Evidence map›Paper›PMID 32900372›Full record

ArticleBMC medicine2020

Treatment estimands in clinical trials of patients hospitalised for COVID-19: ensuring trials ask the right questions.

Brennan C Kahan, Tim P Morris, Ian R White, Conor D Tweed, Suzie Cro, Darren Dahly, Tra My Pham, Hanif Esmail, Abdel Babiker, James R Carpenter

Abstract read
In one paragraph

Article in BMC medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Estimands for factorial trials.Statistics in medicine · 2022
    Trial
  3. Article
  4. Making Sense of Hierarchical Composite End Points in Randomized Clinical Trials-A Primer for Infectious Diseases Clinicians and Researchers.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Eliminating Ambiguous Treatment Effects Using Estimands.American journal of epidemiology · 2023
    Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Review
  17. Article
  18. Article
  19. 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

10 authors.

Brennan C KahanMRC Clinical Trials Unit at UCL, London, UK. b.kahan@ucl.ac.uk.
Tim P MorrisMRC Clinical Trials Unit at UCL, London, UK.
Ian R WhiteMRC Clinical Trials Unit at UCL, London, UK.
Conor D TweedMRC Clinical Trials Unit at UCL, London, UK.
Suzie CroImperial Clinical Trials Unit, Imperial College London, London, UK.
Darren DahlyHRB Clinical Research Facility Cork, Cork, Ireland.
Tra My PhamMRC Clinical Trials Unit at UCL, London, UK.
Hanif EsmailMRC Clinical Trials Unit at UCL, London, UK.
Abdel BabikerMRC Clinical Trials Unit at UCL, London, UK.
James R CarpenterMRC Clinical Trials Unit at UCL, London, UK.

Funding

Medical Research Council MC_UU_12023/21Medical Research Council MC_UU_12023/27Medical Research Council MC_UU_12023/29
6 · The paper itself

Abstract

When designing a clinical trial, explicitly defining the treatment estimands of interest (that which is to be estimated) can help to clarify trial objectives and ensure the questions being addressed by the trial are clinically meaningful. There are several challenges when defining estimands. Here, we discuss a number of these in the context of trials of treatments for patients hospitalised with COVID-19 and make suggestions for how estimands should be defined for key outcomes. We suggest that treatment effects should usually be measured as differences in proportions (or risk or odds ratios) for outcomes such as death and requirement for ventilation, and differences in means for outcomes such as the number of days ventilated. We further recommend that truncation due to death should be handled differently depending on whether a patient- or resource-focused perspective is taken; for the former, a composite approach should be used, while for the latter, a while-alive approach is preferred. Finally, we suggest that discontinuation of randomised treatment should be handled from a treatment policy perspective, where non-adherence is ignored in the analysis (i.e. intention to treat).

Indexed as

BetacoronavirusClinical Trials as TopicCoronavirus InfectionsCOVID-19COVID-19 Drug TreatmentHospitalizationHumansOdds RatioPandemicsPneumonia, ViralResearch DesignSARS-CoV-2COVID-19EstimandIntercurrent eventsRandomised trialTruncation-by-death

Identifiers

PMID32900372
PMCPMC7478913

What OpenQuestion holds

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LicenceCC BY
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.