Canadian Critical Care Trials Group, Toronto, Ontario, Canada.
Crit Care Med. 2010 Apr;38(4 Suppl):e120-32. doi: 10.1097/CCM.0b013e3181d20c77.
As a critical care community, we have an obligation to provide not only clinical care but also the research that guides initial and subsequent clinical responses during a pandemic. There are many challenges to conducting such research. The first is speed of response. However, given the near inevitability of certain events, for example, viral respiratory illness such as the 2009 pandemic, geographically circumscribed natural disasters, or acts of terror, many study and trial designs should be preplanned and modified quickly when specific events occur. Template case report forms should be available for modification and web entry; centralized research ethics boards and funders should have the opportunity to preview and advise on such research beforehand; and national and international research groups should be prepared to work together on common studies and trials for common challenges. We describe the early international critical care research response to the influenza A 2009 (H1N1) pandemic, including specifics of observational study case report form, registry, and clinical trial design, cooperation of international critical care research organizations, and the early results of these collaborations.
作为一个重症监护医学领域的专业人士,我们有责任不仅提供临床护理,还要开展研究,为大流行期间的初始和后续临床应对提供指导。开展此类研究存在诸多挑战。首先是应对速度。然而,鉴于某些事件(例如 2009 年大流行中的病毒性呼吸道疾病、地理上有限的自然灾害或恐怖行为)几乎不可避免,许多研究和试验设计应预先规划,并在特定事件发生时迅速修改。应提供可修改的模板病例报告表,并可通过网络录入;集中的研究伦理委员会和资助者应有机会预先审查此类研究并提出建议;国家和国际研究小组应准备共同开展针对共同挑战的共同研究和试验。我们描述了 2009 年甲型 H1N1 流感大流行期间国际重症监护医学领域的早期研究应对措施,包括观察性研究病例报告表、注册和临床试验设计的具体内容、国际重症监护医学研究组织的合作,以及这些合作的早期结果。