By Jane Carter, Program Manager, CRF Health
While providing site training at an Investigator Meeting recently, I came across some interesting comments from sites that were not familiar with using eDiaries or tablets to capture PRO or ClinRO data. One study coordinator was concerned about using eDiaries with certain populations, and was wondering if we were going to provide paper checklists or backup questionnaires on paper for subjects who were not comfortable using eDiaries. This comment brought me back to the realization that while I have been working with ePRO for over six years, there are some people who still are not familiar with the technology or the risks inherent in mixing modalities of PRO collection. I thought I would speak to some of these items, in hopes of providing a basic understanding of ePRO and some items to consider.
When choosing to collect Patient Reported Outcomes for a clinical trial, particularly for a primary or secondary endpoint, it is important to ensure the quality of the data being collected. Most of us have heard of or experienced firsthand the “parking lot syndrome”, where patients fill in dosing diary cards or other PRO questionnaires in the parking lot immediately before going in for an office visit. This is one of the main reasons sponsors choose ePRO over paper – ePRO technology allows for entry “windows” to ensure the data is being captured in a timely manner, and is not subject to the failings of memory recall. I’m lucky I can remember what I had for breakfast yesterday, let alone how I felt or at what time I took medicine!