Summary
Highlights
Danny, an experienced data manager, describes his relief as clinical research transitions from paper-based Case Report Forms (CRFs) to electronic CRFs. This shift dramatically improved data cleanliness, reduced queries, and accelerated database locking for studies.
Despite advancements in CRFs, Danny's current challenge lies with Patient Reported Outcomes (PROs). Data from patients, including quality of life questionnaires and diaries, are increasingly vital but often suffer from low quality due to issues like poor handwriting, forgotten entries, and incorrect data input, sometimes leading to doubts about data integrity.
For his newest study, Danny had the opportunity to use an Electronic Patient Reported Outcome (ePRO) system. Initially skeptical, especially given the age range of participants (50-70 years old), he was pleasantly surprised by the results.
Danny found that ePRO significantly increased patient compliance. Features like audit trails, consistent data entry, and automated reminders via emails or messages eliminated issues like the 'parking lot phenomenon.' Elderly patients also appreciated the ability to enlarge text on their smartphones, making data entry easier. This eliminated problems related to poor handwriting, making Danny's job much easier.
The ePRO system proved to be cost-effective, not costing more than paper questionnaires. While 95% of patients used their own smartphones, the remaining 5% were provided with devices at a minimal cost compared to the expenses of paper data handling. Danny's belief in PRO is restored, recognizing ePRO's ability to ensure data quality and integrity, leading to less stress, better transparency, higher patient compliance, and lower study costs.