What would be considered a ‘clinical best-practice guideline’ in this new personalized healthcare world? Would they exist?
Personalized medicine is a growing area of healthcare where specific diagnostic tests are carried out to identify biological markers to diagnose, prevent, and treat disease. It moves from a “one size fits all” approach to a personalized approach. For example, in cancer patients, personalized medicine uses specific information about a patients tumor to help diagnose, plan treatment, monitor the treatment progress, or make a prognosis (National cancer institute, 2019). A common theme when researching this question was that the growth of personalized medicine outpaces clinical guideline development. Pritchard, Moeckel, Villa, Housman, McCarty, & McLeod (2017) provide a research article outlining strategies to introduce personalized medicine into healthcare. Clinical guidelines will absolutely have to exist. The issue will be having to update and integrate them into practice. Current clinical guidelines do not reflect current concepts in personalized medicine which discourages its use in healthcare (Pritchard et at., 2017). Strategies suggested by Pritchard et al, 2017 generally revolve around proving personalized medicines worth, educating the healthcare system as well as the patient, ensuring an infrastructure and information management system that can handle this change, and ensuring access to care. Ways suggested include updating current guidelines that focus on the best care for individuals to be updated to include personalized medicine practices and policies, clinical studies, education, patient involvement, develop standards and policies (Pritchard et al., 2017).
I stumbled upon the Clinical Pharmacogenetics Implementation Consortium (CPIC). They claim a barrier to pharmacological testing was translating genetic lab test results into actionable prescribing decisions for affected drugs (CPIC, 2019). Their goal is to provide gene/drug clinical practice guidelines and show clinicians “how genetic test results should be used to optimize drug therapy, rather than whether tests should be ordered (CPIC, 2019).” On their website, you can find an extensive list of guidelines that correspond to a specific drug/gene. https://cpicpgx.org/
What research designs would be best to study cause-effect relationships in healthcare? Would randomized control trials still be the ‘gold-standard’ when clinicians are able to develop treatments and medications specific to an individual’s genomic markers?
Today clinical trials are large, including thousands of people and revolve around finding out if drugs, medical devices, or treatments will work in general with a overall low response rate (Cristol, 2019). But with personalized medicine, its focus is on a particular aspect of the disease (genetic mutation, lifestyle trait) that only some of the people have (Cristol, 2019). By weeding out non-responders you have a better chance of finding something that works.
How would the profession of nursing look in a world where there is a focus on the genetic composition of an individual in terms of their treatment and recovery? What would nursing education/practice need to do to support this refocus on client care? What are the potential legal and ethical considerations that nurses will need to reflect upon?
Currently, advanced practice nurses have little knowledge, understanding, and acceptance of personalized medicine and genetics integration into healthcare (Chadwell, 2013). Precipitated by the fact that there is little to no content included in the nursing curriculum (Chadwell, 2013). This is a huge barrier to its success. Efforts have been made over the past 20 years to integrate genetic and genomic knowledge into nursing practice with the creation of the scope and standards in 1998, the curricula guidelines, and outcome indicators in 2005, and the competencies for nurses in 2012 (Chadwell, 2013). According to Chadwell (2013), the implementation of personalized medicine rests on the understanding and appropriate use by healthcare providers, specifically nurses. In the 2012 guidelines mentioned above competencies outlined include genetic testing, education, ethical, legal, and social implications, and professional role (Chadwell, 2013). Advance practice nurses will be involved in the assessment, diagnosis, and treatment of persons so it is vital they have general knowledge and understanding of genetic testing and guidelines. They also have the opportunity to become certified.
As outlined in the Human Genome Research Institute’s Ethical, Legal and Social Implications Research Program, ethical and legal issues may include informed consent, emotional impact on family, the potential for discrimination, reproductive choices/prenatal testing, inappropriate testing of genetics, setting boundaries in applications of genetic testing, forensic DNA database, and patenting of genes, coverage and reimbursement, genome editing, human subject research, health disparities, intellectual property in genomics, privacy of genomics, synthetic biology, and regulation of genetic tests (Chadwell, 2013; Ethical issues…, 2018; National Human…, 2018). https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications https://www.genetics.edu.au/publications-and-resources/facts-sheets/fact-sheet-19-ethical-issues-in-human-genetics-and-genomics
Do you think ‘personalized medicine/healthcare’ will ever exist?
I absolutely do. However, with healthcare slow to change I feel it is still a ways away. Once there is more education, awareness, and proof I believe the benefit will be seen and then we can really put into action what has been happening behind the scenes.
Centre for Genetics Education (2019). Fact sheet 19. Ethical Issues in Human Genetics and Genomics. e-book. Retrieved from https://www.genetics.edu.au/publications-and-resources/facts-sheets/fact-sheet-19-ethical-issues-in-human-genetics-and-genomics
Chadwell, K. (2013). Clinical Practice on the Horizon. Clinical Nurse Specialist, 27(1), 36–43. doi: 10.1097/NUR.obo13e318277703c
CPIC. (2019). Guidelines. Retrieved from https://cpicpgx.org/guidelines/
CPIC. (2019). Home page. Retrieved from https://cpicpgx.org
Cristol, H. (2019). How Will Precision Medicine Change Clinical Trials? Retrieved from https://www.webmc.com/cancer/features/precision-medicine-clinical-trials#1
National Human Genome Research Institute. (2018). Policy Issues in Genomics. Retrieved from https://www.genome.gov/about-genomics/policy-issues
Pritchard, D. E., Moeckel, F., Villa, M. S., Housman, L. T., Mccarty, C. A., & Mcleod, H. L. (2017). Strategies for integrating personalized medicine into healthcare practice. Personalized Medicine, 14(2), 141-152. doi: 10.2217/pme-2016-0064