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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?