Overview of classical test theory and item response theory for the quantitative assessment of items in developing patient-reported outcomes measures
JC Cappelleri, JJ Lundy, RD Hays�- Clinical therapeutics, 2014 - Elsevier
Abstract Background The US Food and Drug Administration's guidance for industry
document on patient-reported outcomes (PRO) defines content validity as “the extent to
which the instrument measures the concept of interest”(FDA, 2009, p. 12). According to
Strauss and Smith (2009), construct validity" is now generally viewed as a unifying form of
validity for psychological measurements, subsuming both content and criterion validity”(p. 7).
Hence, both qualitative and quantitative information are essential in evaluating the validity of�…
document on patient-reported outcomes (PRO) defines content validity as “the extent to
which the instrument measures the concept of interest”(FDA, 2009, p. 12). According to
Strauss and Smith (2009), construct validity" is now generally viewed as a unifying form of
validity for psychological measurements, subsuming both content and criterion validity”(p. 7).
Hence, both qualitative and quantitative information are essential in evaluating the validity of�…