Beyond mortality: future clinical research in acute lung injury.
Mortality in National Heart, Lung and Blood Institute-sponsored clinical trials of treatments for acute lung injury (ALI) has decreased dramatically during the past two decades. As a consequence, design of such trials based on a mortality outcome requires ever-increasing numbers of patients. Recognizing that advances in clinical trial design might be applicable to these trials and might allow trials with fewer patients, the National Heart, Lung and Blood Institute convened a workshop of extramural experts from several disciplines. The workshop assessed the current state of clinical research addressing ALI, identified research needs, and recommended: (1) continued performance of trials evaluating treatments of patients with ALI; (2) development of strategies to perform ALI prevention trials; (3) observational studies of patients without ALI undergoing prolonged mechanical ventilation; and (4) development of a standardized format for reporting methods, endpoints, and results of ALI trials.
Spragg
Roger G
RG
Division of Lung Diseases, National Heart, Lung, and Blood Institute/ NIH, 6701 Rockledge Drive, Bethesda, MD 20892-7952, USA. Harabin@nih.gov
Bernard
Gordon R
GR
Checkley
William
W
Curtis
J Randall
JR
Gajic
Ognjen
O
Guyatt
Gordon
G
Hall
Jesse
J
Israel
Elliott
E
Jain
Manu
M
Needham
Dale M
DM
Randolph
Adrienne G
AG
Rubenfeld
Gordon D
GD
Schoenfeld
David
D
Thompson
B Taylor
BT
Ware
Lorraine B
LB
Young
Duncan
D
Harabin
Andrea L
AL
D055371:Acute Lung Injury / Q000517:prevention & control / Q000628:therapy*; D035843:Biomedical Research; D002986:Clinical Trials as Topic; D005544:Forecasting; D006801:Humans; D012128:Respiratory Distress Syndrome / Q000517:prevention & control / Q000628:therapy