The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain

John C Licciardone,1 Robert J Gatchel,2 Nicole Phillips,3 Subhash Aryal4 1Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX, USA; 2Department of Psychology, College of Science, University of Texas at Arlington, Arlington, TX, USA; 3Department of Microbiol...

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Main Authors: Licciardone JC, Gatchel RJ, Phillips N, Aryal S
Format: Article
Language:English
Published: Dove Medical Press 2018-09-01
Series:Journal of Pain Research
Subjects:
Online Access:https://www.dovepress.com/the-pain-registry-for-epidemiological-clinical-and-interventional-stud-peer-reviewed-article-JPR
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spelling doaj-179c6b7e77f0463d874a09cf54c0522d2020-11-25T02:19:39ZengDove Medical PressJournal of Pain Research1178-70902018-09-01Volume 111751176040366The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back painLicciardone JCGatchel RJPhillips NAryal SJohn C Licciardone,1 Robert J Gatchel,2 Nicole Phillips,3 Subhash Aryal4 1Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX, USA; 2Department of Psychology, College of Science, University of Texas at Arlington, Arlington, TX, USA; 3Department of Microbiology, Immunology and Genetics, University of North Texas Health Science Center, Fort Worth, TX, USA; 4Department of Biostatistics and Epidemiology, Institute for Patient Safety, University of North Texas Health Science Center, Fort Worth, TX, USA 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. Keywords: PRECISION Pain Research Registry, low back pain, physical functioning, quality of life, opioids, codeine, nonsteroidal anti-inflammatory drugs, pharmacogenetics, precision medicine, biopsychosocial modelhttps://www.dovepress.com/the-pain-registry-for-epidemiological-clinical-and-interventional-stud-peer-reviewed-article-JPRPRECISION Pain Research RegistryLow back painPhysical functioningQuality of lifeOpioidsCodeineNonsteroidal anti-inflammatory drugsPharmacogeneticsPrecision medicineBiopsychosocial model
collection DOAJ
language English
format Article
sources DOAJ
author Licciardone JC
Gatchel RJ
Phillips N
Aryal S
spellingShingle Licciardone JC
Gatchel RJ
Phillips N
Aryal S
The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
Journal of Pain Research
PRECISION Pain Research Registry
Low back pain
Physical functioning
Quality of life
Opioids
Codeine
Nonsteroidal anti-inflammatory drugs
Pharmacogenetics
Precision medicine
Biopsychosocial model
author_facet Licciardone JC
Gatchel RJ
Phillips N
Aryal S
author_sort Licciardone JC
title The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
title_short The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
title_full The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
title_fullStr The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
title_full_unstemmed The Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation (PRECISION): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
title_sort pain registry for epidemiological, clinical, and interventional studies and innovation (precision): registry overview and protocol for a propensity score-matched study of opioid prescribing in patients with low back pain
publisher Dove Medical Press
series Journal of Pain Research
issn 1178-7090
publishDate 2018-09-01
description John C Licciardone,1 Robert J Gatchel,2 Nicole Phillips,3 Subhash Aryal4 1Department of Family Medicine, University of North Texas Health Science Center, Fort Worth, TX, USA; 2Department of Psychology, College of Science, University of Texas at Arlington, Arlington, TX, USA; 3Department of Microbiology, Immunology and Genetics, University of North Texas Health Science Center, Fort Worth, TX, USA; 4Department of Biostatistics and Epidemiology, Institute for Patient Safety, University of North Texas Health Science Center, Fort Worth, TX, USA 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. Keywords: PRECISION Pain Research Registry, low back pain, physical functioning, quality of life, opioids, codeine, nonsteroidal anti-inflammatory drugs, pharmacogenetics, precision medicine, biopsychosocial model
topic PRECISION Pain Research Registry
Low back pain
Physical functioning
Quality of life
Opioids
Codeine
Nonsteroidal anti-inflammatory drugs
Pharmacogenetics
Precision medicine
Biopsychosocial model
url https://www.dovepress.com/the-pain-registry-for-epidemiological-clinical-and-interventional-stud-peer-reviewed-article-JPR
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