Implementation of preemptive DNA sequence–based pharmacogenomics testing across a large academic medical center: The Mayo-Baylor RIGHT 10K Study

Wang, Liewei; Scherer, Steven E.; Bielinski, Suzette J; Muzny, Donna M.; Jones, Leila A.; Black, John L.; Moyer, Ann M.; Giri, Jyothsna; Sharp, Richard R.; Matey, Eric T.; Wright, Jessica A.; Oyen, Lance J.; Nicholson, Wayne T.; Wiepert, Mathieu; Sullard, Terri; Curry, Timothy B.; Vitek, Carolyn R. Rohrer; McAllister, Tammy M.; Sauver, Jennifer L. St.; Caraballo, Pedro J.; Lazaridis, Konstantinos N.; Venner, Eric; Qin, Xiang; Hu, Jianhong; Kovar, Christie; Korchina, Viktoriya; Walker, Kimberly; Doddapaneni, HarshaVardhan; Wu, Tsung-Jung; Raj, Ritika; Denson, Shawn; Li, Wen; Chandanavelli, Gauthami; Zhang, Lan; Wang, Qiaoyan; Kalra, Divya; Karow, Mary Beth; Harris, Kimberley; Sicotte, Hugues; Peterson, Sandra E.; Barthel, Amy E; Moore, Brenda E.; Skierka, Jennifer M.; Kluge, Michelle L.; Kotzer, Katrina E.; Kloke, Karen M.; Pol, Jessica M Vander; Marker, Heather; Sutton, Joseph; Kekic, Adrijana; Ebenhoh, Ashley; Bierle, Dennis M.; Schuh, Michael J.; Grilli, C.; Erickson, Sara M.; Umbreit, Audrey; Ward, Lawrence J. H.; Crosby, Sheena; Nelson, Eric; Levey, Sharon; Elliott, Michelle A.; Peters, Steve G.; Pereira, Naveen L.; Frye, Mark A.; Shamoun, Fadi; Goetz, Matthew P.; Kullo, Iftikhar J.; Wermers, Robert A.; Anderson, Jan A; Formea, Christine M.; Melik, Razan M El; Zeuli, John D.; Herges, Joseph R.; Krieger, Carrie A; Hoel, Robert W; Taraba, Jodi; Thomas, Scott R St; Absah, Imad; Bernard, Matthew E.; Fink, Stephanie; Gossard, Andrea A.; Grubbs, Pamela L; Jacobson, Therese; Takahashi, Paul Y.; Zehe, Sharon C; Buckles, Susan; Bumgardner, Michelle; Gallagher, Colette; Fee-Schroeder, Kelliann C.; Nicholas, Nichole R; Powers, Melody L; Ragab, Ahmed K; Richardson, Darcy M.; Stai, Anthony; Wilson, Jaymi; Pacyna, Joel E.; Olson, Janet E.; Sutton, Erica J.; Beck, Annika T.; Horrow, Caroline; Kalari, Krishna R.; Larson, Nicholas B.; Liu, Hongfang; Wang, Liwei; Lopes, Guilherme S.; Borah, Bijan J.; Freimuth, Robert R.; Zhu, Yong‐Guan; Jacobson, Debra J.; Hathcock, Matthew; Armasu, Sebastian M.; McGree, Michaela E.; Jiang, Ruoxiang; Koep, Tyler; Ross, Jason L.; Hilden, Matthew G; Bosse, Kathleen; Ramey, Bronwyn E.; Searcy, Isabelle; Boerwinkle, Eric; Gibbs, Richard A.; Weinshilboum, Richard M.

doi:10.1016/j.gim.2022.01.022

Cited by 39 publications

(37 citation statements)

References 28 publications

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“…Pre-emptive pharmacogenetic testing involved the reanalysis of whole genome sequencing (WGS) data undertaken as part of separate investigations for congenital cardiac malformations. The Mayo Clinic developed PGRNseq for the RIGHT Study which is a Targeted Capture Sequencing Panel for over 250 genes ( 34 , 41 , 51 ).…”

Section: Resultsmentioning

confidence: 99%

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Characterizing pharmacogenetic programs using the consolidated framework for implementation research: A structured scoping review

et al. 2022

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Several healthcare organizations have developed pre-emptive pharmacogenetic testing programs, where testing is undertaken prior to the prescription of a medicine. This review characterizes the barriers and facilitators which influenced the development of these programs. A bidirectional citation searching strategy identified relevant publications before a standardized data extraction approach was applied. Publications were grouped by program and data synthesis was undertaken using the Consolidated Framework for Implementation Research (CFIR). 104 publications were identified from 40 programs and 4 multi-center initiatives. 26 (66%) of the programs were based in the United States and 95% in high-income countries. The programs were heterogeneous in their design and scale. The Characteristics of the Intervention, Inner Setting, and Process domains were referenced by 92.5, 80, and 77.5% of programs, respectively. A positive institutional culture, leadership engagement, engaging stakeholders, and the use of clinical champions were frequently described as facilitators to implementation. Clinician self-efficacy, lack of stakeholder knowledge, and the cost of the intervention were commonly cited barriers. Despite variation between the programs, there were several similarities in approach which could be categorized via the CFIR. These form a resource for organizations planning the development of pharmacogenetic programs, highlighting key facilitators which can be leveraged to promote successful implementation.

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Section: Resultsmentioning

confidence: 99%

“…The authors of several manuscripts across multiple organizations noted that real world evidence to support the widespread implementation of pharmacogenetics is somewhat variable, which could also impact beliefs about the utility of the intervention. A number of more recent manuscripts have begun to address this lack of evidence ( 51 ).…”

Section: Resultsmentioning

confidence: 99%

Characterizing pharmacogenetic programs using the consolidated framework for implementation research: A structured scoping review

et al. 2022

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“…Thus, reflecting the findings of the Mayo-Baylor RIGHT10K Study survey of 4624 patients 95% of respondents felt that pharmacogenomic testing would help them avoid exposure to medication that might be harmful. 8 …”

Section: Discussionmentioning

confidence: 99%

“… 1 , 2 , 3 Pre-emptive testing is emerging as a best practice, aiming to provide pharmacogenomic data for optimization of drug therapy at point of initial prescribing. 6 , 7 , 8 However, integration of pharmacogenomic testing into clinical practice is largely limited to specialist secondary and tertiary care settings. 2 , 3 …”

Section: Introductionmentioning

confidence: 99%

Public perceptions of pharmacogenomic services in Ireland - Are people with chronic disease more likely to want service availability than those without? A questionnaire study

O'She¹,

Ryan²,

Gallagher³

et al. 2022

Exploratory Research in Clinical and Social Pharmacy

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“…It is estimated that medications with CPIC guidance comprise about 18% of the 4 billion outpatient prescriptions in the US [ 5 ]. In addition, in the few settings where genotype-guided prescribing is part of routine clinical care, 99% of those tested have actionable variants that affect prescribing of at least one medication [ 3 , 4 , 7 , 8 , 9 , 10 , 11 ]. For these medications, pharmacogenetic test results could guide medication choice or dose, thus optimizing outcomes [ 12 ].…”

Section: Introductionmentioning

confidence: 99%

A Mixed-Methods Protocol to Identify Best Practices for Implementing Pharmacogenetic Testing in Clinical Settings

Sperber

Cragun

Roberts

et al. 2022

JPM

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Using a patient’s genetic information to inform medication prescriptions can be clinically effective; however, the practice has not been widely implemented. Health systems need guidance on how to engage with providers to improve pharmacogenetic test utilization. Approaches from the field of implementation science may shed light on the complex factors affecting pharmacogenetic test use in real-world settings and areas to target to improve utilization. This paper presents an approach to studying the application of precision medicine that utilizes mixed qualitative and quantitative methods and implementation science frameworks to understand which factors or combinations consistently account for high versus low utilization of pharmocogenetic testing. This approach involves two phases: (1) collection of qualitative and quantitative data from providers—the cases—at four clinical institutions about their experiences with, and utilization of, pharmacogenetic testing to identify salient factors; and (2) analysis using a Configurational Comparative Method (CCM), using a mathematical algorithm to identify the minimally necessary and sufficient factors that distinguish providers who have higher utilization from those with low utilization. Advantages of this approach are that it can be used for small to moderate sample sizes, and it accounts for conditions found in real-world settings by demonstrating how they coincide to affect utilization.

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Implementation of preemptive DNA sequence–based pharmacogenomics testing across a large academic medical center: The Mayo-Baylor RIGHT 10K Study

Cited by 39 publications

References 28 publications

Characterizing pharmacogenetic programs using the consolidated framework for implementation research: A structured scoping review

Characterizing pharmacogenetic programs using the consolidated framework for implementation research: A structured scoping review

Public perceptions of pharmacogenomic services in Ireland - Are people with chronic disease more likely to want service availability than those without? A questionnaire study

A Mixed-Methods Protocol to Identify Best Practices for Implementing Pharmacogenetic Testing in Clinical Settings

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