In June 2009, a group of experts met in a Longitudinal Analysis of Patient Reported Outcomes Working group as part of the Statistical and Applied Mathematical Sciences Institute Summer Psychometric program to discuss the complex issues that arise when conceptualizing and operationalizing "change" in PRO measures and related constructs. This White Paper summarizes these issues and provides possible paths for dealing with the complexities of measuring change. It will discuss issues associated with: (1) conceptualizing and operationalizing change in PRO measures; (2) modeling change using state-of-the-art statistical methods; (3) impediments to detecting true change; (4) new developments to deal with these challenges; and (5) important gaps that are fertile ground for future research.
Swartz, Richard J.; Basch, Ethan; Cai, Li; H, P; Mcleod, Lori; Mendoza, Tito; Rapkin, Bruce; Schwartz, Carolyn; and Psychometric Program Longitudinal Assessment of Patient Reported Outcomes Working Group, The SAMSI, "The King’s Foot of Patient Reported Outcomes: Current Practices and New Developments for the Measurement of Change" (July 2010). UT MD Anderson Cancer Center Department of Biostatistics Working Paper Series. Working Paper 60.