Implementing a pragmatic clinical trial to tailor opioids for chronic pain on behalf of the IGNITE ADOPT PGx investigators

Skaar TC, Myers RA, Fillingim RB, Callaghan JT, Cicali E, Eadon MT, Elwood EN, Ginsburg GS, Lynch S, Nguyen KA, Obeng AO, Park H, Pratt VM, Rosenman M, Sadeghpour A, Shuman S, Singh R, Tillman EM, Volpi S, Wiisanen K, Winterstein AG, Horowitz CR, Voora D, Orlando L, Chakraborty H, Van Driest S, Peterson JF, Cavallari LA, Johnson JA, Dexter PR

  • DOI: 10.1111/cts.70005

Rationale and design for a pragmatic randomized trial to assess gene-based prescribing for SSRIs in the treatment of depression

Hines LJ, Wilke RA, Myers R, Mathews CA, Liu M, Baye JF, Petry N, Cicali EJ, Duong BQ, Elwood E, Hulvershorn L, Nguyen K, Ramos M, Sadeghpour A, Wu RR, Williamson L, Wiisanen K, Voora D, Singh R, Blake KV, Murrough JW, Volpi S, Ginsburg GS, Horowitz CR, Orlando L, Chakraborty H, Dexter P, Johnson JA, Skaar TC, Cavallari LH, Van Driest SL, Peterson JF

  • DOI: 10.1111/cts.13822

Implementing a Pragmatic Clinical Trial to Tailor Opioids for Acute Pain on behalf of the IGNITE ADOPT PGx Investigators

Larisa H CavallariEmily CicaliKristin Wiisanen, Roger B FillingimHrishikesh ChakrabortyRachel A MyersKathryn V BlakeBolanle AsiyanbolaJordan F BayeWesley H BronsonKelsey J CookErica N ElwoodChancellor F GrayYan Gong, Lindsay HinesJoseph KannryNatalie Kucher, Sheryl LynchKhoa A NguyenAniwaa Owusu ObengVictoria M Pratt, Hernan A PrietoMichelle RamosAzita Sadeghpour, Rajbir SinghMarc RosenmanPetr StarostikCameron D ThomasEmma TillmanPaul R Dexter, Carol R Horowitz, Lori A Orlando, Josh F PetersonTodd C SkaarSara L Van DriestSimona Volpi, Deepak VooraHari K ParvataneniJulie A JohnsonThe IGNITE Pragmatic Trials Network

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.

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Multisite investigation of strategies for the clinical implementation of pre-emptive pharmacogenetic testing

Julio D. Duarte, Rachel Dalton, Amanda L. Elchynski, D. Max Smith, Emily J. Cicali, James C. Lee, Benjamin Q. Duong, Natasha J. Petry, Christina L. Aquilante, Amber L. Beitelshees, Philip E. Empey, Julie A. Johnson, Aniwaa Owusu Obeng, Amy L. Pasternak, Victoria M. Pratt, Laura B. Ramsey, Sony Tuteja, Sara L. Van Driest, Kristin Wiisanen, J. Kevin Hicks, Larisa H. Cavallari & IGNITE Network Pharmacogenetics Working Group

Genetics in Medicine volume 23pages2335–2341 (2021)

Opportunity for Genotype-Guided Prescribing Among Adult Patients in 11 US Health Systems

J. Kevin Hicks, Nihal El Rouby,Henry H. Ong, Jonathan S. Schildcrout, Laura B. Ramsey, Yaping Shi,Leigh Anne Tang, Christina L. Aquilante,Amber L. Beitelshees, Kathryn V. Blake, James J. Cimino,Brittney H. Davis, Philip E. Empey, David P. Kao,Daniel L. Lemkin, Nita A. Limdi, Gloria P. Lipori, Marc B. Rosenman, Todd C. Skaar, Evgenia Teal, Sony Tuteja, Laura K. Wiley, Helen Williams, Almut G. Winterstein, Sara L. Van Driest, Larisa H. Cavallari, Josh F. Peterson, on behalf of the IGNITE Pharmacogenetics Working Group

First published: 11 January 2021 https://doi.org/10.1002/cpt.2161

 

Prescribing Prevalence of Medications With Potential Genotype-Guided Dosing in Pediatric Patients

Laura B. Ramsey, PhD1,2Henry H. Ong, PhD3Jonathan S. Schildcrout, PhD4Yaping Shi, MS4Leigh Anne Tang, BS5J. Kevin Hicks, PharmD, PhD6Nihal El Rouby, PharmD, PhD7,8Larisa H. Cavallari, PharmD7Sony Tuteja, PharmD, MS9Christina L. Aquilante, PharmD10Amber L. Beitelshees, PharmD, MPH11Daniel L. Lemkin, MD, MS12Kathryn V. Blake, PharmD13Helen Williams, BS14James J. Cimino, MD15Brittney H. Davis, PharmD16Nita A. Limdi, PharmD, PhD, MPSH16Philip E. Empey, PharmD, PhD17Christopher M. Horvat, MD, MHA18David P. Kao, MD19Gloria P. Lipori, MT, MBA20Marc B. Rosenman, MD21,22Todd C. Skaar, PhD23Evgenia Teal, MA24Almut G. Winterstein, PhD25Aniwaa Owusu Obeng, PharmD26Daria Salyakina, PhD27Apeksha Gupta, MPH27Joshua Gruber, MPH27Jennifer McCafferty-Fernandez, PhD27Jeffrey R. Bishop, PharmD, MS28,29Zach Rivers, PharmD30Ashley Benner, MPH31Bani Tamraz, PharmD, PhD32Janel Long-Boyle, PharmD, PhD32Josh F. Peterson, MD, MPH33Sara L. Van Driest, MD, PhD33,34for the IGNITE Pharmacogenetics Working Group

JAMA Netw Open. 2020;3(12):e2029411. doi:10.1001/jamanetworkopen.2020.29411

Impact of the CYP2C19*17 Allele on Outcomes in Patients Receiving Genotype-Guided Antiplatelet Therapy After Percutaneous Coronary Intervention

First published: 08 September 2020 https://doi.org/10.1002/cpt.2039