Quality of patient reported outcome data captured using paper and interactive voice response diaries in an allergic rhinitis study; is electronic data capture really better?

Abstract

Rationale Accuracy and reliability of data collected in allergic rhinitis trials depend on how and when information is recorded by subjects. Methods This was a randomized, 3-week, 3-way, cross-over trial, in 87 adults with allergic rhinitis recording diary data at home, comparing paper (optical mark readable) and electronic (telephone, interactive voice response system, IVRS) tools for: 1) Symptoms recorded during weeks when both or only one instrument was used; 2) Missing data; 3) Ease of use and participant preference. Results Over 40,000 symptoms were recorded by 72 protocol correct subjects. Symptoms recorded during the week that both instruments were used (95% CI difference: −0.13 to 0.22 and −0.13 to 0.18 for morning and evening, respectively) and when the two instruments were used alone (95% CI of difference: −1.05 to 1.60 and −1.45 to 1.32 for morning and evening, respectively) were indistinguishable. 0.45% of paper and 4.12% of IVRS symptoms were missing. Of 10,080 paired symptoms collected on paper and IVRS diaries during the week in which subjects used both, 94.44% were identical. Using IVRS, 63.2% of protocol correct data were entered within the designated time. 85% of subjects preferred the paper instrument, 4% preferred IVRS and 11% had no preference. Conclusions A paper based diary instrument can capture data statistically indistinguishable from data captured by using an electronic product. One other interpretation of these data could be that that the frequency of recording symptoms (twice daily, daily, or weekly) might not have an impact on the outcome of studies to examine treatments of allergic rhinitis.