Faculty Bibliography

CONTEXT: In response to reports of unintentional drug overdoses among children given over-the-counter (OTC) liquid medications, in November 2009 the US Food and Drug Administration (FDA) released new voluntary industry guidelines that recommend greater consistency and clarity in OTC medication dosing directions and their accompanying measuring devices. OBJECTIVE: To determine the prevalence of inconsistent dosing directions and measuring devices among popular pediatric OTC medications at the time the FDA's guidance was released. DESIGN AND SETTING: Descriptive study of 200 top-selling pediatric oral liquid OTC medications during the 52 weeks ending October 30, 2009. Sample represents 99% of the US market of analgesic, cough/cold, allergy, and gastrointestinal OTC oral liquid products with dosing information for children younger than 12 years. MAIN OUTCOME MEASURES: Inclusion of measuring device, within-product inconsistency between dosing directions on the bottle's label and dose markings on enclosed measuring device, across-product use of nonstandard units and abbreviations, and presence of abbreviation definitions. RESULTS: Measuring devices were packaged with 148 of 200 products (74.0%). Within this subset of 148 products, inconsistencies between the medication's dosing directions and markings on the device were found in 146 cases (98.6%). These included missing markings (n = 36, 24.3%) and superfluous markings (n = 120, 81.1%). Across all products, 11 (5.5%) used atypical units of measurement (eg, drams, cc) for doses listed. Milliliter, teaspoon, and tablespoon units were used for doses in 143 (71.5%), 155 (77.5%), and 37 (18.5%) products, respectively. A nonstandard abbreviation for milliliter (not mL) was used by 97 products. Of the products that included an abbreviation, 163 did not define at least 1 abbreviation. CONCLUSION: At the time the FDA released its new guidance, top-selling pediatric OTC liquid medications contained highly variable and inconsistent dosing directions and measuring devices

OBJECTIVE: To assess the evidence for interventions designed to prevent or reduce overweight and obesity in children younger than 2 years. DATA SOURCES: MEDLINE, the Cochrane Central Register of Controlled Trials, CINAHL, Web of Science, and references from relevant articles. STUDY SELECTION: Included were published studies that evaluated an intervention designed to prevent or reduce overweight or obesity in children younger than 2 years. DATA EXTRACTION: Extracted from eligible studies were measured outcomes, including changes in child weight status, dietary intake, and physical activity and parental attitudes and knowledge about nutrition. Studies were assessed for scientific quality using standard criteria, with an assigned quality score ranging from 0.00 to 2.00 (0.00-0.99 is poor, 1.00-1.49 is fair, and 1.50-2.00 is good). DATA SYNTHESIS: We retrieved 1557 citations; 38 articles were reviewed, and 12 articles representing 10 studies met study inclusion criteria. Eight studies used educational interventions to promote dietary behaviors, and 2 studies used a combination of nutrition education and physical activity. Study settings included home (n = 2), clinic (n = 3), classroom (n = 4), or a combination (n = 1). Intervention durations were generally less than 6 months and had modest success in affecting measures, such as dietary intake and parental attitudes and knowledge about nutrition. No intervention improved child weight status. Studies were of poor or fair quality (median quality score, 0.86; range, 0.28-1.43). CONCLUSIONS: Few published studies attempted to intervene among children younger than 2 years to prevent or reduce obesity. Limited evidence suggests that interventions may improve dietary intake and parental attitudes and knowledge about nutrition for children in this age group. For clinically important and sustainable effect, future research should focus on designing rigorous interventions that target young children and their families

OBJECTIVES: To assess parents' liquid medication administration errors by dosing instrument type and to examine the degree to which parents' health literacy influences dosing accuracy. DESIGN: Experimental study. SETTING: Interviews conducted in a public hospital pediatric clinic in New York, New York, between October 28, 2008, and December 24, 2008. PARTICIPANTS: Three hundred two parents of children presenting for care were enrolled. MAIN OUTCOME MEASURES: Parents were observed for dosing accuracy (5-mL dose) using a set of standardized instruments (2 dosing cups [one with printed calibration markings, the other with etched markings], dropper, dosing spoon, and 2 oral syringes [one with and the other without a bottle adapter]). RESULTS: The percentages of parents dosing accurately (within 20% of the recommended dose) were 30.5% using the cup with printed markings and 50.2% using the cup with etched markings, while more than 85% dosed accurately with the remaining instruments. Large dosing errors (>40% deviation) were made by 25.8% of parents using the cup with printed markings and 23.3% of parents using the cup with etched markings. In adjusted analyses, cups were associated with increased odds of making a dosing error (>20% deviation) compared with the oral syringe (cup with printed markings: adjusted odds ratio [AOR] = 26.7; 95% confidence interval [CI], 16.8-42.4; cup with etched markings: AOR = 11.0; 95% CI, 7.2-16.8). Compared with the oral syringe, cups were also associated with increased odds of making large dosing errors (cup with printed markings: AOR = 7.3; 95% CI, 4.1-13.2; cup with etched markings: AOR = 6.3; 95% CI, 3.5-11.2). Limited health literacy was associated with making a dosing error (AOR = 1.7; 95% CI, 1.1-2.8). CONCLUSIONS: Dosing errors by parents were highly prevalent with cups compared with droppers, spoons, or syringes. Strategies to reduce errors should address both accurate use of dosing instruments and health literacy

OBJECTIVE: To assess the health literacy of US parents and explore the role of health literacy in mediating child health disparities. METHODS: A cross-sectional study was performed for a nationally representative sample of US parents from the 2003 National Assessment of Adult Literacy. Parent performance on 13 child health-related tasks was assessed by simple weighted analyses. Logistic regression analyses were performed to describe factors associated with low parent health literacy and to explore the relationship between health literacy and self-reported child health insurance status, difficulty understanding over-the-counter medication labeling, and use of food labels. RESULTS: More than 6100 parents made up the sample (representing 72600098 US parents); 28.7% of the parents had below-basic/basic health literacy, 68.4% were unable to enter names and birth dates correctly on a health insurance form, 65.9% were unable to calculate the annual cost of a health insurance policy on the basis of family size, and 46.4% were unable to perform at least 1 of 2 medication-related tasks. Parents with below-basic health literacy were more likely to have a child without health insurance in their household (adjusted odds ratio: 2.4 [95% confidence interval: 1.1-4.9]) compared with parents with proficient health literacy. Parents with below-basic health literacy had 3.4 times the odds (95% confidence interval: 1.6-7.4) of reporting difficulty understanding over-the-counter medication labels. Parent health literacy was associated with nutrition label use in unadjusted analyses but did not retain significance in multivariate analyses. Health literacy accounted for some of the effect of education, racial/ethnic, immigrant-status, linguistic, and income-related disparities. CONCLUSIONS: A large proportion of US parents have limited health-literacy skills. Decreasing literacy demands on parents, including simplification of health insurance and other medical forms, as well as medication and food labels, is needed to decrease health care access barriers for children and allow for informed parent decision-making. Addressing low parent health literacy may ameliorate existing child health disparities

BACKGROUND AND OBJECTIVES: Our objective was to determine the level of adult understanding of dosage instructions for a liquid medication commonly prescribed for children. METHODS: Structured interviews were conducted with 373 adults waiting for an appointment at family medicine clinics serving low-income populations in Shreveport, La; Chicago; and Jackson, Mich, from July 2003-August 2004. Subjects were asked to read a prescription label for amoxicillin and explain how they would take the medication. Correct interpretation was determined by a panel of blinded physician reviewers who coded subjects' verbatim responses. Qualitative methods were used to determine the nature of incorrect responses. RESULTS: Twenty-eight percent of subjects misunderstood medication instructions. The prevalence of misinterpreting instructions among subjects with adequate, marginal, and low literacy was 18%, 34%, and 43%, respectively. Common causes for misunderstanding included problems with dosage measurement (28%; ie, tablespoon instead of teaspoon) and frequency of use (33%; ie, every 3 hours instead of every 6-8 hours). In an adjusted analysis that excluded literacy, African Americans were more likely to misunderstand instructions than Caucasians (adjusted odds ratio [AOR] 1.63, 95% confidence interval [CI]=1.02-2.61). When literacy was included in the model, the effect of race on misunderstanding was reduced and nonsignificant. Inadequate and marginal literacy remained independent predictors of misunderstanding (inadequate--AOR 2.90, 95% CI= 1.41-6.00; marginal--AOR 2.20, 95% CI=1.19-3.97). CONCLUSIONS: Misinterpretation of pediatric liquid medication instructions is common. Limited literacy is a significant risk factor for misunderstanding and could contribute to racial disparities. Instructions should be written in a concise manner and standardized to ensure comprehension

Despite a heightened focus on improving quality, recent studies have suggested that children only receive half of the indicated preventive, acute, or chronic care. Two major areas in need of improvement are chronic illness care and prevention of medical errors. Recently, health literacy has been identified as an important and potentially ameliorable factor for improving quality of care. Studies of adults have documented that lower health literacy is independently associated with poorer understanding of prescriptions and other medical information and worse chronic disease knowledge, self-management behaviors, and clinical outcomes. There is also growing evidence to suggest that health literacy is important in pediatric safety and chronic illness care. Adult studies have suggested that addressing literacy can lead to improved patient knowledge, behaviors, and outcomes. Early studies in the field of pediatrics have shown similar promise. There are significant opportunities to evaluate and demonstrate the importance of health literacy in improving pediatric quality of care. Efforts to address health literacy should be made to apply the 6 Institute of Medicine aims for quality-care that is safe, effective, patient centered, timely, efficient, and equitable. Efforts should also be made to consider the distinct nature of pediatric care and address the '4 D's' unique to child health: the developmental change of children over time; dependency on parents or adults; differential epidemiology of child health; and the different demographic patterns of children and their families

OBJECTIVE: To determine whether maternal literacy level accounts for associations between educational level and the cognitive home environment in low-income families. DESIGN: Analysis of 369 mother-infant dyads participating in a long-term study related to early child development. SETTING: Urban public hospital. PARTICIPANTS: Low-income mothers of 6-month-old infants. MAIN EXPOSURE: Maternal literacy level was assessed using the Woodcock-Johnson III/Bateria III Woodcock-Munoz Tests of Achievement, Letter-Word Identification Test. Maternal educational level was assessed by determining the last grade that had been completed by the mother. MAIN OUTCOME MEASURE: The cognitive home environment (provision of learning materials, verbal responsivity, teaching, and shared reading) was assessed using StimQ, an office-based interview measure. RESULTS: In unadjusted analyses, a maternal literacy level of ninth grade or higher was associated with increases in scores for the overall StimQ and each of 4 subscales, whereas a maternal educational level of ninth grade or higher was associated with increases in scores for the overall StimQ and 3 of 4 subscales. In simultaneous multiple linear regression models including both literacy and educational levels, literacy continued to be associated with scores for the overall StimQ (adjusted mean difference, 3.7; 95% confidence interval, 1.7-5.7) and all subscales except teaching, whereas maternal educational level was no longer significantly associated with scores for the StimQ (1.8; 0.5-4.0) or any of its subscales. CONCLUSIONS: Literacy level may be a more specific indicator of risk than educational level in low-income families. Studies of low-income families should include direct measures of literacy. Pediatricians should develop strategies to identify mothers with low literacy levels and promote parenting behaviors to foster cognitive development in these at-risk families

OBJECTIVE: To evaluate the efficacy of a pictogram-based health literacy intervention to decrease liquid medication administration errors by caregivers of young children. DESIGN: Randomized controlled trial. SETTING: Urban public hospital pediatric emergency department. PARTICIPANTS: Parents and caregivers (N = 245) of children aged 30 days to 8 years who were prescribed liquid medications (daily dose or 'as needed'). INTERVENTION: Medication counseling using plain language, pictogram-based medication instruction sheets. Control subjects received standard medication counseling. OUTCOME MEASURES: Medication knowledge and practice, dosing accuracy, and adherence. RESULTS: Of 245 randomized caregivers, 227 underwent follow-up assessments (intervention group, 113; control group, 114). Of these, 99 were prescribed a daily dose medication, and 158 were prescribed medication taken as needed. Intervention caregivers had fewer errors in observed dosing accuracy (>20% deviation from prescribed dose) compared with caregivers who received routine counseling (daily dose: 5.4% vs 47.8%; absolute risk reduction [ARR], 42.4% [95% confidence interval, 24.0%-57.0%]; number needed to treat [NNT], 2 [2-4]; as needed: 15.6% vs 40.0%; ARR, 24.4% (8.7%-38.8%); NNT, 4 [3-12]). Of intervention caregivers, 9.3% were nonadherent (ie, did not give within 20% of the total prescribed doses) compared with 38.0% of controls (ARR, 28.7% [11.4%-43.7%]; NNT, 3 [2-9]). Improvements were also seen for knowledge of appropriate preparation for both medication types, as well as knowledge of frequency for those prescribed daily dose medications. CONCLUSION: A plain language, pictogram-based intervention used as part of medication counseling resulted in decreased medication dosing errors and improved adherence among multiethnic, low socioeconomic status caregivers whose children were treated at an urban pediatric emergency department. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00537433

OBJECTIVE: To determine whether mothers with plans related to shared reading and baby books in the home at the time of delivery of their newborns would be more likely to engage in shared reading behaviors at age 6 months. METHODS: This was a cohort study with enrollment after birth and follow-up at 6 months in an urban public hospital. Predictors included mothers' attitudes and resources related to shared reading during the postpartum period. Outcomes included mothers' shared reading activities and resources at 6 months, as assessed by the StimQ-READ measure. RESULTS: A total of 173 mother-infant dyads were assessed. In multiple regression analyses adjusting for sociodemographics and maternal depression and literacy, StimQ-READ score at 6 months was increased in association with all 3 postpartum predictors: plans for reading as a strategy for school success (adjusted mean 1.7-point increase in 6-month score; 95% confidence interval [95% CI], 0.3-3.0), plans to read in infancy (3.1-point increase; 95% CI, 1.6-4.6), and having baby books in the home (2.3-point increase; 95% CI, 0.9-3.6). In multiple logistic regression analysis, mothers with 2 or more attitudes and resources had an adjusted odds ratio of 6.2 (95% CI, 2.0-18.9) for having initiated reading at 6 months. CONCLUSIONS: Maternal attitudes and resources in early infancy related to shared reading are important predictors of reading behaviors by 6 months. Cumulative postnatal attitudes and resources are the strongest predictors of later behaviors. Additional research is needed regarding whether guidance about shared reading in early infancy or pregnancy would enhance programs such as Reach Out and Read