Eurolens Research, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.
Centre for Ocular Research & Education (CORE), School of Optometry & Vision Science, University of Waterloo, Waterloo, ON, Canada.
Transl Vis Sci Technol. 2024 Aug 1;13(8):28. doi: 10.1167/tvst.13.8.28.
To determine the minimal clinically important difference (MCID) for contact lens (CL)-related subjective responses and explore whether MCID values differ between subjective responses and study designs.
This was a retrospective analysis of data from seven one-week bilateral crossover studies and 14 one-day contralateral CL studies. For comfort, dryness, vision, or ease of insertion, participants rated on a 0-100 visual analogue scale (VAS) and indicated lens preference on a five-point Likert scale featuring strong, slight, and no preferences. For each criterion, four MCID estimates were calculated and averaged: mean VAS score difference for "slight preference," lower limit of 95% confidence interval VAS score difference for "slight preference," difference in mean VAS score difference between "slight" and "no preference" and 0.5 standard deviation of VAS scores.
The four calculation methods generated a small range of MCID values. For bilateral studies, the averaged MCID was 7.2 (range 5.4-8.8) for comfort, 8.1 (5.2-10.6) for dryness, 7.1 (5.5-9.3) for vision and 7.6 (6.0-10.5) for ease of insertion. For contralateral studies, the averaged MCID was 6.9 (6.1-7.6) for comfort at insertion and 7.5 (6.8-8.2) for end-of-day comfort.
This work demonstrated very similar MCID values across subjective responses and study designs, in a population of habitual soft CL wearers. In all cases, MCID values were on average seven units on a 0 to 100 VAS.
This work provides MCID values which are important for interpreting ocular subjective responses and planning clinical studies.
确定隐形眼镜（CL）相关主观反应的最小临床重要差异（MCID），并探讨 MCID 值在主观反应和研究设计之间是否存在差异。
这是对 7 项为期 1 周的双侧交叉研究和 14 项为期 1 天的对侧 CL 研究数据的回顾性分析。在舒适度、干燥度、视力或插入容易度方面，参与者使用 0-100 视觉模拟量表（VAS）进行评分，并在具有强烈、轻微和无偏好的 5 分李克特量表上表示镜片偏好。对于每个标准，计算并平均四个 MCID 估计值：“轻微偏好”的平均 VAS 评分差异、“轻微偏好”的 95%置信区间 VAS 评分差异下限、“轻微”和“无偏好”之间的平均 VAS 评分差异以及 VAS 评分 0.5 标准差的差异。
四种计算方法产生了较小的 MCID 值范围。对于双侧研究，舒适度的平均 MCID 为 7.2（5.4-8.8），干燥度为 8.1（5.2-10.6），视力为 7.1（5.5-9.3），插入时的易用性为 7.6（6.0-10.5）。对于对侧研究，插入时舒适度的平均 MCID 为 6.9（6.1-7.6），一天结束时的舒适度为 7.5（6.8-8.2）。
这项工作在习惯性软性 CL 佩戴者人群中，证明了主观反应和研究设计之间非常相似的 MCID 值。在所有情况下，MCID 值在 0 到 100 的 VAS 上平均为 7 个单位。
这为解释眼部主观反应和规划临床研究提供了重要的 MCID 值。
