Improved understanding and satisfaction with a modified informed consent document: a randomized study

Correspondence: Peter C Raich University of Colorado Denver, Division of Hematology/Oncology, Denver Health Medical Center, 777 Bannock Street, MC 4001, Denver, CO 80204, USA Tel +1 303 602 6062 Fax +1 303 602 6067 Email peter.raich@dhha.org Background: Informed consent documents need to convey crucial information to prospective study participants. We assessed the impact of an informed consent process designed to be understood by persons with low health literacy skills. Methods: We conducted a randomized controlled trial with ethnically and racially diverse male veterans. Participants were randomly assigned to receive and read the standard consent document for the Selenium and Vitamin E Cancer Prevention Trial prostate cancer prevention trial or a culturally tailored, easy-to-read consent document. Telephone interviews were conducted 2 weeks following consent, assessing comprehension, satisfaction, consent anxiety, state anxiety, decisional conflict, and cultural sensitivity. Results: Of 162 male veterans completing the initial telephone interview, 49.7% were African American, 44.1% were Caucasian, and 6.2% were Hispanic. The mean comprehension score for the consent document and process was significantly increased in the intervention arm participants (17.08) versus the standard consent arm (15.06, P , 0.0001). The satisfaction score with the consent information was higher in participants in the intervention arm (3.67 vs 3.42, P = 0.0009), while the consent anxiety score was reduced (1.31 vs 1.56, P = 0.0067). Conclusion: Modifications in the reading level, format, appearance, interactivity, and cultural sensitivity of an informed consent document in the cancer prevention setting significantly improved comprehension of and satisfaction with the consent document, while decreasing consent anxiety.