1. Legal authorized representative experience with smartphone- based electronic informed consent in an acute stroke trial.
- Author
-
Haussen, Diogo c., Craft, Leah, Doppelheuer, Shannon, Rodrigues, Gabriel Martins, Al-Bayati, Alhamza R., Ravindran, Krishnan, Schultz, Meagan, Sutherly, Loretta, Schindler, Kiva M., Frankel, Michael R., and Nogueira, Raul G.
- Subjects
CLINICAL trials ,CONFIDENCE intervals ,INFORMED consent (Medical law) ,JURISPRUDENCE ,PROXY ,STROKE ,SURVEYS ,MULTIPLE regression analysis ,EDUCATIONAL attainment ,SMARTPHONES ,HUMAN research subjects ,ODDS ratio ,NIH Stroke Scale - Abstract
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. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF