Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations.
Author
Kingsmore, David BEdgar, Ben
Aitken, Emma
Calder, Francis
Franchin, Marco
Geddes, Colin
Inston, Nick
Jackson, Andrew
Jones, Rob G
Karydis, Nikolaos
Kasthuri, Ram
Mestres, Gaspar
Papadakis, Georgios
Sivaprakasam, Rajesh
Stephens, Mike
Stevenson, Karen
Stove, Callum
Szabo, Lazslo
Thomson, Peter C
Tozzi, Matteo
White, Richard D
Publication date
2024-03-19
Metadata
Show full item recordAbstract
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 quality assurance (QA) is defined for both the new approach and the comparator. The aim of this systematic review was to evaluate the QA standards performed in RCT of AVG using a multi-national, multi-disciplinary approach and propose an approach for future RCT. 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.Citation
Kingsmore DB, Edgar B, Aitken E, Calder F, Franchin M, Geddes C, Inston N, Jackson A, Jones RG, Karydis N, Kasthuri R, Mestres G, Papadakis G, Sivaprakasam R, Stephens M, Stevenson K, Stove C, Szabo L, Thomson PC, Tozzi M, White RD. Quality assurance in surgical trials of arteriovenous grafts for haemodialysis: A systematic review, a narrative exploration and expert recommendations. J Vasc Access. 2024 Mar 19:11297298241236521. doi: 10.1177/11297298241236521.Type
ArticleAdditional Links
https://journals.sagepub.com/home/jvaaPMID
38501338Journal
The Journal of Vascular AccessPublisher
Sage Publicationsae974a485f413a2113503eed53cd6c53
10.1177/11297298241236521