An Analysis of Informed Consent Form Readability of Oncology Research Protocols.

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.

A long-term cross-sectional study on gastric bypass surgery: impact of self-reported past sexual abuse.

BACKGROUND: This study examined differences in gastric bypass surgical outcomes by comparing two groups of female patients: those with a history of sexual abuse (SA) and those without a history of sexual abuse (NSA). METHODS: Participants who agreed to participate in the study were assessed at either 6-18 months or 19-40 months postsurgery. Outcome measures included body mass index (BMI), level of depression as measured through the Beck Depression Inventory, level of self-esteem as measured through the Rosenberg Self-esteem Scale, and BISS as measured through the Body Image State Scale. Two-by-two analyses of variance (ANOVAs) were conducted for each of the four outcome variables. RESULTS: ANOVA results revealed that BMI was the only variable to be found statistically significant among the four dependent measures. At 6-18 months postsurgery, the SA group had significantly higher BMI than the NSA group. Compared BMI during the two postsurgery time periods, the SA group had a significantly lower BMI at 19-40 months than the SA group at 6-18 months postsurgery. CONCLUSION: The results suggest that females with a history of sexual abuse did not differ from their counterparts with regard to depression, self-esteem, and body dissatisfaction at baseline, as well as years after surgery. Given the improvement in BMI from the sexual abuse group at 6-18 months postsurgery to 19-40 month postsurgery, patients may not be as concerned with maintaining excess weight as a defense against potential future abuse as originally proposed.