Department of Nephrology, Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, QLD, 4102, Australia.
The Translational Research Institute, Brisbane, Australia.
BMC Nephrol. 2022 Nov 19;23(1):372. doi: 10.1186/s12882-022-02987-1.
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.
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. Validity will be measured by the sensitivity and specificity of the data acquisition process. The sensitivity corresponds to the proportion of correctly identified interventions by Assessor 1, among the interventions identified by Assessor 2 (reference standard). The feasibility of measuring VA function will be assessed by the average data collection time, data completeness, feasibility questionnaires and semi-structured interviews on key feasibility aspects with the assessors.
Accuracy, acceptability, and feasibility of measuring VA function as part of routine clinical practice are required to facilitate global implementation of this core outcome across all HD trials. Global use of a standardized, patient-centered outcome measure for VA function in HD research will enhance the consistency and relevance of trial evidence to guide patient-centered care.
Clinicaltrials.gov: NCT03969225. Registered on 31st May 2019.
功能正常的血管通路（VA）对于提供充分的血液透析（HD）至关重要，被患者和医疗保健专业人员视为极其重要的结果。目前缺乏一种经过验证、对患者重要的 VA 功能结果衡量指标，该指标能够在研究和实践中方便地测量，以获取可靠且相关的证据，从而为以患者为中心的 HD 护理提供信息。血管通路结局衡量指标用于功能：一项血液透析中的验证研究（VALID）旨在评估由国际肾脏病标准化结局倡议（SONG）制定的 VA 功能核心结局衡量指标的准确性和可行性。
VALID 是一项前瞻性、多中心、多国验证研究，旨在评估 VA 功能的准确性和可行性，该功能定义为需要干预措施来启用和维持 VA 用于 HD。主要目标是确定临床工作人员是否可以在 6 个月的随访期间通过常规临床实践准确测量 VA 功能（评估员 1），与由 VA 专家收集的记录 VA 程序的参考标准（评估员 2）进行比较。次要结局包括测量 VA 功能的可行性和可接受性以及 VA 干预的时间、速率和类型。预计将从澳大利亚、加拿大、欧洲和马来西亚的不同规模、类型（家庭、中心和卫星）、治理（私营与公共）和位置（农村与城市）的大约 10 个透析单位招募 612 名参与者。有效性将通过数据采集过程的灵敏度和特异性来衡量。灵敏度对应于评估员 1 正确识别评估员 2 （参考标准）识别的干预措施的比例。VA 功能测量的可行性将通过平均数据收集时间、数据完整性、可行性问卷以及对评估员的关键可行性方面的半结构化访谈进行评估。
VA 功能作为常规临床实践的一部分进行测量的准确性、可接受性和可行性对于在所有 HD 试验中促进该核心结局的全球实施是必需的。在 HD 研究中，全球使用标准化、以患者为中心的 VA 功能结局衡量指标将提高试验证据的一致性和相关性，以指导以患者为中心的护理。
Clinicaltrials.gov：NCT03969225。于 2019 年 5 月 31 日注册。
