Trends of Informed Consent forms for industry-sponsored clinical trials in rheumatology over a 17-year period: Readability, and assessment of patients' health literacy and perceptions.

OBJECTIVE: To assess trends in the length and readability of informed consent forms (ICFs) for industry-sponsored multinational clinical trials (RCTs) in rheumatology over a 17-year period. Additionally, to assess the health literacy (HL) and perceptions of ICFs among participants of current RCTs. METHODS: The readability of ICFs conducted at an outpatient rheumatology clinic between 1999 and 2016 were assessed using the INFLESZ scale. Patients' HL was assessed using SALHSA-50 and STOFHLA. Patient opinions were assessed using a self-reported, in-office questionnaire with an independent patient sample who had signed an ICF in the past 6 months. RESULTS: Thirty-nine ICFs about 22 drugs from 13 pharmaceutical companies were analyzed. The global mean readability was 57 ± 3 (95% CI: 56-58), and all ICFs were categorized as either "somewhat difficult to read" or "average." Readability remained at these levels without significant changes from 1999 to 2016. The mean length of the ICFs written between 1999 and 2005 was 13 ± 5 pages, with a significant increase thereafter (mean 22 ± 8 pages, p = 0.004). Depending on the instrument, of 95 patients participating in the HL assessment, between 18% and 44% had limited HL. Of 90 patients participating in the perceptions questionnaire, 84% reported understanding the ICF well. However, 2-57% misunderstood basic concepts, including the study drug name and placebo. CONCLUSIONS: The disparity between the readability of ICFs with patients' HL and their comprehension of ICFs continues, even after decades of attempts of regulatory agencies and numerous published suggestions.

Adding injury to injury: ethical implications of the Medicaid sterilization consent regulations.

The need for contraceptive and family planning services is often unmet, especially among lower-income women. However, the history of the provision of these services is fraught with coercion and mistrust: in 1979, in response to forced sterilization practices among doctors working with poor and minority populations, the U.S. Department of Health, Education, and Welfare imposed regulations on the informed consent process for Medicaid recipients requesting sterilization. The government mandated, among other requirements, a 30-day waiting period between consent and surgery and proscribed laboring women from providing consent. Initially intended to prevent the exploitation of poor women, these rules have instead become a barrier to many women receiving strongly desired, effective, permanent contraception. More critically, the regulations are ethically flawed: by preventing women from accessing needed family planning services, the Medicaid consent rules violate the standards of beneficence and nonmaleficence; by treating publically insured women differently from privately insured women, they fail the justice standard; and by placing constraints on women's free choice of contraceptive methods, they run afoul of the autonomy standard. The current federal sterilization consent regulations warrant revising. The new rules must simultaneously reduce barriers to tubal ligation while safeguarding the rights of women who have historically suffered mistreatment at the hands of the medical profession. These goals could best be obtained through a combined approach of improved clinician ethics education and a new standardized sterilization consent policy, which applies to all women and which abolishes the 30-day waiting period and the prohibition on obtaining consent in labor.