By Robert Fay

Less than one-third of people understood an informed consent form the first time they were exposed to it, according to a study in the August 2006 Journal of General Internal Medicine, even though the form had been modified to increase understanding. The authors state that they modified the consent forms as a way of increasing comprehension for a trial of advance directives, and the current study grew out of that.

Although informed consent "provides the legal and ethical basis for participation in research and clinical procedures, 40% to 80% of subjects with the capacity to consent do not understand 1 or more aspects of consent information." The authors posited that low literacy is probably an important factor in this outcome. Approximately one-half of adults in the United States read at or below the eighth-grade level, but most informed consent forms are written at a level that far exceeds that. The goal of the current study was to describe the modified consent process the authors developed and to determine whether literacy and other subject characteristics were associated with comprehension of consent information and the number of attempts required for subjects to achieve full comprehension.

The researchers recruited 204 subjects who were self-described as fluent in English or Spanish between August and December 2004. Literacy was assessed using the Short Form Test of Functional Health Literacy in Adults (s-TOHFLA). Forty percent of subjects had limited literacy, which was defined as a score of less than 23 on the s-TOHFLA. The subjects were given an informed consent form that was written at the sixth-grade level in English or Spanish and instructed to read along as a native speaker read the form aloud. In addition, the authors used a teach-to-goal process, in which information a person doesn't understand is repeated until he or she fully understands the subject matter. The speakers stopped frequently to ask if the subjects understood what was being read to them. After reading the consent form, subjects were given a comprehension test of 7 true-or-false questions.

Only 28 percent of subjects answered all 7 questions correctly the first time. Eighty percent of subjects answered all questions correctly after the second pass, and 20 percent of subjects needed 3 or more passes to fully comprehend the form. Two percent of subjects did not fully understand the form after 6 iterations. The authors found that participants with lower literacy and minority status were at greatest risk for poor comprehension.

The authors state that, "Our study has important implications for consent in the research and possibly the clinical setting. First, many subjects may be signing consent forms and agreeing to participate without truly understanding what is being asked of them. This raises ethical concerns for research in vulnerable populations, represents a risk of liability to researchers and clinicians, and may introduce personal risk to study participants or patients, particularly for studies or procedures with high risk to benefit ratio." They conclude, "Despite using a number of modifications, most participants had poor comprehension on the first pass through the consent process," which was attributable to lower literacy and minority status. However, by modifying the process to simplify consent forms and employ a teach-to-goal strategy, physicians may be able to "improve the quality of informed consent for diverse populations."

"This research reveals the magnitude of the comprehension gap for the many patients struggling with low health literacy and the inadequacies of written informed consent forms as the sole means of informed consent," said Eleanor Herriman, MD, MBA, Chief Science Officer for NorthPoint Domain. "The challenges of creating a thoroughly 'informed patient' within the practical constraints of clinical practice are one reason many practices are employing Internet-based 'Informed Care' tools as an adjunct to face-to-face discussions."

NorthPoint Domain remains a leader in the development of physician-directed patient engagement information and Informed Care through its Accelerator Resource Center (ARC) and Patient Literacy Center (PLC) and a forerunner in e-communications between patients and physicians with its Secure Messaging Center (SMC). In addition to articles about specific conditions, tests, and treatments, the PLC features information on how patients can improve their overall health through risk factor management articles that contain advice on exercise, weight loss, and smoking cessation. NorthPoint Domain's wellness library, Take Control of Your Health, also offers easy-to-read lifestyle information, such as tips on healthy eating, being physically active, and reducing stress. To learn more about the ARC, PLC, and SMC, visit NorthPoint Domain.

Source: Sudore RL, Landefeld CS, Williams BA, et al. 2006. Use of a modified informed consent process among vulnerable patients: A descriptive study. Journal of General Internal Medicine 21:867-873.

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