ABSTRACT
This chapter begins with an introduction to the Comparison Study, describing the background, methodology and the patient samples at different stages of the study. It discusses the reasons why improvements in data quality and integrity with ePRO would be expected. The chapter presents evidence that ePRO did improve data quality, based on the differences between paper and ePRO data quality in the Comparison Study, which, when taken together with the experience in hundreds of other clinical trials. It shows that the ePRO pioneers clearly succeeded in delivering a technology that yields better data and a greater quantity of evaluable data. Studies of insomnia frequently use patient-reported outcomes, employ diary and questionnaire instruments, and have large numbers of data points. Furthermore, the PRO measures in such studies are important and often support claims for efficacy in market authorizations. Although the subjects completed a full battery of insomnia assessments, for the chapter analyzes data from one PRO instrument, the Morning Questionnaire (MQ).
