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Saturday, 21 Oct 2017

Informed Consent May Be Compromised By Unrealistic Optimism In Early Cancer Trials

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Can optimism be ethically problematic? Yes, according to a new study, which found unrealistic optimism prevalent among participants in early-phase cancer trials and suggested that it may compromise informed consent.

Many cancer researchers and ethicists assume that hope and optimism in the research context are "always ethically benign, without considering the possibility that they reflect a bias," write the authors of the study, which appears in IRB: Ethics & Human Research. "Others have claimed that unrealistic expectations for benefit are a result of misunderstanding and that the proper response to them is to provide patient-subjects with more information..." But the study cast doubt on both assumptions.

The study included 72 patients with cancer who were enrolled in early-phase oncology trials in the New York metropolitan area between August 2008 and October 2009. Questionnaires assessed signs of unrealistic optimism, as well as participants' understanding of the trials' purpose. Unrealistic optimism, which social psychologists define as being specific to a situation and consider a form of bias, is distinct from "dispositional optimism," which is a general outlook on life and is neither realistic nor unrealistic. Individuals can have one form of optimism without the other.

Study respondents exhibited unrealistic optimism in response to three of five questions about the likelihood of particular events happening to them compared with other trial participants: having their cancer controlled by drugs administered in the trials, experiencing a health benefit from the drugs in the trials, and not experiencing a health problem from the drugs in the trials.

However, a substantial majority of the respondents - 72 percent - accurately understood that the purpose of the trials was to advance knowledge with the potential to benefit future patients and not necessarily to benefit them. Misunderstanding the purpose was not significantly related to unrealistic optimism, the study found.

The authors said that unrealistic optimism has the potential to compromise informed consent "by interfering with the ability to apply information realistically." They concluded: "Improving the consent process in oncology research will require us to do more than address deficits in understanding. It will require us to pay more attention to how patient-subjects apply information to themselves and to become more aware of the social-psychological factors that might impair decision-making in this context."

Notes:

The authors are Lynn A. Jansen, PhD, of Oregon Health and Sciences University; Paul S. Appelbaum, MD, of Columbia University; William M.P. Klein, PhD, of the National Cancer Institute; Neil D. Weinstein, PhD, of the University of Arizona College of Medicine; Jessica S. Fogel, BA, of Columbia University; and Daniel P. Sulmasy, MD, PhD, of the University of Chicago.

Source:
Michael Turton
The Hastings Center

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