To assess for demographic and/or socioeconomic disparities between patients who elect to participate in neurocritical care research and those who decline participation.
The complexity and acuity of neurocritical care introduces unique challenges to the recruitment of patients for randomized clinical trials. Reported declination rates in critical care research are often higher than those in neurological trials outside the intensive care unit. However, factors associated with declination specifically in neurocritical care research have yet to be explored.
In this preliminary analysis, we analyzed screen failure and enrollment data for ongoing neurocritical care clinical trials to compare demographic and socioeconomic trends between patients who were eligible for participation and enrolled (N=52) versus declined (N=20). Declination rates were calculated as the number of patients who declined or withdrew consent divided by the total number of patients deemed eligible for participation. Categorical variables were compared with the Fisher Exact Test; continuous variables were compared with the Mann–Whitney U test.
The declination rate was 27.8% (20/72) among active neurocritical care trials at an academic institution. Among neurocritical care trials, there were no statistically significant differences between enrolled and declined patients in age, gender, primary language, race, ethnicity, living situation, marital status, or median household income by ZIP code. However, employment status was significantly associated with enrollment; 40% (8/20) of patients who declined participation were unemployed, while only 13% (7/52) of patients who enrolled were unemployed (p = 0.011).
While limited by the small sample size of this study, socioeconomic and demographic factors largely do not appear to significantly impact the decision to enroll versus decline participation in research following acute neurological illness. However, the observed association between unemployment and declining to participate in research may reflect important patient concerns and warrants further exploration in larger samples.