Patient-Reported Outcomes in Rheumatoid Arthritis Assessing the Equivalence of Electronic and Paper Data Collection

Background: The questionnaires used in clinical research have often been developed and validated using paper, and in such cases it is necessary to show that the electronic versions are equivalent to the originals. Objective: To determine if electronic versions of questionnaires assessing severity and impact of rheumatoid arthritis (RA) are equivalent to the original paper versions. Methods: Patients (n - 43; 31 female) aged 32-83 years (25 aged <60 years) took part in a single session during which they completed paper and electronic assessments in randomized order, with an interval of 45 minutes between the two modes. Electronic assessments were set up on a Palm TX handheld device. Assessments included measures of pain, fatigue, disability, and health status. Results: Scores were similar between the two modes. All effect sizes for electronic-paper differences were <0.2, and there was no overall tendency for one mode to show higher scores than the other. Intraclass correlation coefficients (ICCs) ranged from 0.72 to 0.96, and were generally similar to reported retest reliabilities of the scales in their paper versions. The Disability Index of the Health Assessment Questionnaire (HAQ-DI) showed an ICC of 0.96. ICCs for the EQ-5D health status scale were utility: 0.79; profile: 0.91; visual analog scale: 0.75. Most patients reported that both modes were easy to use. In general, patients preferred the electronic version over the paper, and this was true for the older as well as the younger patients. Conclusions: Electronic versions of questionnaires assessing severity and impact of RA provide data that correspond closely to those of paper originals, are easy to use, and are acceptable to patients.