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.

在国家癌症研究所（NCI）赞助的临床试验中报告不良事件的标准词汇是不良事件通用术语标准（CTCAE），它由790个单独的项目组成。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，临床医生倾向于少报症状严重程度和发病情况。2008年，NCI与一个多机构联盟签订合同，开发一种患者报告结果（PRO）对应工具，以补充CTCAE。这个名为PRO-CTCAE的系统提供了一个基于网络的平台，用于收集患者在治疗期间所经历的症状报告，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，创建一个被广泛接受的癌症试验中患者自我报告不良症状的系统，为研究人员、监管机构、临床医生和患者提供有用的数据；并且与报告不良事件的现有系统兼容。在CTCAE中确定了81种症状，可由患者报告；每个症状的测量属性包括频率、严重程度和活动干扰。问题和回答选项是标准化的，以及每个症状的简单语言术语。开发并测试了基于网络的PRO-CTCAE项目管理平台。该原型已经过测试，以评估其在各种癌症护理环境中的可用性、后勤可行性和有效性。PRO-CTCAE系统有潜力通过整合患者经验来加强不良事件报告，并可以促进跨研究数据收集方法的一致性。