Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Composite grading algorithm for the National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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DOI：
10.1177/1740774520975120
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发表时间：
2021-03
期刊：
影响因子：
--
通讯作者：
Dueck AC
中科院分区：
文献类型：
--
作者：
Basch E;Becker C;Rogak LJ;Schrag D;Reeve BB;Spears P;Smith ML;Gounder MM;Mahoney MR;Schwartz GK;Bennett AV;Mendoza TR;Cleeland CS;Sloan JA;Bruner DW;Schwab G;Atkinson TM;Thanarajasingam G;Bertagnolli MM;Dueck AC
不良事件通用术语标准 (PRO-CTCAE) 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。为了使 PRO-CTCAE 与包括 CTCAE 在内的其他不良事件评估标准化工具保持一致，开发并测试了一种算法，用于将任何给定不良事件的各个项目映射到单个复合数值等级。使用了五步过程。 (1) 将所有 179 种可能的 PRO-CTCAE 评分组合呈现给 20 名临床研究人员，以主观地将组合映射到 0-3 范围内的单个数字等级。 (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。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、敏感性和臂间划分方面表现良好，与单个项目评分相当。复合分级算法已经开发出来，可以为通过 PRO-CTCAE 评估的不良事件生成单一数字等级，可用于分析和报告。
Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) 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 PRO-CTCAE with other standardized tools for adverse event assessment including CTCAE, an algorithm for mapping individual items for any given adverse event to a single composite numerical grade was developed and tested. A five-step process was used. (1) All 179 possible PRO-CTCAE score combinations were presented to 20 clinical investigators to subjectively map combinations to single numerical grades ranging from 0-3. (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). 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. A composite grading algorithm has been developed and yields single numerical grades for adverse events assessed via PRO-CTCAE, and can be useful in analyses and reporting.
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影响因子：
28.4
作者：
Dueck AC;Mendoza TR;Mitchell SA;Reeve BB;Castro KM;Rogak LJ;Atkinson TM;Bennett AV;Denicoff AM;O'Mara AM;Li Y;Clauser SB;Bryant DM;Bearden JD 3rd;Gillis TA;Harness JK;Siegel RD;Paul DB;Cleeland CS;Schrag D;Sloan JA;Abernethy AP;Bruner DW;Minasian LM;Basch E;National Cancer Institute PRO-CTCAE Study Group
通讯作者：
National Cancer Institute PRO-CTCAE Study Group
影响因子：
10.3
作者：
Basch, Ethan;Jia, Xiaoyu;Schrag, Deborah
通讯作者：
Schrag, Deborah
影响因子：
23.4
作者：
Basch, Ethan M.;Scholz, Mark;Scher, Howard, I
通讯作者：
Scher, Howard, I
DOI：
10.1093/jnci/85.5.365
发表时间：
1993-03-03
期刊：
JOURNAL OF THE NATIONAL CANCER INSTITUTE
影响因子：
--
作者：
AARONSON, NK;AHMEDZAI, S;TAKEDA, F
通讯作者：
TAKEDA, F
影响因子：
10.3
作者：
Reeve, Bryce B.;Mitchell, Sandra A.;Bruner, Deborah Watkins
通讯作者：
Bruner, Deborah Watkins