Department of Epidemiology and Preventative Medicine, School of Public Health and Preventative Medicine, Monash University, Melbourne, Victoria, Australia.
Int Wound J. 2010 Feb;7(1):41-7. doi: 10.1111/j.1742-481X.2009.00645.x.
The randomised controlled trial (RCT) is often considered the gold standard for judging the benefits of treatments. The application of randomised controlled clinical trials to treatments of venous ulcer healing has lagged behind that of other areas of medicine. To interpret the results of an RCT, readers must understand a variety of aspects of their design, analysis and interpretation. Venous ulcer disease has a high prevalence and has a significant socioeconomic impact in most parts of the world. The management of venous ulcers causes a considerable strain on the health system and is likely to worsen in future. The multi-layer high compression system is described as the current gold standard for treating venous ulcers. A recent meta-analysis of bandaging systems found that multi-layer compression bandages appeared to be superior to single-layer bandages in promoting venous ulcer healing. However, it was noted that many of the studies had small sample sizes and the quality of research in the area was poor. The consolidating standards of reporting trials (CONSORT) statement can help clinicians to discern high-quality studies from ones of poorer quality. This paper discusses how CONSORT can help clinicians and researchers to design and report quality studies to contribute to evidence-based venous ulcer healing.
随机对照试验（RCT）通常被认为是判断治疗益处的金标准。将随机对照临床试验应用于静脉溃疡愈合的治疗落后于其他医学领域。为了解释 RCT 的结果，读者必须理解其设计、分析和解释的各个方面。静脉溃疡疾病在世界上大多数地区的发病率都很高，对社会经济有重大影响。静脉溃疡的治疗给医疗系统带来了相当大的压力，而且在未来可能会恶化。多层高压系统被描述为治疗静脉溃疡的当前金标准。最近对包扎系统的荟萃分析发现，多层压缩绷带在促进静脉溃疡愈合方面似乎优于单层绷带。然而，研究人员注意到，许多研究的样本量较小，该领域的研究质量较差。CONSORT（报告试验的统一标准）声明可以帮助临床医生区分高质量研究和低质量研究。本文讨论了 CONSORT 如何帮助临床医生和研究人员设计和报告高质量的研究，以促进基于证据的静脉溃疡愈合。
