Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).
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DOI：
10.1001/jamaoncol.2015.2639
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发表时间：
2015-11
期刊：
影响因子：
28.4
通讯作者：
National Cancer Institute PRO-CTCAE Study Group
中科院分区：
文献类型：
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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
癌症试验中的症状性不良事件（AE）目前由临床医生使用美国国家癌症研究所（NCI）不良事件通用术语标准（CTCAE）报告。为了整合患者的观点，NCI开发了CTCAE的患者报告结局版本（PRO-CTCAE），以直接从患者处获取症状性AE。评估PRO-CTCAE项目的结构效度、重测信度和反应性。受试者在门诊候诊室的平板电脑上完成PRO-CTCAE项目，两次访视间隔1-6周。在首次访视后一个工作日的额外访视期间，一个子集完成了PRO-CTCAE项目。九个美国癌症中心和社区肿瘤学实践。2011年1月至2012年2月期间入组了975例接受门诊化疗和/或放疗的成人癌症患者。资格要求参与者阅读英语，并且没有临床上显著的认知障碍。主要对照药物为临床医生报告的东部肿瘤协作组体能状态（ECOG PS）和欧洲癌症研究与治疗组织核心生活质量问卷（QLQ-C30）。940/975（96%）和852/940（91%）例受试者在每次访视时完成了PRO-CTCAE项目。938/940（99.8%）例受试者（53%为女性，中位年龄59岁，32%为高中或以下学历，17%为ECOG PS 2-4）报告至少有一种症状。所有PRO-CTCAE项目与QLQ-C30量表在预期方向上至少有一个相关性（111/124 P<.05）。PRO-CTCAE项目与概念相关QLQ-C30领域之间的相关性更强。ECOG PS 2-4组的94/124个PRO-CTCAE项目评分高于0-1组（58/124 P<.05）。总体而言，119/124项符合至少一个结构效度标准。对于36/49个预先规定的项目，重测信度是可接受的（组内相关系数中位数为0.76;范围为0.53 - 0.96）。PRO-CTCAE项目变化与相应QLQ-C30量表变化之间的相关性在27个预先规定的项目中达到统计学显著性（中位r= 0.43，范围0.10 - 0.56;所有P≤ 0.006）。证据表明，PRO-CTCAE在接受癌症治疗的美国大样本异质性患者中具有良好的有效性、可靠性和反应性。正在进行评估PRO-CTCAE其他测量特性的研究，以告知PRO-CTCAE的进一步开发及其纳入癌症试验。
Symptomatic adverse events (AEs) in cancer trials are currently reported by clinicians using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE). To integrate the patient perspective, the NCI developed a patient-reported outcomes version of the CTCAE (PRO-CTCAE) to capture symptomatic AEs directly from patients. To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. Participants completed PRO-CTCAE items on tablet computers in clinic waiting rooms at two visits 1-6 weeks apart. A subset completed PRO-CTCAE items during an additional visit one business day after the first visit. Nine U.S. cancer centers and community oncology practices. 975 adult cancer patients undergoing outpatient chemotherapy and/or radiation enrolled between January 2011 and February 2012. Eligibility required participants to read English and be without clinically significant cognitive impairment. Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). 940/975 (96%) and 852/940 (91%) participants completed PRO-CTCAE items at each visit. 938/940 (99.8%) participants (53% female, median age 59, 32% high school education or less, 17% ECOG PS 2-4) reported having at least one symptom. All PRO-CTCAE items had at least one correlation in the expected direction with a QLQ-C30 scale (111/124 P<.05). Stronger correlations were seen between PRO-CTCAE items and conceptually-related QLQ-C30 domains. Scores for 94/124 PRO-CTCAE items were higher in the ECOG PS 2-4 versus 0-1 group (58/124 P<.05). Overall, 119/124 items met at least one construct validity criterion. Test-retest reliability was acceptable for 36/49 pre-specified items (median intra-class correlation coefficient .76; range .53-.96). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes reached statistical significance for 27 pre-specified items (median r=.43, range .10-.56; all P≤.006). Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous U.S. sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are underway to inform further development of PRO-CTCAE and its inclusion in cancer trials.