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Anne Marie Salapatek, Holly Irene Lorentz, Stephanie Recker, Fiona Soong; A Novel Validated Electronic Patient Data Acquisition Tablet (ePDAT) Facilitates and Standardizes Patient Reported Outcomes (PRO) in patients with Dry Eye Syndrome (DE) studied in Environmental Exposure Chamber (EEC) and Field Trials.. Invest. Ophthalmol. Vis. Sci. 2014;55(13):2011.
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PRO data is traditionally collected by paper or computer-based systems during clinical trials, but these options are not ideal for EEC studies with staggered patient entrance and field studies with at-home PRO. The ePDAT is a validated, 21 CFR, Part 11 compliant tool to collect and securely transmit PRO in real-time using either WiFi or cellular networks. The utility of ePDAT for PRO capture was examined in a dry eye EEC study.
8 subjects with DE and 8 without DE (NDE) were exposed to a low humidity EEC for 180min. They were asked to score on six ocular symptoms presented individually on a scale of 0 to 4 at time 0, 10, 20, 30, 60, 90, 120, 150, and 180min (±2min) on ePDAT. After exiting the EEC, subjects remained in the clinic for an additional 60 min and continued to record symptoms at 10, 20, 30 and 60min (±2min) post exit on ePDAT.
The utility of the ePDAT system ie: 1) the length of time required to answer and 2) question set and ePDAT tool acceptability were analyzed. All participants responded within the 4 mins allotted at each timepoint. On average, subjects took 8.10±0.54s to respond to single questions and 48.23±3.05s to respond to a question set. Of the over 1200 data points, 95.12% of them were collected within 30s of a question being presented. After 2 and 4min, 98.94% and 100.00% of the subject’s answers were collected respectively. Significant differences in answering time were found between the DE and NDE groups, with the DE group taking 2x longer record their responses (p<0.0001), and between subjects <40 and ≥ 40 yrs of age (p<0.0001) with the older age group taking 1.7x longer to respond. Significant differences in TOSS were found between DE and NDE participants and between pre-EEC and EEC conditions, p<0.05.
Subjects responded to all questions with ease and full completion. The ePDAT collected PRO data securely with transfer in real-time to a secure server. ePDATs standardized timed question format can be used to measure reading acuity dynamically in DE subjects and in drug onset of action. ePDAT eliminates human error in transcription and improves patient compliance.
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