Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial.

BACKGROUND: The pilot use of a smartphone platform for electronic informed consent (e-Consent) in large vessel occlusion acute stroke (LVOS) trials has recently been reported. The degree of satisfaction from Legal Authorized Representatives (LARs) with regard to this process remains to be established. METHODS: A single-center study evaluating the experience of LARs with the use of e-Consent in a LVOS randomized trial of an investigational drug administered within 12 hours of last known normal was carried out. A structured survey was used to evaluate the experience of the LARs with the e-consenting process. RESULTS: From February to November 2018, 60 consecutive patients were e-Consented. Of these, 53 LARs completed the survey. The median (IQR) age of the patients was 63 (53-70) years, baseline/discharge National Institutes of Health Stroke Scale score was 17 (12-20)/3(1-12), and 45% were independent at discharge. The survey was applied in person in 43% of cases and via telephone in 57%. Median LAR age was 48 (39-59) years, 64% were female, and a multi-ethnic composition was observed. Forty percent of LARs had less than tertiary level of education (high-school or less). Regarding the e-Consent, 98% of LARs reported to be 'clear' and 83% felt 'very comfortable' in signing. The overall experience was 'excellent/good' in 91%. Despite the positive general impression regarding the use of e-Consent, 12 LARs (22%) would have preferred paper consent. Multivariable regression indicated that lower educational status (tertiary education or less: OR 5.09, 95% CI 1.02 to 25.48; p=0.04) and lower baseline ASPECTS score (OR 0.63, 95% CI 0.41 to 0.96; p=0.03) were independently associated with preference for paper consent. CONCLUSIONS: e-Consent was overall very well perceived by LARs in a randomized clinical trial of LVOS. A minority of proxies, who were more commonly less formally educated, would have preferred paper consenting.

Endovascular Reperfusion and Cooling in Cerebral Acute Ischemia (ReCCLAIM I).

BACKGROUND: The efficacy of hypothermia as a neuroprotectant has yet to be demonstrated in acute ischemic stroke. We conducted a phase I pilot study to assess the feasibility and safety of performing intravascular hypothermia after definitive intra-arterial reperfusion therapy (IAT). METHODS: ReCCLAIM (Reperfusion and Cooling in Cerebral Acute Ischemia) is a prospective single-arm open-label clinical trial conducted between May and August 2012 at Grady Memorial Hospital. Twenty patients with Alberta Stroke Program Early CT Score (ASPECTS) 5-7 and NIH Stroke Scale (NIHSS) score > 13 were enrolled and treated with intravascular cooling immediately after IAT. The incidence of pneumonia, deep vein thrombosis, cardiac arrhythmias and postoperative hemorrhages was documented for the entire length of stay. Secondary outcomes included blood-brain barrier (BBB) breakdown on gadolinium-enhanced MRIs and 90-day modified Rankin scores (mRS). RESULTS: The mean age, median NIHSS score and median final infarct volume were 59.7 ± 14.6 years, 19 (IQR16-22) and 78 cm(3) (IQR 16-107), respectively. The average time to the target temperature (33 °C) was 64 ± 50 min. Intracranial hemorrhages were found in three patients, of which one was symptomatic. Evidence of BBB breakdown was observed on 3 of 14 MRIs (21%). Six patients died due to withdrawal of care, whereas six patients (30%) achieved mRS of 0-2 at 90 days. In a binary logistical regression model comparing ReCCLAIM patients with 68 historical controls at our institution, hypothermia was protective against intracerebral hemorrhages (OR 0.09, 95% CI 0.02 to 0.56; p<0.01). CONCLUSIONS: Hypothermia can be safely performed after definitive IAT in patients with large pretreatment core infarcts. A phase II study randomizing patients to hypothermia or normothermia is needed to properly assess the efficacy of hypothermia as a neuroprotectant for reperfusion injury. TRIAL REGISTRATION NUMBER: NCT01585597.