primary outcomes are survival without BPD at 36 weeks’ postmenstrual age (PMA) and its components.

Infants exposed to GDM were associated with a higher rate of survival without BPD (aOR 1.12, 95% CI 1.04 to 1.21) at 36 weeks PMA and lower mortality (aOR 0.75, 95% CI 0.64 to 0.84) before 36 weeks PMA than unexposed infants. However, no significant association was observed between GDM and BPD at 36 weeks PMA (aOR 0.94, 95% CI 0.87 to 1.02), respiratory distress syndrome, need for advanced resuscitation or mechanical ventilation. After propensity score matching, GDM-exposed VPIs maintained higher survival without BPD (aOR 1.13, 95% CI 1.02 to 1.26) and lower mortality (aOR 0.81, 95% CI 0.68 to 0.97). These associations were strongest in infants born before 28 weeks (aOR 1.32, 95% CI 1.11 to 1.57) and those small for gestational age (aOR 1.41, 95% CI 1.11 to 1.80).

GDM was not associated with worsened BPD in VPIs. The positive association with survival and survival without BPD warrants could reflect a selection bias.

Endometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis.

A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis.

This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results.

ACTRN12623000598684p.

Thanks to the introduction of recent national guidelines for treating herpes simplex virus (HSV) encephalitis, health outcomes have improved. This paper evaluates the health system costs and the health-related quality of life implications of these guidelines.

A sub-analysis of data from a prospective, multi-centre, observational cohort ENCEPH-UK study conducted across 29 hospitals in the UK from 2012 to 2015.

Data for patients aged ≥16 years with a confirmed HSV encephalitis diagnosis admitted for treatment with aciclovir were collected at discharge, 3 and 12 months.

Patient health outcomes were measured by the Glasgow outcome score (GOS), modified ranking score (mRS) and the EuroQoL; healthcare costs were estimated per patient at discharge from hospital and at 12 months follow-up. In addition, Quality Adjusted Life Years (QALYs) were calculated from the EQ-5D utility scores. Cost–utility analysis was performed using the NHS and Social Care perspective.

A total of 49 patients were included; 35 were treated within 48 hours, ‘early’ (median (IQR) 8.25 [3.7–20.5]) and 14 were treated after 48 hours ‘delayed’ (median (IQR) 93.9 [66.7–100.1]). At discharge, 30 (86%) in the early treatment group had a good mRS outcome score (0–3) compared with 4 (29%) in the delayed group. According to GOS, 10 (29%) had a good recovery in the early treatment group, but only 1 (7%) in the delayed group. EQ-5D-3L utility value at discharge was significantly higher for early treatment (0.609 vs 0.221, p

This study suggests that early treatment may be associated with better health outcomes and reduced patient healthcare costs, with a potential for savings to the NHS with faster treatment.

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient’s quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals.

We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants’ PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.

The Study Coordination Centre has obtained approval from the London—Surrey Research Ethics Committee and Health Research Authority. We will publish and disseminate the results in local, national and international meetings, in peer-reviewed journals, on social media and on websites.

It has been registered under ‘Investigating Digital Outcomes for Cancer Survivors in the Community’ (NCT06095024).

NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.

Competency assessment tools are well-recognised as a method to achieve a standardised level of practice for a group of healthcare professionals with similar characteristics. The aim of this study is to develop and pilot a new competency assessment tool to support therapists caring for patients with blunt chest trauma from prehospital care through to long-term follow-up following hospital discharge.

A mixed-methods study will be undertaken, with three distinct phases: (1) an integrative narrative review to examine the literature regarding therapist competencies; (2) focus groups with patients, therapists and key stakeholders to explore opinions regarding important aspects of care (phases I and II will inform the content of the tool), followed by final tool development by an international expert panel; and (3) a multicentre pilot study using questionnaires and elicitation interviews, in which final tool acceptability to therapists will be tested. The total sample size will be between 40 and 50 participants for the focus groups. For the final tool development work, a panel of 10 international experts will be identified, with a subgroup of 3–5 experts who will be recruited to confirm content validity. We will pilot the tool at five health boards in Wales, aiming for 10 therapists from each. Elicitation interviews will be undertaken with a smaller sample size of between 15 and 20 therapists. A mixed qualitative and quantitative data analysis approach will be used.

Proportionate ethics approval has been granted (South Yorkshire Research Ethics Committee, reference number: 24/YH/0231). We will publish the work in an open-access peer-reviewed journal to ensure equitable access and present at relevant conferences. Webinars will be used to achieve a wide audience. The results will be shared with the research participants via an infographic which will be designed and developed with the public research partners.

Integrative review is registered at the Open Science Framework: https://doi.org/10.17605/OSF.IO/CEXNR

Point-of-care lung ultrasound (LUS) can assist in diagnosing acute respiratory diseases for its high accuracy and immediate availability at the bedside, including older patients with frailty. Delirium represents a frequent complication of hospitalisation in this setting, frequently triggered by acute respiratory diseases. LUS may therefore help identify individuals at risk of delirium, but the association between LUS abnormalities and delirium remains unexplored.

This study is a prospective, observational, multicentre study, with the main objective of assessing the correlation between LUS abnormalities and incident delirium during hospitalisation (primary outcome). The secondary objectives are to assess correlations between lung and diaphragm ultrasound parameters and clinical outcomes including duration of delirium, severity of respiratory failure and mortality. 480 patients aged ≥65 years old, urgently hospitalised after an emergency department visit for acute respiratory complaints, will be recruited in eleven acute geriatric wards located in eight teaching hospitals across Italy. LUS examinations will be performed by skilled clinicians prior to treatment whenever feasible, and in any case within 48 hours from admission. They will also undergo comprehensive geriatric assessment, and daily delirium assessment through the 4-AT tool. The association between LUS abnormalities, related parameters (LUS score, Pleural Effusion Score) and outcomes will be assessed by linear and logistic regression models.

Ethics Committee approval of the coordinating centre (Comitato Etico Territoriale Lombardia 3, reference ID 4369_20.03.2024_M) and collaborative centres has been obtained. All participants will provide written informed consent. Study results will be publicly available following peer-reviewed publication in international scientific journals.

NCT06670118.

To explore the experience of primary healthcare (PHC) professionals in their professional role during the pandemic and to describe collective coping strategies.

We conducted a qualitative study using interviews, focus groups and photovoice techniques from February to September 2021. The qualitative data were transcribed, aggregated and analysed, from a hermeneutic perspective, using applied thematic analysis and ethnographic approaches.

Primary Care Health Madrid region (Spain).

Convenience sampling was used to select 71 multidisciplinary primary care professionals who were working in 12 PHCs representing diverse socioeconomic, social vulnerability and COVID impact levels in the Madrid region (Spain).

Findings from this study show how lack of protection in the early days, uncertainty about how the disease would evolve and the daily challenges they faced have had an impact on the participants’ perceptions of their professional role. Nuanced differences in impact were found between men and women, age groups, professional roles and territories. The questioning of the basic foundations of primary care and the lack of prospects led to a feeling of demotivation. They perceive a wide gap between their levels of involvement and commitment, the recognition they receive and the attention to resources they need to do their work to a high standard. The support of their colleagues was seen as the most valuable resource for coping with the crisis.

The practitioners’ discourses offer knowledge that could help to face new global health threats; they also identify an urgent need to restore the role and motivation of PHC professionals as part of a wider regeneration of health systems.

Recurrence of hypertriglyceridaemia-associated acute pancreatitis (HTG-AP) is common. Uncontrolled HTG after hospital discharge is an important risk factor for recurrence. However, the optimal triglyceride (TG) goal of lipid-lowering therapy for outpatients remains unclear. The efficacy and safety of intensive TG-lowering therapy on reducing recurrence of HTG-AP trial aims to determine whether intensive TG-lowering therapy (with a TG goal of

This is an investigator-initiated, multicentre, open-label, parallel, superiority, randomised, controlled trial. Adult patients who have been successfully treated and discharged from their index episode of HTG-AP will be screened for eligibility after a 4-week to 3-month run-in period in the outpatient setting, and then patients with the fasting serum TG levels ≥150 mg/dL at baseline are eligible. During the study period, a total of 256 study participants will be randomised to receive either intensive TG-lowering therapy or usual care. In the intensive TG-lowering therapy group, the goal of TG levels is lower than 150 mg/dL, which will be monitored at 1 month, 3 months, 6 months, 12 months and 18 months after randomisation. In the usual care group, the goal of TG levels is lower than 500 mg/dL according to the current guidelines. Lifestyle suggestions and TG-lowering agents are the main strategies to manage the lipid level. The primary endpoint is the incidence of recurrent episodes of HTG-AP at 18 months after randomisation.

This study has been approved by the Ethics Committee of the First Affiliated Hospital of Nanchang University (No. 2023101–3). Ethics approval of each participating centre is required before initiation of enrolment. The results of this study will be published in peer-reviewed journals and reported at international conferences.

ChiCTR2300073483 (Chinese Clinical Trial Registry)

V.4.0 (2024).

This scoping review aims to assess low-cost simulation methods used in nursing education, evaluating how they balance educational effectiveness with budget constraints.

Scoping review conducted in accordance with Arksey and O’Malley’s methodological framework and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews reporting guidelines.

PubMed, Embase and CINAHL were systematically searched for relevant studies published between January 2000 and October 2023.

We included peer-reviewed primary studies involving nurses or nursing students, focused on the use of low-cost simulation in any healthcare setting. Studies had to describe the simulation strategy and its educational application.

Two reviewers independently screened titles, abstracts and full texts and extracted data using a standardised form. Findings were synthesised narratively and categorised by type of simulation, educational context and competencies addressed.

Out of 3332 records, 39 studies met the inclusion criteria. The reviewed studies covered various clinical areas, including critical care, emergency, neonatal, paediatric and obstetric nursing, as well as transversal competencies such as communication and clinical reasoning. Low-cost methods included task trainers, mannequins, computer-based tools, hybrid models and serious games. Only 38% of studies reported detailed cost information.

Low-cost simulation offers promising opportunities in nursing education but suffers from inconsistent cost reporting and a lack of standardisation. Further research is needed to evaluate its long-term effectiveness and support broader implementation.

Randomised controlled trials have aimed to assess the effectiveness of stereotactic ablative radiotherapy (SABR) with curative intent versus surgical resection for individuals diagnosed with early-stage non-small cell lung cancer (NSCLC) but have failed to recruit sufficient numbers of patients. Non-randomised studies for early-stage NSCLC have reported mixed outcomes following curative SABR versus surgical resection, but did not fully address confounding by indication. The Surgery Or RadioTherapy for early-stage cancer study (SORT) will assess the comparative effectiveness of SABR with curative intent versus surgical resection for NSCLC with a target trial emulation approach, as this can reduce biases in observational studies that aim to estimate the causal effect of interventions.

The SORT study will use the National Cancer Registry for individuals diagnosed with early-stage NSCLC in England during 2015–2020 (inclusive) who received SABR with curative intent or surgical resection. These data will be linked to Hospital Episode Statistics, National Radiotherapy Data Set and the Systemic Anti-Cancer Therapy dataset to obtain information on clinical and sociodemographic characteristics and the treatment received. This target trial emulation will define study population eligibility criteria and regimens for SABR with curative intent and surgical resection. We will reduce the risk of residual confounding with instrumental variable analyses that will exploit geographical variation across the National Health Service in England in the use of SABR with curative intent versus surgical resection for early-stage NSCLC. The primary outcome will be 3-year all-cause mortality after treatment initiation. Secondary outcomes will include 3-month, 6-month, 12-month and 24-month all-cause and lung-cancer mortality, time to death, numbers of hospitalisations, incremental costs and incremental cost-effectiveness.

Ethical approval was obtained from the London School of Hygiene and Tropical Medicine Research Ethics Committee (reference number 29 717–1). Results will be disseminated to clinicians, patients, policy-makers and researchers.

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.