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

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 ±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.

Clinical utility of maximum blink interval measured by smartphone application DryEyeRhythm to support dry eye disease diagnosis

“…Additionally, the diagnostic performance of concomitant Japanese version of Ocular Surface Disease Index (J-OSDI) and MBI was satisfactory, with a sensitivity, specificity, and AUC of 75.4%, 92.9%, and 0.938, respectively 16 . The validity and reliability of the app-based J-OSDI were satisfactory, and its performance was comparable with its paper-based counterpart 5 , 14 . Therefore, accurate measurement of MBI using a smartphone app can enable comprehensive assessment of tear film status in a remote setting for DED diagnosis and progression monitoring.…”

“…Dry eye examinations require specialized equipment, such as slit-lamp microscopes and fluorescein dye; moreover, the invasive nature of the examination disrupts the true in vivo tear composition 12 . Therefore, performing a comprehensive DED evaluation in a telehealth setting is impractical, warranting the formal appraisal of various telehealth strategies to remotely diagnose DED and manage its symptoms 5 , 13 , 14 .…”

“…In November 2016, we developed and released an in-house smartphone application (app), DryEyeRhythm, which is capable of measuring MBI and administering DED-specific symptom questionnaires 14 , 17 , 18 with positive and negative predictive values, sensitivity, and specificity of 91.3%, 69.1%, 50.0%, and 95.0%, respectively 5 . DryEyeRhythm could measure MBI by biosensing blinking using smartphone-attached cameras.…”

“…Additionally, recent data on various DED subtypes suggest that MBI monitoring is useful in determining the disease mechanism for stratified and personalized treatment approaches 18 . The administration of DED-specific questionnaires through DryEyeRhythm provides reliable patient-reported data 14 , 17 ; however, MBI measurement through the app must be assessed for reliability and validity.…”

Ocular complications in adults with psoriasis: a cross-sectional study in a referral center in Brazil

“…All participants were interviewed about their eye symptoms and underwent a complete ophthalmic examination performed by two ophthalmology tutors at the same unit (at different times). The Japanese criteria were applied to establish a diagnosis of dry eye disease (DED), including symptomatic assessment, Schirmer’s I test (Schirmer strips 5 × 35 mm, Ophthalmos, Brazil, São Paulo), tear break-up time (TBUT) test (Fludiag, Oftalmofarma, São Paulo, Brazil), and vital dye staining (Rose Bengal) test (Rose Bengal strips, Ophthalmos, São Paulo, Brazil) [ 9 , 10 ]. For a definitive diagnosis, the patient must have symptoms and two positive tests.…”