在肿瘤学领域，记录健康相关生活质量 (HRQOL) 的患者报告结果指标 (PROM) 在临床试验、药物审批和政策制定中发挥着越来越重要的作用。本次范围界定审查旨在识别和详细阐述肾细胞癌 (RCC) 临床试验中使用的以 HRQOL 为中心的 PROM。系统地检索了 MEDLINE、Web of Science、PsychINFO、Academic Search Elite、CINAHL、Embase 和 Cochrane 图书馆以查找原始同行-回顾了 1950 年至 2023 年间发表的涉及 RCC 患者和使用 PROM 的临床试验的文章。提取了预先指定的试验特征和所用 PROM 的信息。计算了分类数据的频率和比例，以及连续变量的范围和中位数。在纳入的 48 项独特研究中，大多数采用随机对照设计（34 项，71%）并评估系统治疗（38 项，79%）。这些试验使用了 27 种不同的 PROM（最大值 = 6，中位数 = 2），其中只有 4 个（15%）是专门为肾癌患者开发的。在这些试验中，46% 没有使用任何 RCC 特定的 PROM。欧洲生活质量 5 维度 (EQ-5D)、欧洲癌症研究和治疗组织生活质量核心问卷 (EORTC QLQ-C30)、癌症治疗肾症状指数功能评估 (FKSI) -15/19 项版本、FKSI-疾病相关症状和癌症治疗一般功能评估 (FACT-G) 是最常用的问卷，其中疼痛、工作能力、疲劳、担忧和睡眠质量是最常评估的问题。 RCC 患者使用了多种 PROM，这阻碍了试验的可解释性。所使用的 PROM 在评估领域以及如何将问题转化为调查问卷项目方面有所不同。尽管存在 RCC 特异性 PROM，但它们在与患者的相关性方面存在缺陷。为了回答预先确定的相关 HRQOL 研究问题，需要修订 RCC 特异性 PROM 并将其纳入临床试验的标准化。研究人员对肾癌患者的健康相关生活质量越来越感兴趣，并使用问卷来衡量。本综述表明，在肾癌患者的临床试验中，有许多不同的健康相关生活质量问卷以不同的组合使用。这使得比较这些研究结果并为实际临床治疗得出可靠的结论变得非常困难。甚至发现，使用的一些调查问卷并未涵盖患者真正认为重要的事情（例如，处理有关癌症和抑郁症的想法等情感问题）。因此，需要做更多的工作来制定调查问卷，询问什么对肾癌患者的健康相关生活质量真正重要。如果这些问卷在临床试验中以一致的方式使用，可以更好地比较结果。这将有助于以最佳方式治疗肾癌患者。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。

In oncology, patient-reported outcome measures (PROMs) capturing health-related quality of life (HRQOL) play an increasing role in clinical trials, drug approval, and policy making. This scoping review aimed to identify and elaborate on HRQOL-focussed PROMs used in renal cell cancer (RCC) clinical trials.MEDLINE, Web of Science, PsychINFO, Academic Search Elite, CINAHL, Embase, and the Cochrane Library were searched systematically for original peer-reviewed articles on clinical trials including RCC patients and using PROMs, published between 1950 and 2023. Prespecified trial characteristics and information on the PROMs used were extracted. Frequencies and proportions of categorical data, and ranges and medians of continuous variables were calculated.Of the 48 unique studies included, the majority followed a randomised controlled design (34, 71%) and evaluated systemic treatments (38, 79%). The trials used 27 different PROMs (max = 6, median = 2), of which only 4 (15%) were developed specifically for kidney cancer patients. Of the trials, 46% did not use any RCC-specific PROM. European Quality of Life-5 Dimensions (EQ-5D), European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI) -15/19-item version, FKSI-Disease Related Symptoms, and Functional Assessment of Cancer Therapy-General (FACT-G) were the most frequently used questionnaires, with pain, ability to work, fatigue, worry, and sleep quality being the most commonly assessed issues.A variety of PROMs are used in RCC patients, hindering interpretability across trials. The PROMs used differ in terms of both the domains assessed and how the issues are translated into questionnaire items. Though RCC-specific PROMs exist, these have flaws in terms of relevance to patients. To answer predefined relevant HRQOL research questions, revised RCC-specific PROMs and standardisation of their integration into clinical trials are warranted.Researchers are more and more interested in the health-related quality of life of kidney cancer patients and use questionnaires to measure it. This review shows that there are many different health-related quality of life questionnaires that are used in different combinations in clinical trials for kidney cancer patients. This makes it very difficult to compare these study results and draw reliable conclusions for the actual clinical treatment. It was even found that some of the questionnaires used do not capture things that patients actually consider important (eg, emotional issues such as dealing with thoughts about cancer and depression). Therefore, more work needs to be done to develop questionnaires that ask what is really important to kidney cancer patients' health-related quality of life. If these questionnaires are used in a consistent way in clinical trials, the results can be better compared. This will help treat kidney cancer patients in the best possible way.Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.