Community and academic hospitals participating in a randomized trial: Patient characteristics, research capacity and trial metrics

IntroductionPatient populations in Canadian community and academic hospitals may differ with respect to demographic and clinical characteristics, as well as outcomes. Community hospitals may also differ with respect to research capacity and trial performance. The objectives of this study are to examine differences between community and academic hospitals participating in the REVISE trial with respect to: 1) patient characteristics; 2) research capacity, and 3) trial metrics. Methods and analysisThis is a preplanned secondary analysis of the REVISE trial (Re-Evaluating the Inhibition of Stress Erosions), which enrolled patients in 42 ICUs in Canada. Baseline demographic and descriptive outcomes for community and academic hospital patients will be reported using descriptive statistics and compared using t-tests, Wilcoxon rank-sum tests or Chi2 test, as appropriate, with p<0.05 indicating statistical significance. To evaluate the impact of site (community versus academic) on the effect of pantoprazole on the primary efficacy and primary safety outcomes, we will use Cox proportional hazards regression analysis, which will be reported as hazard ratio (HR) and 95% confidence intervals, with p<0.05 indicating statistical significance. ResultsResults will be of interest to researchers seeking to improve the generalizability of research findings and to policy makers interested in expanding research capacity in Canadian community hospitals. Ethics and disseminationThe REVISE trial was approved by the research ethics boards of the participating hospitals. The protocol for this study will be reviewed by the Hamilton Integrated Research Ethics Board. Findings will be shared through the Canadian Critical Care Trials Group and will be published through conventional academic channels, including abstracts of critical care meetings and peer-reviewed manuscripts.