Patient-reported outcome (PRO) Andrew Lloyd, DPhil
measures in MS clinical trials of disease-modifying treatment are not evidence-based or
“underpinned by structured systematic approaches,” according to findings published in
Multiple Sclerosis and Related Disorders. Andrew Lloyd, DPhil, and colleagues assessed publications
that mentioned the use of a PRO measure. None of the 36 clinical trials that mentioned the use of
PRO measures (21 protocols and 15 primary publications) described clear PRO or clinical out- come
assessment (COA) strategies, gave clear justifications for PRO choices, or reasons why certain
PRO measures were used when alternatives were available. “This represents a critical area for study
design improvement, as PRO measure results directly affect patient care, PRO measurement has
conceptual and contextual complexities, and there is a wide range of options when selecting a PRO
measure,” Dr. Lloyd and colleagues wrote. “We recommend trial designers use formal approaches for
PRO measure selection to ensure PRO measurement-based decisions are optimized.”
