Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy

for the IGNITE Pharmacogenetics Working Group

doi:10.1111/cts.13154

Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy

for the IGNITE Pharmacogenetics Working Group

Research output: Contribution to journal › Article › peer-review

4 Scopus citations

Abstract

There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management.

Original language	English (US)
Pages (from-to)	371-383
Number of pages	13
Journal	Clinical and translational science
Volume	15
Issue number	2
DOIs	https://doi.org/10.1111/cts.13154
State	Published - Feb 2022

Bibliographical note

Funding Information:
This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, and U01 HG010245, and by the NIH IGNITE Network ( https://gmkb.org/ignite/ ). Additional funding was provided by K23HL143161 and the Penn Center for Precision Medicine for ST; Indiana University Precision Health Initiative for E.R. and T.C.S.; Propeller Health, American Lung Association for K.B.; NIH for K.B., B.Q.D., and L.B.R.; K24HL133373 for N.A.L.; U01HG007775 for A.L.B.; U54TR001857 and the Pitt/UPMC Institute for Precision Medicine for P.E.E.; Agency for Healthcare Research and Quality (AHRQ) and Patient‐Centered Outcomes Research Institute (PCORI) K12HS026379, NIH/NCATS KL2TR002492 for P.M.; NIH/NCATS UL1TR001427 for L.H.C. The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, PCORI, Minnesota Learning Health System Mentored Career Development Program (MN‐LHS), or the National Institutes of Health.

Funding Information:
This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, and U01 HG010245, and by the NIH IGNITE Network (https://gmkb.org/ignite/). Additional funding was provided by K23HL143161 and the Penn Center for Precision Medicine for ST; Indiana University Precision Health Initiative for E.R. and T.C.S.; Propeller Health, American Lung Association for K.B.; NIH for K.B., B.Q.D., and L.B.R.; K24HL133373 for N.A.L.; U01HG007775 for A.L.B.; U54TR001857 and the Pitt/UPMC Institute for Precision Medicine for P.E.E.; Agency for Healthcare Research and Quality (AHRQ) and Patient-Centered Outcomes Research Institute (PCORI) K12HS026379, NIH/NCATS KL2TR002492 for P.M.; NIH/NCATS UL1TR001427 for L.H.C. The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, PCORI, Minnesota Learning Health System Mentored Career Development Program (MN-LHS), or the National Institutes of Health. The authors would like to acknowledge the following for assistance in completion of the surveys: Emily Cicali from the University of Florida; the Pharmacogenomics Implementation Committee Colorado (PICColo) Evaluation Working Group at the University of Colorado; Whitney Mason and Joy Thomas from Intermountain Precision Genomics; April Schultz from Sanford Health Imagenetics; Cindy Prows from the University of Cincinnati; and Michelle Liu and Bart Roland from Vanderbilt University Medical Center.

Funding Information:
D.M.S. has institution‐associated research funding from Kailos Genetics. P.E.E. performs consulting at Cipherome. S.M.S. has a consulting/advisory or non‐promotional speaking role from Exact Sciences (Genomic Health), Genentech/Roche, Daiichi Sankyo, Athenex, Natura, and Silverback Therapeutics, IDMC from AstraZeneca, support for third party writing assistance from Genentech/Roche, and institution‐associated research funding from Genentech and Kailos Genetics. L.B.R. receives research funding from BTG, Intl. All other authors declared no competing interests for this work.

Publisher Copyright:
© 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.

PubMed: MeSH publication types

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, P.H.S.

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10.1111/cts.13154

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@article{c6ccb132c1264cb584ce14d933c792ce,

title = "Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy",

abstract = "There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management.",

author = "{for the IGNITE Pharmacogenetics Working Group} and Sony Tuteja and Salloum, {Ramzi G.} and Elchynski, {Amanda L.} and Smith, {D. Max} and Elizabeth Rowe and Blake, {Kathryn V.} and Limdi, {Nita A.} and Aquilante, {Christina L.} and Jill Bates and Beitelshees, {Amber L.} and Amber Cipriani and Duong, {Benjamin Q.} and Empey, {Philip E.} and Formea, {Christine M.} and Hicks, {J. Kevin} and Pawel Mroz and David Oslin and Pasternak, {Amy L.} and Natasha Petry and Ramsey, {Laura B.} and Allyson Schlichte and Swain, {Sandra M.} and Ward, {Kristen M.} and Kristin Wiisanen and Skaar, {Todd C.} and {Van Driest}, {Sara L.} and Cavallari, {Larisa H.} and Bishop, {Jeffrey R.}",

note = "Funding Information: This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, and U01 HG010245, and by the NIH IGNITE Network ( https://gmkb.org/ignite/ ). Additional funding was provided by K23HL143161 and the Penn Center for Precision Medicine for ST; Indiana University Precision Health Initiative for E.R. and T.C.S.; Propeller Health, American Lung Association for K.B.; NIH for K.B., B.Q.D., and L.B.R.; K24HL133373 for N.A.L.; U01HG007775 for A.L.B.; U54TR001857 and the Pitt/UPMC Institute for Precision Medicine for P.E.E.; Agency for Healthcare Research and Quality (AHRQ) and Patient‐Centered Outcomes Research Institute (PCORI) K12HS026379, NIH/NCATS KL2TR002492 for P.M.; NIH/NCATS UL1TR001427 for L.H.C. The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, PCORI, Minnesota Learning Health System Mentored Career Development Program (MN‐LHS), or the National Institutes of Health. Funding Information: This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, and U01 HG010245, and by the NIH IGNITE Network (https://gmkb.org/ignite/). Additional funding was provided by K23HL143161 and the Penn Center for Precision Medicine for ST; Indiana University Precision Health Initiative for E.R. and T.C.S.; Propeller Health, American Lung Association for K.B.; NIH for K.B., B.Q.D., and L.B.R.; K24HL133373 for N.A.L.; U01HG007775 for A.L.B.; U54TR001857 and the Pitt/UPMC Institute for Precision Medicine for P.E.E.; Agency for Healthcare Research and Quality (AHRQ) and Patient-Centered Outcomes Research Institute (PCORI) K12HS026379, NIH/NCATS KL2TR002492 for P.M.; NIH/NCATS UL1TR001427 for L.H.C. The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, PCORI, Minnesota Learning Health System Mentored Career Development Program (MN-LHS), or the National Institutes of Health. The authors would like to acknowledge the following for assistance in completion of the surveys: Emily Cicali from the University of Florida; the Pharmacogenomics Implementation Committee Colorado (PICColo) Evaluation Working Group at the University of Colorado; Whitney Mason and Joy Thomas from Intermountain Precision Genomics; April Schultz from Sanford Health Imagenetics; Cindy Prows from the University of Cincinnati; and Michelle Liu and Bart Roland from Vanderbilt University Medical Center. Funding Information: D.M.S. has institution‐associated research funding from Kailos Genetics. P.E.E. performs consulting at Cipherome. S.M.S. has a consulting/advisory or non‐promotional speaking role from Exact Sciences (Genomic Health), Genentech/Roche, Daiichi Sankyo, Athenex, Natura, and Silverback Therapeutics, IDMC from AstraZeneca, support for third party writing assistance from Genentech/Roche, and institution‐associated research funding from Genentech and Kailos Genetics. L.B.R. receives research funding from BTG, Intl. All other authors declared no competing interests for this work. Publisher Copyright: {\textcopyright} 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.",

year = "2022",

month = feb,

doi = "10.1111/cts.13154",

language = "English (US)",

volume = "15",

pages = "371--383",

journal = "Clinical and Translational Science",

issn = "1752-8054",

publisher = "Wiley-Blackwell",

number = "2",

}

TY - JOUR

T1 - Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy

AU - for the IGNITE Pharmacogenetics Working Group

AU - Tuteja, Sony

AU - Salloum, Ramzi G.

AU - Elchynski, Amanda L.

AU - Smith, D. Max

AU - Rowe, Elizabeth

AU - Blake, Kathryn V.

AU - Limdi, Nita A.

AU - Aquilante, Christina L.

AU - Bates, Jill

AU - Beitelshees, Amber L.

AU - Cipriani, Amber

AU - Duong, Benjamin Q.

AU - Empey, Philip E.

AU - Formea, Christine M.

AU - Hicks, J. Kevin

AU - Mroz, Pawel

AU - Oslin, David

AU - Pasternak, Amy L.

AU - Petry, Natasha

AU - Ramsey, Laura B.

AU - Schlichte, Allyson

AU - Swain, Sandra M.

AU - Ward, Kristen M.

AU - Wiisanen, Kristin

AU - Skaar, Todd C.

AU - Van Driest, Sara L.

AU - Cavallari, Larisa H.

AU - Bishop, Jeffrey R.

N1 - Funding Information: This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, and U01 HG010245, and by the NIH IGNITE Network ( https://gmkb.org/ignite/ ). Additional funding was provided by K23HL143161 and the Penn Center for Precision Medicine for ST; Indiana University Precision Health Initiative for E.R. and T.C.S.; Propeller Health, American Lung Association for K.B.; NIH for K.B., B.Q.D., and L.B.R.; K24HL133373 for N.A.L.; U01HG007775 for A.L.B.; U54TR001857 and the Pitt/UPMC Institute for Precision Medicine for P.E.E.; Agency for Healthcare Research and Quality (AHRQ) and Patient‐Centered Outcomes Research Institute (PCORI) K12HS026379, NIH/NCATS KL2TR002492 for P.M.; NIH/NCATS UL1TR001427 for L.H.C. The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, PCORI, Minnesota Learning Health System Mentored Career Development Program (MN‐LHS), or the National Institutes of Health. Funding Information: This work was supported by grants from the National Institutes of Health (U01 HG007269, U01 HG010232, and U01 HG010245, and by the NIH IGNITE Network (https://gmkb.org/ignite/). Additional funding was provided by K23HL143161 and the Penn Center for Precision Medicine for ST; Indiana University Precision Health Initiative for E.R. and T.C.S.; Propeller Health, American Lung Association for K.B.; NIH for K.B., B.Q.D., and L.B.R.; K24HL133373 for N.A.L.; U01HG007775 for A.L.B.; U54TR001857 and the Pitt/UPMC Institute for Precision Medicine for P.E.E.; Agency for Healthcare Research and Quality (AHRQ) and Patient-Centered Outcomes Research Institute (PCORI) K12HS026379, NIH/NCATS KL2TR002492 for P.M.; NIH/NCATS UL1TR001427 for L.H.C. The content is solely the responsibility of the authors and does not necessarily represent the official views of AHRQ, PCORI, Minnesota Learning Health System Mentored Career Development Program (MN-LHS), or the National Institutes of Health. The authors would like to acknowledge the following for assistance in completion of the surveys: Emily Cicali from the University of Florida; the Pharmacogenomics Implementation Committee Colorado (PICColo) Evaluation Working Group at the University of Colorado; Whitney Mason and Joy Thomas from Intermountain Precision Genomics; April Schultz from Sanford Health Imagenetics; Cindy Prows from the University of Cincinnati; and Michelle Liu and Bart Roland from Vanderbilt University Medical Center. Funding Information: D.M.S. has institution‐associated research funding from Kailos Genetics. P.E.E. performs consulting at Cipherome. S.M.S. has a consulting/advisory or non‐promotional speaking role from Exact Sciences (Genomic Health), Genentech/Roche, Daiichi Sankyo, Athenex, Natura, and Silverback Therapeutics, IDMC from AstraZeneca, support for third party writing assistance from Genentech/Roche, and institution‐associated research funding from Genentech and Kailos Genetics. L.B.R. receives research funding from BTG, Intl. All other authors declared no competing interests for this work. Publisher Copyright: © 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.

PY - 2022/2

Y1 - 2022/2

N2 - There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management.

AB - There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management.

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JO - Clinical and Translational Science

JF - Clinical and Translational Science

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ER -

Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy

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