%0 Journal Article
%@ 1438-8871
%I JMIR Publications
%V 25
%N 
%P e42638
%T Smartphone App–Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study
%A Nagino,Ken
%A Okumura,Yuichi
%A Akasaki,Yasutsugu
%A Fujio,Kenta
%A Huang,Tianxiang
%A Sung,Jaemyoung
%A Midorikawa-Inomata,Akie
%A Fujimoto,Keiichi
%A Eguchi,Atsuko
%A Hurramhon,Shokirova
%A Yee,Alan
%A Miura,Maria
%A Ohno,Mizu
%A Hirosawa,Kunihiko
%A Morooka,Yuki
%A Murakami,Akira
%A Kobayashi,Hiroyuki
%A Inomata,Takenori
%+ Department of Ophthalmology, Juntendo University Graduate School of Medicine, 2-1-1 Hongo, Bunkyo-ku, Tokyo, 1130033, Japan, 81 338133111, tinoma@juntendo.ac.jp
%K dry eye syndrome
%K mobile app
%K equivalence trial
%K Ocular Surface Disease Index
%K patient-reported outcome measures
%K mobile health
%K reliability
%K validity
%K telemedicine
%K precision medicine
%D 2023
%7 3.8.2023
%9 Original Paper
%J J Med Internet Res
%G English
%X Background: Using traditional patient-reported outcomes (PROs), such as paper-based questionnaires, is cumbersome in the era of web-based medical consultation and telemedicine. Electronic PROs may reduce the burden on patients if implemented widely. Considering promising reports of DryEyeRhythm, our in-house mHealth smartphone app for investigating dry eye disease (DED) and the electronic and paper-based Ocular Surface Disease Index (OSDI) should be evaluated and compared to determine their equivalency. Objective: The purpose of this study is to assess the equivalence between smartphone app–based and paper-based questionnaires for DED. Methods: This prospective, nonblinded, randomized crossover study enrolled 34 participants between April 2022 and June 2022 at a university hospital in Japan. The participants were allocated randomly into 2 groups in a 1:1 ratio. The paper-app group initially responded to the paper-based Japanese version of the OSDI (J-OSDI), followed by the app-based J-OSDI. The app-paper group responded to similar questionnaires but in reverse order. We performed an equivalence test based on minimal clinically important differences to assess the equivalence of the J-OSDI total scores between the 2 platforms (paper-based vs app-based). A 95% CI of the mean difference between the J-OSDI total scores within the ±7.0 range between the 2 platforms indicated equivalence. The internal consistency and agreement of the app-based J-OSDI were assessed with Cronbach α coefficients and intraclass correlation coefficient values. Results: A total of 33 participants were included in this study. The total scores for the app- and paper-based J-OSDI indicated satisfactory equivalence per our study definition (mean difference 1.8, 95% CI –1.4 to 5.0). Moreover, the app-based J-OSDI total score demonstrated good internal consistency and agreement (Cronbach α=.958; intraclass correlation=0.919; 95% CI 0.842 to 0.959) and was significantly correlated with its paper-based counterpart (Pearson correlation=0.932, P<.001). Conclusions: This study demonstrated the equivalence of PROs between the app- and paper-based J-OSDI. Implementing the app-based J-OSDI in various scenarios, including telehealth, may have implications for the early diagnosis of DED and longitudinal monitoring of PROs. 
%M 37535409
%R 10.2196/42638
%U https://www.jmir.org/2023/1/e42638
%U https://doi.org/10.2196/42638
%U http://www.ncbi.nlm.nih.gov/pubmed/37535409