Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
摘要：
■引入新的程序和具有挑战性的既定范例需要精心设计的随机对照试验（RCT）。然而,手术中的RCT提出了独特的挑战，许多治疗方法都是针对患者的个人情况，由经验提炼，受组织因素限制。与AVF相比，动静脉移植物（AVG）的结果存在相当大的争议，但是任何差异都可能反映出不同的实践和潜在的可变性。这是必要的,因此,当考虑一种新的外科手术或设备的RCT时，新方法和比较器都定义了质量保证（QA）。本系统评价的目的是使用多国，多学科方法，并提出未来RCT的方法。
■此方法先前已注册（PROSPERO：CRD420234284280）并已发布。总之,进行了四阶段审查：AVG的RCT鉴定，初步审查，质量保证方法的多学科评估与和解。在四个领域寻求质量保证措施-一般，认证，标准化和监测，数据由多国抽象，多专业审查机构。
■涉及所有四个领域的AVG的RCT中的QA是高度可变的，通常描述得欠佳，在过去的三十年里没有改善。很少有RCT建立或定义了RCT前的经验水平，没有人记录预审教育计划，或者有最低的围手术期管理标准，没有研究有明确的审前监测方案，没有人评估技术性能。
■RCT中的QA是一个相对较新的领域，正在扩大以确保证据的可靠性和可重复性。这篇综述表明，质量保证以前没有详细说明，但可以在血管通路的手术RCT中测量，并且四域方法可以很容易地在未来的RCT中实现。
■此方法先前已注册（PROSPERO：CRD420234284280）并已发布。总之,进行了四阶段审查：AVG的RCT鉴定，初步审查，质量保证方法的多学科评估与和解。在四个领域寻求质量保证措施-一般，认证，标准化和监测，数据由多国抽象，多专业审查机构。
■涉及所有四个领域的AVG的RCT中的QA是高度可变的，通常描述得欠佳，在过去的三十年里没有改善。很少有RCT建立或定义了RCT前的经验水平，没有人记录预审教育计划，或者有最低的围手术期管理标准，没有研究有明确的审前监测方案，没有人评估技术性能。
■RCT中的QA是一个相对较新的领域，正在扩大以确保证据的可靠性和可重复性。这篇综述表明，质量保证以前没有详细说明，但可以在血管通路的手术RCT中测量，并且四域方法可以很容易地在未来的RCT中实现。
