No worries! [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2012-02-08 14:37 (4881 d 14:28 ago) – Posting: # 8077
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Dear AB!

❝ PE is 100 and the number of subjects completed in the study were 70, the resulting CI was well within 80-125 with ISCV of 47%.

❝ could i suspect something wrong went in analysis?


I’m not a friend of post-hoc power calculations, but your result is not surprising:

library(PowerTOST)
power.TOST(theta0=1.00, CV=0.47, n=70, design="2x2x4")
[1] 0.9872979


According to Endrényi & Tóthfalusi, Table A2 (see there), you would have needed only 25 subjects (50% CV, PE 1.00) to show BE with 90% power.

❝ on the other hand if every thing was correct why do we need widening of CI?


You should follow the protocol. See the GL Section 4.1.10:

The request for widened interval must be prospectively specified in the protocol.

No worries; you wasted only money.

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