TY - JOUR
T1 - The Pain Registry for Epidemiological, Clinical, and interventional Studies and Innovation (PRECISION)
T2 - Registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
AU - Licciardone, John C.
AU - Gatchel, Robert J.
AU - Phillips, Nicole
AU - Aryal, Subhash
N1 - Funding Information:
The authors wish to thank the registry research staff, faculty, and community advisory board for their contributions to study implementation. The registry and study protocol described herein have been partially funded by the Osteopathic Heritage Foundation, the American Osteopathic Association (# 131611703 and 751711713), and the Institute for Patient Safety. None of the funding bodies had a role in the design of the registry or study protocol; the plan for collection, analysis, or interpretation of data; or writing the article. JCL is a professor of Family Medicine and Richards-Cohen Distinguished Chair in Clinical Research at the University of North Texas Health Science Center. RJG is a distinguished professor of Psychology and Nancy P. & John G. Penson Endowed Professor of Clinical Health Psychology at the University of Texas at Arlington. NP is an assistant professor of Genetics at the University of North Texas Health Science Center. SA is an associate professor of Biostatistics at the University of North Texas Health Science Center.
Publisher Copyright:
© 2018 Licciardone et al.
PY - 2018
Y1 - 2018
N2 - Background: Low back pain is the leading cause of disability worldwide. Nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended as the first-line pharmacologic therapy for subacute or chronic low back pain, with opioids reserved for patients who fail on NSAIDs. CYP2D6, CYP2C9, and CYP2C19 genes have variants that place patients using analgesics at risk for adverse events. However, precision medicine based on pharmacogenetically informed prescribing is becoming more feasible as genotyping costs decline. This study aims to compare opioids vs NSAIDs in treating adults with subacute or chronic low back pain under the alternative models of usual care and precision medicine. Methods: An observational cohort study within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) will be used to simulate a randomized controlled trial. Patients using opioids and NSAIDs will be optimally matched at baseline using propensity scores. A saliva sample will also be collected to determine patient genotypes for drug metabolism based on CYP2D6 (single-gene model) and CYP2D6, CYP2C9, and CYP2C19 (multigene model). Prescribing that is concordant with pharmacogenetically informed care under these models will be considered “low risk”, whereas discordant prescribing will be considered “high risk”. Primary outcomes will be assessed over 6 months using a Numerical Rating Scale for pain, the Roland-Morris Disability Questionnaire, and the Drug Adverse Events Index. Secondary outcomes will be assessed using quality-of-life measures. An estimated 600 patients will be enrolled to acquire at least 400 patients after attrition and allowing for unmatched patients. This will achieve a statistical power of at least 80% in detecting the effect sizes ranging from 0.35 (small–medium effect) to 0.69 (medium–large effect). Discussion: This PRECISION Pain Research Registry study builds on the concepts espoused in the Precision Medicine Initiative and addresses long-term goals established by the National Institutes of Health by assessing how precision medicine may prevent and treat chronic pain.
AB - Background: Low back pain is the leading cause of disability worldwide. Nonsteroidal anti-inflammatory drugs (NSAIDs) are recommended as the first-line pharmacologic therapy for subacute or chronic low back pain, with opioids reserved for patients who fail on NSAIDs. CYP2D6, CYP2C9, and CYP2C19 genes have variants that place patients using analgesics at risk for adverse events. However, precision medicine based on pharmacogenetically informed prescribing is becoming more feasible as genotyping costs decline. This study aims to compare opioids vs NSAIDs in treating adults with subacute or chronic low back pain under the alternative models of usual care and precision medicine. Methods: An observational cohort study within the Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION) will be used to simulate a randomized controlled trial. Patients using opioids and NSAIDs will be optimally matched at baseline using propensity scores. A saliva sample will also be collected to determine patient genotypes for drug metabolism based on CYP2D6 (single-gene model) and CYP2D6, CYP2C9, and CYP2C19 (multigene model). Prescribing that is concordant with pharmacogenetically informed care under these models will be considered “low risk”, whereas discordant prescribing will be considered “high risk”. Primary outcomes will be assessed over 6 months using a Numerical Rating Scale for pain, the Roland-Morris Disability Questionnaire, and the Drug Adverse Events Index. Secondary outcomes will be assessed using quality-of-life measures. An estimated 600 patients will be enrolled to acquire at least 400 patients after attrition and allowing for unmatched patients. This will achieve a statistical power of at least 80% in detecting the effect sizes ranging from 0.35 (small–medium effect) to 0.69 (medium–large effect). Discussion: This PRECISION Pain Research Registry study builds on the concepts espoused in the Precision Medicine Initiative and addresses long-term goals established by the National Institutes of Health by assessing how precision medicine may prevent and treat chronic pain.
KW - Biopsychosocial model
KW - Codeine
KW - Low back pain
KW - Nonsteroidal anti-inflammatory drugs
KW - Opioids
KW - PRECISION Pain Research Registry
KW - Pharmacogenetics
KW - Physical functioning
KW - Precision medicine
KW - Quality of life
UR - http://www.scopus.com/inward/record.url?scp=85058806055&partnerID=8YFLogxK
U2 - 10.2147/JPR.S169275
DO - 10.2147/JPR.S169275
M3 - Article
AN - SCOPUS:85058806055
SN - 1178-7090
VL - 11
SP - 1751
EP - 1760
JO - Journal of Pain Research
JF - Journal of Pain Research
ER -