Faculty Bibliography

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.

OBJECTIVES: To identify the patient-safety hazards of current medication labeling standards for immigrant and language-minority families. SUMMARY: The Latino population in the United States has increased by more than 40% over the past decade and the total child population born to Latino parents will surpass one-half of the population in many states. With recent health care and immigration policies, this demographic shift has a disproportional effect on the Latino families. Research shows that recent Latin American immigrants face disparities when encountering the U.S. pharmacy system. A review of these disparities shows how new policies should be informed when considering new pharmacy regulations to better address the cultural needs of recent Latin American families to improve medication understanding and adherence. CONCLUSION: To date, research and regulatory requirements for medication safety in the United States have attended insufficiently to the patient-safety risk inherent in providing complex English-language labels to non-English-speaking families, many of whom have limited literacy in their native language. As families move, this patient-safety risk is increased by shifts in pharmacies, which often have different medication-labeling standards. It is important to examine how recent immigrant parents are addressing the medication needs for their children based on their cultural norms and how those cultural practices and acculturation into the U.S. health care system may affect their risk for injury. New research and policy efforts may help to address these barriers to safe medication use.

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.

BACKGROUND AND OBJECTIVES: Poorly designed labels and packaging are key contributors to medication errors. To identify attributes of labels and dosing tools that could be improved, we examined the extent to which dosing error rates are affected by tool characteristics (ie, type, marking complexity) and discordance between units of measurement on labels and dosing tools; along with differences by health literacy and language. METHODS: Randomized controlled experiment in 3 urban pediatric clinics. English- or Spanish-speaking parents (n = 2110) of children 20% deviation; large error defined as > 2 times the dose). RESULTS: A total of 84.4% of parents made >/=1 dosing error (21.0% >/=1 large error). More errors were seen with cups than syringes (adjusted odds ratio = 4.6; 95% confidence interval, 4.2-5.1) across health literacy and language groups (P < .001 for interactions), especially for smaller doses. No differences in error rates were seen between the 2 syringe types. Use of a teaspoon-only label (with a milliliter and teaspoon tool) was associated with more errors than when milliliter-only labels and tools were used (adjusted odds ratio = 1.2; 95% confidence interval, 1.01-1.4). CONCLUSIONS: Recommending oral syringes over cups, particularly for smaller doses, should be part of a comprehensive pediatric labeling and dosing strategy to reduce medication errors.

INTRODUCTION: African American and Latino children experience higher rates of traumatic injury and mortality, but the extent to which parents of different races and ethnicities disparately enact injury prevention behaviors has not been fully characterized. The objective of this study is to evaluate the association between caregiver race/ethnicity and adherence to injury prevention recommendations. METHODS: This was a cross-sectional analysis of caregiver-reported baseline data from the Greenlight study, a cluster-randomized pediatric obesity prevention trial. Data were collected between 2010 and 2012 in four academic pediatric practices and analyzed in 2015. Non-adherence to injury prevention recommendations was based on five domains: car seat safety, sleeping safety, fire safety, hot water safety, and fall prevention. RESULTS: Among 864 caregiver-infant pairs (17.7% white, non-Hispanic; 49.9% Hispanic; 27.7% black, non-Hispanic; 4.7 % other, non-Hispanic), mean number of non-adherent injury prevention behaviors was 1.8 (SD=0.9). In adjusted regression, Hispanic caregivers had higher odds of non-adherence to car seat safety (AOR=2.1, 95% CI=1.2, 3.8), and lower odds of non-adherence with fall prevention (AOR=0.4, 95% CI=0.3, 0.7) compared with whites. Black, non-Hispanic caregivers had higher odds of non-adherence to car seat safety (AOR=2.4, 95% CI=1.3, 4.4) and sleeping safety (AOR=2.1, 95% CI=1.3, 3.2), but lower odds of fall prevention non-adherence (AOR=0.5, 95% CI=0.3, 0.8) compared with whites. CONCLUSIONS: A high prevalence of non-adherence to recommended injury prevention behaviors is common across racial/ethnic categories for caregivers of infants among a diverse sample of families from low-SES backgrounds.

BACKGROUND: More than half of parents underestimate their overweight child's weight; however, previous research focuses on children older than 2 years of age. The objective of this study was to assess whether parents of 2- to 12-month-old infants are able to accurately perceive their children's weight status. METHODS: We performed a cross-sectional analysis of data collected from the Greenlight study, a cluster randomized obesity prevention trial, at 4 pediatric clinics serving diverse and low-income populations. Infants' length and weight were measured at well-child checks, and parents completed questionnaires including demographic characteristics and perception of their children's weight. Weight-for-length (WFL) percentile at the fifth to 95th was considered overweight. We used chi-squared tests to compare accuracy according to weight category and performed logistic regression analysis to assess accuracy at each time point. RESULTS: Approximately 85% to 90% of infants (n = 853 at 2 months, n = 563 at 12 months) were at a healthy WFL at all measurement times, and parents of these infants were more likely to have an accurate perception of their child's weight (accuracy 89%-95%) than overweight children (accuracy 7%-26%; P < .001 across time points). Approximately 10% of healthy weight infants were perceived as underweight by their parents at all time points. At 12 months, mothers who were overweight were significantly more likely to underestimate their child's weight status (P = .008). CONCLUSIONS: In our diverse and low-income sample, parents of overweight infants infrequently know that their infants are overweight. Future studies should examine how perception is related to feeding habits and weight status over time.

OBJECTIVE: Child sleep problems are prevalent and have been linked to poor behavior, worse school performance, and obesity. Low health literacy (HL) is associated with suboptimal parenting practices and worse health outcomes, but the relationship between parent HL and child sleep-related issues is not known. We examined the association between parent HL and child sleep-related issues. DESIGN/METHODS: Cross-sectional analysis of data from caregivers enrolled in a cluster randomized trial of a primary care-based child obesity prevention program in 4 pediatric clinics. Parent HL assessed using the Short Test of Functional HL in Adults. At the 9-month well-child visit, sleep-related factors were assessed: presence of TV in room where child sleeps, regular naptimes and bedtimes (>5 days/week), low daytime and nighttime sleep duration (>1SD below mean based on national data). Adjusted logistic regression analyses performed. RESULTS: 557 caregivers of 9-month olds enrolled (49.7% Hispanic, 26.9% Black, 56.2% <$20K annual income); 49.6% reported having a TV in the room where their child sleeps; 26.6% did not have regular naptimes/bedtimes. Median (IQR) sleep duration was 2.3(1.5-3.0) hours (daytime), 9.0(8.0-10.0) hours (night) (30.2% low daytime; 20.3% low night sleep duration). Children of parents with low HL were more likely to have a bedroom TV (66.7 v. 47.7%, p=0.01; AOR=2.2[95%CI: 1.1-4.3]) and low nighttime sleep (37.0 v. 18.5%, p=0.002; AOR=2.4[1.2-4.8]). CONCLUSIONS: Low parent HL is associated with TV in the bedroom and low night sleep duration. Additional study is needed to further explore these associations and intervention strategies to address child sleep problems.

BACKGROUND: Formula-fed infants may be at greater risk for overfeeding and rapid weight gain. Different size bottles are used for feeding infants, although little is known about whether bottle size is related to weight gain in bottle-fed infants. METHODS: Data from the Greenlight Intervention Study, a cluster randomized trial to prevent childhood obesity at 4 pediatric resident clinics, were used to analyze the exposure to regular (<6 oz) or large (>/=6 oz) bottle size at the 2-month visit on changes in weight, weight-for-age z score (WAZ), and weight-for-length z score (WLZ) at the 6-month visit. Using multivariable regression, we adjusted for potential confounders (birth weight, gender, age, weight measures at 2 months, parent race/ethnicity, education, household income and size, time between 2- and 6-month visits, and first child status). RESULTS: Forty-five percent (n = 386; 41% black, 35% Hispanic, 23% white, 2% other) of infants at the 2-month visit were exclusively formula-fed, and 44% used large (>/=6 oz) bottles. Infants whose parents fed with large bottles had 0.21 kg (95% confidence interval [CI]: 0.05 to 0.37) more weight change, 0.24 U (95% CI: 0.07 to 0.41) more change in WAZ, and 0.31 U (95% CI: 0.08 to 0.54) more change in WLZ during this period than infants fed with regular bottles. CONCLUSIONS: Using a large bottle in early infancy independently contributed to greater weight gain and change in WLZ at the 6-month visit. Although growth in infancy is complex, bottle size may be a modifiable risk factor for rapid infant weight gain and later obesity among exclusively formula-fed infants.