Outcome assessment by central adjudicators in randomised stroke trials: Simulation of differential and non-differential misclassification.

ABSTRACT:

Introduction

Adjudication of the primary outcome in randomised trials is thought to control misclassification. We investigated the amount of misclassification needed before adjudication changed the primary trial results.Patients (or materials) and methods: We included data from five randomised stroke trials. Differential misclassification was introduced for each primary outcome until the estimated treatment effect was altered. This was simulated 1000 times. We calculated the between-simulation mean proportion of participants that needed to be differentially misclassified to alter the treatment effect. In addition, we simulated hypothetical trials with a binary outcome and varying sample size (1000-10,000), overall event rate (10%-50%) and treatment effect (0.67-0.90). We int

SUBMITTER: Godolphin PJ 

PROVIDER: S-EPMC7313361 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature