基于注册的外科随机临床试验：与 ACS-NSQIP 和 AHPBA 合作开展实用临床试验。
Registry-based randomized clinical trials in surgery: Working with ACS-NSQIP and the AHPBA to conduct pragmatic trials.
机构信息
Division of Hepatopancreatobiliary Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.
Department of Surgery, Surgical Outcomes and Quality Improvement Center, Northwestern Medicine, Chicago, Illinois, USA.
出版信息
J Surg Oncol. 2022 Jan;125(1):89-92. doi: 10.1002/jso.26742.
Randomized controlled trials (RCTs) represent the gold standard for evidence in clinical medicine because of their ability to account for the effects of unmeasured confounders and selection bias by indication. However, their complexity and immense costs limit their application, and thus the availability of high-quality data to guide clinical care. Registry-based RCTs are a type of pragmatic trial that leverages existing registries as a platform for data collection, providing a low-cost alternative for randomized studies. Herein, we describe the tenets of registry RCTs and the development of the first AHPBA/ACS-NSQIP-based registry trial.
随机对照试验（RCTs）是临床医学证据的金标准，因为它们能够通过指征来解释未测量的混杂因素和选择偏倚的影响。然而，它们的复杂性和巨大的成本限制了它们的应用，因此可用的高质量数据来指导临床护理。基于注册的 RCT 是一种实用的试验，利用现有的注册平台作为数据收集的平台，为随机研究提供了一种低成本的替代方案。在此，我们描述了注册 RCT 的原则和第一个基于 AHPBA/ACS-NSQIP 的注册试验的开发。
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