TY  - JOUR
AU  - Nagino, Ken
AU  - Okumura, Yuichi
AU  - Akasaki, Yasutsugu
AU  - Fujio, Kenta
AU  - Huang, Tianxiang
AU  - Sung, Jaemyoung
AU  - Midorikawa-Inomata, Akie
AU  - Fujimoto, Keiichi
AU  - Eguchi, Atsuko
AU  - Hurramhon, Shokirova
AU  - Yee, Alan
AU  - Miura, Maria
AU  - Ohno, Mizu
AU  - Hirosawa, Kunihiko
AU  - Morooka, Yuki
AU  - Murakami, Akira
AU  - Kobayashi, Hiroyuki
AU  - Inomata, Takenori
PY  - 2023
DA  - 2023/8/3
TI  - Smartphone App–Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study
JO  - J Med Internet Res
SP  - e42638
VL  - 25
KW  - dry eye syndrome
KW  - mobile app
KW  - equivalence trial
KW  - Ocular Surface Disease Index
KW  - patient-reported outcome measures
KW  - mobile health
KW  - reliability
KW  - validity
KW  - telemedicine
KW  - precision medicine
AB  - 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. 
SN  - 1438-8871
UR  - https://www.jmir.org/2023/1/e42638
UR  - https://doi.org/10.2196/42638
UR  - http://www.ncbi.nlm.nih.gov/pubmed/37535409
DO  - 10.2196/42638
ID  - info:doi/10.2196/42638
ER  -