Title:Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID)

Subtitle:A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice

Background: A functioning vascular access (VA) is crucial to providing adequate hemodialysis (HD) and considered a critically important outcome by patients and healthcare professionals. A validated, patient‑important outcome measure for VA function that can be easily measured in research and practice to harvest reliable and relevant evidence for informing patient‑centered HD care is lacking. Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) aims to assess the accuracy and feasibility of measuring a core outcome for VA function established by the international Standardized Outcomes in Nephrology (SONG) initiative.
Methods: VALID is a prospective, multi‑center, multinational validation study that will assess the accuracy and feasibility of measuring VA function, defined as the need for interventions to enable and maintain the use of a VA for HD.The primary objective is to determine whether VA function can be measured accurately by clinical staff as part of routine clinical practice (Assessor 1) compared to the reference standard of documented VA procedures collected by a VA expert (Assessor 2) during a 6‑month follow‑up period. Secondary outcomes include feasibility and acceptability of measuring VA function and the time to, rate of, and type of VA interventions. An estimated 612 participants will be recruited from approximately 10 dialysis units of different size, type (home‑,in‑center and satellite), governance (private versus public), and location (rural versus urban) across Australia, Canada, Europe, and Malaysia.

Source：Viecelli AK, Teixeira-Pinto A, Valks A, et al. Study protocol for Vascular Access outcome measure for function: a vaLidation study In hemoDialysis (VALID) : A multi-center, multinational validation study to assess the accuracy and feasibility of measuring vascular access function in clinical practice. BMC Nephrol. 2022. 23(1): 372.

标题：血管通路功能评价结局的研究方案：一项血液透析的验证性研究(VALID)

副标题：一项评估临床实践中血管通路功能评价的准确性和可行性的多中心、多国验证研究

背景：患者和医疗保健专业人员认为，有效的血管通路(VA)对于提供充分的血液透析(HD)是至关重要的，同样是相对重要的结局。但目前缺乏一种有效的、且有利于患者的VA功能结局评价方法，该方法即可以在以患者为中心的透析护理研究和实践中轻松测量以获取可靠和相关的证据。血管通路功能评价：一项血液透析的验证性研究(VALID)旨在评估由国际肾脏病标准化结果(SONG)倡议建立的VA功能核心结局评价方法的准确性和可行性。

方法：VALID是一项前瞻性、多中心、多国验证研究，将评估VA功能结局评价方法的准确性和可行性，围绕于透析患者的血管通路启用和维持。主要目标是确定在6个月的随访期内，作为常规临床实践的一部分，临床工作人员(评估者1)是否可以与VA专家(评估者2)收集的文档化VA程序的参考标准进行比较，以确定临床工作人员是否能够准确地评价VA功能。次要结果包括VA功能评价的可行性和可接受性，以及VA干预的时间、比率和类型。预计招募612名参与者，来自澳大利亚、加拿大、欧洲和马来西亚的大约10个不同规模、透析类型(家庭、中心和卫星)、机构特点(私人与公共)和地点(农村与城市)的透析单位。

启发：这是一个前瞻性、多中心的研究方案，主要研究还未结束，没有结果及结论，主要内容集中于研究的设计，包括动静脉内瘘的结局指标、评价方法设计、数据库管理（Redcap）、数据质控等，为开展内瘘相关研究方案的设计提供了参考。