Quality of Life Research

, Volume 24, Issue 7, pp 1585–1586 | Cite as

Content validity and legacy patient-reported outcome measures in cancer

  • Adam B. Smith
  • Kim Cocks


Melanoma Guidance Document Comparative Effectiveness Research Appetite Loss Label Claim 
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  1. 1.
    US Department of Health and Human Services. Guidance for industry: Patient-reported outcome measures: use in medical product development to support labeling claims. December 2009,
  2. 2.
    DeMuro, C., Clark, M., Mordin, M., Fehnel, S., Copley-Merriman, C., & Gnanasakthy, A. (2012). Reasons for rejection of patient-reported outcome label claims: A compilation based on a review of patient-reported outcome use among new molecular entities and biologic license applications, 2006–2010. Value in Health., 15, 443–448.PubMedCrossRefGoogle Scholar
  3. 3.
    Aaronson, N. K., Ahmedzai, S., Bergman, B., Bullinger, M., Cull, A., Duez, N. J., et al. (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute, 85, 365–376.PubMedCrossRefGoogle Scholar
  4. 4.
    Basch, E., Abernethy, A. P., Mullins, C. D., Reeve, B. B., Smith, M. L., Coons, S. J., et al. (2012). Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology. Journal of Clinical Oncology, 30, 4249–4255.PubMedCrossRefGoogle Scholar
  5. 5.
    Velikova, G., Booth, L., Smith, A. B., Brown, P. M., Lynch, P., Brown, J. M., & Selby, P. J. (2004). Measuring quality of life in routine oncology practice improves communication and patient well-being: A randomized controlled trial. Journal of Clinical Oncology, 22, 714–724.PubMedCrossRefGoogle Scholar
  6. 6.
    DeMuro, C., Clark, M., Doward, L., Evans, E., Mordin, M., & Gnanasakthy, A. (2013). Assessment of PRO label claims granted by the FDA as compared to the EMA (2006–2010). Value in Health, 16, 1150–1155.PubMedCrossRefGoogle Scholar
  7. 7.
    EORTC Quality of Life Group. Guidelines for developing questionnaire modules 2011. Accessed October 28, 2014,
  8. 8.
    Reeve, B.B., Mitchell, S.A., Dueck, A.C., Basch, E., Cella, D., Reilly, C.M., Minasian, L.M., Denicoff, A.M., O’Mara, A.M., Fisch, M.J., Chauhan, C., Aaronson, N.K., Coens, C., Bruner, D.W. (2014). Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. Journal of National Cancer Institute, 106(7).Google Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  1. 1.York Health Economics Consortium, Market SquareUniversity of YorkYorkUK
  2. 2.York Trials Unit, Department of Health SciencesUniversity of YorkYorkUK

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