Exclusion of enrolled participants in randomised controlled trials: what to do with ineligible participants?

ABSTRACT:

Objective

Post-randomisation exclusions in randomised controlled trials are common and may include participants identified as not meeting trial eligibility criteria after randomisation. We report how a decision might be reached and reported on, to include or exclude these participants. We illustrate using a motivating scenario from the BREATHE trial (Trial registration ClinicalTrials.gov, NCT02426112) evaluating azithromycin for the treatment of chronic lung disease in people aged 6-19 years with HIV in Zimbabwe and Malawi.

Key points

Including all enrolled and randomised participants in the primary analysis of a trial ensures an unbiased estimate of the intervention effect using intention-to-treat principles, and minimises the effects of confounding through balanced allocat

SUBMITTER: Rehman AM 

PROVIDER: S-EPMC7713189 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature