Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.

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Tác giả: Emma Aitken, Francis Calder, Ben Edgar, Marco Franchin, Colin Geddes, Nick Inston, Andrew Jackson, Rob G Jones, Nikolaos Karydis, Ram Kasthuri, David B Kingsmore, Gaspar Mestres, Georgios Papadakis, Rajesh Sivaprakasam, Mike Stephens, Karen Stevenson, Callum Stove, Lazslo Szabo, Peter C Thomson, Matteo Tozzi, Richard D White

Ngôn ngữ: eng

Ký hiệu phân loại: 618.87 Surgical removal of placenta

Thông tin xuất bản: United States : The journal of vascular access , 2025

Mô tả vật lý:

Bộ sưu tập: NCBI

ID: 688003

BACKGROUND: Introducing new procedures and challenging established paradigms requires well-designed randomised controlled trials (RCT). However, RCT in surgery present unique challenges with much of treatment tailored to the individual patient circumstances, refined by experience and limited by organisational factors. There has been considerable debate over the outcomes of arteriovenous grafts (AVG) compared to AVF, but any differences may reflect differing practice and potential variability. It is essential, therefore, when considering an RCT of a novel surgical procedure or device that METHOD: The methods of this have been previously registered (PROSPERO: CRD420234284280) and published. In summary, a four-stage review was performed: identification of RCT of AVG, initial review, multidisciplinary appraisal of QA methods and reconciliation. QA measures were sought in four areas - generic, credentialing, standardisation and monitoring, with data abstracted by a multi-national, multi-speciality review body. RESULTS: QA in RCT involving AVG in all four domains is highly variable, often sub-optimally described and has not improved over the past three decades. Few RCT established or defined a pre-RCT level of experience, none documented a pre-trial education programme, or had minimal standards of peri-operative management, no study had a defined pre-trial monitoring programme, and none assessed technical performance. CONCLUSION: QA in RCT is a relatively new area that is expanding to ensure evidence is reliable and reproducible. This review demonstrates that QA has not previously been detailed, but can be measured in surgical RCT of vascular access, and that a four-domain approach can easily be implemented into future RCT.
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