Reynolds T, Russell L, Deeth M, Jones H, Birchall L
Queen's Hospital, Burton-on-Trent, UK.
J Wound Care. 2004 Feb;13(2):71-4. doi: 10.12968/jowc.2004.13.2.26577.
This randomised controlled clinical trial compared a capillary dressing (Drawtex, now rebranded as Vibriant RCD [Vibriant Technology Services]) with routine practice for exuding wounds greater than 2.5 x 2.5 cm.
The target population was 300 control and 300 test subjects across three sites in the UK, but recruitment difficulties resulted in only 125 patients being evaluable. Wound progress was recorded by nurses' perception of the progress of wound healing and by objective digital imaging. In the final analysis digital images were randomised (in time order) and a panel of nurses who were not otherwise involved in the research project graded the wound's progress.
After deconvolution of the data, the subjective (nurse perception) method of evaluation determined that the new dressing resulted in wound improvement in 12.7% more patients than did routine practice, but the blinded assessment method (based on the digital images) showed that routine practice was better by 6.6%.
Evaluation of wound progress is clearly difficult. Human nature makes us favour novelty if we believe it is going to be better. Making interpretation more objective removed that bias and did not demonstrate a significant advantage for the test dressing. The findings suggest that unblinded assessment by trial nurses is unacceptable on its own. Blinded assessments may miss finer nuances of wound progression, but are likely to be more accurate. The authors suggest that the true result lies somewhere in the middle, with the trial dressing likely to be as effective as, but not more effective than, a standard dressing.
本随机对照临床试验将一种用于渗出性伤口(伤口面积大于2.5×2.5厘米)的创口贴(Drawtex,现更名为Vibriant RCD [Vibriant技术服务公司])与常规治疗方法进行了比较。
目标人群为英国三个地点的300名对照组和300名试验组受试者,但由于招募困难,最终仅有125名患者可纳入评估。伤口进展情况通过护士对伤口愈合进程的主观判断以及客观的数字成像记录。在最终分析中,数字图像按时间顺序随机排列,由一组未参与该研究项目的护士对伤口进展进行分级。
对数据进行反卷积分析后,主观评估方法(护士的判断)显示,与常规治疗相比,新创口贴使伤口改善的患者比例高出12.7%,但盲法评估(基于数字图像)显示常规治疗效果更好,高出6.6%。
显然,评估伤口进展具有难度。如果我们认为新事物会更好,人性使然会让我们对其青睐有加。使评估更加客观可消除这种偏差,且未显示试验创口贴具有显著优势。研究结果表明,仅由试验护士进行非盲法评估是不可接受的。盲法评估可能会忽略伤口进展的细微差别,但可能更准确。作者认为真实结果可能介于两者之间,试验创口贴的效果可能与标准创口贴相当,但不会更优。