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Article ; Online: Correspondence on "Cost-effectiveness of exome and genome sequencing for children with rare and undiagnosed conditions" by Lavelle et al.

Grosse, Scott D / Gudgeon, James M

Genetics in medicine : official journal of the American College of Medical Genetics

2022 Volume 24, Issue 12, Page(s) 2595–2596

MeSH term(s)	Child ; Humans ; Exome/genetics ; Cost-Benefit Analysis ; Exome Sequencing ; Sequence Analysis, DNA ; Base Sequence ; Rare Diseases/diagnosis ; Rare Diseases/genetics
Language	English
Publishing date	2022-09-22
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	1455352-1
ISSN	1530-0366 ; 1098-3600
ISSN (online)	1530-0366
ISSN	1098-3600
DOI	10.1016/j.gim.2022.08.030
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Article ; Online: Cost or price of sequencing? Implications for economic evaluations in genomic medicine.

Grosse, Scott D / Gudgeon, James M

Genetics in medicine : official journal of the American College of Medical Genetics

2021 Volume 23, Issue 10, Page(s) 1833–1835

MeSH term(s)	Cost-Benefit Analysis ; Evidence-Based Medicine ; Genomics ; Humans
Language	English
Publishing date	2021-06-10
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	1455352-1
ISSN	1530-0366 ; 1098-3600
ISSN (online)	1530-0366
ISSN	1098-3600
DOI	10.1038/s41436-021-01223-9
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Article ; Online: Model-Based Re-Examination of the Effectiveness of Tumor/Immunohistochemistry and Direct-to-Sequencing Protocols for Lynch Syndrome Case Finding in Endometrial Cancer.

Gudgeon, James M / Varner, Michael W / Hao, Jing / Williams, Marc S

JCO oncology practice

2021 Volume 17, Issue 11, Page(s) e1785–e1793

Abstract: Purpose: Despite widespread provision of Lynch syndrome (LS) screening programs, questions remain about the most effective and efficient protocol for LS case finding. The purpose of this study was to explore the performance of the two protocols widely ... ...

Abstract	Purpose: Despite widespread provision of Lynch syndrome (LS) screening programs, questions remain about the most effective and efficient protocol for LS case finding. The purpose of this study was to explore the performance of the two protocols widely shown to be the most efficient and effective, respectively: immunohistochemical (IHC) staining of tumor and direct-to-sequencing (DtS) in endometrial cancer populations. Methods: Simulation models were developed to explore performance of the IHC and DtS protocols, updated to reflect current evidence. Analyses explicitly account for protocol complexity and failure points, as well as decreased sequencing costs. Key outcomes are percent of LS cases identified, total protocol costs and efficiency, and break-even analyses of sequencing costs. All costs are in 2020 US dollars (USD). Results: Under plausible conditions, the IHC protocol is expected to identify 40%-78% of LS cases and DtS protocol from 49% to 97%. When the key variable Conclusion: This study quantifies the plausible differences in the clinical effectiveness and cost-effectiveness of the two LS case-finding protocols. We demonstrate the large influence of success in proceeding to sequencing and potential impact of decreasing sequencing prices.
MeSH term(s)	Colorectal Neoplasms, Hereditary Nonpolyposis/diagnosis ; Colorectal Neoplasms, Hereditary Nonpolyposis/genetics ; Cost-Benefit Analysis ; Endometrial Neoplasms/diagnosis ; Endometrial Neoplasms/genetics ; Female ; Humans ; Immunohistochemistry ; Mass Screening
Language	English
Publishing date	2021-04-22
Publishing country	United States
Document type	Journal Article
ZDB-ID	3028198-2
ISSN	2688-1535 ; 2688-1527
ISSN (online)	2688-1535
ISSN	2688-1527
DOI	10.1200/OP.20.00988
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Article ; Online: Determination of test performance of two contemporary screening tests for Lynch syndrome in endometrial cancer: A clinical trial.

Gudgeon, James M / Wallentine, Jeremy C / Bonham, Emily M / McLaughlin, Hannah D / Dodson, Mark K

Gynecologic oncology

2021 Volume 164, Issue 1, Page(s) 34–38

Abstract: Background/purpose: Published data on the performance of the immunohistochemistry (IHC) test for mismatch repair (MMR) protein expression to detect Lynch syndrome (LS) index cases suggests it is highly variable; its performance in our system was unknown. ...

Abstract	Background/purpose: Published data on the performance of the immunohistochemistry (IHC) test for mismatch repair (MMR) protein expression to detect Lynch syndrome (LS) index cases suggests it is highly variable; its performance in our system was unknown. Moreover, a brief family history questionnaire (bFHQ) developed by Eiriksson and colleagues in Canada demonstrated 100% sensitivity for LS case identification thus was of interest to us, but its performance outside of its original setting was unknown. Determination of the performance of these tests requires complete LS case identification in the testing population. Methods: Two hundred women were recruited during routine care for endometrial cancer (EC) to administer the bFHQ and perform genetic testing for the LS genes. Independently, the IHC test was performed to screen for presumptive LS cases. We determined the sensitivity, specificity, and positive and negative predictive values of the bFHQ and IHC test as well as simulating outcomes of the complete protocols. Results: Genetic testing all participants identified 8 cases of LS out of 200 (4% prevalence), the bFHQ identified 5 of 8 of these cases (62.5%, CI: 31.5%-87.6%), and the IHC test identified 6 or 7 of 8 cases (mean of 75% or 87.5%) depending on interpretation of test results. The specificities of the bFHQ and IHC test were 56.8% (CI: 49.8%-63.7%) and 79.8% (CI: 73.6%-85.1%), respectively. Conclusions: This study is the first, to our knowledge, to test the effectiveness of the bFHQ in an EC population since its original reporting; our results are consistent with many reports of the challenges of collecting family health history. The performance of the IHC test as a screen falls within ranges reported in the literature but do not provide the confidence to drive a decision for or against continued use of this test as a LS screen.
MeSH term(s)	Adult ; Colorectal Neoplasms, Hereditary Nonpolyposis/complications ; Colorectal Neoplasms, Hereditary Nonpolyposis/diagnosis ; Early Detection of Cancer ; Endometrial Neoplasms/complications ; Female ; Genetic Testing ; Humans ; Immunohistochemistry ; Medical History Taking ; Predictive Value of Tests ; Sensitivity and Specificity ; Surveys and Questionnaires
Language	English
Publishing date	2021-10-21
Publishing country	United States
Document type	Evaluation Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	801461-9
ISSN	1095-6859 ; 0090-8258
ISSN (online)	1095-6859
ISSN	0090-8258
DOI	10.1016/j.ygyno.2021.09.022
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Article ; Online: Is immunohistochemistry-based screening for Lynch syndrome in endometrial cancer effective? The consent's the thing.

Gudgeon, James M / Varner, Michael W / Hashibe, Mia / Williams, Marc S

Gynecologic oncology

2019 Volume 154, Issue 1, Page(s) 131–137

Abstract: Purpose: To investigate the plausible failure rate of the immunohistochemistry (IHC)-based screening protocol to identify Lynch syndrome (LS) index cases among endometrial cancer (EC) patients.: Methods: We developed a simulation model of the IHC ... ...

Abstract	Purpose: To investigate the plausible failure rate of the immunohistochemistry (IHC)-based screening protocol to identify Lynch syndrome (LS) index cases among endometrial cancer (EC) patients. Methods: We developed a simulation model of the IHC protocol in this context. The model was populated from systematic and focused reviews, augmented with local data and expert opinion. The virtual cohort represents the number of women expected to be diagnosed with EC in the U.S. in 2018. The outcomes include protocol failure rates and LS cases missed in a variety of hypothetical scenarios. Results: The best estimate of failure rate of the IHC protocol is 58%; minimum and maximum estimates are 33% and 80%, respectively. These failure rates are driven primarily by the high rates of failure to obtain consent from patients for sequencing (25% to 80%). The multiple imperfect tests and potential failure points in this protocol, collectively, make up 7% to 20% of the total failure rate. When consent for sequencing was fixed in the model at 25%, 50%, and 80%; the expected ranges for index case identification failure are 78%-82%, 57%-64%, and 29%-42%, respectively. Conclusion: The primary driver of failure to identify index cases remains consent for sequencing. Consent rates have shown little improvement since LS screening programs were instituted in the U.S., leaving us to conclude these high failure rates are resistant to substantial improvement. These missed opportunities will be magnified because cascade screening for carrier status among family members will not be pursued.
MeSH term(s)	Cohort Studies ; Colorectal Neoplasms, Hereditary Nonpolyposis/diagnosis ; Colorectal Neoplasms, Hereditary Nonpolyposis/metabolism ; Computer Simulation ; Early Detection of Cancer/methods ; Female ; Humans ; Immunohistochemistry/methods ; Models, Statistical ; Systematic Reviews as Topic
Language	English
Publishing date	2019-05-23
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	801461-9
ISSN	1095-6859 ; 0090-8258
ISSN (online)	1095-6859
ISSN	0090-8258
DOI	10.1016/j.ygyno.2019.05.006
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Article ; Online: Canagliflozin impairs T cell effector function via metabolic suppression in autoimmunity.

Cell metabolism

2023 Volume 35, Issue 7, Page(s) 1132–1146.e9

Abstract: Augmented T cell function leading to host damage in autoimmunity is supported by metabolic dysregulation, making targeting immunometabolism an attractive therapeutic avenue. Canagliflozin, a type 2 diabetes drug, is a sodium glucose co-transporter 2 ( ... ...

Abstract	Augmented T cell function leading to host damage in autoimmunity is supported by metabolic dysregulation, making targeting immunometabolism an attractive therapeutic avenue. Canagliflozin, a type 2 diabetes drug, is a sodium glucose co-transporter 2 (SGLT2) inhibitor with known off-target effects on glutamate dehydrogenase and complex I. However, the effects of SGLT2 inhibitors on human T cell function have not been extensively explored. Here, we show that canagliflozin-treated T cells are compromised in their ability to activate, proliferate, and initiate effector functions. Canagliflozin inhibits T cell receptor signaling, impacting on ERK and mTORC1 activity, concomitantly associated with reduced c-Myc. Compromised c-Myc levels were encapsulated by a failure to engage translational machinery resulting in impaired metabolic protein and solute carrier production among others. Importantly, canagliflozin-treated T cells derived from patients with autoimmune disorders impaired their effector function. Taken together, our work highlights a potential therapeutic avenue for repurposing canagliflozin as an intervention for T cell-mediated autoimmunity.
MeSH term(s)	Humans ; Canagliflozin/pharmacology ; Canagliflozin/therapeutic use ; Diabetes Mellitus, Type 2/drug therapy ; Autoimmunity ; T-Lymphocytes ; Sodium-Glucose Transporter 2 Inhibitors/therapeutic use ; Autoimmune Diseases/drug therapy ; Hypoglycemic Agents/pharmacology
Chemical Substances	Canagliflozin (0SAC974Z85) ; Sodium-Glucose Transporter 2 Inhibitors ; Hypoglycemic Agents
Language	English
Publishing date	2023-05-24
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2176834-1
ISSN	1932-7420 ; 1550-4131
ISSN (online)	1932-7420
ISSN	1550-4131
DOI	10.1016/j.cmet.2023.05.001
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Article: Economic Evaluation of Universal Lynch Syndrome Screening Protocols among Newly Diagnosed Patients with Colorectal Cancer.

Hao, Jing / Hassen, Dina / Gudgeon, James M / Snyder, Susan R / Hampel, Heather / Williams, Marc S / Sharaf, Ravi N / Lu, Christine Y / Williams, Janet L / Schlieder, Victoria / Rahm, Alanna Kulchak

Journal of personalized medicine

2021 Volume 11, Issue 12

Abstract: We conducted an updated economic evaluation, from a healthcare system perspective, to compare the relative effectiveness and efficiency of eight Lynch syndrome (LS) screening protocols among newly diagnosed colorectal cancer (CRC) patients. We developed ... ...

Abstract	We conducted an updated economic evaluation, from a healthcare system perspective, to compare the relative effectiveness and efficiency of eight Lynch syndrome (LS) screening protocols among newly diagnosed colorectal cancer (CRC) patients. We developed decision analytic models for a hypothetical cohort of 1000 patients. Model assumptions and parameter values were based on literature and expert opinion. All costs were in 2018 USD. For identifying LS cases, the direct germline sequencing (DGS) protocol provided the best performance (sensitivity 99.90%, 99.57-99.93%; specificity 99.50%, 97.28-99.85%), followed by the tumor sequencing to germline sequencing (TSGS) protocol (sensitivity, 99.42%, 96.55-99.63%; specificity, 96.58%, 96.46-96.60%). The immunohistochemistry (IHC) protocol was most efficient at $20,082 per LS case identified, compared to microsatellite instability (MSI) ($22,988), DGS ($31,365), and TSGS ($104,394) protocols. Adding double-somatic testing to IHC and MSI protocols did not change sensitivity and specificity, increased costs by 6% and 3.5%, respectively, but reduced unexplained cases by 70% and 50%, respectively. DGS would be as efficient as the IHC protocol when the cost of germline sequencing declines under $368 indicating DGS could be an efficient option in the near future. Until then, IHC and MSI protocols with double-somatic testing would be the optimal choices.
Language	English
Publishing date	2021-12-02
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2662248-8
ISSN	2075-4426
ISSN	2075-4426
DOI	10.3390/jpm11121284
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Article ; Online: Economic Evaluation of Universal Lynch Syndrome Screening Protocols among Newly Diagnosed Patients with Colorectal Cancer

Jing Hao / Dina Hassen / James M. Gudgeon / Susan R. Snyder / Heather Hampel / Marc S. Williams / Ravi N. Sharaf / Christine Y. Lu / Janet L. Williams / Victoria Schlieder / Alanna Kulchak Rahm

Journal of Personalized Medicine, Vol 11, Iss 1284, p

2021 Volume 1284

Abstract	We conducted an updated economic evaluation, from a healthcare system perspective, to compare the relative effectiveness and efficiency of eight Lynch syndrome (LS) screening protocols among newly diagnosed colorectal cancer (CRC) patients. We developed decision analytic models for a hypothetical cohort of 1000 patients. Model assumptions and parameter values were based on literature and expert opinion. All costs were in 2018 USD. For identifying LS cases, the direct germline sequencing (DGS) protocol provided the best performance (sensitivity 99.90%, 99.57–99.93%; specificity 99.50%, 97.28–99.85%), followed by the tumor sequencing to germline sequencing (TSGS) protocol (sensitivity, 99.42%, 96.55–99.63%; specificity, 96.58%, 96.46–96.60%). The immunohistochemistry (IHC) protocol was most efficient at $20,082 per LS case identified, compared to microsatellite instability (MSI) ($22,988), DGS ($31,365), and TSGS ($104,394) protocols. Adding double-somatic testing to IHC and MSI protocols did not change sensitivity and specificity, increased costs by 6% and 3.5%, respectively, but reduced unexplained cases by 70% and 50%, respectively. DGS would be as efficient as the IHC protocol when the cost of germline sequencing declines under $368 indicating DGS could be an efficient option in the near future. Until then, IHC and MSI protocols with double-somatic testing would be the optimal choices.
Keywords	decision analysis ; economic evaluation ; Lynch syndrome screening ; colorectal cancer ; Medicine ; R
Subject code	610
Language	English
Publishing date	2021-12-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
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Article ; Online: Impact of age cutoffs on a lynch syndrome screening program.

Gudgeon, James M / Belnap, Thomas W / Williams, Janet L / Williams, Marc S

Journal of oncology practice

2012 Volume 9, Issue 4, Page(s) 175–179

Abstract: Purpose: To determine the impact of applying an age cutoff to tumor-based Lynch syndrome (LS) screening, specifically focusing on changes in relative effectiveness, efficiency, and cost. The project was undertaken to answer questions about ... ...

Abstract	Purpose: To determine the impact of applying an age cutoff to tumor-based Lynch syndrome (LS) screening, specifically focusing on changes in relative effectiveness, efficiency, and cost. The project was undertaken to answer questions about implementation of the LS screening program in an integrated health care delivery system. Patients and methods: Clinical data extracted from an internal cancer registry, previous modeling efforts, published literature, and gray data were used to populate decision models designed to answer questions about the impact of age cutoffs in LS screening. Patients with colorectal cancer (CRC) were stratified at 10-year intervals from ages 50 to 80 years and compared with no age cutoff. Outcomes are reported for a cohort of 325 patients screened and includes total cost to screen, LS cases present in the cutoff category, number of LS cases expected to be identified by screening, cost per LS case detected, and total number and percentage of LS cases missed. Conclusion: Applying an age cutoff to an LS screening program has considerable potential for decreasing total screening costs and increasing efficiency, but at a loss of effectiveness. Imposing an age cutoff of 50 years reduces the cost of the screening program to 16% of a program with no age cutoff, but at the expense of missing more than half of the cases. Failure to identify LS cases is magnified by a cascade effect in family members. The results of this analysis influenced the final policy in our system.
MeSH term(s)	Adult ; Age Factors ; Aged ; Colorectal Neoplasms, Hereditary Nonpolyposis/diagnosis ; Colorectal Neoplasms, Hereditary Nonpolyposis/epidemiology ; Early Detection of Cancer ; Genetic Testing/economics ; Genetic Testing/methods ; Humans ; Mass Screening ; Middle Aged ; Prevalence ; Sensitivity and Specificity
Language	English
Publishing date	2012-11-13
Publishing country	United States
Document type	Journal Article
ZDB-ID	2236338-5
ISSN	1935-469X ; 1554-7477
ISSN (online)	1935-469X
ISSN	1554-7477
DOI	10.1200/JOP.2012.000573
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Article ; Online: Simultaneous multiple interaction T-cell engaging (SMITE) bispecific antibodies overcome bispecific T-cell engager (BiTE) resistance via CD28 co-stimulation.

Correnti, Colin E / Laszlo, George S / de van der Schueren, Willem J / Godwin, Colin D / Bandaranayake, Ashok / Busch, Melanie A / Gudgeon, Chelsea J / Bates, Olivia M / Olson, James M / Mehlin, Christopher / Walter, Roland B

Leukemia

2018 Volume 32, Issue 5, Page(s) 1239–1243

MeSH term(s)	Antibodies, Bispecific/pharmacology ; Antibodies, Bispecific/therapeutic use ; CD28 Antigens/metabolism ; CD3 Complex/metabolism ; Cell Line ; Costimulatory and Inhibitory T-Cell Receptors ; Drug Resistance ; Humans ; Immunotherapy, Adoptive/methods ; Lymphocyte Activation/immunology ; Neoplasms/drug therapy ; Neoplasms/immunology ; T-Lymphocytes/immunology
Chemical Substances	Antibodies, Bispecific ; CD28 Antigens ; CD3 Complex ; Costimulatory and Inhibitory T-Cell Receptors ; blinatumomab (4FR53SIF3A)
Language	English
Publishing date	2018-01-31
Publishing country	England
Document type	Letter ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	807030-1
ISSN	1476-5551 ; 0887-6924
ISSN (online)	1476-5551
ISSN	0887-6924
DOI	10.1038/s41375-018-0014-3
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