Table 1 Our suggestions for a more valid assessment of intervention effects in a randomised clinical superiority trial

1 Calculate and report the confidence intervals and the exact P-values for each pre-specified outcome.

2 Calculate and report the Bayes factor (see Additional file 1: Table S1 for calculations) for the primary outcome. A Bayes factor less than 0.1 may be chosen as threshold for significance.

3 If the a priori estimated sample size has not been reached or if interim analyses have been conducted, then adjust the confidence intervals and the P-values accordingly.

4 If more than one outcome is used, if more than two intervention groups are compared, or if the primary outcome is assessed multiple times (and just one of these outcome comparisons must be significant to reject the overall null hypothesis), then the confidence intervals and the P-values should be adjusted accordingly.

5 If statistical significance has been obtained according to all of the first four points above then assess clinical significance of the trial results.