强烈建议将患者报告的结果（PRO）纳入肿瘤学临床试验。然而，选择最合适的患者报告结果指标 (PROM) 并不容易。本研究旨在开发乳腺癌 (BC) 特定的 PROM 综合档案。作为 PRO4All 项目的一部分，我们通过搜索 facit.org、eortc.org、eprovide.mapi-trust.org、PubMed、 ema.europa.eu（欧洲公共评估报告）和已发表的评论。对于此分析，仅提取了 BC 工具。我们在文献中描述了有关 PROM 名称、调查问卷类型、调查问卷变体、回忆期、项目数量以及是否存在最小临床重要差异 (MCID) 参考的信息。然后，我们根据 38 个项目的预定义分类法将每个项目分配到特定领域以进行结果分类。我们识别并分析了 383 个 PROM。其中，29 个是 BC 特定的，但有 2 个因调查问卷描述不可用而被排除。 6 (22.2%) 是另一份调查问卷的变体。所有问卷均由自我报告。在 6 例 (22.2%) 中，要考虑的回忆期是“上周”。每份问卷的平均项目数为 25.81（范围 6-71）。 602 个项目被分配到一个结果领域：26.6% 的情况下情绪功能/幸福，14.1% 的身体功能，10.8% 的护理服务，10.5% 的一般结果。仅在 4 个 (14.8%) 病例中发现了 MCID 参考。新开发的档案是优化 PROM 在 BC 患者治疗评估中的使用的有用工具，在临床研究和实践中促进以患者为中心的方法。版权所有© 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer (BC) specific comprehensive archive of PROMs.As part of the PRO4All project, we identified available PROMs in oncology by searching facit.org, eortc.org, eprovide.mapi-trust.org, PubMed, ema.europa.eu (European Public Assessment Reports) and published reviews. For this analysis, only BC tools were extracted. We described information about PROM name, type of questionnaire, questionnaire variant(s), recall period, number of items, and presence of minimum clinically important difference (MCID) reference in literature. Then, we assigned each item to a specific domain according to a predefined taxonomy of 38 items for outcome classification.We identified and analyzed 383 PROMs. Of these, 29 were BC specific, but 2 were excluded because the questionnaires description was not available. 6 (22.2 %) were variants of another questionnaire. All questionnaires were self-reported. In 6 cases (22.2 %) the recall period to consider was the "last week". The mean number of items per questionnaire was 25.81 (range 6-71). 602 items were assigned to an outcome domain: emotional functioning/wellbeing in 26.6 % of cases, physical functioning in 14.1 %, delivery of care in 10.8 %, and general outcomes in 10.5 %. MCID reference was found only in 4 (14.8 %) cases.The newly developed archive represents a useful tool to optimize the use of PROMs in the evaluation of treatments in BC patients, promoting a patient-centered approach both in clinical research and practice.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.