Patients, providers, payers, and regulators increasingly demand evidence that new health care interventions make a real difference to people’s lives. Patient-reported outcome (PRO) data are critical for demonstrating the impact of interventions on how a patient feels and functions.
Patient-reported outcomes (e.g., fatigue, pain, physical functioning, social functioning) can provide great value to research but can present significant challenges. This course provides students with the knowledge necessary to incorporate PROs into clinical research. Students will learn the different types and suitability of measures, methods for developing new measures, and best practices for collecting and analyzing PROs in clinical trials. The course will include a friendly introduction to the technical aspects of Classical Test Theory and Item Response Theory for the evaluation of the psychometric properties of a PRO measure. This course incorporates recommendations from the FDA and other regulatory bodies in the design and application of PRO measures in clinical research.