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To proceed after the first stage, responses from seven of 19 patients were needed.
In case series, a minimum of three patients were needed with at least one patient in each treatment arm to be analyzed.
With a standard deviation of 20, a type I error of 0.05, and 80% power, 28 patients were needed per arm.
We considered that 50 patients were needed in the non-survivors group to perform a multivariate analysis with ten variables [13].
We calculated with the method of Obuchowsky et al. [17] that 39 patients were needed in order to detect an area under the ROC curve of 0.75 with a power of 0.9 and an alpha risk of 0.05.
A recent study that used this score in ICU intensivists showed that 31 supervised TEEs in mechanically ventilated ICU patients were needed to reliably achieve competence in advanced critical-care TEE [38].
The sample size calculation showed that 24 patients were needed, and to increase the power even more, it was decided to select 25 and 27 patients for each of the experimental groups.
According to previous results [2], we calculated that 22 patients were needed to show an increase of 20% in sublingual PVD, in response to the fluid challenge, with a power of 80% and a certainty of 95%.
With 90% power and a two-sided type 1 error of 5%, we calculated that 354 patients were needed in each of the treatment arms.
To detect a correlation coefficient of 0.3 between UIE and fetal thyroid size, with alpha set at 2.5% and beta at 10%, 110 patients were needed.
Based on these assumptions, 2035 intervention patients were needed.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com