R&D-OTHER R & D-A RES/EXPL DEV

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• 批准号: 8125388
• 负责人: ETHAN M. BASCH
• 金额: $ 86.22万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-30 至 2012-07-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8125388
• 关键词: Adverse event; Age; Awareness; Cancer Patient; Clinical; Clinical Trials; Common Terminology Criteria for Adverse Events; Complement; Comprehension; Confidentiality; Contractor; Data; Data Collection; Data Reporting; Educational Materials; Electronics; Elements; Frequencies; Health Personnel; Health Status; Language; Length; Monitor; Nurses; Outcome Measure; Paper; Patient Care; Patient Outcomes Assessments; Patients; Physicians; Reporting; Security; Sensitivity and Specificity; Severities; Sex Characteristics; Solutions; Surveys; Symptoms; System; Training; Translations; Validity and Reliability; base; health related quality of life; improved; instrument; interoperability; meetings; response; software systems; tool; user-friendly

The Contractor shall develop the Patient-Reported Outcomes version of symptom elements that are contained within the Common Terminology Criteria for Adverse Events (PRO-CTCAE). This system will collect cancer patients' responses to questions about their health status, symptoms, functioning and health-related quality of life and integrate this information within the NCI adverse event reporting system. The Contractor shall produce a detailed document that identifies barriers, ideal conditions, and solutions to implement the PRO-CTCAE, develop the PRO-CTCAE assessment software system fully integrated with the CTCAE, conduct studies to evaluate the validity, reliability, feasibility and clinical utility of the new PRO-CTCAE, and create Training and Educational Materials to Support the PRO-CTCAE.

承包商应开发包含以下症状要素的患者报告结果版本 不良事件通用术语标准 (PRO-CTCAE) 内。该系统将收集癌症患者的 回答有关其健康状况、症状、功能和健康相关生活质量的问题，并整合 NCI 不良事件报告系统中的此信息。 承包商应制作一份详细的文件，确定障碍、理想条件以及实施的解决方案 PRO-CTCAE，开发与CTCAE完全集成的PRO-CTCAE评估软件系统，进行 研究评估新 PRO-CTCAE 的有效性、可靠性、可行性和临床实用性，并创建培训 支持 PRO-CTCAE 的教育材料。