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Sample size estimation

CM Claudia Di Muzio
IC Ilenia Di Cola
AP Azadeh Shariat Panahi
FU Francesco Ursini
AI Annamaria Iagnocco
RG Roberto Giacomelli
PC Paola Cipriani
PR Piero Ruscitti
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The primary outcome of our study was the change in HOMA2-IR after 6 months of treatment with tofacitinib. To this purpose, we have calculated a sample size of at least 7 patients to detect a difference between pre- and post-treatment values of at least 1 unit of change in HOMA2-IR, according to data published in studies investigating the effect of different bDMARDs on IR [18, 19]. The sample size has been adjusted to 10 patients to account for possible dropouts. Our study was specifically designed to evaluate a difference between pre- and post-treatment of HOMA-IR of 1 unit after 6 months of treatment, not on the proposed estimated means; therefore, we could not provide the standard deviation. For this calculation, the power was set at 80% and the confidence level at 95%. To cover all possible clinical scenarios, 4 groups of patients were assessed, collectively resulting in a planned sample size of 40 patients.

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