Evidence map›Paper›PMID 34980616›Full record

ReviewBMJ open2022

Estimands: bringing clarity and focus to research questions in clinical trials.

Timothy Peter Clark, Brennan C Kahan, Alan Phillips, Ian White, James R Carpenter

Registry-linked trialAbstract readReview
In one paragraph

Review in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06567340 (StratCare Trial 2), which is not on this map. Cited by 35 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing 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.

NCT06567340 narecruitingnot on this mapstarted 2025, after this paper: background citation

StratCare Trial 2: Evaluating the Clinical and Cost-effectiveness of AI-driven Stratified Care for Depression

TypeinterventionalSponsorRotherham Doncaster and South Humber NHS Foundation TrustRan2025 to 2027Enrolled1,252ConditionsDepressionArmsStratCare
3 · Its place in the literature

Who cites it

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

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  13. 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
  14. Review
  15. Analysis and Reporting of Randomized Trials in Cleft Palate Surgery: Learning from the Timing of Primary Surgery (TOPS) Trial.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2025
    Article
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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

5 authors.

Timothy Peter ClarkMRC Clinical Trials Unit at UCL, London, UK tim.clark@ucl.ac.uk.ORCID 0000-0002-3783-6683
Brennan C KahanMRC Clinical Trials Unit at UCL, London, UK.
Alan PhillipsBiostatistics, ICON Clinical Research UK Ltd, Marlow, UK.
Ian WhiteMRC Clinical Trials Unit at UCL, London, UK.
James R CarpenterMRC Clinical Trials Unit at UCL, London, UK.

Funding

Medical Research Council MC_UU_00004/07Medical Research Council MC_UU_00004/09
6 · The paper itself

Abstract

Precise specification of the research question and associated treatment effect of interest is essential in clinical research, yet recent work shows that they are often incompletely specified. The ICH E9 (R1) Addendum on Estimands and Sensitivity Analysis in Clinical Trials introduces a framework that supports researchers in precisely and transparently specifying the treatment effect they aim to estimate in their clinical trial. In this paper, we present practical examples to demonstrate to all researchers involved in clinical trials how estimands can help them to specify the research question, lead to a better understanding of the treatment effect to be estimated and hence increase the probability of success of the trial.

Indexed as

Research DesignData Interpretation, StatisticalHumansProbabilitymedical education & trainingprotocols & guidelinesqualitative research

Identifiers

PMID34980616
PMCPMC8724703

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.