The off- versus on-label use of medical devices in interventional cardiovascular medicine: Clarifying the ambiguity between regulatory labeling and clinical decision-making, Part 1: PCI

2008 ◽  
Vol 72 (4) ◽  
pp. 500-504 ◽  
Author(s):  
Matthew J. Price ◽  
Paul S. Teirstein
2019 ◽  
Vol 40 (25) ◽  
pp. 2058-2073 ◽  
Author(s):  
Chayakrit Krittanawong ◽  
Kipp W Johnson ◽  
Robert S Rosenson ◽  
Zhen Wang ◽  
Mehmet Aydar ◽  
...  

AbstractDeep learning (DL) is a branch of machine learning (ML) showing increasing promise in medicine, to assist in data classification, novel disease phenotyping and complex decision making. Deep learning is a form of ML typically implemented via multi-layered neural networks. Deep learning has accelerated by recent advances in computer hardware and algorithms and is increasingly applied in e-commerce, finance, and voice and image recognition to learn and classify complex datasets. The current medical literature shows both strengths and limitations of DL. Strengths of DL include its ability to automate medical image interpretation, enhance clinical decision-making, identify novel phenotypes, and select better treatment pathways in complex diseases. Deep learning may be well-suited to cardiovascular medicine in which haemodynamic and electrophysiological indices are increasingly captured on a continuous basis by wearable devices as well as image segmentation in cardiac imaging. However, DL also has significant weaknesses including difficulties in interpreting its models (the ‘black-box’ criticism), its need for extensive adjudicated (‘labelled’) data in training, lack of standardization in design, lack of data-efficiency in training, limited applicability to clinical trials, and other factors. Thus, the optimal clinical application of DL requires careful formulation of solvable problems, selection of most appropriate DL algorithms and data, and balanced interpretation of results. This review synthesizes the current state of DL for cardiovascular clinicians and investigators, and provides technical context to appreciate the promise, pitfalls, near-term challenges, and opportunities for this exciting new area.


2011 ◽  
Vol 20 (4) ◽  
pp. 121-123
Author(s):  
Jeri A. Logemann

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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