ISO 14971 as a methodological tool in the validation process of a RIS-PACS system

2011 ◽  
Author(s):  
M. Catelani ◽  
L. Ciani ◽  
S. Diciotti ◽  
F. Dori ◽  
M. Giuntini
Keyword(s):  
Validation Process ◽  
Methodological Tool ◽  
Pacs System

Minimal Invasive Teil-Korporektomie von direkt lateral – Erfahrungen an einer Serie von 45 Patienten

2017 ◽  
Vol 01 (04) ◽  
pp. 303-309
Author(s):  
Stephan Dützmann ◽  
Tyler Cole ◽  
Volker Seifert ◽  
Matthias Setzer ◽  
Lutz Weise
Keyword(s):  
Minimal Invasive ◽  
Postoperative Schmerzen ◽  
Neurologische Komplikationen ◽  
Operativer Zugang ◽  
Mini Open ◽  
Pacs System

Zusammenfassung Hintergrund Der direkt laterale Zugangsweg hat in den letzten Jahren zunehmend an Popularität gewonnen. Er könnte neben der Diskektomie aber auch für Teil-Korporektomien an der thorakolumbalen Wirbelsäule genutzt werden. Wir präsentieren hiermit nun unsere Erfahrung der letzten 5 Jahre (2012 – 2017). Methoden Es wurde retrospektiv unsere Datenbank ausgewertet, die ab 2012 kurz nach Markteinführung alle Patienten erfasste. Es wurden prä- und postoperative CT- und Röntgenaufnahmen in unserem PACS-System gespeichert. Die Patienten wurden 3 Monate nach der Operation erneut in unserer Ambulanz gesehen und das klinische Outcome bestimmt. Eine Vergleichsgruppe konnte für die Schmerzanalyse bei Patienten mit Metastasen an der Wirbelsäule gebildet werden, da nicht alle Patienten über denselben Zugang in dem Zeitraum operiert wurden. Ergebnisse Im Zeitraum zwischen März 2012 und März 2017 wurden 45 Patienten in den Höhen Th7 bis L4 operiert. Bei 30 Patienten waren spinale Metastasen die Indikation und bei 15 Patienten lag eine Berstungsfraktur zugrunde. Im gleichen Zeitraum wurde bei 8 Patienten eine Kostotransversektomie als operativer Zugang zur Resektion von osteolytischen Metastasen an der Wirbelsäule durchgeführt. Bei 88 % der Patienten konnte eine 90 %-Deckplattenabdeckung erreicht werden. In der Vergleichsanalyse zeigte sich, dass die Patienten, die sich einem minimalinvasiven lateralen Zugang unterzogen, einen signifikant geringeren kombinierten Blutverlust und weniger unmittelbar postoperative Schmerzen hatten. Neurologische Komplikationen erlitten 6 Patienten (13 %). Implantatassoziierte Komplikationen wurden in 7 Fällen (15 %) beobachtet, davon 5 revisionspflichtig. Schlussfolgerung Unsere Serie untersucht anhand von 45 Patienten die mini-open direkt laterale Teil-Korporektomie. Diese Technik ist ein wertvolles minimalinvasives Zugangsverfahren für Tumoren und Frakturen der Wirbelsäule insbesondere bei Wirbelkörperdestruktionen mit der Möglichkeit einer exzellenten Deckplattenabdeckung durch das lateral eingebrachte Implantat. Weitere Nachuntersuchungen und Erfahrungen sind notwendig, um das Indikationsspektrum sowie die Langzeitergebnisse zu untersuchen.

Advances in standardizing and validating research techniques for pathogen monitoring in water

2004 ◽  
Vol 4 (2) ◽  
pp. 23-30
Author(s):  
K. Connell ◽  
M. Pope ◽  
K. Miller ◽  
J. Scheller ◽  
J. Pulz
Keyword(s):  
Validation Studies ◽  
Development Process ◽  
Monitoring Methods ◽  
Microbiological Method ◽  
Validation Process ◽  
Method Performance ◽  
Target Analytes ◽  
Interlaboratory Validation ◽  
Quality Control Criteria ◽  
Control Criteria

Designing and conducting standardized microbiological method interlaboratory validation studies is challenging because most methods are manual, rather than instrument-based, and results from the methods are typically subjective. Determinations of method recovery, in particular, are problematic, due to difficulties in assessing the true spike amount. The standardization and validation process used for the seven most recent USEPA 1600-series pathogen monitoring methods has begun to address these challenges. A staged development process was used to ensure that methods were adequately tested and standardized before resources were dedicated to interlaboratory validation. The interlaboratory validation studies for USEPA Method 1622, for Cryptosporidium, USEPA Method 1601 for coliphage, and USEPA Method 1605 for Aeromonas assessed method performance using different approaches, due the differences in the nature of the target analytes and the data quality needs of each study. However, the use of enumerated spikes in all of the studies allowed method recovery and precision to be assessed, and also provided the data needed to establish quantitative quality control criteria for the methods.

Musical Repatriation as Method

2018 ◽  
pp. 262-282
Author(s):  
Michael Iyanaga
Keyword(s):  
Methodological Tool

In ethnomusicology, discussions about repatriation have tended to revolve around “applied” issues. Often left out of the conversation, however, is that when treated as a methodological tool, repatriation can also contribute in profound ways to more theoretical concerns in ethnomusicology. As such, this chapter argues that employing musical repatriation in our fieldwork can help ethnomusicologists write better ethnographies—and thus subsequently to theorize about music and musical people more effectively—as it gives us a privileged avenue to understand the musical communities with which we work. Supported by a case study from Bahia, Brazil, in which a series of repatriation experiences reveal different facets of Catholic saint devotion, this chapter focuses on some of the distinct ethnographic lessons gleaned from the return of several historical recordings to a devotee of Saint Roch more than three decades after the recordings were originally made.

scholarly journals Numerical Study on an Interface Compression Method for the Volume of Fluid Approach

Fluids ◽  
2021 ◽  
Vol 6 (2) ◽  
pp. 80
Author(s):  
Yuria Okagaki ◽  
Taisuke Yonomoto ◽  
Masahiro Ishigaki ◽  
Yoshiyasu Hirose
Keyword(s):  
Linear Theory ◽  
Volume Fraction ◽  
Numerical Study ◽  
Volume Of Fluid ◽  
Interfacial Wave ◽  
Validation Process ◽  
Two Phase ◽  
Numerical Diffusion ◽  
Mesh Resolution ◽  
Water Reactors

Many thermohydraulic issues about the safety of light water reactors are related to complicated two-phase flow phenomena. In these phenomena, computational fluid dynamics (CFD) analysis using the volume of fluid (VOF) method causes numerical diffusion generated by the first-order upwind scheme used in the convection term of the volume fraction equation. Thus, in this study, we focused on an interface compression (IC) method for such a VOF approach; this technique prevents numerical diffusion issues and maintains boundedness and conservation with negative diffusion. First, on a sufficiently high mesh resolution and without the IC method, the validation process was considered by comparing the amplitude growth of the interfacial wave between a two-dimensional gas sheet and a quiescent liquid using the linear theory. The disturbance growth rates were consistent with the linear theory, and the validation process was considered appropriate. Then, this validation process confirmed the effects of the IC method on numerical diffusion, and we derived the optimum value of the IC coefficient, which is the parameter that controls the numerical diffusion.

scholarly journals Bio-Inspired Modality Fusion for Active Speaker Detection

2021 ◽  
Vol 11 (8) ◽  
pp. 3397
Author(s):  
Gustavo Assunção ◽  
Nuno Gonçalves ◽  
Paulo Menezes
Keyword(s):  
Superior Colliculus ◽  
Visual Information ◽  
Human Beings ◽  
Validation Process ◽  
Detection Approach ◽  
Wide Range ◽  
Speaker Detection ◽  
The One ◽  
The Brain ◽  
Fusion Ability

Human beings have developed fantastic abilities to integrate information from various sensory sources exploring their inherent complementarity. Perceptual capabilities are therefore heightened, enabling, for instance, the well-known "cocktail party" and McGurk effects, i.e., speech disambiguation from a panoply of sound signals. This fusion ability is also key in refining the perception of sound source location, as in distinguishing whose voice is being heard in a group conversation. Furthermore, neuroscience has successfully identified the superior colliculus region in the brain as the one responsible for this modality fusion, with a handful of biological models having been proposed to approach its underlying neurophysiological process. Deriving inspiration from one of these models, this paper presents a methodology for effectively fusing correlated auditory and visual information for active speaker detection. Such an ability can have a wide range of applications, from teleconferencing systems to social robotics. The detection approach initially routes auditory and visual information through two specialized neural network structures. The resulting embeddings are fused via a novel layer based on the superior colliculus, whose topological structure emulates spatial neuron cross-mapping of unimodal perceptual fields. The validation process employed two publicly available datasets, with achieved results confirming and greatly surpassing initial expectations.

scholarly journals The development and validation of prognostic models for overall survival in the presence of missing data in the training dataset: a strategy with a detailed example

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Kara-Louise Royle ◽  
David A. Cairns
Keyword(s):  
Overall Survival ◽  
Missing Data ◽  
Prognostic Model ◽  
Prognostic Index ◽  
Risk Groups ◽  
Prognostic Models ◽  
Training Dataset ◽  
Validation Process ◽  
Test Dataset ◽  
Development And Validation

Abstract Background The United Kingdom Myeloma Research Alliance (UK-MRA) Myeloma Risk Profile is a prognostic model for overall survival. It was trained and tested on clinical trial data, aiming to improve the stratification of transplant ineligible (TNE) patients with newly diagnosed multiple myeloma. Missing data is a common problem which affects the development and validation of prognostic models, where decisions on how to address missingness have implications on the choice of methodology. Methods Model building The training and test datasets were the TNE pathways from two large randomised multicentre, phase III clinical trials. Potential prognostic factors were identified by expert opinion. Missing data in the training dataset was imputed using multiple imputation by chained equations. Univariate analysis fitted Cox proportional hazards models in each imputed dataset with the estimates combined by Rubin’s rules. Multivariable analysis applied penalised Cox regression models, with a fixed penalty term across the imputed datasets. The estimates from each imputed dataset and bootstrap standard errors were combined by Rubin’s rules to define the prognostic model. Model assessment Calibration was assessed by visualising the observed and predicted probabilities across the imputed datasets. Discrimination was assessed by combining the prognostic separation D-statistic from each imputed dataset by Rubin’s rules. Model validation The D-statistic was applied in a bootstrap internal validation process in the training dataset and an external validation process in the test dataset, where acceptable performance was pre-specified. Development of risk groups Risk groups were defined using the tertiles of the combined prognostic index, obtained by combining the prognostic index from each imputed dataset by Rubin’s rules. Results The training dataset included 1852 patients, 1268 (68.47%) with complete case data. Ten imputed datasets were generated. Five hundred twenty patients were included in the test dataset. The D-statistic for the prognostic model was 0.840 (95% CI 0.716–0.964) in the training dataset and 0.654 (95% CI 0.497–0.811) in the test dataset and the corrected D-Statistic was 0.801. Conclusion The decision to impute missing covariate data in the training dataset influenced the methods implemented to train and test the model. To extend current literature and aid future researchers, we have presented a detailed example of one approach. Whilst our example is not without limitations, a benefit is that all of the patient information available in the training dataset was utilised to develop the model. Trial registration Both trials were registered; Myeloma IX-ISRCTN68454111, registered 21 September 2000. Myeloma XI-ISRCTN49407852, registered 24 June 2009.

scholarly journals Cultural and linguistic adaptation of the multi-dimensional OXCAP-MH for outcome measurement of mental health among people living with HIV/AIDS in Uganda: the Luganda version

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Kenneth R. Katumba ◽  
Yoko V. Laurence ◽  
Patrick Tenywa ◽  
Joshua Ssebunnya ◽  
Agata Laszewska ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Sub Saharan Africa ◽  
People Living With Hiv ◽  
Care Providers ◽  
English Version ◽  
Validation Process ◽  
Living With Hiv ◽  
Hiv Aids

Abstract Background It is rare to find HIV/AIDS care providers in sub-Saharan Africa routinely providing mental health services, yet 8–30% of the people living with HIV have depression. In an ongoing trial to assess integration of collaborative care of depression into routine HIV services in Uganda, we will assess quality of life using the standard EQ-5D-5L, and the capability-based OxCAP-MH which has never been adapted nor used in a low-income setting. We present the results of the translation and validation process for cultural and linguistic appropriateness of the OxCAP-MH tool for people living with HIV/AIDS and depression in Uganda. Methods The translation process used the Concept Elaboration document, the source English version of OxCAP-MH, and the Back-Translation Review template as provided during the user registration process of the OxCAP-MH, and adhered to the Translation and Linguistic Validation process of the OxCAP-MH, which was developed following the international principles of good practice for translation as per the International Society for Pharmacoeconomics and Outcomes Research’s standards. Results The final official Luganda version of the OxCAP-MH was obtained following a systematic iterative process, and is equivalent to the English version in content, but key concepts were translated to ensure cultural acceptability, feasibility and comprehension by Luganda-speaking people. Conclusion The newly developed Luganda version of the OxCAP-MH can be used both as an alternative or as an addition to health-related quality of life patient-reported outcome measures in research about people living with HIV with comorbid depression, as well as more broadly for mental health research.

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