Use of a Modified Informed Consent Process among Vulnerable Patients: A Descriptive Study



This article is corrected by:

  1. Errata: ERRATA Volume 21, Issue 9, 1009, Article first published online: 1 August 2006

  • The results of this study have not yet been presented.

Address correspondence and requests for reprints to Dr. Sudore: University of California, San Francisco, VAMC, 4150 Clement Street, Box 181G, San Francisco, CA 94121 (e-mail:


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.

DESIGN: 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).

PARTICIPANTS: Two hundred and four ethnically diverse subjects, aged ≥50, consenting for a trial to improve the forms used for advance directives.

MEASUREMENTS: 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.