Electronic Implementation of Patient-Reported Outcomes: Challenges and Potential Solutions
Author(s)
Cassanelli F1, Ferri F2, Ori A2, Simoni L2
1MediNeos Observational Research - IQVIA, Modena, MO, Italy, 2MediNeos Observational Research - IQVIA, Modena, Italy
Presentation Documents
OBJECTIVES: As a consequence of recent advances in information technology and wider availability of personal portable devices, the use of electronic Patient-Reported Outcomes (ePROs) in clinical research is constantly growing. Although ePROs have several advantages (such as limited data entry errors and ease of remote compilation), their employment poses new challenges both when reproducing paper-based PROs onto electronic platforms, and when it is necessary to transfer an already available ePRO from the original implementation platform to a different data collection system. The aim of this work is to report challenges and solutions when implementing ePROs.
METHODS: We implemented 11 different ePROs during 2021-2022. We collected information about whether the ePRO was already available, whether implementation guidelines were available, time for development and revision by ePRO providers.
RESULTS: Two ePROs were already available in electronic format and were migrated from the original implementation platform, 4 had electronic implementation guidelines, and 8 were adopted in several languages. Development time, including the time to discuss alternative implementations with ePRO provider, was on average 20 days, ranging from 2 to 80 days. Longer periods (60-80 days) were necessary for those ePROs that had to be moved to a different electronic platform. Final revision by providers was required in 5 cases, taking 3 days for 2 ePROs and 30 to 60 days in 3 cases. On average 5 days were necessary for each language review, increasing to 9 days in case usability testing was required too.
CONCLUSIONS: ePROs employment in clinical research is becoming more and more widespread. Understanding provider requirements and platform limitations is crucial to plan adequate time for discussion, development, revision, and approval. Being aware of the potential implementation challenges is of paramount importance to ensure data quality and availability of data collections tools in a timely manner.
Conference/Value in Health Info
Value in Health, Volume 25, Issue 12S (December 2022)
Code
RWD70
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation, Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas