Quinn J V, Wells G A
Department of Surgery, University of Michigan, Ann Arbor 48109-0303, USA.
Acad Emerg Med. 1998 Jun;5(6):583-6. doi: 10.1111/j.1553-2712.1998.tb02465.x.
To compare 2 clinical wound scales and to determine a minimal clinically important difference (MCID) on the visual analog cosmesis scale.
Using data from 2 previously published clinical trials, 91 lacerations and 43 surgical incisions were assessed on the 2 scales; a 100-mm visual analog scale (VAS) (0 = worst possible scar, 100 = best possible scar) and a wound evaluation scale (WES) assessing 6 clinical variables (a score of 6 is considered optimal, while a score of < or =5 suboptimal). All wound assessments on the VAS were done by 2 cosmetic surgeons who rated photographs on 2 occasions. A cohort of wounds on the WES were assessed by a second observer. The difference of the mean optimal and suboptimal VAS scores for each study was used to determine a MCID on the VAS scale.
The VAS scale yielded intraobserver agreements of 0.93 and 0.87 (95% CI: 0.89-0.96 and 0.78-0.93) and interobserver agreements of 0.50 and 0.71 (95% CI: 0.32-0.65 and 0.52-0.84) for lacerations and incisions, respectively. Kappa coefficient measuring agreement on the WES was 0.79 (95% CI: 0.57-1.0). The mean (+/-SD) VAS scores of optimal wounds were 72 +/- 12 mm and 65 +/- 20 mm, while the mean scores of suboptimal wounds were 57 +/- 17 mm and 50 +/- 23 mm for lacerations and incisions, respectively.
An MCID on the VAS cosmesis scale is 15 mm. Studies should be designed to have a sample size and power to detect this difference.
比较两种临床伤口评估量表,并确定视觉模拟美容量表上的最小临床重要差异(MCID)。
利用两项先前发表的临床试验数据,对91处裂伤和43处手术切口进行两种量表的评估;一个100毫米视觉模拟量表(VAS)(0 = 可能出现的最差瘢痕,100 = 可能出现的最佳瘢痕)和一个伤口评估量表(WES),该量表评估6个临床变量(6分被认为是最佳,而≤5分为次优)。VAS上的所有伤口评估均由两名美容外科医生进行,他们在两个时间点对照片进行评分。WES上的一组伤口由第二名观察者进行评估。每项研究中最佳和次优VAS评分的平均值差异用于确定VAS量表上的MCID。
对于裂伤和切口,VAS量表的观察者内一致性分别为0.93和0.87(95%CI:0.89 - 0.96和0.78 - 0.93),观察者间一致性分别为0.50和0.71(95%CI:0.32 - 0.65和0.52 - 0.84)。测量WES一致性的kappa系数为0.79(95%CI:0.57 - 1.0)。最佳伤口的平均(±标准差)VAS评分,裂伤为72±12毫米,切口为65±20毫米;次优伤口的平均评分,裂伤为57±17毫米,切口为50±23毫米。
VAS美容量表上的MCID为15毫米。研究设计应具备检测此差异的样本量和效能。