Evidence map›Paper›PMID 30335127›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2019

Interpretation of time-to-event outcomes in randomized trials: an online randomized experiment.

I R Weir, G D Marshall, J I Schneider, J A Sherer, E M Lord, B Gyawali, M K Paasche-Orlow, E J Benjamin, L Trinquart

Abstract read
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
–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

23 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Treatment Effect Measures for Culture Conversion Endpoints in Phase IIb Tuberculosis Treatment Trials.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
    Pooled it
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  10. Communicating Time-to-Event Treatment Effects in Randomized Trials: A Randomized Experiment among General Practitioners.Medical decision making : an international journal of the Society for Medical Decision Making · 2026
    Article
  11. Article
  12. Article
  13. Proportional Hazards Violations in Phase III Cancer Clinical Trials: A Potential Source of Trial Misinterpretation.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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  14. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

I R WeirDepartment of Biostatistics, Boston University School of Public Health, Boston.
G D MarshallDepartment of Biostatistics, Boston University School of Public Health, Boston; Division of General Pediatrics, Department of Medicine, Boston Children's Hospital, Boston.
J I SchneiderDepartment of Emergency Medicine, Boston Medical Center, Boston; Section of General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston.
J A ShererSection of General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston.
E M LordDepartment of Biostatistics, Boston University School of Public Health, Boston.
B GyawaliProgram on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston.
M K Paasche-OrlowSection of General Internal Medicine, Department of Medicine, Boston University School of Medicine, Boston.
E J BenjaminNational Heart, Lung, and Blood Institute's and Boston University's Framingham Heart Study, Framingham; Department of Epidemiology, Boston University School of Medicine, Boston, USA.
L TrinquartDepartment of Biostatistics, Boston University School of Public Health, Boston; National Heart, Lung, and Blood Institute's and Boston University's Framingham Heart Study, Framingham. Electronic address: ludovic@bu.edu.

Funding

Project-005UL1TR001430 · NCATS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI BAIR-MERRITT, MEGAN H, CENTER, DAVID M. · 2015 to 2024
$52.3M
Interdisciplinary Training for BiostatisticiansT32GM074905 · NIGMS · BOSTON UNIVERSITY MEDICAL CAMPUS · PI WHITE, LAURA FORSBERG · 2005 to 2019
$3.0M
NCATS NIH HHS UL1 TR001430NIGMS NIH HHS T32 GM074905
6 · The paper itself

Abstract

Background: Multiple features in the presentation of randomized controlled trial (RCT) results are known to influence comprehension and interpretation. We aimed to compare interpretation of cancer RCTs with time-to-event outcomes when the reported treatment effect measure is the hazard ratio (HR), difference in restricted mean survival times (RMSTD), or both (HR+RMSTD). We also assessed the prevalence of misinterpretation of the HR. Methods: We carried out a randomized experiment. We selected 15 cancer RCTs with statistically significant treatment effects for the primary outcome. We masked each abstract and created three versions reporting either the HR, RMSTD, or HR+RMSTD. We randomized corresponding authors of RCTs and medical residents and fellows to one of 15 abstracts and one of 3 versions. We asked how beneficial the experimental treatment was (0-10 Likert scale). All participants answered a multiple-choice question about interpretation of the HR. Participants were unaware of the study purpose. Results: We randomly allocated 160 participants to evaluate an abstract reporting the HR, 154 to the RMSTD, and 155 to both HR+RMSTD. The mean Likert score was statistically significantly lower in the RMSTD group when compared with the HR group (mean difference -0.8, 95% confidence interval, -1.3 to -0.4, P < 0.01) and when compared with the HR+RMSTD group (difference -0.6, -1.1 to -0.1, P = 0.05). In all, 47.2% (42.7%-51.8%) of participants misinterpreted the HR, with 40% equating it with a reduction in absolute risk. Conclusion: Misinterpretation of the HR is common. Participants judged experimental treatments to be less beneficial when presented with RMSTD when compared with HR. We recommend that authors present RMST-based measures alongside the HR in reports of RCT results.

Indexed as

NeoplasmsOnline SystemsRandomized Controlled Trials as TopicCombined Modality TherapyHumansPrognosisSurvival RateTime Factors

Identifiers

PMID30335127
PMCPMC6336004

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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 OpenQuestion graph.