Point of Care最新文献

Implementation of human immunodeficiency virus rapid and point-of-care tests (RDT/POCT) is understood to be impeded by many different factors that operate at 4 main levels-test devices, patients, providers, and health systems-yet a knowledge gap exists of how they act and interact to impede implementation. To fill this gap, and with a view to improving the quality of implementation, we conducted a systematic review.

Methods: Five databases were searched, 16,672 citations were retrieved, and data were abstracted on 132 studies by 2 reviewers.

Findings: Across 3 levels (ie, patients, providers, and health systems), a majority (59%, 112/190) of the 190 barriers were related to the integration of RDT/POCT, followed by test-device-related concern (ie, accuracy) at 41% (78/190). At the patient level, a lack of awareness about tests (15/54, 28%) and time taken to test (12/54, 22%) dominated. At the provider and health system levels, integration of RDT/POCT in clinical workflows (7/24, 29%) and within hospitals (21/34, 62%) prevailed. Accuracy (57/78, 73%) was dominant only at the device level.

Interpretation: Integration barriers dominated the findings followed by test accuracy. Although accuracy has improved during the years, an ideal implementation could be achieved by improving the integration of RDT/POCT within clinics, hospitals, and health systems, with clear protocols, training on quality assurance and control, clear communication, and linkage plans to improve health outcomes of patients. This finding is pertinent for a future envisioned implementation and global scale-up of RDT/POCT-based initiatives.

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.

With millions of at-risk people undiagnosed with pre-diabetes and diabetes, there is a need to identify alternate screening sites for out-of-range glucose values. We examined practical issues and accuracy (relative to High Performance Liquid Chromatography testing in a laboratory) in the use of the A1cNow point of care device for this screening in general practice dental clinics at a large University-based Dental College. Health care professionals obtained evaluable readings for only 70% of the subjects, even after two attempts, and its use according to manufacturer's instructions was often challenging in the busy environment of the dental clinic. At thresholds for pre-diabetes and diabetes established by the American Diabetes Association, sensitivities of the A1cNow kit relative to the HPLC method were 91.9% and 100%, respectively. However, specificities for pre-diabetes and diabetes were 66.7% and 82.4%, respectively, indicating many false positive results. A better strategy for diabetes screening may involve a laboratory-based analysis approach that is patient- and provider-friendly, with minimal burden to the dental team.

Charting point-of-care results is generally not performed by the laboratory point-of-care team; however, the oversight of this activity remains the responsibility of the point-of-care program. Although point-of-care management and interfacing are not new, there remain a significant number of hospitals not yet utilizing automated electronic interfaces for charting of results to tests performed outside the clinical laboratory (also known as point of care). This article is designed to help quantify the costs associated with manual charting and help build the case for implementing an automated electronic interface through a return-on-investment method.

Point-of-care (POC) testing allows for medical testing to be performed across the disaster-emergency-critical care continuum. The disaster-emergency-critical care continuum begins with the identification of at-risk patients, followed by patient stabilization, and ultimately transfer to an alternate care facility or mobile hospital for comprehensive critical care. Gaps at the interfaces for each of these settings leads to excess mortality and morbidity. Disaster victims are at risk for acute myocardial infarctions, acute kidney injury (AKI), and sepsis. However cardiac biomarker testing, renal function testing, and multiplex rapid pathogen detection are often unavailable or inadequate during disasters. Cardiac biomarker reagents require refrigeration; traditional renal function tests (i.e., serum creatinine) exhibit poor sensitivity for predicting AKI in critically ill patients, and culture-based pathogen detection is too slow to help initiate early-directed antimicrobial therapy. We propose three value propositions detailing how rapid, POC, and environmentally hardened cardiac biomarker, AKI and multiplex pathogen testing harmonizes the interface between disaster, emergency, and critical care.

INTRODUCTION: A point of care test (POCT) for Chlamydia trachomatis detection is an urgent public health need. Technology advances in diagnostics have made solutions possible. Yet no reliable POCT exist. Our goal was to address the gap between chlamydia POCT needs and successful POCT development by determining which characteristics of POCT tests are most critical and if any flexibility in the attributes assigned those characteristics exist between technology developer and end user. METHODS: We employed a process known as WALEX (Warfare Analysis Laboratory Exercise) in combination with Design of Experiment (DOE) methodology using discrete choice experiments (DCE), to describe the attributes of the most realistic, rather than the most ideal POCT. The WALEX was conducted as interactive oral and simultaneous electronic discussion among experts with differing expertise, but linked by a common interest in development of a chlamydia POCT. RESULTS: Our studies demonstrated which features of the ideal chlamydia POCT were considered critical to test acceptance by users and which were open to negotiation. In particular, end users were more lenient on the requirement for the fastest ideal test and the lowest one time instrument costs, if the requirement for higher throughput, lowest cost and vaginal sample source collection were preserved. DOE methods used in forced choice question design provided confirmation of opinions derived from oral and electronic WALEX comments CONCLUSIONS: The WALEX in combination with DCE helped us achieve our goal in identifying the gaps in the chlamydia POCT and determining the most realistic solutions to bridge those gaps.

Resiliency through use of point-of-care (POC) testing in small-world networks will change the future landscape by bringing evidence-based decision-making to sites of need globally. This issue of Point of Care addresses fundamental principles and essential building blocks that mitigate crises and enhance standards of care. Several papers on needs assessment support the case for onsite testing in different medical situations. Then, the focus shifts to how to protect POC devices and reagents from extremes of temperature and humidity that are encountered virtually anywhere POC testing is used outside hospitals. Indeed, the effects of environmental stresses can no longer be ignored. We have observed the advent of the "hybrid laboratory" where POC whole-blood analysis is performed using transportable instruments in non-laboratory settings and the rapid expansion of portable and handheld testing now found ubiquitously worldwide. Emerging new POC technologies will propel personalized medicine by targeting treatment. Trendy as these advances are, in low-resource settings POC instruments often represent the default armamentarium of the small community hospital. Hence, education and competency become essential prerequisites for creating, maintaining, harmonizing, and standardizing accuracy and quality as new cost-effective technologies become available. Excellent performance brings value, which is one of the keys to this next phase in the history of point of care. By increasing the value of decision-making at the site of care, we can assure resiliency, for the individual patient who might be in need of self-monitoring, for rational responses to crises, and for nations made up of more resilient individual communities.

OBJECTIVES: To study health resources and point-of-care (POC) testing requirements for urgent, emergency, and disaster care in Phang Nga Province, Thailand; to determine instrument design specifications through a direct needs assessment survey; to describe POC test menus useful in the small-world network; and to assess strategies for preparedness following the 2004 Tsunami. METHODS: We surveyed medical professionals in community hospitals, a regional hospital, and the Naval Base Hospital; and officials at the offices of Provincial Public Health and Disaster Prevention and Mitigation. Questions covered: a) demographics and test requirements, b) POC needs, c) device design specifications, and d) pathogen detection options. Respondents scored choices. Scores determined priorities. RESULTS: Respondents selected complete blood count, electrolytes/chemistry, blood type, oxygen saturation (by pulse oximeter), hematocrit, and microbiology as top priorities, and preferred direct blood sampling with cassettes. Cardiac biomarkers were important in alternate care facilities. Staphylococcus aureus, SARS, Streptococcus pneumoniae, and hepatitis B were top infectious disease problems. Temperature, vibration, humidity, and impact shock were four important environmental conditions during extreme conditions. CONCLUSIONS: Point-of-care testing can be used on a daily basis for competency and efficiency. Familiarity improves preparedness. Instrument designs must anticipate user preferences and environment stresses. The results show how a region at risk can adapt its small-world network. Point-of-care testing has become an important risk-reducing modality for crises and works equally well in low-resource settings to speed the delivery of routine and urgent care.

BACKGROUND: We assessed point-of-care device specifications and needs for pathogen detection in urgent care, emergencies, and disasters. METHODS: We surveyed American Association for Clinical Chemistry members and compared responses to those of disaster experts. Online SurveyMonkey questions covered performance characteristics, device design, pathogen targets, and other specifications. RESULTS: For disasters, respondents preferred direct sample collection with a disposable test cassette that stores biohazardous material (P<0.001). They identified methicillin-resistant Staphylococcus aureus, Salmonella typhi, Vibrio cholerae, Escherichia coli, Staphylococcus aureus, and Streptococcus pneumoniae as high priority pathogens. First responders were deemed the professional group who should perform POC testing in disasters (P<0.001). CONCLUSIONS: Needs assessment now is requisite for competitive funding, so the results in this report will be useful to investigators preparing grant applications. Point-of-care devices used in disasters should address the needs of first responders, who give high priority to contamination-free whole-blood sampling, superior performance pathogen detection, and HIV-1/2 blood donor screening. There was surprising concordance of preferences among different professional groups, which presages formulation of global consensus guidelines to assist high impact preparedness.