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GRACE: protocol for a UK, secondary care, multicentre, assessor-blinded randomised controlled trial with a non-inferiority comparison to evaluate graduated compression stockings as an adjunct to extended duration pharmacological thromboprophylaxis for ven

Por: Lawton · R. · Heatley · F. · Beggs · A. D. · Everington · T. · Hamady · Z. · Hunt · B. J. · Jasionowska · S. · Kyrgiou · M. · Liddle · A. · Machin · M. · Norrie · J. · Pinkney · T. · Rees · J. L. · Saghdaoui · L. B. · Shalhoub · J. · Smith · S. · Toh · S. · Watkin · N. · Williams · L. · Davi
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ISRCTN11667770.

Understanding family carer experiences and perceptions of engagement in delirium prevention and care for adults in hospital: Qualitative systematic review

Abstract

Aim

To identify, describe and synthesise what is known about family carers' experiences and perspectives of engagement in delirium prevention and care for adults in hospital.

Design

Systematic review and synthesis of qualitative evidence.

Data Sources

Comprehensive literature search within PubMed, CINAHL, EMBASE, Scopus, Cochrane Central and PsycInfo databases to August 2022. Peer reviewed original qualitative research published in English.

Methods

Data were extracted using Covidence systematic review software. Methodological quality was reviewed against the Critical Appraisal Skills Program (CASP) Qualitative Checklist. Thematic synthesis was used to develop analytical themes. Confidence in the Evidence from Reviews of Qualitative Research (GRADE-CERQual) framework was applied to findings.

Results

Of 3429 records identified, 29 met criteria for final inclusion. Studies included a range of settings (intensive care, medical and surgical wards) and family carer types (spouse, daughter, parent and friend). Three primary themes Shared Caregiving, Partnership and Support, Communication for Shared Understanding and three cross-cutting contextual themes Care Transitions, Family Carer Context and Hospital Context were identified. Family carers have mixed experiences of involvement in delirium care and prevention. Family carer engagement in care impacted perceptions of care quality and their own self-efficacy. Where person-centred care expectations were not met, some family carers adopted compensatory or care contingency strategies. Information sharing and timely support from hospital staff who understood the carer context supported carer involvement. Supportive physical environments and addressing power imbalances allowed greater engagement.

Conclusion

Family carers often wish to be involved in delirium prevention and care, but need to be recognised as individuals, listened to, informed and supported to optimise their contribution.

Impact

The review findings can guide health professional and decision makers to optimise family carer involvement in delirium care programs.

Protocol Registration

PROSPERO [CRD42020221854].

Reporting

ENTREQ.

No Patient or Public Contribution.

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