Despite multiple patient assessments and interventions, obesity continues to cause significant morbidity and mortality nationwide. This study assesses the prevalence of obesity and weight control practices among middle-aged African-American women. In 1995, 307 women 30 years of age and older were consecutively selected in a non-random fashion from three clinic sites located within a public university hospital that served largely indigent, inner city African-American populations. Interviewers surveyed the respondents using the Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System (BRFSS). The prevailing demographic profile of patients in the clinic was middle-aged, indigent, ill, and of low educational attainment. Over 35% of individuals were classified as being overweight (BMI 25 to 29.9 kg/m2) and 45% were classified as being obese (BMI > or = 30 kg/m2). Therefore, more than 80% of individuals in this study were either overweight or obese, with BMI exceeding 25 kg/m2. Of the overweight and obese African-American women in this study, only 40% were attempting current weight loss practices, and weight loss attempts varied directly with body mass index. Although 80% of women attempted weight loss by restricting caloric intake, only 50% were also using physical activity as part of their regime. African-American women in this population have a higher prevalence of obesity and encounter great difficulty losing weight. Counselors should emphasize the value and ease of adopting a moderate regimen of physical activity and not just reducing caloric intake when advising African-American women and their peer network.

Objective: Limited health literacy negatively impacts understanding of medication-related information. We describe an innovative methodology designed to optimize user understanding of patient medication labeling through the systematic application of evidence-based health literacy principles, using the Patient Package Insert (PPI) for bezlotoxumab (ZINPLAVA™, Merck & Co., Inc., Kenilworth, NJ, USA) as an example. Methods: We used a mixed-model, iterative approach consisting of three phases: (1) content development; (2) focus group testing; and (3) comprehension testing. Content development was based on evidence-based health literacy principles and conducted through a collaborative partnership between industry and academia professionals. The PPI was then tested in four focus groups, two in Atlanta and two in Chicago, with an emphasis on collecting feedback from respondents with limited health literacy, evaluated using the Newest Vital Sign (NVS) health literacy assessment tool. Subsequent comprehension testing included patients with C. diff, caregivers, and general population members, with a pre-defined target sample of 25% with limited health literacy identified through two health literacy assessment tools: the Single Item Literacy Screener and the NVS. Results: Content development of the bezlotoxumab PPI occurred in May 2015. In June 2015, focus group respondents (n = 34) provided generally favorable feedback, with insights revolving around organization and usability; language and comprehension; and volume of information. Comprehension testing of the revised PPI resulted in average comprehension scores of 96% for the overall population (n = 59), 90% for individuals presenting with limited health literacy (n = 14), and 97% for those with adequate health literacy (n = 45). This PPI development approach was similarly effective for subsequent products across diverse therapeutic areas, with comprehension scores ≥ 86% for all participants (n = 1197). Conclusion: This methodology represents a significant advancement for the development of understandable patient medication labeling, especially for people with limited health literacy.

Objective Hispanic parents in the United States are disproportionately affected by low health literacy and limited English proficiency (LEP). We examined associations between health literacy, LEP, and liquid medication dosing errors in Hispanic parents. Methods Cross-sectional analysis of data from a multisite randomized controlled experiment to identify best practices for the labeling/dosing of pediatric liquid medications (SAFE Rx for Kids study); 3 urban pediatric clinics. Analyses were limited to Hispanic parents of children aged ≤8 years with health literacy and LEP data (n = 1126). Parents were randomized to 1 of 5 groups that varied by pairing of units of measurement on the label/dosing tool. Each parent measured 9 doses (3 amounts [2.5, 5, 7.5 mL] using 3 tools [2 syringes in 0.2 or 0.5 mL increments, and 1 cup] ) in random order. Dependent variable was a dosing error of > 20% dose deviation. Predictor variables included health literacy (Newest Vital Sign) (limited = 0–3; adequate = 4–6) and LEP (speaks English less than “very well”). Results A total of 83.1% made dosing errors (mean [SD] errors per parent = 2.2 [1.9] ). Parents with limited health literacy and LEP had the greatest odds of making a dosing error compared to parents with adequate health literacy who were English proficient (trials with errors per parent = 28.8 vs 12.9%; adjusted odds ratio = 2.2 [95% confidence interval 1.7–2.8]). Parents with limited health literacy who were English proficient were also more likely to make errors (trials with errors per parent = 18.8%; adjusted odds ratio = 1.4 [95% confidence interval 1.1–1.9] ). Conclusions Dosing errors are common among Hispanic parents; those with both LEP and limited health literacy are at particular risk. Further study is needed to examine how the redesign of medication labels and dosing tools could reduce literacy- and language-associated disparities in dosing errors.