Use of a modified informed consent process among vulnerable patients: a descriptive study.
BACKGROUND
Little is known about patient characteristics associated with comprehension of consent information, and whether modifications to the consent process can promote understanding.


OBJECTIVE
To describe a modified research consent process, and determine whether literacy and demographic characteristics are associated with understanding consent information.


METHODS
Descriptive study of a modified consent process: consent form (written at a sixth-grade level) read to participants, combined with 7 comprehension questions and targeted education, repeated until comprehension achieved (teach-to-goal).


METHODS
Two hundred and four ethnically diverse subjects, aged > or = 50, consenting for a trial to improve the forms used for advance directives.


METHODS
Number of passes through the consent process required to achieve complete comprehension. Literacy assessed in English and Spanish with the Short Form Test of Functional Health Literacy in Adults (scores 0 to 36).


RESULTS
Participants had a mean age of 61 years and 40% had limited literacy (s-TOHFLA<23). Only 28% of subjects answered all comprehension questions correctly on the first pass. After adjustment, lower literacy (P=.04) and being black (P=.03) were associated with requiring more passes through the consent process. Not speaking English as a primary language was associated with requiring more passes through the consent process in bivariate analyses (P<.01), but not in multivariable analyses (P>.05). After the second pass, most subjects (80%) answered all questions correctly. With a teach-to-goal strategy, 98% of participants who engaged in the consent process achieved complete comprehension.


CONCLUSIONS
Lower literacy and minority status are important determinants of understanding consent information. Using a modified consent process, little additional education was required to achieve complete comprehension, regardless of literacy or language barriers.
Sudore
Rebecca L
RL
Division of Geriatrics, San Francisco Veterans Administration Medical Center, University of California, San Francisco, CA 94121, USA. rsucsf@yahoo.com
Landefeld
C Seth
CS
Williams
Brie A
BA
Barnes
Deborah E
DE
Lindquist
Karla
K
Schillinger
Dean
D
D000368:Aged; D032882:Comprehension; D032962:Consent Forms; D004521:Educational Measurement; D005260:Female; D006801:Humans; D007258:Informed Consent; D008297:Male; D016743:Mental Competency; D008875:Middle Aged; D010353:Patient Education as Topic; D012959:Socioeconomic Factors