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An Analysis of Informed Consent Form Readability of Oncology Research Protocols.
- Source :
-
Journal of Empirical Research on Human Research Ethics . Oct2018, Vol. 13 Issue 4, p363-367. 5p. - Publication Year :
- 2018
-
Abstract
- Twenty-two percent of adults in the United States have only basic health literacy skills. We used a multiple linear regression model to identify associations between readability of informed consent documents with study sponsor, study phase, and approval year using a sample of 143 oncology studies at Ochsner Medical Center. The M ± SD Flesh-Kincaid Reading Grade Level (RGL) was 10.33 ± 0.85 and Flesh Reading Ease (FRE) was 52.89 ± 5.49. National Cancer Institute studies had a significantly lower mean RGL and FRE as compared with other sponsors (RGL 9.85 ± 0.66 vs. 10.72 ± 0.79; p value < .0001). Mean RGL did not differ by study phase. Future research should include assessment and improvement of the readability of informed consent documents. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 15562646
- Volume :
- 13
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Journal of Empirical Research on Human Research Ethics
- Publication Type :
- Academic Journal
- Accession number :
- 131881885
- Full Text :
- https://doi.org/10.1177/1556264618795057