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Therefore, we considered reasonable to assume a difference in BMI of 0,6 kg/m between control and intervention group.
A comparison between the control group and the intervention groups will require 72 persons in the control group, if we assume a difference of at least 20%.
If we assume a difference of 10% (a difference of 4.4 EMS calls per 100 residents per year) between the intervention and control groups, with 0.8 β and α of 0.05, we would need a sample of 131 per group.
Table 1 shows the timing of the outcome assessment We assume a difference of more than 5° of knee flexion mobility (SD 8°) at the end of the CPM application to be clinically relevant.
Since the PORPUS-P has a 0 to 100 point scale, we assume a difference of 5 points is clinically relevant (but further studies have to validate this assumption).
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One long-standing issue about ambiguity is that it assumes a difference between something like sense and reference.
We assumed a difference of 1.5 days between both groups with a standard deviation (SD) of 1.5, based on prior preventive clinical trial studies.
Assuming a difference in prevalence of 12%, using a power of 0.80 and a significance level of 5%, a minimum of 280 patients without side shift had to be included in the present study.
The power of the study was 85% with n = 20 in each group, α = 0.05, assuming a difference in PaO2 of 25% with a standard deviation at 0.25 of mean.
In the design phase of this trial, we assumed a difference of 15 points between groups to be clinically relevant.
For the a priori power calculations, we assumed a difference between mean glucose incremental AUC of at least 20% and an SD of the difference of 18%.
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