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Language Problems May Contribute to Misconceptions About Trials

Language Problems May Contribute to Misconceptions About Trials

BOSTON—Misconceptions about cancer clinical trials are common among trial participants, according to a survey of 205 patients and 61 providers conducted at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Massachusetts General Hospital.

Most of the participants said they were satisfied with the informed consent process and considered themselves well informed. Nonetheless, 74% did not recognize that their treatment was considered nonstandard; 62% did not understand the potential for risk; and 71% were not aware that the treatment was unproven.

Among the participants, 25% did not agree with the statement that trials are performed primarily to benefit future patients, a misconception shared by 54% of the providers.

Among the factors associated with better knowledge of clinical trials were college education, speaking only English at home, use of the National Cancer Institute consent form template, not signing the consent form at initial discussion, presence of a nurse at the consent discussion, and careful reading of the consent form (Lancet 358:1772-1777, 2001).

"Although there were few non-native English speakers, their reduced scores are of great concern," said lead author Jane C. Weeks, MD. "Efforts are needed to ensure that their consent is adequately informed, perhaps by expanding the use of interpreters and translated consent forms." She also suggested several simple interventions to improve understanding, including use of a structured consent template and the presence of a professional third party such as a nurse.

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