Use of a screen log to audit patient recruitment into multiple randomized trials in the intensive care unit. Canadian Critical Care Trials Group.
OBJECTIVE
To develop and evaluate a screen log for monitoring enrollment in multiple randomized clinical trials conducted in a single center.


METHODS
University-affiliated 20-bed tertiary care medical-surgical intensive care unit (ICU).


METHODS
Consecutive ICU patients admitted between April 1995 and March 1997.


METHODS
We developed a screen log for multicentered studies conducted in our ICU. Using a multiple-project, unicenter perspective, we evaluated the screen log as a tool for monitoring eligibility and enrollment of patients in four multicentered randomized trials focused on stress ulcer prophylaxis, blood transfusion thresholds, immunotherapy for sepsis and mechanical ventilation strategies.


RESULTS
The screen log was used as an instrument to monitor trial execution. We recorded all aspects of study enrollment and created a taxonomy of reasons for nonenrollment into each trial. We calculated enrollment efficiency rates and used these data to develop strategies to maximize accrual. The screen log became a communication tool that fostered research-oriented continuous quality improvement initiatives for the management of concurrently conducted randomized trials in our ICU.


CONCLUSIONS
Intensivists participating in several clinical trials may be interested in monitoring and maximizing enrollment when conducting multiple studies and understanding the influence of each trial on enrollment into the others. The unicenter, multiple-project screen log is one tool that may help to achieve these goals.
Foster
D
D
Department of Clinical Care, University of Toronto, Ontario, Canada.
Cook
D
D
Granton
J
J
Steinberg
M
M
Marshall
J
J
D002170:Canada; D003422:Critical Care; D005568:Forms and Records Control; D006801:Humans; D007362:Intensive Care Units; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*