scholarly journals Validation process of EDTA for infusion/ injection with ceftriaxone and sulbactam

2021 ◽  
Vol 9 (3) ◽  
pp. 39-47
Author(s):  
Md. Semimul Akhtar ◽  
Akash Babu ◽  
Sudip Kumar Mandal
Keyword(s):  
Validation Process

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.

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.

A digital contract for restoration of the Earth System mediated by a Planetary Boundary Exchange Unit

2021 ◽  
pp. 205301962098727
Author(s):  
Orfeu Bertolami ◽  
Frederico Francisco
Keyword(s):  
Earth System ◽  
New Governance ◽  
Validation Process ◽  
Operational Conditions ◽  
Blockchain Technology ◽  
The Earth ◽  
Optimal Functioning ◽  
Operating Space ◽  
Exchange Unit ◽  
Safe Operating

In this paper, we propose a new governance paradigm for managing the Earth System based on a digital contract inspired on blockchain technology. This proposal allows for a radical decentralisation of the procedures of controlling, maintaining and restoring ecosystems by a set of networks willing to engage in improving the operational conditions of local ecosystems so to contribute to an optimal functioning of the Earth System. These procedures are aimed to improve local Planetary Boundary parameters so that they approach the optimal Holocene reference values, the so-called Safe Operating Space, via a reciprocal validation process and an exchange unit that internalises the state of the Earth System.

scholarly journals Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures

2020 ◽  
Vol 4 (1) ◽  
Author(s):  
Shawn McKown ◽  
Catherine Acquadro ◽  
Caroline Anfray ◽  
Benjamin Arnold ◽  
Sonya Eremenco ◽  
...  
Keyword(s):  
Cultural Adaptation ◽  
Patient Reported Outcome ◽  
Validation Process ◽  
Linguistic Validation ◽  
Performance Outcome ◽  
Industry Standard ◽  
Patient Reported ◽  
And Performance ◽  
Clinical Outcome Assessments ◽  
Translation And Cultural Adaptation

Abstract Within current literature and practice, the category of patient-reported outcome (PRO) measures has been expanded into the broader category of clinical outcome assessments (COAs), which includes the subcategory of PRO, as well as clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO) measure subcategories. However, despite this conceptual expansion, recommendations associated with translation, cultural adaptation, and linguistic validation of COAs remain focused on PRO measures, which has created a gap in specific process recommendations for the remaining types. This lack of recommendations has led to inconsistent approaches being implemented, leading to uncertainty in the scientific community regarding suitable methods. To address this gap, the ISOQOL Translation and Cultural Adaptation Special Interest Group (TCA-SIG) has developed recommendations specific to each of the three COA types currently lacking such documentation to support a standardized approach to their translation, cultural adaptation, and linguistic validation. The recommended process utilized to translate ObsRO, ClinRO and PerfO measures from one language to another aligns closely with the industry standard process for PRO measures. The substantial differences between respondent categories across COA types require targeted approaches to the cognitive interviewing procedures utilized within the linguistic validation process, including the use of patients for patient-facing text in ClinRO measures, and the need to interview the targeted observers for ObsROs measures.

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