Use of a modified informed consent process among vulnerable patients: a descriptive study.

Full Abstract

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 > or = 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.

Learn Faster Today Improve your study skills

Author information

Author/s: Sudore, Rebecca L (RL); Landefeld, C Seth (CS); Williams, Brie A (BA); Barnes, Deborah E (DE); Lindquist, Karla (K); Schillinger, Dean (D);

Affiliation: Division of Geriatrics, San Francisco Veterans Administration Medical Center, University of California, San Francisco, CA 94121, USA. rsucsf(-atsign-)yahoo.com

Grants: AG000212 (Agency:NIA NIH HHS) ; K-23 RR16539-03 (Agency:NCRR NIH HHS) ; K07 AG000912 (Agency:NIA NIH HHS)

Journal and publication information

Publication Type: Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't

Journal: Journal of general internal medicine : official journal of the Society for Research and Education in Primary Care Internal Medicine (J Gen Intern Med), published in United States. (Language: eng)

Reference: 2006-Aug; vol 21 (issue 8) : pp 867-73

Dates: Created 2006/08/02; Completed 2006/09/27; Revised 2008/11/20;

PMID: 16881949, status: MEDLINE (last retrieval date: 12/26/2008)

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

Comments and Corrections

CommentIn: J Gen Intern Med. 2006 Aug;21(8):898-9. (PMID: 16881957)

ErratumIn: J Gen Intern Med. 2006 Sep;21(9):1009.

External Links for this article (including full text providers, if available):

Click Electronic Full-text Provider Links to see options for finding the electronic full text links to this article. Note there may be a subscription or fee required for access to the full text. See our FAQ for information on finding FREE full text articles.

This article may also be located in paper journal collections available in many libraries. Use the Journal and Publication Information above to find the full article.

MeSH headings (categories)

This article was linked to the MESH Headings shown below.

These are the highest related articles currently in the database:

Understanding of informed consent by demented individuals. 21 Dec 2003
Competence to consent to voluntary psychiatric hospitalization: a test of a standard proposed by APA. American Psychiatric Association. 30 Aug 1998
Informed consent for short-stay surgery. 30 Oct 1999
Does the current consent process minimize the risks of genetics research? 29 Nov 2002
[Patient education before a coronary angiography] 30 Dec 2002
Therapeutic misconception in early phase gene transfer trials. 3 Jul 2005
Research on stored biological samples: views of African American and White American cancer patients. 30 Mar 2006
Validity of informed consent. 30 Oct 1978
Patients' perceived understanding of informed consent in investigational drug studies. 28 Feb 1992
Are we getting informed consent from patients with cancer? 29 Jun 1990

See 100+ related articles.