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Data from the pilot cannot be carried forward to the main trial dataset.
Pilot data can be carried forward to the main trial dataset.
Transparent recording of monitoring methods and outcomes facilitated decision-making on whether data could be appropriately pooled with the main trial dataset.
A high proportion of missing data would have led to a decision to exclude pilot data from the main trial dataset.
A decision was therefore made that pilot data should not be held back from being pooled with the main trial dataset on grounds of variation in intervention fidelity.
Their approach is valuable when assessing feasibility and acceptability of study methods, but is not focussed on decision-making relating to the appropriateness or otherwise of carrying data forward to the main trial dataset.
We describe the development of a checklist for use in decision-making on whether pilot data can be carried forward to the main trial dataset without compromising trial integrity.
Similar(4)
Whilst the trial dataset will be used to provide parameters for several states, the main data sources for the extrapolation will come from existing literature and registries as the model horizon greatly exceeds the trial length.
Irish Commission for Energy Regulation (CER) smart metering trial dataset is used for this analysis.
The R-factor during main trial recruitment was 0.96.
The state Supreme Court is the main trial court in New York.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com