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Audiotaping of Informed Consent
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To the Editor: Dr Kodish and colleagues1 reported that 50% of parents of children enrolled in clinical trials of leukemia did not understand the concept of randomization, 18% did not understand they could refuse study enrollment, and 20% did not know they could withdraw their child from the trial at any time. Simes et al2 and Dunn et al3 reported similar results.
Although Kodish et al provided a number of suggestions to improve understanding of randomization, they did not discuss the use of audiotapes. A recent systematic review4 of 8 randomized trials determined that patients with cancer found recordings of medical consultations valuable and 5 of 6 studies showed that they improved recall of the discussion. Thus, audiotapes may also be of benefit in the context of discussing informed consent.
This letter was shown to Dr Kodish, who declined to reply.ED.
Carmen E. Guerra, MD
carmen.guerra{at}uphs.upenn.edu Division of General Internal Medicine University of Pennsylvania School of Medicine Philadelphia
1. Kodish E, Eder M, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA. 2004;291:470-475.
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2. Simes RJ, Tattersall MH, Coates AS, et al. Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment of cancer. BMJ. 1986;293:1065-1068.
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3. Dunn SM, Butow PN, Tattersall MH, et al. General information tapes inhibit recall of the cancer consultation. J Clin Oncol. 1993;11:2279-2285.
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4. Tatterstall MH, Butow PN. Consultation audio tapes: an underused cancer patient information aid and clinical research tool. Lancet Oncol. 2002;3:431-437.
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Letters Section Editor: Stephen J. Lurie, MD, PhD, Senior Editor.
JAMA. 2004;291:1699.
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Communication of Randomization in Childhood Leukemia Trials
Eric Kodish, Michelle Eder, Robert B. Noll, Kathleen Ruccione, Beverly Lange, Anne Angiolillo, Rebecca Pentz, Stephen Zyzanski, Laura A. Siminoff, and Dennis Drotar
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