Key Decision Points Research Articles

Clinical Transformation Through Change Management Case Study: Chest Pain in the Emergency Department

Introduction/BackgroundAdults with chest pain presenting to an emergency department are high-risk and high-volume. A methodology which gathers practicing physicians together to review evidence and share practice experience to formulate a written algorithm with key decision points and measures is discussed with implementation, based on change management principles, and results. MethodsA methodology was followed to “establish the standard-of-care”. Literature and data were reviewed, a written consensus algorithm was designed with ability to track adherence and deviations. We performed a before and after analysis of a performance improvement intervention in adult patients with undifferentiated chest pain in our nine-campus hospital system in Florida between January 1st, 2014 and December 31st, 2018. ResultsA total of 200,691 patients were identified as adults with chest pain and the algorithm was used. A dramatic change in the disposition decision rate was noted. When the ‘Baseline-Year’ was compared with the ‘Performance-Year’, chest pain patients discharged from the ED increased by 99%, those going to the ‘Observation’ status decreased by 20%, and inpatient admissions decreased by 63% (p < 0.0001) All patients were tracked for 30-days for major adverse cardiac event (MACE) or return to the ED within the same system. If the s emergency physicians had not changed their practice/behavior and the Baseline-Year decision rate during the entire Performance-Year was unchanged, then 4563 more patients would have gone to Observation and 7986 patients to Inpatient. The opportunity costs avoided would be approximately $31million (US$. ConclusionsFor successful clinical transformation through change management, we learned: select strategic topics, get active physicians together, write a consensus algorithm with freedom to deviate, identify and remove barriers, communicate vision, pilot with feedback, implement, sustain by “hard wiring” into the electronic medical record and measure outputs.

The European guideline on management of major bleeding and coagulopathy following trauma: fifth edition

BackgroundSevere traumatic injury continues to present challenges to healthcare systems around the world, and post-traumatic bleeding remains a leading cause of potentially preventable death among injured patients. Now in its fifth edition, this document aims to provide guidance on the management of major bleeding and coagulopathy following traumatic injury and encourages adaptation of the guiding principles described here to individual institutional circumstances and resources.MethodsThe pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004, and the current author group included representatives of six relevant European professional societies. The group applied a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were re-examined and revised based on scientific evidence that has emerged since the previous edition and observed shifts in clinical practice. New recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated.ResultsAdvances in our understanding of the pathophysiology of post-traumatic coagulopathy have supported improved management strategies, including evidence that early, individualised goal-directed treatment improves the outcome of severely injured patients. The overall organisation of the current guideline has been designed to reflect the clinical decision-making process along the patient pathway in an approximate temporal sequence. Recommendations are grouped behind the rationale for key decision points, which are patient- or problem-oriented rather than related to specific treatment modalities. While these recommendations provide guidance for the diagnosis and treatment of major bleeding and coagulopathy, emerging evidence supports the author group’s belief that the greatest outcome improvement can be achieved through education and the establishment of and adherence to local clinical management algorithms.ConclusionsA multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. If incorporated into local practice, these clinical practice guidelines have the potential to ensure a uniform standard of care across Europe and beyond and better outcomes for the severely bleeding trauma patient.

Synthesis of Deuterium Labeled 5, 5-Dimethyl-3-(α, α, α-trifluoro-4-nitro-m-tolyl) Hydantoin.

Stable and non-radioactive isotope labeled compounds gained significance in recent drug discovery and other various applications such as bio-analytical studies. The modern bioanalytical techniques can study the adverse therapeutic effects of drugs by comparing isotopically labeled internal standards. A well-designed labeled compound can provide high-quality information about the identity and quantification of drug-related compounds in biological samples. This information can be very useful at key decision points in drug development. In this study, we tried to synthesize Nilutamide- d6 which can be useful to study the adverse effects of Nilutamide, and based on these can modify or widen the new drug derivatives. Nilutamide is a nonsteroidal antiandrogen which is used in the treatment of prostate cancer. The aim of this study was to develop a synthetic approach to prepare deuterium labeled [2H6]-5, 5-dimethylimidazolidine-2, 4-dione and [2H6]-nilutamide. Since nilutamide is a derivative of hydantoin, it involves the synthesis of Dimethylhydantoin via Bucherer-Bergs hydantoin synthesis, followed by oxidative N-arylation with 4-iodo-1-nitro-2- (trifluoromethyl) benzene. We successfully synthesized [2H6]-nilutamide and [2H6]-dimethylhydantoin with good isotopic purity, measured to be of adequate quality for use as internal standards in bio-analytical studies. A brief mechanistic study of Bucherer-Bergs hydantoin reaction was carried and the reason for possible H/D exchange was explained.

PMU100 - MAPPING BENEFIT-RISK DECISION-MAKING PROCESSES AND IDENTIFYING DECISION POINTS WITH THE POTENTIAL TO INCLUDE PATIENT PREFERENCE INFORMATION THROUGHOUT THE MEDICAL PRODUCT LIFECYCLE

Patient preference information (PPI) has not been effectively integrated in decision-making throughout the medical product lifecycle (MPLC). A first step requires an understanding of existing processes and decision points to know how to incorporate PPI to improve patient-centric decision making. The aims were to: 1) identify the decision-making processes and decision points throughout the MPLC for stakeholders, and 2) determine which decision points have potential to include PPI. A 3-step approach was conducted, including a scoping literature review identifying relevant white and grey literature, validation meetings with stakeholders to confirm decision-making processes, and semi-structured interviews with representatives of 3 stakeholder groups (industry n=24, regulatory n=22, HTA n=24). The literature review was conducted using five scientific databases, and interviews were conducted within seven different European countries and the US. Six decision points were identified for industry decision-making process: 1) Select & prioritize targets and leads; 2) Prioritize studies; 3) Prioritize assets; 4) Optimize & Prioritize assets; 5) Regulatory Submission & Launch; and 6) Manage MPLC & Prioritize opportunities. Four decisions points for the regulatory decision-making process: 1) Submission and validation; 2) Scientific opinion; 3) Orphan designation; and 4) Commission decision. Six decision points for HTA decision-making: 1) Filtration; 2) Prioritization; 3) Appraisal; 4) Filtration II; 5) Prioritization II; and 6) Appraisal II. PPI is currently not considered required information to be submitted for decision-making, but has the potential to be included at most key decision points. Currently, PPI is not considered as obligatory information to submit for any of the MPLC decision points, nor is it a pre-set criterium for decision-making. PPI is considered an important component by most stakeholders to inform future decision-making across the MPLC. Acknowledgement: This work received support from the EU/EFPIA Innovative Medicines Initiative [2] Joint Undertaking PREFER grant n° 115966

Fishing in greener waters: Understanding the impact of harmful algal blooms on Lake Erie anglers and the potential for adoption of a forecast model

Harmful algal blooms (HABs) pose public health risks worldwide, because of the toxins that they can produce. Researchers have explored the impact of HABs on local economies, but know relatively little about the decision-making that informs these behaviors that lead to financial losses. Understanding the factors that inform this decision-making is critical to developing mitigative solutions. This study seeks to understand how HABs in Western Lake Erie affect angler decision-making, before evaluating a possible decision-support tool—a harmful algal bloom forecast known as the Experimental Lake Erie HAB Tracker. The HAB Tracker provides a nowcast and five-day forecast of the spatial distribution and transport of Microcystis, the predominant species of harmful algae in Western Lake Erie. Data collected using focus groups and surveys were coded to identify key themes that influence angler decision-making. The theory of the diffusion of innovations provides an analytical framework to evaluate the potential for widespread adoption of the HAB forecast among Lake Erie anglers. Analysis of emerging themes revealed that Lake Erie anglers face three key decision-points when fishing in HABs: whether to fish, where to fish, and whether to eat the fish. Five primary variables factored into angler decisions on where and whether to fish including 1) perceptions of HAB aesthetics, 2) perceptions of the impact of HABs on angler health, 3) perceptions of the impact of HABs on fish, 4) communication methods, 5) perceptions of HABs by customers of charter captains. Most participants in this study sought to avoid fishing in HABs primarily for aesthetic reasons. Recreational anglers are more likely than charter captains to adopt the HAB Tracker as a decision-support tool, because it is compatible with their information needs and provides a relative advantage over existing sources of information. Charter captains are less likely to adopt the HAB Tracker, because they rely on their existing knowledge and social network for HAB information. If researchers can reduce the complexity of forecast information while increasing its accessibility and reliability, then all anglers will be more likely to adopt a HAB forecast as a decision-support tool while fishing in Lake Erie during bloom season.

Self-Organizing Cooperative Dynamics in Government Extended Enterprises

This paper presents the results of our research into cooperation in Government Extended Enterprises, a type of system of systems. The effort proposed and evaluated a novel theory that these decisions are the result of the interaction of four canonical forces—Sympathy, Trust, Fear, and Greed. A computational simulation involving the Stag Hunt game examined information sharing decisions in a series of key decision points in three large case studies. For the five hypotheses tested, exploratory data analysis and nonparametric statistical testing show strong support for three of the hypotheses (cooperation is positively correlated with actors’ levels of Sympathy and Trust and negatively correlated with actors’ levels of Fear) and moderate support for the fourth (cooperation is negatively correlated with actors’ levels of Greed). Indications are that the fifth hypothesis (cooperation is correlated with history of behavior) is not needed to explain observed behavior. Multiple correspondence analysis showed significant interactions both among pairs of forces and when a force is paired with decision making strategies. These results can form the basis for: 1) analysis of additional case studies; 2) development of an agent-based simulation; and 3) creation of training programs for current and future organizational leaders.

Peer-Based Strategies to Support Physical Activity Interventions for Older Adults: A Typology, Conceptual Framework, and Practice Guidelines.

Despite the documented and well-publicized health and well-being benefits of regular physical activity (PA), low rates of participation have persisted among American older adults. Peer-based intervention strategies may be an important component of PA interventions, yet there is inconsistent and overlapping terminology and a lack of clear frameworks to provide a general understanding of what peer-based programs are exactly and what they aim to accomplish in the current gerontological, health promotion literature. Therefore, a group of researchers from the Boston Roybal Center for Active Lifestyle Interventions (RALI) collaborated on this paper with the goals to: (a) propose a typology of peer-based intervention strategies for use in the PA promotion literature and a variety of modifiable design characteristics, (b) situate peer-based strategies within a broader conceptual framework, and (c) provide practice guidelines for designing, implementing, and reporting peer-based PA programs with older adults. We advance clarity and a common terminology and highlight key decision points that offer guidance for researchers and practitioners in using peers in their health promotions efforts, and anticipate that it will facilitate appropriate selection, application, and reporting of relevant approaches in future research and implementation work.

The educational experiences of Moroccan Dutch youth in the Netherlands: place-making against a backdrop of racism, discrimination and inequality

ABSTRACTThis study focuses on life histories collected from Moroccan Dutch youth in Amsterdam and Rotterdam and describes their experiences in diverse programs of the Dutch secondary education system. The study questions whether the present Dutch educational system facilitates the ‘gaining of place’ for the youth within Dutch society or whether it diminishes their opportunities. This qualitative study uses participant observation and semi-structured interviews of 15 Moroccan Dutch male and female youth, aged 18–24, and of 3 Moroccan Dutch male and female adults, aged 35. Life histories of 7 of the youths and 3 of the adults were of particular focus. Presented are the key decision-making points, based on the multiple challenges and structural obstacles the youth encounter in upper and lower levels of secondary education. The findings of the study reveal that the youth have developed educational resilience and a positive self-image which rely on the support from peers, family and role models outside of the school environment. Highlighted are how the strengths and weaknesses of Dutch education policies can best be captured through the life history approach, and how intercultural education, renamed citizenship education since 2006, needs to be better implemented to benefit Moroccan Dutch youth.

Organising safe and sustainable care in alongside midwifery units: Findings from an organisational ethnographic study

Aims and backgroundAlongside midwifery units (AMUs, also known as hospital or co-located birth centres) were identified as a novel hybrid organisational form in the Birthplace in England Research Programme. This follow-on study aimed to investigate how AMUs are organised, staffed and managed, the experiences of women, and maternity staff including those who work in AMUs and in adjacent obstetric units. This article focuses on study findings relating to the organisation and management of AMUs. MethodsAn organisational ethnography approach was used, incorporating case studies of four AMUs, selected for maximum variation on the basis of geographical context, length of establishment, size of unit, leadership and physical design. Interviews were conducted between December 2011 and October 2012 with service managers and key stakeholders (n = 35), with professionals working within and in relation to AMUs (n = 54) and with postnatal women and birth partners (n = 47). Observations were conducted of key decision-making points in the service (n = 20). FindingsManagers saw four key areas as vital to developing and sustaining good quality midwifery unit care: finance and service management support, staffing, training, and appropriate guidelines. Development of AMUs was often opportunistic, with service leaders making use of service reconfigurations to achieve change, including development of MUs and new care pathways. Midwives working in AMUs valued the environment, approach and the opportunity to exercise greater clinical judgement but relations between groups of midwives in different units could be experienced as problematic. Key potential challenges for the quality, safety and sustainability of AMU care included: boundary work and management; professional issues; developing appropriate staffing models and relationships; midwives’ skills and confidence; and information and access for women. Responses to such challenges included greater focus on interdisciplinary skills training, and integrated models of midwifery and care pathways. Positive leadership and appropriate development and use of guidelines were important to underpin the development and sustainability of midwifery units. ConclusionsThe units studied had been developed to form a key part of the maternity service, and their role was increasingly being recognised as valid and as maintaining the quality and safety of care in the maternity service as a whole. However, each was providing birth care for only about a third of women who had been classified as eligible to plan birth outside an obstetric unit at the end of pregnancy. Developing midwifery units involves aligning physical, professional and philosophical boundaries. However, this poses challenges when managing the service, to ensure it is sustainable, of high quality and safe. In order to fulfil evidence-based guidelines on providing midwifery unit care, further attention is needed to staff training and support; the development of integrated, continuity-based staffing models; and ensuring AMUs are positioned as a core service rather than a marginal one.

Abstract LB-025: A decision support system for the treatment of esophageal cancer

Abstract Introduction In oncology deciding which treatment to use and when to apply them in an optimal way can be challenging. Currently there are no global approaches available to optimise the treatment path for an individual patient. Focusing on esophageal cancer, we have developed a prototype of a model-based Decision Support System (DSS). It integrates a novel range of drug, tumour and patient data to better plan clinical treatment, optimise the patient care path, and ultimately deliver improved cancer care. Methods This tool was developed using data from an historical cohort of patients with operable esophageal cancer. This cohort comprised 465 patients who were treated at Oxford University Hospitals NHS Foundation Trust between 2007 and 2014. An initial data analysis focussed on using un-supervised learning methods to identify key variables that differentiated groups of patients. These variables were then used to analyse their correlation to survival and key decision points using parametric statistical models. The final models were then used to create a web-based DSS prototype. The prototype allows users to see throughout a patient's treatment journey what factors influence prognosis including key interventions such as surgery. Results The key results within the analysis centered around treatment effects on FDG-avid nodal status, using positron emission tomography-computed tomography (PET-CT). We found that change in nodal avidity due to chemotherapy is a key prognostic factor. Furthermore, this change correlated with the change in avidity and size of the primary tumour i.e. there is a degree of correlation between the primary tumour and nodes. No difference was found between the four chemotherapy regimens analysed in their ability to reduce tumour size and also change nodal status. However a hypothesis that might be tested through further research is that titrating duration of treatment and doses to the achievement of change in avid nodal status may have a significant impact on individual patient prognosis. The above key results as well as others pertaining to attempted and successful surgery can all be explored using the dynamic web-based interface developed. Conclusion We have created a DSS tool using historical data to support Cancer Multidisciplinary Teams in understanding how key variables affect treatment choices and how these in turn relate to disease outcomes. The tool has the potential to be used to support the optimisation of treatment for individual patients based on the characteristics of their disease. Thus the DSS tool developed is a first step to personalised treatment of cancer. Citation Format: Hitesh Mistry, Fernando Ortega, Frances A Brightman, John M Findlay, Mark R Middleton, Christophe Chassagnole. A decision support system for the treatment of esophageal cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr LB-025.

Closing Knowledge Gaps to Optimize Patient Outcomes and Advance Precision Medicine.

Realizing the promise of precision medicine requires patient engagement at the key decision points throughout the cancer journey. Previous research has shown that patients who make the "right" decisions, such as being treated at a high-volume academic medical center, for example, have better outcomes. An online survey was conducted to understand awareness of and barriers to these decision points among patients with multiple myeloma and pancreatic, lung, prostate, and metastatic breast cancers. Survey respondents were identified by 5 participating foundations (multiple myeloma: n = 86, pancreatic: n = 108, lung: n = 56, prostate: n = 50, metastatic breast: n = 86) and recruited by an e-mail or social media invitation. Descriptive analyses were calculated, and the proportion of patients from each of the 5 groups was compared for each response category for each survey item. Consistent gaps in knowledge and actions were identified across all cancers evaluated in terms of finding the right doctors/team at the right center; getting the right diagnostic testing done before beginning treatment; engaging in the right course of treatment, including clinical trials; and in sharing data. Improving awareness of and changing behavior around these 4 decision points will allow patients to receive better care and contribute to the advancement of precision medicine.

Using discrete choice experiments to examine the stepwise nature of avalanche risk management decisions—An example from mountain snowmobiling

The risk from avalanches when travelling in uncontrolled backcountry terrain is managed by a) assessing current conditions based on available information and b) adjusting terrain choices to keep the residual risk below the personal risk tolerance level. Mountain snowmobilers have become an increasingly important target audience for North American avalanche warning services due to a significant increase in the number of related avalanche fatalities in recent years. Having an in-depth understanding of currently used avalanche safety practices is critical for developing effective prevention initiatives.This paper presents an analysis of a sequence of three consecutive and incrementally expanding discrete choice experiments (DCE) that were embedded in an extensive online survey on mountain snowmobiling and avalanche awareness conducted in British Columbia, Canada. The series of DCE explicitly emulates the stepwise nature of the risk management process by representing key decision points in avalanche risk management: planning a trip from home, at the staging area, and riding in the backcountry. Participating mountain snowmobilers were provided with increasingly detailed avalanche safety information and their task was to choose their riding terrain accordingly. In the analysis, the progression was implemented by including the terrain preferences identified in the preceding DCEs as personalized constants in the multinomial logistic regression model of the next DCE. The results of this study provide valuable insight about the current strengths and weaknesses in the avalanche risk management practices of mountain snowmobilers and the realism of the results confirms the value of carefully designed DCEs for avalanche safety research. Management implicationsThe results of this study provide valuable information for guiding avalanche safety training for mountain snowmobilers:1)Mountain snowmobilers’ linear perception of the danger scale is inconsistent with the understanding of avalanche professionals that the avalanche hazard increases non-linearly.2)The challenge of persistent slab avalanche problems for avalanche risk management is not well understood among mountain snowmobilers and should be highlighted more clearly.3)Mountain snowmobilers should be encouraged to manage their risk during elevated avalanche hazard by first migrating to less exposed terrain and not by retreating to areas with high snowmobile traffic. Even though snowmobile traffic does modify the snowpack, it is not a reliable indicator of low hazard areas.4)Mountain snowmobilers interpret instability observations (e.g., whumpfs) significantly more seriously than other important warning signs of elevated avalanche hazard. The importance of other warning signs should be emphasized.

Genome Sequencing.

Strategies for sequencing fungal genomes on next-generation sequencing (NGS) platforms depend on the characteristics of the genome of the targeted species, quantity and quality of the genomic DNA, and cost considerations. Massively parallel sequencing with sequencing by synthesis (SBS) approach by Illumina produces terabases of short read sequences (i.e., ~300bp) in a time and cost-effective manner, though the read length can limit the assembly particularly in repetitive regions. The single molecule, real-time (SMRT) sequencing approach by Pacific Biosciences (PacBio) produces longer reads (i.e., ~12,500bp) which can facilitate de novo assembly of genomes that contain long repetitive sequences, though due to the lower-throughput of this platform achieving the coverage needed for assembly is more expensive than by SBS. Additionally, the Illumina SBS platforms can handle low quantity/quality of genomic DNA materials, while the SMRT system requires undamaged long DNA fragments as input to ensure that high-quality data is produced. Both platforms are discussed in this chapter including key decision-making points.

Selecting optimal second-generation antihistamines for allergic rhinitis and urticaria in Asia

BackgroundAllergic diseases are on the rise in many parts of the world, including the Asia–Pacific (APAC) region. Second-generation antihistamines are the first-line treatment option in the management of allergic rhinitis and urticaria. International guidelines describe the management of these conditions; however, clinicians perceive the additional need to tailor treatment according to patient profiles. This study serves as a consensus of experts from several countries in APAC (Hong Kong, Malaysia, the Philippines, Singapore, Thailand, Vietnam), which aims to describe the unmet needs, practical considerations, challenges, and key decision factors when determining optimal second-generation antihistamines for patients with allergic rhinitis and/or urticaria.MethodsSpecialists from allergology, dermatology, and otorhinolaryngology were surveyed on practical considerations and key decision points when treating patients with allergic rhinitis and/or urticaria.ResultsClinicians felt the need for additional tools for diagnosis of these diseases and a single drug with all preferred features of an antihistamine. Challenges in treatment include lack of clinician and patient awareness and compliance, financial constraints, and treatment for special patient populations such as those with concomitant disease. Selection of optimal second-generation antihistamines depends on many factors, particularly drug safety and efficacy, impact on psychomotor abilities, and sedation. Country-specific considerations include drug availability and cost-effectiveness. Survey results reveal bilastine as a preferred choice due to its high efficacy and safety, suitability for special patient populations, and the lack of sedative effects.ConclusionsCompliance to the international guidelines is present among allergists, dermatologists and otorhinolaryngologists; however, this is lower amongst general practitioners (GPs). To increase awareness, allergy education programs targeted at GPs and patients may be beneficial. Updates to the existing international guidelines are suggested in APAC to reflect appropriate management for different patient profiles and varying symptoms of allergic rhinitis and urticaria.

Building Strong Family–School Partnerships: Transitioning from Basic Findings to Possible Practices

In the present article, we describe the translational process undergirding a particular aspect of family science: families working in partnership with schools to achieve mutual goals for children's optimal functioning. In doing so, we illustrate a translational cycle that began with identifying problems of practice and led to the development of a family–school intervention (i.e., conjoint behavioral consultation) in a way that embraced families as partners in goal‐setting and problem‐solving. We discuss the evolution of the intervention from development to efficacy trials and practice guidelines. Key decision points borne out of practical relevance, empirical investigations, tests of mechanisms and conditions, and efforts pertaining to implementation and dissemination are illustrated. Finally, we highlight key research needed to advance the translation of the science related to conjoint behavioral consultation into widespread practice.

Optimizing empiric therapy for Gram-negative bloodstream infections in children

Antimicrobial stewardship can be challenging in children with bloodstream infections (BSIs) caused by Gram-negative bacilli (GNB). This retrospective cohort study explored how data elements in the electronic health record could potentially optimize empiric antibiotic therapy for BSIs caused by GNB, via the construction of customized antibiograms for categorical GNB infections and identification of opportunities to minimize organism-drug mismatch and decrease time to effective therapy. Our results suggest potential strategies that could be implemented at key decision points in prescribing at initiation, modification, and targeting of therapy.

Clinical Pharmacology Tools and Evaluations to Facilitate Comprehensive Dose Finding in Oncology: A Continuous Risk-Benefit Approach.

Targeted therapies are now considered an integral component in the treatment armamentarium for many malignancies, and the approach to developing these drugs needs to be refined from the previous cytotoxic paradigm of toxicity-guided dose finding and identification of maximum tolerated dose to a paradigm driven by target activity. Moving away from the toxicity-driven dose finding and justification model requires an integrated approach in order to adequately characterize the risk-benefit of a drug. This approach starts with understanding the importance of collecting samples for pharmacokinetic and pharmacodynamic assessments in all phases of clinical development to fully characterize the pharmacokinetics and identify covariates and then correlating exposure to key markers of safety and efficacy in pharmacometric analyses to perform a robust risk-benefit assessment and establish the right dose. In addition, for oral agents, decisions on administering the drug with respect to food can impact dose among other clinical trial outcomes such as tolerability and patient compliance. Understanding the importance of model-based drug development as a decision-making tool to support drug development through incorporation of all relevant data allows for a robust risk-benefit assessment at key decision points. Utilization of clinical pharmacology tools and assessments throughout development will provide the key components of a successful oncology development program.

Simulation-Based Evaluation of Ease of Wayfinding Using Digital Human and As-Is Environment Models

As recommended by the international standards, ISO 21542, ease of wayfinding must be ensured by installing signage at all key decision points on walkways such as forks because signage greatly influences the way in which people unfamiliar with an environment navigate through it. Therefore, we aimed to develop a new system for evaluating the ease of wayfinding, which could detect spots that cause disorientation, i.e., “disorientation spots”, based on simulated three-dimensional (3D) interactions between wayfinding behaviors and signage location, visibility, legibility, noticeability, and continuity. First, an environment model reflecting detailed 3D geometry and textures of the environment, i.e., “as-is environment model”, is generated automatically using 3D laser-scanning and structure-from-motion (SfM). Then, a set of signage entities is created by the user. Thereafter, a 3D wayfinding simulation is performed in the as-is environment model using a digital human model (DHM), and disorientation spots are detected. The proposed system was tested in a virtual maze and a real two-story indoor environment. It was further validated through a comparison of the disorientation spots detected by the simulation with those of six young subjects. The comparison results revealed that the proposed system could detect disorientation spots, where the subjects lost their way, in the test environment.

Use of the Columbia-Suicide Severity Rating Scale (C-SSRS) to Classify Suicidal Behaviors

Efforts to better understand and prevent suicide have increasingly pointed to the prospective assessment of suicidal behaviors in clinical trials. These assessments are aided by instruments such as the Columbia-Suicide Severity Rating Scale (C-SSRS), which have sought to improve the conceptual uniformity and ease by which suicidal behaviors are classified. At the same time, assessment and classification of suicidal behaviors has been a longtime challenge in the field. To aid users of the C-SSRS, this article illustrates the use of the C-SSRS in instances where classification complexities arise. Illustrations are presented based on cases encountered during a clinical trial for a suicide prevention intervention. Key decision points are summarized and classification issues that warrant consideration for future refinement of such decisions are discussed.

Explorations of a Very-large-screen Digital Library Interface

While digital libraries accommodate remote access via the web and mobile devices, their physical presence tends to be minuscule. A locally-developed prototype digital library application called DLib Wall, connected to MultiTaction display hardware from MultiTouch Ltd., is an attempt to create a rich and engaging onsite presence for the digital collections of the University of Nevada, Las Vegas Libraries. DLib Wall is one of the first applications of its kind, and demonstrates several relatively unexplored interaction modalities. In late 2014, it was deployed in the Goldfield Room — a conference room in the Lied Library — on a wall-mounted array of six 42-inch touch displays. DLib Wall represents both application development and the work of a collaborative team charged with creating a large, interactive, and content-rich media wall experience on a limited resource budget. The group's work included: evaluating and recommending technologies, managing the custom development for the DLib Wall application, and creating an initial content plan for the public rollout. This article highlights the technical aspects of the application while sharing key decision points that the team encountered in the process of bringing the project from conception to completion.