nformed-consent forms should be shortened, simplified, bioethicists say

From the Science Daily 15 July 2011 article

An in-depth review of consent forms provided to volunteers for HIV/AIDS research in the United States and abroad about study procedures, risks and benefits has found that the forms were extremely long and used wording that may have been complex enough to hinder full understanding, according to bioethicists at The Johns Hopkins University.
A systematic analysis of 124 informed-consent documents for U.S. government-sponsored, multinational HIV/AIDS research conducted in 2006 revealed that the forms spanned more than 20 pages, says the study’s lead investigator, Nancy Kass, Sc.D., deputy director for public health at the Johns Hopkins Berman Institute of Bioethics.
“While we were familiar with many fairly long consent forms for several different types of studies,” Kass says, “we were honestly surprised to see that the median length was 22 pages, and the median length for adult forms was a full 27 pages.”
Their study, described in the August issue of the Journal of General Internal Medicine, and funded by the National Institute of Allergy and Infectious Diseases, also found that commonly misunderstood research concepts — namely, randomization and placebos — seemed to be explained with far less attention. For instance, whereas confidentiality sections had a median length of about two pages, randomization was treated to just 53 words….

Risk-Benefit Data Does Not Always Lead To Informed Decision-Making

From the 15 April 2011 Medical News Today article

Giving patients data about the risks and benefits of a medical intervention is not always helpful and may even lead them to irrational decisions, according to an article in the Hastings Center Report. That finding calls into question whether it is essential to disclose quantitative data to patients to help them make informed decisions. An accompanying commentary calls for experimental evidence to determine the best way to provide information to patients.

The analyses come at a time when many patient advocates and others are embracing the “quantitative imperative” – the obligation to disclose risk-related data to patients to ensure informed consent and promote shared decision-making. Because patients often do not get information about all of their options by talking to their health care providers, decision aids – pamphlets, videos, and computer programs – increasingly are being used to convey such data more comprehensively. There are more than 500 decision aids and more than 55 randomized controlled trials studying their impact. A recent review concluded that decision aids increase patient knowledge and the feeling of being informed while decreasing indecision and passivity. ….

…However, disclosure of quantitative data can backfire. ..

…One problem is that more than half of adults have significant difficulty understanding or applying probabilistic and mathematical concepts. National surveys suggest that at least 22 percent of adults have only the most basic quantitative skills, such as counting, while another 33 percent fare only slightly better and are able to do simple arithmetic.

But even people who have a good grasp of probability and math are prone to biases in how they interpret data on risks, Schwartz says, citing 30 years of psychology literature. They may give exaggerated importance to small risks or, conversely, exhibit “optimism bias” and exaggerate the chance that they will be in the “lucky” group. …

An abstract of the report (Questioning the Quantitative Imperative: Decision Aids, Prevention, and the Ethics of Disclosure)
may be found here.

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• True Grit and sharing decisions on health care with our doctors
• Young adults’ beliefs about their health clash with risky behaviors (Science Daily 2 May 2011)
• Too Much Information? Risk-benefit data does not always lead to informed decision-making (eurekalert.org)