Over the past 20 years, interest has grown to include patient-reported outcomes (PRO) in cancer clinical trials, evidenced by guidance documents from international regulatory authorities (1) and a steady increase of PRO-based endpoints in protocols (eg, pain improvement) (2). But is inclusion of PRO endpoints rigorous and systematic? Concerns have been raised previously about incomplete reporting of PRO results in clinical trial publications, which may reflect underlying design weaknesses (3). These concerns have prompted recent international collaborative efforts to standardize expectations for describing PRO endpoints in protocols and publications.

中文翻译：

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临床试验方案和出版物中患者报告结果的报告标准。

在过去的20年中，越来越多的兴趣包括癌症临床试验中的患者报告结局（PRO），国际监管机构（1）的指导文件证明了这一点，方案中基于PRO的终点指标不断增加（例如，疼痛改善）（2）。但是，对PRO端点的包含是否严格而系统化？先前已经有人提出对临床试验出版物中PRO结果报告不完整的担忧，这可能反映了潜在的设计缺陷（3）。这些担忧促使最近的国际合作努力标准化了在协议和出版物中描述PRO端点的期望。