BACKGROUND Patient-reported outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. METHODS We systematically investigated a cohort of randomized controlled cancer trials that included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. RESULTS Protocols (101 sourced, 44.3%) included a mean (SD) of 10 (4) of 33 (range = 2-19) PRO protocol checklist items. Recommended items frequently omitted included the rationale and objectives underpinning PRO collection and approaches to minimize/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% confidence interval = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49 568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean [SD] inclusion of 3 [3] of 14 [range = 0-11]) CONSORT PRO Extension checklist items). More than one-half of trials publishing PRO results in a secondary publication (12 of 22, 54.5%) took 4 or more years to do so following trial closure, with eight (36.4%) taking 5-8 years and one trial publishing after 14 years. CONCLUSIONS PRO protocol content is frequently inadequate, and nonreporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians, and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

中文翻译：

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癌症试验中患者报告的结果方案内容和报告的系统评估。

背景 在癌症试验中捕获患者报告的结果 (PRO)，以帮助未来的患者及其临床医生做出更明智的治疗决策。然而，PRO 试验设计和报告标准的可变性威胁着这些终点在临床实践中应用的有效性。方法 我们系统地研究了一组随机对照癌症试验，其中包括主要或次要 PRO。对于每项试验，都使用标准检查表对方案和报告质量进行评估。还探讨了报告的一般模式。结果 协议（101 个来源，44.3%）包括 33 个（范围 = 2-19）PRO 协议清单项目中的 10 (4) 个平均值 (SD)。经常被忽略的建议项目包括支持 PRO 收集的基本原理和目标以及尽量减少/解决缺失 PRO 数据的方法。在已发表结果的 160 项试验中，61 项（38.1%，95% 置信区间 = 30.6% 至 45.7%）未能将其 PRO 研究结果纳入任何出版物中（平均随访时间为 6.43 年）；这些试验有 49 568 名参与者。尽管三分之二的纳入试验发表了 PRO 结果，但根据国际指南，报告标准往往不够充分（平均 [SD] 纳入 14 项中的 3 [3] 项 [范围 = 0-11]）CONSORT PRO 扩展清单项目）。超过一半的试验（22 项中的 12 项，54.5%）在试验结束后需要 4 年或更长的时间才能在二级出版物上发表 PRO 结果，其中 8 项（36.4%）需要 5-8 年，其中一项试验在试验结束后才发表14年。结论 PRO 方案内容经常不充分，并且不报告 PRO 结果的现象很普遍，这意味着患者重要的信息可能无法使患者、临床医生和监管者受益。即使在发布 PRO 数据的情况下，通常也会出现相当大的延迟，并且报告质量也不尽如人意。本研究提出了关键建议，以提高未来成功交付 PRO 的可能性。