Atkinson Thomas M, Ryan Sean J, Bennett Antonia V, Stover Angela M, Saracino Rebecca M, Rogak Lauren J, Jewell Sarah T, Matsoukas Konstantina, Li Yuelin, Basch Ethan
Department of Psychiatry & Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 641 Lexington Ave., 7th Floor, New York, NY, 10022, USA.
City University of New York, New York, NY, USA.
Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3.
PURPOSE: Symptomatic adverse events (AEs) are monitored by clinicians as part of all US-based clinical trials in cancer via the U.S. National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) for the purposes of ensuring patient safety. Recently, there has been a charge toward capturing the patient perspective for those AEs amenable to patient self-reporting via patient-reported outcomes (PRO). The aim of this review was to summarize the empirically reported association between analogous CTCAE and PRO ratings. METHODS: A systematic literature search was conducted using PubMed, EMBASE, Web of Science, and Cochrane databases through July 2015. From a total of 5658 articles retrieved, 28 studies met the inclusion criteria. RESULTS: Across studies, patients were of mixed cancer types, including anal, breast, cervical, chronic myeloid leukemia, endometrial, hematological, lung, ovarian, pelvic, pharyngeal, prostate, and rectal. Given this mixture, the AEs captured were variable, with many common across studies (e.g., dyspnea, fatigue, nausea, neuropathy, pain, vomiting), as well as several that were disease-specific (e.g., erectile dysfunction, hemoptysis). Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had a large variation across the majority of studies (n = 21). CONCLUSIONS: The range of measures used and symptoms captured varied greatly across the reviewed studies. Regardless of concordance metric employed, reported agreement between CTCAE and PRO ratings was moderate at best. To assist with reconciliation and interpretation of these differences toward ultimately improving patient care, an important next step is to explore approaches to integrate PROs with clinician reporting of AEs.
目的:作为美国所有癌症临床试验的一部分,临床医生会依据美国国立癌症研究所的不良事件通用术语标准(CTCAE)监测有症状的不良事件(AE),以确保患者安全。最近,人们开始关注收集患者对那些适合通过患者报告结局(PRO)进行自我报告的不良事件的看法。本综述的目的是总结经验性报道的类似CTCAE与PRO评分之间的关联。 方法:通过检索PubMed、EMBASE、科学网和Cochrane数据库,对截至2015年7月的文献进行了系统检索。在总共检索到的5658篇文章中,有28项研究符合纳入标准。 结果:在各项研究中,患者的癌症类型各异,包括肛门癌、乳腺癌、宫颈癌、慢性髓性白血病、子宫内膜癌、血液系统癌症、肺癌、卵巢癌、盆腔癌、咽癌、前列腺癌和直肠癌。鉴于这种多样性,所捕获的不良事件各不相同,许多不良事件在多项研究中都很常见(如呼吸困难、疲劳、恶心、神经病变、疼痛、呕吐),还有一些是特定疾病的(如勃起功能障碍、咯血)。总体而言,CTCAE与PRO评分之间的量化关联处于一般到中等范围,并且在大多数研究(n = 21)中差异很大。 结论:在所综述的研究中,所使用的测量方法和所捕获的症状差异很大。无论采用何种一致性指标,CTCAE与PRO评分之间报告的一致性充其量只是中等。为了有助于协调和解释这些差异以最终改善患者护理,下一步重要的是探索将PRO与临床医生对不良事件的报告相结合的方法。
Cochrane Database Syst Rev. 2018-1-16
Cochrane Database Syst Rev. 2020-10-19
Cochrane Database Syst Rev. 2021-4-19
Cochrane Database Syst Rev. 2020-1-9
Cochrane Database Syst Rev. 2022-11-17
Health Technol Assess. 2024-10
Cochrane Database Syst Rev. 2017-12-22
Asia Pac J Oncol Nurs. 2025-5-5
Clin Transl Radiat Oncol. 2025-5-2