Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit

Objective: To develop and evaluate a screen log for monitoring enrollment i n multiple randomized clinical trials conducted in a single center. Setting: University-affiliate 20-bed tertiary care medical-surgical intensi ve care unit (ICU). Patients: Consecutive ICU patients admitted between April 1995 and March 19 97. Methods: We developed a screen log for multicentered studies conducted in o ur ICU. Using a multiple-project, unicenter perspective, we evaluated the s creen log as a tool for monitoring eligibility and enrollment of patients i n four multicentered randomized trials focused on stress ulcer prophylaxis, blood transfusion thresholds, immunotherapy for sepsis and mechanical vent ilation strategies. Results: The screen log was used as an instrument to monitor trial executio n. We recorded ail aspects of study enrollment and created a taxonomy of re asons for nonenrollment into each trial. We calculated enrollment efficienc y rates and used these data to develop strategies to maximize accrual, The screen log became a communication tool that fostered research-oriented cont inuous quality improvement initiatives far the management of concurrently c onducted randomized trials in our ICU. Conclusions: Intensivists participating in several clinical trials may be i nterested in monitoring and maximizing enrollment when conducting multiple studies and understanding the influence of each trial on enrollment into th e others. The unicenter, multiple-project screen log is one tool that may h elp to achieve these goals.