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Recent topics of health outcomes research in oncology

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Abstract

This article reviews recent topics in health outcomes research. First, we discuss the concept and importance of ‘subjective’ assessment of quality of life (QOL), and introduce new guidance, by the respective medical product regulatory authorities in Europe and the United States, for labeling claims of medical products that are assessed for outcomes related to QOL. Second, we address the application of item response theory (IRT) in developing and assessing QOL measures to compensate for several drawbacks of the classical psychometric approach, which has been commonly used to verify the reliability and validity of QOL instruments. Third, the relevance and determination of the minimally clinically important difference (MID) of QOL scores is discussed. Finally, we address the so-called ‘response shift’ which may affect the reliability of analysis results of QOL scores in longitudinal studies such as randomized clinical trials.

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Abbreviations

QOL:

Quality of life

HRQOL:

Health-related quality of life

PRO:

Patient-reported outcomes

IRT:

Item response theory

CAT:

Computer adaptive testing

MID:

Minimally important difference

EBM:

Evidence-based medicine

ES:

Effect size

SD:

Standard deviation

SEM:

Standard error of measurement

RS:

Response shift

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Author information

Authors and Affiliations

  1. Department of Healthcare and Social Services, University of Marketing and Distribution Sciences, Japan

    Kojiro Shimozuma

  2. Institute for Stress Science, Public Health Research Foundation, Japan

    Kojiro Shimozuma

  3. Department of Epidemiology, National Institute of Public Health, Japan

    Hirohisa Imai

  4. Division of Surgery/Breast Oncology, Nyuwakai Oikawa Hospital, Japan

    Katsumasa Kuroi

  5. Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Japan

    Shozo Ohsumi

  6. Department of Health Science and Social Welfare, School of Human Sciences, Waseda University, Japan

    Michikazu Ono

Authors
  1. Kojiro Shimozuma
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  2. Hirohisa Imai
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  3. Katsumasa Kuroi
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  4. Shozo Ohsumi
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  5. Michikazu Ono
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Corresponding author

Correspondence to Kojiro Shimozuma.

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Shimozuma, K., Imai, H., Kuroi, K. et al. Recent topics of health outcomes research in oncology. Breast Cancer 14, 60–65 (2007). https://doi.org/10.2325/jbcs.14.60

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  • DOI: https://doi.org/10.2325/jbcs.14.60

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