Evidence map›Paper›PMID 37408080›Full record

ArticleTrials2023

Starting a conversation about estimands with public partners involved in clinical trials: a co-developed tool.

Suzie Cro, Brennan C Kahan, Akshaykumar Patel, Ania Henley, Joanna C, Paul Hellyer, Manos Kumar, Yasmin Rahman, Beatriz Goulão

Open access · goldAbstract read
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
11.8field-weighted citation impact, top 1% 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

11 citing papers in PubMed, 27 citations in OpenAlex.

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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

9 authors at 4 institutions in 1 country.

Suzie CroImperial Clinical Trials Unit, Imperial College London, London, UK. s.cro@imperial.ac.uk.ORCID http://orcid.org/0000-0002-6113-1173
Brennan C KahanMRC Clinical Trials Unit at UCL, London, UK.
Akshaykumar PatelCritical Care and Perioperative Medicine Research Group, Queen Mary University, London, UK.
Ania HenleyHEALTHY STATS Public Partner Co-Chair with Imperial Clinical Trials Unit, Imperial College London, London, UK.
Joanna CHEALTHY STATS Public Partner with Imperial Clinical Trials Unit, Imperial College London, London, UK.
Paul HellyerHEALTHY STATS Public Partner with Imperial Clinical Trials Unit, Imperial College London, London, UK.
Manos KumarHEALTHY STATS Public Partner with Imperial Clinical Trials Unit, Imperial College London, London, UK.
Yasmin RahmanHEALTHY STATS Public Partner with Imperial Clinical Trials Unit, Imperial College London, London, UK.
Beatriz GoulãoHealth Services Research Unit, University of Aberdeen, Aberdeen, UK.
Imperial College London · GBMRC Clinical Trials Unit at UCL · GBQueen Mary University of London · GBUniversity of Aberdeen · GB

Funding

Chief Scientist Office HSRU1Medical Research Council MC_UU_00004/07Medical Research Council MC_UU_00004/09
6 · The paper itself

Abstract

backgroundClinical trials aim to draw conclusions about the effects of treatments, but a trial can address many different potential questions. For example, does the treatment work well for patients who take it as prescribed? Or does it work regardless of whether patients take it exactly as prescribed? Since different questions can lead to different conclusions on treatment benefit, it is important to clearly understand what treatment effect a trial aims to investigate-this is called the 'estimand'. Using estimands helps to ensure trials are designed and analysed to answer the questions of interest to different stakeholders, including patients and public. However, there is uncertainty about whether patients and public would like to be involved in defining estimands and how to do so. Public partners are patients and/or members of the public who are part of, or advise, the research team. We aimed to (i) co-develop a tool with public partners that helps explain what an estimand is and (ii) explore public partner's perspectives on the importance of discussing estimands during trial design.

methodsAn online consultation meeting was held with 5 public partners of mixed age, gender and ethnicities, from various regions of the UK. Public partner opinions were collected and a practical tool describing estimands, drafted before the meeting by the research team, was developed. Afterwards, the tool was refined, and additional feedback sought via email.

resultsPublic partners want to be involved in estimand discussions. They found an introductory tool, to be presented and described to them by a researcher, helpful for starting a discussion about estimands in a trial design context. They recommended storytelling, analogies and visual aids within the tool. Four topics related to public partners' involvement in defining estimands were identified: (i) the importance of addressing questions that are relevant to patients and public in trials, (ii) involving public partners early on, (iii) a need for education and communication for all stakeholders and (iv) public partners and researchers working together.

conclusionsWe co-developed a tool for researchers and public partners to use to facilitate the involvement of public partners in estimand discussions.

Indexed as

CommunicationResearch DesignClinical Trials as TopicEducational StatusHumansResearch PersonnelUncertaintyClinical trialEstimandPatient and public involvement

Identifiers

PMID37408080
PMCPMC10324181
OpenAlexW4383302811

What Socratic holds

Textmetadata
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 Socratic graph.