Signant Health, Ground Floor, Waterfront Embankment, Manbre Road, Hammersmith, London, W6 9RH, UK.
YPrime, Malvern, PA, USA.
Ther Innov Regul Sci. 2022 May;56(3):394-404. doi: 10.1007/s43441-022-00376-2. Epub 2022 Feb 10.
Visual analogue scales (VASs) are used in a variety of patient-, observer- and clinician-reported outcome measures. While typically included in measures originally developed for pen-and-paper completion, a greater number of clinical trials currently use electronic approaches to their collection. This leads researchers to question whether the measurement properties of the scale have been conserved during the migration to an electronic format, particularly because electronic formats often use a different scale length than the 100 mm paper standard.
We performed a review of published studies investigating the measurement comparability of paper and electronic formats of the VAS.
Our literature search yielded 26 studies published between 1997 and 2018 that reported comparison of paper and electronic formats using the VAS. After excluding 2 publications, 23 of the remaining 24 studies included in this review reported electronic formats of the VAS (eVAS) and paper formats (pVAS) to be equivalent. A further study concluded that eVAS and pVAS were both acceptable but should not be interchanged. eVAS length varied from 21 to 200 mm, indicating that 100 mm length is not a requirement.
The literature supports the hypothesis that eVAS and pVAS provide comparable results regardless of the VAS length. When implementing a VAS on a screen-based electronic mode, we recommend following industry best practices for faithful migration to minimise the likelihood of non-comparability with pVAS.
视觉模拟评分(VAS)广泛应用于患者自评、观察者评估和临床医生报告的结果测量中。尽管通常包含在最初为纸笔完成而开发的测量中,但目前越来越多的临床试验使用电子方法来收集数据。这使得研究人员质疑在向电子格式迁移的过程中,该量表的测量特性是否得到了保留,特别是因为电子格式通常使用的量表长度与 100mm 纸标准不同。
我们对已发表的研究进行了回顾,这些研究调查了 VAS 的纸质和电子格式的测量可比性。
我们的文献检索共产生了 26 项发表于 1997 年至 2018 年的研究,这些研究报告了使用 VAS 比较纸质和电子格式的结果。排除 2 篇出版物后,在本综述中包括的 24 项剩余研究中有 23 项报告了 VAS 的电子格式(eVAS)和纸质格式(pVAS)等效。另一项研究的结论是 eVAS 和 pVAS 都是可以接受的,但不应互换使用。eVAS 的长度从 21 到 200mm 不等,这表明 100mm 的长度并非必需。
文献支持了这样一种假设,即无论 VAS 长度如何,eVAS 和 pVAS 都能提供可比的结果。当在基于屏幕的电子模式下实施 VAS 时,我们建议遵循行业最佳实践进行忠实迁移,以最大程度地降低与 pVAS 不可比的可能性。