User-Centered Design of a Diabetes Self-Management Tool for Underserved Populations.

BACKGROUND: User-centered design (UCD) or user experience design (UXD) methods have gained recent popularity for the design of mobile health (mHealth) interventions. However, there is a gap in application of these methods for diabetes self-management. This study aims to document the UCD process for a self-management mobile application aimed for patients with diabetes in underserved communities. METHODS: A UCD mixed-methods approach including interviews with patients and providers, a review of literature, and a technology landscape analysis were used to define the app functional information requirements that informed the user experience/user interface design process. Usability studies with the app designers and developers, intended users, and a focus group of nurse educators and dieticians were used to test and improve the design. RESULTS: An mHealth app was developed with health-tracking features for stress, blood sugar, food, exercise, medications, weight, and blood pressure. We tackled a range of usability and user experience challenges, which encompassed addressing issues like low health literacy by employing a combination of user interface design principles, intuitive visualizations, customizable icons, seamless database integration, and automated data input features. Special attention was given to the design of educational content accounting for the intended users' cultural background and literacy levels. CONCLUSIONS: User-centered design approach contributed to a better understanding of the intended users' needs, limitations, mental models, and expectations, facilitating the design of a comprehensive mobile app for patients with diabetes in underserved communities that includes essential features for self-management while providing a strong educational component, addressing an important gap in the literature.

Investigating the Food and Drug Administration Biotherapeutics Review and Approval Process: Narrative Review.

BACKGROUND: The development, review, and approval process of therapeutic biological products in the United States presents two primary challenges: time and cost. Advancing a biotherapeutic from concept to market may take an average of 12 years, with costs exceeding US $1 billion, and the product may still fail the US Food and Drug Administration (FDA) approval process. Despite the FDA's practices to expedite the approval of new therapies, seeking FDA approval remains a long, costly, and risky process. OBJECTIVE: The objective of this paper is to explore the factors and gaps related to the FDA review and approval process that contribute to process inefficiencies and complexities as well as proposed methods and solutions to address such gaps. This paper also aims to investigate the available modeling efforts for the FDA approval process of therapeutic biological products. METHODS: A narrative review of literature was conducted to understand the scope of published knowledge about challenges, opportunities, and specific methods to address the factors and gaps related to the review and approval of new drugs, including therapeutic biological products. Relevant peer-reviewed journal articles, conference proceedings, book chapters, official reports from public policy professional centers, and official reports and guidelines from the FDA were reviewed. RESULTS: Of the 23 articles identified in this narrative literature review, none modeled the current FDA review and approval process structure to address issues related to the robustness, reliability, and efficiency of its operations from an external point of view. Although several studies summarize the FDA approval process with clarity, in addition to bringing to light the problems and challenges faced by the regulatory agency, only a few attempts have been made to provide solutions for the problems and challenges identified. In addition, although several reform models have been discussed, these models lack the application of scientific methodologies and modeling techniques in understanding FDA as a complex sociotechnical system. Furthermore, tools and methods to assess the efficacy of the models before implementation are largely absent. CONCLUSIONS: The findings suggest the efficacy of model-based systems engineering approaches for identifying opportunities for significant improvements to the FDA review and approval process. Using this holistic approach will serve several investigative purposes: identify influential sources of variability that cause major delays, including individual, team, and organizational decision making; identify the human-system bottlenecks; identify areas of opportunity for design-driven improvements; study the effect of induced changes in the system; and assess the robustness of the structure of the FDA approval process in terms of enforcement and information symmetry.

Eliciting Requirements for a Diabetes Self-Management Application for Underserved Populations: A Multi-Stakeholder Analysis.

Medically underserved communities have limited access to effective disease management resources in the U.S. Mobile health applications (mHealth apps) offer patients a cost-effective way to monitor and self-manage their condition and to communicate with providers; however, current diabetes self-management apps have rarely included end-users from underserved communities in the design process. This research documents key stakeholder-driven design requirements for a diabetes self-management app for medically underserved patients. Semi-structured survey interviews were carried out on 97 patients with diabetes and 11 healthcare providers from medically underserved counties in South Texas, to elicit perspectives and preferences regarding a diabetes self-management app, and their beliefs regarding such an app's usage and utility. Patients emphasized the need for accessible educational content and for quick access to guidance on regulating blood sugar, diet, and exercise and physical activity using multimedia rather than textual forms. Healthcare providers indicated that glucose monitoring, educational content, and the graphical visualization of diabetes data were among the top-rated app features. These findings suggest that specific design requirements for the underserved can improve the adoption, usability, and sustainability of such interventions. Designers should consider health literacy and numeracy, linguistic barriers, data visualization, data entry complexity, and information exchange capabilities.