ArticleJMIR formative research2022
Validation of the Mobile App Version of the EQ-5D-5L Quality of Life Questionnaire Against the Gold Standard Paper-Based Version: Randomized Crossover Study.
Article in JMIR formative research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07424378 (Randomized Controlled Trial of Epoprostenol Versus Placebo in Addition to Standard Therapy for Severe Frostbite Injury), which is not on this map. Not yet cited in PubMed.
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Randomized Controlled Trial of Epoprostenol Versus Placebo in Addition to Standard Therapy for Severe Frostbite Injury
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Abstract
backgroundStudy participants and patients often perceive (long) questionnaires as burdensome. In addition, paper-based questionnaires are prone to errors such as (unintentionally) skipping questions or filling in a wrong type of answer. Such errors can be prevented with the emergence of mobile questionnaire apps.
objectiveThis study aimed to validate an innovative way to measure the quality of life using a mobile app based on the EQ-5D-5L questionnaire. This validation study compared the EQ-5D-5L questionnaire requested by a mobile app with the gold standard paper-based version of the EQ-5D-5L.
methodsThis was a randomized, crossover, and open study. The main criteria for participation were participants should be aged ≥18 years, healthy at their own discretion, in possession of a smartphone with at least Android version 4.1 or higher or iOS version 9 or higher, digitally skilled in downloading the mobile app, and able to read and answer questionnaires in Dutch. Participants were recruited by a market research company that divided them into 2 groups balanced for age, gender, and education. Each participant received a digital version of the EQ-5D-5L questionnaire via a mobile app and the EQ-5D-5L paper-based questionnaire by postal mail. In the mobile app, participants received, for 5 consecutive days, 1 question in the morning and 1 question in the afternoon; as such, all questions were asked twice (at time point 1 [App T1] and time point 2 [App T2]). The primary outcomes were the correlations between the answers (scores) of each EQ-5D-5L question answered via the mobile app compared with the paper-based questionnaire to assess convergent validity.
resultsA total of 255 participants (healthy at their own discretion), 117 (45.9%) men and 138 (54.1%) women in the age range of 18 to 64 years, completed the study. To ensure randomization, the measured demographics were checked and compared between groups. To compare the results of the electronic and paper-based questionnaires, polychoric correlation analysis was performed. All questions showed a high correlation (0.64-0.92; P<.001) between the paper-based and the mobile app-based questions at App T1 and App T2. The scores and their variance remained similar over the questionnaires, indicating no clear difference in the answer tendency. In addition, the correlation between the 2 app-based questionnaires was high (>0.73; P<.001), illustrating a high test-retest reliability, indicating it to be a reliable replacement for the paper-based questionnaire.
conclusionsThis study indicates that the mobile app is a valid tool for measuring the quality of life and is as reliable as the paper-based version of the EQ-5D-5L, while reducing the response burden.
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