Tools to help patients and other stakeholders'input into choice of estimand and intercurrent event strategy in randomised trials
🤖 AI Summary
This study addresses the challenge that the complexity of estimands and associated intercurrent event strategies in randomized clinical trials often hinders effective engagement of patients and other stakeholders in design decisions. To bridge this gap, the project introduces— for the first time—a systematic, multimedia toolkit that translates the estimand framework into accessible formats through visualization and plain-language communication. The toolkit includes instructional videos, infographics, and editable slide decks, which collectively lower the cognitive barrier for non-specialists. By enhancing comprehension, it empowers patients and stakeholders to meaningfully participate in selecting appropriate estimands during trial design. This approach establishes an innovative communication paradigm that advances patient-centered clinical research.
Application Category
📝 Abstract
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 should be addressed in the estimand definition typically involve complex concepts as well as technical language. We three tools to facilitate conversations between researchers and patients and other stakeholders about the choice of estimand and intercurrent event strategy: (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. 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.
Problem
Research questions and friction points this paper is trying to address.
estimand
intercurrent event
randomised trials
stakeholder engagement
patient involvement
Innovation
Methods, ideas, or system contributions that make the work stand out.
estimand
intercurrent event
patient engagement
clinical trial design
decision support tools
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