Outcome reporting in studies on sacrococcygeal teratoma (SCT) is highly heterogeneous, which limits comparability across studies and thus hampers the development of international treatment guidelines.

Variation in treatment and access to facilities contributes to differences in outcome reporting between centres and countries. Establishing a Core Outcome Set (COS) can improve consistency in outcome reporting and facilitate global collaboration and data comparison. We therefore aim to develop a Core Outcome Set for SCT (COS-SCT) using the Delphi method to achieve consensus on key outcomes. This will enhance the standardisation of outcome reporting and improve the quality of research and clinical care for SCT patients globally.

The development of the COS-SCT will consist of three phases. First, a systematic review will be performed to identify outcomes reported in studies on the surgical treatment of SCT in children. Second, an international Delphi survey will be conducted among key stakeholders, including clinicians, researchers and patient representatives, to establish consensus on outcome prioritisation. Finally, a consensus meeting with representatives from all stakeholder groups will be held to ratify the final Core Outcome Set. The study will follow methodological guidance from the Core Outcome Measures in Effectiveness Trials (COMET) initiative and will be developed and reported in accordance with the Core Outcome Set Standards for Development (COS-STAD) and Core Outcome Set Standards for Reporting (COS-STAR).

The medical research ethics committee of the Amsterdam University Medical Centre (Amsterdam UMC) confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study, and therefore a full review by the ethics committee is not required. This study is registered in the COMET initiative database. Results will be disseminated in peer-reviewed academic journals and conference presentations.

Trial registration number: COMET registration number 3485

To characterise the reporting practices of sequential multiple assignment randomised trials (SMARTs) in human health research.

Scoping review of protocol and primary analysis papers describing SMARTs published between January 2009 and February 2024.

SMARTs are innovative trial designs that allow for multiple stages of randomisation to treatment, with randomization potentially based on a patient’s response(s) to previous treatment(s). They are uniquely designed to develop sequential adaptive interventions (dynamic treatment regimes (DTRs)) to support personalized clinical decision-making over time. Previous reviews have identified inconsistencies in how the design, implementation and results of SMARTs have been reported in published studies. A comprehensive assessment of SMART reporting practices is lacking and necessary for developing standardised SMART-specific reporting guidelines.

We systematically searched multiple databases for SMART-related protocol and primary analysis papers published between January 2009 and February 2024. Title, abstract and full-text screenings were performed by pairs of reviewers, with disagreements resolved by consensus. Data extraction included study characteristics, design elements and analytical approaches for embedded or tailored DTRs. Results were synthesised qualitatively and presented descriptively.

From 5486 screened studies, 103 (59 protocol papers, 16 primary analysis papers, 14 protocol papers with corresponding primary analysis papers) met the inclusion criteria. Most studies targeted adults (62.7% protocols, 62.5% primary analyses, 42.9% protocol+primary analyses) and were primarily conducted in the USA. Behavioural and mental health constituted the most frequent therapeutic domain. While intervention descriptions and re-randomisation criteria were consistently reported, operational characteristics such as blinding (protocols: 64.4%, primary analyses: 62.5%, protocols+primary analyses: 71.4%) and randomisation details (protocols: 55.9%, primary analyses: 37.5%, protocols+primary analyses: 50.0%) were inconsistently documented. Only 46.7% of primary analyses evaluated embedded DTRs, and none explored deeply tailored DTRs.

Despite the increased adoption of SMART designs, substantial reporting variability persists. Most primary analyses underuse the capability of SMARTs to generate data for developing DTRs. SMART-specific standardised reporting guidelines can help accelerate the scientific and clinical impact of SMARTs.

Many researchers conduct a process evaluation alongside an effectiveness trial of a public health intervention to better understand mechanisms behind observed effects. Yet, there is no standardised, scientifically accepted guideline for reporting such process evaluations, which impedes interpretation and comparison of study results. The aim of this project was to develop a consensus-based and expert-based guideline for reporting process evaluations of public health interventions conducted alongside an effectiveness trial.

We conducted an e-Delphi study with a large panel of international experts.

Based on purposive sampling, we invited 137 international experts that had been involved in the design of process evaluations, researchers who published high-profile process evaluations or frameworks, editors of journals that publish process evaluations, and authors of other reporting guidelines.

Based on a literature search, a first draft of the reporting guideline included 32 items, which was proposed to panel members during the first round. Of the invited 137 invited international experts, 73 (53%) participated in at least one round of the e-Delphi study. Participants rated the inclusion and comprehensibility of the proposed items on a 5-point Likert scale and provided comments and suggestions for relevance and definitions of the items. Adjustments to the items and descriptions were proposed to the e-Delphi panel until consensus of ≥67% for each individual item was reached. In total, 64 (88% of 73) completed round 2, and 55 (76% of 73) completed round 3. This resulted in 19 items that are included in the consensus-based process evaluation reporting guideline for public health intervention studies (CONPHES) guideline. The items cover a detailed description of the intervention that is evaluated, the implementation strategies applied, and underlying causal pathways, and the role of the delivery and support team. The guideline also requires describing the evaluation framework and how evaluation outcomes were assessed. Lastly, the guideline includes items on providing a detailed description of applied analyses (both quantitative and qualitative) and measures for assuring quality. The guideline is accompanied by an Explanation and Elaboration document, with a more detailed explanation of each item.

We expect that the CONPHES reporting guideline for process evaluations of public health interventions can improve the reporting of process evaluations of interventions aimed at promoting public health. This can potentially facilitate more effective translation of public health research into practice and contribute to improving both individual and population health outcomes.

The Veterans Health Administration (VA) integrated mental and physical health services to better detect and treat depression. Primary care nurses conduct screening annually. Clinicians, including Primary Care Mental Health Integration (PCMHI) specialists, follow-up as needed for treatment. Depression detection and management processes are complex, involve multilevel stakeholders, and are subject to significant disruption from COVID-19 and from the resulting expansion of telehealth, aiming to preserve care access. This study aimed to examine whether the COVID-19 pandemic worsened depression-related care quality and/or patient outcomes (eg, suicide).

Given hypothesised care disruption (lowered care quality) during COVID-19, we will first assess the VA population’s trajectory from a new positive depression (and suicide risk) screen to appropriate treatment (ie, medication, therapy) in the Fiscal Year 2019–2323. We will also examine the changing mix of virtual and in-person depression care delivered. Second, we will use interrupted time series analyses to explore the extent to which psychiatric emergency visits and hospitalisations may be mitigated by clinician detection of depression. As well as compare mental health-related mortality rates between patients detected and not detected to have depression. Subanalyses will reveal where (eg, clinics with low PCMHI access) and for whom (eg, minorities) detection does not systematically occur, and downstream negative sequelae, to guide future intervention. Finally, we will interview 40 veterans, half of whom were detected and half not detected to have depression and 40 VA primary care and PCMHI providers about changes brought on by the pandemic and the expansion of virtual care across three VA facilities. In addition to contextualising disrupted care findings, qualitative data will help identify best practices on patient-to-provider and provider-to-provider interactions in hybrid in-person/telehealth depression care models.

Ethics approval was granted by the VA Greater Los Angeles Healthcare System Institutional Review Board. Alongside journal publications, dissemination activities include briefings to our policy and operational partners, and presentations to clinical, research and policy-oriented audiences.

To identify enablers and barriers for scaling up non-communicable disease (NCD) interventions across diverse global contexts and to map these factors to the WHO’s health system building blocks.

A multi-method qualitative study applying the Consolidated Framework for Implementation Research to analyse data from multiple projects nearing or completing scale-up.

Global Alliance for Chronic Diseases-funded implementation research projects conducted across 18 low- and middle-income countries and high-income settings.

Data was derived from documents (n=77) including peer-reviewed publications, policy briefs, and reports and interviews with stakeholders (n=18) (eg, principal investigators, medical professionals, public health workers).

Various context-specific interventions targeting sustainable scale-up of NCD (eg, diabetes, hypertension, cardiovascular disease) interventions at the community, primary care or policy levels.

The primary outcome was identifying contextual enablers and barriers to intervention scale-up. Secondary outcomes included exploring how these factors aligned with health system building blocks (eg, leadership/governance, healthcare workforce).

Twenty enablers (eg, intervention adaptability, strong stakeholder engagement, local empowerment) and 25 barriers (eg, resource limitations, intervention complexity, stakeholder burnout) were identified. Contextual alignment, supportive governance and capacity building were critical for sustainability, while cultural misalignment and socio-political instability frequently hampered scaling efforts.

Tailoring interventions to local health systems, ensuring stakeholder co-ownership and incorporating strategies to mitigate stakeholder burn-out are essential to achieving sustainable, scalable NCD solutions. Future research should focus on integrating systematic cultural adaptation, sustainable financing and workforce capacity building into scale-up planning.

In recent decades, transcranial electrical stimulation (tES) has become a widely used non-invasive method for modulating brain function in clinical and non-clinical populations. However, existing tES trials exhibit substantial methodological heterogeneity, often limiting the reproducibility and interpretability of findings. There currently exists a paucity of consensus-driven, standardised recommendations outlining the key factors that should be reported and/or controlled in tES studies. Accordingly, this project aims to develop Consolidated Guidelines for Reporting and Evaluation of studies using tES (CoRE-tES), a tool designed to assess the methodological quality and reporting of laboratory-based and home-based tES studies. These guidelines will support improved quality, consistency, replication and transparency in research involving tES modalities, including transcranial direct current stimulation, transcranial alternating current stimulation and transcranial random noise stimulation.

CoRE-tES will be developed and disseminated over five stages. Stage 1 will comprise a review of recent tES literature to assess methodological and reporting quality. Stage 2 will employ a Delphi process to seek agreement among international tES experts on a list of items for inclusion in CoRE-tES. In stage 3, a consensus meeting will be held to synthesise and prioritise the agreed items to form CoRE-tES. Stage 4 will involve production of the final CoRE-tES checklist and an accompanying evaluation and elaboration document. In stage 5, CoRE-tES will be disseminated via journal publication, conferences, professional meetings and social media campaigns.

Ethics approval has been obtained from the Western Sydney University Human Research Ethics Committee (approval number H16803). Findings will be disseminated through scientific conferences and peer-reviewed journal publications, and CoRE-tES will be indexed on the Enhancing the QUAlity and Transparency Of health Research Network website.

To describe the lessons learnt during the promotion of a new approach to the care of critically ill patients in TanzaniaEssential Emergency and Critical Care (EECC).

A descriptive qualitative study using thematic analysis of structured interviews.

The study was conducted in Tanzania, involving 11 policymakers, researchers and senior clinicians who participated in the promotion of EECC in the country.

Five inter-related themes emerged from the promotion of EECC in Tanzania: (1) early and close collaboration with the government and stakeholders; (2) conduct research and use evidence; (3) prioritise advocacy and address misconceptions about EECC; (4) leverage events and embed activities in other health system interventions; and (5) employ a multifaceted implementation strategy. The themes map to the normalisation process theory domains of coherence, cognitive participation, collective action and reflexive monitoring.

The integration of EECC into Tanzania’s health policy is a result of a multidisciplinary collaboration including government and partners that has used evidence, advocacy and context and included multifaceted implementation strategies. The lessons from Tanzania’s experience provide guidance for adoption in similar settings to improve critical care systems, foster access to care and optimal outcomes for all critically ill patients.

The vast majority of healthcare research in the UK is investigator-led. While national progress in patient and public involvement (PPI) increasingly mandates patient consultation, research questions and outcomes still frequently misalign with patient priorities. This is particularly important in rare disease research, as more than 95% of 11 000 conditions have no effective or curative treatment, and around 20% are not clinically defined, making them difficult to diagnose and manage. The unmet physical, mental and emotional needs of people living with rare diseases are immense. Extensive guidance and toolkits exist to support investigators with PPI, but none target patient communities attempting to promote their own priorities, initiate or co-lead research.

This communication article introduces the newly established patient-led Rare Disease Research Network (RDRN).

Launched in November 2024, the RDRN is an open-access collaborative platform designed to support patient-driven and co-produced research, connecting patient and professional partners with similar research interests. Originally conceived by an ultra-rare patient group, the network was co-produced with the rare disease community, including individuals living with rare conditions, parents, carers and charity advocates, whose lived experience and priorities shaped every aspect of its design. Supported by academic and research networks, its collaborative development ensures RDRN removes barriers to participation while complementing existing initiatives. RDRN is a novel approach to driving new impactful research by aligning investigator priorities with real-world needs and building capacity from patients outward. Rare disease communities bring lived expertise, creativity and motivation. Yet without a structured route to collaborate, their insights are often lost. RDRN offers an inclusive space, fostering new partnerships and supporting upstream collaboration. The approach enables patients to become ‘research ready’ and empowers them to have an active role in generating ideas and delivering research from inception, leading to innovative research and driving meaningful change in patients’ lives. With further development, RDRN could present a lasting, scalable and unified model for co-designed rare disease research. By enabling trust, capacity and shared purpose, it can drive discovery, improve outcomes and build a more resilient and self-sustaining research ecosystem, underpinning key pillars of the 2021 UK Rare Diseases Framework.

This study aimed to estimate reductions in travel-related carbon dioxide (CO₂) emissions, travel time and distance resulting from a telemedicine service for patients with chronic conditions, and to assess its potential to contribute to more equitable access to specialised care in Northeast Brazil.

Cross-sectional study.

Primary healthcare units in the Northeast region of Brazil.

Patients between birth and 104 years of age with chronic conditions who received video-based teleconsultations between June 2022 and November 2023.

The primary outcome was the reduction in travel-related carbon emissions due to avoided in-person referrals. Secondary outcomes included travel time and travel distance savings. Round-trip distances between primary healthcare units and referral centres were estimated using geolocation data. CO₂ emissions were calculated using the Greenhouse Gas (GHG) Protocol adapted to Brazil (Brazilian GHG Protocol Programme), focusing on Scope 3 emissions from patient travel.

A total of 4642 teleconsultations were conducted with 4106 patients. Of these, 4021 (86.6%) avoided in-person referrals, resulting in estimated savings of 226 900 miles in travel distance and 488 584 min in travel time. The estimated CO₂ emissions avoided totalled 21 593 kg (21 930 kg CO₂ equivalent), with a mean of 5.37 kg (SD±5.5) per teleconsultation (5.4 kg CO₂ equivalent ; SD±5.5). Greater travel distance savings were observed among patients living in municipalities with lower Municipal Human Development Index (mean 92.3±104.2 miles vs 17.3±8.4 miles; p

Telemedicine use in Northeast Brazil significantly reduced patient travel, leading to substantial savings in CO₂ emissions. These savings were more pronounced for patients in smaller, less developed municipalities. By reducing the need for travel, telemedicine can improve access to healthcare for remote or underserved populations, while also supporting environmental sustainability.

Photobiomodulation therapy (PBMT), particularly when combined with a static magnetic field (PBMT-sMF), is a promising non-pharmacological approach for managing musculoskeletal disorders. However, high-quality evidence for its efficacy in lateral epicondylitis remains limited.

The study aims to investigate the effectiveness of PBMT-sMF vs placebo in reducing pain, improving function and modulating inflammatory markers in individuals with lateral epicondylitis.

Multicentre, randomised, triple-blinded, placebo-controlled trial.

Three outpatient physiotherapy clinics in Brazil.

50 adults (18–50 years) with unilateral lateral epicondylitis and baseline pain ≥50 on the visual analogue scale (VAS).

Participants received either active PBMT-sMF (n=25) or placebo (n=25), 2 times per week for 3 weeks. PBMT-sMF involved multi-wavelength irradiation at 4 epicondyle sites (60 s; 27.1 J/site). The placebo group underwent the same procedure without active irradiation.

The primary outcome was degree of pain rating (VAS). Secondary outcomes included forearm disability (Patient-Rated Tennis Elbow Evaluation, PRTEE), grip strength, serum tumour necrosis factor-alpha (TNF-α) levels and treatment satisfaction. Assessments were conducted at baseline, post-treatment (3 weeks) and at 4-week follow-up.

PBMT-sMF yielded a higher responder rate (defined as the proportion of participants achieving at least a 30% reduction in pain intensity relative to baseline) than placebo (72% vs 40%, p=0.045), with a clinically and statistically significant between-group difference. Compared with placebo, the PBMT-sMF group showed significantly greater reductions in pain intensity both at the end of treatment (51.4±19.8 vs 36.9±22.6; p=0.0223) and at follow-up (37.4±24.1 vs 20.3±21.2; p=0.0049). TNF-α levels also decreased significantly in the PBMT-sMF group compared with placebo at both time points (p

PBMT-sMF significantly reduced pain intensity and TNF-α levels, suggesting an anti-inflammatory mechanism. Although functional outcomes were not improved, PBMT-sMF may be a valuable short-term, non-invasive option for lateral epicondylitis pain management.

NCT04829734 on ClinicalTrials.gov

The development of effective vaccines targeting human papillomavirus (HPV) has significantly contributed to disease prevention, highly relevant in immunosuppressed patients who have higher incidence of HPV-related cancers than their non-immunosuppressed counterparts. However, the acceptance and uptake of the HPV vaccine among immunosuppressed individuals pose unique challenges. Immunocompromised patients’ acceptance of the HPV vaccine is influenced by multifaceted factors, including concerns about safety and effectiveness, interactions with immunosuppressive medications and uncertainties due to their compromised immunity. This systematic review aims to identify the main factors influencing HPV vaccine acceptance among immunosuppressed patients.

A comprehensive search strategy will be executed across databases such as MEDLINE/PubMed, Embase, Scopus, Web of Science, ScienceDirect, Latin American and Caribbean Literature in Health Sciences, Cumulative Index to Nursing and Allied Health Literature and Cochrane Database. The review will encompass the three WHO-endorsed HPV vaccines (quadrivalent, bivalent and nonavalent) and will consider studies related to HPV vaccines and their administration. The scope includes study focusing on immunosuppressed patients who received organ transplants, cancer treatments or are HIV-positive. No temporal restrictions will be applied, and searches will be conducted until December 2025. Observational studies, including retrospective/prospective cohorts, case–control and cross-sectional studies, reporting factors influencing HPV vaccination in immunosuppressed populations will be included. Studies with overlapping patient populations will be excluded. Data extraction will include study details, demographics, vaccine type, risk/protective factors, outcomes and medical history. Validation and cross-verification will ensure data accuracy. Risk of bias will be assessed using ROBINS-I (Risk Of Bias In Non-randomised Studies of Interventions), and GRADE (Grading of Recommendations Assessment, Development and Evaluation) will rate evidence certainty. Meta-analysis, guided by Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, will employ fixed/random-effects models, assessing heterogeneity using I² statistics.

This research will analyse previously published data, so ethical approval is not required. The results of the systematic review will be submitted for publication in a peer-reviewed journal.

CRD42023452537.

Young-onset type 2 diabetes (YOD), diagnosed before 40 years of age, entails a high disease burden and potential for early dependence on disability benefits. The risk of type 2 diabetes (T2D) varies with socio-economic status and ethnic background, yet the relationship between these factors and age at diagnosis is insufficiently explored. We aimed to study associations between YOD and living on disability benefits, educational level and country background.

Cross-sectional data on 8640 individuals with T2D, linked to data on educational level and country background, were compared with population data from the same residential areas. Similar comparisons were made for data on disability benefits among 3854 individuals of working age (

The risk of being dependent on disability benefits was three times higher in YOD (adjusted incidence rate ratio, aIRR (95% CI) 3.1 (2.7 to 3.5)) and twice as high in later-onset T2D (1.9 (1.8 to 2.1)) as in the general population. People of Norwegian background with low educational levels had threefold higher YOD risk (3.3 (2.4 to 4.4)) than those with a tertiary degree, while people of non-Western backgrounds with low educational levels had a smaller increase in YOD risk (1.5 (1.1 to 2.1)). People of non-Western backgrounds had higher YOD risk than those of Norwegian background (4.2 (3.5 to 5.0)), while people of south Asian background had an even greater relative YOD risk (9.0 (7.3 to 11.0)), threefold higher than for later-onset T2D (3.2 (2.8 to 3.7)).

Lifetime risk of being dependent on disability benefits was substantially higher for individuals with YOD than in later onset T2D. Non-Western and particularly south Asian backgrounds were associated with increased YOD risk. Low education was an important YOD risk factor only for people with Norwegian background.

Various psychological, cognitive, behavioural, medication and neurostimulation treatments can improve the outcomes of people with depressive and anxiety disorders. However, in usual practice, there is large variability in treatment delivery and treatments are poorly characterised. The effectiveness and quality of mental health services in the community are not accurately monitored and are poorly understood. At present, healthcare organisations, payers and policy makers know little about the quality of care they support. Similarly, patients and families have limited information on quality to guide choice of provider or organisation. It will be necessary to implement monitoring of treatment quality so that treatment and outcomes can be improved. This study develops, tests and validates a new, transdiagnostic outcome-focused mental health quality measure. This measure is based on routine, regular patient reports of their symptoms. It is designed to be aggregated at the provider, clinic, organisation or plan level; inform choice of provider; and be used to improve routine delivery of services and quality of care among patients with common psychiatric disorders.

The project analyses existing data with responses to a wide variety of items that are known to assess depression or anxiety and empirically selects symptom items for a transdiagnostic outcome-focused quality measure. The project informs risk adjustment and benchmarking of the quality measure by studying how patient, provider and practice factors, including health-related social needs, baseline symptom severity and diagnoses, affect outcomes. Drawing on these, the project specifies an outcome-focused quality measure that includes risk adjustment and benchmarks for improvement; and studies, at practices nationally, its feasibility and psychometric properties, the effect of treatment characteristics on the quality of care, and the effect of quality on health-related quality of life.

Results will be published. The quality measure is designed to be broadly relevant across community settings and populations and to be submitted for endorsement by regulatory and governing bodies.

Surgical oncology patients often experience doubts and uncertainties in the preoperative and postoperative periods, which can be addressed remotely through telenursing. Expanding telenursing services could contribute to more comprehensive perioperative care. We conducted a scoping review to characterise these telenursing services, identify their outcome indicators and examine the content of the care delivered.

A scoping review was conducted in accordance with the Joanna Briggs Institute (JBI) recommendations.

MEDLINE (PubMed), EMBASE, CINAHL, SCOPUS, Web of Science and Virtual Health Library (VHL), with searches performed up to 5 May 2025.

We included studies that implemented telenursing interventions in the preoperative or postoperative period in adult oncology patients.

Two independent reviewers used a standardised search to select and extract data from the included studies. Study characteristics were presented descriptively using absolute and relative frequencies, and the content of telenursing interventions was organised into a circular thematic matrix.

A total of 37 studies were included, published between 1996 and 2024, conducted in 12 countries and primarily focused on postoperative telenursing via telephone or video calls. Preoperative care focused on psychosocial support and guidance related to surgical preparation. Postoperative topics included surgical wound care; handling of devices such as drains, ostomy bags and catheters; instructions for returning to work and support groups for financial and social assistance. Outcome indicators were primarily related to care, including levels of anxiety, stress, depression and quality of life.

Oncologic surgical telenursing remains primarily focused on postoperative care and the delivery of personalised support. Reporting on the protocols used, frequency and duration of sessions, nurse training and profiles, integration with in-person care workflows and operational cost data could strengthen the knowledge base for perioperative telenursing in oncology.

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.