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Article ; Online: Improving Equivalency in Metagenomics: A Harmonized Process to Extract Fecal DNA.

Gifford, Jessica L

2020 Volume 64, Issue 6, Page(s) 983–984

Language	English
Publishing date	2020-02-26
Publishing country	England
Document type	Journal Article
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1373/clinchem.2018.286518
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Article ; Online: Increased Lp(a) Workload Volumes Reflect Uptake of the 2021 Canadian Cardiovascular Society Guidelines for Management of Dyslipidemia.

Orton, Dennis J / Gifford, Jessica L / Raizman, Joshua E / Pearson, Glen J / Tsui, Albert K Y

The Canadian journal of cardiology

2024

Language	English
Publishing date	2024-03-01
Publishing country	England
Document type	Letter
ZDB-ID	632813-1
ISSN	1916-7075 ; 0828-282X
ISSN (online)	1916-7075
ISSN	0828-282X
DOI	10.1016/j.cjca.2024.02.019
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Article ; Online: Filling in the GAPS: validation of anion gap (AGAP) measurement uncertainty estimates for use in clinical decision making.

Gifford, Jessica L / Seiden-Long, Isolde

Clinical chemistry and laboratory medicine

2022 Volume 60, Issue 6, Page(s) 851–858

Abstract: ... for paired specimen data by the two platforms was 5.2-6.1 mmol/L assuming no correlation and 2.6-3.1 mmol/L ... AGAP has a 95% confidence interval of ±6.0 mmol/L. When the MU-derived RCV assuming correlation is ... variation contribution of 2.9-3.5 mmol/L to the AGAP observed variation. In contrast, assuming no ...

Abstract	Objectives: We compare measurement uncertainty (MU) calculations to real patient result variation observed by physicians using as our model anion gap (AGAP) sequentially measured on two different instrument types. An approach for discretely quantifying the pre-analytical contributions and validating AGAP MU estimates for interpretation of patient results is proposed. Methods: AGAP was calculated from sodium, chloride, and bicarbonate reported from chemistry or blood gas analyzers which employ different methodologies and specimen types. AGAP MU was calculated using a top-down approach both assuming no correlation between measurands and alternatively, including consideration of measurand correlation. MU-derived reference change values (RCV) were calculated between chemistry and blood gas analyzers results. Observational paired AGAP data (n=39,626 subjects) was obtained from retrospectively analyzed specimens from five urban tertiary care hospitals in Calgary, Alberta, Canada. Results: The MU derived AGAP RCV for paired specimen data by the two platforms was 5.2-6.1 mmol/L assuming no correlation and 2.6-3.1 mmol/L assuming correlation. From the paired chemistry and blood gas data, total observed variation on a reported AGAP has a 95% confidence interval of ±6.0 mmol/L. When the MU-derived RCV assuming correlation is directly compared against the observed distribution of patient results, we obtained a pre-analytical variation contribution of 2.9-3.5 mmol/L to the AGAP observed variation. In contrast, assuming no correlation leads to a negligible pre-analytical contribution (<1.0 mmol/L). Conclusions: MU estimates assuming no correlation are more representative of the total variation seen in real patient data. We present a pragmatic approach for validating an MU calculation to inform clinical decisions and determine the pre-analytical contribution to MU in this system.
MeSH term(s)	Acid-Base Equilibrium ; Clinical Decision-Making ; Humans ; Reference Values ; Retrospective Studies ; Uncertainty
Language	English
Publishing date	2022-04-20
Publishing country	Germany
Document type	Journal Article
ZDB-ID	1418007-8
ISSN	1437-4331 ; 1434-6621 ; 1437-8523
ISSN (online)	1437-4331
ISSN	1434-6621 ; 1437-8523
DOI	10.1515/cclm-2021-1279
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Article ; Online: Not T too! False elevations in high-sensitivity cardiac troponin T (hs-TnT) following specimen transport.

Paul, Heather A / Chi, Qingli / Gifford, Jessica L / Seiden-Long, Isolde

Clinical biochemistry

2022 Volume 115, Page(s) 86–91

Abstract: ... decrease = 9.9 ng/L). Onsite testing or transported aliquots demonstrated no discrepancy. After being kept ...

Abstract	Though false elevations attributed to preanalytical specimen handling have been widely reported for Troponin I (TnI), Troponin T (TnT) has appeared more robust to falsely elevated Tn. We describe reproducible false elevations in high sensitivity TnT (hs-TnT) in specimens after courier transport in plasma separator tubes (PST) off-site for testing. Hs-TnT was measured under 5 different conditions: 1) at collection location (N = 24); 2) after transport upright in racks (N = 66); 3) after transport with no control over tube agitation (N = 69); 4) on transported aliquots (N = 84); or 5) immediately after transport with no control over tube agitation (N = 16), followed by keeping the specimen upright and re-measuring at 1hr, 2hr, 4hr, and 20-24hrs (N = 6). To assess the degree of discrepancy, plasma from the original PST was aliquotted, re-centrifuged, potential debris removed, and hs-TnT re-measured. 43% of PST specimens collected offsite and transported with no control over tube agitation had clinically significant false elevations of hs-TnT which subsequently decreased following aliquotting and re-centrifugation (median decrease = 9.9 ng/L). Onsite testing or transported aliquots demonstrated no discrepancy. After being kept upright, discrepant specimens were not different from re-centrifuged aliquots by 4hrs (p = 0.6141, repeated measures ANOVA with Dunn's multiple comparisons). Clinically significant false elevations of hs-TnT occurred in approximately 40% of separated PSTs that were transported in containers where specimens are transported with no control over tube agitation. This interference does not occur if plasma is aliquoted or if hs-TnT is tested at the collection site. In order to prevent these false elevations, and their potential patient impact on the diagnosis of acute myocardial infarction, specimens for hs-TnT measurement should be aliquoted at the collection location prior to transport.
MeSH term(s)	Humans ; Troponin T ; Biomarkers ; Myocardial Infarction ; Troponin I ; Prognosis
Chemical Substances	Troponin T ; Biomarkers ; Troponin I
Language	English
Publishing date	2022-08-23
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.2022.08.008
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Article ; Online: Negative clinic experiences as a barrier to care for people with HIV and their impact on patient preferences for intervention support: a qualitative study in Cape Town, South Africa.

Killian, Clare / West, Rebecca L / Orrell, Catherine / Gifford, Allen / Haberer, Jessica E / Halim, Nafisa / Jennings, Lauren / Berkowitz, Natacha / Fourie, Stephanie / Sabin, Lora

AIDS care

2024 , Page(s) 1–10

Abstract: We conducted qualitative research among people with HIV (PWH) and care providers in Cape Town, South Africa to understand the impact of negative clinic experiences on adherence and support preferences. In-depth interviews were conducted with 41 patients ... ...

Abstract	We conducted qualitative research among people with HIV (PWH) and care providers in Cape Town, South Africa to understand the impact of negative clinic experiences on adherence and support preferences. In-depth interviews were conducted with 41 patients with an unsuppressed viral load or a treatment gap, and focus group discussions with physicians, nurses, counselors, and community health workers. Questions addressed treatment history and adherence barriers, then participants evaluated evidence-based adherence interventions for potential scale up. Inductive analysis examined care experiences and corresponding preference for intervention options. More than half of PWH described negative experiences during clinic visits, including mistreatment by staff and clinic administration issues, and these statements were corroborated by providers. Those with negative experiences in care stated that fear of mistreatment led to nonadherence. Most patients with negative experiences preferred peer support groups or check-in texts to clinic-based interventions. We found that PWH's negative clinic experiences were a primary reason behind nonadherence and influenced preferences for support mechanisms. These findings emphasize the importance of HIV treatment adherence interventions at multiple levels both in and outside of the clinic, and providing more comprehensive training to providers to better serve PWH in adherence counseling, especially those who are most vulnerable..
Language	English
Publishing date	2024-04-27
Publishing country	England
Document type	Journal Article
ZDB-ID	1012651-x
ISSN	1360-0451 ; 0954-0121
ISSN (online)	1360-0451
ISSN	0954-0121
DOI	10.1080/09540121.2024.2346255
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Article: A high-throughput test for diabetes care: An evaluation of the next generation Roche Cobas c 513 hemoglobin A

Gifford, Jessica L / Higgins, Trefor / Sadrzadeh, S M Hossein

Practical laboratory medicine

2019 Volume 17, Page(s) e00147

Abstract: Objectives: The level of glycated hemoglobin A (HbA: Design and methods: Performance was assessed with regards to imprecision, accuracy, linearity, method comparison against the Roche Cobas Integra 800 CTS, specimen stability, interference from ... ...

Abstract	Objectives: The level of glycated hemoglobin A (HbA Design and methods: Performance was assessed with regards to imprecision, accuracy, linearity, method comparison against the Roche Cobas Integra 800 CTS, specimen stability, interference from common hemoglobin variants and hemoglobin F, and throughput. Results: Within-run and between-run precisions were 0.5-0.7 and 0.8-1.3%CV, respectively. An average bias of -1.6% to proficiency survey samples was observed. The c 513 correlated well with the Integra (slope = 0.94, Conclusions: The c 513 is a precise, accurate, automated high throughput analyzer for measuring HbA
Language	English
Publishing date	2019-11-09
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	2834973-8
ISSN	2352-5517
ISSN	2352-5517
DOI	10.1016/j.plabm.2019.e00147
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Article ; Online: Biotin interference: Underrecognized patient safety risk in laboratory testing.

Gifford, Jessica L / Sadrzadeh, S M Hossein / Naugler, Christopher

Canadian family physician Medecin de famille canadien

2018 Volume 64, Issue 5, Page(s) 370

MeSH term(s)	Biotin/blood ; Diagnostic Errors ; Dietary Supplements ; Humans ; Immunoassay ; Patient Safety ; Streptavidin ; Thyroid Function Tests
Chemical Substances	Biotin (6SO6U10H04) ; Streptavidin (9013-20-1)
Language	English
Publishing date	2018-05-09
Publishing country	Canada
Document type	Journal Article
ZDB-ID	2146676-2
ISSN	1715-5258 ; 0008-350X
ISSN (online)	1715-5258
ISSN	0008-350X
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Article ; Online: Low partial pressure of oxygen causes significant and unrecognized under-recovery of glucose on blood gas analyzers.

Wayne Lewis, Cody / Butorin, Yury / de Koning, Lawrence / Paul, Heather A / Gifford, Jessica L / Venner, Allison A / Seiden-Long, Isolde

Clinical biochemistry

2022

Abstract: ... with an incalculable ("incalc") error code for glucose result or that had a glucose ≥ 20 mmol/L were retested ...

Abstract	Background: Blood gas analyzers employing glucose-oxidase biosensors under-recover glucose when pO Methods: Whole blood specimens were tested by GEM®Premier™ 4000 (GEM 4000) and 5000 (GEM 5000). Specimens with an incalculable ("incalc") error code for glucose result or that had a glucose ≥ 20 mmol/L were retested on a second analyzer of the same type within 5 min over the course of 30 months in 5 hospitals in Calgary, Alberta. Discordant retests were defined as either: 1) paired numeric results with a difference >10 %, or 2) an "incalc" code that yielded a numeric result upon retesting. Glucose recovery in relation to pO Results: Of 1,776 glucose tests repeated on the GEM 5000 or 1,544 on GEM 4000, 10% were discordant. GEM 5000 produced twice as many discordant numeric retests versus the GEM 4000 [5.9% (98/1,651) vs 2.7% (38/1,391)]. The majority of "incalc" error codes repeated with a numeric glucose result on both GEM analyzers [(79.7% (122/153) vs 75.2% (94/125)]. Among specimens experimentally depleted of pO Conclusions: The algorithm in the GEM®Premier
Language	English
Publishing date	2022-10-21
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.2022.10.008
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Article ; Online: Major β cell-specific functions of NKX2.2 are mediated via the NK2-specific domain.

Abarinov, Vladimir / Levine, Joshua A / Churchill, Angela J / Hopwood, Bryce / Deiter, Cailin S / Guney, Michelle A / Wells, Kristen L / Schrunk, Jessica M / Guo, Yuchun / Hammelman, Jennifer / Gifford, David K / Magnuson, Mark A / Wichterle, Hynek / Sussel, Lori

Genes & development

2023 Volume 37, Issue 11-12, Page(s) 490–504

Abstract: The consolidation of unambiguous cell fate commitment relies on the ability of transcription factors (TFs) to exert tissue-specific regulation of complex genetic networks. However, the mechanisms by which TFs establish such precise control over gene ... ...

Abstract	The consolidation of unambiguous cell fate commitment relies on the ability of transcription factors (TFs) to exert tissue-specific regulation of complex genetic networks. However, the mechanisms by which TFs establish such precise control over gene expression have remained elusive-especially in instances in which a single TF operates in two or more discrete cellular systems. In this study, we demonstrate that β cell-specific functions of NKX2.2 are driven by the highly conserved NK2-specific domain (SD). Mutation of the endogenous NKX2.2 SD prevents the developmental progression of β cell precursors into mature, insulin-expressing β cells, resulting in overt neonatal diabetes. Within the adult β cell, the SD stimulates β cell performance through the activation and repression of a subset of NKX2.2-regulated transcripts critical for β cell function. These irregularities in β cell gene expression may be mediated via SD-contingent interactions with components of chromatin remodelers and the nuclear pore complex. However, in stark contrast to these pancreatic phenotypes, the SD is entirely dispensable for the development of NKX2.2-dependent cell types within the CNS. Together, these results reveal a previously undetermined mechanism through which NKX2.2 directs disparate transcriptional programs in the pancreas versus neuroepithelium.
MeSH term(s)	Homeodomain Proteins/genetics ; Homeodomain Proteins/metabolism ; Homeobox Protein Nkx-2.2 ; Transcription Factors/genetics ; Transcription Factors/metabolism ; Insulin-Secreting Cells ; Cell Differentiation ; Zebrafish Proteins/genetics
Chemical Substances	Homeodomain Proteins ; Homeobox Protein Nkx-2.2 ; Transcription Factors ; Zebrafish Proteins
Language	English
Publishing date	2023-06-26
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	806684-x
ISSN	1549-5477 ; 0890-9369
ISSN (online)	1549-5477
ISSN	0890-9369
DOI	10.1101/gad.350569.123
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Article ; Online: Protocol for an evaluation of adherence monitoring and support interventions among people initiating antiretroviral therapy in Cape Town, South Africa-a multiphase optimization strategy (MOST) approach using a fractional factorial design.

Jennings, Lauren / West, Rebecca L / Halim, Nafisa / Kaiser, Jeanette L / Gwadz, Marya / MacLeod, William B / Gifford, Allen L / Haberer, Jessica E / Orrell, Catherine / Sabin, Lora L

Trials

2023 Volume 24, Issue 1, Page(s) 310

Abstract: Background: South Africa bears a large HIV burden with 7.8 million people with HIV (PWH). However, due to suboptimal antiretroviral therapy (ART) adherence and retention in care, only 66% of PWH in South Africa are virally suppressed. Standard care only ...

Abstract	Background: South Africa bears a large HIV burden with 7.8 million people with HIV (PWH). However, due to suboptimal antiretroviral therapy (ART) adherence and retention in care, only 66% of PWH in South Africa are virally suppressed. Standard care only allows for suboptimal adherence detection when routine testing indicates unsuppressed virus. Several adherence interventions are known to improve HIV outcomes, yet few are implemented in routinely due to the resources required. Therefore, determining scalable evidence-based adherence support interventions for resource-limited settings (RLS) is a priority. The multiphase optimization strategy (MOST) framework allows for simultaneous evaluation of multiple intervention components and their interactions. We propose to use MOST to identify the intervention combination with the highest levels of efficacy and cost-effectiveness that is feasible and acceptable in primary care clinics in Cape Town. Methods: We will employ a fractional factorial design to identify the most promising intervention components for inclusion in a multi-component intervention package to be tested in a future randomized controlled trial. We will recruit 512 participants initiating ART between March 2022 and February 2024 in three Cape Town clinics and evaluate acceptability, feasibility, and cost-effectiveness of intervention combinations. Participants will be randomized to one of 16 conditions with different combinations of three adherence monitoring components: rapid outreach following (1) unsuppressed virus, (2) missed pharmacy refill collection, and/or (3) missed doses as detected by an electronic adherence monitoring device; and two adherence support components: (1) weekly check-in texts and (2) enhanced peer support. We will assess viral suppression (<50 copies/mL) at 24 months as the primary outcome; acceptability, feasibility, fidelity, and other implementation outcomes; and cost-effectiveness. We will use logistic regression models to estimate intervention effects with an intention-to-treat approach, employ descriptive statistics to assess implementation outcomes, and determine an optimal intervention package. Discussion: To our knowledge, ours will be the first study to use the MOST framework to determine the most effective combination of HIV adherence monitoring and support intervention components for implementation in clinics in a RLS. Our findings will provide direction for pragmatic, ongoing adherence support that will be key to ending the HIV epidemic. Trial registration: ClinicalTrials.gov NCT05040841. Registered on 10 September 2021.
MeSH term(s)	Humans ; Anti-HIV Agents/therapeutic use ; South Africa/epidemiology ; Anti-Retroviral Agents/therapeutic use ; HIV Infections/diagnosis ; HIV Infections/drug therapy ; HIV Infections/epidemiology ; Medication Adherence ; Randomized Controlled Trials as Topic
Chemical Substances	Anti-HIV Agents ; Anti-Retroviral Agents
Language	English
Publishing date	2023-05-05
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2040523-6
ISSN	1745-6215 ; 1468-6694 ; 1745-6215
ISSN (online)	1745-6215
ISSN	1468-6694 ; 1745-6215
DOI	10.1186/s13063-023-07322-z
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