Objectives of pilot studies

  • A pilot uses a small sample to test the feasability of the actual research endeavor
  • Data obtained in the piloting phase must not be used for the main study

Test-run the Study Protocol

  • Recruitment procedure
  • Inclusion and exclusion criteria
  • Randomization procedure
  • Data acquisition (forms, questionnaires, physiol. data, etc.)
  • Acceptability of intervention
  • Instructing the RA
  • RA’s adherence to protocol

Test-run the Data Analysis Workflow

  • Use all the data obtained
  • Is the data ‘missingness’ acceptable?
  • Run cleaning and data wrangling routines
  • Run every single analysis step
  • Check results for plausibility
  • Is the analysis work flow sufficiently automated?

What a Pilot Study Cannot Do

  • Allow statistical inference

  • Determine the sample size
  • Help selecting the primary outcome
  • Provide data for the main study

Wrapping up

Pilots are used to test-run

  • the data acquisition procedures
  • the data analysis workflow

and inform about potential problems