Evidence map›Paper›PMID 31563252›Full record

ArticleValue in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research2019

A Value of Information Analysis of Research on the 21-Gene Assay for Breast Cancer Management.

Natalia R Kunst, Fernando Alarid-Escudero, A David Paltiel, Shi-Yi Wang

Open access · greenAbstract read
In one paragraph

Article in Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
0.8field-weighted citation impact, top 32% 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

12 citing papers in PubMed, 20 citations in OpenAlex.

  1. Review
  2. Article
  3. Accurate EVSI Estimation for Nonlinear Models Using the Gaussian Approximation Method.Medical decision making : an international journal of the Society for Medical Decision Making · 2024
    Article
  4. Article
  5. Article
  6. Cost-Effectiveness Analysis of the Oncotype DX Breast Recurrence ScoreClinicoEconomics and outcomes research : CEOR · 2024
    Article
  7. Article
  8. Article
  9. A Value-of-Information Framework for Personalizing the Timing of Surveillance Testing.Medical decision making : an international journal of the Society for Medical Decision Making · 2022
    Article
  10. Review
  11. Early Cost-effectiveness Analysis of Risk-Based Selection Strategies for Adjuvant Treatment in Stage II Colon Cancer: The Potential Value of Prognostic Molecular Markers.Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology · 2021
    Article
  12. Computing the Expected Value of Sample Information Efficiently: Practical Guidance and Recommendations for Four Model-Based Methods.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2020
    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

4 authors at 3 institutions in 4 countries.

Natalia R KunstDepartment of Health Management and Health Economics, University of Oslo, Oslo, Norway; Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA; Department of Epidemiology and Biostatistics, Amsterdam UMC, Amsterdam, the Netherlands; LINK Medical Research, Oslo, Norway. Electronic address: n.r.kunst@medisin.uio.no.
Fernando Alarid-EscuderoDrug Policy Program, Center for Research and Teaching in Economics (CIDE), Aguascalientes, Mexico; National Council on Science and Technology (CONACyT), Mexico City, Mexico.
A David PaltielDepartment of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA.
Shi-Yi WangDepartment of Chronic Disease Epidemiology, Yale University School of Public Health, New Haven, CT, USA; Cancer Outcomes, Public Policy, and Effectiveness Research Center, Yale Cancer Center and Yale University School of Medicine, New Haven, CT, USA.
Consejo Nacional de Humanidades, Ciencias y Tecnologías · MXUniversity of Oslo · NOYale Cancer Center · US

Funding

Making Better Decisions: Policy Modeling for AIDS and Drug AbuseR01DA015612 · NIDA · STANFORD UNIVERSITY · PI OWENS, DOUGLAS K · 2002 to 2017
$9.4M
Making Better Decisions: Policy Modeling for AIDS and Drug AbuseR37DA015612 · NIDA · STANFORD UNIVERSITY · PI DOUGLAS K OWENS · 2019 to 2026
$6.3M
Comparative Modeling of Colorectal Cancer: Informing Health Policies and Prioritizing Future ResearchU01CA199335 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI KUNTZ, KAREN M, LANSDORP-VOGELAAR, IRIS · 2015 to 2019
$5.5M
Novel approaches to the design and evaluation of combination HIV preventionR01MH105203 · NIMH · YALE UNIVERSITY · PI PALTIEL, A. DAVID · 2014 to 2018
$3.3M
AHRQ HHS K01 HS023900NCI NIH HHS U01 CA199335NIDA NIH HHS R01 DA015612NIDA NIH HHS R37 DA015612NIMH NIH HHS R01 MH105203
6 · The paper itself

Abstract

objectivesThe 21-gene assay Oncotype DX (21-GA) shows promise as a guide in deciding when to initiate adjuvant chemotherapy in women with hormone receptor-positive early-stage breast cancer. Nevertheless, its routine use remains controversial, owing to insufficient evidence of its clinical utility and cost-effectiveness. Accordingly, we aim to quantify the value of conducting further research to reduce decision uncertainty in the use of the 21-GA.

methodsUsing value of information methods, we first generated probability distributions of survival and costs for decision making with and without the 21-GA alongside traditional risk prediction. These served as the input to a comparison of 3 alternative study designs: a retrospective observational study to update risk classification from the 21-GA, a prospective observational study to estimate prevalence of chemotherapy use, and a randomized controlled trial (RCT) of the 21-GA predictive value.

resultsWe found that current evidence strongly supports the use of the 21-GA in intermediate- and high-risk women. Further research should focus on low-risk women, among whom the cost-effectiveness findings remained equivocal. For this population, we identified a high value of reducing uncertainty in the 21-GA use for all proposed research studies. The RCT had the greatest potential to efficiently reduce the likelihood of choosing a suboptimal strategy, providing a value between $162 million and $1.1 billion at willingness-to-pay thresholds of $150 000 to $200 000/quality-adjusted life years.

conclusionFuture research to inform 21-GA decision making is of high value. The RCT of the 21-GA predictive value has the greatest potential to efficiently reduce decision uncertainty around 21-GA use in women with low-risk early-stage breast cancer.

Indexed as

Genetic ResearchBiomarkers, TumorBreast NeoplasmsChemotherapy, AdjuvantCost-Benefit AnalysisDecision MakingFemaleGene Expression ProfilingGene Expression Regulation, NeoplasticHumansMarkov ChainsNeoplasm Recurrence, LocalPrecision MedicineProspective StudiesBiomarkers, Tumor21-gene assaybreast cancercost-effectivenessdecision makingdecision uncertaintygene expression profilingprecision medicineresearch design and prioritizationvalue of information

Identifiers

PMID31563252
PMCPMC7343670
OpenAlexW2965569600

What OpenQuestion holds

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LicenceTDM
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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.