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BackgroundCertain medications may increase the risk of death or death from specific causes (eg, sudden cardiac death), but these risks may not be identified in premarket randomized trials. Having the capacity to examine death in postmarket safety surveillance activities is important to the US Food and Drug Administration’s (FDA) mission to protect public health. Distributed networks of electronic health plan databases used by the FDA to conduct multicenter research or medical product safety surveillance studies often do not systematically include death or cause-of-death information. ObjectiveThis study aims to develop reusable, generalizable methods for linking multiple health plan databases with the Centers for Disease Control and Prevention’s National Death Index Plus (NDI+) data. MethodsWe will develop efficient administrative workflows to facilitate multicenter institutional review board (IRB) review and approval within a distributed network of 6 health plans. The study will create a distributed NDI+ linkage process that avoids sharing of identifiable patient information between health plans or with a central coordinating center. We will develop standardized criteria for selecting and retaining NDI+ matches and methods for harmonizing linked information across multiple health plans. We will test our processes within a use case comprising users and nonusers of antiarrhythmic medications. ResultsWe will use the linked health plan and NDI+ data sets to estimate the incidences and incidence rates of mortality and specific causes of death within the study use case and compare the results with reported estimates. These comparisons provide an opportunity to assess the performance of the developed NDI+ linkage approach and lessons for future studies requiring NDI+ linkage in distributed database settings. This study is approved by the IRB at Harvard Pilgrim Health Care in Boston, MA. Results will be presented to the FDA at academic conferences and published in peer-reviewed journals. ConclusionsThis study will develop and test a reusable distributed NDI+ linkage approach with the goal of providing tested NDI+ linkage methods for use in future studies within distributed data networks. Having standardized and reusable methods for systematically obtaining death and cause-of-death information from NDI+ would enhance the FDA’s ability to assess mortality-related safety questions in the postmarket, real-world setting. International Registered Report Identifier (IRRID)DERR1-10.2196/21811

We detected human metapneumovirus (HMPV) in 54 (5%) of 1055 children aged 5 to 13 years with acute respiratory illness (ARI) identified by outpatient and emergency department surveillance between November and May 2003-2009. Its clinical features were similar to those of HMPV-negative ARI, except a diagnosis of pneumonia was more likely (13% vs 4%, respectively; P = .005) and a diagnosis of pharyngitis (7% vs 24%, respectively; P = .005) was less likely in patients with HMPV- positive ARI than those with HMPV-negative ARI.

Objective Opioids are commonly prescribed to women for acute pain following childbirth. Postpartum prescription opioid exposure is associated with adverse opioid-related morbidities but the association with all-cause mortality is not well studied. This study aimed to examine the association between postpartum opioid prescription fills and the 1-year risk of all-cause mortality among women with live births. Methods In a retrospective cohort study of live births among women enrolled in Tennessee Medicaid (TennCare) between 2007 and 2015, we compared women who filled two or more postpartum outpatient opioid prescriptions (up to 41 days of postdelivery discharge) to women who filled one or fewer opioid prescription. Women were followed from day 42 postdelivery discharge through 365 days of follow-up or date of death. Deaths were identified using linked death certificates (2007–2016). We used Cox's proportional hazard regression and inverse probability of treatment weights to compare time to death between exposure groups while adjusting for relevant confounders. We also examined effect modification by delivery route, race, opioid use disorder, use of benzodiazepines, and mental health condition diagnosis. Results Among 264,135 eligible births, 216,762 (82.1%) had one or fewer maternal postpartum opioid fills and 47,373 (17.9%) had two or more fills. There were 182 deaths during follow-up. The mortality rate was higher in women with two or more fills (120.5 per 100,000 person-years) than in those with one or fewer (57.7 per 100,000 person-years). The risk of maternal death remained higher in participants exposed to two or more opioid fills after accounting for relevant covariates using inverse probability of treatment weighting (adjusted hazard ratio: 1.46 [95% confidence interval: 1.01, 2.09]). Findings from stratified analyses were consistent with main findings. Conclusion Filling two or more opioid prescriptions during the postpartum period was associated with a significant increase in 1-year risk of death among new mothers. Key Points Opioid prescribing in the postpartum period is common. Prior studies show that >1 postnatal opioid fill is associated with adverse opioid-related events. > 1 opioid fill within 42 days of delivery was associated with an increase in 1-year risk of death. [ABSTRACT FROM AUTHOR]

Streptococcus pneumoniae (pneumococcus) is one of the most important bacterial causes of pneumonia among children and adults worldwide (1-3). Nasopharyngeal pneumococcal colonization is common in young children and represents a [...]

BackgroundThe Shingles Prevention Study (SPS) demonstrated zoster vaccine efficacy through 4 years postvaccination. A Short-Term Persistence Substudy (STPS) demonstrated persistence of vaccine efficacy for at least 5 years. A Long-Term Persistence Substudy (LTPS) was undertaken to further assess vaccine efficacy in SPS vaccine recipients followed for up to 11 years postvaccination. Study outcomes were assessed for the entire LTPS period and for each year from 7 to 11 years postvaccination.MethodsSurveillance, case determination, and follow-up were comparable to those in SPS and STPS. Because SPS placebo recipients were offered zoster vaccine before the LTPS began, there were no unvaccinated controls. Instead, SPS and STPS placebo results were used to model reference placebo groups.ResultsThe LTPS enrolled 6867 SPS vaccine recipients. Compared to SPS, estimated vaccine efficacy in LTPS decreased from 61.1% to 37.3% for the herpes zoster (HZ) burden of illness (BOI), from 66.5% to 35.4% for incidence of postherpetic neuralgia, and from 51.3% to 21.1% for incidence of HZ, and declined for all 3 outcome measures from 7 through 11 years postvaccination. Vaccine efficacy for the HZ BOI was significantly greater than zero through year 10 postvaccination, whereas vaccine efficacy for incidence of HZ was significantly greater than zero only through year 8.ConclusionsEstimates of vaccine efficacy decreased over time in the LTPS population compared with modeled control estimates. Statistically significant vaccine efficacy for HZ BOI persisted into year 10 postvaccination, whereas statistically significant vaccine efficacy for incidence of HZ persisted only through year 8.

In 1992 the Interstate New Teacher Assessment and Support Consortium (INTASC) coined the term "Dispositions"; the National Council for the Accreditation of Teacher Education (NCATE, 2002) defined dispositions making dispositions a part of every teacher accreditation process. Since that time educators have struggled over the inevitable challenges of identifying, infusing, and investing dispositions in teacher education programs. Dispositions have become a critical ingredient in the production of new teachers and administrators. With the dawn of the new "Conceptual Age," dispositions are in the center of any discussion of teacher education. This paper examines the topic of teacher education dispositions, both in defining and implementing the concept and process. The Charleston Southern University School of Education's continuing process through the dispositions milieu is addressed.

In the first half of 2007, Catholic Education an Irish Schools Trust (CEIST) was established when several Religious Congregations handed trusteeship of their schools to a lay company. As CEIST--in the Irish language the word 'CEIST' means 'question'--completes 10 years serving the needs of its 110 secondary schools, it seems an appropriate time to take a retrospective and a prospective look at that experience and the questions it raises.

An editorial discusses the postmarketing vaccine safety assessments conducted by the US FDA and CDC following the emergency use authorization of COVID-19 vaccines. It identifies potential adverse events associated with vaccine receipt, particularly concerning a safety signal related to ischemic stroke after receiving a COVID-19 bivalent mRNA vaccine, especially when given concomitantly with a high-dose or adjuvanted influenza vaccine.

Streptococcus pneumoniae commonly colonizes the nasopharynx of young children (1). Nasopharyngeal colonization density is relevant for transmission of bacteria and pathogenesis of pneumococcal diseases (2). Few studies have evaluated the [...]