Evidence mapPaperPMID 32941098Full record

ArticleJournal of biopharmaceutical statistics2020

The precision interventions for severe and/or exacerbation-prone asthma (PrecISE) adaptive platform trial: statistical considerations.

Anastasia Ivanova, Elliot Israel, Lisa M LaVange, Michael C Peters, Loren C Denlinger, Wendy C Moore, Leonard B Bacharier, M Alison Marquis, Nathan M Gotman, Michael R Kosorok and 33 more

Open access · greenAbstract read
In one paragraph

Article in Journal of biopharmaceutical statistics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.2field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Clinical Trial Design Innovations for Precision Medicine in Asthma.Advances in experimental medicine and biology · 2023
    Article
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. National Asthma Education and Prevention Program 2020 Guideline Update: Where Do We Go from Here?American journal of respiratory and critical care medicine · 2021
    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

43 authors at 20 institutions in 1 country.

Anastasia IvanovaUniversity of North Carolina, Chapel Hill, NC.
Elliot IsraelBrigham and Women's Hospital and Harvard Medical School, Boston, MA.
Lisa M LaVangeUniversity of North Carolina, Chapel Hill, NC.
Michael C PetersUniversity of California, San Francisco.
Loren C DenlingerUniversity of Wisconsin, Madison.
Wendy C MooreWake Forest School of Medicine, Winston-Salem, NC.
Leonard B BacharierVanderbilt University, Nashville, TN.
M Alison MarquisUniversity of North Carolina, Chapel Hill, NC.
Nathan M GotmanUniversity of North Carolina, Chapel Hill, NC.
Michael R KosorokUniversity of North Carolina, Chapel Hill, NC.
Chalmer TomlinsonUniversity of North Carolina, Chapel Hill, NC.
David T MaugerPenn State University, Hershey, PA.
Steve N GeorasUniversity of Rochester, Rochester, NY.
Rosalind J WrightIcahn School of Medicine at Mount Sinai, New York, NY.
Patricia NoelDivision of Lung Diseases, National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Bethesda, MD.
Gary L RosnerSidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD.
Praveen AkuthotaUniversity of California, San Diego.
Dean BillheimerAsthma and Airway Disease Research Center, University of Arizona, Tucson.
Eugene R BleeckerAsthma and Airway Disease Research Center, University of Arizona, Tucson.
Juan Carlos CardetUniversity of South Florida, Tampa, FL.
Mario CastroUniversity of Kansas School of Medicine, Kansas City.
Emily A DiMangoColumbia University, New York, NY.
Serpil C ErzurumCleveland Clinic, Cleveland, OH.ORCID 0000-0001-5202-9065
John V FahyUniversity of California, San Francisco.
Merritt L FajtUniversity of Pittsburgh, Pittsburgh, PA.
Benjamin M GastonWells Center for Pediatric Research, Indiana University, Indianapolis.
Fernando HolguinUniversity of Colorado School of Medicine, Aurora.ORCID 0000-0003-0979-8234
Sonia JainUniversity of Colorado School of Medicine, Aurora.
Nicholas J KenyonUniversity of California, Davis.
Jerry A KrishnanUniversity of Illinois, Chicago.
Monica KraftAsthma and Airway Disease Research Center, University of Arizona, Tucson.
Rajesh KumarLurie Children's Hospital, Chicago, IL.
Mark C LiuJohns Hopkins University, Baltimore, MD.
Ngoc P LyBrigham and Women's Hospital and Harvard Medical School, Boston, MA.
James N MoyRush University Medical Center, Chicago, IL.
Wanda PhipatanakulBoston Children's Hospital and Harvard Medical School, Boston, MA.
Kristie RossUH Rainbow Babies and Children's Hospitals, Cleveland, OH.
Lewis J SmithNorthwestern University, Chicago, IL.
Stanley J SzeflerChildren's Hospital Colorado and University of Colorado School of Medicine, Aurora, CO.
W Gerald TeagueUniversity of Virginia, Charlottesville.
Michael E WechslerNational Jewish Health, Denver, CO, and University of Colorado School of Medicine, Aurora, CO.
Sally E WenzelUniversity of Pittsburgh, Pittsburgh, PA.
Steven R WhiteUniversity of Chicago, Chicago, IL.
University of North Carolina at Chapel Hill · USUniversity of Arizona · USBrigham and Women's Hospital · USJohns Hopkins University · USUniversity of California, San Francisco · USUniversity of Colorado Denver · USUniversity of Pittsburgh · USBoston Children's Hospital · USChildren's Hospital Colorado · USCleveland Clinic · USColumbia University · USIcahn School of Medicine at Mount Sinai · USIndiana University – Purdue University Indianapolis · USLurie Children's Hospital · USNational Institutes of Health · USNational Jewish Health · USNorthwestern University · USPenn State Milton S. Hershey Medical Center · USRainbow Babies & Children's Hospital · USRush University Medical Center · US

Funding

VISUAL INDICES OF NEUROTOXICITYP30ES001247 · UNIVERSITY OF ROCHESTER · 1985 to 2025
$10.5M
Frontiers Clinical and Translational Science Institute at the University of KansasUL1TR002366 · UNIVERSITY OF KANSAS MEDICAL CENTER · 2025 to 2025
$3.7M
UC Davis Environmental Health Sciences Core CenterP30ES023513 · UNIVERSITY OF CALIFORNIA AT DAVIS · 2025 to 2025
$1.6M
NCATS NIH HHS UL1 TR002366NHLBI NIH HHS K23 HL138303NHLBI NIH HHS U24 HL138998NHLBI NIH HHS UG1 HL139054NHLBI NIH HHS UG1 HL139098NHLBI NIH HHS UG1 HL139106NHLBI NIH HHS UG1 HL139117NHLBI NIH HHS UG1 HL139118NHLBI NIH HHS UG1 HL139119NHLBI NIH HHS UG1 HL139123NHLBI NIH HHS UG1 HL139124NHLBI NIH HHS UG1 HL139125NHLBI NIH HHS UG1 HL139126NIAID NIH HHS K23 AI125785NIEHS NIH HHS P30 ES001247NIEHS NIH HHS P30 ES023513
6 · The paper itself

Abstract

The Precision Interventions for Severe and/or Exacerbation-prone Asthma (PrecISE) study is an adaptive platform trial designed to investigate novel interventions to severe asthma. The study is conducted under a master protocol and utilizes a crossover design with each participant receiving up to five interventions and at least one placebo. Treatment assignments are based on the patients' biomarker profiles and precision health methods are incorporated into the interim and final analyses. We describe key elements of the PrecISE study including the multistage adaptive enrichment strategy, early stopping of an intervention for futility, power calculations, and the primary analysis strategy.

Indexed as

AsthmaAdaptive Clinical Trials as TopicBiomarkersHumansResearch DesignBiomarkersadaptive enrichmentcompexcovariate adaptive randomizationMaster protocolplatform trialsevere asthma

Identifiers

PMID32941098
PMCPMC7954787
OpenAlexW3087659366

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.