Department of Quality Assurance and Process Innovation, University of Amsterdam, Amsterdam, the Netherlands.
Wound Repair Regen. 2012 Jul-Aug;20(4):449-55. doi: 10.1111/j.1524-475X.2012.00799.x. Epub 2012 May 29.
The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes. This article proposes strategies for improving the evidence base for wound care decision making.
慢性和急性伤口的护理是全球范围内的一个重大问题。这导致了大量用于加速愈合的产品。不幸的是，评估此类伤口护理产品疗效的研究质量往往较低。随机临床试验被普遍认为是比较治疗效果的首选研究设计，因为它们消除了几种偏倚来源。我们提出了一个未来随机临床试验的设计和实施框架，为伤口护理干预措施的有效性提供强有力的科学证据。虽然随机化是一项稳健的比较研究的必要特征，但它不足以确保研究的偏倚风险较低。随机临床试验还应确保适当的分配隐藏和结果评估者的盲法，应用意向治疗分析，并使用以患者为中心的结果。本文提出了改善伤口护理决策证据基础的策略。
