Randomized in error in pragmatic clinical trials.

ABSTRACT:

Background

Pragmatic trials that combine electronic health record data and patient-reported data may be subject to selection bias due to the differential post-randomization exclusion of participants who are randomized in error. Such situations are often caused by inevitable reasons, such as incomplete patient medical records at the pre-randomization stage. This can lead to participants in the intervention arm being identified as ineligible after randomization, while randomized-in-error participants in the usual care are often not discernable. The differential exclusion can present analytic challenges and threaten result validity.

Methods

Under the potential outcomes framework, we developed a Bayesian model that jointly identifies the randomized-in-error status and estimates

SUBMITTER: Tong G 

PROVIDER: S-EPMC11752791 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature