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?

Background: Accuracy and reliability of diary data collected in allergic rhinitis trials depends on how and when the information is recorded by the subjects.

Objective: To compare diary data collected by using paper (optical mark readable) and electronic [telephone, interactive voice response system (IVRS)] tools.

Methods: There was a randomized, 3-week, 3-way, crossover trial, in 87 adults with allergic rhinitis recording diary data at home. Outcome measures were (1) comparison of symptom data during weeks when both or only 1 instrument was used; (2) missing data: and (3) ease of use and participant preference.

Results: More than 40,000 symptom data elements were recorded by 72 protocol-correct subjects. Symptoms recorded during the week that both instruments were used and when the 2 instruments were used alone were indistinguishable. Overall, 0.45% of paper and 4.12% of IVRS symptom data were missing. Of 10,080 paired data 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 and 87.6% within 1 half-day of the time specified; 85% of subjects preferred the paper instrument, 4% preferred IVRS, and 11% had no preference.

Conclusions: A paper-based instrument can capture data indistinguishable from data captured from an electronic product. Processes to collect diary data should be evaluated for each study rather than simply to use the "latest" technology. Another interpretation is that frequency of recording diary data does not have a significant impact on outcomes.