1. Legal authorized representative experience with smartphone-based electronic informed consent in an acute stroke trial
- Author
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Diogo C Haussen, Loretta J. Sutherly, Alhamza R Al-Bayati, Gabriel M Rodrigues, Meagan Schultz, Michael R Frankel, Leah Craft, Krishnan Ravindran, Kiva M Schindler, Shannon Doppelheuer, and Raul G Nogueira
- Subjects
Male ,medicine.medical_specialty ,Investigational drug ,Pilot Projects ,030218 nuclear medicine & medical imaging ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,Informed consent ,law ,Surveys and Questionnaires ,medicine ,Humans ,Tertiary level ,Stroke ,Aged ,Acute stroke ,Informed Consent ,business.industry ,Stroke scale ,General Medicine ,Middle Aged ,medicine.disease ,Family medicine ,Female ,Surgery ,Smartphone ,Neurology (clinical) ,business ,030217 neurology & neurosurgery ,Large vessel occlusion - Abstract
BackgroundThe 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.MethodsA 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.ResultsFrom 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.Conclusionse-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.
- Published
- 2019