1,720,963 research outputs found
How accurate do you want it? Defining minimum required accuracy for medical artificial intelligence
Full text linkArtificial intelligence (AI) is becoming a more and more common component of biomedical engineering solutions, and these latter systems are getting promising results in terms of diagnostic and prognostic accuracy. Medical AI (MAI) is then reaching the maturity level for its appropriate use in clinical practice, but to this end, its efficacy needs to be demonstrated first. Currently, this efficacy is proven in terms of the reported accuracy of the algorithm, especially for diagnostic tasks. But also in this case, how much accurate is "enough" accurate? To address this question means to define the minimum required accuracy for a system to be valid, that is fit to its intended use. To this aim, we propose a risk-based approach to the definition of adequate accuracy, in accordance with a risk-based regulatory classification. We investigated whether the current state of the art is already compliant with this standard-based approach, by performing a literature review in four application domains, one for each of the four risk classes we identified: the diagnosis of psoriasis, of knee osteoarthritis, the screening of breast cancer screening, and the detection of influenza outbreaks. The evaluation of the literature review highlighted that this approach is still not widely adopted, but that there is a partial presence of an implicit, conventional scheme that is similar to our proposal, especially in the high-impact literature. We also provide some guideline to assess the minimum required accuracy but also sheds light on the need for further official guidelines that ensure the wider application of the regulatory risk-based approach by the scholarly community of MAI
Methods for preclinical validation of software as a medical device
Full text linkSoftware as a medical device is subject to dedicated regulatory requirements before it can be used on human beings. The certification process in Europe requires that sufficient data on clinical benefits are available before the device is CE marked. This position paper describes our proposal of a risk-based approach to technical and preclinical validation of software as medical devices. This approach ensures that all technical solutions for safety are implemented in the software and that all information for safe use is consistent before the software can be made available to patients. This approach is compliant to the main international standards ISO 13485 on quality systems and ISO 14971 on risk management and therefore ensures regulatory compliance as well as patient protection. This integrated approach allows the designers of the software to integrate regulatory and safety testing in the technical testing of the candidate release version of the device. This approach ensures patient safety and regulatory compliance at the same time as technical functionality
Validazione tecnica delle terapie digitali
No full textAnalogamente a quanto accade per gli altri dispositivi medici, le Terapie Digitali (Digital Therapeutics - DTx) devono rispettare i Requisiti Essenziali previsti dalle norme europee. Questi requisiti sono stati definiti
nella attuale Direttiva e riconfermati, pur se con delle importanti novità
per quanto riguarda la dimostrazione di beneficio clinico, dal nuovo Regolamento 2017/745/CE. Questi possono essere riassunti da tre parole chiave: sicurezza, efficacia, qualità. I fabbricanti possono dimostrare di aver
adempiuto agli obblighi definiti dai Requisiti Essenziali per mezzo dell’applicazione di standard internazionali.
In questo testo gli autori si sono concentrati sul processo di sviluppo e
validazione tecnica delle DTx come definito dagli standard ISO 13485 e IEC
62304, fino alla fase immediatamente precedente la validazione clinica
Going Beyond Counting First Authors in Author Co-citation Analysis
Full text linkThe present study examines one of the fundamental aspects of author co-citation analysis (ACA) - the way co-citation
counts are defined. Co-citation counting provides the data on which all subsequent statistical analyses and mappings
are based, and we compare ACA results based on two different types of co-citation counting - the traditional type that
only counts the first one among a cited work's authors on the one hand and a non-traditional type that takes into
account the first 5 authors of a cited work on the other hand. Results indicate that the picture produced through this non-traditional author co-citation counting contains more coherent author groups and is therefore considerably clearer. However, this picture represents fewer specialties in the research field being studied than that produced through the traditional first-author co-citation counting when the same number of top-ranked authors is selected and analyzed. Reasons for these effects are discussed
Variations on the Author
Full text link“Variations on the Author” discusses two of Eduardo Coutinho’s recent films (Um Dia na Vida, from 2010, and Últimas Conversas, posthumously released in 2015) and their contribution to the general question of documentary authorship. The director’s filmography is characterized by a consistent yet self-effacing form of authorial self-inscription: Coutinho often features as an interviewer that rather than express opinions propels discourses; an interviewer that is good at listening. This mode of self-inscription characterizes him as an author who is not expressive but who is nonetheless markedly present on the screen. In Um Dia na Vida, however, Coutinho is completely absent form the image, while Últimas Conversas, on the contrary, includes a confessional prologue that moves the director from the margins to the center of his films. This article examines the ways in which these works stand out in the filmography of a director who offers new insights into the notion of cinematic authorship
Appropriate Similarity Measures for Author Cocitation Analysis
Full text linkWe provide a number of new insights into the methodological discussion about author cocitation analysis. We first argue that the use of the Pearson correlation for measuring the similarity between authors’ cocitation profiles is not very satisfactory. We then discuss what kind of similarity measures may be used as an alternative to the Pearson correlation. We consider three similarity measures in particular. One is the well-known cosine. The other two similarity measures have not been used before in the bibliometric literature. Finally, we show by means of an example that our findings have a high practical relevance.information science;Pearson correlation;cosine;similarity measure;author cocitation analysis
All you need is higher accuracy? On the quest for minimum acceptable accuracy for medical artificial intelligence
No full textIn this paper we will discuss the concept of the minimum level of accuracy an Artificial Intelligence system must exhibit in medical settings to be fit to its intended use and improve the daily practice of its intended users, the medical doctors. We will consider simple binary classification tasks in both diagnostic and prognostic ambit (like to discriminate between normal/abnormal case, and improvement/no improvement prospects). We will make the point that the common ways to determine this minimum acceptable accuracy are fraught with many conceptual and practical troubles. We will report about a small user study conducted to elicit the discriminative requirements from a sample of medical doctors, stratified both in general practitioners and specialists. Finally, we will present a simple nomogram by which to determine the minimum accuracy of a technological aid, once the human average performance and the desired level of accuracy are known. The nomogram is to be intended as a provocative simple tool to recognize that the technological tool is less important than a sound protocol in which to use it, responsibly and paying due attention to the role of the human decision makers
A novel method for validating multi-classifiers. A case study for ICF-based health status classification
Full text linkIn this paper, we propose a novel method for the validation of a multi-classification model according to the intended use and aim of a device for health status classification and the clinical needs of the practitioners involved
Dispelling the Myths Behind First-author Citation Counts
Full text linkWe conducted a full-scale evaluative citation analysis study of scholars in the XML research field to explore just how different from each other author rankings resulting from different citation counting methods actually are, and to demonstrate the capability of emerging data and tools on the Web in supporting more realistic citation counting methods. Our results contest some common arguments for the continued
use of first-author citation counts in the evaluation of scholars, such as high correlations between author rankings by first-author citation counts and other citation
counting methods, and high costs of using more realistic citation counting methods that are not well-supported by the ISI databases. It is argued that increasingly available digital full text research papers make it possible for citation analysis studies to go beyond what the ISI databases have directly supported and to employ more
sophisticated methods
- …
