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"Gerald, Joe K"
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COVID-19 Infection, Reinfection, and Vaccine Effectiveness in Arizona Frontline and Essential Workers: Protocol for a Longitudinal Cohort Study
2021
BackgroundCOVID-19 has spread worldwide since late 2019, with an unprecedented case count and death toll globally. Health care personnel (HCP), first responders, and other essential and frontline workers (OEWs) are at increased risk of SARS-CoV-2 infection because of frequent close contact with others. ObjectiveThe Arizona Healthcare, Emergency Response, and Other Essential Workers Study (AZ HEROES) aims to examine the epidemiology of SARS-CoV-2 infection and COVID-19 illness among adults with high occupational exposure risk. Study objectives include estimating the incidence of SARS-CoV-2 infection in essential workers by symptom presentation and demographic factors, determining independent effects of occupational and community exposures on incidence of SARS-CoV-2 infection, establishing molecular and immunologic characteristics of SARS-CoV-2 infection in essential workers, describing the duration and patterns of real-time reverse transcription–polymerase chain reaction (rRT-PCR) positivity, and examining postvaccine immunologic response. MethodsEligible participants include Arizona residents aged 18 to 85 years who work at least 20 hours per week in an occupation involving regular direct contact (ie, within 3 feet) with others. Recruitment goals are stratified by demographic characteristics (50% aged 40 years or older, 50% women, and 50% Hispanic or American Indian), by occupation (40% HCP, 30% first responders, and 30% OEWs), and by prior SARS-CoV-2 infection (with up to 50% seropositive at baseline). Information on sociodemographics, health and medical history, vaccination status, exposures to individuals with suspected or confirmed SARS-CoV-2 infection, use of personal protective equipment, and perceived risks are collected at enrollment and updated through quarterly surveys. Every week, participants complete active surveillance for COVID-like illness (CLI) and self-collect nasal swabs. Additional self-collected nasal swab and saliva specimens are collected in the event of CLI onset. Respiratory specimens are sent to Marshfield Laboratories and tested for SARS-CoV-2 by rRT-PCR assay. CLI symptoms and impact on work and productivity are followed through illness resolution. Serum specimens are collected every 3 months and additional sera are collected following incident rRT-PCR positivity and after each COVID-19 vaccine dose. Incidence of SARS-CoV-2 infections will be calculated by person-weeks at risk and compared by occupation and demographic characteristics as well as by seropositivity status and infection and vaccination history. ResultsThe AZ HEROES study was funded by the US Centers for Disease Control and Prevention. Enrollment began on July 27, 2020; as of May 1, 2021, a total of 3165 participants have been enrolled in the study. Enrollment is expected to continue through December 1, 2021, with data collection continuing through at least April 2022, contingent upon funding. ConclusionsAZ HEROES is unique in aiming to recruit a diverse sample of essential workers and to prospectively follow strata of SARS-CoV-2 seronegative and seropositive adults. Survey results combined with active surveillance data on exposure, CLI, weekly molecular diagnostic testing, and periodic serology will be used to estimate the incidence of symptomatic and asymptomatic SARS-CoV-2 infection, assess the intensity and durability of immune responses to natural infection and COVID-19 vaccination, and contribute to the evaluation of COVID-19 vaccine effectiveness. International Registered Report Identifier (IRRID)DERR1-10.2196/28925
Journal Article
Randomized trial of the feasibility of ED-initiated school-based asthma medication supervision (ED-SAMS)
by
VanBuren, John M.
,
Denninghoff, Kurt
,
Startup, Emily
in
Antiasthmatic agents
,
Asthma
,
Asthma in children
2021
Background
While using an inhaled corticosteroid (ICS) in the weeks after an ED visit reduces repeat visits, few children receive a needed prescription. Because a prescription may not be filled or used, dispensing ICS at discharge and supervising its use at school could overcome both barriers until follow-up care is established. To assess the feasibility of such an intervention, we conducted a pilot study among elementary-age school children with persistent asthma who were discharged from the ED following an asthma exacerbation.
Methods
Eligible children were randomly assigned to ED-dispensing of ICS with home supervision
or
ED-dispensing of ICS with home
and
school supervision. The primary outcomes were ability to recruit and retain participants, ability to initiate school-supervised medication administration within 5 days of discharge, and participant satisfaction.
Results
Despite identifying 437 potentially eligible children, only 13 (3%) were enrolled with 6 being randomized to the intervention group and 7 to the control group. Eleven (85%) randomized participants completed the 90-day interview (primary outcome) and 8 (62%) completed the 120-day interview (safety endpoint). Four (67%) intervention participants started their school regimen within 5 business days and 2 started within 6 business days.
Conclusion
While our pilot study did not meet its recruitment goal, it did achieve its primary purpose of assessing feasibility before undertaking a larger, more intensive study. Several major recruitment barriers need to be mitigated before EDs can successfully partner with schools to establish supervised ICS treatment.
Trial registration
ClinicalTrials.gov
,
NCT03952286
. Registered 16 May 2019,
Journal Article
Improving the Affordability of Prescription Medications for People with Chronic Respiratory Disease. An Official American Thoracic Society Policy Statement
by
Brown, Lee K.
,
Patel, Minal R.
,
Costello, Richard W.
in
Asthma
,
Chronic illnesses
,
Chronic obstructive pulmonary disease
2018
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.
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.
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.
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.
Journal Article
Ten Principles to Guide Health Reform
2017
Americans face inevitable trade-offs between health care affordability, accessibility, and innovation. Although numerous reforms have been proposed, universal principles to guide decision-making are lacking. Solving the challenges that confront us will be difficult, owing to intense partisan divisions and a dysfunctional political process. Nevertheless, we must engage in reasoned debate that respects deeply held differences of opinion regarding our individual and collective obligations to promote healthy living and ensure affordable access to health care. Otherwise, our decisions will be expressed through political processes that reflect the preferences of narrow interests rather than the general public. Our health care system can be made more efficient and equitable by incentivizing consumers and providers to utilize high-value care and avoid low-value care. To accomplish this, we must understand the determinants of consumer and provider behavior and implement policies that encourage, but do not force, optimal decision-making. Although distinguishing between low- and high-value treatments will invariably threaten established interests, we must expand our capacity to make such judgements. Throughout this process, consumers, taxpayers, and policy makers must maintain realistic expectations. Although realigning incentives to promote high-value care will improve efficiency, it is unlikely to control increasing medical expenditures because they are not primarily caused by inefficiency. Rather, rising medical expenditures are driven by medical innovation made possible by increasing incomes and expanding health insurance coverage. Failure to recognize these linkages risks adopting indiscriminate policies that will reduce spending but slow innovation and impair access to needed care.
Journal Article
Why Every School Should Have a Stock Inhaler: One Nurse’s Experience
2019
Elaine, a contract nurse employed by the Baltimore Health Department in Maryland and working in the Baltimore City public schools, lost her job when she treated a student's severe asthma attack with another student's inhaler. It does not have to be this way. A small but growing number of states have adopted stock inhaler laws that allow schools to maintain a single albuterol inhaler for emergency use and indemnify school personnel who use it in good faith.1 We share this nurse's experience, a common fear among school nurses, alongside expert commentary in the following sections.
Journal Article
An Official American Thoracic Society Research Statement: Implementation Science in Pulmonary, Critical Care, and Sleep Medicine
by
Redeker, Nancy S.
,
Bender, Bruce G.
,
Cloutier, Michelle M.
in
American Thoracic Society Document
,
Critical Care - standards
,
Diffusion of Innovation
2016
Many advances in health care fail to reach patients. Implementation science is the study of novel approaches to mitigate this evidence-to-practice gap.
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.
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.
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.
Journal Article
Translating Research into Health Policy: Stock Albuterol Legislation
by
Burkholder, Barbara
,
Gerald, Lynn B.
,
Strother, JoAnna
in
Adolescent
,
Advocacy
,
Albuterol - supply & distribution
2018
To address this problem, the U.S. Centers for Disease Control and Prevention and the National Heart, Lung, and Blood Institute recommend that comprehensive school-based asthma programs maintain stock inhalers so that multiple students may share a single inhaler via reusable and/or disposable holding chambers (6, 7). [...]we enlisted support from Thayer Medical Corporation, an Arizona-based company that manufactures disposable, valved holding chambers. Before the formal committee vote, a public hearing was held, where testimony was solicited in support of or opposition to the bill. Because Arizona requires speakers to preregister, it was important to designate a single individual (J.S.) to actively monitor the committee's agenda to ensure that our speakers were registered. Once the rule making was complete, we conducted outreach to inform schools, pharmacists, physicians, nurses, and others about the legislation and its requirements. Because the legislation did not provide funding, financial barriers remained an important obstacle.
Journal Article
School-based Stock Inhaler Programs and Neighborhood Disadvantage
2022
Ensuring students with asthma residing in disadvantaged communities have access to rescue medication (albuterol) is important.
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.
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).
Students attending schools in the second most deprived communities, as opposed to most deprived, may have the most tenuous albuterol access.
Journal Article