Site Based ePRO

Electronic patient reported outcomes (ePRO) are collected on a frequent basis in the context of the patient's daily life, or when the patient visits a clinic for a healthcare or clinical trial appointment. This paper discusses the second type of ePRO, site-based assessments, and the considerations for successfully collecting patient data at the site.

The use of ePRO reduces or eliminates missing and inconsistent data, thus improving data quality and integrity. Data management is simplified, as editing and manual data entry are eliminated. Data security and privacy issues are readily managed with modern network and data encryption methods. In many cases the cost of implementing ePRO is less than the cost of paper. In other cases, it represents only a modest increase in study costs given the gains in efficiency and data quality.

A variety of platforms have been used for ePRO, including conventional computers, computers with touchscreens, tablet PCs and personal digital assistants (PDAs), with screen sizes ranging from 3.5 to 12 inches or more.

Patients generally find ePRO easy to use, and often prefer it to paper. This is equally true of the elderly, those unfamiliar with computers, and those with special use needs, such as Parkinson’s patients. Thoughtful evaluation of applications and the flexibility of design makes ePRO possible for anyone.

A large body of data supports the validity of ePRO and the equivalence of ePRO versions of questionnaires to paper originals. In particular the use of small screens, requiring presentation of single items per screen, does not have any significant impact on data provided that all important information is available on a single screen. This may put a lower bound on screen size in some cases, though many questionnaires have been successfully implemented on a 3.5" screen. This validity data influences the design and implementation choices for both everyday life and site-based assessments.