Browsing by Author "Levy, Kenneth D."

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    Correction: Opportunities to implement a sustainable genomic medicine program: lessons learned from the IGNITE Network
    (Springer Nature, 2021) Levy, Kenneth D.; Blake, Kathryn; Fletcher-Hoppe, Colette; Franciosi, James; Goto, Daisuke; Hicks, James K.; Holmes, Ann M.; Kanuri, Sri Harsha; Madden, Ebony B.; Musty, Michael D.; Orlando, Lori; Pratt, Victoria M.; Ramos, Michelle; Wu, Ryanne; Ginsburg, Geoffrey S.; Medicine, School of Medicine
    Correction to: Genetics in Medicine 21:2019; 10.1038/s41436-018-0080-y; published online 12 July 2018 The original version of this Article contained an error in the spelling of the author Daisuke Goto, which was incorrectly given as Diasuke Goto. This has now been corrected in both the PDF and HTML versions of the Article.
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    Correction: Opportunities to implement a sustainable genomic medicine program: lessons learned from the IGNITE Network
    (Springer Nature, 2019-07) Levy, Kenneth D.; Blake, Kathryn; Fletcher-Hoppe, Colette; Franciosi, James; Goto, Diasuke; Hicks, James K.; Holmes, Ann M.; Kanuri, Sri Harsha; Madden, Ebony B.; Musty, Michael D.; Orlando, Lori; Pratt, Victoria M.; Ramos, Michelle; Wu, Ryanne; Ginsburg, Geoffrey S.; Medicine, School of Medicine
    The original version of this Article contained an error in the spelling of the author Geoffrey S. Ginsburg, which was incorrectly given as Geoffrey Ginsburg. This has now been corrected in both the PDF and HTML versions of the Article.
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    Developing a Common Framework for Evaluating the Implementation of Genomic Medicine Interventions in Clinical Care: The IGNITE Network’s Common Measures Working Group
    (Nature Publishing group, 2018-06) Orlando, Lori A.; Sperber, Nina R.; Voils, Corrine; Nichols, Marshall; Myers, Rachel A.; Wu, R. Ryanne; Rakhra-Burris, Tejinder; Levy, Kenneth D.; Levy, Mia; Pollin, Toni I.; Guan, Yue; Horowitz, Carol R.; Ramos, Michelle; Kimmel, Stephen E.; McDonough, Caitrin W.; Madden, Ebony B.; Damschroder, Laura J.; Medicine, School of Medicine
    Purpose Implementation research provides a structure for evaluating the clinical integration of genomic medicine interventions. This paper describes the Implementing GeNomics In PracTicE (IGNITE) Network’s efforts to promote: 1) a broader understanding of genomic medicine implementation research; and 2) the sharing of knowledge generated in the network. Methods To facilitate this goal the IGNITE Network Common Measures Working Group (CMG) members adopted the Consolidated Framework for Implementation Research (CFIR) to guide their approach to: identifying constructs and measures relevant to evaluating genomic medicine as a whole, standardizing data collection across projects, and combining data in a centralized resource for cross network analyses. Results CMG identified ten high-priority CFIR constructs as important for genomic medicine. Of those, eight didn’t have standardized measurement instruments. Therefore, we developed four survey tools to address this gap. In addition, we identified seven high-priority constructs related to patients, families, and communities that did not map to CFIR constructs. Both sets of constructs were combined to create a draft genomic medicine implementation model. Conclusion We developed processes to identify constructs deemed valuable for genomic medicine implementation and codified them in a model. These resources are freely available to facilitate knowledge generation and sharing across the field.
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    Drug–gene and drug–drug interactions associated with tramadol and codeine therapy in the INGENIOUS trial
    (Future Medicine, 2019-04) Fulton, Cathy R.; Zang, Yong; Desta, Zeruesenay; Rosenman, Marc B.; Holmes, Ann M.; Decker, Brian S.; Zhang, Yifei; Callaghan, John T.; Pratt, Victoria M.; Levy, Kenneth D.; Gufford, Brandon T.; Dexter, Paul R.; Skaar, Todd C.; Eadon, Michael T.; Medicine, School of Medicine
    Background: Tramadol and codeine are metabolized by CYP2D6 and are subject to drug-gene and drug-drug interactions. Methods: This interim analysis examined prescribing behavior and efficacy in 102 individuals prescribed tramadol or codeine while receiving pharmaco-genotyping as part of the INGENIOUS trial (NCT02297126). Results: Within 60 days of receiving tramadol or codeine, clinicians more frequently prescribed an alternative opioid in ultrarapid and poor metabolizers (odds ratio: 19.0; 95% CI: 2.8-160.4) as compared with normal or indeterminate metabolizers (p = 0.01). After adjusting the CYP2D6 activity score for drug-drug interactions, uncontrolled pain was reported more frequently in individuals with reduced CYP2D6 activity (odds ratio: 0.50; 95% CI: 0.25-0.94). Conclusion: Phenoconversion for drug-drug and drug-gene interactions is an important consideration in pharmacogenomic implementation; drug-drug interactions may obscure the potential benefits of genotyping.
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    Enrollment of Diverse Populations in the INGENIOUS Pharmacogenetics Clinical Trial
    (Frontiers, 2020-06) Shah-Williams, Ebony; Levy, Kenneth D.; Zang, Yong; Holmes, Ann M.; Stoughton, Christa; Dexter, Paul; Skaar, Todd C.; Medicine, School of Medicine
    Recruitment of diverse populations and subjects living in Medically Underserved Areas and Populations (MUA/P’s) into clinical trials is a considerable challenge. Likewise, representation of African-Americans in pharmacogenetic trials is often inadequate, but critical for identifying genetic variation within and between populations. To identify enrollment patterns and variables that predict enrollment in a diverse underserved population, we analyzed data from the INGENIOUS (Indiana GENomics Implementation and Opportunity for the UnderServed), pharmacogenomics implementation clinical trial conducted at a community hospital for underserved subjects (Safety net hospital), and a statewide healthcare system (Academic hospital). We used a logistic regression model to identify patient variables that predicted successful enrollment after subjects were contacted and evaluated the reasons that clinical trial eligible subjects refused enrollment. In both healthcare systems, African-Americans were less likely to refuse the study than non-Hispanic Whites (Safety net, OR = 0.68, and p < 0.002; Academic hospital, OR = 0.64, and p < 0.001). At the Safety net hospital, other minorities were more likely to refuse the study than non-Hispanic Whites (OR = 1.58, p < 0.04). The odds of refusing the study once contacted increased with patient age (Safety net hospital, OR = 1.02, p < 0.001, Academic hospital, OR = 1.02, and p < 0.001). At the Academic hospital, females were less likely to refuse the study than males (OR = 0.81, p = 0.01) and those not living in MUA/P’s were less likely to refuse the study than those living in MUA/P’s (OR = 0.81, p = 0.007). The most frequent barriers to enrollment included not being interested, being too busy, transportation, and illness. A lack of trust was reported less frequently. In conclusion, African-Americans can be readily recruited to pharmacogenetic clinical trials once contact has been successfully initiated. However, health care initiatives and increased recruitment efforts of subjects living in MUA/Ps are needed. Enrollment could be further enhanced by improving research awareness and knowledge of clinical trials, reducing time needed for participation, and compensating for travel.
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    FDA’s Draft Guidance on Laboratory-Developed Tests Increases Clinical and Economic Risk to Adoption of Pharmacogenetic Testing
    (Wiley, 2015-07) Levy, Kenneth D.; Pratt, Victoria M.; Skaar, Todd C.; Vance, Gail H.; Flockhart, David A.; Department of Medicine, IU School of Medicine
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    Lessons Learned When Introducing Pharmacogenomic Panel Testing into Clinical Practice
    (Elsevier, 2017-01-01) Rosenman, Marc B.; Decker, Brian; Levy, Kenneth D.; Holmes, Ann M.; Pratt, Victoria M.; Eadon, Michael T.; Medicine, School of Medicine
    Objectives: Implementing new programs to support precision medicine in clinical settings is a complex endeavor. We describe challenges and potential solutions based on the Indiana GENomics Implementation: an Opportunity for the Underserved (INGenious) program at Eskenazi Health-one of six sites supported by the Implementing GeNomics In pracTicE network grant of the National Institutes of Health/National Human Genome Research Institute. INGenious is an implementation of a panel of genomic tests. Methods: We conducted a descriptive case study of the implementation of this pharmacogenomics program, which has a wide scope (14 genes, 27 medications) and a diverse population (patients who often have multiple chronic illnesses, in a large urban safety-net hospital and its outpatient clinics). Challenges: We placed the clinical pharmacogenomics implementation challenges into six categories: patient education and engagement in care decision making; clinician education and changes in standards of care; integration of technology into electronic health record systems; translational and implementation sciences in real-world clinical environments; regulatory and reimbursement considerations, and challenges in measuring outcomes. A cross-cutting theme was the need for careful attention to workflow. Our clinical setting, a safety-net health care system, presented some distinctive challenges. Patients often had multiple chronic illnesses and sometimes were taking more than one pharmacogenomics-relevant medication. Reaching patients for recruitment or follow-up was another challenge. Conclusions: New, large-scale endeavors in health care are challenging. A description of the challenges that we encountered and the approaches that we adopted to address them may provide insights for those who implement and study innovations in other health care systems.
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    Opportunities to implement a sustainable genomic medicine program: lessons learned from the IGNITE Network
    (Springer Nature, 2019-03) Levy, Kenneth D.; Blake, Kathryn; Fletcher-Hoppe, Colette; Franciosi, James; Goto, Diasuke; Hicks, James K.; Holmes, Ann M.; Kanuri, Sri Harsha; Madden, Ebony B.; Musty, Michael D.; Orlando, Lori; Pratt, Victoria M.; Ramos, Michelle; Wu, Ryanne; Ginsburg, Geoffrey; Medicine, School of Medicine
    PURPOSE: While there is growing scientific evidence for and significant advances in the use of genomic technologies in medicine, there is a significant lag in the clinical adoption and sustainability of genomic medicine. Here we describe the findings from the National Human Genome Research Institute's (NHGRI) Implementing GeNomics In pracTicE (IGNITE) Network in identifying key constructs, opportunities, and challenges associated with driving sustainability of genomic medicine in clinical practice. METHODS: Network members and affiliates were surveyed to identify key drivers associated with implementing and sustaining a genomic medicine program. Tallied results were used to develop and weigh key constructs/drivers required to support sustainability of genomic medicine programs. RESULTS: The top three driver-stakeholder dyads were (1) genomic training for providers, (2) genomic clinical decision support (CDS) tools embedded in the electronic health record (EHR), and (3) third party reimbursement for genomic testing. CONCLUSION: Priorities may differ depending on healthcare systems when comparing the current state of key drivers versus projected needs for supporting genomic medicine sustainability. Thus we provide gap-filling guidance based on IGNITE members' experiences. Although results are limited to findings from the IGNITE network, their implementation, scientific, and clinical experience may be used as a road map by others considering implementing genomic medicine programs.
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    Pharmacogenomically actionable medications in a safety net health care system
    (2016) Carpenter, Janet S.; Rosenman, Marc B.; Knisely, Mitchell R.; Decker, Brian S.; Levy, Kenneth D.; Flockhart, David A.; IU School of Nursing
    OBJECTIVE: Prior to implementing a trial to evaluate the economic costs and clinical outcomes of pharmacogenetic testing in a large safety net health care system, we determined the number of patients taking targeted medications and their clinical care encounter sites. METHODS: Using 1-year electronic medical record data, we evaluated the number of patients who had started one or more of 30 known pharmacogenomically actionable medications and the number of care encounter sites the patients had visited. RESULTS: Results showed 7039 unique patients who started one or more of the target medications within a 12-month period with visits to 73 care sites within the system. CONCLUSION: Findings suggest that the type of large-scale, multi-drug, multi-gene approach to pharmacogenetic testing we are planning is widely relevant, and successful implementation will require wide-scale education of prescribers and other personnel involved in medication dispensing and handling.
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    Physician-Reported Benefits and Barriers to Clinical Implementation of Genomic Medicine: A Multi-Site IGNITE-Network Survey
    (MDPI, 2018-07-24) Obeng, Aniwaa Owusu; Fei, Kezhen; Levy, Kenneth D.; Elsey, Amanda R.; Pollin, Toni I.; Ramirez, Andrea H.; Weitzel, Kristin W.; Horowitz, Carol R.; Medicine, School of Medicine
    Genetic medicine is one of the key components of personalized medicine, but adoption in clinical practice is still limited. To understand potential barriers and provider attitudes, we surveyed 285 physicians from five Implementing GeNomics In pracTicE (IGNITE) sites about their perceptions as to the clinical utility of genetic data as well as their preparedness to integrate it into practice. These responses were also analyzed in comparison to the type of study occurring at the physicians' institution (pharmacogenetics versus disease genetics). The majority believed that genetic testing is clinically useful; however, only a third believed that they had obtained adequate training to care for genetically "high-risk" patients. Physicians involved in pharmacogenetics initiatives were more favorable towards genetic testing applications; they found it to be clinically useful and felt more prepared and confident in their abilities to adopt it into their practice in comparison to those participating in disease genetics initiatives. These results suggest that investigators should explore which attributes of clinical pharmacogenetics (such as the use of simplified genetics-guided recommendations) can be implemented to improve attitudes and preparedness to implement disease genetics in care. Most physicians felt unprepared to use genetic information in their practice; accordingly, major steps should be taken to develop effective clinical tools and training strategies for physicians.