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: 8338732
• 负责人: ETHAN M. BASCH
• 金额: $ 176.98万
• 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/8338732
• 关键词: Adverse event; Cancer Patient; Clinical Trials; Clinical Trials Network; Common Terminology Criteria for Adverse Events; Complement; Contracts; Data; Data Collection; Development; Dose; Drug Labeling; Event; Feasibility Studies; Fostering; Frequencies; Goals; Home environment; Individual; Institution; Internet; Language; Malignant Neoplasms; Measures; Methods; Modeling; National Cancer Institute; Online Systems; Patient Outcomes Assessments; Patient Self-Report; Patients; Quality of life; Reporting; Research Personnel; Schedule; Severities; Symptoms; System; Terminology; Testing; Time; Translations; Voice; Work; cancer care; compliance behavior; cost; drug efficacy; experience; instrument; prototype; response; satisfaction; usability

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.

美国国家癌症研究所（NCI）申办的临床试验中报告不良事件的标准词汇是不良事件通用术语标准（CTCAE），由790个单项组成。历史上，临床医生曾报告过不良事件。然而，多项研究发现，与患者自我报告相比，临床医生倾向于低估症状的严重程度和发作。2008年，NCI与一个多机构联盟签订合同，开发患者报告结局（PRO）对应工具，以补充CTCAE。该系统（称为PRO-CTCAE）提供了一个基于网络的平台，用于收集患者在治疗期间出现的症状报告，以加强不良事件（AE）报告。PRO-CTCAE计划的总体目标是采用严格的科学方法创建一个癌症试验中患者自我报告不良症状的系统，该系统被广泛接受，为研究者、监管机构、临床医生和患者生成有用的数据;并与现有的不良事件报告系统兼容。在CTCAE中确定了81种症状可供患者报告;每种症状的测量属性包括频率、严重程度和活动干扰。问题和回答选项被标准化，沿着每个症状的简单语言术语。开发并测试了一个基于网络的平台，用于管理PRO-CTCAE项目。原型已经过测试，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经验来增强不良事件报告，并可促进研究间数据收集方法的一致性。