PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This work provides MCID values which are important for interpreting ocular subjective responses and planning clinical studies.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: This work provides MCID values which are important for interpreting ocular subjective responses and planning clinical studies.
摘要：
■确定隐形眼镜（CL）相关主观反应的最小临床重要差异（MCID），并探讨主观反应和研究设计之间的MCID值是否不同。
这是对来自7项为期一周的双侧交叉研究和14项为期一天的对侧CL研究的数据的回顾性分析。为了舒适，干燥度,愿景,或易于插入，参与者以0-100视觉模拟量表（VAS）进行评分，并以五点李克特量表表示镜头偏好，轻微的，没有偏好。对于每个标准，计算了四个MCID估计值并取平均值：“轻微偏好”的平均VAS得分差异，“轻微偏好的95%置信区间VAS评分差异的下限，“轻微”和“无偏好”之间的平均VAS评分差异和VAS评分的0.5标准差。
■四种计算方法生成了较小范围的MCID值。对于双边研究，舒适度的平均MCID为7.2(范围5.4-8.8)，8.1（5.2-10.6）干燥，7.1（5.5-9.3）用于视觉，7.6（6.0-10.5）用于易于插入。对于对侧研究，插入时舒适度的平均MCID为6.9(6.1~7.6),日终舒适度的平均MCID为7.5(6.8~8.2).
■这项工作表明，在主观反应和研究设计中，MCID值非常相似，在一群习惯性的软CL穿着者中。在所有情况下,MCID值在0至100VAS上平均为7个单位。
■这项工作提供了MCID值，这对于解释眼部主观反应和计划临床研究很重要。
这是对来自7项为期一周的双侧交叉研究和14项为期一天的对侧CL研究的数据的回顾性分析。为了舒适，干燥度,愿景,或易于插入，参与者以0-100视觉模拟量表（VAS）进行评分，并以五点李克特量表表示镜头偏好，轻微的，没有偏好。对于每个标准，计算了四个MCID估计值并取平均值：“轻微偏好”的平均VAS得分差异，“轻微偏好的95%置信区间VAS评分差异的下限，“轻微”和“无偏好”之间的平均VAS评分差异和VAS评分的0.5标准差。
■四种计算方法生成了较小范围的MCID值。对于双边研究，舒适度的平均MCID为7.2(范围5.4-8.8)，8.1（5.2-10.6）干燥，7.1（5.5-9.3）用于视觉，7.6（6.0-10.5）用于易于插入。对于对侧研究，插入时舒适度的平均MCID为6.9(6.1~7.6),日终舒适度的平均MCID为7.5(6.8~8.2).
■这项工作表明，在主观反应和研究设计中，MCID值非常相似，在一群习惯性的软CL穿着者中。在所有情况下,MCID值在0至100VAS上平均为7个单位。
■这项工作提供了MCID值，这对于解释眼部主观反应和计划临床研究很重要。
