ABSTRACT
As with other PROs, the development of screeners, expectation, goal assessment, and satisfaction questionnaires must be done scientifically following recommended development guidelines and must have been psychometrically validated to ensure that results are accurate ( 1-3 ). The development process steps-from conceptual design through cognitive debriefings, psychometric, and linguistic validation-are described in detail in chapter 12 (Coyne and Sexton). Prior to using a PRO in clinical trials or clinical practice, it is important to verify the validity of multiple aspects of the tool, including the way in which it was developed, administration (paper or electronically), the population in which it is to be used (elderly, surgical, etc.), and the usage setting (clinical practice vs. research). Prior to using PROs in multilingual environments, the tool should be linguistically validated instead of merely translated.
