Current status and future perspectives of patient-reported outcome research in clinical trials for patients with breast cancer in Japan

Breast Cancer : the Journal of the Japanese Breast Cancer Society
Shozo Ohsumi, Kojiro Shimozuma

Abstract

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...Continue Reading

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Citations

Jul 15, 2015·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Hiroshi YagataKojiro Shimozuma
Jan 10, 2018·Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG·Nicola Wagner, Petra Staubach
Jan 10, 2018·Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG·Nicola Wagner, Petra Staubach
Jan 9, 2016·Asian Pacific Journal of Cancer Prevention : APJCP·Jun ZhangJin Hai Tang

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