scholarly journals Variation in LOD Across SARS-CoV-2 Assay Systems: Need for Standardization

2020 ◽  
Author(s):  
Youvraj Sohni
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Limit Of Detection ◽  
Clinical Decision ◽  
International Standards ◽  
Performance Characteristics ◽  
Clinical Testing ◽  
Factors Affecting ◽  
Diagnostic Assays ◽  
Technology Platforms

Abstract Multiple SARS-CoV-2 emergency use authorization (EUA) tests are being used for clinical testing across various clinical testing laboratories for meeting the diagnostic challenges of the ongoing pandemic. However, cross-assay variations in performance characteristics need to be recognized. A better understanding is needed of the clinical implications of cross-assay variation in performance characteristics, particularly in the limit of detection (LOD) of the SARS-CoV-2 assays used for clinical testing. Herein, a snapshot of the diversity of SARS-CoV-2 EUA analytical assay systems including methodologies, assay designs, and technology platforms is presented. Factors affecting the variations in LOD are discussed. Potential measures that may standardize across the various assay systems are suggested. Development of international standards and reference materials for the establishment of performance characteristics may substantially alleviate potential clinical decision-making challenges. Finally, cross-assay variation in LODs among the diverse SARS-CoV-2 diagnostic assays impacts clinical decision-making with multiple assay systems in use and lack of standardization across platforms. International standards in parallel with continued cross-platform studies and collaborative efforts across pertinent healthcare entities will help mitigate some of the clinical decision-making challenges.

scholarly journals Investigating the factors affecting participation in clinical decision-making from viewpoint of physicians and nurses of educational hospitals of Qazvin

2019 ◽  
Vol 29 (3) ◽  
pp. 249-257
Author(s):  
Niloofar Movafegh ◽  
Shahlla Mohamadzade Zarankesh ◽  
Mohammad Kazem Naeeni ◽  
◽  
◽  
...  
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Factors Affecting

scholarly journals A importância do treinamento, reprodutibilidade e calibragem para a qualidade dos estudos

2021 ◽  
Vol 41 (1) ◽  
pp. 3-7
Author(s):  
Cristiano Susin ◽  
Cassiano Kuchenbecker Rösing
Keyword(s):  
Decision Making ◽  
Scientific Knowledge ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
International Standards ◽  
Scientific Methodology ◽  
Biological Processes ◽  
The Way

Dentistry is undergoing a deep transformation in its way of producing, using and interpreting the scientific knowledge. The need for utilizing the best possible evidence for the understanding of the physical and biological processes, as well as to clinical decision making, has risen the interest in the study of subjects that were not regarded as important before. In this scene, the capacity of evaluating the quality of different studies and of producing them under international standards has enhanced the seeking for knowledge in scientific methodology. The way by which the data are obtained and the procedures are performed in research might definitively influence its capacity to generate evidence. Thus, training, reproducibility and calibration are principles that have to be part of everything concerning the process of creating and using the knowledge.

Utilization and contemporary results of renal mass biopsy.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 623-623
Author(s):  
David Cahn ◽  
Caitlin Lim ◽  
Rosaleen Parsons ◽  
Benjamin T. Ristau ◽  
Alexander Kutikov ◽  
...  
Keyword(s):  
Decision Making ◽  
Surgical Resection ◽  
Renal Mass ◽  
Clinical Decision Making ◽  
Clinical Decision ◽  
Performance Characteristics ◽  
Published Data ◽  
Renal Masses ◽  
Poor Grade ◽  
Renal Mass Biopsy

623 Background: Renal mass biopsy (RMB) for localized renal masses (RM) is being re-evaluated to improve risk stratification and minimize morbidity from over-treatment. We review our institutional experience with RMB to identify performance characteristics and highlight opportunities to improve management. Methods: Using our prospectively maintained database, we identified patients who underwent core RMB +/- fine needle aspiration (FNA). We describe performance characteristics and assess pathologic concordance. Using the University of Michigan (UM) algorithm, we reviewed the potential that RMB influenced therapeutic decision-making. Results: We noted 374 RMBs performed from 1999-2015 (66% within last 5 years). Core RMB (+/- FNA) was performed in 65.2% (244/374) of cases, of which 41% (99/244) underwent surgical resection. Initial core RMB was non-diagnostic in 9% (9/99) of surgical cases and subsequently diagnosed with RCC. RCC diagnosed on core RMB that underwent surgical resection demonstrated histologic and grade concordance of 94.3% and 62.5%. All discordant grades were upgraded at surgery. 11% of all RMB were benign and no surgical intervention occurred. In our cohort, 19% of all RMB patients treated surgically had tumors classified as favorable or intermediate < 2cm using the UM algorithm and might otherwise have been candidates for AS. Conversely, 42% of all surgically treated patients had UM favorable characteristics but had tumors > 4cm and therefore underwent surgical resection based on size criteria in the context of RMB results. Conclusions: RMB is effective in the evaluation of RM with minimal morbidity. Our histologic/grade concordance is consistent with published data and underscores that RMB harbors clinical uncertainties. Clinical management pathways incorporating RMB may decrease over-treatment but also may risk under-treatment based on poor grade concordance. Using the UM algorithm, 30% of lesions in our cohort were AS candidates after RMB (over-treatment risk). Conversely, 18% of surgically treated lesions were UM AS candidates after RMB and upgraded on final pathology, demonstrating the risk of under treatment. RMB may be considered in patients where results would influence clinical decision-making.

Debates in Dysphagia Management: How Do You Use Evidence-Based Practice in Your Dysphagia Patient Care?

2011 ◽  
Vol 20 (4) ◽  
pp. 121-123
Author(s):  
Jeri A. Logemann
Keyword(s):  
Decision Making ◽  
Patient Care ◽  
Clinical Outcomes ◽  
Clinical Judgment ◽  
Clinical Decision Making ◽  
Evidence Based Practice ◽  
Clinical Decision ◽  
Evidence Based ◽  
Clinical Method ◽  
Do So

Evidence-based practice requires astute clinicians to blend our best clinical judgment with the best available external evidence and the patient's own values and expectations. Sometimes, we value one more than another during clinical decision-making, though it is never wise to do so, and sometimes other factors that we are unaware of produce unanticipated clinical outcomes. Sometimes, we feel very strongly about one clinical method or another, and hopefully that belief is founded in evidence. Some beliefs, however, are not founded in evidence. The sound use of evidence is the best way to navigate the debates within our field of practice.

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