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Measurement of Patient-Reported Outcomes of Health Services

  • Joseph C. CappelleriEmail author
  • Andrew G. Bushmakin
Reference work entry
Part of the Health Services Research book series (HEALTHSR)

Abstract

A patient-reported outcome (PRO) is any report on the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else. The measurement of PROs should address key protocol elements that include the rationale for the specific aspect of PRO being measured, explicit research objectives and endpoints, strategies for minimizing the exclusion of subjects from the study, rationale for timing of assessments and off-study rules, rationale for instruction selection, details for administration of PRO assessments to minimize bias and missing data, sample size estimation, and analytic plan. Another key element involves the measurement properties of a PRO. These protocol elements are central to this chapter as they relate to the design and measurement of PROs. These elements are discussed and framed within the five characteristics that tend to be associated with PROs: missing and incomplete data, psychometric validation, interpretation, multiple testing, and longitudinal analysis. Special consideration is given for developing a PRO measurement strategy in a regulatory context where the intent is to have a labeling claim on a PRO.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  1. 1.Global Product DevelopmentPfizer IncGrotonUSA

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