Recruitment of Ischemic Stroke Patients in Clinical trials in General Practice and Implications for Generalizability of Results

Abstract

Background: While results of clinical trials are used to impact practice among patients with ischemic
stroke, very little information is available regarding proportion and characteristics of patients recruited in
clinical trials in general practice.
Methods: We performed this analysis to provide an audit of recruitment in clinical trials among patients
with acute ischemic stroke using data from the University Healthsystems Consortium benchmarking
project. A review of 40 consecutive ischemic stroke cases meeting inclusion criteria and discharge within a
6-month period was conducted in 32 hospitals.
Results: A total of 1256 patients (mean age 67 years, range 18--99 years) were included. A total of 77
(6%) patients were recruited in clinical trials; 33 and 14 patients recruited in drug or device trials, respectively. In the multivariate analysis, age under 80 years (odd ratio [OR] 2.2, 95% confidence interval [CI]
1.0--4.9), white or African-American race as compared with others (OR 2.5, 95% CI 0.98--6.6), evaluation
by a neurologist or stroke team (OR 14.8, 95% CI 2.0--108), the use of intravenous thrombolysis (OR 8.4,
95% CI 4.9--14.4), and history of hypertension (OR 1.9, 95% CI 1.0--3.4) were associated with recruitment
in clinical trials. There was no relationship between patient’s gender and recruitment in clinical trials. The
rate of intracranial hemorrhage (6% vs 2%, p<0.05) and progression of stroke (12% vs 3%, p<0.05) were
higher among those recruited in clinical trials.
Conclusions: Patients recruited in clinical trials appear to have different characteristics from those who
are not recruited limiting the generalizability of results from current trials.