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

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

doi:10.1038/s41436-021-01269-9

Cited by 31 publications

(37 citation statements)

References 19 publications

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“…Investigators could leverage large databases of real-world evidence collected from sites that are conducting GITR testing and using results to guide treatment. Although this is lesser quality evidence, 64 this information could be useful to glean evidence of the efficacy and toxicity of alternative treatment in GITR-positive patients. Relatedly, there may be an opportunity to use these real-world data to conduct synthetic clinical trials 65 that mimic a prospective randomized trial to estimate the reduced toxicity and/or efficacy from alternative treatment compared with SOC.…”

Section: Levels Of Evidence To Support Clinical Utility Of Gitrmentioning

confidence: 99%

Defining Clinical Utility of Germline Indicators of Toxicity Risk: A Perspective

Hertz

McShane

Hayes

2022

JCO

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Section: Levels Of Evidence To Support Clinical Utility Of Gitrmentioning

confidence: 99%

Defining Clinical Utility of Germline Indicators of Toxicity Risk: A Perspective

Hertz

McShane

Hayes

2022

JCO

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“…Institutions that are more experienced with implementation may realize this strategy alone is not sufficient for implementation success and have appointed formal implementation leaders to oversee all phases of implementation and provide a cohesive strategy. Dedicated precision medicine or PGx teams have been cited as leading these types of implementations [ 25 , 26 ]. Another construct that was identified as important but not necessarily different by class included patient needs and resources.…”

Section: Discussionmentioning

confidence: 99%

Best–worst scaling methodology to evaluate constructs of the Consolidated Framework for Implementation Research: application to the implementation of pharmacogenetic testing for antidepressant therapy

Salloum

Bishop

Elchynski

et al. 2022

Implement Sci Commun

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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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“…The reactive approach is the most used in psychiatry. 25 Users of this approach offer PGx testing after an individual experiences an inadequate response or intolerable sideeffects to a psychotropic drug. The notion being that individuals who experience inadequate response or intolerable side-effects may be more likely to carry genetic variants that predispose them to unfavorable drug outcomes and that PGx testing could prevent future unfavorable drug outcomes.…”

Section: Timing Of Pgx Testingmentioning

confidence: 99%

“…PGx testing is offered using three main approaches: reactive, point‐of‐care, and preemptive (Figure 1). The reactive approach is the most used in psychiatry 25 . Users of this approach offer PGx testing after an individual experiences an inadequate response or intolerable side‐effects to a psychotropic drug.…”

Section: Approachesmentioning

confidence: 99%

“…PGx testing is offered by commercial and noncommercial entities, although most testing in psychiatry is being performed by commercial laboratories. In the United States alone, 76 commercial laboratories offer PGx testing16 and testing in about 50 medical centers or health systems worldwide, 14 including approximately 18 Children's Hospitals in the United States,25 includes a mix of commercial and noncommercial testing. Both commercial and noncommercial PGx testing are mostly performed in an accredited clinical laboratory (e.g., College of American Pathologists/Clinical Laboratory Improvement Amendments [CAP/CLIA]; International Organization of Standardization [ISO] 15189; Canadian Association For Laboratory Accreditation [CALA]).…”

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confidence: 99%

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Approaches and hurdles of implementing pharmacogenetic testing in the psychiatric clinic

Maruf

Bousman

2022

PCN Reports

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Pharmacogenetic (PGx) testing has emerged as a tool for predicting a person's ability to process and react to drugs. Despite the growing evidence‐base, enthusiasm, and successful efforts to implement PGx testing in psychiatry, a consensus on how best to implement PGx testing into practice has not been established and numerous hurdles to widespread adoption remain to be overcome. In this article, we summarize the most used approaches and commonly encountered hurdles when implementing PGx testing into routine psychiatric care. We also highlight effective strategies that have been used to overcome hurdles. These strategies include the development of user‐friendly clinical workflows for test ordering, use, and communication of results, establishment of test standardization and reimbursement policies, and development of tailored curriculums for educating health‐care providers and the public. Although knowledge and awareness of these approaches and strategies to overcome hurdles alone may not be sufficient for successful implementation, they are necessary to ensure the effective spread, scale, and sustainability of PGx testing in psychiatry and other areas of medicine.

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

Cited by 31 publications

References 19 publications

Defining Clinical Utility of Germline Indicators of Toxicity Risk: A Perspective

Defining Clinical Utility of Germline Indicators of Toxicity Risk: A Perspective

Best–worst scaling methodology to evaluate constructs of the Consolidated Framework for Implementation Research: application to the implementation of pharmacogenetic testing for antidepressant therapy

Approaches and hurdles of implementing pharmacogenetic testing in the psychiatric clinic

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