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

Table 2 Factors independently associated with co-enrollment in multivariate analysis

	Odds ratio (95% CI)	P-value
Patient demographics
Age (10-year increase)	0.96 (0.91, 1.02)	0.155
Female	0.92 (0.77, 1.11)	0.403
APACHE II score (10-point increase)	1.35 (1.19, 1.53)	< 0.001
Medical versus surgical	1.26 (1.01, 1.57)	0.041
Individual consenting
Substitute decision-maker versus patient	3.31 (2.03, 5.41)	< 0.001
Years of procuring consent for clinical studies in ICU
> 0 to 10 years versus 0 years	0.83 (0.55, 1.25)	< 0.001
> 10 years versus 0 years	2.67 (1.74, 4.11)
Center size (beds screened for PROTECT patients)
15 to 20 beds versus < 15 beds	20.06 (7.56, 53.25)	< 0.001
> 20 beds versus < 15 beds	13.76 (5.15, 36.80)
Full time ICU research staff
1 FTE versus < 1 FTE	1.13 (0.41, 3.11)	0.966
> 1 versus < 1 FTE	1.10 (0.40, 3.03)
Formal trials group affiliation
Yes versus no	5.59 (3.49, 8.95)	< 0.001
Year of PROTECT
Year 1 versus Pilot	8.22 (1.95, 34.61)	< 0.001
Year 2 versus Pilot	32.89 (7.95, 135.98)
Year 3 versus Pilot	38.15 (9.24, 157.51)
Year 4 versus Pilot	24.53 (5.94, 101.25)

In this table, we present the independent factors associated with co-enrollment of one patient into two or more studies identified by multivariate regression analysis, presented using odds ratios (OR) and 95% confidence intervals (95% CI). P-values refer to results of multivariate analyses. ANZICS, Australian and New Zealand Intensive Care Society Clinical Trials Group; APACHE II score, Acute Physiology and Chronic Health Evaluation II score; CCCTG, Canadian Critical Care Trials Group; FTE, full time equivalent; ICU, intensive care unit.

ISSN: 1364-8535