Trotti Andy, Colevas A Dimitrios, Setser Ann, Basch Ethan
Division of Radiation Oncology, H. Lee Moffitt Cancer Center at University of South Florida, Tampa, FL 33612-9416, USA.
J Clin Oncol. 2007 Nov 10;25(32):5121-7. doi: 10.1200/JCO.2007.12.4784.
Adverse event (AE) reporting in oncology has evolved from informal descriptions to a highly systematized process. The Common Terminology Criteria for Adverse Events (CTCAE) is the predominant system for describing the severity of AEs commonly encountered in oncology clinical trials. CTCAE clinical descriptors have been developed empirically during more than 30 years of use. The method of data collection is clinician based. Limitations of the CTC system include potential for incomplete reporting and limited guidance on data analysis and presentation methods. The Medical Dictionary for Regulatory Activities (MedDRA) is a comprehensive medical terminology system used for regulatory reporting and drug labeling. MedDRA does not provide for severity ranking of AEs. CTC-based data presentations are the primary method of AE data reporting used in scientific journals and oncology meetings. Patient-reported outcome instruments (PROs) cover the subjective domain of AEs. Exploratory work suggests PROs can be used with a high degree of patient engagement and compliance. Additional studies are needed to determine how PROs can be used to complement current AE reporting systems. Potential models for integrating PROs into AE reporting are described in this review. AE reporting methods will continue to evolve in response to changing therapies and growing interest in measuring the impact of cancer treatment on health status. Although integration of PROs into AE reporting may ultimately improve the comprehensiveness and quality of collected data, it may also increase the administrative burden and cost of conducting trials. Therefore, care must be used when developing health outcomes and safety data collection plans.
肿瘤学中的不良事件(AE)报告已从非正式描述发展为高度系统化的过程。《不良事件通用术语标准》(CTCAE)是描述肿瘤学临床试验中常见不良事件严重程度的主要系统。CTCAE临床描述符是在30多年的使用过程中根据经验制定的。数据收集方法以临床医生为基础。CTCAE系统的局限性包括报告可能不完整,以及在数据分析和呈现方法方面的指导有限。《监管活动医学词典》(MedDRA)是一个用于监管报告和药品标签的综合医学术语系统。MedDRA未提供不良事件的严重程度分级。基于CTCAE的数据呈现是科学期刊和肿瘤学会议中使用的不良事件数据报告的主要方法。患者报告结局工具(PROs)涵盖了不良事件的主观领域。探索性工作表明,PROs可以在患者高度参与和依从的情况下使用。需要进一步的研究来确定如何使用PROs来补充当前的不良事件报告系统。本综述描述了将PROs整合到不良事件报告中的潜在模型。随着治疗方法的不断变化以及人们对衡量癌症治疗对健康状况影响的兴趣日益浓厚,不良事件报告方法将继续发展。虽然将PROs整合到不良事件报告中最终可能会提高所收集数据的全面性和质量,但也可能增加开展试验的管理负担和成本。因此,在制定健康结局和安全数据收集计划时必须谨慎。
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