DOI: 10.1097/01.ccm.0000475130.54744.03
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Issn Print: 0090-3493
Publication Date: 2015/12/01
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Excerpt
Methods: We conducted a prospective single-center multi-study analysis in a medical-surgical ICU in Hamilton, Canada, documenting outcomes of screening, consenting, and enrolling patients over 10 years. During weekdays, 1 of 2 full-time Research Coordinators (RCs) electronically screened patients for eligibility. Flowsheets displaying study-specific inclusion and exclusion criteria were pre-configured in a computerized clinical information system (CareVue and ICIP, Phillips Inc, Andover, MA, USA). Subsequently, RCs precisely assessed eligibility by bedside paper chart review and clinician dialogue. Consecutive screened or enrolled patients from June 1 2006 to May 31 2015 were entered into an electronic Research Database (Microsoft Access, 2010, Version: 14.0.7128.5000).
Results: RCs had 24,498 screening episodes for 6671 ICU admissions. There were 2,434 enrollments into 55 academic studies (16 randomized controlled trials, 14 audits, and 25 non-randomized interventional or observational studies). 45 (82%) were multicenter studies. Canadian Critical Care Trials Group represented 29 (53%) studies, reflecting 94% of the RCTs conducted. Themes were respiratory (17), resuscitation (8), gastrointestinal or metabolic (8), hematology (6), rehabilitation (4), consent (3), compassionate care (3), and miscellaneous (6). Consent was waved for 20 (36%) of the studies, informed consent was required for 35 of the studies; 27 (49%) used an a priori model, and 8 (15%) used deferred consent. For studies requiring consent, it was obtained in 1355/1404 consent encounters (96.5% consent rate).
Conclusions: A computerized clinical information system adapted to research, along with careful clinical bedside assessment facilitated efficient screening, consenting and patient enrolment in 55 academic critical care studies over 10 years.
