Cited by 612Statistical Methods in EpidemiologyStatistical Methods in Clinical TrialsMeta-analysis and systematic reviews

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A simple formula for the calculation of sample size in pilot studies

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Viechtbauer, Wolfgang, Smits, Luc, Kotz, Daniel, Budé, Luc, Spigt, Mark, Serroyen, Jan, Crutzen, Rik·2015·Journal of Clinical Epidemiology

DOI 10.1016/j.jclinepi.2015.04.014

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Abstract

One of the goals of a pilot study is to identify unforeseen problems, such as ambiguous inclusion or exclusion criteria or misinterpretations of questionnaire items. Although sample size calculation methods for pilot studies have been proposed, none of them are directed at the goal of problem detection. In this article, we present a simple formula to calculate the sample size needed to be able to identify, with a chosen level of confidence, problems that may arise with a given probability. If a problem exists with 5% probability in a potential study participant, the problem will almost certainly be identified (with 95% confidence) in a pilot study including 59 participants.

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A tutorial on pilot studies: the what, why and how
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“These considerations have led to various guidelines for choosing an appropriate sample size for a pilot study, such as 12 participants per group [3], values in the range of 10 to 40 participants per group depending on the parameter of interest [4,5], at least 9% of the main trial’s sample size [6], or at least 50 part…”
Background
On the use of a pilot sample for sample size determination
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“smaller scale can help to identify unforeseen problems that could compromise the quality or flow of the study [2].”
Background

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Authors: Viechtbauer, W., Smits, L., Kotz, D., Budé, L., Spigt, M., Serroyen, J., & Crutzen, R.
Affiliations: Maastricht University (NL)
Corresponding author: Crutzen, Rik
ORCID: Viechtbauer, Wolfgang
Smits, Luc
Kotz, Daniel
Spigt, Mark
Crutzen, Rik
Venue: Journal of Clinical Epidemiology
Publisher: Elsevier BV
Published: 2015-11
Volume: 68
Issue: 11
Pages: 1375-1379
ISSN: 0895-4356 (ISSN-L)
DOI: 10.1016/j.jclinepi.2015.04.014
OpenAlex: W1763526952
Cited by: 612
References: 15
Citations by year: 2026: 56 · 2025: 91 · 2024: 93 · 2023: 82 · 2022: 77 · 2021: 69 · 2020: 50 · 2019: 39 · 2018: 31 · 2017: 16 · 2016: 8
FWCI: 16.32
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Journal of Clinical Epidemiology (publishedVersion)
PubMed (publishedVersion)
Research Publications (Maastricht University) (publishedVersion, other-oa)
Lirias (submittedVersion)
Research Publications (Maastricht University) (submittedVersion, other-oa)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
Keywords: sample size determination, pilot study, problem identification, inclusion and exclusion criteria, statistical power
MeSH terms: Humans, Pilot Projects, Sample Size, Mathematical Concepts

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A simple formula for the calculation of sample size in pilot studies

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