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Accepted for/Published in: Journal of Medical Internet Research

Date Submitted: Sep 12, 2022
Open Peer Review Period: Sep 12, 2022 - Nov 7, 2022
Date Accepted: Jul 12, 2023
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Smartphone App–Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study

Nagino K, Okumura Y, Akasaki Y, Fujio K, Huang T, Sung J, Midorikawa-Inomata A, Fujimoto K, Eguchi A, Hurramhon S, Yee A, Miura M, Kuwahara M, Hirosawa K, Morooka Y, Murakami A, Kobayashi H, Inomata T

Smartphone App–Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study

J Med Internet Res 2023;25:e42638

DOI: 10.2196/42638

PMID: 37535409

PMCID: 10436120

Smartphone application- and paper-based patient-reported outcomes using a disease-specific questionnaire for dry eye disease: A randomized cross-over equivalence study

  • Ken Nagino; 
  • Yuichi Okumura; 
  • Yasutsugu Akasaki; 
  • Kenta Fujio; 
  • Tianxiang Huang; 
  • Jaemyoung Sung; 
  • Akie Midorikawa-Inomata; 
  • Keiichi Fujimoto; 
  • Atsuko Eguchi; 
  • Shokirova Hurramhon; 
  • Alan Yee; 
  • Maria Miura; 
  • Mizu Kuwahara; 
  • Kunihiko Hirosawa; 
  • Yuki Morooka; 
  • Akira Murakami; 
  • Hiroyuki Kobayashi; 
  • Takenori Inomata

ABSTRACT

Background:

A large proportion of patients with dry eye disease may be undiagnosed and untreated despite experiencing dry eye symptoms. Hence, to prevent dry eye disease progression and decreased quality of life due to chronic dry eye disease, early detection followed by longitudinal monitoring and intervention is crucial.

Objective:

This study assessed the equivalence between smartphone application- and paper-based questionnaires for dry eye disease.

Methods:

For this prospective, non-blinded, randomized cross-over study, 34 participants were recruited between April and June 2022 at a university hospital in Japan. The equivalence test based on the minimal clinically important difference was used to assess the equivalence of total scores of the Japanese version of the Ocular Surface Disease Index between two platforms. Equivalence was determined if the 95% confidence interval of the mean difference between total scores of the application- and paper-based Japanese version of the Ocular Surface Disease Index was within the ±7.0 range.

Results:

A total of 33 participants were included. The total scores for the application- and paper-based Japanese version of the Ocular Surface Disease Index were equivalent (mean difference: 1.8; 95% confidence interval: -1.4 to 5.0). The total score for the application-based Japanese version of the Ocular Surface Disease Index showed good internal consistency and agreement (Cronbach alpha coefficient=0.958; intraclass correlation coefficient=0.919) and was significantly correlated with the total score for the paper-based Japanese version of the Ocular Surface Disease Index (Pearson correlation coefficient=0.932).

Conclusions:

This study demonstrated the equivalence of patient-reported outcomes between the application- and paper-based Japanese version of the Ocular Surface Disease Index. Implementing the application-based Japanese version of the Ocular Surface Disease Index could have implications for the early diagnosis of dry eye disease and longitudinal monitoring of patient-reported outcomes.


 Citation

Please cite as:

Nagino K, Okumura Y, Akasaki Y, Fujio K, Huang T, Sung J, Midorikawa-Inomata A, Fujimoto K, Eguchi A, Hurramhon S, Yee A, Miura M, Kuwahara M, Hirosawa K, Morooka Y, Murakami A, Kobayashi H, Inomata T

Smartphone App–Based and Paper-Based Patient-Reported Outcomes Using a Disease-Specific Questionnaire for Dry Eye Disease: Randomized Crossover Equivalence Study

J Med Internet Res 2023;25:e42638

DOI: 10.2196/42638

PMID: 37535409

PMCID: 10436120

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