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

Overview

Journal J Gen Intern Med

Publisher Springer

Specialty General Medicine

Date 2006 Aug 3

PMID 16881949

Citations 114

Authors

Rebecca L Sudore

C Seth Landefeld

Brie A Williams

Deborah E Barnes

Karla Lindquist

Dean Schillinger

Affiliations

Soon will be listed here.

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.

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References

Davis T, Holcombe R, Berkel H, Pramanik S, Divers S . Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998; 90(9):668-74. DOI: 10.1093/jnci/90.9.668. View

Leyva M, Sharif I, Ozuah P . Health literacy among Spanish-speaking Latino parents with limited English proficiency. Ambul Pediatr. 2005; 5(1):56-9. DOI: 10.1367/A04-093R.1. View

Corbie-Smith G . Minority recruitment and participation in health research. N C Med J. 2005; 65(6):385-7. View

Tait A, Voepel-Lewis T, Malviya S, Philipson S . Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding. Arch Pediatr Adolesc Med. 2005; 159(4):347-52. DOI: 10.1001/archpedi.159.4.347. View

Paasche-Orlow M, Riekert K, Bilderback A, Chanmugam A, Hill P, Rand C . Tailored education may reduce health literacy disparities in asthma self-management. Am J Respir Crit Care Med. 2005; 172(8):980-6. PMC: 2718412. DOI: 10.1164/rccm.200409-1291OC. View

Wirshing D, Wirshing W, Marder S, Liberman R, Mintz J . Informed consent: assessment of comprehension. Am J Psychiatry. 1998; 155(11):1508-11. DOI: 10.1176/ajp.155.11.1508. View

Murphy D, OKeefe Z, Kaufman A . Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Educ Prev. 1999; 11(5):389-99. View

Bjorn E, Rossel P, Holm S . Can the written information to research subjects be improved?--an empirical study. J Med Ethics. 1999; 25(3):263-7. PMC: 479221. DOI: 10.1136/jme.25.3.263. View

Wendler D . Can we ensure that all research subjects give valid consent?. Arch Intern Med. 2004; 164(20):2201-4. DOI: 10.1001/archinte.164.20.2201. View

10.

Rogers C, Tyson J, Kennedy K, Broyles R, Hickman J . Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. J Pediatr. 1998; 132(4):606-11. DOI: 10.1016/s0022-3476(98)70347-6. View

11.

Betancourt J, Jacobs E . Language barriers to informed consent and confidentiality: the impact on women's health. J Am Med Womens Assoc (1972). 2000; 55(5):294-5. View

12.

Joffe S, Cook E, Cleary P, Clark J, Weeks J . Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001; 93(2):139-47. DOI: 10.1093/jnci/93.2.139. View

13.

Dresden G, Levitt M . Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Acad Emerg Med. 2001; 8(3):246-52. DOI: 10.1111/j.1553-2712.2001.tb01300.x. View

14.

Dunn L, Jeste D . Enhancing informed consent for research and treatment. Neuropsychopharmacology. 2001; 24(6):595-607. DOI: 10.1016/S0893-133X(00)00218-9. View

15.

Stiles P, Poythress N, Hall A, Falkenbach D, Williams R . Improving understanding of research consent disclosures among persons with mental illness. Psychiatr Serv. 2001; 52(6):780-5. DOI: 10.1176/appi.ps.52.6.780. View

16.

Young D, Hooker D, Freeberg F . Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990; 12(3):1-5. View

17.

Roberts C . Meeting the needs of patients with limited English proficiency. J Med Pract Manage. 2001; 17(2):71-5. View

18.

Joffe S, Cook E, Cleary P, Clark J, Weeks J . Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001; 358(9295):1772-7. DOI: 10.1016/S0140-6736(01)06805-2. View

19.

Dunn L, Lindamer L, Palmer B, Golshan S, Schneiderman L, Jeste D . Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. Am J Geriatr Psychiatry. 2002; 10(2):142-50. View

20.

Schillinger D, Grumbach K, Piette J, Wang F, Osmond D, Daher C . Association of health literacy with diabetes outcomes. JAMA. 2002; 288(4):475-82. DOI: 10.1001/jama.288.4.475. View