Quality of Life Research

, Volume 23, Issue 8, pp 2405–2406 | Cite as

Cappelleri JC, Zou KH, Bushmakin AG, Alvir JMJ, Alemayehu D, Symonds T: Patient-reported outcomes, measurement, implementation and interpretation

CRC Press, Boca Raton, 2014 (Hardback), ISBN: 978-1-4398-7367-0
  • Adam B. Smith
Book Review

The recent book, Patient-Reported Outcomes, Measurement, Implementation and Interpretation, by Cappelleri and his colleagues [1] is a timely synthesis of the current thinking and practice of psychometrics applied to patient-reported outcomes (PROs), and PRO data analysis. Written primarily by statisticians drawn from the same large multinational pharmaceutical company, the book is squarely aimed at health economists, outcomes researchers and statisticians in the industry who may require a foundation in psychometrics and the analysis of PRO data. That said it may also be of benefit and utility to advanced researchers in academia and consultancy wanting to increase their knowledge in this field.

The publication of the European Medicines Agency’s (EMA) Reflection paper [2] and that, in particular, of the US Food & Drug Administration’s Guidance for Industry [3] marked a sea change in the regulatory approach to the use of PRO in the drug development process. It is no longer sufficient...


  1. 1.
    Cappelleri, J. C., Zou, K. H., Bushmakin, A. G., Alvir, J. M. J., Alemayehu, D., & Symonds, T. (2014). Patient-reported outcomes: Measurement, implementation and interpretation. Boca Raton: CRC Press.Google Scholar
  2. 2.
    Committee for Medicinal Products for Human Use (CHMP) (2005). Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products.
  3. 3.
    Food and Drug Administration (FDA) (2009). Guidance for industry on patient–reported outcome measures: Use in medical product development to support labelling claims.
  4. 4.
    Patrick, D. L., Burke, L. B., Gwaltney, C. J., et al. (2011). Content validity—Establishing and reporting the evidence in newly-developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: Part 1—Eliciting concepts for a new PRO instrument. Value Health, 14, 967–977.PubMedCrossRefGoogle Scholar
  5. 5.
    Reeve, R. B., Wyrwich, K. W., Wu, A. W., Velikova, G., Terwee, C. B., Snyder, C. F., et al. (2013). ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res, 22(8), 1889–1905.CrossRefGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  1. 1.YorkUK

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