Evidence of unexplained discrepancies between planned and conducted statistical analyses: a review of randomised trials.

ABSTRACT:

Background

Choosing or altering the planned statistical analysis approach after examination of trial data (often referred to as 'p-hacking') can bias the results of randomised trials. However, the extent of this issue in practice is currently unclear. We conducted a review of published randomised trials to evaluate how often a pre-specified analysis approach is publicly available, and how often the planned analysis is changed.

Methods

A review of randomised trials published between January and April 2018 in six leading general medical journals. For each trial, we established whether a pre-specified analysis approach was publicly available in a protocol or statistical analysis plan and compared this to the trial publication.

Results

Overall, 89 of 101 eligible trials (

SUBMITTER: Cro S 

PROVIDER: S-EPMC7257229 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature