Matching Items (21)
Description
In a world in which technologies proliferate at a rapid rate, it is no surprise that the medical device industry has grown in leaps and bounds. This surge in medical technology, especially implantable medical technology, has altered the modern operating room, transforming surgery from a technique-driven activity into a technology-driven profession. This reliance upon technologies has fostered close ties between physicians and the medical device industry and within this relationship, medical device representatives play an integral role. This paper will investigate the relationship that exists between physicians and the medical device industry along with the potential conflicts of interest that may result due to this relationship. I will focus in particular on orthopedic medical devices due to media attention as a result of a 2007 Department of Justice settlement involving the leading orthopedic companies. This case proved instrumental in highlighting previously unknown instances in which conflicts of interest were occurring in the medical device industry.
ContributorsLove, Kailey (Author) / Robert, Jason (Thesis director) / Marchant, Gary (Committee member) / Buchholtz, Stephanie (Committee member) / Barrett, The Honors College (Contributor) / School of International Letters and Cultures (Contributor) / School of Life Sciences (Contributor) / School for the Science of Health Care Delivery (Contributor)
Created2014-05
Description
ABSTRACT Whole genome sequencing (WGS) and whole exome sequencing (WES) are two comprehensive genomic tests which use next-generation sequencing technology to sequence most of the 3.2 billion base pairs in a human genome (WGS) or many of the estimated 22,000 protein-coding genes in the genome (WES). The promises offered from WGS/WES are: to identify suspected yet unidentified genetic diseases, to characterize the genomic mutations in a tumor to identify targeted therapeutic agents and, to predict future diseases with the hope of promoting disease prevention strategies and/or offering early treatment. Promises notwithstanding, sequencing a human genome presents several interrelated challenges: how to adequately analyze, interpret, store, reanalyze and apply an unprecedented amount of genomic data (with uncertain clinical utility) to patient care? In addition, genomic data has the potential to become integral for improving the medical care of an individual and their family, years after a genome is sequenced. Current informed consent protocols do not adequately address the unique challenges and complexities inherent to the process of WGS/WES. This dissertation constructs a novel informed consent process for individuals considering WGS/WES, capable of fulfilling both legal and ethical requirements of medical consent while addressing the intricacies of WGS/WES, ultimately resulting in a more effective consenting experience. To better understand components of an effective consenting experience, the first part of this dissertation traces the historical origin of the informed consent process to identify the motivations, rationales and institutional commitments that sustain our current consenting protocols for genetic testing. After understanding the underlying commitments that shape our current informed consent protocols, I discuss the effectiveness of the informed consent process from an ethical and legal standpoint. I illustrate how WGS/WES introduces new complexities to the informed consent process and assess whether informed consent protocols proposed for WGS/WES address these complexities. The last section of this dissertation describes a novel informed consent process for WGS/WES, constructed from the original ethical intent of informed consent, analysis of existing informed consent protocols, and my own observations as a genetic counselor for what constitutes an effective consenting experience.
ContributorsHunt, Katherine (Author) / Hurlbut, J. Benjamin (Thesis advisor) / Robert, Jason S. (Thesis advisor) / Maienschein, Jane (Committee member) / Northfelt, Donald W. (Committee member) / Marchant, Gary (Committee member) / Ellison, Karin (Committee member) / Arizona State University (Publisher)
Created2013
Description
Gender and sex are often conflated. Our laws, policies, and even science establish sex and gender as intrinsically linked and dimorphic in nature. This dissertation examines the relationship between sex and gender and the repercussions of this linked dimorphism in the realms of law, politics, and science. Chapter One identifies the legal climate for changing one's sexual identity post-surgical reassignment. It pays particular attention to the ability of postsurgical transsexuals to marry in their acquired sex. Chapter Two considers the process for identifying the sex of athletes for the purposes of participation in sex-segregated athletic events, specifically the role of testing and standards for categorization. Chapter Three explores the process of identifying and assigning the sex of intersex children. Chapter Four examines the process of prenatal sex selection and its ethical implications. Chapter Four also offers an anticipatory governance framework to address these implications.
ContributorsParsi, John (Author) / Crittenden, Jack (Thesis advisor) / Guston, David H. (Committee member) / Marchant, Gary (Committee member) / Arizona State University (Publisher)
Created2013
Description
The NFL is one of largest and most influential industries in the world. In America there are few companies that have a stronger hold on the American culture and create such a phenomena from year to year. In this project aimed to develop a strategy that helps an NFL team be as successful as possible by defining which positions are most important to a team's success. Data from fifteen years of NFL games was collected and information on every player in the league was analyzed. First there needed to be a benchmark which describes a team as being average and then every player in the NFL must be compared to that average. Based on properties of linear regression using ordinary least squares this project aims to define such a model that shows each position's importance. Finally, once such a model had been established then the focus turned to the NFL draft in which the goal was to find a strategy of where each position needs to be drafted so that it is most likely to give the best payoff based on the results of the regression in part one.
ContributorsBalzer, Kevin Ryan (Author) / Goegan, Brian (Thesis director) / Dassanayake, Maduranga (Committee member) / Barrett, The Honors College (Contributor) / Economics Program in CLAS (Contributor) / School of Mathematical and Statistical Sciences (Contributor)
Created2015-05
Description
Objective: To assess and quantify the effect of state’s price transparency regulations (hereafter, PTR) on healthcare pricing.
Data Sources: I use the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) from 2000 to 2011. The NIS is a 20% sample of all inpatient claims. The Manhattan Institute supplied data on the availability of health savings accounts in each state. State PTR implementation dates were gathered by Hans Christensen, Eric Floyd, and Mark Maffett of University of Chicago’s Booth School of Business by contacting the health department, hospital association, or website controller in each state.
Study Design: The NIS data was collapsed by procedure, hospital, and year providing averages for the dependent variable, Cost, and a host of covariates. Cost is a product of Total Charges within the NIS and the hospital’s Cost to Charge ratio. A new binary variable, PTR, was defined as ‘0’ if the year was strictly less than the disclosure website’s implementation date, ‘1’ for afterwards, and missing for the year of implementation. Then, using multivariate OLS regression with fixed effect modeling, the change in cost from before to after the year of implementation is estimated.
Principal Findings: The analysis estimates the effect of PTR to decrease the average cost per procedure by 7%. Specifications identify within state, within hospital, and within procedure variation, and reports that 78% of the cost decrease is due to within-hospital, within-procedure price discounts. An additional model includes the interaction of PTR with the prevalence of health savings accounts (hereafter, HSAs) and procedure electivity. The results show that PTR lowers costs by an additional 3 percent with each additional 10 percentage point increase in the availability of HSAs. In contrast, the cost reductions from PTR were much smaller for procedures more frequently coded as elective.
Conclusions: The study concludes price transparency regulations can lead to a decrease in a procedure’s costs on average, primarily through price discounts and slightly through lower cost procedures, but not due to patients moving to cheaper hospitals. This implies that hospitals are taking initiative and lowering prices as the competition’s prices become publically available suggesting that hospitals – not patients – are the biggest users of price transparency websites. Hospitals are also finding some ways to provide cheaper alternatives to more expensive procedures. State regulators should evaluate if a better metric other than charge prices, such as expected out-of-pocket payments, would evoke greater patient participation. Furthermore, states with higher prevalence of HSAs experience greater effects of PTR as expected since patients with HSAs have greater incentives to lower their costs. Patients should expect a shift towards plans that offer these types of savings accounts since they’ve shown to have a reduction of health costs on average per procedure in states with higher prevalence of HSAs.
Data Sources: I use the Healthcare Cost and Utilization Project’s Nationwide Inpatient Sample (NIS) from 2000 to 2011. The NIS is a 20% sample of all inpatient claims. The Manhattan Institute supplied data on the availability of health savings accounts in each state. State PTR implementation dates were gathered by Hans Christensen, Eric Floyd, and Mark Maffett of University of Chicago’s Booth School of Business by contacting the health department, hospital association, or website controller in each state.
Study Design: The NIS data was collapsed by procedure, hospital, and year providing averages for the dependent variable, Cost, and a host of covariates. Cost is a product of Total Charges within the NIS and the hospital’s Cost to Charge ratio. A new binary variable, PTR, was defined as ‘0’ if the year was strictly less than the disclosure website’s implementation date, ‘1’ for afterwards, and missing for the year of implementation. Then, using multivariate OLS regression with fixed effect modeling, the change in cost from before to after the year of implementation is estimated.
Principal Findings: The analysis estimates the effect of PTR to decrease the average cost per procedure by 7%. Specifications identify within state, within hospital, and within procedure variation, and reports that 78% of the cost decrease is due to within-hospital, within-procedure price discounts. An additional model includes the interaction of PTR with the prevalence of health savings accounts (hereafter, HSAs) and procedure electivity. The results show that PTR lowers costs by an additional 3 percent with each additional 10 percentage point increase in the availability of HSAs. In contrast, the cost reductions from PTR were much smaller for procedures more frequently coded as elective.
Conclusions: The study concludes price transparency regulations can lead to a decrease in a procedure’s costs on average, primarily through price discounts and slightly through lower cost procedures, but not due to patients moving to cheaper hospitals. This implies that hospitals are taking initiative and lowering prices as the competition’s prices become publically available suggesting that hospitals – not patients – are the biggest users of price transparency websites. Hospitals are also finding some ways to provide cheaper alternatives to more expensive procedures. State regulators should evaluate if a better metric other than charge prices, such as expected out-of-pocket payments, would evoke greater patient participation. Furthermore, states with higher prevalence of HSAs experience greater effects of PTR as expected since patients with HSAs have greater incentives to lower their costs. Patients should expect a shift towards plans that offer these types of savings accounts since they’ve shown to have a reduction of health costs on average per procedure in states with higher prevalence of HSAs.
ContributorsSabol, Joshua Lawrence (Author) / Reiser, Mark (Thesis director) / Ketcham, Jonathan (Committee member) / Dassanayake, Maduranga (Committee member) / Barrett, The Honors College (Contributor) / School of Mathematical and Statistical Sciences (Contributor) / Department of Supply Chain Management (Contributor)
Created2015-05
Description
Noninvasive prenatal testing using cell-free fetal DNA (CffDNA) testing is a rapidly developing area in prenatal diagnosis. Fetal genetic testing can occur with a simple maternal blood sample, since CffDNA can be found in maternal plasma. Thus, no harm is caused to mother or fetus to obtain this genetic information, providing significant benefits for those users. How the test should be integrated in existing prenatal programs has yet to be seen. CffDNA testing is an exciting technology and has attracted attention from many stakeholders, yet the lack of regulation and guidance has left legal, ethical, and social questions unanswered. This paper outlines a number of those issues expressed in the present literature on the matter.
ContributorsVeeder, Shaylynn Lee (Author) / Marchant, Gary (Thesis director) / Robert, Jason (Committee member) / Milleson, Valerye (Committee member) / Barrett, The Honors College (Contributor) / School of Social Transformation (Contributor) / School of Politics and Global Studies (Contributor) / Sandra Day O'Connor College of Law (Contributor) / Department of Psychology (Contributor)
Created2014-05
Description
In 2004, the South Korean geneticist Woo-Suk Hwang published what was widely regarded as the most important research result in biotechnology of the year. In the prestigious American journal Science, he claimed that he had succeeded in cloning a human blastocyst, an embryo in its early stages (Hwang et al. 2004). A year later, in a second Science article, he made the earth-shattering announcement that he had derived eleven embryonic stem cell lines using his cloning technique (Hwang et al. 2005). The international scientific community was stunned. American scientists publicly fretted that President George W. Bush‘s 2001 executive order limiting federal funding for stem-cell research in the United States had put American bioscience behind the Koreans‘ (Paarlberg 2005). These breakthroughs offered potential solutions to immune system rejection of transplanted organs and possible cures for diseases such as rheumatoid arthritis, Parkinson‘s, Down‘s syndrome, and paralysis (Svenaeus 2007). However, within a year, Hwang was exposed as a fraud who had faked his results and pressured his female colleagues to donate eggs without informed consent. Despite protests against his methods from Korean religious and nongovernmental organizations, Hwang had used his prestige to ignore his ethical obligations. The Korean government, too, was slow to investigate Hwang and to subject his work to appropriate regulation.
ContributorsClay, Anne (Author) / Hurlbut, James (Thesis director) / Maienschein, Jane (Committee member) / Marchant, Gary (Committee member) / Barrett, The Honors College (Contributor) / School of Life Sciences (Contributor)
Created2012-12
Description
The thesis is an investigation on current regulations of commercial aircraft landing and take-off procedures and an analysis of potential weaknesses within the regulatory system for commercial aerospace. To determine such flaws, an area of worse-case scenarios with regard to the aforementioned flight operations was researched. The events selected to best-depict these scenarios where incidents of aircraft overrunning the runway, referred to as runway excursions. A case-study conducted of 44 federal investigations of runway excursions produced data indicating four influential factors within these incidents: weather, pilot error, instrument malfunction, and runway condition. Upon examination, all but pilot error appeared to have federal enforcement to diminish the occurrence of future incidents. This is a direct result of the broad possibilities that make up this factor. The study then searched for a consistent fault within the incidents with the results indicating an indirect relationship of thrust reversers, a technique utilized by pilots to provide additional braking, to these excursions. In cases of thrust reverser failure, pilots' over-reliance on the system lead to time being lost from the confusion produced by the malfunction, ultimately resulting in several different runway excursions. The legal implication with the situation is that current regulations are ambiguous on the subject of thrust reversers and thus do not properly model the usage of the technique. Thus, to observe the scope of danger this ambiguity presents to the industry, the relationship of the technique to commercial aerospace needed to be determined. Interviews were set-up with former commercial pilots to gather data related to the flight crew perspective. This data indicated that thrust reversers were actively utilized by pilots within the industry for landing operations. The problem with the current regulations was revealed that the lack of details on thrust reverser reflected a failure of regulations to model current industry flight operations. To improve safety within the industry, new data related to thrust reverser deployment must be developed and enforced to determine appropriate windows to utilize the technique, thus decreasing time lost in confusion that results from thrust reversers malfunction. Future work would be based on producing simulations to determine said data as well as proposing the policy suggestions produced by this thesis.
ContributorsCreighton, Andrew John (Author) / Takahashi, Timothy (Thesis director) / Marchant, Gary (Committee member) / Kimberly, Jimmy (Committee member) / Barrett, The Honors College (Contributor) / Mechanical and Aerospace Engineering Program (Contributor) / School of Mathematical and Statistical Sciences (Contributor) / School of Politics and Global Studies (Contributor)
Created2014-05
Description
The focus shift towards Silicon Valley and similar ecosystems in the past decade, the recent boom in startups and entrepreneurship, and the resurgence of venture capital funding is fueling rapid advancement of modern technologies, such as software, biotechnology, and renewable energy. One facet of the growing entrepreneurial landscape features healthcare technology—a field of research centered upon various technical advances in medicine, software, and hardware. Trends in healthcare technology commercialization represent a promising opportunity for disruption in the healthcare industry. The integration of rapidly iterating software with medical research, timed perfectly with the passage of the Affordable Care Act and the boom of venture capital investment in both Big Data and mobile technology, has the healthcare technology primed for explosive growth over the next decade. Investment data indicates that strong public market activity in the past year will continue to fuel venture capital growth in both the biotechnology and digital health sectors, with the potential for multiple large exits by life sciences companies, more than even software, in the coming year.
ContributorsPatel, Nisarg (Co-author) / Yun, Kwanho (Co-author) / Wang, Xiao (Thesis director) / Marchant, Gary (Committee member) / Peck, Sidnee (Committee member) / Barrett, The Honors College (Contributor) / Department of Management (Contributor) / School of Politics and Global Studies (Contributor) / School of Life Sciences (Contributor)
Created2014-05
Description
I will be redacting my thesis on a project I will be a party of over the next two semesters through Innovation Space. This program is a joint venture between the Herberger Institute for Design and the Arts, Ira A. Fulton School of Engineering and W.P. Carey School of Business in which we form an interdisciplinary team to work on and develop products that create market value all the while serving societal needs and minimizing environmental impacts. In short we are an entrepreneurial venture that will go through every facet of bringing a project from the imagination to market. My role in this project will be to conduct research while brainstorming potential applications of my results. I will be in addition sharing and exercising my expertise in the field of Supply Chain management and business in general to support the other disciplines on my team. Furthermore, as a business student I will be personally responsible for developing a strategic plan once we have determined a potential product, I will analyze any sort of market forecast applicable to my topic and ideate any sort of customer relations to follow through with our product. To add to these tasks, I will also ensure a positive cash flow for the project in general. As the thesis specific part of the project I will be writing about the legal implications involved in the development of an idea into a marketable and financially viable product. I will be analyzing various aspects of patent law as well as potentially private international law in regards to sourcing.
ContributorsGanase, Ketan Mael (Author) / Marchant, Gary (Thesis director) / Peck, Sidnee (Committee member) / Boradkar, Prasad (Committee member) / Barrett, The Honors College (Contributor) / Department of Supply Chain Management (Contributor)
Created2013-05