Objective: To evaluate the validity, in terms of the patients' acceptance, preference, feasibility and reliability of an innovative, interactive computerized system for collection of patient-reported outcome (PRO) data on axial SpA against the paper-and-pencil version.
Methods: Fifty-five patients with axial SpA completed both the touch screen and the paper-and-pencil set of questionnaires. A computerized touch-screen system, SPEAMonitor, was developed to capture PRO data. Variables recorded included demographic data, patient's assessment of general health status, BASDAI, BASFI, BASMI and acute-phase reactant levels. In order to assess the patient's acceptance of, preference for and feasibility of computer-based questionnaires, the participants filled in an additional questionnaire. The time taken to complete both formats was measured. In a further test-retest study, 25 patients were re-evaluated.
Results: The agreement between the paper-administered and computer touch-screen format of the BASFI, BASDAI questionnaires and the Ankylosing Spondylitis Disease Activity Scores was excellent. Intraclass correlation coefficients (ICCs) between data ranged from 0.90 to 0.96. Additionally the test-retest study showed a very good agreement between the scores for the two administrations (ICC ≥ 0.90). Age, computer experience and education level had no significant impact on the results. The computerized questionnaires were reported to be easier to use. The mean time spent completing the questionnaires on a touch screen was 5.1 min and on paper 7.9 min.
Conclusion: Our newly developed computer-assisted touch-screen questionnaires for PRO in axial SpA were well accepted by patients, with good data quality, reliability and score agreement.
Keywords: SPEAMonitor; axial spondyloarthritis; electronic data capture; patient-reported outcomes; self-administered questionnaires; touch screen.