在COVID-19大流行期间实施协议:随机试验压力预防的经验
Brittany Dennis1, Adam Deane2, François Lauzier3
1Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
该REVISE试验成功地适应了其在COVID-19大流行期间的国际压力预防研究. 尽管面临挑战,招聘增加,同意模型演变,并启动了COVID-19子研究.
科学领域:
- 临界护理医学 临界护理医学
- 临床试验 临床试验
- 传染病流行病学 传染病流行病学
背景情况:
- 在COVID-19大流行期间,重症监护室 (ICU) 重定向了资源,经常停止了非COVID研究.
- 这种转变影响了正在进行的临床试验,需要适应性策略来继续研究.
研究的目的:
- 在COVID-19大流行期间详细说明国际重评估ICU压力侵蚀抑制 (REVISE) 随机试验的操作行为.
- 分析招生模式,中心参与,同意程序,数据收集和监控适应.
主要方法:
- 在REVISE试验中,机械通风患者被随机分配给潘托普拉或安慰剂,以预防压力.
- 协议实施记录时间为2020年3月至2022年8月,分析了同意模式和招生变化.
- 开发了一个嵌套的COVID-19子研究,并调整监测策略以适应远程和面对面的方法.
主要成果:
- 尽管存在大流行,但仍有41个新中心加入,将试验扩展到59个参与站点,并招募了2961名患者.
- 注册暂停占可用月的8.6%;然而,知情同意率略有增加,电话同意率大幅上升.
- 管理了患者转移,并成功实施了COVID-19子研究.
结论:
- REVISE试验证明了在疫情期间通过适应性策略成功实施协议.
- 关键的适应包括不断发展的同意模型,保持高的同意率,并启动一个COVID-19副研究.
- 增加招聘,优化患者转移和灵活的监测方法确保了试验的连续性.
更多相关视频
00:04A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
06:05The Participant-Reported Implementation Update and Score PRIUS: A Novel Method for Capturing Implementation-Related Data Over Time
Published on: February 19, 2021
相关概念视频
Peptic Ulcer Disease IV: Management
The therapeutic approach involves ensuring adequate rest, implementing drug therapy, promoting smoking cessation, making dietary modifications, and emphasizing long-term follow-up care.
Pharmacological management
The prevailing therapy for peptic ulcers involves a combination of managing the patient's current...
Peptic Ulcer Disease V: Surgical Management and Nursing Care
Surgical Interventions for Peptic Ulcer Disease
Treating Helicobacter pylori in Peptic Ulcers: Antimicrobial Therapy
Drugs for Peptic Ulcer Disease: Prostaglandin Analogs as Mucosal Protective Agents
Non-steroidal anti-inflammatory drugs (NSAIDs) can induce peptic ulcers by inhibiting cyclooxygenase, decreasing...
Peptic Ulcer Disease III: Clinical Manifestations and Diagnostic Studies
Few clinical manifestations differentiate gastric ulcers from duodenal ulcers. Distinctions in the location, timing, and pain relief are crucial for healthcare providers in differentiating between gastric and duodenal ulcers during clinical assessments.
Pathophysiology of Peptic Ulcer Disease: Mucosal Defense Factors
