Current status and future perspectives of patient-reported outcome research in clinical trials for patients with breast cancer in Japan.
Current status and future perspectives of patient-reported outcome research in clinical trials for patients with breast cancer in Japan.
复制标题
日本乳腺癌患者临床试验中患者报告结果研究的现状和未来前景。
DOI：
10.1007/s12282-012-0368-8
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发表时间：
2013
期刊：
影响因子：
4
通讯作者：
Shimozuma K
中科院分区：
文献类型：
--
作者：
Ohsumi S;Shimozuma K
医疗服务提供者的目的是帮助患者恢复健康和/或保持或增加他们的幸福感。医疗质量可以通过生存率等指标进行客观评估，但主观评估有时比客观评估更重要，因为患者是否感到健康或快乐是他们最关心的问题。生活质量（QOL）研究是一种典型的主观健康评价方法。使用自我管理的健康相关QOL（HRQOL）问卷获得患者报告结局（PRO）数据。PRO由美国食品和药物管理局（FDA）定义为直接来自患者的患者健康状况状态的任何报告，而无需临床医生或其他任何人解释患者的反应。在评估患者症状和HRQOL方面，PRO数据被认为比临床医生评定的数据更准确。公共卫生研究基金会的健康结果研究综合支持项目与肿瘤研究综合支持项目合作开展了许多PRO研究，特别是在随机对照试验（RCT）中。在这里，我们回顾了在日本进行的随机对照试验中的PRO研究结果，并探讨了该领域的未来前景。
The aim of healthcare providers is to help patients regain their health and/or maintain or increase their happiness. The quality of healthcare can be assessed objectively by using indices such as survival rates, but subjective assessment is sometimes more important than objective evaluation, because whether patients feel healthy or happy or not is their major concern. Quality of life (QOL) research is a typical approach to subjective assessment of health. Self-administered health-related QOL (HRQOL) questionnaires are used to obtain patient-reported outcome (PRO) data. PRO is defined by the US Food and Drug Administration (FDA) as any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. PRO data are regarded as more accurate than clinician-rated ones in terms of assessing patients’ symptoms and HRQOL. The Comprehensive Support Project for Health Outcome Research of the Public Health Research Foundation has conducted much PRO research in collaboration with the Comprehensive Support Project for Oncology Research, especially in randomized controlled trials (RCTs). Here, we review the results of PRO research in RCTs conducted in Japan and examine future perspectives in this field.