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Assessing assumptions for statistical analyses in randomised clinical trials

Emil Eik Nielsen, Anders Kehlet Nørskov, Theis Lange, Lehana Thabane, Jørn Wetterslev, Jan Beyersmann, Jacobo de Uña-Álvarez, Valter Torri, Laurent Billot, Hein Putter, Per Winkel, Christian Gluud, Janus Christian Jakobsen

32 Citations (Scopus)

Abstract

In order to ensure the validity of results of randomised clinical trials and under some circumstances to optimise statistical power, most statistical methods require validation of underlying statistical assumptions. The present paper describes how trialists in major medical journals report tests of underlying statistical assumptions when analysing results of randomised clinical trials. We also consider possible solutions how to improve current practice by adequate reporting of tests of underlying statistical assumptions. We conclude that there is a need to reach consensus on which underlying assumptions should be assessed, how these underlying assumptions should be assessed and what should be done if the underlying assumptions are violated.

Original languageEnglish
JournalBMJ Evidence-Based Medicine
Volume24
Issue number5
Pages (from-to)185-189
Number of pages5
ISSN1356-5524
DOIs
Publication statusPublished - 4 Apr 2019

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