TAS::75 0849::TAS - PATIENT REPORTED OUTCOMES VERSION OF THE COMMON TERMINOLOGY

TAS::75 0849::TAS - 通用术语的患者报告结果版本

• 批准号: 8165963
• 负责人: ETHAN M. BASCH
• 金额: $ 153.78万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8165963
• 关键词: TAS; 75; 0849; PATIENT; REPORTED

The standard lexicon for reporting adverse events in National Cancer Institute (NCI) sponsored clinical trials is the Common Terminology Criteria for Adverse Events (CTCAE), which consists of 790 individual items. Historically, adverse events have been reported by clinicians. However, multiple studies have found that clinicians tend to underreport symptom severity and onset compared with patient self-reports. In 2008, the NCI contracted a multi-institution consortium to develop a patient-reported outcome (PRO) counterpart instrument to complement to the CTCAE. This system, called PRO-CTCAE provides a web-based platform to collect patient reports of symptoms they are experiencing during treatment for the purpose of enhancing adverse event (AE) reporting. The overall goal of the PRO-CTCAE initiative is to employ rigorous scientific methods to create a system for patient self-reporting of adverse symptoms in cancer trials that is widely accepted, generates useful data for investigators, regulators, clinicians and patients; and is compatible with existing systems for reporting adverse events. 81 symptoms were identified in the CTCAE to be amenable to patient reporting; the measured attributes for each symptom include frequency, severity, and activity interference. Questions and response options were standardized, along with plain language terms for each symptom. A web-based platform was developed and tested for administering the PRO-CTCAE items. The prototype has undergone undergoing testing to assess usability, logistical feasibility, and validity in a variety of cancer care settings. The PRO-CTCAE system has the potential to enhance adverse event reporting by integrating patient experiences and can foster consistency of data collection methods across studies.

国家癌症研究所（NCI）赞助的临床试验中报告不良事件的标准词典是不良事件的常见术语标准（CTCAE），该标准由790个单独的项目组成。从历史上看，临床医生已经报道了不良事件。然而，多项研究发现，与患者自我报告相比，临床医生往往会低估症状的严重程度和发作。 2008年，NCI签订了一个多机构财团，以开发患者报告的结果（PRO）对应作用，以补充CTCAE。该系统称为Pro-CTCAE提供了一个基于Web的平台，以收集患者在治疗过程中经历的症状报告，以增强不良事件（AE）报告。 Pro-CTCAE计划的总体目标是采用严格的科学方法来创建一种系统，以在癌症试验中自我报告的患者自我报告，该系统被广泛接受，为研究人员，调节者，临床医生和患者生成了有用的数据；并且与现有的用于报告不良事件的系统兼容。在CTCAE中发现了81个症状，可与患者报告相应；每种症状的测量属性包括频率，严重性和活动干扰。问题和响应选项是标准化的，以及每种症状的简单语言术语。开发并测试了一个基于Web的平台，用于管理Pro-CTCAE项目。该原型已经进行了测试，以评估各种癌症护理环境中的可用性，后勤可行性和有效性。 Pro-CTCAE系统有可能通过整合患者体验来增强不良事件报告，并可以促进跨研究的数据收集方法的一致性。