Overcoming Challenges with the Adoption of Point-of-Care Testing: From Technology Push and Clinical Needs to Value Propositions.

Major technical challenges often prevent developers from producing new point-of-care technologies that deliver the required clinical performance in the intended settings of use. But even when devices meet clinical requirements, they can fail to be adopted and successfully implemented. Adoption barriers occur when decision makers do not understand the "value proposition" of new technologies. Current discussions of value in the context of point-of-care testing focus predominantly on the intended use and performance of the device from the manufacturer's point-of-view. However, the perspective of potential adopters in determining whether new devices provide value is also important, as is the opinion of all stakeholders who will be impacted. Incorporating value concepts into decisions made across the full development-to-adoption continuum can increase the likelihood that point-of-care testing will have the desired impact on health care delivery and patient outcomes. This article discusses how various approaches to technology development impact adoption and compares the characteristics of these approaches to emerging value concepts. It also provides an overview of value initiatives and tools that are being developed to support the evaluation of value propositions. These are presented for a range of technology adoption decision contexts, with particular applicability to point-of-care testing. Expanding the focus of research to address gaps in both the creation and evaluation of value propositions is imperative in order for value concepts to positively influence the adoption of point-of-care testing.

Systems Engineering and Point of Care Testing: Report from the NIBIB POCT/Systems Engineering Workshop.

The first part of this manuscript is an introduction to systems engineering and how it may be applied to health care and point of care testing (POCT). Systems engineering is an interdisciplinary field that seeks to better understand and manage changes in complex systems and projects as whole. Systems are sets of interconnected elements which interact with each other, are dynamic, change over time and are subject to complex behaviors. The second part of this paper reports on the results of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) workshop exploring the future of point of care testing and technologies and the recognition that these new technologies do not exist in isolation. That they exist within ecosystems of other technologies and systems; and these systems influence their likelihood of success or failure and their effectiveness. In this workshop, a diverse group of individuals from around the country, from disciplines ranging from clinical care, engineering, regulatory affairs and many others to members of the three major National Institutes of Health (NIH) funded efforts in the areas the Centers for POCT for sexually transmitted disease, POCT for the future of Cancer Care, POCT primary care research network, gathered together for a modified deep dive workshop exploring the current state of the art, mapping probable future directions and developing longer term goals. The invitees were broken up into 4 thematic groups: Home, Outpatient, Public/shared space and Rural/global. Each group proceeded to explore the problem and solution space for point of care tests and technology within their theme. While each thematic area had specific challenges, many commonalities also emerged. This effort thus helped create a conceptual framework for POCT as well as identifying many of the challenges for POCT going forward. Four main dimensions were identified as defining the functional space for both point of care testing and treatment, these are: Time, Location, Interpretation and Tempo. A framework is presented in this paper. There were several current and future challenges identified through the workshop. These broadly fall into the categories of technology development and implementation. More specifically these are in the areas of: 1) Design, 2) Patient driven demand and technology, 3) Information Characteristics and Presentation, 4) Health Information Systems, 5) Connectivity, 6) Workflow and implementation, 7) Maintenance/Cost, and 8) Quality Control. Definitions of these challenge areas and recommendations to address them are provided.

Telehealth tools for public health, emergency, or disaster preparedness and response: a summary report.

Rapid advances in telehealth development and adoption are increasing the spectrum of information and communication technologies that can be applied not only to individual patient care but more broadly to population health as well. Participants in this breakout session were asked to address, from their diverse perspectives, a series of questions relating to the current and potential uses of telehealth applications and networks for public health and emergency/disaster preparedness and response systems. Participants identified several gaps in current understanding and research emphasis. There is a clear need for more and larger outcome studies to assess the impact and cost benefit of telehealth applications in terms of improving public health at the population and community levels. In addition, more research is needed to demonstrate the ability of telehealth tools and technologies to facilitate and extend the reach of major national clinical and public health research initiatives. Perhaps most importantly, the National Institutes of Health should develop and/or strengthen strategic partnerships with other funding agencies with overlapping or complementary interests to accelerate interdisciplinary research in this rapidly evolving but relatively understudied and complex field.

The NIBIB Point of Care Technologies Research Network Center Themes and Opportunities for Exploratory POC Projects.

This article describes the new National Institute of Biomedical Imaging and Bioengineering Point-of-Care (POC) Technologies Research Network and its 4 Centers. The goal is to build expertise in development of integrated systems that address unmet POC testing clinical needs. Centers will work individually and also collectively as part of the national network to coordinate development, clinical evaluation, and reduction to practice of new POC devices.

Point-of-care biosensor systems for cancer diagnostics/prognostics.

With the growing number of fatalities resulting from the 100 or so cancer-related diseases, new enabling tools are required to provide extensive molecular profiles of patients to guide the clinician in making viable diagnosis and prognosis. Unfortunately with cancer-related diseases, there is not one molecular marker that can provide sufficient information to assist the clinician in making effective prognoses or even diagnoses. Indeed, large panels of markers must typically be evaluated that cut across several different classes (mutations in certain gene fragments--DNA; over/under-expression of gene activity as monitored by messenger RNAs; the amount of proteins present in serum or circulating tumor cells). The classical biosensor format (dipstick approach for monitoring the presence of a single element) is viewed as a valuable tool in many bioassays, but possesses numerous limitations in cancer due primarily to the single element nature of these sensing platforms. As such, if biosensors are to become valuable tools in the arsenal of the clinician to manage cancer patients, new formats are required. This review seeks to provide an overview of the current thinking on molecular profiling for diagnosis and prognosis of cancers and also, provide insight into the current state-of-the-art in the biosensor field and new strategies that must be considered to bring this important technology into the cancer field.