title: An informatics strategy to assure enrollment criteria compliance in studies of the critically ill.
abstract: Up to 18% of acutely ill patients randomized into multicenter clinical trials may not satisfy inclusion/exclusion criteria. To improve compliance with such criteria in an ICU-based multicenter international drug trial, we established a novel Internet/telephone-based strategy for providing rapid case approval or disapproval by centralized panels of critical care physicians. We assessed whether these panels could acquire and record accurate patient information, and whether this approach would minimize enrollment of ineligible patients and could be accomplished in a timely fashion. Analysis of the first 1000 submitted patients showed accurate data capture for 98.7% of enrolled and randomized patients. Median response time from case submission to panel member decision was 34.7 min. Over 99% of enrolled patients met critical study criteria. We conclude that, an Internet-based communications strategy appears to be a valuable adjunct to multicenter clinical trials in acutely ill patients when rapid assurance of eligibility is required.
authors.affiliation: Department of Medicine, University of California San Diego School of Medicine, San Diego, CA, USA. rspragg@ucsd.edu
authors.forename: Roger G
authors.initials: RG
authors.lastname: Spragg
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Masys
authors.forename: David
authors.initials: D
authors.lastname: Sergeant
authors.forename: Thomas
authors.initials: T
authors.lastname: Lawrie
authors.forename: Friedemann J H
authors.initials: FJ
authors.lastname: Taut
mesh_terms: D016638:Critical Illness; D003625:Data Collection; D006801:Humans; D007362:Intensive Care Units; D020407:Internet; D008491:Medical Informatics Applications; D015337:Multicenter Studies as Topic; D018579:Patient Selection; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D013689:Telephone