Building a National Capability to Monitor and Assess Medical Countermeasure Use During a Public Health Emergency Going Beyond the Last Mile: Proceedings of a Workshop (2017) / Chapter Skim
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2 Setting the Stage: Defining Terminologies and Sharing Stakeholder Perspectives
2 Setting the Stage: Defining Terminologies and Sharing Stakeholder Perspectives
Pages 17-30
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From page 17... ...
Lushniak and Perren Cobb, director of Surgical Critical Care Institute and clinical professor of surgery and anesthesiology at the Keck School of Medicine, University of Southern California, provided definitions and general background on operations for response and clinical networks, respectively. To set the stage for the workshop discussions, Yon Yu, associate d irector, Regulatory Affairs, National Center for Emerging and Zoonotic Infectious Diseases, CDC, HHS, asked a panel of stakeholders to consider the primary data sources discussed during the lightning terminology presentations and share perspectives on how their sector might contribute to a coordinated MCM monitoring and assessment effort during a PHE, which is presented in the second half of this chapter.
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DEFINING TERMINOLOGIES USED THROUGHOUT THE WORKSHOP Electronic Health Data Platt offered a framework for thinking about electronic health data in which he highlighted five key types of electronic health data that are developed principally during the delivery of health care: EHR, electronic BOX 2-1 Types of Electronic Health Data Electronic Health Records • Practice and hospital-based systems (e.g., EpicCare, Meditech, Cerner) • Timeliness: potentially same day; often next day • alient positive features (selected)
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: S o oes not capture many vaccines or medications dispensed as part of D an MCM program o Does not reliably capture drugs with low co-pays o Does not capture over-the-counter drugs Public Health Registries • S tate or other agency information reported directly by providers • T imeliness: highly variable • S alient positive features (selected) : may be the most complete record in a jurisdiction • alient negative features (selected)
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Platt observed that EHRs were designed for use in individual health care settings, making it difficult to extract and analyze compatible population data for surveillance efforts. This is not an informatics problem, he continued, but an information problem.
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There are CONOPS for many different threat response capabilities, Lushniak explained, and the task of this workshop is to discuss how to build big data, electronic health data, and clinical networks for MCM monitoring and assessment into these operations. Coordination of operations across local, state, and national levels and across all stakeholders is needed, he said.
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Critical Illness and Injury Trials Group to bring together individuals and subject-matter experts from the federal government, academia, industry, and the community to identify key clinical questions that need to be answered in response to any type of PHE, across all hazards. The group developed a list of six questions they believed would be useful to clinicians and researchers and persons responsible for systems and operational evaluations (Murphy et al., 2015)
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From page 23... ...
; CDC National Ebola Training and Education Center; sites of the Johns Hopkins University Research Network; Pediatric Emergency Care and Research Network sites; Pediatric Acute Lung Injury and Sepsis Network Investigators; and the National Heart, Lung, and Blood Institute (NHLBI) -funded Prevention and Early Treatment of Acute Lung Injury Research Network.
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Similarly, she said, local health departments struggle with risk calculations regarding messaging for promoting healthy behavior in the public during a PHE. Considerations for this calculation include noting that there are many different ways people prefer to receive information, differing functional and access needs, and language barriers.
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He emphasized the importance of providing action steps that the public can take for themselves, and being transparent regarding any prioritization for MCM dispensing. Communicating MCM prioritization helps to foster public trust and adherence with any MCM dispensed.
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The key to success, Ataher suggested, is to plan for the unexpected by understanding what data will be needed in order to develop predefined clinical protocols that can be deployed for individual products in an emergency setting. One difficulty in conducting clinical research during PHEs is the inability to conduct randomized clinical trials in defined populations; rather, products are administered to a generalized group of patients with limited background health data at the time of MCM administration, said Ataher.
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From page 27... ...
For example, Wilcox noted that during the 2009 H1N1 influenza pandemic, a research team at Columbia University quickly assessed incoming data from CDC to assess the origins, diversification, and spread of the virus. Using innovative bioinformatics techniques, the team was able to decipher the genetic origins of the virus and determine that in the recent past, the virus was endemic to pigs -- that is, swine flu -- and not birds, as originally thought.
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From page 28... ...
Wilcox noted that this is a common phenomenon across the board: increased data collection can result in increased capture of the target population, which should not be misinterpreted as increased treatment effect. Understanding data collection methodologies and associated biases, such as those represented in this depression study, are simi larly important for MCM monitoring and assessment efforts, emphasized Wilcox.
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From page 29... ...
DEFINING TERMINOLOGIES AND SHARING STAKEHOLDER PERSPECTIVES 29 in the identification of or response to an emergency. Having more granular information about the specific devices used would be of value, he said.
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