Bolognese J A, Schnitzer T J, Ehrich E W
Merck Research Labs, RY34-304, P.O. Box 2000, Rahway, NJ 07065, USA.
Osteoarthritis Cartilage. 2003 Jul;11(7):499-507. doi: 10.1016/s1063-4584(03)00082-7.
OBJECTIVE/BACKGROUND: Efficacy in osteoarthritis (OA) is principally measured using subjective visual analogue (VAS) and/or Likert scale responses. The relationship between these two scales and their relative precision in discriminating active from placebo treatment in OA patients was determined.
DESIGN/METHODS: Patient overall pain assessment, and patient and investigator global assessments were each measured on a 100mm VAS and on a 0 to 4 point Likert scale in a 6-week OA study of rofecoxib vs placebo. The relationship between the VAS and Likert responses was examined graphically and via summary statistics. Analysis of variance was used to assess consistency of the VAS/Likert relationship over time and across the different endpoints. Precision was compared using effect size, and normality of VAS scale of measurement was assessed using the Shapiro-Wilk test.
Mean VAS scores and changes from baseline at individual time points were generally highly correlated with corresponding Likert responses (r-values generally approximately 0.7-0.8). The magnitude of VAS values and changes varied depending on endpoint, on the associated magnitude of increment of Likert score, and on the Likert baseline value (i.e., where on the Likert scale the change was occurring). Precision of VAS and Likert responses to detect difference between treatments was generally similar with effect sizes approximately 1. Normality and homogeneity of variance of VAS scores was most closely approximated by actual changes in comparison to percent change or log-transformed measures.
VAS and Likert responses are highly correlated and yield similar precision for discriminating treatments in OA patients. Since Likert responses are easier to administer and interpret, they may be preferable to measure OA response.
目的/背景:骨关节炎(OA)的疗效主要通过主观视觉模拟量表(VAS)和/或李克特量表反应来衡量。确定了这两种量表之间的关系及其在区分OA患者中活性治疗与安慰剂治疗方面的相对精度。
设计/方法:在一项为期6周的罗非昔布与安慰剂对照的OA研究中,患者总体疼痛评估、患者及研究者整体评估均采用100mm VAS和0至4分的李克特量表进行测量。通过图形和汇总统计数据研究了VAS与李克特反应之间的关系。采用方差分析评估VAS/李克特关系随时间和不同终点的一致性。使用效应量比较精度,并使用夏皮罗-威尔克检验评估VAS测量量表的正态性。
各个时间点的平均VAS评分及与基线的变化通常与相应的李克特反应高度相关(r值一般约为0.7 - 0.8)。VAS值及变化的幅度因终点、李克特评分的相关增量幅度以及李克特基线值(即变化发生在李克特量表的哪个位置)而异。检测治疗差异时,VAS和李克特反应的精度通常相似,效应量约为1。与百分比变化或对数转换测量相比,实际变化最接近VAS评分的正态性和方差齐性。
VAS和李克特反应高度相关,在区分OA患者的治疗方面具有相似的精度。由于李克特反应更易于实施和解释,因此在测量OA反应时可能更可取。