Revised ITT analysis of Swedish RCT shows unchanged significant effect

The objective of this revision was to compare the results of the current standard intention-to-treat (ITT) analysis with the results of the previously published Swedish randomised controlled trial (RCT), and to perform a retrospective quality control and reanalysis of the data.

The revision included a renewed extraction of data from the original database, with the addition of 350 cases compared to the modified ITT analysis in the first publication. All cases with low Apgar score, low cord pH and/or admittance to neonatal care in the original database were checked with the aim of detecting any missing cases of asphyxia in the original analysis.

 

 

 

 

 

In conclusion the authors state that when adding ST Analysis to CTG, the impact on adverse neonatal outcome remained significant regardless of the method for the ITT analysis.

 

 

In the same issue of the journal, the difficulties and pitfalls involved in analysing data from randomised trials were commented by the Editor in Chief of the journal.

Abstract – Amer-Wahlin et al. 2011

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