Minasian Lori M, O'Mara Ann, Mitchell Sandra A
Division of Cancer Prevention, National Cancer Institute, Bethesda, MD, USA.
Consultant, ICF, Fairfax, VA, USA.
Patient Relat Outcome Meas. 2022 Dec 8;13:249-258. doi: 10.2147/PROM.S256567. eCollection 2022.
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.
在症状性不良事件报告中纳入患者视角，能为临床医生使用不良事件通用术语标准（CTCAE）报告提供不同且互补的信息。美国国立癌症研究所的患者报告结局版不良事件通用术语标准（PRO-CTCAE）旨在让患者以补充CTCAE报告的方式自我报告其症状性不良事件。同时使用CTCAE和PRO-CTCAE有可能加深我们对可能导致选择性停药和生活质量下降的低级别不良事件的发生率和发展轨迹的理解。本综述阐述了PRO-CTCAE的发展，重点关注PRO-CTCAE评分与CTCAE严重程度分级之间的差异。在评估、分级和报告癌症临床试验中的毒性和耐受性时，这种区分很重要。
