Figure 1.

Enrollment and outcomes. ACOS = Adult Respiratory Distress Syndrome Cognitive Outcomes Study. *Of 1,001 Fluid and Catheter Treatment Trial (FACTT) subjects who underwent randomization, 227 were ineligible for long-term follow-up as part of Economic Analysis of the Pulmonary-Artery Catheter (EA-PAC) because no regulatory approval was in place and 119 declined consent (33). ^†Subjects were categorized as ineligible if the time window to be tested had elapsed because of the regulatory halt, as incapable if self-determined or determined by a surrogate to be physically or mentally incapable of telephone-based neuropsychological testing, and as lost to follow-up if consent was obtained but the subject was not tested. Of 53 subjects categorized as lost to follow-up, no contact information was available for 1 subject, no telephone service was available for 1 subject, no explanation was provided for 1 subject, and the remaining 50 subjects were recorded as “lost to follow-up.” ^‡Of 52 subjects tested at 2 months, 32 were retested at 12 months. The reasons for 20 subjects being tested at 2 months but not at 12 months were that 11 patients were lost to follow-up, 5 declined, 3 died, and 1 was incarcerated. Subjects were not required to undergo testing at 2 months to be tested at 12 months.