Table 2

Reasons for conducting pilot studies

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?


Thabane et al. BMC Medical Research Methodology 2010 10:1   doi:10.1186/1471-2288-10-1

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