Smartphone Application- and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: A Randomized Cross-Over Equivalence Study

Abstract

Purpose : Smartphone application-based patient-reported outcomes may be useful for early diagnosis, prompt intervention, and continuous monitoring for dry eye disease (DED). However, a comprehensive evaluation and comparison of the smartphone application- and paper-based patient-reported outcomes is warranted to assess the equivalency of the two platforms. We performed the prospective, non-blinded, randomized cross-over study to assess the equivalence between a smartphone application- and paper-based questionnaires for DED.

Methods : In this study, we recruited 34 participants aged ≥20 years between April and June 2022, at a university hospital in Japan. Patients with any missing data were excluded from the analysis. The equivalence test based on minimal clinically important difference (MCID) was used to assess the equivalence of the Japanese version of the Ocular Surface Disease Index (J-OSDI) total scores between two platforms. Equivalence was determined if the 95% confidence interval (CI) of the mean difference between total scores of the application- and paper-based J-OSDI was within the ± 7.0 range. Reliability of the application- based J-OSDI was evaluated using Cronbach’s alpha and intraclass correlation coefficients. The correlation between the application- and paper-based J-OSDIs was assessed using Pearson correlation coefficient.

Results : In total, 33 participants were included. One patient was excluded due to missing data due to poor internet connection. The application- and paper-based J-OSDI total scores were equivalent (mean difference, 1.8, 95% CI, -1.4 to 5.0). The application-based J-OSDI total score showed good internal consistency and agreement (Cronbach’s alpha coefficient = 0.958, intraclass correlation coefficient = 0.919) and was significantly correlated with the paper-based J-OSDI total score (Pearson correlation coefficient = 0.932).

Conclusions : This study demonstrated the equivalence of patient-reported outcomes between the application- and paper-based J-OSDI. Implementing the application-based J-OSDI as a tool for mobile health management of DED could have implications for the early diagnosis of DED and longitudinal patient-reported outcomes monitoring.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.