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Table 2 Reasons for conducting pilot studies

From: A tutorial on pilot studies: the what, why and how

Main Reason Examples
Process: This assesses the feasibility of the processes that are key to the success of the main study • Recruitment rates
  • Retention rates
  • Refusal rates
  • Failure/success rates
  • (Non)compliance or adherence rates
  • eligibility criteria
     - Is it obvious who meets and who does not meet the eligibility requirements?
     - Are the eligibility criteria sufficient or too restrictive?
  • Understanding of study questionnaires or data collection tools:
     - Do subjects provide no answer, multiple answers, qualified answers, or unanticipated answers to study questions?
Resources: This deals with assessing time and resource problems that can occur during the main study • Length of time to fill out all the study forms
  • Determining capacity:
     - Will the study participants overload your phone lines or overflow your waiting room?
  • Determining process time
     - How much time does it take to mail out a thousand surveys?
  • Is the equipment readily available when and where it is needed?
  • What happens when it breaks down or gets stolen?
  • Can the software used for capturing data read and understand the data?
  • Determining centre willingness and capacity
     - Do the centres do what they committed to doing?
     - Do investigators have the time to Perform the tasks they committed to doing?
     - Are there any capacity issues at each participating centre?
Management: This covers potential human and data management problems • What are the challenges that participating centres have with managing the study?
  • What challenges do study personnel have?
  • Is there enough room on the data collection form for all of the data you receive?
  • Are there any problems entering data into the computer?
  • Can data coming from different sources be matched?
  • Were any important data values forgotten about?
  • Do data show too much or too little variability?
Scientific: This deals with the assessment of treatment safety, dose, response, effect and variance of the effect • Is it safe to use the study drug/intervention?
  • What is the safe dose level?
  • Do patients respond to the drug?
  • What is the estimate of the treatment effect?
  • What is the estimate of the variance of the treatment effect?