@Article{info:doi/10.2196/42638,
author="Nagino, Ken
and Okumura, Yuichi
and Akasaki, Yasutsugu
and Fujio, Kenta
and Huang, Tianxiang
and Sung, Jaemyoung
and Midorikawa-Inomata, Akie
and Fujimoto, Keiichi
and Eguchi, Atsuko
and Hurramhon, Shokirova
and Yee, Alan
and Miura, Maria
and Ohno, Mizu
and Hirosawa, Kunihiko
and Morooka, Yuki
and Murakami, Akira
and Kobayashi, Hiroyuki
and Inomata, Takenori",
title="Smartphone App--Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study",
journal="J Med Internet Res",
year="2023",
month="Aug",
day="3",
volume="25",
pages="e42638",
keywords="dry eye syndrome; mobile app; equivalence trial; Ocular Surface Disease Index; patient-reported outcome measures; mobile health; reliability; validity; telemedicine; precision medicine",
abstract="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 {\textpm}7.0 range between the 2 platforms indicated equivalence. The internal consistency and agreement of the app-based J-OSDI were assessed with Cronbach $\alpha$ 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 $\alpha$=.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. ",
issn="1438-8871",
doi="10.2196/42638",
url="https://www.jmir.org/2023/1/e42638",
url="https://doi.org/10.2196/42638",
url="http://www.ncbi.nlm.nih.gov/pubmed/37535409"
}