Tools to help patients and other stakeholders’ input into choice of intercurrent event strategy for estimands in randomised trials
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Published version
Author(s)
Type
Journal Article
Abstract
Background
Estimands can help to clarify the research questions being addressed in randomised trials. Because the choice of estimand can affect how relevant trial results are to patients and other stakeholders, such as clinicians or policymakers, it is important for them to be involved in these decisions. However, there are barriers to having these conversations. For instance, discussions around how intercurrent events (post-randomisation events which affect the interpretation or existence of the outcome) should be addressed in the estimand definition typically involve complex concepts as well as technical language. We aimed to provide tools that could facilitate conversations between researchers and patients and other stakeholders about the choice of intercurrent event strategy for estimands.
Methods
We developed three tools: (i) a video explaining the concept of an estimand and the five different ways that intercurrent events can be incorporated into the estimand definition; (ii) an infographic outlining these five strategies; and (iii) an editable PowerPoint slide which can be completed with trial-specific details to facilitate conversations around choice of estimand for a particular trial. Each tool was produced through collaboration between researchers and public partners. This involved (i) an initial meeting between researchers and public partners to discuss the aims of the tool; (ii) a draft of the tool being prepared by the research team; (iii) public partners providing feedback; and (iv) the research team updating and finalising the tool.
Results
These resources can help to start conversations between the trial team and patients and other stakeholders about the best choice of estimand and intercurrent event strategies for a randomised trial. The video and infographic—which explain estimands and intercurrent events with reference to imagined examples—can be sent to stakeholders in advance of a consultation, or presented in the meeting itself. It is important that a member of the trial team is available to answer questions or clarify concepts following this. The editable slide can be completed by the trial team with the specific details of their trial, and then shown to patients or other stakeholders during the meeting to facilitate discussion around which intercurrent event strategy is most relevant for the trial. An example of a completed editable slide is also provided for an example weight loss trial.
Conclusions
We developed three tools to help researchers to have conversations with patients and other stakeholders about estimands, and how intercurrent events should be incorporated into the target estimand for a randomised trial. Further work to evaluate the tools in real-world settings across different stakeholder groups could help to validate the tools and reveal any further refinements necessary to improve their utility.
Estimands can help to clarify the research questions being addressed in randomised trials. Because the choice of estimand can affect how relevant trial results are to patients and other stakeholders, such as clinicians or policymakers, it is important for them to be involved in these decisions. However, there are barriers to having these conversations. For instance, discussions around how intercurrent events (post-randomisation events which affect the interpretation or existence of the outcome) should be addressed in the estimand definition typically involve complex concepts as well as technical language. We aimed to provide tools that could facilitate conversations between researchers and patients and other stakeholders about the choice of intercurrent event strategy for estimands.
Methods
We developed three tools: (i) a video explaining the concept of an estimand and the five different ways that intercurrent events can be incorporated into the estimand definition; (ii) an infographic outlining these five strategies; and (iii) an editable PowerPoint slide which can be completed with trial-specific details to facilitate conversations around choice of estimand for a particular trial. Each tool was produced through collaboration between researchers and public partners. This involved (i) an initial meeting between researchers and public partners to discuss the aims of the tool; (ii) a draft of the tool being prepared by the research team; (iii) public partners providing feedback; and (iv) the research team updating and finalising the tool.
Results
These resources can help to start conversations between the trial team and patients and other stakeholders about the best choice of estimand and intercurrent event strategies for a randomised trial. The video and infographic—which explain estimands and intercurrent events with reference to imagined examples—can be sent to stakeholders in advance of a consultation, or presented in the meeting itself. It is important that a member of the trial team is available to answer questions or clarify concepts following this. The editable slide can be completed by the trial team with the specific details of their trial, and then shown to patients or other stakeholders during the meeting to facilitate discussion around which intercurrent event strategy is most relevant for the trial. An example of a completed editable slide is also provided for an example weight loss trial.
Conclusions
We developed three tools to help researchers to have conversations with patients and other stakeholders about estimands, and how intercurrent events should be incorporated into the target estimand for a randomised trial. Further work to evaluate the tools in real-world settings across different stakeholder groups could help to validate the tools and reveal any further refinements necessary to improve their utility.
Date Issued
2026-07-01
Date Acceptance
2026-05-01
Citation
Trials, 2026, 27
ISSN
1745-6215
Publisher
BMC
Journal / Book Title
Trials
Volume
27
Copyright Statement
© The Author(s) 2026. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
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Publication Status
Published
Article Number
458
Date Publish Online
2026-05-08