文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

基于临床医生的不良事件通用术语标准(CTCAE)与患者报告结局(PRO)之间的关联:一项系统评价。

The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review.

作者信息

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

机构信息

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.

出版信息

Support Care Cancer. 2016 Aug;24(8):3669-76. doi: 10.1007/s00520-016-3297-9. Epub 2016 Jun 3.


DOI:10.1007/s00520-016-3297-9
PMID:27260018
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4919215/
Abstract

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.

摘要

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。

相似文献

[1]
The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review.

Support Care Cancer. 2016-8

[2]
Eliciting adverse effects data from participants in clinical trials.

Cochrane Database Syst Rev. 2018-1-16

[3]
A rapid and systematic review of the clinical effectiveness and cost-effectiveness of topotecan for ovarian cancer.

Health Technol Assess. 2001

[4]
Drugs for preventing postoperative nausea and vomiting in adults after general anaesthesia: a network meta-analysis.

Cochrane Database Syst Rev. 2020-10-19

[5]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2021-4-19

[6]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2020-1-9

[7]
Electronic cigarettes for smoking cessation.

Cochrane Database Syst Rev. 2022-11-17

[8]
A rapid and systematic review of the clinical effectiveness and cost-effectiveness of paclitaxel, docetaxel, gemcitabine and vinorelbine in non-small-cell lung cancer.

Health Technol Assess. 2001

[9]
Antidepressants for pain management in adults with chronic pain: a network meta-analysis.

Health Technol Assess. 2024-10

[10]
Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.

Cochrane Database Syst Rev. 2017-12-22

引用本文的文献

[1]
Japanese version of the MD Anderson Symptom Inventory for Head and Neck Tumor module: Validation study.

Asia Pac J Oncol Nurs. 2025-5-5

[2]
Implementation of a Program for Combined Intra-Gestational and Systemic Methotrexate Injection to Treat Non-Tubal Ectopic Pregnancy: A Report of Outcomes and Feasibility.

Reprod Sci. 2025-8

[3]
Real-world experience of hetrombopag in immune thrombocytopenia treatment: a retrospective cohort study.

Eur J Med Res. 2025-7-5

[4]
Patient-reported outcomes between proton and photon therapy in nasopharyngeal carcinoma patients: A longitudinal cohort study.

Clin Transl Radiat Oncol. 2025-5-2

[5]
The efficacy and safety of tislelizumab with or without tyrosine kinase inhibitor as adjuvant therapy in hepatocellular carcinoma with high-risk of recurrence after curative resection.

Front Immunol. 2025-6-18

[6]
Machine Learning-Based Prediction of Clinical Outcomes in Patients With Cancer Receiving Systemic Treatment Using Step Count Data Measured With Smartphones.

JCO Clin Cancer Inform. 2025-7

[7]
Measure selection for an electronic patient-reported outcome (ePRO) system for CAR T-cell therapy patients: a modified Delphi consensus study.

EClinicalMedicine. 2025-5-28

[8]
Overall Survival and Quality-of-Life Superiority in Modern Phase 3 Oncology Trials: A Meta-Epidemiological Analysis.

JAMA Oncol. 2025-6-1

[9]
Langerhans Cell Histiocytosis With Mutation Successfully Treated With Trametinib.

EJHaem. 2025-5-27

[10]
Risk factors for rectal bleeding in prostate cancer after radiotherapy with a validation of current rectal dose constraints.

Acta Oncol. 2025-5-8

本文引用的文献

[1]
Prevalence of patient-reported gastrointestinal symptoms and agreement with clinician toxicity assessments in radiation therapy for anal cancer.

Qual Life Res. 2017-9-7

[2]
Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

JAMA Oncol. 2015-11

[3]
Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials.

J Clin Oncol. 2015-1-26

[4]
Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

J Natl Cancer Inst. 2014-9-29

[5]
Investigation of a Patient Reported Outcome tool to assess radiotherapy-related toxicity prospectively in patients with lung cancer.

Radiother Oncol. 2014-8

[6]
Incidence and dose-volume analysis of acute bladder toxicity following pelvic radiotherapy.

Tumori. 2014

[7]
Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15).

Eur J Cancer. 2014-1-11

[8]
Patient-reported neuropathy and taxane-associated symptoms in a phase 3 trial of nab-paclitaxel plus carboplatin versus solvent-based paclitaxel plus carboplatin for advanced non-small-cell lung cancer.

J Thorac Oncol. 2014-1

[9]
New frontiers in patient-reported outcomes: adverse event reporting, comparative effectiveness, and quality assessment.

Annu Rev Med. 2013-11-20

[10]
Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin.

Ann Oncol. 2013-11-19

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索