This becomes even more apparent when we compare the vaccination trend to that of a cohort of comparable aged children in Massachusetts. This suggests that our interventions provided additional momentum in the vaccination effort above and beyond what would have occurred in the absence of this project. Second, we compared the vaccination rate achieved to the counterfactual prediction of the vaccination rate for children with SCD and exceeded the prediction. Although special cause variation was also noted on May 15, we chose not to shift the mean line because the increase in vaccination rates was not sustained in the periods that followed. Although these increases look modest, we demonstrate a greater than 2-fold increase in vaccination rates over the intervention period with an increase in the mean from 2.1% to 7.2% on February 1. We addressed this issue in 2 ways: first, we present a noncumulative percentage of patients with SCD vaccinated against COVID-19 for each period. This issue is complicated by the fact that although a cumulative percentage of patients with SCD who had been fully vaccinated was felt to be the most clinically meaningful measure, the denominators of eligible patients from 1 period to the next are not independent and there is likely autocorrelation. The first is that the vaccination rate among children with SCD increased during the preintervention period and therefore may have continued to increase during the intervention period in the absence of this project. This study has several important limitations. Vaccination statuses were not amended retrospectively for previous months based on the reconciliation of outside vaccinations. These doses would then be reflected in the EDW at the start of the next period and the patient’s vaccination status would be amended going forward. If a patient was classified as “received a vaccine that was not captured,” the doses were then reconciled via the Massachusetts Immunization Information System or manually added. The categories were vaccine booked, vaccine refused, received a vaccine that was not captured, barrier, or concern to vaccination, and unable to reach. As a process measure, we evaluated the effectiveness of vaccine scheduling calls. Vaccination status was manually verified by a nurse before a patient’s hematology appointment. Vaccination data can be viewed in our electronic health records by all care providers, and patients with overdue COVID-19 vaccinations were flagged by clinical decision support as such. Vaccine data travel to the EDW in 3 ways: (1) vaccines administered at our institution are automatically captured, (2) vaccines administered at other Massachusetts centers can be reconciled by providers via the Massachusetts Immunization Information System, and (3) vaccines administered out of state can be manually added by providers. Vaccination status was determined based on the number of vaccine doses in our EDW at each 2-week interval. The number and dates of vaccinations were obtained from our EDW. Vaccine adherence was assessed over the 5 months before project initiation and then biweekly during the project. A secondary outcome was the proportion of unvaccinated eligible patients at the start of each 2-week interval that received a vaccine during that interval. The primary outcome measure was the cumulative proportion of patients with SCD who received ≥2 doses of any COVID-19 vaccine (booster dose not required for the purpose of this project). 15 Given the lack of data indicating any unique safety concerns for children receiving the COVID-19 vaccine and the convincing data showing its efficacy in protecting children from COVID-19, vaccinating children with SCD against COVID-19 is widely recommended. However, given the lack of control group the study could not conclude that the rate of admissions for pain was greater than what would otherwise be expected for this cohort. 14 In 1 study of vaccine safety involving 75 children with SCD, 3 children were admitted with pain after vaccination. 12, 13 Very few studies have specifically examined the safety of the vaccine in children with SCD, but studies of adults with SCD have shown a favorable safety profile for the vaccines. 10 Longitudinal COVID-19 vaccine studies have shown that the vaccine is a safe and effective way to protect children from COVID-19. 10, 11 The Centers for Disease Control recognized the importance of vaccinating patients with SCD and prioritized patients with SCD to receive the COVID-19 vaccine. Public health agencies have advocated for vaccination against COVID-19.
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