Stakeholder engagement infrastructure to support multicenter research networks: Advances from the clinical research networks participating in PCORnet.

Background: The evidence based on the inclusion of patients and other stakeholders as partners in the clinical research process has grown substantially. However, little has been reported on how stakeholders are engaged in the governance of large-scale clinical research networks and the infrastructure used by research networks to support engagement in network-affiliated activities. Objectives: The objective was to document engagement activities and practices emerging from Clinical Research Networks (CRNs) participating in PCORnet, the National Patient-Centered Clinical Research Network, specifically regarding governance and engagement infrastructure. Methods: We conducted an environmental scan of PCORnet CRN engagement structures, assets, and services, focusing on network oversight structures for policy development and strategic decision-making. The scan included assets and services for supporting patient/stakeholder engagement. Data were collected by searching web-based literature and tool repositories, review of CRN Engagement Plans, analysis of previously collected key informant interviews, and CRN-based iterative review of structured worksheets. Results: We identified 87 discrete engagement structures, assets, and services across nine CRNs. All CRNs engage patients/stakeholders in their governance, maintain workgroups and/or staff dedicated to overseeing engagement strategies, and offer one or more services to non-CRN researchers to enhance conducting engaged clinical research. Conclusions: This work provides an important resource for the research community to explore engagement across peers, reflect on progress, consider opportunities to leverage existing infrastructure, and identify new collaborators. It also serves to highlight PCORnet as a resource for non-CRN researchers seeking to efficiently conduct engaged clinical research and a venue for advancing the science of engagement.

Social Vulnerability and Access of Local Medical Care During Hurricane Harvey: A Spatial Analysis.

OBJECTIVES: When Hurricane Harvey struck the coastline of Texas in 2017, it caused 88 fatalities and over US $125 billion in damage, along with increased emergency department visits in Houston and in cities receiving hurricane evacuees, such as the Dallas-Fort Worth metroplex (DFW).This study explored demographic indicators of vulnerability for patients from the Hurricane Harvey impact area who sought medical care in Houston and in DFW. The objectives were to characterize the vulnerability of affected populations presenting locally, as well as those presenting away from home, and to determine whether more vulnerable communities were more likely to seek medical care locally or elsewhere. METHODS: We used syndromic surveillance data alongside the Centers for Disease Control and Prevention Social Vulnerability Index to calculate the percentage of patients seeking care locally by zip code tabulation area. We used this variable to fit a spatial lag regression model, controlling for population density and flood extent. RESULTS: Communities with more patients presenting for medical care locally were significantly clustered and tended to have greater socioeconomic vulnerability, lower household composition vulnerability, and more extensive flooding. CONCLUSIONS: These findings suggest that populations remaining in place during a natural disaster event may have needs related to income, education, and employment, while evacuees may have more needs related to age, disability, and single-parent household status.

A Spatial and Temporal Investigation of Medical Surge in Dallas-Fort Worth During Hurricane Harvey, Texas 2017.

OBJECTIVE: When 2017 Hurricane Harvey struck the coastline of Texas on August 25, 2017, it resulted in 88 fatalities and more than US $125 billion in damage to infrastructure. The floods associated with the storm created a toxic mix of chemicals, sewage and other biohazards, and over 6 million cubic meters of garbage in Houston alone. The level of biohazard exposure and injuries from trauma among persons residing in affected areas was widespread and likely contributed to increases in emergency department (ED) visits in Houston and cities receiving hurricane evacuees. We investigated medical surge resulting from these evacuations in Dallas-Fort Worth (DFW) metroplex EDs. METHODS: We used data sourced from the North Texas Syndromic Surveillance Region 2/3 in ESSENCE to investigate ED visit surge following the storm in DFW hospitals because this area received evacuees from the 60 counties with disaster declarations due to the storm. We used the interrupted time series (ITS) analysis to estimate the magnitude and duration of the ED surge. ITS was applied to all ED visits in DFW and visits made by patients residing in any of the 60 counties with disaster declarations due to the storm. The DFW metropolitan statistical area included 55 hospitals. Time series analyses examined data from March 1, 2017-January 6, 2018 with focus on the storm impact period, August 14-September 15, 2017. Data from before, during, and after the storm were visualized spatially and temporally to characterize magnitude, duration, and spatial variation of medical surge attributable to Hurricane Harvey. RESULTS: During the study period overall, ED visits in the DFW area rose immediately by about 11% (95% CI: 9%, 13%), amounting to ~16 500 excess total visits before returning to the baseline on September 21, 2017. Visits by patients identified as residing in disaster declaration counties to DFW hospitals rose immediately by 127% (95% CI: 125%, 129%), amounting to 654 excess visits by September 29, 2017, when visits returned to the baseline. A spatial analysis revealed that evacuated patients were strongly clustered (Moran's I = 0.35, P < 0.0001) among 5 of the counties with disaster declarations in the 11-day window during the storm surge. CONCLUSIONS: The observed increase in ED visits in DFW due to Hurricane Harvey and ensuing evacuation was significant. Anticipating medical surge following large-scale hurricanes is critical for community preparedness planning. Coordinated planning across stakeholders is necessary to safeguard the population and for a skillful response to medical surge needs. Plans that address hurricane response, in particular, should have contingencies for support beyond the expected disaster areas.

The Impact of a Case of Ebola Virus Disease on Emergency Department Visits in Metropolitan Dallas-Fort Worth, TX, July, 2013-July, 2015: An Interrupted Time Series Analysis.

BACKGROUND: The first Ebola virus disease (EVD) case in the United States (US) was confirmed September 30, 2014 in a man 45 years old. This event created considerable media attention and there was fear of an EVD outbreak in the US. METHODS: This study examined whether emergency department (ED) visits changed in metropolitan Dallas-Fort Worth--, Texas (DFW) after this EVD case was confirmed. Using Texas Health Services Region 2/3 syndromic surveillance data and focusing on DFW, interrupted time series analyses were conducted using segmented regression models with autoregressive errors for overall ED visits and rates of several chief complaints, including fever with gastrointestinal distress (FGI). Date of fatal case confirmation was the "event." RESULTS: Results indicated the event was highly significant for ED visits overall (P<0.05) and for the rate of FGI visits (P<0.0001). An immediate increase in total ED visits of 1,023 visits per day (95% CI: 797.0, 1,252.8) was observed, equivalent to 11.8% (95% CI: 9.2%, 14.4%) increase ED visits overall. Visits and the rate of FGI visits in DFW increased significantly immediately after confirmation of the EVD case and remained elevated for several months even adjusting for seasonality both within symptom specific chief complaints as well as overall. CONCLUSIONS: These results have implications for ED surge capacity as well as for public health messaging in the wake of a public health emergency.

Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke.

BACKGROUND: Quantifying relative harm caused by inhaling the aerosol emissions of vapourised nicotine products compared with smoking combustible tobacco is an important issue for public health. METHODS: The cancer potencies of various nicotine-delivering aerosols are modelled using published chemical analyses of emissions and their associated inhalation unit risks. Potencies are compared using a conversion procedure for expressing smoke and e-cigarette vapours in common units. Lifetime cancer risks are calculated from potencies using daily consumption estimates. RESULTS: The aerosols form a spectrum of cancer potencies spanning five orders of magnitude from uncontaminated air to tobacco smoke. E-cigarette emissions span most of this range with the preponderance of products having potencies<1% of tobacco smoke and falling within two orders of magnitude of a medicinal nicotine inhaler; however, a small minority have much higher potencies. These high-risk results tend to be associated with high levels of carbonyls generated when excessive power is delivered to the atomiser coil. Samples of a prototype heat-not-burn device have lower cancer potencies than tobacco smoke by at least one order of magnitude, but higher potencies than most e-cigarettes. Mean lifetime risks decline in the sequence: combustible cigarettes >> heat-not-burn >> e-cigarettes (normal power)≥nicotine inhaler. CONCLUSIONS: Optimal combinations of device settings, liquid formulation and vaping behaviour normally result in e-cigarette emissions with much less carcinogenic potency than tobacco smoke, notwithstanding there are circumstances in which the cancer risks of e-cigarette emissions can escalate, sometimes substantially. These circumstances are usually avoidable when the causes are known.

Chemometric and trace element profiling methodologies for authenticating, crossmatching and constraining the provenance of illicit tobacco products.

BACKGROUND: Illicit tobacco products have a disproportionately negative effect on public health. Counterfeits and cheap whites as well as legal brands smuggled from countries not adopting track and trace technologies will require novel forensic tools to aid the disruption of their supply chains. METHODS: Data sets of trace element concentrations in tobacco were obtained using X-ray fluorescence spectrometry on samples of legal and illicit products mainly from Europe. Authentic and counterfeit products were discriminated by identifying outliers from data sets of legal products using Mahalanobis distance and graphical profiling methods. Identical and closely similar counterfeits were picked out using Euclidean distance, and counterfeit provenance was addressed using chemometric methods to identify geographical affinities. RESULTS: Taking Marlboro as an exemplar, the major brands are shown to be remarkably consistent in composition, in marked contrast to counterfeits bearing the same brand name. Analysis of 35 illicit products seized in the European Union (EU) indicates that 18 are indistinguishable or closely similar to Marlboro legally sold in the EU, while 17 are sufficiently different to be deemed counterfeit, among them being 2 counterfeits so closely similar that their tobaccos are likely to come from the same source. The tobacco in the large majority of counterfeits in this data set appears to originate in Asia. CONCLUSIONS: Multivariate and graphical analysis of trace elements in tobacco can effectively authenticate brands, crossmatch illicit products across jurisdictions and may identify their geographical sources.

Prosthetic rehabilitation of an extensive midfacial and palatal postsurgical defect with an implant-supported cross arch framework: a clinical report.

When aggressive cancer is surgically treated, the extent of the lesion dictates the amount of tissue excised. The removal of extensive amounts of tissue, including crucial landmarks, complicates prosthesis design. This clinical report details the rehabilitation of a patient who had a total maxillectomy coupled with extensive surgical removal of the midface. With the aid of computer-generated implant placement, a large computer-aided design and computer-aided manufacturing milled titanium framework, a Hader bar, and magnetic keepers, a successful implant retained definitive obturator and facial prosthesis were fabricated that satisfied both esthetic and functional needs.

Controls on the valence species of arsenic in tobacco smoke: XANES investigation with implications for health and regulation.

Arsenic (As) is one of four metals/metalloids in tobacco being considered for regulation. In vitro toxicological response to As varies substantially, determined primarily by valence and compound speciation, and inorganic arsenite (As(III)) compounds are the most toxic to humans. This study uses X-ray absorption near edge structure (XANES) to determine valence states of As from the tobacco plant to the crucial combustion stage that creates respirable smoke. Samples studied include cultivated plants (some burdened with additional As), reference standards, and commercial products, along with smoke condensate and ash from these samples. The relative contributions of As(III) and As(V) to the XANES spectra are analyzed, and a consistent pattern of redox changes emerges. Tobacco leaf and manufactured products tend to be dominated by As(V) whereas combustion produces respirable smoke invariably in As(III) form and ash invariably as As(V). The valence state of precursor tobacco is not a controlling factor because all the As mobilized in smoke is reduced during combustion. This study concludes that tobacco combustion exposes smokers to potentially the most toxic forms of arsenic, and this exposure is magnified in regions where arsenic is present in tobacco crops at relatively high concentrations.

Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) Technology Infrastructure for a Distributed Data Network.

INTRODUCTION: Distributed Data Networks (DDNs) offer infrastructure solutions for sharing electronic health data from across disparate data sources to support comparative effectiveness research. Data sharing mechanisms must address technical and governance concerns stemming from network security and data disclosure laws and best practices, such as HIPAA. METHODS: The Scalable Architecture for Federated Translational Inquiries Network (SAFTINet) deploys TRIAD grid technology, a common data model, detailed technical documentation, and custom software for data harmonization to facilitate data sharing in collaboration with stakeholders in the care of safety net populations. Data sharing partners host TRIAD grid nodes containing harmonized clinical data within their internal or hosted network environments. Authorized users can use a central web-based query system to request analytic data sets. DISCUSSION: SAFTINet DDN infrastructure achieved a number of data sharing objectives, including scalable and sustainable systems for ensuring harmonized data structures and terminologies and secure distributed queries. Initial implementation challenges were resolved through iterative discussions, development and implementation of technical documentation, governance, and technology solutions.

Environmental pollen trapped by tobacco leaf as indicators of the provenance of counterfeit cigarette products: a preliminary investigation and test of concept.

The global trade in counterfeit tobacco products is increasingly taking market share from legal brands in many parts of the developed world, with attendant adverse economic, health, criminal, and other societal impacts. Knowing the geographical source is central to developing new strategies for curbing this illicit trade, and here, the potential of environmental pollen extracted from manufactured cigarettes is examined. Two samples representing U.S. and Chinese brands were investigated for their pollen content. Results indicate that tobacco leaf very efficiently captures environmental pollen (about 1800 and 12,600 grains per cigarette, respectively) with no detectable self-contamination by the tobacco plant. In both cases, the flora is typical of open space environments, but pollen type counts indicate very different distributions of species. This preliminary investigation indicates that palynology has the potential to constrain geographical source(s) of tobacco, particularly if regionally localized species can be recognized among the pollen.

The TRITON Project: Design and Implementation of an Integrative Translational Research Information Management Platform.

Multi-site consortia have become the preferred setting for team-based translational research programs. Such consortia are able to facilitate increased breadth and depth of basic science and clinical research activities, but also present numerous challenges related to data collection, analysis, storage, and exchange. The Chronic Lymphocytic Leukemia (CLL) Research Consortium (CRC), a s a prototypical instance of such a consortia, uses numerous loosely coupled web applications to address its informatics needs. Over a decade of operations have allowed the CRC to identify usability and computational limitations relative to the preceding information management architecture. In response, the CRC has launched the TRITON project, with the ultimate objective of developing an open-source, extensible, and fully integrative translational research information management platform. In this manuscript, we describe the architecture, design processes, and initial implementation of thatplatform.

Acute renal failure, systemic lupus erythematosus and thrombotic microangiopathy following treatment with beta-interferon for multiple sclerosis: case report and review of the literature.

We report a man with type 1 diabetes mellitus, autoimmune hypothyroidism and a tentative diagnosis of multiple sclerosis. Following treatment with beta interferon, he developed systemic lupus erythematosus with pericarditis, pleural effusions, cerebral infarction associated with anti-phospholipid antibody and acute renal failure due to thrombotic microangiopathy. He responded well to immunosuppression and anticoagulation. These complications may represent the most severe autoimmune reaction to beta interferon reported to date.

Willow water uptake and shoot extension growth in response to nutrient and moisture on a clay landfill cap soil.

Extension growth of willow (Salix viminalis L.) and changes in soil water were measured in lysimeters containing clay and sandy loam soils with different amendment and watering treatments. No water uptake was found below 0.3m in the nutritionally poor unamended clay; amendment with organic matter to 0.4m depth resulted in water extraction down to 0.5m depth whereas in the sandy loam, there was greater extraction from all depths down to 0.6m. With water stress, wilting of plants occurred when the volumetric soil water content at 0.1m was about 31% in the clay and 22% in the sandy loam. Compared with shoots on plants in the amended clay, those in the unamended treatment showed reduced extension growth, little increase in stem basal area (SBA) and a small shoot leaf area, resulting from a reduced number of leaves shoot(-1) and a small average area leaf(-1). Water stress also reduced shoot extension growth, SBA gain and the leaf area on extension growth. Shoot growth rates were significantly correlated with air temperature and base temperatures between 2.0 and 7.6 degrees C were indicated for the different treatments. These studies have helped to explain some of the large treatment effects described previously on biomass production and plant leaf area.

Willow growth in response to nutrients and moisture on a clay landfill cap soil. I. Growth and biomass production.

The growth and biomass production by willow (Salix viminalis L.) was studied in lysimeters containing Oxford clay landfill cap soil with different amendments, bulk densities and watering regimes. Three years from planting, stem biomass in well-watered plants was least (0.28 kg plant(-1)) with high bulk density soil (1480 kg m(-3)) and no nutritional amendment but was increased 10-fold (2.53 kg plant(-1)) by reducing soil bulk density (1200 kg m3) and adding amendments. In comparison, on a sandy loam soil it was 6.23 kg plant(-1). There were similar differences in number of stems plant(-1), stem basal area plant(-1) and plant leaf area which can be attributed to low nitrogen and phosphorus levels in Oxford clay. Water stress reduced stem biomass production by 26-37% and caused higher root:stem ratios. These were also higher on Oxford clay than on the sandy loam. Successful biomass production from willow on Oxford clay landfill caps will therefore require nutritional amendment.

Willow growth in response to nutrients and moisture on a clay landfill cap soil. II: Water use.

Water use by willow (Salix viminalis L.) was studied in lysimeters containing clay landfill cap and sandy loam soils under different watering and amendment regimes. With plentiful water and amendments, seasonal ET increased annually and was highest in the sandy loam, increasing from 360 l plant(-1) in the establishment year to almost 1200 l plant(-1) in the third year. Seasonal ET was highly correlated with leaf area duration. Amendment of Oxford clay resulted in increases in plant leaf area, dry matter production and seasonal ET. Water stress reduced seasonal ET by 10-14% in the second year and 25-41% in the third. Water use efficiency was low for the un-amended clay treatment (1.4 g kg(-1)) but was similar in the amended clay (5.0 g kg(-1)) and sandy loam (4.9 g kg(-1)). This highlights the interdependence of water use and biomass production in willow.

Growth, productivity and water use in three hybrid poplar clones.

Three drought treatments (none, medium and severe) were applied to three container-grown, hybrid poplar clones (Beaupré, Trichobel and Ghoy) as a series of drying cycles over two years-in a greenhouse in 1994 and outside in 1995. Leaf area development, annual biomass production and annual water use were recorded. Clone Beaupré had greater rates of leaf area development (up to 11.8 x 10(-4) m(2) degrees C day(-1)) and subsequently greater dry matter production (up to 816 g tree(-1) year(-1)) and water use (up to 168 l tree(-1) year(-1)) than the other two clones. In all clones, rates of leaf area development, annual biomass production and water use were less under drought conditions than under well-watered conditions. On a proportional basis, the highest reduction in biomass by drought was in Trichobel (up to 74%), whereas, in absolute terms, the reduction was greatest in Beaupré (up to 500 g tree(-1)). However, under drought conditions, annual biomass production was greater in Clone Beaupré than in the other clones. The relationship between water use and biomass production was constant over both years, and was similar for Beaupré and Trichobel at 4.4 g l(-1), but was less for Ghoy at 3.5 g l(-1).