Systems approach to assessing and improving local human research Institutional Review Board performance.

ObjectiveTo quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.MethodsOver 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.ResultsStaffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.ConclusionsUnderstanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics

Fenchel Conjugate of Set-Valued Mappings

In this paper, we present a novel concept of the Fenchel conjugate for set-valued mappings and investigate its properties in finite and infinite dimensions. After establishing the fundamental properties of the Fenchel conjugate for set-valued mappings, we derive its main calculus rules in various settings. Our approach is geometric and draws inspiration from the successful application of this method by B.~S.~Mordukhovich and coauthors in variational and convex analysis. Subsequently, we demonstrate that our new findings for the Fenchel conjugate of set-valued mappings can be utilized to obtain many established calculus rules of convex generalized differentiation in both finite and infinite dimensions

Are topical nitrates safe and effective for upper extremity tendinopathies?

Q. Are topical nitrates safe and effective for upper extremity tendinopathies? A. Topical nitrates provide short-term relief with some side effects, especially headache. Topical nitroglycerin (NTG) patches improve subjective pain scores by about 30% and range of motion over 3 days in patients with acute shoulder tendinopathy (strength of recommendation [SOR]: C, small randomized controlled trial [RCT] with no methodologic flaws). NTG patches, when combined with tendon rehabilitation, improve subjective pain ratings by about 30% and shoulder strength by about 10% in patients with chronic shoulder tendinopathy over 3 to 6 months, but not in the long term (SOR: C, RCTs with methodologic flaws). They improve pain and strength 15% to 50% for chronic extensor tendinosis of the elbow over a 6-month period (SOR: C, small RCT with methodologic flaws). NTG patches used without tendon rehabilitation don't improve pain or strength in chronic lateral epicondylitis over 8 weeks (SOR: C, RCT). Topical NTG patches commonly produce headaches and rashes (SOR: B, multiple RCTs)

Paclitaxel Drug Elution from a Biodegradable Stent

Recently, drug-eluting stents have become a common treatment for coronary heart disease. These stents are usually loaded with a drug that prevents restenosis. Unfortunately, there are risks associated with the placement of these metallic structures in the body. Stent thrombosis is one such problem, and can lead to restenosis despite the presence of drug. Advances in biomaterials have led to the development of biodegradable stents, which can reduce the risks associated with stents. However, since it is a relatively new technology, it is not known to what degree the biodegradability affects the drug releasing properties of the stent. We hope to characterize these effects and to determine if the biodegradability reduces the efficacy of the stent when compared to normal non-degradable stents. To accomplish this, we modeled a stent that diminished in size over time using COMSOL Multiphysics, and monitored the drug concentration in the nearby tissue. We established that our model was a viable predictor of actual stent behavior by comparing our simulated results with previous studies. We were then able to determine the optimal initial loading stent concentration of our modeled drug, paclitaxel, to ensure therapeutic levels in the tissue. Lastly, we found that drug concentrations in the tissue were not substantially different between the degradable and non-degradable models. This affirms the effectiveness of using biodegradable stents, showing them as a viable alternative to traditional metal stents

Compositions and methods for controlling the stability of ethersulfate surfactants at elevated temperatures

The present invention describes the method of making an ether sulfate surfactant solution hydrolytically stable by adding one or more alkalinity generating agents at levels greater than 0.05%. The surfactant solutions of the present invention have half-lives >8 months at 100° C. and find uses in EOR applications, environmental cleanups, detergent industry, and any other surfactant based high temperature applications.Board of Regents, University of Texas Syste

Team 3: Exploring the relationship of systems research to systems literacy

In this paper, the Systems Research Team (SRT) details the activities and outcomes of the 2016 IFSR Conversation in Linz, Austria. The 2016 SRT includes: Mary Edson (team leader), Pam Buckle Henning, Tim Ferris, Andreas Hieronymi, Ray Ison, Gary Metcalf, George Mobus, Nam Nguyen, David Rousseau, and Shankar Sankaran, with guest team member, Peter Tuddenham, anchoring the endeavor in Systems Literacy. While the 2014 SRT’s focus was answering the question, “What distinguishes Systems Research from other types of research?” an internal focus intended to provide grounding for researchers new to the Systems Sciences, the 2016 SRT’s focus is on reaching out to a broader community in order to provide a foundation for Systems Literacy. The team’s Conversation revolved around the question, “How can Systems Research be in service to Systems Literacy?” The team’s discussions were directed into two essential aspects, separate and integrated, of this question. First, Systems Research serves Systems Literacy by providing a credible foundation for the principles and practices of Systems Science and Systems Thinking in both systematic and systemic modes. Second, Systems Research provides a neutral frame for development of ethical applications of those principles and practices. The SRT recognizes the exigency in providing foundational principles that can be effectively adopted and disseminated through Systems Literacy. The team’s narrative begins with an understanding the urgency for application of Systems Sciences and Systems Thinking to critical issues. Systems research, as with other types of research, is typically a slow generation of results; however, the body of knowledge gained through this process can be confidently used to address complexity in timely ways. The criticality of the need for salient approaches to complexity is shown in a graphic representation of some possible trajectories of applying or not applying these Systems principles in practice. The choice of how we respond to these issues relates to a process model that can be applied. Through understanding the relationship of the process model to the trajectory, the team directed its focus to developing a MindMap (Eppler, 2006) of eight essential aspects or features of how Systems Research can support Systems Literacy. These include: Systems Science knowledge base, roles and personas, maturity models, role profile, ontology/vocabulary, perspective/framing choice, frameworks, and political ecology. Each of these eight has its own process of unpacking, which was demonstrated to the Conversation participants by delving more deeply into the aspect of knowledge base. The eight relate to unpacking the Systems landscape in a coherent but loosely coupled investment portfolio (economic, social, and relational) for building systemic sensibility in such a way as to be dis/aggregated for different audiences. The week’s work culminated in a plan for “Looking Ahead,” which outlines the intentions of the SRT to continue its activities in support of Systems Literacy in the upcoming months. An example of this continued work is a workshop, “Toward Systems Literacy, the Role of Systems Research,” that was conducted at the 60th Meeting of the International Society for the Systems Sciences in Boulder, July 25, 2016

Fenchel-Rockafellar Theorem in Infinite Dimensions via Generalized Relative Interiors

In this paper we provide further studies of the Fenchel duality theory in the general frame work of locally convex topological vector (LCTV) spaces. We prove the validity of the Fenchel strong duality under some qualification conditions via generalized relative interiors imposed on the epigraphs and the domains of the functions involved. Our results directly generalize the classical Fenchel-Rockafellar theorem on strong duality from finite dimensions to LCTV spaces.Comment: arXiv admin note: text overlap with arXiv:1812.0060

Inferring behavioral specifications from large-scale repositories by leveraging collective intelligence

Despite their proven benefits, useful, comprehensible, and efficiently checkable specifications are not widely available. This is primarily because writing useful, non-trivial specifications from scratch is too hard, time consuming, and requires expertise that is not broadly available. Furthermore, the lack of specifications for widely-used libraries and frameworks, caused by the high cost of writing specifications, tends to have a snowball effect. Core libraries lack specifications, which makes specifying applications that use them expensive. To contain the skyrocketing development and maintenance costs of high assurance systems, this self-perpetuating cycle must be broken. The labor cost of specifying programs can be significantly decreased via advances in specification inference and synthesis, and this has been attempted several times, but with limited success. We believe that practical specification inference and synthesis is an idea whose time has come. Fundamental breakthroughs in this area can be achieved by leveraging the collective intelligence available in software artifacts from millions of open source projects. Finegrained access to such data sets has been unprecedented, but is now easily available. We identify research directions and report our preliminary results on advances in specification inference that can be had by using such data sets to infer specifications