Blinding of outcome assessors and its association with outcome in a randomized open-label stroke trial.

ABSTRACT:

Background

It is challenging for outcome assessors to remain blinded during outcome assessment in trials with prospective randomized open blinded endpoint (PROBE) design. If assessors are able to guess the correct treatment allocation more often than expected based on chance, the assessors may have been not properly blinded.

Aims

We aimed to assess blinding of outcome assessors in a stroke trial with PROBE design and its association with outcome.

Methods

We used data of the Interventional Management of Stroke (IMS) III trial. The modified Rankin Scale (mRS) at 90 days was assessed by local assessors who were unaware of treatment allocation. To assess success of blinding, each assessor was asked to guess the patient's treatment allocation. We assessed whether the perce

SUBMITTER: van der Ende NA 

PROVIDER: S-EPMC10196921 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature