BACKGROUND The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events is an item library designed for eliciting patient-reported adverse events in oncology. For each adverse event, up to three individual items are scored for frequency, severity, and interference with daily activities. To align the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events with other standardized tools for adverse event assessment including the Common Terminology Criteria for Adverse Events, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested. METHODS A five-step process was used: (1) All 179 possible Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0 to 3. (2) Combinations with <75% agreement were presented to investigator committees at a National Clinical Trials Network cooperative group meeting to gain majority consensus via anonymous voting. (3) The resulting algorithm was refined via graphical and tabular approaches to assure directional consistency. (4) Validity, reliability, and sensitivity were assessed in a national study dataset. (5) Accuracy for delineating adverse events between study arms was measured in two Phase III clinical trials (NCT02066181 and NCT01522443). RESULTS In Step 1, 12/179 score combinations had <75% initial agreement. In Step 2, majority consensus was reached for all combinations. In Step 3, five grades were adjusted to assure directional consistency. In Steps 4 and 5, composite grades performed well and comparably to individual item scores on validity, reliability, sensitivity, and between-arm delineation. CONCLUSION A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events, and can be useful in analyses and reporting.

中文翻译：

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美国国家癌症研究所不良事件通用术语标准 (PRO-CTCAE) 患者报告结果版本的综合分级算法


背景技术不良事件通用术语标准的患者报告结果版本是一个项目库，旨在引出患者报告的肿瘤学不良事件。对于每种不良事件，最多可根据频率、严重程度和对日常活动的干扰对三个单独项目进行评分。使不良事件通用术语标准的患者报告结果版本与不良事件评估的其他标准化工具保持一致，包括不良事件通用术语标准，这是一种将任何给定不良事件的各个项目映射到单个复合数字等级的算法被开发和测试。方法 采用五步流程：(1) 将不良事件通用术语标准评分组合的所有 179 种可能的患者报告结果版本呈现给 20 名临床研究人员，以主观地将组合映射到 0 到 3 的单一数字等级。 (2) 在国家临床试验网络合作小组会议上，将同意率<75%的组合提交给研究者委员会，以通过匿名投票获得多数共识。 (3) 通过图形和表格方法对所得算法进行改进，以确保方向一致性。 (4) 在国家研究数据集中评估有效性、可靠性和敏感性。 (5) 在两项 III 期临床试验（NCT02066181 和 NCT01522443）中测量了描述研究组之间不良事件的准确性。结果 在步骤 1 中，12/179 分数组合的初始一致性 <75%。在步骤 2 中，所有组合都达成了多数共识。在步骤 3 中，调整了五个等级以确保方向一致性。 在第 4 步和第 5 步中，综合评分在有效性、可靠性、敏感性和臂间描述方面表现良好，与单个项目评分相当。结论 已经开发出一种复合分级算法，并通过不良事件通用术语标准的患者报告结果版本评估不良事件产生单一数字等级，并且可用于分析和报告。