Abstract W MP7: Predictors and Implications of Capacity to Provide Informed Consent for Acute Ischemic Stroke Treatment Trials

Abstract

Background and objectives: Enrollment into AIS trials has always been limited by the ability of the patient to give informed consent or the availability of a Legally Authorized Representative (LAR) in decision making capacity on behalf of the patient. In this analysis we try to identify the factors contributing to an acute ischemic stroke (AIS) patient’s inability to give informed consent. We hypothesized that clinical features and demographics would differ between those patients with and without capacity to consent. Methods: This analysis includes patients who enrolled into the coordinating center of the prospective, randomized ARTSS-2 clinical trial (Argatroban + TPA for acute ischemic stroke) and also screen failures due to inability to consent. Data is collected prospectively in the study screening log. The data collected included age, gender, race, NIHSS, lesion location, ER arrival time and mode of consent (self-consent, LAR-consent and unable to consent). Results: Between 12/11 and 06/13, a total of 33 acute ischemic stroke patients received IV-tPA and were eligible for the ARTSS-2 study. While 19 were enrolled, 14/33 (42.4%) were otherwise eligible, but not enrolled due to inability to self-consent and no LAR present. Patients not enrolled due to lack of capacity to consent and without LAR present tended to have higher median NIHSS scores and greater proportions of drowsiness and aphasia compared to the other groups (see table). Conclusion: Approximately 2 in 5 AIS patients are not eligible for AIS clinical trials based solely on their lack of capacity for informed consent. It is remains ethically imperative that current clinical trials as well as future study designs address this disregarded group of patients who deserve the right to be able to participate in research. Addressing this group of patients through exception from informed consent (EFIC) will both extend research to all stroke patients, but also greatly enhance AIS research.

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