[慢性伤口领域真实世界研究的进展]
[Research advances of real world study in the field of chronic wound].
作者信息
Chen L X, Jia C Y, He Y
机构信息
Department of Burns and Plastic & Wound Repair Surgery, Xiang'an Hospital of Xiamen University, Xiamen 361102, China.
出版信息
Zhonghua Shao Shang Yu Chuang Mian Xiu Fu Za Zhi. 2022 Mar 20;38(3):291-295. doi: 10.3760/cma.j.cn501120-20210121-00031.
In recent years, as a powerful supplement to the randomized controlled trial (RCT), real world study (RWS) has received more and more attention. However, in the field of chronic wounds, most of the patients have complex condition, and the strict inclusion and exclusion criteria of RCT were lack of practical application values. The RWS provides data closer to the real medical environment in clinical medical practice, drug and medical device supervision, and health technology evaluation. However, RWS has some problems that need to be resolved, such as inconsistent diagnostic criteria and unclear research endpoints. In addition, RWS in chronic wound research in China seems to have not really started yet, and institutions at all levels need to work together to promote the development of RWS.
近年来，作为随机对照试验（RCT）的有力补充，真实世界研究（RWS）受到越来越多的关注。然而，在慢性伤口领域，大多数患者病情复杂，RCT严格的纳入和排除标准缺乏实际应用价值。RWS在临床医学实践、药品和医疗器械监管以及卫生技术评估中提供了更贴近真实医疗环境的数据。然而，RWS存在一些需要解决的问题，如诊断标准不一致和研究终点不明确。此外，我国慢性伤口研究中的RWS似乎尚未真正起步，各级机构需要共同努力推动RWS的发展。
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