Assuring the Patient Centeredness of Patient-Reported Outcomes: Content Validity in Medical Product Development and Comparative Effectiveness Research

摘要

Not all patient-reported outcomes (PROs) are patient centered, and not all patient-centered outcomes are patient reported.The essential characteristic of a patient-centered approach to outcome measurement is that it assesses concepts (i.e., health-related phenomena) that are considered most important by members of a given target population, based on direct input from representatives of that population. Concepts for measurement should not be selected based solely on convenience or interest to investigators. Patient-centered patient-reported outcome measures must meet this criterion and also be meaningful and comprehensible to members of a population when administered, including among those with diverse racial/cultural backgrounds and lower educational/literacy levels.