Kingsmore David B, Edgar 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
Renal and Transplant Surgery, Queen Elizabeth University Hospital, Glasgow, UK.
Vascular Surgery, Queen Elizabeth University Hospital, Glasgow, UK.
J Vasc Access. 2025 Mar;26(2):389-399. doi: 10.1177/11297298241236521. Epub 2024 Mar 19.
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 (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.
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.
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.
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.
引入新的手术程序并挑战既定范式需要精心设计的随机对照试验（RCT）。然而，外科手术中的RCT存在独特的挑战，因为许多治疗是根据个体患者情况量身定制的，会受到经验的影响，并受到组织因素的限制。与动静脉内瘘（AVF）相比，动静脉移植物（AVG）的疗效一直存在相当大的争议，但任何差异可能反映了不同的实践和潜在的变异性。因此，在考虑对一种新型手术程序或设备进行RCT时，为新方法和对照方法都定义质量保证（QA）至关重要。本系统评价的目的是采用多国、多学科方法评估AVG的RCT中所执行的QA标准，并为未来的RCT提出一种方法。
本研究的方法先前已注册（PROSPERO：CRD420234284280）并发表。简而言之，进行了四个阶段的评价：识别AVG的RCT、初步评价、QA方法的多学科评估和核对。在四个领域寻求QA措施——通用、资质认证、标准化和监测，数据由一个多国、多专业的评价机构提取。
涉及AVG的RCT在所有四个领域的QA差异很大，通常描述不够理想，并且在过去三十年中没有改善。很少有RCT确定或定义RCT前的经验水平，没有一个记录了术前教育计划，或者围手术期管理的最低标准，没有研究有明确的术前监测计划，也没有评估技术性能。
RCT中的QA是一个相对较新的领域，正在不断扩展以确保证据可靠且可重复。本评价表明，QA以前没有详细说明，但可以在血管通路的外科RCT中进行测量，并且四领域方法可以很容易地应用于未来的RCT。
