Attendees will obtain a working knowledge of methods for RWE outcome validation as well as for developing health measurements, drawing from the paradigm of clinical outcome assessments (COAs).

Dr. Ritchey will introduce the importance of rigorous development and validation of outcome measurements in studies using RWE (15 min.). Ms. Norquist will discuss traditional approaches to developing health measurements, including COAs beginning with identifying relevant and feasible concept of interest and derivation of measures relevant to patients, and she will review what constitutes good measurement properties and interpretation for COAs that are meaningful to patients (15 min.). Dr. Girman will propose steps for development and justification to support use of outcomes that are fit-for-purpose for specific RWE study objectives (15 min).