ABSTRACT
Patient-reported outcomes (PROs) are important assessment tools increasingly used in clinical trials to allow information about such outcomes as symptoms, health-related quality of life (HRQL), and treatment satisfaction to be collected directly from the patient. The rise in the use of PRO measures has occurred because some treatment effects are known only to patients, their perspective is unique, and important information may not be measured if only clinician or biological assessments are made (Kerr et al., 2010). Rigor in the development of the content of aPRO is essential to ensure that the concept of interest is measured accurately, to capture issues of most relevanceto the patient, and to subscribe to alanguage that allows patients to understand and respond without confusion. Items within a questionnaire with little relevance to the patient population being investigated, or if poorly written, will lead to measurement error and bias.
