This book is organized as one volume with interconnected chapters, with each chapter devoted to the methodology of assessments of specific measurement properties of clinical outcome assessments (COAs), which include patientreported outcomes (PRO), clinician-reported outcomes (ClinRO), observerreported outcomes (ObsRO), and performance outcome assessments (PerfO). In covering the topics, we made a considerable effort to illustrate the methodology with an extensive number of simulated examples, motivated by and grounded in our experience with practical applications, covering all key topics of the quantitative validation of a COA scale. All simulations are conducted in SAS, the primary software used in the pharmaceutical industry.
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