Informed Consent for Clinical Trials: a Comparative Study of Standard Versus Simplified Forms
| Autor: | Sumona Pramanik, Hans Berkel, Terry C. Davis, Randall F. Holcombe, Stephen G. Divers |
|---|---|
| Rok vydání: | 1998 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Teaching Materials media_common.quotation_subject Literacy Informed consent medicine Humans media_common Clinical Trials as Topic Informed Consent Literacy skill business.industry Middle Aged Confidence interval Surgery Test (assessment) Comprehension Clinical trial Clinical research Reading Oncology Family medicine Educational Status Female business |
| Zdroj: | JNCI Journal of the National Cancer Institute. 90:668-674 |
| ISSN: | 1460-2105 0027-8874 |
| DOI: | 10.1093/jnci/90.9.668 |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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