在肿瘤学领域，患者报告的结果测量(INRMs)提供了重要的数据，帮助确保捕捉和报告与患者相关的终点。通过试验方法的一致和透明报告，有助于在现实世界的临床医生和患者中利用这些信息进行治疗决策。为了确定和比较在晚期肾细胞癌(RCC)试验中使用的INRMs，包括选择措施的理由、终点层次(PROMs)、评估时间点、统计方法和解释的统计指标。通过在四个在线数据库(2016-2021年)和最新的会议摘要(2019-2021年)进行系统文献综述，共鉴定了2616篇文章，根据"优选报告系统性综述和Meta分析指南"，其中33篇文章被纳入综述。在包括的33项临床研究中，鉴定了19种不同的INRMs：3种肾癌特异性量表，2种肿瘤特异性量表，2种通用量表和12种症状特异性量表。42%的研究中报告了患者报告结果( PRO)评估的终点层次；其中一项研究将PRO作为主要终点。关于时间点、最小有效差异和统计分析的报告高度异质。在临床研究中，包括了多种不同的INRMs，用于晚期/转移性RCC患者。预定的PRO评估分析通常未说明，而分析方法和报告则各不相同。各项研究之间的协调将更好地为监管、市场准入、报销和临床决策提供信息，以改善患者护理质量。我们回顾了在肾癌临床试验中如何测量癌症治疗对患者健康结果的影响。技术和报告在试验中有所不同。规范这些数据的捕捉和报告方式可能会改善肾癌患者的护理和决策。版权所有©2023年欧洲泌尿协会。由Elsevier B.V.出版。保留所有权利。

In the oncology setting, patient-reported outcome measures (PROMs) provide important data that help to ensure patient-relevant endpoints are captured and reported. Use of this information for treatment decision-making by clinicians and patients in real-world settings is facilitated by consistent and transparent reporting of trial methods.To identify and compare PROMs used in advanced renal cell carcinoma (RCC) trials in terms of the rationale for the choice of measure, endpoint hierarchy (primary, secondary, exploratory), assessment time points, statistical methods, and statistical metrics for interpretation.A systematic literature review via searches of four online databases (2016-2021) and recent conference abstracts (2019-2021) identified 2616 articles, of which 33 were included in the review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.Among the 33 clinical studies included, 19 different PROMs were identified: three kidney cancer-specific scales, two cancer-specific scales, two generic scales, and 12 symptom-specific scales. The endpoint hierarchy for patient reported outcome (PRO) assessment was reported in 42% of the studies; one study included PROs as a primary endpoint. Reporting of time points, minimal important differences, and statistical analyses was highly heterogeneous.A diverse range of PROMs have been included in clinical studies for patients with advanced/metastatic RCC. Prespecified analyses for PRO assessments were generally not stated, while analytical methods and reporting varied. An improvement in alignment across studies would better inform regulatory, market-access, reimbursement, and clinical decision-making to improve patient care.We reviewed how the impact of cancer therapies on health outcomes from the patient's point of view is being measured in clinical trials for kidney cancer. The techniques and reporting varied across trials. Standardisation of how these data are captured and reported may improve care and decision-making for patients with kidney cancer.Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.