© 1998 by Oxford University Press
Journal Of The National Cancer Institute, Vol 90, 668-674, Copyright © 1998 by Oxford University Press
TC Davis, RF Holcombe, HJ Berkel, S Pramanik and SG Divers
BACKGROUND: A high level of reading skill and comprehension is necessary to
understand and complete most consent forms that are required for
participation in clinical research studies. This study was conducted to
test the hypothesis that a simplified consent form would be less
intimidating and more easily understood by individuals with low-
to-marginal reading skills. METHODS: During July 1996, 183 adults (53
patients with cancer or another medical condition and 130 apparently
healthy participants) were tested for reading ability and then asked to
read either the standard Southwestern Oncology Group (SWOG) consent form
(16th grade level) or a simplified form (7th grade level) developed at
Louisiana State University Medical Center-Shreveport (LSU). Participants
were interviewed to assess their attitudes toward and comprehension of the
form read. Then they were given the alternate consent form and asked which
one they preferred and why. RESULTS: Overall, participants preferred the
LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG
form (38%; 95% CI = 30.8%- 45.2%) (P = .0033). Nearly all participants
thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%)
than the SWOG form (75%; 95% CI = 65.1%-85.7%) (P<.0001). However, the
degree to which the participants understood the forms was essentially the
same for the LSU form (58%; 95% CI = 48.6%-67.0%) and the SWOG form (56%;
95% CI = 43.8%- 66.8%). IMPLICATIONS: These findings raise serious
questions regarding the adequacy of the design of written informed consent
documents for the substantial proportion of Americans with low-to-marginal
literacy skills.
ARTICLES
Informed consent for clinical trials: a comparative study of standard versus simplified forms
Department of Medicine and Pediatrics, Feist-Weiller Cancer Center, Louisiana State University Medical Center-Shreveport 71130, USA. tdavis@mail-sh.lsumc.edu
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