UPDATES AND INNOVATIONS IN ELECTRONIC PATIENT-REPORTED DATA CAPTURE- A REVIEW OF THE EVOLUTION AND FUTURE DIRECTIONS OF EPRO
Author(s)
Curry CPHT Corporation, Boston, MA, USA
Presentation Documents
OBJECTIVES: In clinical trials, the capture of patient-reported outcome (PRO) data has increased over the past decade. Regulatory guidelines, including the EMEA’s concern of Health-Related Quality of Life (HRQL) measurements and the FDA’s emphasis on PRO data to support labeling claims, have led to a greater inclusion of PRO as clinical trial endpoints. As sponsors include more PRO measurements, many turn to electronic PRO (ePRO) data capture. This presentation summarizes literature from the last 9 years to report changes in the use of ePRO including projections for future applications in clinical trials, disease management and health policy. METHODS: This presentation is a synthesis of literature in peer reviewed journals regarding ePRO from 2000 to 2010. Key search terms include “patient reported outcomes”, “electronic patient reported outcomes”, “electronic diaries”, “interactive voice response system”, “interactive web response system” and “digital pen”. The literature review made use of meta-databases such as PubMed and Medline. RESULTS: The use of ePRO has increased since a decade ago, due to greater movement in healthcare towards electronic solutions and to regulatory emphasis on PRO collection in clinical trials. The presentation will detail how ePRO is being used and provide a synthesis of recommendations for future ePRO use based on the literature. The session will examine the indications and therapeutic areas, population types, and applications of ePRO within healthcare and will review evidence showing whether ePRO data quality is higher than that of data captured using paper methods. CONCLUSIONS: The presentation deals with the evolving questions of ePRO – projected limitations and actual scope of experience with ePRO. Due to literature emphasis, the presentation will focus on clinical trials but will also examine other healthcare fields such as disease management and health policy. Attendees will learn about the evolution of ePRO and forthcoming directions and receive a bibliography of current literature.
Conference/Value in Health Info
2010-11, ISPOR Europe 2010, Prague, Czech Republic
Value in Health, Vol. 13, No. 7 (November 2010)
Code
PMC48
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Multiple Diseases