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Background: Assessing the real-world effectiveness of COVID-19 vaccines and understanding the incidence and severity of SARS-CoV-2 illness in children are essential to inform policy and guide health care professionals in advising parents and caregivers of children who test positive for SARS-CoV-2., Objective: This report describes the objectives and methods for conducting the Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT) study. PROTECT is a longitudinal prospective pediatric cohort study designed to estimate SARS-CoV-2 incidence and COVID-19 vaccine effectiveness (VE) against infection among children aged 6 months to 17 years, as well as differences in SARS-CoV-2 infection and vaccine response between children and adolescents., Methods: The PROTECT multisite network was initiated in July 2021, which aims to enroll approximately 2305 children across four US locations and collect data over a 2-year surveillance period. The enrollment target was based on prospective power calculations and accounts for expected attrition and nonresponse. Study sites recruit parents and legal guardians of age-eligible children participating in the existing Arizona Healthcare, Emergency Response, and Other Essential Workers Surveillance (HEROES)-Research on the Epidemiology of SARS-CoV-2 in Essential Response Personnel (RECOVER) network as well as from surrounding communities. Child demographics, medical history, COVID-19 exposure, vaccination history, and parents/legal guardians' knowledge and attitudes about COVID-19 are collected at baseline and throughout the study. Mid-turbinate nasal specimens are self-collected or collected by parents/legal guardians weekly, regardless of symptoms, for SARS-CoV-2 and influenza testing via reverse transcription-polymerase chain reaction (RT-PCR) assay, and the presence of COVID-like illness (CLI) is reported. Children who test positive for SARS-CoV-2 or influenza, or report CLI are monitored weekly by online surveys to report exposure and medical utilization until no longer ill. Children, with permission of their parents/legal guardians, may elect to contribute blood at enrollment, following SARS-CoV-2 infection, following COVID-19 vaccination, and at the end of the study period. PROTECT uses electronic medical record (EMR) linkages where available, and verifies COVID-19 and influenza vaccinations through EMR or state vaccine registries., Results: Data collection began in July 2021 and is expected to continue through the spring of 2023. As of April 13, 2022, 2371 children are enrolled in PROTECT. Enrollment is ongoing at all study sites., Conclusions: As COVID-19 vaccine products are authorized for use in pediatric populations, PROTECT study data will provide real-world estimates of VE in preventing infection. In addition, this prospective cohort provides a unique opportunity to further understand SARS-CoV-2 incidence, clinical course, and key knowledge gaps that may inform public health., International Registered Report Identifier (irrid): RR1-10.2196/37929., (©Joy Burns, Patrick Rivers, Lindsay B LeClair, Krystal S Jovel, Ramona P Rai, Ashley A Lowe, Laura J Edwards, Sana M Khan, Clare Mathenge, Maria Ferraris, Jennifer L Kuntz, Julie Mayo Lamberte, Kurt T Hegmann, Marilyn J Odean, Hilary McLeland-Wieser, Shawn Beitel, Leah Odame-Bamfo, Natasha Schaefer Solle, Josephine Mak, Andrew L Phillips, Brian E Sokol, James Hollister, Jezahel S Ochoa, Lauren Grant, Matthew S Thiese, Keya B Jacoby, Karen Lutrick, Felipe A Pubillones, Young M Yoo, Danielle Rentz Hunt, Katherine Ellingson, Mark C Berry, Joe K Gerald, Joanna Lopez, Lynn B Gerald, Meredith G Wesley, Karl Krupp, Meghan K Herring, Purnima Madhivanan, Alberto J Caban-Martinez, Harmony L Tyner, Jennifer K Meece, Sarang K Yoon, Ashley L Fowlkes, Allison L Naleway, Lisa Gwynn, Jefferey L Burgess, Mark G Thompson, Lauren EW Olsho, Manjusha Gaglani. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 28.07.2022.)

Background: US fruit and vegetable (FV) intake remains below recommendations, particularly for low-income populations. Evidence on effectiveness of rebates in addressing this shortfall is limited., Objective: This study evaluated the USDA Healthy Incentives Pilot (HIP), which offered rebates to Supplemental Nutrition Assistance Program (SNAP) participants for purchasing targeted FVs (TFVs)., Design: As part of a randomized controlled trial in Hampden County, Massachusetts, 7500 randomly selected SNAP households received a 30% rebate on TFVs purchased with SNAP benefits. The remaining 47,595 SNAP households in the county received usual benefits. Adults in 5076 HIP and non-HIP households were randomly sampled for telephone surveys, including 24-h dietary recall interviews. Surveys were conducted at baseline (1-3 mo before implementation) and in 2 follow-up rounds (4-6 mo and 9-11 mo after implementation). 2784 adults (1388 HIP, 1396 non-HIP) completed baseline interviews; data were analyzed for 2009 adults (72%) who also completed ≥1 follow-up interview., Results: Regression-adjusted mean TFV intake at follow-up was 0.24 cup-equivalents/d (95% CI: 0.13, 0.34 cup-equivalents/d) higher among HIP participants. Across all fruit and vegetables (AFVs), regression-adjusted mean intake was 0.32 cup-equivalents/d (95% CI: 0.17, 0.48 cup-equivalents/d) higher among HIP participants. The AFV-TFV difference was explained by greater intake of 100% fruit juice (0.10 cup-equivalents/d; 95% CI: 0.02, 0.17 cup-equivalents/d); juice purchases did not earn the HIP rebate. Refined grain intake was 0.43 ounce-equivalents/d lower (95% CI: -0.69, -0.16 ounce-equivalents/d) among HIP participants, possibly indicating substitution effects. Increased AFV intake and decreased refined grain intake contributed to higher Healthy Eating Index-2010 scores among HIP participants (4.7 points; 95% CI: 2.4, 7.1 points)., Conclusions: The HIP significantly increased FV intake among SNAP participants, closing ∼20% of the gap relative to recommendations and increasing dietary quality. More research on mechanisms of action is warranted. The HIP trial was registered at clinicaltrials.gov as NCT02651064., (© 2016 American Society for Nutrition.)

Objective: Falls are physically and financially costly, but may be preventable with targeted intervention. The Minimum Data Set (MDS) is one potential source of information on fall risk factors among nursing home residents, but its limited breadth and relatively infrequent updates may limit its practical utility. Richer, more frequently updated data from electronic medical records (EMRs) may improve ability to identify individuals at highest risk for falls., Methods: The authors applied a repeated events survival model to analyze MDS 3.0 and EMR data for 5129 residents in 13 nursing homes within a single large California chain that uses a centralized EMR system from a leading vendor. Estimated regression parameters were used to project resident fall probability. The authors examined the proportion of observed falls within each projected fall risk decile to assess improvements in predictive power from including EMR data., Results: In a model incorporating fall risk factors from the MDS only, 28.6% of observed falls occurred among residents in the highest projected risk decile. In an alternative specification incorporating more frequently updated measures for the same risk factors from the EMR data, 32.3% of observed falls occurred among residents in the highest projected risk decile, a 13% increase over the base MDS-only specification., Conclusions: Incorporating EMR data improves ability to identify those at highest risk for falls relative to prediction using MDS data alone. These improvements stem chiefly from the greater frequency with which EMR data are updated, with minimal additional gains from availability of additional risk factor variables., (© The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Objective: The present study examines the impact of Health Bucks, a farmers' market incentive programme, on awareness of and access to farmers' markets, and fruit and vegetable purchase and consumption in low-income New York City neighbourhoods., Design: The evaluation used two primary data collection methods: (i) an on-site point-of-purchase survey of farmers' market shoppers; and (ii) a random-digit-dial telephone survey of residents in neighbourhoods where the programme operates. Additionally, we conducted a quasi-experimental analysis examining differential time trends in consumption before and after programme introduction using secondary Community Health Survey (CHS) data., Setting: New York City farmers' markets and communities., Subjects: Farmers' market shoppers (n 2287) completing point-of-purchase surveys in a representative sample of New York City farmers' markets in 2010; residents (n 1025) completing random-digit-dial telephone survey interviews in 2010; and respondents (n 35 606) completing CHS interviews in 2002, 2004, 2008 and 2009., Results: Greater Health Bucks exposure was associated with: (i) greater awareness of farmers' markets; (ii) increased frequency and amount of farmers' market purchases; and (iii) greater likelihood of a self-reported year-over-year increase in fruit and vegetable consumption. However, our CHS analysis did not detect impacts on consumption., Conclusions: While our study provides promising evidence that use of farmers' market incentives is associated with increased awareness and use of farmers' markets, additional research is needed to better understand impacts on fruit and vegetable consumption.

Background: Fewer than 10% of US children and adolescents consume the recommended amounts of fruits and vegetables (F/V). The US Department of Agriculture's Fresh Fruit and Vegetable Program (FFVP) is intended to increase child F/V consumption by funding low-income schools to distribute free fresh F/V snacks outside of school mealtimes., Objective: The evaluation assessed FFVP effects on student F/V consumption and total energy intake in and out of school., Design: The evaluation employed a regression discontinuity design; that is, cross-sectional comparisons of a sample of students in schools just above and just below the FFVP funding cutoff for the program, which depended on the proportion of students eligible for free or reduced-price meals. During the 2010-2011 school year within a randomly selected sample of states, we selected schools in closest proximity to each state-specific FFVP funding cutoff. Interviewers conducted 24-hour diary-assisted recall interviews to assess dietary intake among children in selected schools., Participants/setting: Participants were 4,696 students (grades 4 to 6) from 214 elementary schools in 16 randomly selected states., Statistical Analyses Performed: Analysis proceeded via multivariate regression, comparing adjusted mean student intake in schools just above and just below the funding cutoff., Results: Adjusted mean daily F/V intake was one-third of a cup per day higher in FFVP-participating schools than in nonparticipating schools (0.32 cups per day; P<0.001), a difference of 15.5%. This included one-quarter cup higher daily F/V intake during school hours (0.26 cups; P<0.001) among students attending FFVP-participating schools. Fresh (but not total) F/V consumption also increased outside of school., Conclusions: The FFVP increases child fresh and total F/V intake in school, and fresh F/V intake outside of school., (Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.)

Background: No studies have examined the effectiveness of influenza vaccine against intensive care unit (ICU) admission associated with influenza virus infection among children., Methods: In 2010-2011 and 2011-2012, children aged 6 months to 17 years admitted to 21 US pediatric intensive care units (PICUs) with acute severe respiratory illness and testing positive for influenza were enrolled as cases; children who tested negative were PICU controls. Community controls were children without an influenza-related hospitalization, matched to cases by comorbidities and geographic region. Vaccine effectiveness was estimated with logistic regression models., Results: We analyzed data from 44 cases, 172 PICU controls, and 93 community controls. Eighteen percent of cases, 31% of PICU controls, and 51% of community controls were fully vaccinated. Compared to unvaccinated children, children who were fully vaccinated were 74% (95% CI, 19% to 91%) or 82% (95% CI, 23% to 96%) less likely to be admitted to a PICU for influenza compared to PICU controls or community controls, respectively. Receipt of 1 dose of vaccine among children for whom 2 doses were recommended was not protective., Conclusions: During the 2010-2011 and 2011-2012 US influenza seasons, influenza vaccination was associated with a three-quarters reduction in the risk of life-threatening influenza illness in children., (Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2014. This work is written by (a) US Government employee(s) and is in the public domain in the US.)

Objective: Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study., Methods: We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients., Results: Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs. 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs. 12.2%; P = .004). The overall refusal rate across both groups was 33.3%., Conclusions: IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period., (Copyright © 2014 by the American Academy of Pediatrics.)

Objectives: To determine whether antibiotic prescribing can be reduced in nursing homes using a quality improvement (QI) program that involves providers, staff, residents, and families., Design: A 9-month quasi-experimental trial of a QI program in 12 nursing homes (6 comparison, 6 intervention) conducted from March to November 2011., Setting: Nursing homes in two regions of North Carolina, roughly half of whose residents received care from a single practice of long-term care providers., Participants: All residents, including 1,497 who were prescribed antibiotics., Intervention: In the intervention sites, providers in the single practice and nursing home nurses received training related to prescribing guidelines, including situations for which antibiotics are generally not indicated, and nursing home residents and their families were sensitized to matters related to antibiotic prescribing. Feedback on prescribing was shared with providers and nursing home staff monthly., Measurements: Rates of antibiotic prescribing for presumed urinary tract, skin and soft tissue, and respiratory infections., Results: The QI program reduced the number of prescriptions ordered between baseline and follow-up more in intervention than in comparison nursing homes (adjusted incidence rate ratio = 0.86, 95% confidence interval = 0.79-0.95). Based on baseline prescribing rates of 12.95 prescriptions per 1,000 resident-days, this estimated adjusted incidence rate ratio implies 1.8 prescriptions avoided per 1,000 resident-days., Conclusion: This magnitude of effect is unusual in efforts to reduce antibiotic use in nursing homes. Outcomes could be attributed to the commitment of the providers; outreach to providers and staff; and a focus on common clinical situations in which antibiotics are generally not indicated; and suggest that similar results can be achieved on a wider scale if similar commitment is obtained and education provided., (© 2014, Copyright the Authors Journal compilation © 2014, The American Geriatrics Society.)

Background: Pressure ulcers present serious health and economic consequences for nursing home residents. The Agency for Healthcare Research & Quality, in partnership with the New York State Department of Health, implemented the pressure ulcer module of On-Time Quality Improvement for Long Term Care (On-Time), a clinical decision support intervention to reduce pressure ulcer incidence rates., Objective: To evaluate the effectiveness of the On-Time program in reducing the rate of in-house-acquired pressure ulcers among nursing home residents., Research Design and Subjects: We employed an interrupted time-series design to identify impacts of 4 core On-Time program components on resident pressure ulcer incidence in 12 New York State nursing homes implementing the intervention (n=3463 residents). The sample was purposively selected to include nursing homes with high baseline prevalence and incidence of pressure ulcers and high motivation to reduce pressure ulcers. Differential timing and sequencing of 4 core On-Time components across intervention nursing homes and units enabled estimation of separate impacts for each component. Inclusion of a nonequivalent comparison group of 13 nursing homes not implementing On-Time (n=2698 residents) accounts for potential mean-reversion bias. Impacts were estimated via a random-effects Poisson model including resident-level and facility-level covariates., Results: We find a large and statistically significant reduction in pressure ulcer incidence associated with the joint implementation of 4 core On-Time components (incidence rate ratio=0.409; P=0.035). Impacts vary with implementation of specific component combinations., Conclusions: On-Time implementation is associated with sizable reductions in pressure ulcer incidence.

Objectives: To provide empirically based recommendations for incorporating body temperature into clinical decision-making regarding diagnosing infection in nursing home (NH) residents., Design: Retrospective., Setting: Twelve North Carolina NHs., Participants: NH residents (N = 1,007) with 1,858 randomly selected antibiotic prescribing episodes., Measurements: Maximum prescription-day temperature plus the three most recent nonillness temperatures were recorded for each prescribing episode. Two empirically based definitions of fever were developed: population-based (population mean nonillness temperature plus 2 population standard deviations (SDs)) and individualized (individual mean nonillness temperature plus 2 population SDs). These definitions were used along with previously published fever criteria and Infectious Diseases Society of America (IDSA) criteria to determine how often each prescribing episode was associated with a "fever" according to each definition., Results: Mean population nonillness temperature was 97.7 ± 0.5 ºF. If "normal" were defined as less than 2 SDs above the mean, fever would be defined as any temperature above 98.7 ºF, and the previously published fever cutpoints and the IDSA criteria are 4.8 SDs above this mean. Between 30% and 32% of the 1,858 prescribing episodes examined were associated with temperatures more than 2 SDs above the population mean nonillness temperature, whereas only 10% to 11% of episodes met the previously published and IDSA fever definitions., Conclusion: Clinicians should apply empirically based definitions to assess fever in NH residents. Furthermore, low fever prevalence in residents treated with antibiotics according to all definitions suggests that some prescribing may not be associated with acute bacterial infection.

Background: Environmental biomonitoring data provide one way to examine race/ethnicity and income-related exposure disparity and identify potential environmental justice concerns., Methods: We screened U.S. National Health and Nutrition Examination Survey (NHANES) 2001-2008 biomonitoring data for 228 chemicals for race/ethnicity and income-related disparity. We defined six subgroups by race/ethnicity-Mexican American, non-Hispanic black, non-Hispanic white-and income-Low Income: poverty income ratio (PIR) <2, High Income: PIR ≥ 2. We assessed disparity by comparing the central tendency (geometric mean [GM]) of the biomonitoring concentrations of each subgroup to that of the reference subgroup (non-Hispanic white/High Income), adjusting for multiple comparisons using the Holm-Bonferroni procedure., Results: There were sufficient data to estimate at least one geometric mean ratio (GMR) for 108 chemicals; 37 had at least one GMR statistically different from one. There was evidence of potential environmental justice concern (GMR significantly >1) for 12 chemicals: cotinine; antimony; lead; thallium; 2,4- and 2,5-dichlorophenol; p,p'-dichlorodiphenyldichloroethylene; methyl and propyl paraben; and mono-ethyl, mono-isobutyl, and mono-n-butyl phthalate. There was also evidence of GMR significantly <1 for 25 chemicals (of which 17 were polychlorinated biphenyls)., Conclusions: Although many of our results were consistent with the U.S. literature, findings relevant to environmental justice were novel for dichlorophenols and some metals.

Objective: Intake of white potatoes in and out of school was estimated to provide context for a recent proposal by the U.S. Department of Agriculture to limit provision of white potatoes in U.S. school meals., Design: Mean daily servings of white potatoes and other vegetables consumed in and out of school for school-aged children were estimated from two days of 24 h dietary recall data from the National Health and Nutrition Examination Surveys (NHANES). Total energy intake and percentage energy contribution from discretionary oils and solid fats were also estimated for all white potato dishes consumed., Setting: The NHANES is nationally representative of the U.S. civilian noninstitutionalized population., Subjects: Children and adolescents aged 6–19 years (n 8466) from three combined NHANES cycles (2003–2004, 2005–2006 and 2007–2008)., Results: White potatoes represented 32% of all vegetable servings consumed by U.S. children and adolescents. Preparations high in fats and oils, including French fries, were most popular both in and out of school. Mean consumption of white potatoes obtained from school cafeterias was approximately 0.05 servings/d among all children and adolescents, and about 0.15 servings/d among children and adolescents acquiring at least one item from the school cafeteria, implying current weekly intake levels well below the limit of 2 servings/week proposed by the U.S. Department of Agriculture., Conclusions: Although white potatoes represent a substantial proportion of vegetable consumption among school-aged children, it is unclear that proposed limits would influence white potato intake from school cafeterias. Policy makers should consider targeting preparation methods to improve the healthfulness of white potato dishes.

Objective: Medication errors in hospitals are common, expensive, and sometimes harmful to patients. This study's objective was to derive a nationally representative estimate of medication error reduction in hospitals attributable to electronic prescribing through computerized provider order entry (CPOE) systems., Materials and Methods: We conducted a systematic literature review and applied random-effects meta-analytic techniques to derive a summary estimate of the effect of CPOE on medication errors. This pooled estimate was combined with data from the 2006 American Society of Health-System Pharmacists Annual Survey, the 2007 American Hospital Association Annual Survey, and the latter's 2008 Electronic Health Record Adoption Database supplement to estimate the percentage and absolute reduction in medication errors attributable to CPOE., Results: Processing a prescription drug order through a CPOE system decreases the likelihood of error on that order by 48% (95% CI 41% to 55%). Given this effect size, and the degree of CPOE adoption and use in hospitals in 2008, we estimate a 12.5% reduction in medication errors, or ∼17.4 million medication errors averted in the USA in 1 year., Discussion: Our findings suggest that CPOE can substantially reduce the frequency of medication errors in inpatient acute-care settings; however, it is unclear whether this translates into reduced harm for patients., Conclusions: Despite CPOE systems' effectiveness at preventing medication errors, adoption and use in US hospitals remain modest. Current policies to increase CPOE adoption and use will likely prevent millions of additional medication errors each year. Further research is needed to better characterize links to patient harm.

Objectives: The Loeb minimum criteria (LMC), developed by a 2001 consensus conference, are minimum standards for initiation of antibiotics in long term care settings, intended to reduce inappropriate prescribing. This study examined the relationship between nursing home prescriber adherence to the LMC and antibiotic prescribing rates, overall and for each of three specific conditions (urinary tract infections, respiratory infections, and skin and soft tissue infections)., Design: We performed a cross-sectional analysis at the resident-day level. We estimated multivariate models adjusting for nursing home characteristics via multilevel Poisson regression, with robust standard errors to account for clustering of prescriptions within residents within nursing homes., Setting: Data were collected through medical record abstraction in 12 North Carolina nursing homes between March and May 2011., Participants: In total, we identified 3381 antibiotic prescriptions across the 3-month observation period, representing 110,810 nursing home resident-days. In addition, we performed chart audits for a random sample of 653 prescriptions for urinary tract, respiratory, and skin and soft tissue infections to create measures of LMC adherence., Measurements: The primary outcome was a count of prescriptions per resident per day, and the key explanatory variable was a nursing home-level estimate of the proportion of antibiotic prescriptions that adhered to the LMC., Results: Only 12.7% of prescriptions were classified as LMC adherent, although there was substantial variation across study nursing homes (range: 4.8% to 22.0%) and by infection type (1.9% adherence for respiratory infections, 10.2% for urinary tract infections, and 42.7% for skin and soft tissue infections). We found no statistically significant relationship between adherence to the LMC and total prescribing rates (IRR 1.00, 95% CI 0.98-1.03; P = .84). Similarly, there was no significant relationship between LMC adherence and prescribing rates for treating urinary tract infections (IRR 0.99, 95% CI 0.96-1.02; P = .49), respiratory infections (IRR 0.91, 95% CI 0.76-1.08; P = .28), or skin and soft tissue infections (IRR 0.99, 95% CI 0.98-1.01; P = .39) considered alone., Conclusion: We found little evidence that prescribers in study nursing homes considered the LMC when making prescribing decisions. Further, we found no evidence that greater adherence to the LMC was associated with lower rates of antibiotic prescribing. Evidence-based guidelines for antibiotic initiation must be adopted more widely before any substantial gains from adherence are likely to be recognized., (Copyright © 2013 American Medical Directors Association, Inc. All rights reserved.)