Early observational research and registries during the 2009-2010 influenza A pandemic.
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.
Fowler
Robert A
RA
Canadian Critical Care Trials Group, Toronto, Ontario, Canada. rob.fowler@sunnybrook.ca
Webb
Steven A R
SA
Rowan
Kathy M
KM
Sprung
Charles L
CL
Thompson
B Taylor
BT
Randolph
Adrienne G
AG
Jouvet
Philippe
P
Lapinsky
Stephen
S
Rubinson
Lewis
L
Rello
Jordi
J
Cobb
J Perren
JP
Rice
Todd W
TW
Uyeki
Tim
T
Marshall
John C
JC
D003422:Critical Care / Q000458:organization & administration; D003710:Demography; D018563:Disease Notification / Q000379:methods*; D006302:Health Services Research / Q000458:organization & administration*; D006280:Health Workforce; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype; D007251:Influenza, Human; D012042:Registries; D016896:Treatment Outcome