Hey,
I have been doing an a priori sample size calculation but the figures I get are so small that I am no sure that they are correct. The primary outcome parameter is a PROM (max 100). I have the following values from a preliminary study for the intervention:
Mean±SD: 96±4
Sample siz: 39 patients
And I have the minimal clinically relevant change for the PROM, which would be 6.8
What would be the sample size I need, if I just want to hit the minimal clinically relevant change.
Thanks for you help!