I’ve been digesting the results since they dropped and have also watched the Webinar a couple of times. I’ve been waiting to see if any of the regular posters would bring up an issue that has been bothering me. Nobody has said much about it at this stage so it’s likely of no concern but I would be grateful for others point of view.The results of the 2 mg/kg iPPS twice weekly for 6 weeks reported clinically meaningful outcomes at 12 months (Day 365) compared to placebo as follows:
Significant pain reduction (p=0.054).
Significant function improvement (p=0.048.
Significant improvement in overall WOMAC scores (p=0.054).
Highly statistically significant improvement for Patient Global Impression of Change (PGIC) (p=0.005)
From my very, very basic knowledge of statistics, I immediately recognised that two are above the magical value of 5%. I consulted with trusty Google and did a bit of reading and on the surface it would appear that the reduction from baseline in WOMAC (p=0.054) and the overall WOMAC score (p=0.054) are not statistically significant and would indicate that the null hypothesis is confirmed rather than rejected. I understand that both of these results are very close to statistical significance but I still would have loved to have seen them both under 5%.My question for those with knowledge of statistics is, will these values above 5% reduce as the value of “n” increases? I note that “n = 19” for these results which is a small sample.
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