What is a pilot study?

Posted on July 31, 2017

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Pilot studies can play a very important role prior to conducting a full-scale research project

Pilot studies are small-scale, preliminary studies which aim to investigate whether crucial components of a main study – usually a randomized controlled trial (RCT) – will be feasible. For example, they may be used in attempt to predict an appropriate sample size for the full-scale project and/or to improve upon various aspects of the study design. Often RCTs require a lot of time and money to be carried out, so it is crucial that the researchers have confidence in the key steps they will take when conducting this type of study to avoid wasting time and resources.

Thus, a pilot study must answer a simple question: “Can the full-scale study be conducted in the way that has been planned or should some component(s) be altered?”

The reporting of pilot studies must be of high quality to allow readers to interpret the results and implications correctly. This blog will highlight some key things for readers to consider when they are appraising a pilot study.

What are the main reasons to conduct a pilot study?

Pilot studies are conducted to evaluate the feasibility of some crucial component(s) of the full-scale study. Typically, these can be divided into 4 main aspects:

Reasons for not conducting a pilot study

A study should not simply be labelled a ‘pilot study’ by researchers hoping to justify a small sample size. Pilot studies should always have their objectives linked with feasibility and should inform researchers about the best way to conduct the future, full-scale project.

How to interpret a pilot study

Readers must interpret pilot studies carefully. Below are some key things to consider when assessing a pilot study:

After an interpretation of results, pilot studies should conclude with one of the following:

(1) the main study is not feasible;

(2) the main study is feasible, with changes to the protocol;

(3) the main study is feasible without changes to the protocol OR

(4) the main study is feasible with close monitoring.

Any recommended changes to the protocol should be clearly outlined.

Take home message

References

Thabane L, Ma J, Chu R, et al. A tutorial on pilot studies: what, why and how? BMC Med Res Methodol. 2010; 10: 1.

Cocks K and Torgerson DJ. Sample Size Calculations for Randomized Pilot Trials: A Confidence Interval approach. Journal of Clinical Epidemiology. 2013.

Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004; 10 (2): 307-12.

Moore et al. Recommendations for Planning Pilot Studies in Clinical and Translational Research. Clin Transl Sci. 2011 October ; 4(5): 332–337.

Luiz Cadete

I'm a Physical Therapist and a Master's student from Brazil who really loves Methodology and Shoulder problems. Just a guy trying to be a researcher! Feel free to contact me at luiz.scola@yahoo.com.br

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What is a pilot study? by Luiz Cadete is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. Unless otherwise stated, all images used within the blog are not available for reuse or republication as they are purchased for Students 4 Best Evidence from shutterstock.com.

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