Use of a modified informed consent process among vulnerable patients

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.

[1]  G. Harry McLaughlin,et al.  SMOG Grading - A New Readability Formula. , 1969 .

[2]  T. Pape.  Legal and ethical considerations of informed consent. , 1997, AORN journal.

[3]  Dean Schillinger,et al.  Functional health literacy and the quality of physician-patient communication among diabetes patients. , 2004, Patient education and counseling.

[4]  Nina S. Parikh,et al.  The health care experience of patients with low literacy. , 1996, Archives of family medicine.

[5]  R. Liberman,et al.  Informed consent: assessment of comprehension. , 1998, The American journal of psychiatry.

[6]  Michael K Paasche-Orlow,et al.  Readability standards for informed-consent forms as compared with actual readability. , 2003, The New England journal of medicine.

[7]  M. Boccia,et al.  The effect of format modifications and reading comprehension on recall of informed consent information by low-income parents: a comparison of print, video, and computer-based presentations. , 2004, Patient education and counseling.

[8]  E F Cook,et al.  Quality of informed consent: a new measure of understanding among research subjects. , 2001, Journal of the National Cancer Institute.

[9]  F. E. Freeberg,et al.  Informed consent documents: increasing comprehension by reducing reading level. , 1990, IRB.

[10]  Patrick Heagerty,et al.  Randomized, Controlled Evaluation of a Prototype Informed Consent Process for HIV Vaccine Efficacy Trials , 2003, Journal of acquired immune deficiency syndromes.

[11]  Robert J. Levine,et al.  Ethics and Regulation Of Clinical Research , 1982 .

[12]  James Flory,et al.  Interventions to improve research participants' understanding in informed consent for research: a systematic review. , 2004, JAMA.

[13]  Taub Ha,et al.  A reevaluation of informed consent in the elderly: a method for improving comprehension through direct testing. , 1984 .

[14]  D A Murphy,et al.  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. , 1999, AIDS education and prevention : official publication of the International Society for AIDS Education.

[15]  D. Jeste,et al.  Enhancing Informed Consent for Research and Treatment , 2001, Neuropsychopharmacology.

[16]  E. J. Mayeaux,et al.  Parent comprehension of polio vaccine information pamphlets. , 1996, Pediatrics.

[17]  J R Betancourt,et al.  Language barriers to informed consent and confidentiality: the impact on women's health. , 2000, Journal of the American Medical Women's Association.

[18]  Jay S. Blanchard,et al.  Illiteracy among Medicaid Recipients and its Relationship to Health Care Costs , 2010, Journal of health care for the poor and underserved.

[19]  Debra L Roter,et al.  Patient-Centered Communication, Ratings of Care, and Concordance of Patient and Physician Race , 2003, Annals of Internal Medicine.

[20]  S. Tannenbaum.  The eye chart and Dr. Snellen. , 1971, Journal of the American Optometric Association.

[21]  M. Levitt,et al.  Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. , 2001, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[22]  Terri Voepel-Lewis,et al.  Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding. , 2005, Archives of pediatrics & adolescent medicine.

[23]  E Bjørn,et al.  Can the written information to research subjects be improved?--an empirical study. , 1999, Journal of medical ethics.

[24]  Michael K Paasche-Orlow,et al.  Tailored education may reduce health literacy disparities in asthma self-management. , 2005, American journal of respiratory and critical care medicine.

[25]  C. Roberts.  Meeting the needs of patients with limited English proficiency. , 2001, The Journal of medical practice management : MPM.

[26]  D. Baker,et al.  Development of a brief test to measure functional health literacy. , 1999, Patient education and counseling.

[27]  G. Corbie-Smith.  Minority recruitment and participation in health research. , 2004, North Carolina medical journal.

[28]  J. Tyson,et al.  Conventional consent with opting in versus simplified consent with opting out: an exploratory trial for studies that do not increase patient risk. , 1998, The Journal of pediatrics.

[29]  Peijun Chen,et al.  The Mini‐Cog as a Screen for Dementia: Validation in a Population‐Based Sample , 2003, Journal of the American Geriatrics Society.

[30]  D. Jeste,et al.  Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. , 2002, The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry.

[31]  T. Habermann,et al.  Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. , 2003, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[32]  C. Arnold,et al.  A polio immunization pamphlet with increased appeal and simplified language does not improve comprehension to an acceptable level. , 1998, Patient education and counseling.

[33]  R. M. Cooper,et al.  Readability of informed consent forms. , 1991, American journal of hospital pharmacy.

[34]  G. E. Kline,et al.  Comprehension of informed consent information by young-old through old-old volunteers. , 1987, Experimental aging research.

[35]  I. Sharif,et al.  Health literacy among Spanish-speaking Latino parents with limited English proficiency. , 2005, Ambulatory pediatrics : the official journal of the Ambulatory Pediatric Association.

[36]  R. Holcombe,et al.  Informed consent for clinical trials: a comparative study of standard versus simplified forms. , 1998, Journal of the National Cancer Institute.

[37]  N. Poythress,et al.  Improving understanding of research consent disclosures among persons with mental illness. , 2001, Psychiatric services.

[38]  Steven Joffe,et al.  Quality of informed consent in cancer clinical trials: a cross-sectional survey , 2001, The Lancet.

[39]  G. Corbie-Smith,et al.  African American patients' perspectives on medical decision making. , 2004, Archives of internal medicine.

[40]  R. Kirby.  Ethics and Regulation Of Clinical Research , 1982 .

[41]  R. P. Fishburne,et al.  Derivation of New Readability Formulas (Automated Readability Index, Fog Count and Flesch Reading Ease Formula) for Navy Enlisted Personnel , 1975 .

[42]  T M Grundner,et al.  On the readability of surgical consent forms. , 1980, The New England journal of medicine.

[43]  G. E. Kline,et al.  The elderly and informed consent: effects of vocabulary level and corrected feedback. , 1981, Experimental aging research.

[44]  D. Schillinger,et al.  Association of health literacy with diabetes outcomes. , 2002, JAMA.

[45]  R. Barbarash,et al.  The Deaconess Informed Consent Comprehension Test: An Assessment Tool for Clinical Research Subjects , 1996, Pharmacotherapy.

[46]  H. Taub,et al.  The effect of repeated testing upon comprehension of informed consent materials by elderly volunteers. , 1983, Experimental aging research.

[47]  C. Kaestle,et al.  Literacy and reading performance in the United States, from 1880 to the present , 1987 .

[48]  D. Wendler.  Can we ensure that all research subjects give valid consent? , 2004, Archives of internal medicine.