NanoDefiner e-Tool: An Implemented Decision Support Framework for Nanomaterial Identification.
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ABSTRACT:
SUBMITTER: Brungel R
PROVIDER: S-EPMC6803960 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Appropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients.This is a retrospective cohort study of patients with paroxysmal or persistent nonvalvular AF. We updated an Atrial Fibrillation Decision Support Tool (AFDST) to include DOACs as treatment options. The tool generates patient-specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding using quality-adjusted life-years (QALYs) calculated for each treatment strategy by a decision analytic model. The setting included inpatient and ambulatory sites in an academic health center in the midwestern United States. The study involved 5,121 adults with nonvalvular AF seen for any ambulatory visit or inpatient hospitalization over the 1-year period (January through December 2016). Outcome measure was net clinical benefit in QALYs.When DOACs are a therapeutic option, the AFDST recommends OAT for 4,134 (81%) patients and no antithrombotic therapy or aspirin for 489 (9%). A strong recommendation for OAT could not be made in 498 (10%) patients. When warfarin is the only option, OAT is recommended for 3,228 (63%) patients and no antithrombotic therapy or aspirin for 973 (19%). A strong recommendation for OAT could not be made in 920 (18%) patients. In total, 1,508 QALYs could be gained if treatment were changed to that recommended by the AFDST.Availability of DOACs increases the proportion of patients for whom oral anticoagulation therapy is recommended in a real-world cohort of AF patients and increased projected QALYs by more than 1,500 when all patients are receiving thromboprophylaxis as recommended by the AFDST compared with current treatment.
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Project description:Newly recognized as natural nanocarriers that deliver biological information between cells, extracellular vesicles (EVs), including exosomes and microvesicles, provide unprecedented therapeutic opportunities. Large-scale and cost-effective manufacturing is imperative for EV products to meet commercial and clinical demands; successful translation requires careful decisions that minimize financial and technological risks. Here, we develop a decision support tool (DST) that computes the most cost-effective technologies for manufacturing EVs at different scales, by examining the costs of goods associated with using published protocols. The DST identifies costs of labor and consumables during EV harvest as key cost drivers, substantiating a need for larger-scale, higher-throughput, and automated technologies for harvesting EVs. Importantly, we highlight a lack of appropriate technologies for meeting clinical demands, and propose a potentially cost-effective solution. This DST can facilitate decision-making very early on in development and be used to predict, and better manage, the risk of process changes when commercializing EV products.
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| S-EPMC7544061 | biostudies-literature
Project description:The new recommended definition of a nanomaterial, 2022/C 229/01, adopted by the European Commission in 2022, will have a considerable impact on European Union legislation addressing chemicals, and therefore tools to implement this new definition are urgently needed. The updated NanoDefiner framework and its e-tool implementation presented here are such instruments, which help stakeholders to find out in a straightforward way whether a material is a nanomaterial or not. They are two major outcomes of the NanoDefine project, which is explicitly referred to in the new definition. This work revisits the framework and e-tool, and elaborates necessary adjustments to make these outcomes applicable for the updated recommendation. A broad set of case studies on representative materials confirms the validity of these adjustments. To further foster the sustainability and applicability of the framework and e-tool, measures for the FAIRification of expert knowledge within the e-tool's knowledge base are elaborated as well. The updated framework and e-tool are now ready to be used in line with the updated recommendation. The presented approach may serve as an example for reviewing existing guidance and tools developed for the previous definition 2011/696/EU, particularly those adopting NanoDefine project outcomes.
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Project description:BackgroundPromising health interventions tested in pilot studies will only achieve population-wide impact if they are implemented at scale across communities and health systems. Scaling up effective health interventions is vital as not doing so denies the community the most effective services and programmes. However, there remains a paucity of practical tools to assess the suitability of health interventions for scale-up. The Intervention Scalability Assessment Tool (ISAT) was developed to support policy-makers and practitioners to make systematic assessments of the suitability of health interventions for scale-up.MethodsThe ISAT was developed over three stages; the first stage involved a literature review to identify similar tools and frameworks that could be used to guide scalability assessments, and expert input to develop draft ISAT content. In the second stage, the draft ISAT tool was tested with end users. The third stage involved revising and re-testing the ISAT with end users to further refine the language and structure of the final ISAT.ResultsA variety of information and sources of evidence should be used to complete the ISAT. The ISAT consists of three parts. Part A: 'setting the scene' requires consideration of the context in which the intervention is being considered for scale-up and consists of five domains, as follows: (1) the problem; (2) the intervention; (3) strategic/political context; (4) evidence of effectiveness; and (5) intervention costs and benefits. Part B asks users to assess the potential implementation and scale-up requirements within five domains, namely (1) fidelity and adaptation; (2) reach and acceptability; (3) delivery setting and workforce; (4) implementation infrastructure; and (5) sustainability. Part C generates a graphical representation of the strengths and weaknesses of the readiness of the proposed intervention for scale-up. Users are also prompted for a recommendation as to whether the intervention (1) is recommended for scale-up, (2) is promising but needs further information before scaling up, or (3) does not yet merit scale-up.ConclusionThe ISAT fills an important gap in applied scalability assessment and can become a critical decision support tool for policy-makers and practitioners when selecting health interventions for scale-up. Although the ISAT is designed to be a health policy and practitioner tool, it can also be used by researchers in the design of research to fill important evidence gaps.
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Project description:BACKGROUND:The overuse of cranial computed tomography (CT) to diagnose potential traumatic brain injuries (TBIs) exposes children with minor blunt head trauma to unnecessary ionizing radiation. The Pediatric Emergency Care Applied Research Network and the Clinical Research on Emergency Services and Treatments Network implemented TBI prediction rules via electronic health record (EHR) clinical decision support (CDS) to decrease use of CTs in children with minor blunt head trauma. OBJECTIVE:This article aims to facilitate implementation and dissemination of a CDS alert into emergency departments around the country. METHODS:We evaluated the EHR CT CDS tool through a mixed-methods analysis of 38 audio-recorded interviews with health care stakeholders and quantitative data sources, using the Reach, Efficacy, Adoption, Implementation, and Maintenance framework. RESULTS:Reach -: The demographics of participants enrolled in the clinical trial were consistent with national estimates of TBI prevalence. Efficacy-There was a variable and modest reduction in CT rates for the 8,067 children with minor head trauma whose clinicians received CDS. Adoption -: The EHR CT CDS tool was well matched with the organizational mission, values, and priorities of the implementation sites. Implementation- The most important predisposing factors for successful implementation were the presence of an approachable clinical champion at each site and belief that the tool was a relevant, reusable knowledge asset. Enabling factors included an effective integration within the clinical workflow, organizational investment in user training, and ease of use. Maintenance -: Reinforcing factors for the EHR CT CDS tool included a close fit with the institutional culture, belief that it was useful for providers and families, and a good educational and informational tool. As such, the EHR CT CDS tool was maintained in clinical practice long after study completion. CONCLUSION:Data from this mixed-methods study complement findings from the efficacy trial and provide critical components for consideration prior to integration and subsequent dissemination of the EHR CT CDS tool. TRIAL REGISTRATION:NCT01453621, Registered September 27, 2011.
| S-EPMC6125135 | biostudies-literature
Project description:This article overviews the prairie and tree planting tool or PT2 (1.0), an online GIS-based decision support tool for landowners interested in exploring opportunities to plant prairie or trees in and around their farm fields for conservation or production purposes. PT2 1.0 can be found online at: https://pt2.nrem.iastate.edu/. With the PT2 (1.0) users locate farm fields of interest in an online aerial photograph and mapping geographic information system (GIS). Users explore areas they are considering for prairie or tree cover by examining different data layers: soil maps, 2-foot contour topography maps, LiDAR hillshade maps, and a map of current land values based on estimated land rent. Users then utilize scaled dimensional drawing tools to measure and delineate areas of interest for planting trees and or prairie. Once an area is delineated, users select from drop-down menus prairie seed mixes or woody species that are suitable for the soils present, and users can select basic long-term management options. PT2 (1.0) estimates total annualized costs for tree or prairie establishment, long-term management, and opportunity costs (based on area weighted expected soil rent), and factors in the potential benefit of utilizing government cost-share programming, e.g., Environmental Quality Incentive Program or the Conservation Reserve Program. Key data layers are currently functional in Iowa, likewise the financial data underlying the cost analysis are specific to Iowa. PT2 (1.0) is, however, open source and open code and guidance is provided regarding how to access and adapt the data for use in other states. Supplementary Information The online version contains supplementary material available at 10.1007/s10457-021-00686-8.
| S-EPMC8507355 | biostudies-literature