305

Abstract

fentanyl (OR 0.78;) was associated with delirium. Conclusions: Delirium was associated with prolonged ICU stay. Risk of delirium is increased by intubation on admission, lorazepam, and clonidine. Hydrocortisone may decrease risk of delirium.Learning Objectives: Reporting of consent rates in published articles is important in order to determine potential sources of bias, and the validity and generalizability of the results. This is especially true for research in vulnerable populations such as critically ill patients. We therefore sought to determine the percentage of critical care studies for which the actual consent rate was reported. Methods: We conducted a retrospective review of all articles published in eight specific high impact medical journals in 2013. Studies meeting the following inclusion criteria were selected: 1) randomized controlled trial (RCT) or observational clinical study, 2) study population involving critically ill patients, and 3) at least part of the study took place in an ICU. Results: 1871 articles were screened and 156 met the eligibility criteria. The consent rate was reported in only 30.8 % of articles (48/156, 95% CI: 24.1, 38.4). The median consent rate of studies in which it was reported was 86.9 % (IQR 71.6, 94.1). No studies provided any demographic information on patients who were eligible but did not provide consent. A statement on Research Ethics Board (REB) approval was included in 96.8% of studies and the method used to obtain consent was reported in 90.4% of articles. There was a significant difference in reporting of consent rates between RCTs and non-RCTs (58.70% versus 19.09%, P < 0.0001), and North American based studies ha versus those from European countries (52.0% versus 25.5%, P = 0.05).Conclusions: Actual consent rates are reported in less than one third of recent critical care studies which may have implications for the generalizability of their results and planning of future studies. We would strongly encourage journals to require reporting of obtained consent rates and would encourage investigators to ask their REBs for permission to collect a minimum, de-identified dataset on patients who are eligible for research studies but elect not to participate. These two measures would improve the interpretation, validity and generalizability of the results in critical care studies.