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Introduction
Within the rapid growth and development of the healthcare industry, pharmacogenetics (PGx) addresses critical difficulties concerning data integration into clinical practice. It is necessary to design simple and convenient to use bioinformatics means to assist the clinicians in the fast access and usage of data in clinical decision-making. Weitzel, Cavallari & Lesko (2017) believe that the health care system should concentrate on developing and disseminating needed resources to provide doctors with clinical implementation of pharmacogenetics (p. 1551). The advances in extensive pharmacogenomics implementation strategies contribute to the production of new drugs based on a better understanding of genetic control of cellular functions.
Brief Summary of the Phenomenon
Pharmacogenomics is a broader concept that involves integrating information about the patients genotype into pharmacotherapy decisions and aims to provide the most efficient and safe therapy. Considerable patient variability in terms of drug response is, to a great extent, connected with the inherent differences among individuals. To be more specific, these differences are related to patients ability to process and respond to medications (Francis Lam, 2019, p. 2). The genomic variants are highly significant in regular clinical practice for adjusting medical therapy. As described by Baskys (2018), advances in pharmacogenomics significantly enhanced the general understanding of the correlation between genetic variations and drug efficiency, or their side effects. Such advances are mainly caused by the increase of drug labels that include pharmacogenomics guidance, pre-prescription testing, and the development of prescribing guidelines.
Interpretation of the research knowledge into the clinical experience usually involves multiple challenges, highlighting the need for changes to the process and organizational culture. Abou et al. (2019) define the following universal challenges concerning pharmacogenetics testing, such as the insufficient knowledge, the lack of evidence for clinical utility, and the gap between PGx experts and physicians (p. 2085). With that said, the PGx segment requires a more comprehensive understanding of how clinicians respond to genomic data in routine care provision. Thus, a qualitative approach will be applied for further research through semi-structured interviews with healthcare practitioners. The main research question is: How do clinicians perceive the use of pharmacogenomics in practice, and what kind of unforeseen barriers emerge within medication-gene interactions in routine healthcare practice?
Description of the Sample and Recruitment
The research will be based on panel-based genotyping, pharmacy monitoring, as well as medical decision support by electronic health records to promote genome-guided prescribing of target pharmaceuticals. Furthermore, the sampling plan for interviews will be designed considering two perspectives, such as patterns of use and practice domain. According to Kim et al. (2017), an examination of the PGx test application criteria, result from analysis, and reporting methods based on current literature enhances the clinical utility of pharmacogenetic tests (p. 181). The sample will engage ten clinicians from different kinds of practice and different usage categories, including primary care and cardiology, due to the evidence for the widely used drugs. The physicians perceptions and knowledge about PGx testing will be evaluated through semi-structured interviews based on prior experience assessing health information technology and programs. The additional interviews might be conducted in case of the need for significant supplementary knowledge or even with nurse practitioners who actively prescribe medications and engage with clinical decision support.
A Structured Interview Guide
It is intended to conduct semi-structured interviews with ten physicians related to various clinical practices and nurse practitioners. Hence, it is crucial to design an interview guide based on the key questions about implementing pharmacogenetics in the clinical practice (Unertl, Jaffa, Field, Price & Peterson, 2015). The in-depth research on pharmacogenetics testing might improve clinical outcomes (Johnson et al., 2017). The interview guide consists of the following sections, such as role and computer usage, significance and use of pharmacogenetics, experience with PREDICT, language and word choice, and general questions.
Role and computer use
This part of the interview aims at identifying the interview subjects role in the provision of healthcare and interaction with health information technology.
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How can you describe your current role in healthcare? What is the most prevalent type of patient?
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What are the tools that you apply for ordering tests and procedures? Do you use computers in healthcare frequently?
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Are you familiar with any other health information technology systems?
Significance and Use of pharmacogenetics
The goal is to understand how clinicians conceptualize pharmacogenomics and its role in the healthcare system.
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How do you define the concept of pharmacogenetics and your personal experience with PGx?
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How did this perception change over the time of your clinical practice?
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Did you receive any informal or formal training in PGx?
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How can you describe the role of pharmacogenomics testing in your current healthcare practice? What are your suggestions concerning the PGxs role in the future?
Experience with PREDICT
Pharmacogenomic Resource for Enhanced Decisions in Care & Treatment enables patients and clinicians with the genetic data needed to predict and prevent adverse medication reactions. The questions are focused on gathering current usage of PREDICT, an example of current experience with the use of PREDICT, and subjects anticipated future use.
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How frequently do you use the results of PREDICT tests?
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Can you outline some of the reasons why you order PREDICT testing during clinical meetings?
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Are there any conditions that can make you doubt whether to order a PREDICT test?
The choice of language and words
This part is targeted at investigating how the phrasing of PREDICT prompts influences their understanding.
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How do you consider the PREDICT guideline recommendation language, which is currently demonstrated?
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How do you rank the words of pharmacogenomics guideline recommendations from highest to lowest degree of obligation?
General questions
The goal implies concluding the interview, acquiring any additional comments that clinicians would like to share.
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What are your recommendations concerning the best integration practice of pharmacogenomics data into the clinical environment?
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Do you want to provide any other comments about your interaction with PREDICT?
Interview Setting and Method
The study is designed for a medical center to be performed through semi-structured interviews to evaluate clinician attitudes and knowledge based on prior experience in terms of health information technology and program evaluations. It is a preferred method due to the limited time that a specific physician can devote to interact with pharmacogenomics testing or clinical decision support. Bank, Swen & Guchelaar (2018) state that the current lack of policy concerning PGx testing coverage is a critical reason why the implementation of pharmacogenomics among healthcare professionals is low (p. 222). Different categories of the research questions aimed at receiving particular feedback regarding pharmacogenomics adoption in practice. Before the interview, clinicians can choose between the two options of audio or video record and review a written informed agreement document.
Conclusion
The recent improvements in the understanding of the effect of genetic differences on interpersonal variability in drug response significantly contributed to the development of pharmacogenetics. Pharmacogenetics testing is used to determine genetic mutations that anticipate patient responses to pharmacological treatment. A semi-structured interviewing was selected as a preferred qualitative method commonly applied to healthcare research. Therefore, the questions were designed per the research questions inspiring the study and existing knowledge. To conclude, improvements in PGx testing might surpass the preparedness and responsiveness of physicians and other medical staff to use the results efficiently to adapt therapy.
References
Abou Diwan, E., Zeitoun, R., Abou Haidar, L., Cascorbi, I., & Zgheib, N. K. (2019). Implementation and obstacles of pharmacogenetics in clinical practice: An international survey. British Journal of Clinical Pharmacology, 85(9), 20762088.
Bank, P. C. D., Swen, J. J., & Guchelaar H. J. (2018). Implementation of pharmacogenomics in everyday clinical settings. In K. Brosen & P. Damkier (Eds.), Pharmacogenetics (p. 219240). Academic Press.
Baskys, A. (2018). Application of pharmacogenetics in clinical practice: problems and solutions. Journal of Neural Transmission, 126(1), 109113.
Francis Lam, Y. W. (2018). Principles in pharmacogenomics: Pharmacokinetic, pharmacodynamics, and clinical implications. In Y. W. Francis Lam & S. R. Scott (Eds.), Pharmacogenomics: Challenges and opportunities in therapeutic implementation (pp. 238). Academic Press.
Johnson, J., Caudle, K., Gong, L., Whirl-Carrillo, M., Stein, C., Scott, S., & Wadelius, M. (2017). Clinical pharmacogenetics implementation consortium (CPIC) guideline for pharmacogenetics-guided warfarin dosing: 2017 update. Clinical Pharmacology & Therapeutics, 102(3), 397404.
Kim, S., Yun, Y.-M., Chae, H.-J., Cho, H.-J., Ji, M., Kim, I.-S., & Chun, S. (2017). Clinical pharmacogenetic testing and application: Laboratory medicine clinical practice guidelines. Annals of Laboratory Medicine, 37(2), 180193.
Unertl, K. M., Jaffa, H., Field, J. R., Price, L., & Peterson, J. F. (2015). Clinician perspectives on using pharmacogenomics in clinical practice. Personalized Medicine, 12(4), 339347.
Weitzel, K. W., Cavallari, L. H., & Lesko, L. J. (2017). Preemptive panel-based pharmacogenetic testing: The time is now. Pharmaceutical Research, 34(8), 15511555.
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