Faculty Bibliography

BACKGROUND AND OBJECTIVES: Poorly designed labels and dosing tools contribute to dosing errors. We examined the degree to which errors could be reduced with pictographic diagrams, milliliter-only units, and provision of tools more closely matched to prescribed volumes. METHODS: This study involved a randomized controlled experiment in 3 pediatric clinics. English- and Spanish-speaking parents (n = 491) of children 20% deviation), and large error (>2x dose). RESULTS: We found that 83.5% of parents made >/=1 dosing error (overdosing was present in 12.1% of errors) and 29.3% of parents made >/=1 large error (>2x dose). The greatest impact on errors resulted from the provision of tools more closely matched to prescribed dose volumes. For the 2-mL dose, the fewest errors were seen with the 5-mL syringe (5- vs 10-mL syringe: adjusted odds ratio [aOR] = 0.3 [95% confidence interval: 0.2-0.4]; cup versus 10-mL syringe: aOR = 7.5 [5.7-10.0]). For the 7.5-mL dose, the fewest errors were with the 10-mL syringe, which did not necessitate measurement of multiple instrument-fulls (5- vs 10-mL syringe: aOR = 4.0 [3.0-5.4]; cup versus 10-mL syringe: aOR = 2.1 [1.5-2.9]). Milliliter/teaspoon was associated with more errors than milliliter-only (aOR = 1.3 [1.05-1.6]). Parents who received text only (versus text and pictogram) instructions or milliliter/teaspoon (versus milliliter-only) labels and tools made more large errors (aOR = 1.9 [1.1-3.3], aOR = 2.5 [1.4-4.6], respectively). CONCLUSIONS: Provision of dosing tools more closely matched to prescribed dose volumes is an especially promising strategy for reducing pediatric dosing errors.

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 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.

Importance: Medical errors and adverse events (AEs) are common among hospitalized children. While clinician reports are the foundation of operational hospital safety surveillance and a key component of multifaceted research surveillance, patient and family reports are not routinely gathered. We hypothesized that a novel family-reporting mechanism would improve incident detection. Objective: To compare error and AE rates (1) gathered systematically with vs without family reporting, (2) reported by families vs clinicians, and (3) reported by families vs hospital incident reports. Design, Setting, and Participants: We conducted a prospective cohort study including the parents/caregivers of 989 hospitalized patients 17 years and younger (total 3902 patient-days) and their clinicians from December 2014 to July 2015 in 4 US pediatric centers. Clinician abstractors identified potential errors and AEs by reviewing medical records, hospital incident reports, and clinician reports as well as weekly and discharge Family Safety Interviews (FSIs). Two physicians reviewed and independently categorized all incidents, rating severity and preventability (agreement, 68%-90%; kappa, 0.50-0.68). Discordant categorizations were reconciled. Rates were generated using Poisson regression estimated via generalized estimating equations to account for repeated measures on the same patient. Main Outcomes and Measures: Error and AE rates. Results: Overall, 746 parents/caregivers consented for the study. Of these, 717 completed FSIs. Their median (interquartile range) age was 32.5 (26-40) years; 380 (53.0%) were nonwhite, 566 (78.9%) were female, 603 (84.1%) were English speaking, and 380 (53.0%) had attended college. Of 717 parents/caregivers completing FSIs, 185 (25.8%) reported a total of 255 incidents, which were classified as 132 safety concerns (51.8%), 102 nonsafety-related quality concerns (40.0%), and 21 other concerns (8.2%). These included 22 preventable AEs (8.6%), 17 nonharmful medical errors (6.7%), and 11 nonpreventable AEs (4.3%) on the study unit. In total, 179 errors and 113 AEs were identified from all sources. Family reports included 8 otherwise unidentified AEs, including 7 preventable AEs. Error rates with family reporting (45.9 per 1000 patient-days) were 1.2-fold (95% CI, 1.1-1.2) higher than rates without family reporting (39.7 per 1000 patient-days). Adverse event rates with family reporting (28.7 per 1000 patient-days) were 1.1-fold (95% CI, 1.0-1.2; P = .006) higher than rates without (26.1 per 1000 patient-days). Families and clinicians reported similar rates of errors (10.0 vs 12.8 per 1000 patient-days; relative rate, 0.8; 95% CI, .5-1.2) and AEs (8.5 vs 6.2 per 1000 patient-days; relative rate, 1.4; 95% CI, 0.8-2.2). Family-reported error rates were 5.0-fold (95% CI, 1.9-13.0) higher and AE rates 2.9-fold (95% CI, 1.2-6.7) higher than hospital incident report rates. Conclusions and Relevance: Families provide unique information about hospital safety and should be included in hospital safety surveillance in order to facilitate better design and assessment of interventions to improve safety.

OBJECTIVE: Determine maternal and infant characteristics associated with adding cereal into the bottle. DESIGN: Secondary data analysis. PARTICIPANTS: Study participants were immigrant, low-income, urban mother-infant dyads (n = 216; 91% Hispanic, 19% US-born) enrolled in a randomized controlled trial entitled the Bellevue Project for Early Language, Literacy and Education Success. MAIN OUTCOME MEASURES: Maternal characteristics (age, marital status, ethnicity, primary language, country of origin, education, work status, income, depressive symptoms, and concern about infant's future weight) and infant characteristics (gender, first born, and difficult temperament). ANALYSIS: Fisher exact test, chi-square test, and simultaneous multiple logistic regression of significant (P < .05) variables identified in unadjusted analyses. RESULTS: Twenty-seven percent of mothers added cereal into the bottle. After adjusting for confounding variables identified in bivariate analyses, mothers who were single (P = .02), had moderate to severe depressive symptoms (P = .01) and perceived their infant had a difficult temperament (P = .03) were more likely to add cereal into the bottle. Conversely, mothers who expressed concern about their infants becoming overweight were less likely to add cereal (P = .02). CONCLUSIONS AND IMPLICATIONS: Health care providers should screen for adding cereal in infant bottles. Further research is needed to investigate the impact of adding cereal into the bottle on weight trajectories over time. Causal associations also need to be identified to effectively prevent this practice.

OBJECTIVE: Some experts recommend eliminating "teaspoon" and "tablespoon" terms from pediatric medication dosing instructions, as they may inadvertently encourage use of nonstandard tools (i.e. kitchen spoons), which are associated with dosing errors. We examined whether use of "teaspoon" or "tsp" on prescription labels affects parents' choice of dosing tools, and the role of health literacy and language. METHODS: Analysis of data collected as part of a controlled experiment (SAFE Rx for Kids study), which randomized English/Spanish-speaking parents (n=2110) of children <8 years old to 1 of 5 groups which varied in unit of measurement pairings on medication labels/dosing tools. Outcome assessed was parent self-reported choice of dosing tool. Parent health literacy measured using the Newest Vital Sign. RESULTS: 77.0% had limited health literacy (36.0% low, 41.0% marginal); 35.0% completed assessments in Spanish. Overall, 27.7% who viewed labels containing either "tsp" or "teaspoon" units (alone or with "mL") chose nonstandard dosing tools (i.e. kitchen teaspoon, kitchen tablespoon), compared to 8.3% who viewed "mL"-only labels (AOR=4.4[95%CI: 3.3-5.8]). Odds varied based on whether "teaspoon" was spelled out or abbreviated ("teaspoon"-alone: AOR=5.3[3.8-7.3]); "teaspoon" with mL: AOR=4.7[3.3-6.5]; "tsp" with mL (AOR=3.3[2.4-4.7]); p<0.001)). Similar findings were noted across health literacy and language groups. CONCLUSIONS: Use of teaspoon units ("teaspoon" or "tsp) on prescription labels is associated with increased likelihood of parent choice of nonstandard dosing tools. Future studies may be helpful to examine the real-world impact of eliminating teaspoon units from medication labels, and identify additional strategies to promote the safe use of pediatric liquid medications.