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Article: Using Sigma metrics to establish analytical product performance requirements and optimize analytical performance of an

Petrides, Victoria / Schneider, Sharon

2018 Volume 28, Issue 2, Page(s) 20903

Abstract: Introduction: Establishing analytical performance requirements for in vitro diagnostic (IVD) assays is a challenging process. Manufacturers try to optimize analytical performance by choosing amongst many combinations of different product performance ... ...

Abstract	Introduction: Establishing analytical performance requirements for in vitro diagnostic (IVD) assays is a challenging process. Manufacturers try to optimize analytical performance by choosing amongst many combinations of different product performance characteristics. Sigma metrics and method decision charts can be helpful aids in choosing appropriate analytical performance requirements. The objective of this research was to demonstrate the use of Sigma metrics and method decision charts to help establish analytical performance requirements and to optimize analytical performance at medical decision concentrations for an IVD assay. Materials and methods: A range of possible Sigma metrics were determined using three sources for total allowable error (TEa) and hypothetical total PSA assay results. Method decision charts were created for each TEa source and used to identify the maximum precision and bias that the assay could have to maintain sigma level performance of at least 3. Results: To achieve a sigma performance level of at least 3 for a hypothetical total PSA assay, the maximum allowable coefficient of variation ranged from 5.0% to 11.2% depending on the TEa source. To achieve a sigma performance level of at least 6, the maximum allowable coefficient of variation ranged from 2.5% to 5.6% depending on the TEa source. Conclusions: Using Sigma metrics and method decision charts when establishing analytical performance requirements can help manufacturers choose product requirements that will optimize IVD assay product performance.
MeSH term(s)	Bias ; Clinical Chemistry Tests ; Diagnosis ; Humans ; Prostate-Specific Antigen/analysis ; Research Design ; Total Quality Management
Chemical Substances	Prostate-Specific Antigen (EC 3.4.21.77)
Language	English
Publishing date	2018-06-30
Publishing country	Croatia
Document type	Journal Article
ZDB-ID	1208725-7
ISSN	1846-7482 ; 1330-0962
ISSN (online)	1846-7482
ISSN	1330-0962
DOI	10.11613/BM.2018.020903
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Article ; Online: Hypothalamic involvement in multiple system atrophy: A structural MRI study.

Pasquini, Jacopo / Firbank, Michael J / Best, Laura / Foster, Victoria / Galley, Debra / Silani, Vincenzo / Ceravolo, Roberto / Petrides, George / Brooks, David J / Anderson, Kirstie N / Pavese, Nicola

Journal of the neurological sciences

2024 Volume 460, Page(s) 122985

Abstract: Objective: To investigate hypothalamic atrophy and its clinical correlates in multiple system atrophy (MSA) in-vivo.: Background: MSA is characterized by autonomic dysfunction and parkinsonian/cerebellar manifestations. The hypothalamus regulates ... ...

Abstract	Objective: To investigate hypothalamic atrophy and its clinical correlates in multiple system atrophy (MSA) in-vivo. Background: MSA is characterized by autonomic dysfunction and parkinsonian/cerebellar manifestations. The hypothalamus regulates autonomic and homeostatic functions and is also involved in memory and learning processes. Methods: 11 MSA, 18 Parkinson's Disease (PD) and 18 Healthy Controls (HC) were included in this study. A validated and automated hypothalamic segmentation tool was applied to 3D-T1-weighted images acquired on a 3T MRI scanner. MSA hypothalamic volumes were compared to those of PD and HC. Furthermore, the association between hypothalamic volumes and scores of autonomic, depressive, sleep and cognitive manifestations were investigated. Results: Posterior hypothalamus volume was reduced in MSA compared to controls (t = 2.105, p = 0.041) and PD (t = 2.055, p = 0.046). Total hypothalamus showed a trend towards a reduction in MSA vs controls (t = 1.676, p = 0.101). Reduced posterior hypothalamus volume correlated with worse MoCA scores in the parkinsonian (MSA + PD) group and in each group separately, but not with autonomic, sleep, or depression scores. Conclusions: In-vivo structural hypothalamic involvement may be present in MSA. Reduced posterior hypothalamus volume, which includes the mammillary bodies and lateral hypothalamus, is associated with worse cognitive functioning. Larger studies on hypothalamic involvement in MSA and its clinical correlates are needed.
Language	English
Publishing date	2024-04-02
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	80160-4
ISSN	1878-5883 ; 0022-510X ; 0374-8642
ISSN (online)	1878-5883
ISSN	0022-510X ; 0374-8642
DOI	10.1016/j.jns.2024.122985
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Article ; Online: Ensuring suitable quality of clinical measurements through design.

Orzechowski, Anthony / Petrides, Victoria / Scopp, Richard

Clinical biochemistry

2018 Volume 57, Page(s) 48–55

Abstract: To design and deliver high quality, safe and effective products, manufacturers of in vitro diagnostic (IVD) products follow a structured, traceable process for controlling the uncertainty of results reported from their measurement systems. This process ... ...

Abstract	To design and deliver high quality, safe and effective products, manufacturers of in vitro diagnostic (IVD) products follow a structured, traceable process for controlling the uncertainty of results reported from their measurement systems. This process and its results however, are not often shared in detail with those outside of the manufacturing company. The objective of this paper is to facilitate discussion by describing some of the best practices used during the IVD design and development process, highlighting some design challenges manufacturers face, and to offer ideas for how IVD manufacturers and laboratories could work together to drive further improvement to public health.
MeSH term(s)	Calibration ; Clinical Chemistry Tests/instrumentation ; Clinical Chemistry Tests/standards ; Equipment Design ; Humans ; Quality Control ; Uncertainty
Language	English
Publishing date	2018-04-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2018.04.012
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Article: Efficacy of mobile application interventions for the treatment of post-traumatic stress disorder: A systematic review.

Wickersham, Alice / Petrides, Petros Minas / Williamson, Victoria / Leightley, Daniel

Digital health

2019 Volume 5, Page(s) 2055207619842986

Abstract: Background: Many adults with post-traumatic stress disorder (PTSD) are unable to access healthcare services for treatment due to logistical, social, and attitudinal barriers. Interventions delivered via mobile applications (apps) may help overcome these ...

Abstract	Background: Many adults with post-traumatic stress disorder (PTSD) are unable to access healthcare services for treatment due to logistical, social, and attitudinal barriers. Interventions delivered via mobile applications (apps) may help overcome these barriers. Objective: The aim of this study is to systematically evaluate the most recent evidence from trials investigating the efficacy of mobile apps for treating PTSD. Methods: PubMed, Web of Science, Embase, PsycINFO, and Medline were searched in February 2018. Randomised controlled trials (RCTs) were included if they quantitatively evaluated the efficacy of a mobile app for treating PTSD as part of the primary aim. Findings were presented in a narrative synthesis. Results: In the five identified RCTs, the use of app-based interventions appeared to be associated with reductions in PTSD symptoms. However, the strength of evidence for this association appeared to be inconsistent, and there was little evidence that those using the apps experienced greater reductions in PTSD symptoms than those in control conditions. Nonetheless, there was some evidence that app-based interventions are both a feasible and acceptable treatment pathway option. Conclusions: Included studies were often limited by small sample sizes, brief intervention, and follow-up periods, and self-reported measures of PTSD. Evidence for the efficacy of mobile interventions for treating PTSD was inconclusive, but promising. Healthcare professionals should exercise caution in recommending app-based interventions until the potentially adverse effects of app use are better understood and larger-scale studies have taken place.
Language	English
Publishing date	2019-04-12
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2819396-9
ISSN	2055-2076
ISSN	2055-2076
DOI	10.1177/2055207619842986
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Article ; Online: Immunodeficiency Accelerates Vitamin A Deficiency.

De Luca, Luigi M / Petrides, Victoria Hill / Darwiche, Nadine / Armey, Laura / Palmer, Amanda / West, Keith P

Current developments in nutrition

2021 Volume 5, Issue 11, Page(s) nzab129

Abstract: Background: Vitamin A deficiency increases susceptibility to infection caused by impaired immune function.: Objectives: We investigated whether immunodeficiency could facilitate the development of vitamin A deficiency.: Methods: Vitamin A ... ...

Abstract	Background: Vitamin A deficiency increases susceptibility to infection caused by impaired immune function. Objectives: We investigated whether immunodeficiency could facilitate the development of vitamin A deficiency. Methods: Vitamin A deficiency was followed in 2 mouse models of immunodeficiency: the athymic nude mouse ( Results: The immunodeficient Conclusions: Our findings are consistent with an increased usage of liver retinol and retinyl palmitate in the immunocompromised
Language	English
Publishing date	2021-10-27
Publishing country	United States
Document type	Journal Article
ISSN	2475-2991
ISSN (online)	2475-2991
DOI	10.1093/cdn/nzab129
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Article ; Online: Efficacy of mobile application interventions for the treatment of post-traumatic stress disorder

Alice Wickersham / Petros Minas Petrides / Victoria Williamson / Daniel Leightley

Digital Health, Vol

A systematic review

2019 Volume 5

Abstract: Background Many adults with post-traumatic stress disorder (PTSD) are unable to access healthcare services for treatment due to logistical, social, and attitudinal barriers. Interventions delivered via mobile applications (apps) may help overcome these ... ...

Abstract	Background Many adults with post-traumatic stress disorder (PTSD) are unable to access healthcare services for treatment due to logistical, social, and attitudinal barriers. Interventions delivered via mobile applications (apps) may help overcome these barriers. Objective The aim of this study is to systematically evaluate the most recent evidence from trials investigating the efficacy of mobile apps for treating PTSD. Methods PubMed, Web of Science, Embase, PsycINFO, and Medline were searched in February 2018. Randomised controlled trials (RCTs) were included if they quantitatively evaluated the efficacy of a mobile app for treating PTSD as part of the primary aim. Findings were presented in a narrative synthesis. Results In the five identified RCTs, the use of app-based interventions appeared to be associated with reductions in PTSD symptoms. However, the strength of evidence for this association appeared to be inconsistent, and there was little evidence that those using the apps experienced greater reductions in PTSD symptoms than those in control conditions. Nonetheless, there was some evidence that app-based interventions are both a feasible and acceptable treatment pathway option. Conclusions Included studies were often limited by small sample sizes, brief intervention, and follow-up periods, and self-reported measures of PTSD. Evidence for the efficacy of mobile interventions for treating PTSD was inconclusive, but promising. Healthcare professionals should exercise caution in recommending app-based interventions until the potentially adverse effects of app use are better understood and larger-scale studies have taken place.
Keywords	Computer applications to medicine. Medical informatics ; R858-859.7
Subject code	150
Language	English
Publishing date	2019-04-01T00:00:00Z
Publisher	SAGE Publishing
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Early FDG-PET response predicts CAR-T failure in large B-cell lymphoma.

Kuhnl, Andrea / Roddie, Claire / Kirkwood, Amy A / Menne, Tobias / Cuadrado, Maria / Marzolini, Maria A V / Osborne, Wendy / Sanderson, Robin / O'Reilly, Maeve / Townsend, William / Benjamin, Reuben / Potter, Victoria / Patten, Piers E M / Yallop, Deborah / Voo, Stefan / Petrides, George S / Mulholland, Nicola / Kayani, Irfan

Blood advances

2021 Volume 6, Issue 1, Page(s) 321–326

MeSH term(s)	Fluorodeoxyglucose F18 ; Humans ; Lymphoma, Large B-Cell, Diffuse/diagnostic imaging ; Positron-Emission Tomography ; Receptors, Chimeric Antigen
Chemical Substances	Receptors, Chimeric Antigen ; Fluorodeoxyglucose F18 (0Z5B2CJX4D)
Language	English
Publishing date	2021-10-26
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2021005807
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Article ; Online: Assessing precision, bias and sigma-metrics of 53 measurands of the Alinity ci system.

Westgard, Sten / Petrides, Victoria / Schneider, Sharon / Berman, Marvin / Herzogenrath, Jörg / Orzechowski, Anthony

Clinical biochemistry

2017

Abstract: Assay performance is dependent on the accuracy and precision of a given method. These attributes can be combined into an analytical Sigma-metric, providing a simple value for laboratorians to use in evaluating a test method's capability to meet its ... ...

Abstract	Assay performance is dependent on the accuracy and precision of a given method. These attributes can be combined into an analytical Sigma-metric, providing a simple value for laboratorians to use in evaluating a test method's capability to meet its analytical quality requirements. Sigma-metrics were determined for 37 clinical chemistry assays, 13 immunoassays, and 3 ICT methods on the Alinity ci system. Methods: Analytical Performance Specifications were defined for the assays, following a rationale of using CLIA goals first, then Ricos Desirable goals when CLIA did not regulate the method, and then other sources if the Ricos Desirable goal was unrealistic. A precision study was conducted at Abbott on each assay using the Alinity ci system following the CLSI EP05-A2 protocol. Bias was estimated following the CLSI EP09-A3 protocol using samples with concentrations spanning the assay's measuring interval tested in duplicate on the Alinity ci system and ARCHITECT c8000 and i2000 Results: The Sigma-metrics and Normalized Method Decision charts demonstrate that a majority of the Alinity assays perform at least at five Sigma or higher, at or near critical medical decision levels. Conclusion: More than 90% of the assays performed at Five and Six Sigma. None performed below Three Sigma. Sigma-metrics plotted on Normalized Method Decision charts provide useful evaluations of performance. The majority of Alinity ci system assays had sigma values >5 and thus laboratories can expect excellent or world class performance. Laboratorians can use these tools as aids in choosing high-quality products, further contributing to the delivery of excellent quality healthcare for patients.
Language	English
Publishing date	2017-09-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2017.09.005
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Article ; Online: Germline mismatch repair (MMR) gene analyses from English NHS regional molecular genomics laboratories 1996-2020: development of a national resource of patient-level genomics laboratory records.

Loong, Lucy / Huntley, Catherine / McRonald, Fiona / Santaniello, Francesco / Pethick, Joanna / Torr, Bethany / Allen, Sophie / Tulloch, Oliver / Goel, Shilpi / Shand, Brian / Rahman, Tameera / Luchtenborg, Margreet / Garrett, Alice / Barber, Richard / Bedenham, Tina / Bourn, David / Bradshaw, Kirsty / Brooks, Claire / Bruty, Jonathan /

Burghel, George J / Butler, Samantha / Buxton, Chris / Callaway, Alison / Callaway, Jonathan / Drummond, James / Durkie, Miranda / Field, Joanne / Jenkins, Lucy / McVeigh, Terri P / Mountford, Roger / Nyanhete, Rodney / Petrides, Evgenia / Robinson, Rachel / Scott, Tracy / Stinton, Victoria / Tellez, James / Wallace, Andrew J / Yarram-Smith, Laura / Sahan, Kate / Hallowell, Nina / Eccles, Diana M / Pharoah, Paul / Tischkowitz, Marc / Antoniou, Antonis C / Evans, D Gareth / Lalloo, Fiona / Norbury, Gail / Morris, Eva / Burn, John / Hardy, Steven / Turnbull, Clare

Journal of medical genetics

2022 Volume 60, Issue 7, Page(s) 669–678

Abstract: Objective: To describe national patterns of National Health Service (NHS) analysis of mismatch repair (MMR) genes in England using individual-level data submitted to the National Disease Registration Service (NDRS) by the NHS regional molecular genetics ...

Abstract	Objective: To describe national patterns of National Health Service (NHS) analysis of mismatch repair (MMR) genes in England using individual-level data submitted to the National Disease Registration Service (NDRS) by the NHS regional molecular genetics laboratories. Design: Laboratories submitted individual-level patient data to NDRS against a prescribed data model, including (1) patient identifiers, (2) test episode data, (3) per-gene results and (4) detected sequence variants. Individualised per-laboratory algorithms were designed and applied in NDRS to extract and map the data to the common data model. Laboratory-level MMR activity audit data from the Clinical Molecular Genetics Society/Association of Clinical Genomic Science were used to assess early years' missing data. Results: Individual-level data from patients undergoing NHS MMR germline genetic testing were submitted from all 13 English laboratories performing MMR analyses, comprising in total 16 722 patients (9649 full-gene, 7073 targeted), with the earliest submission from 2000. The NDRS dataset is estimated to comprise >60% of NHS MMR analyses performed since inception of NHS MMR analysis, with complete national data for full-gene analyses for 2016 onwards. Out of 9649 full-gene tests, 2724 had an abnormal result, approximately 70% of which were (likely) pathogenic. Data linkage to the National Cancer Registry demonstrated colorectal cancer was the most frequent cancer type in which full-gene analysis was performed. Conclusion: The NDRS MMR dataset is a unique national pan-laboratory amalgamation of individual-level clinical and genomic patient data with pseudonymised identifiers enabling linkage to other national datasets. This growing resource will enable longitudinal research and can form the basis of a live national genomic disease registry.
MeSH term(s)	Humans ; State Medicine ; DNA Mismatch Repair/genetics ; Laboratories ; Neoplasms ; Genomics
Language	English
Publishing date	2022-12-26
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	220881-7
ISSN	1468-6244 ; 0022-2593
ISSN (online)	1468-6244
ISSN	0022-2593
DOI	10.1136/jmg-2022-108800
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Article ; Online: Normalization of low-density lipoprotein receptor expression in receptor defective homozygous familial hypercholesterolemia by inhibition of PCSK9 with alirocumab.

Lambert, Gilles / Chatelais, Mathias / Petrides, Francine / Passard, Maxime / Thedrez, Aurélie / Rye, Kerry-Anne / Schwahn, Uwe / Gusarova, Viktoria / Blom, Dirk J / Sasiela, William / Marais, A David

Journal of the American College of Cardiology

2014 Volume 64, Issue 21, Page(s) 2299–2300

MeSH term(s)	Antibodies, Monoclonal/pharmacology ; Cells, Cultured ; Fibroblasts/metabolism ; Flow Cytometry ; Homozygote ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology ; Hyperlipoproteinemia Type II/drug therapy ; Hyperlipoproteinemia Type II/genetics ; Hyperlipoproteinemia Type II/metabolism ; Lovastatin/analogs & derivatives ; Lovastatin/pharmacology ; Proprotein Convertase 9 ; Proprotein Convertases/antagonists & inhibitors ; Receptors, LDL/genetics ; Receptors, LDL/metabolism ; Serine Endopeptidases
Chemical Substances	Antibodies, Monoclonal ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; Receptors, LDL ; mevastatin (1UQM1K0W9X) ; Lovastatin (9LHU78OQFD) ; PCSK9 protein, human (EC 3.4.21.-) ; Proprotein Convertase 9 (EC 3.4.21.-) ; Proprotein Convertases (EC 3.4.21.-) ; Serine Endopeptidases (EC 3.4.21.-) ; alirocumab (PP0SHH6V16)
Language	English
Publishing date	2014-12-02
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	605507-2
ISSN	1558-3597 ; 0735-1097
ISSN (online)	1558-3597
ISSN	0735-1097
DOI	10.1016/j.jacc.2014.07.995
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