临床医生和患者在癌症临床试验中对症不良事件的报告:使用CTCAE和PRO-CTCAE®提供两个不同的和互补的观点。

IF 1.8 Q3 HEALTH CARE SCIENCES & SERVICES
Lori M Minasian, Ann O'Mara, Sandra A Mitchell
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引用次数: 5

摘要

在有症状的不良事件报告中纳入患者的观点,与临床医生使用不良事件通用术语标准(CTCAE)报告提供了不同的和补充的信息。国家癌症研究所不良事件通用术语标准(PRO-CTCAE®)的患者报告结果版本是为患者以补充CTCAE报告的方式自我报告其症状性不良事件而设计的。将CTCAE和PRO-CTCAE结合使用,有可能改善我们对低级别不良事件的患病率和发展轨迹的理解,这些不良事件可能导致选择性停止治疗和生活质量下降。本综述探讨了PRO-CTCAE的发展,重点讨论了PRO-CTCAE评分和CTCAE严重等级之间的差异。在癌症临床试验中评估、分级和报告毒性和耐受性时,这种区别是很重要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE<sup>®</sup> to Provide Two Distinct and Complementary Perspectives.

Clinician and Patient Reporting of Symptomatic Adverse Events in Cancer Clinical Trials: Using CTCAE and PRO-CTCAE® to Provide Two Distinct and Complementary Perspectives.

Inclusion of the patient perspective in the reporting of symptomatic adverse events provides different and complementary information to clinician reporting using the Common Terminology Criteria for Adverse Events (CTCAE). The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) is designed for patients to self-report their symptomatic adverse events in a manner that complements CTCAE reporting. Using CTCAE and PRO-CTCAE together offers the potential to refine our understanding of the prevalence and trajectory of lower grade AEs that can lead to elective discontinuation of therapy and diminished quality of life. This review addresses the development of PRO-CTCAE with an emphasis on the differences between PRO-CTCAE scores and CTCAE severity grades. This distinction is important when evaluating, grading and reporting toxicity and tolerability in cancer clinical trials.

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来源期刊
Patient Related Outcome Measures
Patient Related Outcome Measures HEALTH CARE SCIENCES & SERVICES-
自引率
4.80%
发文量
27
审稿时长
16 weeks
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