scholarly journals Rational clinical use of near-patient analytical systems for molecular detection of infectious agents

2021 ◽  
Vol 45 (3) ◽  
pp. 159-165
Author(s):  
Peter B. Luppa ◽  
Holger F. Rabenau ◽  
Norbert Gässler ◽  
Daniela Huzly ◽  
Matthias Nauck ◽  
...  
Keyword(s):  
Best Practice ◽  
Improve Patient Safety ◽  
Point Of Care ◽  
Hospital Setting ◽  
Special Role ◽  
Clinical Use ◽  
Test Specifications ◽  
Pathogen Dna ◽  
Biological Methods ◽  
Patient Use

Abstract Background Tests for diagnosing infectious diseases (ID-POCT) play a special role among the available point-of-care testing (POCT) methods. Methods A systematic literature search was performed in PubMed. Based on this literature review and our own experience, aspects associated with using molecular biological methods in the diagnostic amplification of pathogen DNA/RNA (nucleic acid testing = NAT) and/or signal amplification were discussed in an interdisciplinary manner. This resulted in the following recommendations for the near-patient use of NAT methods. Results Due to the current rise in the use of near-patient NAT testing (e.g., using disposable cartridges), recommendations are made for their implementation and appropriate clinical use in the hospital setting. Particular emphasis is placed on the analytical quality of the results. Furthermore, internal best-practice rules and selection criteria are proposed to ensure rapid diagnosis. Equally important are a medically valid interpretation of results and compliance with hygiene requirements. These recommendations emphasize that near-patient NAT should always be procured in conjunction with a (preferably) multidisciplinary institution responsible for POCT and knowledge of the test specifications and risks, as well as quality assurance need to be in place before they are carried out. Conclusions These recommendations are intended to improve patient safety and to avoid economically questionable expenditures.

scholarly journals Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

2021 ◽  
Author(s):  
Isabell Wagenhaeuser ◽  
Kerstin Knies ◽  
Vera Rauschenberger ◽  
Michael Eisenmann ◽  
Miriam McDonogh ◽  
...  
Keyword(s):  
Performance Evaluation ◽  
Viral Load ◽  
Clinical Performance ◽  
Point Of Care ◽  
Hospital Setting ◽  
High Viral Load ◽  
Evaluation Study ◽  
Study Cohort ◽  
Protein Variant ◽  
Atypical Symptoms

Background Antigen rapid diagnostic tests (RDT) for SARS-CoV-2 are fast, broadly available, and inexpensive. Despite this, reliable clinical performance data is sparse. Methods In a prospective performance evaluation study, RDT from three manufacturers (NADAL, Panbio, MEDsan) were compared to quantitative reverse transcription polymerase chain reaction (RT-qPCR) in 5 068 oropharyngeal swabs for detection of SARS-CoV-2 in a hospital setting. Viral load was derived from standardized RT-qPCR Cycle threshold (Ct) values. The data collection period ranged from November 12, 2020 to February 28, 2021. Findings Overall, sensitivity of RDT compared to RT-qPCR was 42.57% (95% CI 33.38%-52.31%), and specificity 99.68% (95% CI 99.48%-99.80%). Sensitivity declined with decreasing viral load from 100% in samples with a deduced viral load of 10^8 SARS-CoV-2 RNA copies per ml to 8.82% in samples with a viral load lower than 104 SARS-CoV-2 RNA copies per ml. No significant differences in sensitivity or specificity could be observed between the three manufacturers, or between samples with and without spike protein variant B.1.1.7. The NPV in the study cohort was 98.84%; the PPV in persons with typical COVID-19 symptoms was 97.37%, and 28.57% in persons without or with atypical symptoms. Interpretation RDT are a reliable method to diagnose SARS-CoV-2 infection in persons with high viral load. RDT are a valuable addition to RT-qPCR testing, as they reliably detect infectious persons with high viral loads before RT-qPCR results are available. Funding German Federal Ministry for Education and Science (BMBF), Free State of Bavaria

BMJ Best Practice

2021 ◽  
Vol 22 (3) ◽  
pp. 18-22
Author(s):  
Jamie Saragossi
Keyword(s):  
Health Care Services ◽  
Best Practice ◽  
Drug Information ◽  
Point Of Care ◽  
The United States ◽  
Evidence Based ◽  
End User ◽  
Quality Research ◽  
Care Services ◽  
Clinical Topic

BMJ Best Practice is an evidence-based point of care tool that helps support clinical decisions by providing the latest and highest quality research available to clinicians. The target audience for this resource is anyone delivering health care services. Currently, BMJ Best Practice is available as an institutional subscription in the United States. The resource includes clinical summaries based on the latest evidence, drug information, clinical calculators, evidence-based tool kits, and patient leaflets. The content provided goes through a rigorous editorial process by expert reviewers who have been required to disclose any financial conflicts. This process can however be relatively time consuming therefore updates that do not pose an immediate harm to patient care could potentially take anywhere from 1 to 3 months to be reflected in the clinical topic overviews. Overall, the tools and content provided on the platform are reliable and easy to navigate for the end user.

Proving the Preclusion of Data Manipulation Using Parallel Data Acquisition in Chromatography

2018 ◽  
Vol 941 ◽  
pp. 2390-2394
Author(s):  
David Thomas Marehn ◽  
Detlef Wilhelm ◽  
Heike Pospisil ◽  
Roberto Pizzoferrato
Keyword(s):  
Data Acquisition ◽  
Best Practice ◽  
Sampling Rate ◽  
Good Manufacturing Practice ◽  
Special Role ◽  
Analytical Instruments ◽  
Data Collector ◽  
Parallel Data ◽  
Time Variations ◽  
Hplc Detector

Traceability has an enormous value for companies, but especially for those working in the regulated environment. It plays a special role in the field of pharmacy with respect to manufacturing, controlling and distributing batches of drugs. Through the guidance of Good Manufacturing Practice (GMP) traceability should be ensured. An increasing number of pharmaceutical companies are member of one of the global pharmacopoeias (United States Pharmacopeia, European Pharmacopeia and Japanese Pharmacopeia). The specifications of these pharmacopoeias describe the best practice in documentation, control, qualification and risk management. But however, the pharmacopoeias are written very generally and do not distinguish between the vendors of the analytical instruments. Here, we analyze how chromatographic analyses and data acquisition rely on a specific vendor of the device and the chromatography data system (CDS), the controlling software. We present a way to compare the data acquisition of different CDSs communicating with HPLC instruments. A newly developed software called Data Collector allows the acquisition of data from a HPLC detector parallel to the controlling CDS in the same run. Two HPLC systems and two different CDSs using a well defined sample standard have been tested. The direct comparison of the acquired data precludes unexpected data manipulations of both tested CDSs and shows that there are primarily deviations between the CDSs due to time variations only which depend on the sampling rate. All in all the Data Collector can be used for the traceability of data acquisition.

scholarly journals Successful utilization of the EMR in a multiple sclerosis clinic to support quality improvement and research initiatives at the point of care

2018 ◽  
Vol 4 (4) ◽  
pp. 205521731881373 ◽  
Author(s):  
Kelly Claire Simon ◽  
Afif Hentati ◽  
Susan Rubin ◽  
Tiffani Franada ◽  
Darryck Maurer ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Quality Improvement ◽  
Best Practice ◽  
Point Of Care ◽  
Free Text ◽  
Office Visits ◽  
Quality Initiatives ◽  
Practice Based Research ◽  
Demyelinating Disorders ◽  
Research Initiatives

Background Many physicians enter data into the electronic medical record (EMR) as unstructured free text and not as discrete data, making it challenging to use for quality improvement or research initiatives. Objectives The objective of this research paper was to develop and implement a structured clinical documentation support (SCDS) toolkit within the EMR to facilitate quality initiatives and practice-based research in a multiple sclerosis (MS) practice. Methods We built customized EMR toolkits to capture standardized data at office visits. Content was determined through physician consensus on necessary elements to support best practices in treating patients with demyelinating disorders. We also developed CDS tools and best practice advisories within the toolkits to alert physicians when a quality improvement opportunity exists, including enrollment into our DNA biobanking study at the point of care. Results We have used the toolkit to evaluate 541 MS patients in our clinic and begun collecting longitudinal data on patients who return for annual visits. We provide a description and example screenshots of our toolkits, and a brief description of our cohort to date. Conclusions The EMR can be effectively structured to standardize MS clinic office visits, capture data, and support quality improvement and practice-based research initiatives at the point of care.

scholarly journals Introducing point-of-care testing into a rural hospital setting: thematic analysis of interviews with providers

2010 ◽  
Vol 2 (1) ◽  
pp. 54 ◽  
Author(s):  
Katharina Blattner ◽  
Garry Nixon ◽  
Chrystal Jaye ◽  
Susan Dovey
Keyword(s):  
Rural Community ◽  
Thematic Analysis ◽  
Professional Education ◽  
Point Of Care ◽  
Hospital Setting ◽  
Daily Practice ◽  
Care Providers ◽  
Diagnostic Certainty ◽  
Care Systems ◽  
Education Gaps

INTRODUCTION: Hauora Hokianga Enterprises Trust, an integrated Primary Health Organisation (PHO), which provides primary and intermediate/secondary care to a remote rural community, introduced point-of-care (POC) testing at Rawene Hospital in June 2008. Previously, all laboratory tests were undertaken in Whangarei, with a one to three day turn-around for results. This study aimed to identify the perceived impact of POC testing on clinicians and the community. METHOD: Face-to-face interviews were conducted with 13 health professionals working at Rawene Hospital. The qualitative data analysis computer programme Atlas.ti v5.2 was used to assist the thematic analysis. FINDINGS: Three overall themes captured the main issues with introducing POC testing: (1) POC testing increased clinicians’ confidence, certainty and assurance in their daily practice; (2) POC testing improved diagnostic certainty and this impacted on patients and their families/whanau; (3) the challenges associated with POC testing included increased workload, pressure to up-skill, over-testing, and continuing professional education gaps. CONCLUSION: POC testing is an invaluable technological adjunct for improving clinical decisions and culturally safe care provided to a remote rural community, but it brings challenges to care providers in managing higher workloads and pressures to up-skill. POC testing can improve the acute medical care (access and quality) provided to an economically-deprived, predominantly Maori, rural community. KEYWORDS: Hospitals, rural; point-of-care systems; rural health

Caring for people with dementia in hospital: findings from a survey to identify barriers and facilitators to implementing best practice dementia care

2016 ◽  
Vol 29 (3) ◽  
pp. 467-474 ◽  
Author(s):  
Joanne Tropea ◽  
Dina LoGiudice ◽  
Danny Liew ◽  
Carol Roberts ◽  
Caroline Brand
Keyword(s):  
Best Practice ◽  
Quality Care ◽  
Hospital Setting ◽  
Hospital Staff ◽  
Dementia Care ◽  
Perceived Barriers ◽  
Barriers And Enablers ◽  
People With Dementia ◽  
Multidisciplinary Staff ◽  
Survey Responses

ABSTRACTBackground:Best practice dementia care is not always provided in the hospital setting. Knowledge, attitudes and motivation, practitioner behavior, and external factors can influence uptake of best practice and quality care. The aim of this study was to determine hospital staff perceived barriers and enablers to implementing best practice dementia care.Methods:A 17-item survey was administered at two Australian hospitals between July and September 2014. Multidisciplinary staff working in the emergency departments and general medical wards were invited to participate in the survey. The survey collected data about the respondents’ current role, work area, and years of experience, their perceived level of confidence and knowledge in dementia care and common symptoms of dementia, barriers and enablers to implementing best practice dementia care, job satisfaction in caring for people with dementia, and to rate the hospital's capacity and available resources to support best practice dementia care.Results:A total of 112 survey responses were received. The environment, inadequate staffing levels and workload, time, and staff knowledge and skills were identified as barriers to implementing best practice dementia care. Most respondents rated their knowledge of dementia care and common symptoms of dementia, and confidence in recognizing whether a person has dementia, as moderate or high dementia. Approximately, half the respondents rated access to training and equipment as low or very low.Conclusion:The survey findings highlighted hospital staff perceived barriers to implementing best practice dementia care that can be used to inform locally tailored improvement interventions.

scholarly journals Enabling Better Use of Person-Generated Health Data in Stroke Rehabilitation Systems: Systematic Development of Design Heuristics

10.2196/17132 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e17132
Author(s):  
Gerardo Luis Dimaguila ◽  
Kathleen Gray ◽  
Mark Merolli
Keyword(s):  
Stroke Rehabilitation ◽  
Information Technologies ◽  
Best Practice ◽  
Health Data ◽  
Health Information Technologies ◽  
Positive Effects ◽  
Credible Set ◽  
Remote Patient ◽  
Patient Use

Background An established and well-known method for usability assessment of various human-computer interaction technologies is called heuristic evaluation (HE). HE has been adopted for evaluations in a wide variety of specialized contexts and with objectives that go beyond usability. A set of heuristics to evaluate how health information technologies (HITs) incorporate features that enable effective patient use of person-generated health data (PGHD) is needed in an era where there is a growing demand and variety of PGHD-enabled technologies in health care and where a number of remote patient-monitoring technologies do not yet enable patient use of PGHD. Such a set of heuristics would improve the likelihood of positive effects from patients’ use of PGHD and lower the risk of negative effects. Objective This study aims to describe the development of a set of heuristics for the design and evaluation of how well remote patient therapeutic technologies enable patients to use PGHD (PGHD enablement). We used the case of Kinect-based stroke rehabilitation systems (K-SRS) in this study. Methods The development of a set of heuristics to enable better use of PGHD was primarily guided by the R3C methodology. Closer inspection of the methodology reveals that neither its development nor its application to a case study were described in detail. Thus, where relevant, each step was grounded through best practice activities in the literature and by using Nielsen’s heuristics as a basis for determining the new set of heuristics. As such, this study builds on the R3C methodology, and the implementation of a mixed process is intended to result in a robust and credible set of heuristics. Results A total of 8 new heuristics for PGHD enablement in K-SRS were created. A systematic and detailed process was applied in each step of heuristic development, which bridged the gaps described earlier. It is hoped that this would aid future developers of specialized heuristics, who could apply the detailed process of heuristic development for other domains of technology, and additionally for the case of PGHD enablement for other health conditions. The R3C methodology was also augmented through the use of qualitative studies with target users and domain experts, and it is intended to result in a robust and credible set of heuristics, before validation and refinement. Conclusions This study is the first to develop a new set of specialized heuristics to evaluate how HITs incorporate features that enable effective patient use of PGHD, with K-SRS as a key case study. In addition, it is the first to describe how the identification of initial HIT features and concepts to enable PGHD could lead to the development of a specialized set of heuristics.

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