Pragmatic Trials in Genomic Medicine: The Integrating Pharmacogenetics In Clinical Care (I‐PICC) Study

Autor: Andrew J. Zimolzak, Charles A. Brunette, Cynthia Hau, Sophie A. Ludin, Jason L. Vassy, Lauren MacMullen, Sanjay Advani, Stephen J. Miller, Nilla Majahalme
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Adult
Male
030213 general clinical medicine
medicine.medical_specialty
Pharmacogenomic Variants
Psychological intervention
MEDLINE
030226 pharmacology & pharmacy
General Biochemistry
Genetics and Molecular Biology
Article
03 medical and health sciences
0302 clinical medicine
Pragmatic Clinical Trials as Topic
medicine
Genomic medicine
Humans
Generalizability theory
General Pharmacology
Toxicology and Pharmaceutics
Clinical care
Intensive care medicine
Aged
Primary Health Care
business.industry
Liver-Specific Organic Anion Transporter 1
lcsh:Public aspects of medicine
General Neuroscience
Research
lcsh:RM1-950
lcsh:RA1-1270
General Medicine
Articles
Middle Aged
Pharmacogenomic Testing
Clinical trial
lcsh:Therapeutics. Pharmacology
Clinical research
Cardiovascular Diseases
Research Design
Feasibility Studies
Female
Hydroxymethylglutaryl-CoA Reductase Inhibitors
business
Pharmacogenetics
Zdroj: Clinical and Translational Science
Clinical and Translational Science, Vol 13, Iss 2, Pp 381-390 (2020)
ISSN: 1752-8062
1752-8054
Popis: Pragmatic clinical trials (PCTs) have an established presence in clinical research and yet have only recently garnered attention within the landscape of genomic medicine. Using the PRagmatic‐Explanatory Continuum Indicator Summary 2 (PRECIS‐2) as a framework, this paper illustrates the application of PCT principles to The Integrating Pharmacogenetics In Clinical Care (I‐PICC) Study, a trial of pharmacogenetic testing prior to statin initiation for cardiovascular disease prevention in primary care. The trial achieved high engagement with providers (85% enrolled of those approached) and enrolled a representative sample of participants for which statin therapy would be recommended. The I‐PICC Study has a high level of pragmatism, which should enhance the generalizability of its findings. The PRECIS‐2 may be useful in the design and evaluation of PCTs of genomic medicine interventions, contributing to the generation of evidence that can bridge the gap between genomics innovation and clinical adoption.
Databáze: OpenAIRE
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