Abstract 70: Importance of Both Self-consent and Proxy- consent Enrollments to Avoid Bias in Acute Stroke Randomized Trials
| Autor: | Mark Eckstein, Nerses Sanossain, Nelson Wu, Miguel Valdes-Sueiras, David S Liebeskind, Lucas Restrepo, May Kim-Tenser, Jeffrey L. Saver, Robin Conwit, Kristina Shkirkova, Scott Hamilton, Samuel J. Stratton, Sidney Starkman, Latisha K Sharma, Frank Pratt |
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| Rok vydání: | 2017 |
| Předmět: | |
| Zdroj: | Stroke. 48 |
| ISSN: | 1524-4628 0039-2499 |
| Popis: | Background: Informed consent options for acute stroke randomized trials include self-consent from patients with retained competency, proxy consent from a legally authorized representative (LAR), and exception from informed consent in emergency circumstances (EFIC). Mechanisms other than self-consent trespass upon the ethical principle of autonomy (respect for persons), and should be used only if self-consent alone would bias the patient population. Methods: We analyzed acute stroke patients enrolled within 2h of symptom onset in the NIH Phase 3 Field Administration of Stroke Therapy - Magnesium (FAST-MAG) trial, comparing entry characteristics and outcomes with different consent mechanisms. Results: Among 1700 patients, median time from onset to study entry was 45 min (IQR 35-62). Overall, 60% of patients were competent and provided self-consent, 39% noncompetent and enrolled by proxy consent from an on-scene LAR, and 1% noncompetent enrolled using EFIC/delayed consent. Compared to self-consented patients, proxy-consented patients were: older, 73.8 vs 66.5, p Conclusions: Proxy-informed consent patients differ systematically from self-consent patients, with older age, more comorbidities, more severe deficits, and worse long term outcomes. To ensure that acute stroke trial cohorts are representative of the general stroke population, it is important that enrollment mechanisms include proxy and/or deferred consent. |
| Databáze: | OpenAIRE |
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