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This is an open-label trial with an intended sample size of 100 patients.
Of an intended sample size of 550, 527 persons (291 in primary care and 236 in secondary care) agreed to participate.
However, to account for an estimated 15% loss during patient follow-up, the sample size was increased by 15% resulting in an intended sample size of 69 patients.
An assumption of an 11 point difference in SGRQ between the treatment arm and the control arm at 12 months with a standard deviation of 14 leads to an intended sample size of 60 patients.
An assumption of a 12% predicted difference in FEV1 between the treatment arm and the control arm at 12 months with an assumed standard deviation of 15 leads to an intended sample size of 59 patients.
Similar(55)
All of these subgroup analyses were underpowered, and even the full trial was much smaller than intended (the intended sample size was 1,620; achieved was 838).
Its application will provide a guarantee that data generated originates from the intended sample and only the intended sample.
As this is a pilot study, the intended sample size is small and plans to recruit only 60 participants.
If the planned sample size is not derived statistically, then this should be explicitly stated along with a rationale for the intended sample size (eg, exploratory nature of pilot studies; pragmatic considerations for trials in rare diseases).
11 Given the sampling frame in each area and the intended sample size, a systematic random sample of households was drawn.
On the other hand, a significant proportion of the intended sample size was reached, as respondents were able to answer the survey questions irrespective of their physical availability or current location given internet connectivity.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com