Verbal Labels Can Triple Perceived Risk in Clinical Trials
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Verbal Labels Can Triple Perceived Risk in Clinical Trials
Dianne C. Berry, B k , DPkil Professor Psychology and Pro-Vice-Chancellor. University of Reading. Whiteknights House. Whiteknights. Reading. UK Mark Hothkoursr, PhD Readability Consultant. Golden Valley, Minnesota. USA
Key Words Risk communication: Medicine side effects; Adverse events; Patient information; Clinical trials; Informed consent Corraspondentr Address Professor Dianne B e y Universityof Reading. Whiteknights House, Whiteknights. Reading, RG6 6AH. UK (e-mail: [email protected]). Presented in part at DIA 41st Annual Meeting. lune 26-30. 2005.in Washington. DC.
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The Drug Information Association is accredited by the Accreditalion Councilfor Conlinuing Medical Education to provide continuing medical education for physicians. The Drug Information Association designates fhis educationalactivity for a maximum of I category 1 credit toward theAMA Physiciank Recognition Award. Each physician should only claim those credits that he/she actually spent in the activity lfyou would like lo receive a statement ofcredit,you must review the arficle.answer the questions to the posttest on the Post-test and Evaluation Form and submit it to the DIA. Participants must receive a passing score of 80%or better on the post-test in order to receive a statemenf ofcredit. Statementsof credit will be mailed within one month ofreceipt ofthe Post-test and Evalualion Form. There is no fee to receiveyour statement of credit. Release Date: August 2006 Expiration Date: lufy 31, 2006 Estimated time to complete the activity: I hour
INTRODUCTION The effective communication of risk information is recognized as one of the most challenging aspects of the informed consent process (1). Whether seeking consent for medical treatments or participation in clinical trials, patients must be adequately informed about any potential risks of the procedures or treatments involved. Furthermore, current ethical practice requires that patients not only are given the appropriate information, but also are provided the information in a form that they can readily understand and apply to their own circumstances. Unfortunately, whether in treatment or research settings, health care providers rarely meet the requirement of ensuring that patients understand the necessary information. Titus and Keane (2), for example, studied 167 principal investigators applying to the Midwestern Review Board in the United States for approval for
clinical trials and found that few of the researchers seemed to have any appreciation of the need to assess potential participants’ understanding of what they had been told. In line with this, several studies have shown that the level of patient understanding when making consent decisions is often limited. Joffe et al. (3),for instance, found that 30% of patients in a cross section of oncology clinical trials believed that their treatments had already been proven to be the best treatment for their cancer. In addition, the majority did not recognize the potential for i
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