title: Optimizing informed consent in living liver donors: Evaluation of a comprehension assessment tool.
abstract: Adult-to-adult living liver donation is associated with considerable risks with no direct medical benefit to liver donors (LDs). Ensuring that potential LDs comprehend the risks of donation is essential to medically and ethically justify the procedure. We developed and prospectively evaluated the initial psychometrics of an "Evaluation of Donor Informed Consent Tool" (EDICT) designed to assess LDs' comprehension about the living donation process. EDICT includes 49 true/false/unsure items related to LD informed consent. Consecutive LDs undergoing evaluation at 1 academic medical center from October 2012 to September 2014 were eligible for participation in pretest/posttest interviews. Medical records were reviewed for postdonation complications. Twenty-seven LDs participated (96% participation rate). EDICT demonstrated good internal consistency reliability at pretest, 2 days before donating (Cronbach's α = 0.78), and posttest, 1 week after donating (α = 0.70). EDICT scores significantly increased over time (P = 0.01) and demonstrated good test-retest reliability (r = 0.68; P < 0.001). EDICT was associated with race/ethnicity (P = 0.02) and relationship to the recipient (P = 0.01; pretest), and income (P = 0.01) and insurance (P = 0.01; posttest), but not with decisional conflict, preoperative preparedness, satisfaction, or decisional regret (pretest and posttest). Donor complications did not impact postdonation EDICT scores. In conclusion, EDICT has promising measurement properties and may be useful in the evaluation of informed consent for potential LDs.
authors.affiliation: Comprehensive Transplant Center, Feinberg School of Medicine, Northwestern University, Chicago, IL.
authors.forename: Elisa J
authors.initials: EJ
authors.lastname: Gordon
authors.affiliation: Center for Healthcare Studies, Feinberg School of Medicine, Northwestern University, Chicago, IL.
authors.forename: Jack
authors.initials: J
authors.lastname: Mullee
authors.affiliation: Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL.
authors.forename: Zeeshan
authors.initials: Z
authors.lastname: Butt
authors.affiliation: Department of Epidemiology and Biostatistics, Feinberg School of Medicine, Northwestern University, Chicago, IL.
authors.forename: Joseph
authors.initials: J
authors.lastname: Kang
authors.affiliation: Division of Transplantation, Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL.
authors.forename: Talia
authors.initials: T
authors.lastname: Baker
mesh_terms: D000328:Adult; D002755:Choice Behavior; D003220:Conflict, Psychological; D046148:Donor Selection; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D057220:Health Literacy; D006498:Hepatectomy / Q000009:adverse effects; D006801:Humans; D007258:Informed Consent; D016031:Liver Transplantation / Q000009:adverse effects / Q000379:methods*; D019520:Living Donors / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011237:Predictive Value of Tests; D011594:Psychometrics; D015203:Reproducibility of Results; D018570:Risk Assessment; D012307:Risk Factors; D011795:Surveys and Questionnaires; D055815:Young Adult