@article{e6215e783bf34cd2bf0ea232194a44cd,
title = "Early observational research and registries during the 2009-2010 influenza A pandemic",
abstract = "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. Copyrignt",
keywords = "Critical care, H1N1, influenza, pandemic, Intensive care, Registry",
author = "Fowler, \{Robert A.\} and Webb, \{Steven A.R.\} and Rowan, \{Kathy M.\} and Sprung, \{Charles L.\} and Thompson, \{B. Taylor\} and Randolph, \{Adrienne G.\} and Philippe Jouvet and Stephen Lapinsky and Lewis Rubinson and Jordi Rello and Cobb, \{J. Perren\} and Rice, \{Todd W.\} and Tim Uyeki and Marshall, \{John C.\}",
note = "Funding Information: The Acute Respiratory Distress Syndrome Network (ARDSNet) is a consortium of academic medical centers and affiliated hospitals across the United States funded by the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The Office of the Assistant Secretary for Preparedness and Response within the United States Department of Health and Human Services and the United States Centers for Disease Control and Prevention have collaborated with NHLBI and ARDSNet to establish an adult registry of critically ill novel influenza H1N1 because it has been successful at conducting multicentered clinical trials and because of its diverse regional representation and established infrastructure. Representatives from the United States Food and Drug Administration and the National Institute of Allergy and Infectious Diseases are also involved with the registry. The goal of the registry is to obtain a better understanding of the burden of disease, severity of illness, clinical course, and resource utilization needed to optimize patient care for H1N1-associated critical illness. The ARDSNet data set will collect information from 12 core academic medical centers and >50 ICUs from 42 hospitals. The PALISI Network joined this novel partnership and is leading the registry efforts regarding the pediatric experience. ",
year = "2010",
doi = "10.1097/CCM.0b013e3181d20c77",
language = "English",
volume = "38",
pages = "e120--e132",
journal = "Critical Care Medicine",
issn = "0090-3493",
publisher = "Lippincott Williams \& Wilkins",
number = "SUPPL. 4",
}