Optimizing Informed Consent in Live Liver Donors: Evaluation of a Comprehension Assessment Tool.

Gordon, Edward J.; Vera, Karina; Disharoon, Amy; Mullee, Jack; Butt, Zoltan; Sohn, Mark; Baker, T.

doi:10.1097/00007890-201407151-02787

Cited by 1 publication

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“…The final EDICT items and its performance have been previously described, in which over a year's number of participating living liver donor candidates were provided a copy of the EDICT before and assessed again after donating. 16 EDICT Instrument items pertained to standard consent domains (e.g., procedures, risks, benefits, alternatives, voluntariness) that were tailored to the live liver donor context necessary for potential donors to comprehend for providing informed consent to donate. The preliminary item set included 112 items derived from CMS regulations, OPTN/UNOS guidelines for donor informed consent, literature reviews, liver donor consent forms, and an expert panel feedback.…”

Section: Methodsmentioning

confidence: 99%

Live liver donors’ information needs: A qualitative study of practical implications for informed consent

Gordon

Mullee

Skaro

et al. 2016

Surgery

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Background As live donor liver transplantation is increasingly used to expand the donor pool, concerns remain regarding ensuring live liver donors' informed consent. This study assessed donors' information preferences and perceptions of informed consent. Methods Cognitive interviews were conducted with donors by telephone about how knowledge items in a new survey instrument were material to informed consent, between November 2011 and April 2012. Thematic analysis was used to analyze qualitative data until reaching saturation. Results Twenty-nine liver donors participated (85% participation rate). Donors commonly reported being unable to understand or retain much information disclosed during education. Donors preferred information about major donation risks, e.g., death, and minor risks that would likely affect their daily lives, e.g., wound infection. Donors expressed less interest in information about their rights, confidentiality, or the medical procedure. Donors' preferences varied regarding statistical information. Many perceived the disclosure of risk information to be excessive, and rationalized risks believed to be uncommon or not serious. Donors were disappointed by the brevity of the post-donation hospital stay. Conclusions Our findings suggest that the complexity and volume of disclosed information during evaluation was difficult for donors to adequately comprehend. Donors' lack of appreciation for the seriousness of complications may undermine their ability to provide informed consent. Future research should develop effective information delivery methods to enhance informed consent.

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Section: Methodsmentioning

confidence: 99%