Evidence map›Paper›PMID 35899435›Full record

ArticleClinical and translational science2022

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators.

Larisa H Cavallari, Emily Cicali, Kristin Wiisanen, Roger B Fillingim, Hrishikesh Chakraborty, Rachel A Myers, Kathryn V Blake, Bolanle Asiyanbola, Jordan F Baye, Wesley H Bronson and 30 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04445792 nacompletednot on this map

A Depression and Opioid Pragmatic Trial in Pharmacogenetics

TypeinterventionalSponsorDuke UniversityRan2021 to 2024Enrolled4,284ConditionsDepression, Acute Pain, Chronic PainArmsPharmacogenetic testing, Clinical decisions support
NCT05966129 nacompletednot on this map

A Depression and Opioid Pragmatic Trial in Pharmacogenetics

TypeinterventionalSponsorDuke UniversityRan2021 to 2024Enrolled1,602ConditionsAcute PainArmsPharmacogenetic testing, Clinical decisions support
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
  8. Pharmacogenetics: Opportunities for theAnnual review of pharmacology and toxicology · 2025
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. CYP2D6 pharmacogenetics and phenoconversion in personalized medicine.Expert opinion on drug metabolism & toxicology · 2022
    Review
  15. Article
  16. Article
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

40 authors at 13 institutions in 1 country.

Larisa H CavallariDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID 0000-0002-7184-5292
Emily CicaliDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
Kristin WiisanenDepartment of Community Dentistry and Behavioral Science, College of Dentistry, University of Florida, Gainesville, Florida, USA.
Roger B FillingimDepartment of Community Dentistry and Behavioral Science, College of Dentistry, University of Florida, Gainesville, Florida, USA.
Hrishikesh ChakrabortyDepartment of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
Rachel A MyersDuke Center for Applied Genomics & Precision Medicine, Duke University, Durham, North Carolina, USA.
Kathryn V BlakeCenter for Pharmacogenomics and Translational Research, Nemours Children's Health, Jacksonville, Florida, USA.ORCID 0000-0001-9959-8572
Bolanle AsiyanbolaDepartment of Surgery, Meharry Medical College, Nashville, Tennessee, USA.
Jordan F BayeImagenetics, Sanford Health, Sioux Falls, South Dakota, USA.
Wesley H BronsonDepartment of Orthopaedic Surgery, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Kelsey J CookCenter for Pharmacogenomics and Translational Research, Nemours Children's Health, Jacksonville, Florida, USA.ORCID 0000-0002-0184-7022
Erica N ElwoodDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
Chancellor F GrayDepartment of Orthopaedic Surgery, College of Medicine, University of Florida, Gainesville, Florida, USA.
Yan GongDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID 0000-0002-8218-1620
Lindsay HinesBrain and Spine Center, Sanford Health, Fargo, North Dakota, USA.
Joseph KannryDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Natalie KucherDivision of Genomic Medicine, National Human Genome Research Institute, NIH, Bethesda, Maryland, USA.
Sheryl LynchDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Khoa A NguyenDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
Aniwaa Owusu ObengDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Victoria M PrattDepartment of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Hernan A PrietoDepartment of Orthopaedic Surgery, College of Medicine, University of Florida, Gainesville, Florida, USA.
Michelle RamosDepartment of Population Health Science and Policy and Institute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Azita SadeghpourDuke Center for Applied Genomics & Precision Medicine, Duke University, Durham, North Carolina, USA.
Rajbir SinghMeharry Medical College, Nashville, Tennessee, USA.
Marc RosenmanSchool of Medicine, Indiana University, Indianapolis, Indiana, USA.
Petr StarostikDepartment of Pathology, College of Medicine, University of Florida, Gainesville, Florida, USA.
Cameron D ThomasDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.ORCID 0000-0001-5040-2313
Emma TillmanDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Paul R DexterSchool of Medicine, Indiana University, Indianapolis, Indiana, USA.
Carol R HorowitzDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Lori A OrlandoDuke Center for Applied Genomics & Precision Medicine, Duke University, Durham, North Carolina, USA.
Josh F PetersonDepartments of Biomedical Informatics and Medicine, Vanderbilt University, Medical Center, Nashville, Tennessee, USA.
Todd C SkaarDivision of Clinical Pharmacology, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Sara L Van DriestDepartments of Pediatrics and Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID 0000-0003-2580-1405
Simona VolpiDivision of Genomic Medicine, National Human Genome Research Institute, NIH, Bethesda, Maryland, USA.
Deepak VooraDuke Center for Applied Genomics & Precision Medicine, Duke University, Durham, North Carolina, USA.ORCID 0000-0003-0015-5179
Hari K ParvataneniDepartment of Orthopaedic Surgery, College of Medicine, University of Florida, Gainesville, Florida, USA.ORCID 0000-0001-5547-405X
Julie A JohnsonDepartment of Pharmacotherapy and Translational Research and Center for Pharmacogenomics and Precision Medicine, College of Pharmacy, University of Florida, Gainesville, Florida, USA.
IGNITE Pragmatic Trials Network
University of Florida · USDuke University · USIcahn School of Medicine at Mount Sinai · USIndiana University School of MedicineMeharry Medical College · USMount Sinai Health System · USNational Human Genome Research Institute · USSanford Health · USVanderbilt University Medical Center · USIndiana University Indianapolis · USNemours Children's Health System · USNorthwestern University · USOptum (United States) · US

Funding

Sparking Advancements in Genomic MedicineU01HG007269 · NHGRI · UNIVERSITY OF FLORIDA · PI CAVALLARI, LARISA HUMMA, JOHNSON, JULIE A. · 2013 to 2024
$17.0M
The IGNITE II CC: Engagement, Coordination, Demonstration, and DisseminationU01HG010225 · NHGRI · DUKE UNIVERSITY · PI CHAKRABORTY, HRISHIKESH, WYATT, CHRISTINA M · 2018 to 2024
$15.1M
Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.U01HG010245 · NHGRI · INDIANA UNIVERSITY INDIANAPOLIS · PI DEXTER, PAUL, SKAAR, TODD C. · 2018 to 2024
$9.4M
GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York CityU01HG010248 · NHGRI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HOROWITZ, CAROL R · 2018 to 2024
$9.0M
Integrated, Individualized, and Intelligent Prescribing (I3P) Clinical Trial NetworkU01HG010232 · NHGRI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI CAVANAUGH, KERRI, PETERSON, JOSEPH F. · 2018 to 2024
$8.2M
IGNITE Cost Extension- Year 7U01HG010231 · NHGRI · DUKE UNIVERSITY · PI ORLANDO, LORI ANN · 2018 to 2024
$6.7M
NHGRI NIH HHS U01 HG007269NHGRI NIH HHS U01 HG010225NHGRI NIH HHS U01 HG010231NHGRI NIH HHS U01 HG010232NHGRI NIH HHS U01 HG010245NHGRI NIH HHS U01 HG010248NIH HHS U01 HG0010245NIH HHS U01 HG007269NIH HHS U01 HG010225NIH HHS U01 HG010231NIH HHS U01 HG010232NIH HHS U01 HG010248
6 · The paper itself

Abstract

Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.

Indexed as

Acute PainAnalgesics, OpioidPostoperative PainCodeineCytochrome P-450 CYP2D6HumansHydrocodoneMulticenter Studies as TopicPractice Patterns, Physicians'Pragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicTramadolAnalgesics, OpioidCodeineCytochrome P-450 CYP2D6HydrocodoneTramadol

Identifiers

PMID35899435
PMCPMC9579394
OpenAlexW4288077397

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.