Browsing by Subject "Design"
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Item Open Access A New Take on Gamification: Playing the Culture Shock Experience in a Digital Card Game(2020) Yan, AnniIn 2018-2019, over 1 million international students from all over the world come to the United States to seek higher education. Along with their hope for quality education, they bring their own cultures. The clash of the United States (US) culture and the foreign culture produces “culture shock”, the progress of learning and adjusting to new environments. This process of working through culture shock, which can take from days to months, exposes the foreign students to loneliness, depression, and lack of belonging. International students also face challenges from language barriers, identity crises, and mental distress. To cope with the stress, they might choose to remain in their comfort zone and isolate themselves from other cultures, but this prevents them from taking full advantage of their new environment and communities. Many institutions offer programs to help students from different backgrounds to embrace diversity by hosting student groups, culture fest, and seminars. They have tried to solve this problem, but for many individuals, it is still difficult to encounter culture shock.This thesis analyzes the effects of culture shocks, the usage of games in empathy building, and aid in the understanding of cultural barriers. It first explores the challenges international students face and their coping strategies. It then surveys research into existing empathy-building games that have shown a positive impact on the targeted audience. Finally, the thesis introduces a digital card game, Cultivated, which was developed to act upon these research findings and to create an experience that helps to address the issue of cultural shock. The game is designed for domestic students to discover cultural differences. The players are asked to develop a new culture of communication together, to experience “culture shock”, and most importantly learn about each other’s culture in real life by exploring the following five aspects of the phenomenon: language, value, symbol, norm, and ritual. The paper argues that a gamified approach to the problem, a digital card game thematized around addressing culture shock, can help tell the story of international students to others and themselves and that playing the game can help break down cultural barriers.
Item Open Access A Virtual Reality Application: Creating an Alternative Immersive Experience for Dunhuang Mogao Cave Visitors(2023) Zhao, XinqianAs the largest cave of Buddhist art with thousands of murals spanning ten dynasties, the Dunhuang Mogao cave has been described as a “peerless cave” because of its fabulous frescos and handcrafted delicate sculptures. However, tourism and in-cave human activities had damaged the frescos; only a few caves are now open with limited accessibility for global visitors and the public. In addition, Dunhuang Cave authorities set strict rules to exclude some people, such as people in wheelchairs, to protect the murals and sculptures from possible damage. This thesis project aims to address this problem by modeling how digital environments might provide universal access to the cave by marginalized and excluded groups. The thesis project includes two separate digital sections: a Unity VR (Virtual Reality) immersive experience and a web-based Story Map with a three-dimensional view of selected murals. The thesis project not only provides an immersive experience for worldwide visitors but also unlocks the door for the possibilities of preserving cultural heritage by using innovative digital methods. Through the use of Maya and Steam, the Unity game engine can be used to curate a virtual space by placing the audience into well-textured 3D cave models, while the web-based story map can be used to contextualize basic background knowledge and provides a comprehensive text explanation of the Silk Road and Buddhist culture to inform the user’s understanding of what they are seeing. Overall, this thesis demonstrates endeavors to discover more possibilities and opportunities for historical and cultural heritage protection while not losing access.
Item Open Access Bennett Place AR: Evaluating an AR Application at a Historic Site from a UX Design Perspective(2023) Shi, RuojinThis thesis explores the integration of User Experience (UX) Design in digital humanities, with a focus on Augmented Reality (AR) at Bennett Place. It draws on Brennan's public digital humanity concept, emphasizing the need for public-oriented approaches in digital humanities. The research employs UX design methods, adhering to a workflow comprising research, ideation, design, and user testing.In the research stage, Bennett Place's historical context and visitor personas are analyzed to inform design objectives and user expectations. The ideation stage addresses content design and AR technology selection, aiming for effective information delivery and inclusive user experiences. The design stage details the digital project's implementation. The final delivery of this thesis is an iOS AR app the final stage involves user testing to evaluate the application of AR in enhancing on-site visiting experience at Bennett Place. Although the testing results are not definitive, they provide valuable insights for future digital humanities projects, particularly in public engagement. This thesis demonstrates the effectiveness of AR in enhancing on-site visiting experience at Bennett Place and highlights the potential for incorporating UX methodologies in digital humanities, advocating for more user-focused, engaging, and informative experiences.
Item Open Access Constructal Design of Energy Systems(2016) Alalaimi, Mohammad AliThis dissertation shows the use of Constructal law to find the relation between the morphing of the system configuration and the improvements in the global performance of the complex flow system. It shows that the better features of both flow and heat transfer architecture can be found and predicted by using the constructal law in energy systems. Chapter 2 shows the effect of flow configuration on the heat transfer performance of a spiral shaped pipe embedded in a cylindrical conducting volume. Several configurations were considered. The optimal spacings between the spiral turns and spire planes exist, such that the volumetric heat transfer rate is maximal. The optimized features of the heat transfer architecture are robust. Chapter 3 shows the heat transfer performance of a helically shaped pipe embedded in a cylindrical conducting volume. It shows that the optimized features of the heat transfer architecture are robust with respect to changes in several physical parameters. Chapter 4 reports analytically the formulas for effective permeability in several configurations of fissured systems, using the closed-form description of tree networks designed to provide flow access. The permeability formulas do not vary much from one tree design to the next, suggesting that similar formulas may apply to naturally fissured porous media with unknown precise details, which occur in natural reservoirs. Chapter 5 illustrates a counterflow heat exchanger consists of two plenums with a core. The results show that the overall flow and thermal resistance are lowest when the core is absent. Overall, the constructal design governs the evolution of flow configuration in nature and energy systems.
Item Open Access Design, Characterization, and Evaluation of a Surface Plasmon Resonance Sensor(2012) Greenley, MichaelCharacterization of thin films, prominently including self-assembled monolayers is important to the understanding of interfacial events in both biological and manufactured systems. To facilitate such work, a surface plasmon resonance device, or SPR, was constructed, and tests were conducted to evaluate the performance of the system relative to current systems and mathematical models. First, relevant analytical equations are introduced to describe the behavior of the system. In subsequent chapters, the design of the device, its calibration, and operating procedure are explained. Finally, the system is tested against samples with known behaviors, and the experimental and analytical results are compared.
Item Open Access FAILURE-SPARKED INNOVATION: THE KEY TO ENSURING THE FUTURE OF LOCAL CHURCHES(2021) Edwards, Kaury CharlesWithin the current cultural milieu of eclectic pluralism the Western Church currently finds itself in, innovation must be a central focus within all aspects of ministry in the Christian Church. With the focus that the local church must put on innovation, one aspect that will continually be an important factor is how the Church understands, interprets, and utilizes failure. The challenge for the local church is to rethink its notion of failure which will allow for creativity, new life, and ultimately, transformational innovation. By establishing a proper framework and definition of failure, the Church will be able to embrace good failure and the benefits it can offer. Calling the Church to embrace failure is also a call to embrace innovation and Design Thinking. Good failure is not fully beneficial without these two essential and creative tools. For every church struggling to muster the confidence to dive into creative exploration and experimentation or the minister who wrestles with sustaining a culture open to change and new ideas, applying the principles of innovation and Design Thinking aid immensely on one’s journey towards success. This path towards success will not be simple. At times, the path will be consumed with failure and disruption. Still, good failure must be embraced in order to foster adaptive learning, growth, and mastery. By adopting an innovative culture and leaning into good failure, the Church embraces culture that generates change, pursues excellence, ensures vitality, makes a difference in the world, and seeks to meet the needs of people. As the Church wrestles with failure as a means to produce and promote innovation, the local church responds to God’s call and partners with God in God’s creative and redemptive work throughout the world. Thus, as the Church seeks to continue its impactful work in the world, the Church must establish a sound methodology for innovation and untap the creative fountain of Design Thinking. Throughout the history of the Christian Church, there have been countless extraordinary saints who have innovated, revolutionized, and championed fresh expressions and aspects of the Church. However, while it is important to remember the Church’s noteworthy saints and their significant contributions, we should not forget that there were failures along the way, and these should not be ignored. For the majority of United Methodist ministers, John Wesley is one of the most esteemed and highlighted saints who dynamically revolutionized, innovated, and restructured the Church. Nevertheless, he too experienced failures throughout his life and ministry. Still, with each moment of failure, Wesley pressed on and pivoted to innovate in successful ways that changed the world forever, even birthing and shaping the people called Methodists. In today’s rapidly changing world, local churches need to follow the example of John Wesley – embrace good failure, practice innovation, and restore imagination to ensure their future. Regardless of how fast the world continues to spin, churches must recognize profound changes must be made to establish a sound framework for failure and innovation, foster an innovative culture, and evoke an operational model change that allows the Church to be better than it was yesterday. Ultimately, local churches must awaken its innovative spirit and join God in God’s ministry throughout the world.
Item Open Access FAILURE-SPARKED INNOVATION: THE KEY TO ENSURING THE FUTURE OF LOCAL CHURCHES(2021) Edwards, Kaury CharlesWithin the current cultural milieu of eclectic pluralism the Western Church currently finds itself in, innovation must be a central focus within all aspects of ministry in the Christian Church. With the focus that the local church must put on innovation, one aspect that will continually be an important factor is how the Church understands, interprets, and utilizes failure. The challenge for the local church is to rethink its notion of failure which will allow for creativity, new life, and ultimately, transformational innovation. By establishing a proper framework and definition of failure, the Church will be able to embrace good failure and the benefits it can offer. Calling the Church to embrace failure is also a call to embrace innovation and Design Thinking. Good failure is not fully beneficial without these two essential and creative tools. For every church struggling to muster the confidence to dive into creative exploration and experimentation or the minister who wrestles with sustaining a culture open to change and new ideas, applying the principles of innovation and Design Thinking aid immensely on one’s journey towards success. This path towards success will not be simple. At times, the path will be consumed with failure and disruption. Still, good failure must be embraced in order to foster adaptive learning, growth, and mastery. By adopting an innovative culture and leaning into good failure, the Church embraces culture that generates change, pursues excellence, ensures vitality, makes a difference in the world, and seeks to meet the needs of people. As the Church wrestles with failure as a means to produce and promote innovation, the local church responds to God’s call and partners with God in God’s creative and redemptive work throughout the world. Thus, as the Church seeks to continue its impactful work in the world, the Church must establish a sound methodology for innovation and untap the creative fountain of Design Thinking. Throughout the history of the Christian Church, there have been countless extraordinary saints who have innovated, revolutionized, and championed fresh expressions and aspects of the Church. However, while it is important to remember the Church’s noteworthy saints and their significant contributions, we should not forget that there were failures along the way, and these should not be ignored. For the majority of United Methodist ministers, John Wesley is one of the most esteemed and highlighted saints who dynamically revolutionized, innovated, and restructured the Church. Nevertheless, he too experienced failures throughout his life and ministry. Still, with each moment of failure, Wesley pressed on and pivoted to innovate in successful ways that changed the world forever, even birthing and shaping the people called Methodists. In today’s rapidly changing world, local churches need to follow the example of John Wesley – embrace good failure, practice innovation, and restore imagination to ensure their future. Regardless of how fast the world continues to spin, churches must recognize profound changes must be made to establish a sound framework for failure and innovation, foster an innovative culture, and evoke an operational model change that allows the Church to be better than it was yesterday. Ultimately, local churches must awaken its innovative spirit and join God in God’s ministry throughout the world.
Item Open Access Faith by Design: Exploiting intersections between Acts and design thinking to cultivate the conditions for innovation in the local church as an expression of traditioned innovation(2021) Aho, Christopher R.In 2021, congregational life in America feels troubled. The residue of vitality in vacant Sunday school classrooms, dated worship bulletins, antiquated committee structures, and worn pew cushions reminds churchgoers of the ways congregations once successfully capitalized on the intersection of industrialization and an evangelical spirit. However, today, the world has changed. Traditional churches that mirror a now-shuttered factory across town struggle under the weight of dated, worker-dependent, industrial expressions of congregational life. These congregations feel trapped, which inhibits innovation and steers churches toward the same fate as those factories across town. Some believe that what local churches need is a way to cultivate innovation. To do this, congregations need the tools and a pathway that leads to innovative breakthroughs. Design thinking is a process built on an accessible set of tools that can provide teams in any field the steps necessary to cultivate innovation. For the church, and specifically local congregations, innovation cannot happen in a vacuum. Churches have histories and traditions, most of which root themselves in a tradition connected to the book of Acts. As churches cling to specific traditions, they often maintain practices as traditionalism, which begets a shallow expression of tradition. In these instances, faithful innovation is necessary. However, to innovate for the sake of innovation alone represents a shallow expression of innovation. The church needs to hold together tradition and innovation in ways that give life to a shared life rooted through embodied traditions. Faith by Design explores and exploits intersections between the embodied traditions outlined in Acts and the modern pathway to innovation described in design thinking. By adapting the approaches, tools, and practices of design thinkers and then exploiting these processes' intersections with the stories of the early church in Acts, the congregations can discover and design a renewed sense of life and vitality. Faith by Design invites congregations to explore the design thinking process and practices within the rich Christian tradition in ways that will help cultivate the conditions necessary for the emergence of renewed practices and behaviors which beget life, vitality, and hope.
Item Unknown Faith by Design: Exploiting intersections between Acts and design thinking to cultivate the conditions for innovation in the local church as an expression of traditioned innovation(2021) Aho, Christopher R.In 2021, congregational life in America feels troubled. The residue of vitality in vacant Sunday school classrooms, dated worship bulletins, antiquated committee structures, and worn pew cushions reminds churchgoers of the ways congregations once successfully capitalized on the intersection of industrialization and an evangelical spirit. However, today, the world has changed. Traditional churches that mirror a now-shuttered factory across town struggle under the weight of dated, worker-dependent, industrial expressions of congregational life. These congregations feel trapped, which inhibits innovation and steers churches toward the same fate as those factories across town. Some believe that what local churches need is a way to cultivate innovation. To do this, congregations need the tools and a pathway that leads to innovative breakthroughs. Design thinking is a process built on an accessible set of tools that can provide teams in any field the steps necessary to cultivate innovation. For the church, and specifically local congregations, innovation cannot happen in a vacuum. Churches have histories and traditions, most of which root themselves in a tradition connected to the book of Acts. As churches cling to specific traditions, they often maintain practices as traditionalism, which begets a shallow expression of tradition. In these instances, faithful innovation is necessary. However, to innovate for the sake of innovation alone represents a shallow expression of innovation. The church needs to hold together tradition and innovation in ways that give life to a shared life rooted through embodied traditions. Faith by Design explores and exploits intersections between the embodied traditions outlined in Acts and the modern pathway to innovation described in design thinking. By adapting the approaches, tools, and practices of design thinkers and then exploiting these processes' intersections with the stories of the early church in Acts, the congregations can discover and design a renewed sense of life and vitality. Faith by Design invites congregations to explore the design thinking process and practices within the rich Christian tradition in ways that will help cultivate the conditions necessary for the emergence of renewed practices and behaviors which beget life, vitality, and hope.
Item Unknown Inflected wings in flight: Uniform flow of stresses makes strong and light wings for stable flight.(Journal of theoretical biology, 2021-01) Mardanpour, Pezhman; Izadpanahi, Ehsan; Powell, Shanae; Rastkar, Siavash; Bejan, AdrianFlying animals morph and flex their wings during their flight. Their wings morph with the turbulent flow created around them. The wings of modern airplanes do not have this ability. In this study we show that the ability to flex the wings leads to greater stability (higher flutter speed), and that this is due to the more uniform distribution of stresses in the flexing wing. This way the flexing wing becomes the lightest per unit of flapping force, or the strongest per unit of weight.Item Unknown Modeling Generative Artificial Intelligence(2023) Xiong, HaochenThe release of ChatGPT-4 has led to the prevalent use of a new term in the field of artificial intelligence (AI): generative AI. This paper aims to understand generative AI more thoroughly and place it within a broader framework of models and their relationship with knowledge. By closely examining AI’s historical development, this paper will first introduce the concept of emergence to distinguish generative AI from other forms of AI. Second, by theorizing generative AI as models, this paper will evaluate their significance in human knowledge production. Third, by classifying generative AI specifically as generative models, this paper will demonstrate their unique potential, especially for art creation.
Item Unknown Morphing the design to go with the times(International Communications in Heat and Mass Transfer, 2021-01-01) Bejan, A; Gucluer, S© 2020 Elsevier Ltd The recorded history of technology and science and art shows that the evolutionary path of design is toward a greater number of dimensions, more degrees of freedom, and greater performance, efficiency and economy. Until now, designs have evolved in steps from one to two and three dimensions. The future will bring one more step, to four dimensions: three-dimensional objects that morph in time in accord with their time-changing environmental conditions. This concept is illustrated with the thermo-fluid design and time-behavior of a volume filled with parallel plates cooled by forced convection. When the pressure difference that drives the flow varies stepwise in time, the plate to plate spacing for maximum heat transfer density must change. If the structure is free to morph to maintain its optimal spacings in step with its changing environment, then the time-integrated performance of the morphing object is maximum. If the structure is rigid (sized optimally for one flow condition), its performance is inferior. The general significance and applicability of this future of design activity is discussed.Item Unknown Rotor Vibration Reduction Using Multi-Element Multi-Path Design(2013) Su, KeyeMulti-Element Multi-Path (MEMP) structural design is a new concept for rotor vibration reduction. This thesis explores the possibility of applying MEMP design to helicopter rotor blades. A conceptual design is developed to investigate the MEMP blade's vibration reduction performance. In the design, the rotor blade is characterized by two centrifugally loaded beams which are connected to each other through linear and torsional springs. A computer program is built to simulate the behavior of such structures. Detailed parametric studies are conducted. The main challenges in this thesis involve the blade hub load vibration analysis, the blade thickness constraint and the blade parameter selection. The results show substantial vibration reduction for the MEMP design but the large relative deflection between the two beams, conceptualized as an internal spar and airfoil shell, remains a problem for further study.
Item Open Access Structural Studies of Arabidopsis Thaliana Inositol Polyphosphate Multi-Kinase(2009) Endo-Streeter, Stuart TamotsuInositol Polyphosphate Multi-Kinase (IPMK, also known as ArgRIII, Arg82, and IPK2) is a central component of the inositol signaling system, catalyzing the phosphorylation of at least four different inositol polyphosphate species in vivo with in vitro activity observed for three more. Each of these IP species is sterically unique and the phosphorylation target varies between the 6'-, 3'-, or 5'-hydroxyls, classifying IPMK as a 6/3/5-kinase. The products of IPMK have been linked to multiple processes including cell cycle regulation, transcriptional control, telomere length regulation, mRNA export and various phenotypes including mouse embryonic and fly larvae development, and stress responses in plants and yeast. Linking specific IP species and cellular processes has been complicated by the inability to distinguish between the different effects of the various IP species generated by IPMK. Deletion of IPMK affects the IP populations of all its various substrates and products and therefore the role of a single IP species cannot be tracked. The goals of this work were to address the question of substrate selectivity and develop new tools to probe inositol signaling in vivo through a combination of structural, enzymatic, and genomic techniques.
The structure of Arabidopsis thaliana IPMK is reported at 2.9Å resolution and in conjunction with a new model of inositol selectivity has been used to design constructs with altered substrate profiles. In vitro and in vivo experiments have confirmed that IPMK identifies substrate inositol polyphosphate species through a recognition surface that requires phosphate groups occupy specific pockets and rejects those with axial phosphate groups in specific regions. In vivo experiments have linked specific inositol polyphosphate species to nitrogen metabolism and temperature sensitivity in yeast and established the potential for these constructs to be used to probe signaling in other organisms.
Item Open Access Tailoring renewable portfolio standards to achieve disparate economic and environmental goals(2008-12-05T21:40:16Z) Martin, GarrettWithin the United States, Renewable Portfolio Standard (RPS) programs have become a popular public policy initiative for states to enact in order to encourage the use of renewable resources for meeting state energy demand. As more states have adopted RPS programs, the design of these programs have grown more varied and complex as states seek to increase the benefits and decrease the costs of RPS programs by tailoring program design to suit the interests and characteristics of a state. The purpose of this Masters Project is to create a primer for policymakers, interested in designing new, or amending existing, RPS programs, to better understand the policy design options available when developing an RPS program, the potential impacts of structuring an RPS program in a particular manner, and the current best practices and national trends in designing RPS programs. My report uses best practice RPS design principles, created by Wiser et al. in 2003, to evaluate the positive and negative impacts RPS component options have on each principle. The use of an energy-based compliance requirement, unbundled renewable energy certificates (RECs), REC banking, true-up periods, and clearly defined financial penalties for non-compliance are necessary components for the optimal performance of any state RPS program. The goals emphasized by different RPS programs and state-specific characteristics dictate the additional RPS components needed to complete the optimal RPS design for a state. Of the RPS design options analyzed, most have positive impacts on some best practice principles while having negative impacts on others. As a result, it is important for policymakers to clearly define the relative importance of different policy goals that an RPS program aims to achieve in order to select the appropriate RPS component options.Item Open Access The Art of Artificial Neural Networks: Emergent Creativity in Artificial Intelligence(2018) Rajkumar, Vijay GauthamThis M.A. thesis in Computational Media is an exploration of how artificial neural networks could be used by an artist; it is a transdisciplinary study of topics in computer science, light art and installation art. The study culminates in the design and production of two installations that attempt to respond to the question: how does one draw on high-level Artificial Intelligence algorithms and human aesthetic intuition informed by contemporary and historical research of art history, to generate a new hybrid art form?
Item Open Access The Living Web(2019) LeGrand, Luke C.As the role of Internet Connected Technologies (ICTs) increases exponentially, and as all student populations (highly motivated or not) become increasingly composed of digital natives, it is imperative that the academy adapt to these new challenges. A university is obligated to ensure its students are adequately prepared for the Digital Age. This paper seeks to examine and evaluate the current scholarship of coding pedagogy, digital learning, and information science education, to leverage these evaluations towards the construction of a course of study which is informed by critical thought and current scholarship. It is the author’s hope to provide methods and approaches through which students who may lack an academic background in Computer Science can develop critical and analytic thinking skills alongside essential understandings of the technologies underpinning their daily lives.
Item Open Access The Pocket Colposcope, a Novel Low Cost Digital Colposcope, to Improve Access to Cervical Screening in Resource Limited Settings(2019) Lam, Christopher ThyAddressing disparities in the global cancer burden is a key part of the post-2015 Millennium Development Goals (MDGs). Cervical cancer is emblematic of that disparity, with 85% of cases and cancer-related deaths occurring in low and middle-income countries (LMICs). Many LMICs lack the health care infrastructure and highly trained personnel required for cytology-based screening and subsequent referral colposcopy based diagnosis, which have dramatically reduced the disease burden in wealthier countries. The World Health Organization (WHO) recommends adoption of alternative protocols that employ low-cost and simple-to-use screening technologies and treat all women who are positive based on these tests. Even those who manage to receive a proper diagnostic test are all too frequently lost to follow up care, leading to a disproportionately high burden of cervical cancer mortality in LMICs. One strategy, highly sensitive human papillomavirus (HPV) testing has been shown to reduce the incidence and mortality from cervical cancer when coupled directly with outpatient treatment for women with HPV-positive results. Although, recent guidelines have moved back from this “screen & treat” approach, given concerns about overtreatment. The American Society of Clinical Oncology (ASCO) and World Health Organization (WHO) recently released guidelines recommending that HPV be used as a screening test, followed by triage with visual inspection with acetic acid (VIA) or visual inspection with Lugol’s iodine (VILI) to confirm the presence of lesions. Uptake of HPV testing requires a significant capital investment in the automated device and samples are often banked and run in batches to reduce waste of reagents. While this co-testing methodology may decrease overtreatment, VIA or VILI still remains a poor triage test because of low sensitivity and specificity, and wide variability in interpretation due to poor quality control. Thus, there exists a need for a triage test that is low-cost, easy-to-use, and will provide reliable immediate results at the point-of-care setting.
The goal of the work presented here is to establish the design, development, and validation of a low cost portable digital colposcope that has comparable image quality, functionality, and diagnostic capability when compared to standard-of-care digital colposcopes and gold-standard histopathology.
Three specific aims were proposed to address this goal. First, the conceptualization, design, and validation of this device, the Pocket Colposcope will be presented. The Pocket Colposcope is shaped like a tampon and can be inserted and positioned such that it is 5-50 mm away from the cervix, obviating the need for high-end glass optics, high-resolution cameras, and high power illumination sources used in state of the art colposcopes, which typically operate at a working distance of 300 mm. An off the shelf miniature color complementary metal-oxide-semiconductor (CMOS) camera, with plastic injection molded lens, and small light emitting diodes (LEDs) could be repackaged inside the compact tampon like form factor and powered directly by a smartphone, tablet, or laptop through the universal serial bus (USB).
Each evolution of the Pocket Colposcope was quantitatively assessed with respect to standard-of-care digital colposcope or predicate device using industry standardized protocols and in preparation for the application to the US Food and Drug Administration (FDA) 510(k) preexisting medical device approval pathway. The Edan C3A/C6A digital colposcope (K151878) was used as the predicate reference device within the Pocket Colposcope’s 510(k) application which was successfully approved on September 25th, 2018 (K181034), which was granted on September 25th, 2018. We also characterized and compare the Pocket Colposcope to the standard-of-care digital colposcope at Duke University Medical Center (DUMC) the Leisegang Optik 2 (K140754), which was use as part of multisite international clinical trial evaluating the diagnostic performance of Pocket Colposcope discussed in Aim 2. The essential imaging parameters were characterized with industry standards: ISO 8600-5 used for optical resolution, ISO 8600-3 used for field of view, ISO 9039 and ISO 12233 used for distortion, depth of field, and ISO 18221 used for magnification. The essential illumination characteristics were characterized with: ANSI FL-1 was used for both beam diameter and illumination intensity.
The optical resolution for all the generations of Pocket Colposcope ranged between 10-72 line pairs per mm (lp/mm) and was substantially equivalent to the optical resolution range of 10-29 lp/mm of the pair of predicate devices. The field of view of all generations of the Pocket Colposcope ranged from 8-52 mm and was substantially equivalent to the field of view range of 12-76 mm reported by the predicate device pair. The picture-height distortion for all generations of the Pocket Colposcope ranged between -4.5 to -1.1% and were substantially equivalent to the 3-7% distortion reported by the pair of predicate devices. The depth of field range between 0.5-12 mm for all generations of the Pocket Colposcope were substantially equivalent to 6-20 mm range reported by the predicate device pair.
The illumination intensity range of 2,800 to 20,000 lux for all generations of the Pocket Colposcope was substantially equivalent to the reported range of 3,000 to 24,000 lux of the pair of predicate devices. Similarly, the beam diameter range of 33.8 to 49.0 mm for all generations of the Pocket Colposcope was substantially equivalent to 60-62.1 mm range reported by the pair of predicate devices.
The proof of concept first generation Pocket Colposcope was successful in capturing VIA and VILI images of the cervix, but suffered from issues that were addressed in subsequent generations. These issues included: frequent lens fogging, which required the use of anti-fogging wipes prior to each patient use, the need for ethylene oxide (EtO) gas sterilization between patient uses, a difficulty maintaining image focus due to lack of automated mechanism, and a reduced image quality due to specular reflection from the moist cervical tissue when compared to standard-of-care digital colposcope.
The second aim was to demonstrates concordant diagnostic performance of the Pocket Colposcope when compared to reference standard-of-care digital colposcopes and gold-standard histopathology in a multi-institution clinical trial.
An image concordance study was conducted under IRB approval and written informed consent of participants. Images of the cervix were collected by the Pocket Colposcope and standard-of-care device (if available) along with gold standard histopathology. These image pairs would be split, randomized, and digitally sent to blinded highly trained reviewers for clinical interpretation. These expert colposcopists were blinded to any demographic information of the patient, prior referral test results (Pap smear cytology, HPV status, HIV status, or histopathology), and each other’s interpretation of the image. A secure online questionnaire was sent to reviewers to record their responses. All data was stored securely on a Duke University Medical Center managed REDCap database server.
These interpretations would be compared between the Pocket Colposcope and standard-of-care device to demonstrate concordance performance or level agreement with the devices. The diagnostic performance of the Pocket Colposcope and standard-of-care devices were assessed by comparing the image interpretation to gold-standard histopathology with the generation of 2x2 contingency tables with entries for True Positives (TP), True Negatives (TN), False Positives (FP), and False Negatives (FN). The two binary diagnostic cut-offs were used: normal vs. LSIL/CIN1+ and normal vs. HSIL/CIN2+. From these 2x2 contingency tables sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). Lastly, the diagnostic performance would be stratified by level of contrast used using Receiver Operating Characteristic (ROC) curves where the y-axis is the sensitivity and the x-axis is 1-specificity. The resultant area under the curve (AUC) can be compared using logistic regression to determine how changing the type of contrasts used impacts overall diagnostic performance.
A pilot clinical study (n=45 eligible subjects and read by 10 blinded highly trained clinicians) at Duke University Medical Center (Durham, NC) using the Generation 1 and 2 Pocket Colposcope, a standard-of-care digital colposcope (Leisegang Optik 2), using the contrast technique of visual inspection with acetic acid (VIA), and with gold-standard histopathology (from biopsy or post loop electrosurgical excision procedure (LEEP) specimen). The level of agreement between the Pocket Colposcope and standard-of-care when using the LSIL/CIN1+ vs. normal diagnostic cut-off was 77.8% with a moderate strength Cohen’s kappa coefficient () of 0.53, p<0.01. When the diagnostic cut-off was changed to HSIL/CIN2+ vs. normal the level of agreement between Pocket Colposcope and standard-of-care improved to 86.0% with a strong Cohen’s () of 0.64, p<0.01. The Pocket Colposcope and standard-of-care performed similarly when compared to the gold-standard histopathology. The overall accuracy when using the LSIL/CIN1+ vs. normal diagnostic cut-off and comparing to gold-standard histopathology was between 56.1-63.9%, with sensitivity between 39.1-56.0%, with specificity between 73.9-72.7%, for the Pocket Colposcope and standard-of-care, respectively. The diagnostic performance improved for both devices when the diagnostic cut-off was set to HSIL/CIN2+ vs. normal with accuracy climbing to 68.9-74.7%, with sensitivity unchanged 40.9- 56.4%, with specificity improving by ~14% for both systems to 86.1 to 86.4%, with respect to Pocket Colposcope vs. standard-of-care.
The performance of the Pocket Colposcope was now assessed in a resource limited setting with a clinical study (n=129 eligible subjects and read by 4 blinded highly trained clinicians) at La Liga contra Cancer (Lima, Peru) using the Generation 3 and 4 Pocket Colposcope, a standard-of-care digital colposcope (Goldway SLC-2000B), using the contrast techniques of visual inspection with acetic acid (VIA) and visual inspection with Lugol’s iodine (VILI), and with gold-standard histopathology (from biopsy or post loop electrosurgical excision procedure (LEEP) specimen). The level of agreement between the Pocket Colposcope and standard-of-care when using the LSIL/CIN1+ vs. normal diagnostic cut-off was 83.6 % with a strong Cohen’s kappa coefficient () of 0.67, p<0.01. When the diagnostic cut-off was changed to HSIL/CIN2+ vs. normal the level of agreement between Pocket Colposcope and standard-of-care improved to 86.2% with a strong Cohen’s () of 0.66, p<0.01. The Pocket Colposcope and standard-of-care performed similarly when compared to the gold-standard histopathology. The overall accuracy when using the LSIL/CIN1+ vs. normal diagnostic cut-off and comparing to gold-standard histopathology was between 63.9-67.6%, with sensitivity between 71.2-79.8%, with specificity between 57.5-56.6%, for the Pocket Colposcope and standard-of-care, respectively. The diagnostic performance was unchanged for both devices when the diagnostic cut-off was set to HSIL/CIN2+ vs. normal with accuracy of 63.1% for both systems, with sensitivity increasing slightly 80.7-82.2%, with specificity unchanged to 57.5-56.6%, with respect to Pocket Colposcope vs. standard-of-care.
The performance of the Pocket Colposcope was now assessed as part of the multinational clinical study with two additional partner sites joining the two prior sites: Kilimanjaro Christian Medical Center (KCMC) (Moshi, Tanzania) which used a digital camera (Canon SX40HS) as the standard-of-care device for part of the study, however the device broke and wasn’t repaired until this summer so some patients didn’t have matched standard-of-care images) and Centre for Infectious Disease Control Zambia (CDZIR) (Lusaka, Zambia) which used naked eye inspection and did not employ a standard-of-care device for this study. Pocket Colposcope Generation 1 through Beta and standard-of-care device (if available) were used to collect VIA, green light inspection (GLI), and/or VILI depending on the standard of practice at the clinical site. Gold-standard histopathology (from biopsy or post loop electrosurgical excision procedure (LEEP) specimen or post large loop excision of the transformation zone (LEETZ) specimen) were collected for eligible patients. Overall n=388 subjects have been enrolled from four clinical sites, with n=129 subjects undergoing VIA with 10 blinded expert reviewers, with n=92 subjects undergoing VIA+GLI with 7 blinded expert reviewers, with n=127 subjects undergoing VIA+VILI with 6 blinded expert reviewers, and n=40 subjects undergoing VIA+GLI+VILI with 4 blinded expert reviewers. For the purposes of this analysis we will focus on the Pocket Colposcope versus gold-standard histopathology stratified by the types of contrasts used. The overall accuracy when using the LSIL/CIN1+ vs. normal diagnostic cut-off and comparing to gold-standard histopathology increased consistently with type of contrasts used (VIA only, VIA+GLI, VIA+VILI, and culminating with VIA-GLI-VILI) with overall agreement improving from 53.4-70.1% with sensitivity improving from 42.3-68.1%, with specificity improving from 65.3-73.3%. The diagnostic performance when the diagnostic cut-off was set to HSIL/CIN2+ vs. normal generally followed the prior trend with consistent increases with type of contrast used (VIA only to VIA+GLI+VILI) with rising accuracy 55.9-70.8%, with sensitivity increasing 41.9-52.2%, with specificity improving 78.2-88.0%. Increasing the number of contrast agents used significantly improved the diagnostic performance of the Pocket Colposcope when compared to gold-standard histopathology.
The final aim is to add fluorescent imaging capability to the Pocket Colposcope to provide an additional source of contrast targeting metabolic and/or structural biomarkers that will further improve clinical performance of our system to match gold standard histology pathology and expand the application of the device. We there is broad applicability in other organ sites including: oral cavity, gastrointestinal tract, and skin.
The Beta generation of the Pocket Colposcope was modified for fluorescent imaging by adding excitation LEDs, repurposing of the Generation 3 external LED driver circuit to drive the excitation source, a matched band-pass optical filter for emission, reintroduction of cross-polarization to improve the fluorescent signal to noise, and modular tip that houses the LED ring and optical components without destructive modification of the Pocket Colposcope. A proof of concept device was characterized using a similar set of procedures used to assess the Pocket Colposcope for the 510(k) regulatory approval pathway. Ex-vivo and in-vivo pilot animal studies were conducted to demonstrate successful implementation of the fluorescent imaging capability using a FITC (Fluorescein isothiocyanate) tagged binding ligand (HS-27) with a strong affinity for the heat shock protein-90 (Hsp-90) chaperone molecule (a potential biomarker of cancer). The real time visual tracking of diffusion of ethanol from an ethyl-cellulose gel to surrounding tissue by using solvent properties of ethanol for FITC when compared to water (20 mg per mL vs. 0.1 mg per mL). This ethyl-cellulose gel is being investigated as a potential low cost technique for treating cancer with extended release of ethanol over time to localize treatment. Lastly, the fluorescent Pocket Colposcope was used in a pilot ex-vivo clinical studies in subjects undergoing breast biopsy to evaluate the diagnostic potential of HS-27 when compared to gold-standard histopathology.
Item Open Access Uncontrollable: A User Experience Design Proposal for a Hands-Free Gaming Accessibility Framework(2021) Brucculeri, AndreaThe technology necessary for hands-free video gaming is available, especially for head-gesture-centric controls. However, remapping controls to head gestures ranges from frustratingly tedious to impossible. I propose a common language of gestures and game actions that categorizes the controls by their use frequency. My suggested categories are primary, secondary, tertiary, and quaternary. The most preferred gestures and more frequently used controls are classified as primary while the least preferred gestures and least frequently used controls classified as quaternary. I also propose constructing an interface software and API to gather data from game designers, hardware designers, and users to suggest optimized game controls for users requiring accessibility. I created a demo for one branch of this for my technical project -- a game to help players determine which gestures they can perform the most accurately so that these gestures may be paired with controls most vital to successful gameplay.
Item Open Access VR Touch Museum(2018) Zhao, YuchenIn recent years, digital technology has become ubiquitous in the museum. They have changed the ways museums document, preserve and present cultural heritage. Now, we are exploring if there are some ways that could provide more historical context to a displayed object and make an exhibition more immersive. Therefore, we did a project called “The Virtual Reality Touch Museum” and used an experiment to test if such museum performs better on “Presence” and learning achievements. As the results show, our VR Touch Museum was outstanding in “presence” but more research is necessary to verify how effective it is for learning.