Evidence map›Paper›PMID 30661240›Full record

ArticleClinical pharmacology and therapeutics2019

Demonstrating Heterogeneity of Treatment Effects Among Patients: An Overlooked but Important Step Toward Precision Medicine.

Jennifer S Gewandter, Michael P McDermott, Hua He, Shan Gao, Xueya Cai, John T Farrar, Nathaniel P Katz, John D Markman, Stephen Senn, Dennis C Turk and 1 more

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
–field-weighted citation impact
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

24 citing papers in PubMed.

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  13. Design, analysis, and interpretation of treatment response heterogeneity in personalized nutrition and obesity treatment research.Obesity reviews : an official journal of the International Association for the Study of Obesity · 2023 · on this map
    Review
  14. Review
  15. Causal models and causal modelling in obesity: foundations, methods and evidence.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2023
    Review
  16. Review
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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

11 authors.

Jennifer S GewandterDepartment of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.ORCID 0000-0001-7938-6775
Michael P McDermottDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.
Hua HeDepartment of Epidemiology, Tulane University, New Orleans, Louisiana, USA.
Shan GaoDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.
Xueya CaiDepartment of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.
John T FarrarDepartment of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Nathaniel P KatzAnalgesic Solutions, Natick, Massachusetts, USA.
John D MarkmanDepartment of Neurosurgery, University of Rochester, Rochester, New York, USA.
Stephen SennLuxembourg Institute of Health, Strassen, Luxembourg.
Dennis C TurkDepartment of Anesthesiology & Pain Medicine, University of Washington, Seattle, Washington, USA.
Robert H DworkinDepartment of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.

Funding

Combined Behavioral & Analgesic Trial for Fibromyalgia (COMBAT-FM)R01AR059102 · NIAMS · UNIVERSITY OF WASHINGTON · PI DWORKIN, ROBERT H, ROBINSON, JAMES · 2011 to 2015
$5.5M
Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) Public-Private PartnershipU01FD005936 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2016 to 2020
$2.5M
Analgesic Clinical Trial Innovations,Opportunities,and Networks(ACTION)U01FD004187 · FDA · UNIVERSITY OF ROCHESTER · PI DWORKIN, ROBERT H · 2011 to 2014
$1.8M
FDA HHS U01 FD004187FDA HHS U01 FD005936FDA HHS U01 FD007474NIAMS NIH HHS R01 AR059102
6 · The paper itself

Abstract

Although heterogeneity in the observed outcomes in clinical trials is often assumed to reflect a true heterogeneous response, it could actually be due to random variability. This retrospective analysis of four randomized, double-blind, placebo-controlled multiperiod (i.e., episode) crossover trials of fentanyl for breakthrough cancer pain illustrates the use of multiperiod crossover trials to examine heterogeneity of treatment response. A mixed-effects model, including fixed effects for treatment and episode and random effects for patient and treatment-by-patient interaction, was used to assess the heterogeneity in patients' responses to treatment during each episode. A significant treatment-by-patient interaction was found for three of four trials (P < 0.05), suggesting heterogeneity of the effect of fentanyl among different patients in each trial. Similar analyses in other therapeutic areas could identify conditions and therapies that should be investigated further for predictors of treatment response in efforts to maximize the efficiency of developing precision medicine strategies.

Indexed as

Analgesics, OpioidCancer PainCross-Over StudiesDouble-Blind MethodFentanylHumansPrecision MedicineRandomized Controlled Trials as TopicAnalgesics, OpioidFentanyl

Identifiers

PMID30661240
PMCPMC6784315

What OpenQuestion holds

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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 OpenQuestion graph.