The Urban CoCreation Lab—An Integrated Platform for Remote and Simultaneous Collaborative Urban Planning and Design through Web-Based Desktop 3D Modeling, Head-Mounted Virtual Reality and Mobile Augmented Reality: Prototyping a Minimum Viable Product and Developing Specifications for a Minimum Marketable Product

Both policy and research highlight the importance of diverse stakeholder input in urban development processes but visualizing future built environments and creating two-way design communication for non-expert stakeholders are challenging. The present study develops an intuitive and simplified 3D modeling platform that integrates web-based desktop, virtual reality and mobile augmented reality technologies for remote simultaneous urban design collaboration. Through iterative prototyping, based on two series of workshops with stakeholders, the study resulted in such an integrated platform as a minimum viable product as well as specifications for a minimum marketable product to be used in real projects. Further study is required to evaluate the minimum level of detail in the 3D modeling necessary for good perception of scale and environmental impact simulation.

Impact of the 4 Helix Model on the Sustainability of Tourism Social Entrepreneurships in Jalisco and Nayarit, Mexico

Given the uncertain outlook caused by COVID-19, it is important to carry out a review of the conditions in which the collective enterprises are influenced by the four helix model, specifically those dedicated to the sector most affected by the pandemic, tourism, for which raises the question: What have been the results of the four helix model in the social tourism entrepreneurships (STE) of Jalisco and Nayarit? In addition to: the participation of the actors of the four helix model has contributed to face the repercussions of COVID-19? The objective is to identify stakeholder input from the core elements of the four helix model and sustainability to the STEs during COVID-19. The methodology used was qualitative and involved the comparison of information from 12 key stakeholders from the government, social, academic and private sectors through Atlas.ti-8. Some results indicate that from the perception of the participants interviewed, the COVID-19 crisis has promoted innovation, support, and incentives among the four helixes, in which the STEs have benefited. As conclusions, the four helix model is functional to face the adversities of COVID-19 as long as there is planning within the entrepreneurships and the link with said model helix participants.

Positive Effect of a Successfully Implemented Model of Care on Unplanned Transfers to Hospital

Models of care have shown effectiveness in reducing unplanned transfers in nursing homes (NHs) from 11.7% to 6.1%. These include coordination of care and access to skilled medical providers such as geriatricians, specialist nurses or registered nurses with additional training. A hybrid type-2 effectiveness-implementation project (INTERCARE) was developed to improve intervention uptake and to understand the mechanisms behind results. INTERCARE consisted of six core elements and was rolled-out to 11 Swiss NHs with a stepped-wedge design allowing all NHs to receive the intervention. 942 residents were recruited (June 2018 -January 2020). INTERCARE showed a significant reduction of unplanned transfers during the intervention period compared with baseline. The successful implementation of INTERCARE relied on the use of implementation science, building on stakeholder input and careful theory-driven contextual adaptations. INTERCARE’s success was driven by registered nurses with expanded roles, on-site coaching, and the use of tools for clinical decision making.

Reducing Kidney Discard With Artificial Intelligence Decision Support: the Need for a Transdisciplinary Systems Approach

Purpose of Review A transdisciplinary systems approach to the design of an artificial intelligence (AI) decision support system can more effectively address the limitations of AI systems. By incorporating stakeholder input early in the process, the final product is more likely to improve decision-making and effectively reduce kidney discard. Recent Findings Kidney discard is a complex problem that will require increased coordination between transplant stakeholders. An AI decision support system has significant potential, but there are challenges associated with overfitting, poor explainability, and inadequate trust. A transdisciplinary approach provides a holistic perspective that incorporates expertise from engineering, social science, and transplant healthcare. A systems approach leverages techniques for visualizing the system architecture to support solution design from multiple perspectives. Summary Developing a systems-based approach to AI decision support involves engaging in a cycle of documenting the system architecture, identifying pain points, developing prototypes, and validating the system. Early efforts have focused on describing process issues to prioritize tasks that would benefit from AI support.

The Integration of the Evidence-Based Framework and Military Judgment and Decision-Making

This article is the second in a four-part series that discusses the integration of evidence-based framework and military judgment and decision-making (MJDM). The series is written as a conceptualization and implementation of the presidential memorandum on restoring faith in government dated 27 January 2021. The focus of the series is on integrating the evidence-based framework into defense planning and decision-making as an operational art. The series frames this integration in terms of basing decisions on the best evidence in four categories: subject matter expertise, stakeholder input, organizational data, and scholarship. It also recognizes that scholarship is the single component within the evidence-based framework not currently integrated into military planning.

Development of 4to24, a Transition Application for Parents of Students With Visual Impairments

Introduction This article focuses on the development of 4to24, an informational app for parents of students with visual impairments, with emphasis on obtaining stakeholder input, developing content, and establishing content validity. The app provides information, resources, and activities to help students, ages 4–24 years, prepare for independence and employment as an adult. Method App design and content development involved multiple phases of iterative design and writing. Stakeholder input was obtained via an advisory board and user focus groups with parents and students. Experts reviewed and validated content with ratings and recommendations on accuracy, age-appropriateness, and relevance. Results Advisory board members identified important domains to address in 4to24 including social skills, technology, travel skills, health and fitness, independent living, career education, and self-determination. They recommended focusing on elevating parents’ expectations and confidence in supporting and teaching their children. Focus group participants recommended accessibility, ease of use, and relevant information to make the app appealing to users. The content validation process supported the content’s relevance, accuracy, and age-appropriateness and resulted in a final count of 410 informational modules. Discussion Parent involvement and expectations are critical to students’ preparation for future employment. 4to24 provides support for parents to collaborate with service providers and reinforce concepts and skills outside of school. Development of the app technology and its large volume of content required a full 5-year process. Implications for practitioners Lessons learned from this project can inform future resource development projects, including recommendations to start small and define goals early in the process. The 4to24 app is a new resource for parents of students with visual impairments that can supplement services provided by professionals.

Transition of Pharmaceutical Regulations: The New Regulatory Era after Brexit

Aims: The current research paper describes the regulatory changes in different pharmaceutical sectors, which are affected after the Brexit and build new guidelines that were derived from the Medicines and Healthcare Products Regulatory Agency (MHRA). Study Design: Retrospective and concurrent review were employed to get idea regarding the regulatory changes in various pharmaceutical sectors that took place after dissimilation of Europe and Britain. Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., from January 2021 to April 2021. Methodology: On January 1, 2021, the MHRA had published a library of new guidance that applied as the transition period came to an end. This guidance covers the various sectors of pharmaceuticals like Clinical trials, medical devices, Importing and Exporting of pharmaceuticals, Legislation, New licensing, Pharmacovigilance and Pediatrics, which are affected due to Brexit. Results: The MHRA laid out the future BRITAIN requirements for registering clinical trials, legal representation and importing Investigational Medicinal Products (IMPs) after the end of the Brexit, Pediatric Investigation Plan (PIP) must be included in an application for BRITAIN marketing authorization (MA). Change in Licensing procedure and the Innovative licensing and access Pathway (ILAP) provides opportunities for enhanced regulatory and other stakeholder input, including interactions with National Institute for Health and Care Excellence. Early Access to Medicines Scheme (NICE.EAMS) providing access to unlicensed, promising treatments to patients who have life threatening or rare disease indications. Conclusion: To ensure the new approach builds on our previous success and exploits the opportunities that arise from Brexit, the industrial strategy should adopt a sophisticated supply chain view to develop an empirical base for pragmatic, joined up policies to help pharmaceutical sector grow. These policies and support will drive the BRITAIN’s pharmaceutical sector in a Post-Brexit era.

Building a precision medicine platform for the clinic: the UCSF BRIDGE experience. (Preprint)

BACKGROUND Despite an ever-expanding number of analytics with the potential to impact clinical care, the field currently lacks point-of-care technological tools that allow clinicians to efficiently select disease-relevant data about their patient, algorithmically derive clinical indices (e.g. risk scores), and view them in straightforward graphical formats to inform real-time clinical decisions. Thus far, solutions to this problem have relied on either bottom-up approaches limited to a single clinic, or generic top-down approaches that do not address clinical users’ specific, setting- or disease-relevant needs. OBJECTIVE As a roadmap to develop similar platforms, we describe our experience with building a custom but institution-wide platform that enables economies of time, cost, and expertise. METHODS The BRIDGE platform was designed to be modular, scalable, and customized to data types relevant to given clinical contexts within a major university medical center. The development process occurred using a series of human-centered design phases with extensive, consistent stakeholder input. RESULTS This institution-wide approach yielded a unified, carefully regulated cross-specialty clinical research platform that launches from a patient’s Electronic Health Record (EHR) encounter. It pulls clinical data from the EHR (Epic) as well as other clinical and research sources in real time, analyzes the combined data to derive clinical indices, and displays them in simple clinician-designed visual formats targeted to each disorder and clinic. CONCLUSIONS By integrating an application into the clinical workflow and allowing clinicians to access data sources that would otherwise be cumbersome to assemble, view and manipulate, institution-wide platforms represent an alternative approach to achieving the vision of true personalized medicine. CLINICALTRIAL N/A

A Five-Step Stakeholder Communication Plan for More Effective Natural Resource Management

Effectively communicating with diverse groups involved in environmental management is critical to facilitating successful projects. This five-step communication plan is designed to enable resource managers and extension professionals to successfully engage their stakeholders. This plan, which uses oyster reef management as an example, was informed by two primary sources: an expert meeting with stakeholder leaders and coastal res- idents and a review of relevant literature. By incorporating stakeholder input throughout the planning and imple- mentation of natural resource management projects, new and innovative ideas emerge, and relationships between stakeholders, managers, and extension agents are strengthened.

Considerations for designing and implementing combination HIV cure trials: findings from a qualitative in-depth interview study in the United States

Background An increasing number of HIV cure trials involve combining multiple potentially curative interventions. Until now, considerations for designing and implementing complex combination HIV cure trials have not been thoroughly considered. Methods We used a purposive method to select key informants for our study. Informants included biomedical HIV cure researchers, regulators, policy makers, bioethicists, and community members. We used in-depth interviews to generate ethical and practical considerations to guide the design and implementation of combination HIV cure research. We analyzed the qualitative data using conventional content analysis focused on inductive reasoning. Results We interviewed 11 biomedical researchers, 4 community members, 2 regulators, 1 policy researcher, and 1 bioethicist. Informants generated considerations for designing and implementing combination interventions towards an HIV cure, focused on ethical aspects, as well as considerations to guide trial design, benefit/risk determinations, regulatory requirements, prioritization and sequencing and timing of interventions, among others. Informants also provided considerations related to combining specific HIV cure research modalities, such as broadly neutralizing antibodies (bNAbs), cell and gene modification products, latency-reversing agents and immune-based interventions. Finally, informants provided suggestions to ensure meaningful therapeutic improvements over standard antiretroviral therapy, overcome challenges of designing combination approaches, and engage communities around combination HIV cure research. Conclusion The increasing number of combination HIV cure trials brings with them a host of ethical and practical challenges. We hope our paper will inform meaningful stakeholder dialogue around the use of combinatorial HIV cure research approaches. To protect the public trust in HIV cure research, considerations should be periodically revisited and updated with key stakeholder input as the science continues to advance.