Age-, sex-, and race-based differences among patients enrolled versus not enrolled in acute lung injury clinical trials.
OBJECTIVE
Little is known about the participation of racial/ethnic minorities, women, and the elderly into critical care clinical trials. We sought to characterize the representation of racial and ethnic minorities, women, and older patients in clinical trials of patients with acute lung injury and to determine the reasons for nonenrollment.


METHODS
We performed a cross-sectional analysis of pooled screening logs from 44 academic hospitals participating in three multicentered, randomized, controlled trials conducted by the Acute Respiratory Distress Syndrome Network from 1996 to 2005.


METHODS
None.


RESULTS
We calculated odds ratios of enrollment for age, sex, racial groups, and the odds ratio for the presence of each exclusion criterion by age, sex, and race adjusted for demographics, acute lung injury risk factor, study, and study center. A total of 10.4% of 17,459 screened patients with acute lung injury were enrolled. The median (range) enrollment by center was 15% (2% to 88%). Older patients of both sexes were less likely to be enrolled, but older women were more likely to be enrolled than older men. The adjusted odds ratio (95% confidence interval) for enrollment among men > or =75 yrs of age was 0.59 (0.45 to 0.77) and for women > or =75 yrs of age was 0.45 (0.32 to 0.62) compared with men <35 yrs of age. There were no differences in the likelihood of enrollment among all racial/ethnic groups. Older patients and men were less likely to be enrolled because of medical comorbidity. Among all patients who were not enrolled, black patients and their families refused participation more often than white patients.


CONCLUSIONS
Older patients are less likely to be enrolled in acute lung injury clinical trials. There is no evidence that women or racial/ethnic minorities are underrepresented in acute lung injury clinical trials.
Cooke
Colin R
CR
Division of Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA. crcooke@umich.edu
Erickson
Sara E
SE
Watkins
Timothy R
TR
Matthay
Michael A
MA
Hudson
Leonard D
LD
Rubenfeld
Gordon D
GD
D055371:Acute Lung Injury / Q000208:ethnology* / Q000628:therapy; D000328:Adult; D000367:Age Factors; D000368:Aged; D003430:Cross-Sectional Studies; D005006:Ethnicity / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008913:Minority Groups / Q000706:statistics & numerical data*; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic; D012737:Sex Factors; D044465:White People / Q000706:statistics & numerical data*
Chest. 2008 Oct;134(4):719-723
18689583
Arch Intern Med. 2002 Aug 12-26;162(15):1682-8
12153370
Am J Respir Crit Care Med. 2008 Feb 1;177(3):279-84
17975201
N Engl J Med. 2002 May 2;346(18):1373-82
11986412
Clin Pharmacol Ther. 2007 Apr;81(4):600-2
17314925
Cancer. 2001 Jan 1;91(1 Suppl):233-6
11148585
Chest. 1997 May;111(5):1334-9
9149591
JAMA. 2000 Dec 6;284(21):2762-70
11105183
N Engl J Med. 2005 Oct 20;353(16):1685-93
16236739
Crit Care Med. 2006 Jan;34(1):15-21
16374151
BMJ. 2005 Nov 5;331(7524):1036-7
16269472
Arch Intern Med. 2002 Nov 25;162(21):2458-63
12437405
N Engl J Med. 2000 May 4;342(18):1301-8
10793162
N Engl J Med. 2006 Jun 15;354(24):2564-75
16714767
Curr Opin Crit Care. 2003 Aug;9(4):316-20
12883288
Lancet. 2005 Jan 1-7;365(9453):82-93
15639683
J Gen Intern Med. 2006 Jun;21(6):559-63
16808736
N Engl J Med. 2004 Jul 22;351(4):327-36
15269312
N Engl J Med. 2006 May 25;354(21):2213-24
16714768
J Natl Med Assoc. 1996 Oct;88(10):630-4
8918067
Ann Intern Med. 2002 Jan 1;136(1):25-36
11777361
BMJ. 1997 Oct 25;315(7115):1059
9366735
Crit Care Med. 2008 Sep;36(9):2504-10
18679127
JAMA. 2007 Mar 21;297(11):1233-40
17374817
Ann Intern Med. 2001 Jul 17;135(2):112-23
11453711
Crit Care Med. 2009 Jan;37(1):1-6
19050621
Ethn Health. 1997 Mar-Jun;2(1-2):31-45
9395587
Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 1):818-24
7509706
N Engl J Med. 2003 Apr 17;348(16):1546-54
12700374
Cancer Nurs. 2007 Jul-Aug;30(4):261-9
17666974
Ann Epidemiol. 2002 May;12(4):248-56
11988413
Ann Intern Med. 2001 Apr 17;134(8):657-62
11304106
JAMA. 2004 Jun 9;291(22):2720-6
15187053