先行走，再奔跑：来自 PROCLAIM 研究的可行性挑战和经验教训，该研究是一项关于 COVID-19 期间米索前列醇预防复发性艰难梭菌的多中心随机对照试验。
Walk before you run: Feasibility challenges and lessons learned from the PROCLAIM study, a multicenter randomized controlled trial of misoprostol for prevention of recurrent Clostridioides difficile during COVID-19.
机构信息
The Vanderbilt Institute for Clinical and Translational Research (VICTR), Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Medicine, Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.
出版信息
Anaerobe. 2023 Apr;80:102699. doi: 10.1016/j.anaerobe.2023.102699. Epub 2023 Jan 23.
Abstract
We analyzed our challenging experience with a randomized controlled trial of misoprostol for prevention of recurrent C. difficile. Despite careful prescreening and thoughtful protocol modifications to facilitate enrollment, we closed the study early after enrolling just 7 participants over 3 years. We share lessons learned, noting the importance of feasibility studies, inclusion of biomarker outcomes, and dissemination of such findings to inform future research design and implementation successes.
摘要
我们分析了一项关于米索前列醇预防复发性艰难梭菌感染的随机对照试验的挑战性经验。尽管进行了仔细的预筛选，并对方案进行了深思熟虑的修改以促进入组，但在 3 年内仅入组了 7 名参与者后，我们就提前关闭了该研究。我们分享了所学到的经验教训，指出了可行性研究、纳入生物标志物结果以及传播这些发现的重要性，以告知未来的研究设计和实施成功。
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