Development of a consensus extension of the estimands framework for cluster randomised trials (CRT-estimands): results from an international Delphi study.

ABSTRACT:

Background

Estimands are increasingly used in randomised trials to clarify research objectives. The ICH E9(R1) addendum sets out five attributes necessary to describe a well-defined estimand. However, the addendum was primarily developed for individually randomised trials. There is growing recognition that estimand descriptions for cluster randomised trials, where groups of individuals are randomised, may require specification of additional considerations. We conducted a Delphi study to assess stakeholder views on additional items for inclusion in a consensus extension of the ICH E9(R1) for cluster randomised trials.

Methods

We invited experts in estimands and cluster randomised trials to participate in a modified Delphi process to identify critical items for describing esti

SUBMITTER: Kahan BC 

PROVIDER: S-EPMC12822161 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature