TABLE 6.
Comparisons of Trial Metrics Between Community and Academic ICUs
| Trial Metrics | Community, n = 352 | Academic, n = 2203 | Total, n = 2555 | p Adjusted for Center |
|---|---|---|---|---|
| Total approached for consent, n | 410 | 2,888 | 3,298 | |
| Informed consent obtained, n | 352 | 2203 | 2,555 | |
| Consent rate (%) | 85.9 | 76.3 | 77.5 | 0.149 |
| Monthly enrollment per 15-bed ICU, mean (sd) | 2.1 (1.4) | 1.1 (0.7) | 1.3 (0.9) | 0.119a |
| Coenrolled, n (%) | 28 (8.0) | 508 (23.1) | 536 (21.0) | 0.061 |
| Protocol adherence | ||||
| Either a) received study product or b) had a legitimate reason not to receive study product on ≥90% of ICU days, n (%) | 319 (90.6) | 2,019 (91.6) | 2,338 (91.5) | 0.207 |
| Received at least one dose of study product, n (%) | 348 (98.9) | 2,187 (99.3) | 2,535 (99.2) | 0.422 |
| No protocol violationb, n (%) | 318 (90.3) | 2,052 (93.1) | 2,370 (92.8) | 0.232 |
aCenter is the unit of analysis for month enrollment; therefore, a t test was performed without adjustment for center.
bNo protocol violation refers to patients who experienced none of the following: 1) received dose(s) of wrong study product, 2) received dose(s) not staggered by 4 hr when concurrently receiving a Lactobacillus-sensitive oral antibiotic, and 3) received dose(s) of open label probiotic.