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将 EQ-5D-5L 生活质量问卷的移动应用版本与金标准纸质版本进行对比验证:随机交叉研究。

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.

作者信息

Kamstra Regina J M, Boorsma André, Krone Tanja, van Stokkum Robin M, Eggink Hannah M, Peters Ton, Pasman Wilrike J

机构信息

Netherlands Organization for Applied Scientific Research (TNO), Zeist, Netherlands.

Netherlands Organization for Applied Scientific Research (TNO), Utrecht, Netherlands.

出版信息

JMIR Form Res. 2022 Aug 11;6(8):e37303. doi: 10.2196/37303.

Abstract

BACKGROUND

Study 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.

OBJECTIVE

This 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.

METHODS

This 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.

RESULTS

A 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.

CONCLUSIONS

This 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.

摘要

背景

研究参与者和患者常常认为(冗长的)问卷很繁琐。此外,纸质问卷容易出现诸如(无意地)跳过问题或填写错误答案类型等错误。移动问卷应用程序的出现可以防止此类错误。

目的

本研究旨在验证一种基于EQ-5D-5L问卷的使用移动应用程序测量生活质量的创新方法。这项验证研究将移动应用程序要求填写的EQ-5D-5L问卷与EQ-5D-5L的纸质金标准版本进行了比较。

方法

这是一项随机、交叉和开放的研究。参与的主要标准是参与者年龄≥18岁,自行判断身体健康,拥有至少安卓4.1版或更高版本或iOS 9版或更高版本的智能手机,具备下载移动应用程序的数字技能,并且能够用荷兰语阅读和回答问卷。参与者由一家市场研究公司招募,该公司将他们分为两组,在年龄、性别和教育程度方面保持平衡。每位参与者通过移动应用程序收到一份EQ-5D-5L问卷的数字版本,并通过邮政邮件收到EQ-5D-5L纸质问卷。在移动应用程序中,参与者连续5天每天上午收到1个问题,下午收到1个问题;因此,所有问题都被问了两次(时间点1 [应用程序T1] 和时间点2 [应用程序T2])。主要结果是通过移动应用程序回答的每个EQ-5D-5L问题的答案(分数)与纸质问卷之间的相关性,以评估收敛效度。

结果

共有255名参与者(自行判断身体健康),年龄在18至64岁之间,其中117名(45.9%)男性和138名(54.1%)女性完成了研究。为确保随机化,对测量的人口统计学数据进行了检查并在组间进行了比较。为了比较电子问卷和纸质问卷的结果,进行了多变量相关分析。在应用程序T1和应用程序T2时,所有问题在纸质问卷和基于移动应用程序的问题之间均显示出高度相关性(0.64 - 0.92;P <.001)。问卷中的分数及其方差保持相似,表明答案倾向没有明显差异。此外,两个基于应用程序的问卷之间的相关性很高(>0.73;P <.001),说明重测信度很高,表明它是纸质问卷的可靠替代品。

结论

本研究表明,移动应用程序是测量生活质量的有效工具,与EQ-5D-5L纸质版本一样可靠,同时减轻了回答负担。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/72b8/9412727/8b259425d1d4/formative_v6i8e37303_fig1.jpg

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