Abstract
Background:
Obtaining consent from eligible patients in randomized stroke trials can be challenging. Stem cells are controversial in general and may add further hurdles to consent. We investigated the rate of patient and legally authorized representative (LAR) consent and factors determining consent in the first US intra-arterial autologous stem cell Phase 2 multicenter trial: RECOVER Stroke. Methods: In this trial, eligible patients were identified at one week from stroke onset. We performed a retrospective analysis of all eligible patients who were approached for consent at 2 out of 8 actively recruiting centers in the trial. Analyzed data including age, gender, race, NIHSS, lesion location, prior recanlization therapy and mode of consent (self-consent, LAR-consent). Results: Of the 44 patients approached for consent at the two centers, 22 (50%) agreed to participate in the clinical research trial. A trend for higher rate of consent refusal in older patients was noted (mean age of consented patients was 61±11 vs 69±12 on patients with declined consent; p=0.06). The mode of consenting (self-consent vs. LAR-consent) had no impact consenting/refusal rates. Males gender was associated with a significantly higher rate of consent, as well as patients with lower NIHSS. Race and lesion location had no impact on the rates of consent refusal. The multivariate logistic regression analysis revealed male gender as the only variable independently associated with higher rate of consent (OR 7.2; 95%CI 1.6-31.5; p=0.008). The only variable independently associated with LAR-consenting after multivariate binary logistic regression was NIHSS (OR 1.15; 95%CI 1.01-1.31; p=0.03).
Conclusions:
There was a high rate of consent among eligible patients in the first US intra-arterial trial of stem cell therapy for stroke. Male gender was significantly associated with higher overall consent rate and lower NIHSS with proxy consenting.