Woo Karen, Fuld Robert, Grandinetti Amanda, Lawson Jeffrey, Litchfield Terry, Ohan Mark, Peipert John Devin, Rivara Matthew B, Roberts Glenda, Roy-Chaudhury Prabir, Underwood Margo, Nordyke Robert J
Division of Vascular Surgery, Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.
Dialysis Access Specialists, Mid Atlantic Nephrology Associates, Timonium, MD, USA.
J Vasc Access. 2022 Nov;23(6):973-980. doi: 10.1177/11297298211018295. Epub 2021 May 25.
While access-related dysfunction is a clear driver of clinical outcomes and costs, the full impact of vascular access dysfunction on patient experience and quality of life is not fully characterized in the literature. One way to more comprehensively characterize the patient experience from the patient perspective is through patient reported outcomes (PROs). However, the limited implementation of PROs in clinical trials, patient registries, quality measurement, and other research settings has significantly constrained the patient voice in evaluation of vascular access outcomes and vascular access decision-making. To address these issues, the Kidney Health Initiative, a public-private partnership between the American Society of Nephrology and the U.S. Food and Drug Administration, assembled an interdisciplinary workgroup to enhance uptake of access-related PROs with the aims of: (1) reviewing the domains of HRQOL that are affected by vascular access, collect information on existing instruments that measure access-specific HRQOL in hemodialysis, and identify gaps in existing measures; (2) identifying and critically assessing barriers to widespread use of access-specific PRO measures; and (3) defining initiatives to overcome barriers and make recommendations for strategies to improve the use and utility of access-specific PRO measures. A consensus group process identified potential barriers to use of PRO measures in six categories: (1) PRO misperceptions, (2) patient factors, (3) regulators and payers, (4) instrument factors, (5) study design, and (6) physicians. The workgroup provided recommendations for actions to promote the widespread utilization of vascular access-related PRO measures in five categories: (1) development of vascular access-specific PRO measures, (2) ensuring comprehensive assessment when using vascular access PRO measures, (3) ensuring accessibility and applicability of vascular access PRO measures to all end stage kidney disease populations, (4) establishing universal guidelines and accepted vascular access PRO measures, and (5) engaging stakeholders across all facets.
虽然与血管通路相关的功能障碍是临床结果和成本的明确驱动因素，但血管通路功能障碍对患者体验和生活质量的全面影响在文献中尚未得到充分描述。从患者角度更全面地描述患者体验的一种方法是通过患者报告结局（PROs）。然而，PROs在临床试验、患者登记、质量测量和其他研究环境中的有限应用，严重限制了患者在评估血管通路结局和血管通路决策中的发言权。为了解决这些问题，由美国肾脏病学会和美国食品药品监督管理局公私合作成立的肾脏健康倡议组织召集了一个跨学科工作组，以提高与血管通路相关的PROs的应用，目标如下：（1）审查受血管通路影响的健康相关生活质量（HRQOL）领域，收集有关测量血液透析中特定通路HRQOL的现有工具的信息，并识别现有测量方法中的差距；（2）识别并严格评估广泛使用特定通路PRO测量方法的障碍；（3）确定克服障碍的举措，并就改善特定通路PRO测量方法的使用和效用的策略提出建议。一个共识小组过程确定了在六个类别中使用PRO测量方法的潜在障碍：（1）对PRO的误解，（2）患者因素，（3）监管机构和支付方，（4）工具因素，（5）研究设计，以及（6）医生。工作组针对五个类别提出了促进血管通路相关PRO测量方法广泛应用的行动建议：（1）开发特定于血管通路的PRO测量方法，（2）在使用血管通路PRO测量方法时确保全面评估，（3）确保血管通路PRO测量方法对所有终末期肾病患者群体的可及性和适用性，（4）建立通用指南和被认可的血管通路PRO测量方法，以及（5）让各方面的利益相关者参与进来。
