In this case, with 60 patients in each group, the study had 89% power at 5% significance to detect a clinically significance difference (20%) to be no inferior FP group versus specialist care group.
With 41 subjects in each group, the study had 90% power at 5% significance (2-sided) for difference = 0 versus difference = 0.72, to detect a clinically significance difference (10%) in the HbA1c value between both FP group and specialist care group.
Of those included in the cohort, 457/1931 samples had a reportable microarray result (23.7%) (ie, clinically significant, uncertain clinical significance, likely significant, uncertain clinical significance, uncertain clinical significance, likely benign), and 1474/1931 results (76.3%) were considered benign.
In addition, we used a narrow characterization of uncertainty: (i) clinically significant+uncertain clinical significance, likely significant, (ii) uncertain clinical significance, and (iii) uncertain clinical significance, likely benign+benign.
CNV classifications were: (i) clinically significant, (ii) uncertain clinical significance, likely significant, (iii) uncertain clinical significance, (iv) uncertain clinical significance, likely benign, and (v) benign.
For CMA type, we first constructed a five-level variable characterizing result types as: (i) clinically significant, (ii) uncertain clinical significance, likely significant, (iii) uncertain clinical significance, (iv) uncertain clinical significance, likely benign, and (v) benign.
The threshold for clinical significance or minimal clinically significant difference (MCSD) on the SGRQ total score is a change in 4 units [ 32].
Interested in the effect of characterizing uncertainty in different ways, we then constructed a broad characterization of uncertainty: (i) clinically significant, (ii) uncertain clinical significance, likely significant+uncertain clinical significance+uncertain clinical significance, likely benign, and (iii) benign.
bArrows show directions of association with HSV-2; '?' denotes borderline statistical significance or clinically significant differences not meeting statistical significance.
Overall, 24.8% of the CMA results were clinically significant/likely clinically significant, 25.7% were of uncertain clinical significance, and 49.6% were uncertain clinical significance, likely benign/benign.
If we doubled our sample size to 800 anticoagulation-free treatments and had the same 1% clotting rate, and were able to compare it with 800 anticoagulated treatments in which 0% clotting occurred, this would achieve statistical significance at P = 0.01, but one could question if this statistical significance is clinically significant or certainly worth the risks associated with anticoagulation.
