Abstract 3769: Barriers to Obtaining Informed Consent in Acute Stroke Clinical Trials
Background Identification of barriers to enrollment in acute stroke clinical trials may identify ways to improve enrollment and expedite completion of clinical research trials. In this exploratory analysis we sought to evaluate the differences in presenting characteristics between patients who are able to provide informed consent (IC) compared with those who were enrolled by the legal authorized representative (LAR).
Methods From our single center, prospectively collected registry, we identified consecutive patients with acute ischemic stroke (AIS) who presented to our emergency department and were enrolled into acute (<8hrs from symptom onset) prospective clinical treatment trials. Data collected included arrival time, thrombolysis time, IC time, source of IC (LAR or patient), aphasia or neglect and method of arrival. For analysis, the patients who were consented by a LAR were compared with patients who provided their own IC.
Results From 2003 - 2011, we identified 124 patients who met inclusion criteria. There were no differences in age, sex, presentation or door to needle times (Table 1). Patients who were able to provide IC presented with less severe stroke (p<0.0001). Aphasia and neglect were significantly more common when a LAR provided IC (p<0.0001). LAR consent required a significantly longer amount of time (90 vs. 71 min., p=0.04).
Conclusions In our single center study, we found that patients with milder stroke are able to provide IC and the presence of aphasia or neglect can hinder enrollment in the absence of a LAR. In addition, when patients are able to provide IC, they do so almost on average 20 minutes faster than the LAR. Additional evaluation is necessary to determine the reasons for delay. Since good outcomes with investigational therapies for AIS treatment are likely to be time dependent, further efforts should target improvement of the IC process to minimize delay in clinical trial enrollment.
- © 2012 by American Heart Association, Inc.