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The criteria for success of this pilot was based on the primary feasibility objective (adherence to the exercise plan), and methodological standards for being adherent to training.
The trial achieved its primary feasibility objective with a treatment assignment within the prespecified timeframe in 71 of 81 patients (88%).
However, the confidence interval approach may be used to calculate and justify the sample size based on key feasibility objective(s).
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The feasibility objectives were: (1) ability of the ICU team to recruit a sufficient number of patients, (2) the rate of crossover between the two study arms, (3) the ability of the study team to collect data, (4) any severe adverse event during protocol application and (5) providing data to estimate the parameters required to design a definitive RCT.
Concerning the feasibility objectives, the primary outcome of the study, the ability of the ICU team to recruit the patients was evaluated by tracking all patients admitted to the ICU and reporting the number of patients screened by the study team and the percentage of the enrolled patients.
The criteria should be based on the primary feasibility objectives.
The specific feasibility objectives of this study are... [state the specific feasibility objectives of the pilot study].
In addition, clearly defined feasibility objectives and rationale to justify piloting should be provided.
It is important to clearly indicate the feasibility objectives as the primary focus for the pilot.
Clearly describe the criteria for assessing success of feasibility - these should be based on the feasibility objectives.
State the specific scientific primary and secondary objectives and hypotheses for the main study and the specific feasibility objectives.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com