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Randomized, Controlled Trial of an Easy-to-Read Informed Consent Statement for Clinical Trial Participation: A Study of the Eastern Cooperative Oncology Group

Cathy A. Coyne, Ronghui Xu, Peter Raich, Kathy Plomer, Mark Dignan, Lari B. Wenzel, Diane Fairclough, Thomas Habermann, Linda Schnell, Susan Quella, David Cella

From the Department of Community Medicine, School of Medicine, West Virginia University, Morgantown, WV; Dana Farber Cancer Institute and Harvard School of Public Health, Boston, MA; AMC Cancer Research Center and Colorado Health Outcomes Program, University of Colorado Health Sciences Center, Denver, CO; Prevention Research Center, University of Kentucky, Lexington, KY; Epidemiology Division, University of California, Irvine, Irvine, CA; Mayo Clinic, Rochester; Metro-Minnesota CCOP, Abbott-NW, St. Louis Park, MN; Evanston Northwestern Healthcare, Evanston, IL.

Address reprint requests to Cathy A. Coyne, PhD, Department of Community Medicine, School of Medicine, West Virginia University, PO Box 9190, Morgantown, WV 26506; email: ccoyne{at}hsc.wvu.edu.

Purpose: Studies have documented that the majority of consent documents for medical diagnosis and treatment are written at a reading level above that of the majority of the U.S. population. This study hypothesized that use of an easy-to-read consent statement, when compared with a standard consent statement, will result in higher patient comprehension of the clinical treatment protocol, lower patient anxiety, higher patient satisfaction, and higher patient accrual.

Methods: A randomized controlled trial was conducted in 44 institutions that were members or affiliates of three cooperative oncology groups. Institutions were randomly assigned to administer either an easy-to-read consent statement or the standard consent statement to patients being recruited to participate in selected cancer treatment trials. Telephone interviews were conducted with a total of 207 patients to assess study outcomes.

Results: Patients in the intervention arm demonstrated significantly lower consent anxiety and higher satisfaction compared with patients in the control arm. Patient comprehension and state anxiety were not affected by the intervention. Accrual rates into the parent studies also did not differ significantly between the two study groups.

Conclusion: Clinical trial informed consent statements can be modified to be easier to read without omitting critical information. Patient anxiety and satisfaction can be affected by the consent document. The generalizability of these study results is limited by the characteristics of the patient sample. Ninety percent of the sample were white women, and the mean Rapid Estimate of Adult Literacy in Medicine score was approximately 64, indicating a literacy level at or above the ninth grade.

Supported in part by Public Health Service grants CA23318, CA21115, CA13650, and CA72592, and grants from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services.

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