Effectiveness of 2-Dose BNT162b2 (Pfizer BioNTech) mRNA Vaccine in Preventing SARS-CoV-2 Infection Among Children Aged 5-11 Years and Adolescents Aged 12-15 Years - PROTECT Cohort, July 2021-February 2022.

The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine was recommended by CDC's Advisory Committee on Immunization Practices for persons aged 12-15 years (referred to as adolescents in this report) on May 12, 2021, and for children aged 5-11 years on November 2, 2021 (1-4). Real-world data on vaccine effectiveness (VE) in these age groups are needed, especially because when the B.1.1.529 (Omicron) variant became predominant in the United States in December 2021, early investigations of VE demonstrated a decline in protection against symptomatic infection for adolescents aged 12-15 years and adults* (5). The PROTECT† prospective cohort of 1,364 children and adolescents aged 5-15 years was tested weekly for SARS-CoV-2, irrespective of symptoms, and upon COVID-19-associated illness during July 25, 2021-February 12, 2022. Among unvaccinated participants (i.e., those who had received no COVID-19 vaccine doses) with any laboratory-confirmed SARS-CoV-2 infection, those with B.1.617.2 (Delta) variant infections were more likely to report COVID-19 symptoms (66%) than were those with Omicron infections (49%). Among fully vaccinated children aged 5-11 years, VE against any symptomatic and asymptomatic Omicron infection 14-82 days (the longest interval after dose 2 in this age group) after receipt of dose 2 of the Pfizer-BioNTech vaccine was 31% (95% CI = 9%-48%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. Among adolescents aged 12-15 years, adjusted VE 14-149 days after dose 2 was 87% (95% CI = 49%-97%) against symptomatic and asymptomatic Delta infection and 59% (95% CI = 22%-79%) against Omicron infection. Fully vaccinated participants with Omicron infection spent an average of one half day less sick in bed than did unvaccinated participants with Omicron infection. All eligible children and adolescents should remain up to date with recommended COVID-19 vaccinations.

Ensuring Access to Albuterol in Schools: From Policy to Implementation. An Official ATS/AANMA/ALA/NASN Policy Statement.

Rationale: For children with asthma, access to quick-relief medications is critical to minimizing morbidity and mortality. An innovative and practical approach to ensure access at school is to maintain a supply of stock albuterol that can be used by any student who experiences respiratory distress. To make this possible, state laws allowing for stock albuterol are needed to improve medication access.Objectives: To provide policy recommendations and outline steps for passing and implementing stock albuterol laws.Methods: We assembled a diverse stakeholder group and reviewed guidelines, literature, statutes, regulations, and implementation documents related to school-based medication access. Stakeholders were divided into two groups-legislation and implementation-on the basis of expertise. Each group met virtually to review documents and draft recommendations. Recommendations were compiled and revised in iterative remote meetings with all stakeholders.Main Results: We offer several recommendations for crafting state legislation and facilitating program implementation. 1) Create a coalition of stakeholders to champion legislation and implement stock albuterol programs. The coalition should include school administrators, school nurses and health personnel, parents, or caregivers of children with asthma, pediatric primary care and subspecialty providers (e.g., pulmonologists/allergists), pharmacists, health department staff, and local/regional/national advocacy organizations. 2) Legislative components critical for effective implementation of stock albuterol programs include specifying that medication can be administered in good faith to any child in respiratory distress, establishing training requirements for school staff, providing immunity from civil liability for staff and prescribers, ensuring pharmacy laws allow prescriptions to be dispensed to schools, and suggesting inhalers with valved holding chambers/spacers for administration. 3) Select an experienced and committed legislator to sponsor legislation and guide revisions as needed during passage and implementation. This person should be from the majority party and serve on the legislature's health or education committee. 4) Develop plans to disseminate legislation and regulations/policies to affected groups, including school administrators, school nurses, pharmacists, emergency responders, and primary/subspecialty clinicians. Periodically evaluate implementation effectiveness and need for adjustments.Conclusions: Stock albuterol in schools is a safe, practical, and potentially life-saving option for children with asthma, whether asthma is diagnosed or undiagnosed, who lack access to their personal quick-relief medication. Legislation is imperative for aiding in the adoption and implementation of school stock albuterol policies, and key policy inclusions can lay the groundwork for success. Future work should focus on passing legislation in all states, implementing policy in schools, and evaluating the impact of such programs on academic and health outcomes.

Managing respiratory emergencies at school: A county-wide stock inhaler program.

BACKGROUND: A total of 15 states allow schools to manage respiratory emergencies among multiple students by using a single albuterol inhaler (stock inhaler) paired with a disposable holding chamber. OBJECTIVE: Our aim was to evaluate implementation barriers and facilitators, as well as satisfaction with a stock inhaler program across K through12 schools in Pima County, Arizona. METHODS: All public, charter, private, and parochial schools were offered supplies, web-based training, and technical assistance at no cost. The RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance) framework was used to evaluate program implementation. School documentation logs were reviewed, school health personnel were surveyed, and a convenience sample of health personnel were interviewed. Chi-square tests evaluated categoric outcomes and Poisson hurdle regression examined stock inhaler use by school organization type, grade levels served, and type of school health personnel employed. RESULTS: In all, 229 schools (68%) participated, reaching 82% of students in the county. A total of 152 schools (66%) used a stock inhaler, accounting for 1038 events. The mean number of puffs administered was 2.7 (SD = 1.2) per event, and most events (79%) involved students with asthma. Although most events (83.9%) resulted in the student returning to class, 15.6% resulted in students being sent home. Only 6 events resulted in 911 calls, and 5 of these led to an ambulance transport. School health personnel reported high levels of satisfaction, and all schools renewed participation for a second year. Program costs were $156 per school. CONCLUSION: With technical assistance, stock inhaler programs can be feasibly implemented by schools in a wide range of settings, thereby increasing their capacity to safely manage respiratory emergencies.

Compliance to a Standardized Protocol for Stock Albuterol Medication among School Staff.

A stock inhaler program provided access to rescue medication (albuterol sulfate) for school children. School staff were provided with a standardized protocol for medication administration. We hypothesized licensed nurses were more likely to report compliant events compared to unlicensed school staff. Stock inhaler events were defined as either compliant or non-compliant. A school protocol compliance score was calculated using the total number of compliant events divided by the total number of all events. The protocol for administration indicated 4 puffs for mild respiratory distress and 8 puffs for severe respiratory distress; therefore, events were defined as compliant if the dose of medication was divisible by 4. A Cragg Poisson hurdle regression was used to examine the association between compliance score and school staff experience. One-hundred fifty-two schools reported 999 stock inhaler events. Of these events, 28% were compliant and 72% of events were non-compliant. After controlling for school organizational type, grades served, and school size, school staff experience was not predictive of protocol compliance. Future efforts should focus on improving protocol compliance among licensed nurses and unlicensed school staff.

Medication Administration Practices in United States' Schools: A Systematic Review and Meta-synthesis.

Schools often provide medication management to children at school, yet, most U.S. schools lack a full-time, licensed nurse. Schools rely heavily on unlicensed assistive personnel (UAP) to perform such tasks. This systematic review examined medication management among K-12 school nurses. Keyword searches in three databases were performed. We included studies that examined: (a) K-12 charter, private/parochial, or public schools, (b) UAPs and licensed nurses, (c) policies and practices for medication management, or (d) nurse delegation laws. Three concepts were synthesized: (a) level of training, (b) nurse delegation, and (c) emergency medications. One-hundred twelve articles were screened. Of these, 37.5% (42/112) were comprehensively reviewed. Eighty-one percent discussed level of training, 69% nurse delegation, and 57% emergency medications. Succinct and consistent policies within and across the United States aimed at increasing access to emergency medications in schools remain necessary.

Interim Estimate of Vaccine Effectiveness of BNT162b2 (Pfizer-BioNTech) Vaccine in Preventing SARS-CoV-2 Infection Among Adolescents Aged 12-17 Years - Arizona, July-December 2021.

The BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccine has demonstrated high efficacy in preventing infection with SARS-CoV-2 (the virus that causes COVID-19) in randomized placebo-controlled Phase III trials in persons aged 12-17 years (referred to as adolescents in this report) (1); however, data on real-word vaccine effectiveness (VE) among adolescents are limited (1-3). As of December 2021, the Pfizer-BioNTech vaccine is approved by the Food and Drug Administration (FDA) for adolescents aged 16-17 years and under FDA emergency use authorization for those aged 12-15 years. In a prospective cohort in Arizona, 243 adolescents aged 12-17 years were tested for SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR) each week, irrespective of symptoms, and upon onset of COVID-19-like illness during July 25-December 4, 2021; the SARS-CoV-2 B.1.617.2 (Delta) variant was the predominant strain during this study period. During the study, 190 adolescents contributed fully vaccinated person-time (≥14 days after receiving 2 doses of Pfizer-BioNTech vaccine), 30 contributed partially vaccinated person-time (receipt of 1 dose or receipt of 2 doses but with the second dose completed <14 days earlier), and 66 contributed unvaccinated person-time. Using the Cox proportional-hazards model, the estimated VE of full Pfizer-BioNTech vaccination for preventing SARS-CoV-2 infection was 92% (95% CI = 79%-97%), adjusted for sociodemographic characteristics, health information, frequency of social contact, mask use, location, and local virus circulation. These findings from a real-world setting indicate that 2 doses of Pfizer-BioNTech vaccine are highly effective in preventing SARS-CoV-2 infection among Arizona adolescents. CDC recommends COVID-19 vaccination for all eligible persons in the United States, including persons aged 12-17 years.

School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial.

BACKGROUND: School-supervised use of a once-daily inhaled corticosteroid regimen (supervised therapy) can improve medication adherence and asthma control. OBJECTIVE: We sought to evaluate the effectiveness of supervised therapy in a unique setting and population. METHODS: We conducted a cluster randomized trial of supervised therapy in 20 elementary schools with a disproportionate enrollment of low-income Latino students. Schools were purposively selected, matched, and randomized to receive 9 months of supervised therapy with mometasone furoate or usual care. All English- or Spanish-speaking students with self-reported asthma were eligible. The Asthma Control Questionnaire (ACQ) was interviewer administered quarterly at school. Students in supervised therapy schools were hypothesized to have lower ACQ scores than students in usual-care schools. RESULTS: Of 393 enrolled students, 189 students receiving immediate intervention and 143 students receiving delayed intervention provided 1 or more ACQ data points, were between 6 and 10 years of age, and were included in the primary analysis. At baseline, 39% of students reported taking a controller medication, and 24% had well-controlled asthma. Eighty percent of students receiving immediate intervention were prescribed mometasone. Schools administered 98% of prescribed doses when students attended school. Absences, weekends, and holidays reduced calendar adherence to 53%. During the first year, the mean ACQ score for students receiving immediate and delayed intervention was 1.55 (95% CI, 1.41-1.70) and 1.64 (95% CI, 1.47-1.80), respectively. The estimated treatment effect was -0.08 (95% CI, -0.31 to 0.14). DISCUSSION: Compared with usual care, supervised therapy did not improve asthma control among this population of Latino students. Additional research is warranted to confirm these results.

Cost-benefit of point-of-use devices for lead reduction.

BACKGROUND: Lead exposure represents a significant human health concern that often occurs with little warning to the consumer. Water lead levels can be mitigated by point-of-use (POU) devices such as reverse osmosis, distillation, or activated carbon with lead reduction media. OBJECTIVES: This study assessed a partial cost-benefit of residential installation of POU devices to reduce lead concentrations in drinking water and examined the economic impact at the community level based on exposures reported in Flint, Michigan. METHODS: We calculated the individual consumer breakeven point for each lead abatement option by subtracting the lifetime cost of device installation and maintenance from the lifetime cost of lead exposure through its impact on intelligence (IQ) and lifetime earnings. This approach was then extrapolated to the community level based on reported lead exposures in Flint, Michigan. RESULTS: Based on operating POU device costs, lead absorption from water, and economic losses associated with reduced IQ, initial water lead levels associated with consumer breakeven points for reverse osmosis (7.31 µg/L), activated carbon (3.73 µg/L), and distillation (12.0 µg/L) were calculated. For example, an individual consuming water with 25 µg/L of lead, similar to the 90th percentile of concentrations measured in Flint, Michigan, would have an expected blood lead level of 1.25 µg/dL, a corresponding loss of 0.641 IQ points, and a lifetime economic earnings loss of $14,284. Over 70 years of continued use, activated carbon with lead reduction media is the least expensive device to maintain and operate as compared to reverse osmosis and distillation. CONCLUSIONS: Infrastructure failures related to drinking water are unpredictable and exposure to contaminates can have significant economic ramifications. POU devices represent a cost-effective option to reduce the impact of lead exposure, particularly when water lead concentrations exceed regulated levels.

Improving the Affordability of Prescription Medications for People with Chronic Respiratory Disease. An Official American Thoracic Society Policy Statement.

BACKGROUND: Mounting evidence indicates that out-of-pocket costs for prescription medications, particularly among low- and middle-income patients with chronic diseases, are imposing financial burden, reducing medication adherence, and worsening health outcomes. This problem is exacerbated by a paucity of generic alternatives for prevalent lung diseases, such as asthma and chronic obstructive pulmonary disease, as well as high-cost medicines for rare diseases, such as cystic fibrosis. Affordability and access challenges are especially salient in the United States, as citizens of many other countries pay lower prices for and have greater access to prescription medications. METHODS: The American Thoracic Society convened a multidisciplinary committee comprising experts in health policy pharmacoeconomics, behavioral sciences, and clinical care, along with individuals providing industry and patient perspectives. The report and its recommendation were iteratively developed over a year of in-person, telephonic, and electronic deliberation. RESULTS: The committee unanimously recommended the establishment of a publicly funded, politically independent, impartial entity to systematically draft evidence-based pharmaceutical policy recommendations. The goal of this entity would be to generate evidence and action steps to ensure people have equitable and affordable access to prescription medications, to maximize the value of public and private pharmaceutical expenditures on health, to support novel drug development within a market-based economy, and to preserve clinician and patient choice regarding personalized treatment. An immediate priority is to examine the evidence and make recommendations regarding the need to have essential medicines with established clinical benefit from each drug class in all Tier 1 formularies and propose recommendations to reduce barriers to timely generic drug availability. CONCLUSIONS: By making explicit, evidence-based recommendations, the entity can support the establishment of coherent national policies that expand access to affordable medications, improve the health of patients with chronic disease, and optimize the use of public and private resources.

An Official American Thoracic Society Research Statement: Implementation Science in Pulmonary, Critical Care, and Sleep Medicine.

BACKGROUND: Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap. METHODS: The American Thoracic Society (ATS) created a multidisciplinary ad hoc committee to develop a research statement on implementation science in pulmonary, critical care, and sleep medicine. The committee used an iterative consensus process to define implementation science and review the use of conceptual frameworks to guide implementation science for the pulmonary, critical care, and sleep community and to explore how professional medical societies such as the ATS can promote implementation science. RESULTS: The committee defined implementation science as the study of the mechanisms by which effective health care interventions are either adopted or not adopted in clinical and community settings. The committee also distinguished implementation science from the act of implementation. Ideally, implementation science should include early and continuous stakeholder involvement and the use of conceptual frameworks (i.e., models to systematize the conduct of studies and standardize the communication of findings). Multiple conceptual frameworks are available, and we suggest the selection of one or more frameworks on the basis of the specific research question and setting. Professional medical societies such as the ATS can have an important role in promoting implementation science. Recommendations for professional societies to consider include: unifying implementation science activities through a single organizational structure, linking front-line clinicians with implementation scientists, seeking collaborations to prioritize and conduct implementation science studies, supporting implementation science projects through funding opportunities, working with research funding bodies to set the research agenda in the field, collaborating with external bodies responsible for health care delivery, disseminating results of implementation science through scientific journals and conferences, and teaching the next generation about implementation science through courses and other media. CONCLUSIONS: Implementation science plays an increasingly important role in health care. Through support of implementation science, the ATS and other professional medical societies can work with other stakeholders to lead this effort.

Self-reported depression and perceived financial burden among long-term rectal cancer survivors.

OBJECTIVES: Types of surgery for rectal cancer (RC), including permanent ostomy (PO) or temporary ostomy followed by anastomosis (TO) or initial anastomosis (AN), can affect psychological and financial well-being during active treatment. However, these relationships have not been well studied among long-term survivors (≥5 years post-diagnosis). METHODS: A mailed survey with 576 long-term RC survivors who were members of Kaiser Permanente was conducted in 2010-2011. Prevalence of current depression was ascertained using a score of ≤45.6 on the Short Form-12 version 2 mental component summary. Perceived financial burden was assessed using a Likert scale ranging from 0 (none) to 10 (severe). Regression analyses were used to measure associations after adjustment for covariates. RESULTS: The overall prevalence of depression was 24% among RC survivors with the highest prevalence among those with a history of PO (31%). The adjusted odds of depression among TO and AN survivors were lower than that among PO survivors, 0.42 (CI95% 0.20-0.89) and 0.59 (CI95% 0.37-0.93), respectively. Twenty-two percent perceived moderate-to-high current financial burden (≥4 points). PO survivors also reported higher mean financial burden than AN survivors (2.6 vs. 1.6, respectively; p = 0.002), but perceived burden comparably to TO survivors (2.3). Self-reported depression was associated with higher perceived financial burden (p < 0.001); surgical procedure history did not modify this relationship. CONCLUSIONS: Depression was reported frequently among these long-term RC survivors, particularly among PO survivors. Depression was associated with greater perception of financial burden. Screening for depression and assessing financial well-being might improve care among long-term RC survivors.Copyright © 2015 John Wiley & Sons, Ltd.

An official American Thoracic Society research statement: comparative effectiveness research in pulmonary, critical care, and sleep medicine.

BACKGROUND: Comparative effectiveness research (CER) is intended to inform decision making in clinical practice, and is central to patient-centered outcomes research (PCOR). PURPOSE: To summarize key aspects of CER definitions and provide examples highlighting the complementary nature of efficacy and CER studies in pulmonary, critical care, and sleep medicine. METHODS: An ad hoc working group of the American Thoracic Society with experience in clinical trials, health services research, quality improvement, and behavioral sciences in pulmonary, critical care, and sleep medicine was convened. The group used an iterative consensus process, including a review by American Thoracic Society committees and assemblies. RESULTS: The traditional efficacy paradigm relies on clinical trials with high internal validity to evaluate interventions in narrowly defined populations and in research settings. Efficacy studies address the question, "Can it work in optimal conditions?" The CER paradigm employs a wide range of study designs to understand the effects of interventions in clinical settings. CER studies address the question, "Does it work in practice?" The results of efficacy and CER studies may or may not agree. CER incorporates many attributes of outcomes research and health services research, while placing greater emphasis on meeting the expressed needs of nonresearcher stakeholders (e.g., patients, clinicians, and others). CONCLUSIONS: CER complements traditional efficacy research by placing greater emphasis on the effects of interventions in practice, and developing evidence to address the needs of the many stakeholders involved in health care decisions. Stakeholder engagement is an important component of CER.

Can a school-based hand hygiene program reduce asthma exacerbations among elementary school children?

BACKGROUND: Viral upper respiratory tract infections have been implicated as a major cause of asthma exacerbations among school-aged children. Regular hand washing is the most effective method to prevent the spread of viral respiratory tract infections, but effective hand-washing practices are difficult to establish in schools. OBJECTIVES: This randomized controlled trial evaluated whether a standardized regimen of hand washing plus alcohol-based hand sanitizer could reduce asthma exacerbations more than schools' usual hand hygiene practices. METHODS: This was a 2-year, community-based, randomized controlled crossover trial. Schools were randomized to usual care and then intervention (sequence 1) or intervention and then usual care (sequence 2). Intervention schools were provided with alcohol-based hand sanitizer, hand soap, and hand hygiene education. The primary outcome was the proportion of students experiencing an asthma exacerbation each month. Generalized estimating equations were used to model the difference in the marginal rate of exacerbations between sequences while controlling for individual demographic factors and the correlation within each student and between students within each school. RESULTS: Five hundred twenty-seven students with asthma were enrolled among 31 schools. The hand hygiene intervention did not reduce the number of asthma exacerbations compared with the schools' usual hand hygiene practices (P = .132). There was a strong temporal trend because both sequences experienced fewer exacerbations during year 2 compared with year 1 (P < .001). CONCLUSIONS: Although the intervention was not found to be effective, the results were confounded by the H1N1 influenza pandemic that resulted in substantially increased hand hygiene behaviors and resources in usual-care schools. Therefore these results should be viewed cautiously.

Comparison of breast and cervical cancer screening utilization among rural and urban Hispanic and American Indian women in the Southwestern United States.

OBJECTIVE: Rural Hispanic and American Indian (AI) women are at risk of non-participation in cancer screening programs. The objective of this study was to compare breast and cervical cancer screening utilization among Hispanic and AI women that reside in rural areas of the Southwestern United States to their urban counterparts and to assess characteristics that influence cancer screening. METHODS: This study utilizes Behavioral Risk Factor Surveillance System (BRFSS) data from 2006 to 2008 for Arizona and New Mexico. The BRFSS is a federally funded telephone survey to collect data on risk factors contributing to the leading causes of death and chronic diseases. RESULTS: Rural Hispanic and AI populations reported some differences in screening rates compared with their urban counterparts. Among Hispanic women, 58 % of rural residents reported having had a mammogram within the past year, compared with 66 % of urban residents. Among AI women, 81 % of rural residents had ever had a mammogram, compared with 89 % of urban residents. Rural AI women were less likely to have ever had a mammogram (OR = 0.5; 95 % CI = 0.3-0.9) compared with urban AI women. Rural Hispanic women were less likely to have had a mammogram within 1 year (OR = 0.7; 95 % CI = 0.5-0.9) compared with urban Hispanic women. Results suggest that rural Hispanic women were less likely to have had a Pap smear within 3 years (OR = 0.7; 95 % CI = 0.4-1.3) compared with urban Hispanic women. CONCLUSION: Our results provide some evidence that Hispanic and AI women that reside in rural areas of the Southwestern United States have lower rates of breast and cervical cancer screening use compared with their urban counterparts. Special efforts are needed to identify ways to overcome barriers to breast and cervical cancer screening for rural Hispanic and AI women.

Measurement characteristics of the pediatric asthma health outcome measure.

INTRODUCTION: The Pediatric Asthma Health Outcome Measure (PAHOM) was designed to measure quality-adjusted life years (QALYs) in children with asthma. Our objective was to compare parent- and child-reported PAHOM scores to each other, to parent-reported scores on the Juniper Asthma Control Questionnaire (ACQ), and to physician-rated asthma control. METHODS: A convenience sample of primarily African-American parent-child dyads (N = 261) was recruited from asthma clinics between May 2008 and May 2010. Correlations and differences in scores between the instruments and respondents were compared across variables of interest. The sensitivity and specificity of each, relative to physician-rated asthma control, were estimated. RESULTS: Mean (SD) parent- and child-reported PAHOM scores were significantly different, 0.91 (0.13) and 0.95 (0.08), respectively, (p < .01) and were weakly correlated (0.24). Parent-reported PAHOM and parent-reported ACQ, 5-item version (ACQ5) scores were moderately correlated (-0.69). Both the parent- and child-reported PAHOM scores distinguished between physician-rated well-controlled and not well-controlled asthma (p < .01 and p < .01, respectively). When compared with physician-rated asthma control, the areas under the receiver operating characteristic (ROC) curves for the parent-reported PAHOM and the ACQ5 were similar (p = .11), but both performed better than the child-reported PAHOM (both p < .01). Discussion. The validity of the PAHOM is supported by its moderate correlation with the ACQ and its association with physician-rated asthma control. Although intended to be administered to children, parent-reported scores were better predictors of physician-rated asthma control. CONCLUSIONS: A validation study in a more economically and ethnically diverse population is needed. Until then, we recommend the PAHOM to be administered to both parents and children.

School-based Stock Inhaler Programs and Neighborhood Disadvantage.

INTRODUCTION: Ensuring students with asthma residing in disadvantaged communities have access to rescue medication (albuterol) is important. METHODS: Using the Area Deprivation Index (ADI), we examined relationships between albuterol use and neighborhood deprivation among schools participating in the Pima County (Arizona) Stock Inhaler Program. Schools were categorized into quartiles based on their census block ADI. A hurdle regression examined associations between ADI and stock inhaler use after controlling for school characteristics. RESULTS: Among 228 participating schools, only those in the second worst ADI quartile were more likely to use a stock inhaler than those in the most deprived quartile (referent), OR 1.9 (95% CI 1.2-2.9). Middle schools had 2.1 times higher odds (95% CI 1.3-3.4) of ever using a stock inhaler than elementary schools (referent). CONCLUSION: Students attending schools in the second most deprived communities, as opposed to most deprived, may have the most tenuous albuterol access.

Pediatric Research Observing Trends and Exposures in COVID-19 Timelines (PROTECT): Protocol for a Multisite Longitudinal Cohort Study.

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.