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Table 1 Characteristics of factors associated and not associated with co-enrollment

From: Co-enrollment of critically ill patients into multiple studies: patterns, predictors and consequences

 

Total

patients

(N= 3,746)

Not

co-enrolled

(N= 3,033)

Co-enrolled

patients

(N= 713)

P-value

Patient characteristics

Age, mean (SD)

61.4 (16.5)

61.4 (16.6)

61.4 (15.9)

0.996

Female, N (%)*

1,614 (43.3)

1,319 (43.8)

295 (41.4)

0.257

APACHE II score, mean (SD)**

21.5 (7.8)

21.1 (7.8)

23.3 (7.6)

< 0.001

Medical admission type, N (%)

2,831 (75.6)

2,262 (74.6)

569 (79.8)

0.004

Person consenting, N (%)***

Patient

354 (9.5)

335 (11.1)

19 (2.7)

< 0.001

Substitute decision-maker

3,380 (90.5)

2,686 (88.9)

694 (97.3)

 

Research coordinator characteristics

Years of non-research ICU experience, N (%)

0 years

572 (15.3)

491 (16.2)

81 (11.4)

0.003

> 0 to 10 years

1,254 (33.5)

1,017 (33.5)

237 (33.2)

 

> 10 years

1,920 (51.3)

1,525 (50.3)

395 (55.4)

 

Years of procuring consent for clinical studies in ICU, N (%)

0 years

302 (8.1)

268 (8.8)

34 (4.8)

< 0.001

> 0 to 10 years

2,652 (70.8)

2,276 (75.0)

376 (52.7)

 

> 10 years

792 (21.1)

489 (16.1)

303 (42.5)

 

Center characteristics

Number of ICU beds screened, N (%)

< 15 beds

420 (11.2)

414 (13.6)

6 (0.8)

< 0.001

15 to 20 beds

1622 (43.3)

1,218 (40.2)

404 (56.7)

 

> 20 beds

1,704 (45.5)

1,401 (46.2)

303 (42.5)

 

Full time ICU research staff, N (%)

< 1 FTE

286 (7.6)

280 (9.2)

6 (0.8)

< 0.001

1 FTE

740 (19.8)

622 (20.5)

118 (16.5)

 

> 1 FTE

2,720 (72.6)

2,131 (70.3)

589 (82.6)

 

Formal trials group affiliation, N (%)

Yes

3,224 (86.1)

2,533 (83.5)

691 (96.9)

< 0.001

No

522 (13.9)

500 (16.5)

22 (3.1)

 

Country, N (%)

Canada

2,456 (65.6)

1,818 (59.9)

638 (89.5)

< 0.001

Australia

768 (20.5)

715 (23.6)

53 (7.4)

 

Brazil

275 (7.3)

272 (9.0)

3 (0.4)

 

Saudi Arabia

138 (3.7)

135 (4.5)

3 (0.4)

 

United States

91 (2.4)

77 (2.5)

14 (2.0)

 

United Kingdom

18 (0.5)

16 (0.5)

2 (0.3)

 

Characteristic of enrollment phase, N (%)

Pilot trial

128 (3.4)

126 (4.2)

2 (0.3)

< 0.001

Year 1

556 (14.8)

504 (16.6)

52 (7.3)

 

Year 2

826 (22.1)

626 (20.6)

200 (28.1)

 

Year 3

1,009 (26.9)

761 (25.1)

248 (34.8)

 

Year 4

1,227 (32.8)

1,016 (33.5)

211 (29.6)

 
  1. In this table, we compare patients, person consenting, approaches to consent and research environment associated with co-enrollment versus no co-enrollment. Formal trials group affiliation refers to a center associated with either the Canadian Critical Care Trials Group or the Australian and New Zealand Intensive Care Society Clinical Trials Group. P-values refer to results of univariate analyses. APACHE II score, Acute Physiology and Chronic Health Evaluation II score; ICU, intensive care unit; SD, standard deviation.