Added Value of a Blinded Outcome Adjudication Committee in an Open-Label Randomized Stroke Trial.

ABSTRACT:

Background and purpose

Blinded outcome assessment in trials with prospective randomized open blinded end point design is challenging. Unblinding can result in misclassified outcomes and biased treatment effect estimates. An outcome adjudication committee assures blinded outcome assessment, but the added value for trials with prospective randomized open blinded end point design and subjective outcomes is unknown. We aimed to assess the degree of misclassification of modified Rankin Scale (mRS) scores by a central assessor and its impact on treatment effect estimates in a stroke trial with prospective randomized open blinded end point design.

Methods

We used data from the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the

SUBMITTER: van der Ende NAM 

PROVIDER: S-EPMC8700318 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature