Cappelleri JC, Zou KH, Bushmakin AG, Alvir JMJ, Alemayehu D, Symonds T: Patient-reported outcomes, measurement, implementation and interpretation
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The recent book, Patient-Reported Outcomes, Measurement, Implementation and Interpretation, by Cappelleri and his colleagues  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  and that, in particular, of the US Food & Drug Administration’s Guidance for Industry  marked a sea change in the regulatory approach to the use of PRO in the drug development process. It is no longer sufficient...
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