Evidence map›Paper›PMID 32927092›Full record

ArticleContemporary clinical trials2020

Selecting appropriate endpoints for assessing treatment effects in comparative clinical studies for COVID-19.

Zachary R McCaw, Lu Tian, Kevin N Sheth, Wan-Ting Hsu, W Taylor Kimberly, Lee-Jen Wei

Abstract read
In one paragraph

Article in Contemporary clinical trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Evaluating Primary Endpoints for COVID-19 Therapeutic Trials to Assess Recovery.American journal of respiratory and critical care medicine · 2022
    Article
  5. Review
  6. Article
  7. Article
  8. Guest editors-in-chief note to COVID-19 special issue.Contemporary clinical trials · 2021
    Article
  9. Article
  10. 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

6 authors.

Zachary R McCawGoogle, Mountain View, CA, United States of America.
Lu TianDepartment of Biomedical Data Science, Stanford University, Stanford, CA, United States of America.
Kevin N ShethDivision of Neurocritical Care and Emergency Neurology, Yale School of Medicine, New Haven, CT, United States of America.
Wan-Ting HsuMedical Wizdom, LLC, Brookline, MA, United States of America.
W Taylor KimberlyDivision of Neurocritical Care, Department of Neurology, Massachusetts General Hospital, Boston, MA, United States of America.
Lee-Jen WeiHarvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: wei@hsph.harvard.edu.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Statistical Methods for Optimizing Personalized Treatment SelectionR01HL089778 · NHLBI · STANFORD UNIVERSITY · PI LU TIAN · 2008 to 2026
$4.8M
NCATS NIH HHS UL1 TR001863NHLBI NIH HHS R01 HL089778
6 · The paper itself

Abstract

To evaluate the efficacy and safety of a new treatment for COVID-19 vs. standard care, certain key endpoints are related to the duration of a specific event, such as hospitalization, ICU stay, or receipt of supplemental oxygen. However, since patients may die in the hospital during study follow-up, using, for example, the duration of hospitalization to assess treatment efficacy can be misleading. If the treatment tends to prolong patients' survival compared with standard care, patients in the new treatment group may spend more time in hospital. This can lead to a "survival bias" issue, where a treatment that is effective for preventing death appears to prolong an undesirable outcome. On the other hand, by using hospital-free survival time as the endpoint, we can circumvent the survival bias issue. In this article, we use reconstructed data from a recent, large clinical trial for COVID-19 to illustrate the advantages of this approach. For the analysis of ICU stay or oxygen usage, where the initiating event is potentially an outcome of treatment, standard survival analysis techniques may not be appropriate. We also discuss issues with analyzing the durations of such events.

Indexed as

Clinical Trials as TopicCOVID-19Duration of TherapyPatient Care ManagementSurvival AnalysisBiasEndpoint DeterminationHospitalizationHumansIntensive Care UnitsOxygen Inhalation TherapySARS-CoV-2

Identifiers

PMID32927092
PMCPMC7486285

What OpenQuestion holds

Textmetadata
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.