Browsing by Author "Petry, Natasha"

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    Best-worst scaling methodology to evaluate constructs of the Consolidated Framework for Implementation Research: application to the implementation of pharmacogenetic testing for antidepressant therapy.
    (BMC, 2022-05-14) Salloum, Ramzi G.; Bishop, Jeffrey R.; Elchynski, Amanda L.; Smith, D. Max; Rowe, Elizabeth; Blake, Kathryn V.; Limdi, Nita A.; Aquilante, Christina L.; Bates, Jill; Beitelshees, Amber L.; Cipriani, Amber; Duong, Benjamin Q.; Empey, Philip E.; Formea, Christine M.; Hicks, J. Kevin; Mroz, Pawel; Oslin, David; Pasternak, Amy L.; Petry, Natasha; Ramsey, Laura B.; Schlichte, Allyson; Swain, Sandra M.; Ward, Kristen M.; Wiisanen, Kristin; Skaar, Todd C.; Van Driest, Sara L.; Cavallari, Larisa H.; Tuteja, Sony
    BACKGROUND: Despite the increased demand for pharmacogenetic (PGx) testing to guide antidepressant use, little is known about how to implement testing in clinical practice. Best-worst scaling (BWS) is a stated preferences technique for determining the relative importance of alternative scenarios and is increasingly being used as a healthcare assessment tool, with potential applications in implementation research. We conducted a BWS experiment to evaluate the relative importance of implementation factors for PGx testing to guide antidepressant use. METHODS: We surveyed 17 healthcare organizations that either had implemented or were in the process of implementing PGx testing for antidepressants. The survey included a BWS experiment to evaluate the relative importance of Consolidated Framework for Implementation Research (CFIR) constructs from the perspective of implementing sites. RESULTS: Participating sites varied on their PGx testing platform and methods for returning recommendations to providers and patients, but they were consistent in ranking several CFIR constructs as most important for implementation: patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and identification of champions. CONCLUSIONS: This study demonstrates the feasibility of using choice experiments to systematically evaluate the relative importance of implementation determinants from the perspective of implementing organizations. BWS findings can inform other organizations interested in implementing PGx testing for mental health. Further, this study demonstrates the application of BWS to PGx, the findings of which may be used by other organizations to inform implementation of PGx testing for mental health disorders.
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    Multi-site investigation of strategies for the implementation of CYP2C19 genotype-guided antiplatelet therapy
    (Wiley, 2018) Empey, Philip E.; Stevenson, James M.; Tuteja, Sony; Weitzel, Kristin W.; Angiolillo, Dominick J.; Beitelshees, Amber L.; Coons, James C.; Duarte, Julio D.; Franchi, Francesco; Jeng, Linda J. B.; Johnson, Julie A.; Kreutz, Rolf P.; Limdi, Nita A.; Maloney, Kristin A.; Obeng, Aniwaa Owusu; Peterson, Josh F.; Petry, Natasha; Pratt, Victoria M.; Rollini, Fabiana; Scott, Stuart A.; Skaar, Todd C.; Vesely, Mark R.; Stouffer, George A.; Wilke, Russell A.; Cavallari, Larisa H.; Lee, Craig R.; Medicine, School of Medicine
    CYP2C19 genotype-guided antiplatelet therapy following percutaneous coronary intervention is increasingly implemented in clinical practice. However, challenges such as selecting a testing platform, communicating test results, building clinical decision support processes, providing patient and provider education, and integrating methods to support the translation of emerging evidence to clinical practice are barriers to broad adoption. In this report, we compare and contrast implementation strategies of 12 early adopters, describing solutions to common problems and initial performance metrics for each program. Key differences between programs included the test result turnaround time and timing of therapy changes which are both related to CYP2C19 testing model and platform used. Sites reported the need for new informatics infrastructure, expert clinicians such as pharmacists to interpret results, physician champions, and ongoing education. Consensus lessons learned are presented to provide a path forward for those seeking to implement similar clinical pharmacogenomics programs within their institutions. This article is protected by copyright.
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    Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy.
    (Wiley, 2022-02) Tuteja, Sony; Salloum, Ramzi G.; Elchynski, Amanda L.; Smith, D. Max; Rowe, Elizabeth; Blake, Kathryn V.; Limdi, Nita A.; Aquilante, Christina L.; Bates, Jill; Beitelshees, Amber L.; Cipriani, Amber; Duong, Benjamin Q.; Empey, Philip E.; Formea, Christine M.; Hicks, J. Kevin; Mroz, Pawel; Oslin, David; Pasternak, Amy L.; Petry, Natasha; Ramsey, Allyson; Swain, Sandra M.; Ward, Kristen M.; Wiisanen, Kristin; Skaar, Todd C.; Van Driest, Sara L.; Cavallari, Larisa H.; Bishop, Jeffrey R.
    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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    Multisite Investigation of Strategies for the Implementation of CYP2C19 Genotype-Guided Antiplatelet Therapy
    (Wiley, 2018-10) Empey, Philip E.; Stevenson, James M.; Tuteja, Sony; Weitzel, Kristin W.; Angiolillo, Dominick J.; Beitelshees, Amber L.; Coons, James C.; Duarte, Julio D.; Franchi, Francesco; Jeng, Linda J.B.; Johnson, Julie A.; Kreutz, Rolf P.; Limdi, Nita A.; Maloney, Kristin A.; Obeng, Aniwaa Owusu; Peterson, Josh F.; Petry, Natasha; Pratt, Victoria M.; Rollini, Fabiana; Scott, Stuart A.; Skaar, Todd C.; Vesely, Mark R.; Stouffer, George A.; Wilke, Russell A.; Cavallari, Larisa H.; Lee, Craig R.; IGNITE Network; Medicine, School of Medicine
    CYP2C19 genotype-guided antiplatelet therapy following percutaneous coronary intervention is increasingly implemented in clinical practice. However, challenges such as selecting a testing platform, communicating test results, building clinical decision support processes, providing patient and provider education, and integrating methods to support the translation of emerging evidence to clinical practice are barriers to broad adoption. In this report, we compare and contrast implementation strategies of 12 early adopters, describing solutions to common problems and initial performance metrics for each program. Key differences between programs included the test result turnaround time and timing of therapy changes, which are both related to the CYP2C19 testing model and platform used. Sites reported the need for new informatics infrastructure, expert clinicians such as pharmacists to interpret results, physician champions, and ongoing education. Consensus lessons learned are presented to provide a path forward for those seeking to implement similar clinical pharmacogenomics programs within their institutions
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    Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression
    (Wiley, 2024) Hines, Lindsay J.; Wilke, Russell A.; Myers, Rachel; Mathews, Carol A.; Liu, Michelle; Baye, Jordan F.; Petry, Natasha; Cicali, Emily J.; Duong, Benjamin Q.; Elwood, Erica; Hulvershorn, Leslie; Nguyen, Khoa; Ramos, Michelle; Sadeghpour, Azita; Wu, R. Ryanne; Williamson, Lloyda; Wiisanen, Kristin; Voora, Deepak; Singh, Rajbir; Blake, Kathryn V.; Murrough, James W.; Volpi, Simona; Ginsburg, Geoffrey S.; Horowitz, Carol R.; Orlando, Lori; Chakraborty, Hrishikesh; Dexter, Paul; Johnson, Julie A.; Skaar, Todd C.; Cavallari, Larisa H.; Van Driest, Sara L.; Peterson, Josh F.; IGNITE Pragmatic Trials Network; Psychiatry, School of Medicine
    Specific selective serotonin reuptake inhibitors (SSRIs) metabolism is strongly influenced by two pharmacogenes, CYP2D6 and CYP2C19. However, the effectiveness of prospectively using pharmacogenetic variants to select or dose SSRIs for depression is uncertain in routine clinical practice. The objective of this prospective, multicenter, pragmatic randomized controlled trial is to determine the effectiveness of genotype-guided selection and dosing of antidepressants on control of depression in participants who are 8 years or older with ≥3 months of depressive symptoms who require new or revised therapy. Those randomized to the intervention arm undergo pharmacogenetic testing at baseline and receive a pharmacy consult and/or automated clinical decision support intervention based on an actionable phenotype, while those randomized to the control arm have pharmacogenetic testing at the end of 6-months. In both groups, depression and drug tolerability outcomes are assessed at baseline, 1 month, 3 months (primary), and 6 months. The primary end point is defined by change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression score assessed at 3 months versus baseline. Secondary end points include change inpatient health questionnaire (PHQ-8) measure of depression severity, remission rates defined by PROMIS score < 16, medication adherence, and medication side effects. The primary analysis will compare the PROMIS score difference between trial arms among those with an actionable CYP2D6 or CYP2C19 genetic result or a CYP2D6 drug-drug interaction. The trial has completed accrual of 1461 participants, of which 562 were found to have an actionable phenotype to date, and follow-up will be complete in April of 2024.
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    The Pharmacogenomics Global Research Network Implementation Working Group: global collaboration to advance pharmacogenetic implementation
    (Wolters Kluwer, 2025) Cavallari, Larisa H.; Hicks, J. Kevin; Patel, Jai N.; Elchynski, Amanda L.; Smith, D. Max; Bargal, Salma A.; Fleck, Ashley; Aquilante, Christina L.; Killam, Shayna R.; Lemke, Lauren; Ochi, Taichi; Ramsey, Laura B.; Haidar, Cyrine E.; Ho, Teresa; El Rouby, Nihal; Monte, Andrew A.; Allen, Josiah D.; Beitelshees, Amber L.; Bishop, Jeffrey R.; Bousman, Chad; Campbell, Ronald; Cicali, Emily J.; Cook, Kelsey J.; Duong, Benjamin; Tsermpini, Evangelia Eirini; Girdwood, Sonya Tang; Gregornik, David B.; Grimsrud, Kristin N.; Lamb, Nathan; Lee, James C.; Lopez, Rocio Ortiz; Mazhindu, Tinashe Adrian; Morris, Sarah A.; Nagy, Mohamed; Nguyen, Jenny; Pasternak, Amy L.; Petry, Natasha; van Schaik, Ron H. N.; Schultz, April; Skaar, Todd C.; Al Alshaykh, Hana; Stevenson, James M.; Stone, Rachael M.; Tran, Nam K.; Tuteja, Sony; Woodahl, Erica L.; Yuan, Li-Chi; Lee, Craig R.; Medicine, School of Medicine
    Pharmacogenetics promises to optimize treatment-related outcomes by informing optimal drug selection and dosing based on an individual's genotype in conjunction with other important clinical factors. Despite significant evidence of genetic associations with drug response, pharmacogenetic testing has not been widely implemented into clinical practice. Among the barriers to broad implementation are limited guidance for how to successfully integrate testing into clinical workflows and limited data on outcomes with pharmacogenetic implementation in clinical practice. The Pharmacogenomics Global Research Network Implementation Working Group seeks to engage institutions globally that have implemented pharmacogenetic testing into clinical practice or are in the process or planning stages of implementing testing to collectively disseminate data on implementation strategies, metrics, and health-related outcomes with the use of genotype-guided drug therapy to ultimately help advance pharmacogenetic implementation. This paper describes the goals, structure, and initial projects of the group in addition to implementation priorities across sites and future collaborative opportunities.