Method document
Sample size for a chi-square goodness-of-fit test
How many participants are needed to show that one categorical variable does not follow a stated distribution, from the distribution expected under the null and the one expected in truth. Covers clustering and dropout.
https://statwisely.com/methods/proportions-goodness-of-fit/
When to use it
- Testing whether categories occur in stated proportions: equal use of four clinics, or a population’s known distribution of blood groups.
Not for
- Two variables against each other. Use the test of independence.
Notation
- Number of participants
- Number of categories
- Category probabilities under the null and the alternative
- Cohen’s effect size
- Significance level: the chance of a false positive
- Power: the chance of detecting the effect if it is real
- Intracluster correlation coefficient (ICC)
- Average number of participants per cluster
- Coefficient of variation of cluster size
- Clusters per group
- Expected loss of whole clusters
- Expected dropout
Formulas
Cohen’s w from the two distributions
The chi-square discrepancy per participant between the expected and true distributions [1].
The smallest N with enough power
On k − 1 degrees of freedom. More categories at the same w need more participants.
Clustering
When participants are recruited or randomised in clusters, observations within a cluster repeat information, and the sample is multiplied by the design effect. With equal clusters (CV = 0) this is 1 + (m − 1)ρ [2, 3].
Few clusters
Optional. A cluster trial is analysed on cluster-level summaries, so its critical values come from t on 2(C − 1) degrees of freedom rather than the normal distribution. With few clusters this costs participants; because C depends on the sample, it is iterated until it settles [4].
All adjustments together
The adjustments multiply, in this order, and the result is rounded up once. Any adjustment not used contributes a factor of 1.
Dropout
Applied last, to the participants actually recruited.
Clusters to recruit
Per group. Losing a whole cluster loses every participant in it, so an expected loss of clusters inflates the clusters recruited rather than the participants.
Parameters
Expected distribution
Values: One probability per category, each above 0, adding to 1
The distribution the test is against: the null hypothesis.
True distribution to detect
Values: One probability per category, each above 0, adding to 1
The smallest departure from the expected distribution that would matter.
Significance level
Values: Between 0 and 1; usually 0.05
The false-positive rate you accept. A smaller α, for example to allow for several primary outcomes, needs a larger sample.
Power
Values: Between 0 and 1; usually 0.80 or 0.90
The chance of a significant result if the assumed effect is real. Funders and ethics committees commonly expect at least 0.80.
Expected dropoutOptional
Values: 0% up to, but not including, 100%
The share of participants expected to provide no outcome, from comparable studies. Recruiting more restores the numbers, not the comparability of the groups: if dropout is related to the outcome, the estimate can still be biased.
Intracluster correlation (ICC)Optional
Values: From 0 to 1
For clustered designs only. Published ICCs for health outcomes in primary-care and community clusters are mostly small, often below 0.05 [5]; prefer an estimate from a comparable trial.
Average cluster sizeOptional
Values: At least 1
The average number of participants per cluster. Given with the ICC.
Variation in cluster sizeOptional
Values: 0 or more; 0 for equal clusters
The SD of cluster sizes divided by their mean. Unequal clusters cost power on their own account [3].
Expected loss of whole clustersOptional
Values: 0% up to, but not including, 100%
Clusters, such as practices or schools, expected to withdraw entirely.
Correction for few clustersOptional
Values: On or off
Worth applying when there are few clusters per group, roughly fewer than 15–20.
Assumptions
- Participants are independent apart from any clustering specified, each in exactly one category.
- Every category expects at least 5 participants, so the chi-square approximation holds.
- With clustering: clusters are independent, with the same ICC throughout, and the analysis accounts for the clustering, for example with a mixed model or cluster-level summaries [2].
- Dropout is unrelated to the outcome; recruiting more participants restores the numbers but cannot remove bias.
Worked examples
Four categories
Expected 25% in each of four categories; true 35%, 25%, 25% and 15%: w = √(0.04 + 0.04) = 0.283 on 3 degrees of freedom; α = 0.05, 80% power: N = 137.
Sample size: 137
Open this example in the calculatorProtocol statement
To detect a departure from the expected distribution of w = 0.283 with 80% power at a significance level of 0.05, using a chi-square goodness-of-fit test across 4 categories, the required sample size is 137 participants. Calculated with StatWisely (statwisely.com) using: N: solve the noncentral chi-square power at λ=Nw² on k-1 df. These are planning estimates; confirm the final design with a qualified statistician.
Allowing for dropout
Expecting 10% to provide no outcome: 137 / 0.9 = 152.2, so 153 are recruited.
Needed for analysis: 137 · To recruit: 153
Open this example in the calculatorProtocol statement
To detect a departure from the expected distribution of w = 0.283 with 80% power at a significance level of 0.05, using a chi-square goodness-of-fit test across 4 categories, the required sample size is 137 participants. Allowing for 10% dropout, 153 participants should be recruited. Calculated with StatWisely (statwisely.com) using: N: solve the noncentral chi-square power at λ=Nw² on k-1 df. These are planning estimates; confirm the final design with a qualified statistician.
Validation
- Every worked example on this page is recomputed by the StatWisely engine whenever the software is built. If a number or formula here stopped matching the calculator, the release would be stopped until this document was corrected.
- An independent implementation in R recomputes this test every night and before each production release, and the results are compared with the engine’s.
How to cite
StatWisely. Sample size for a chi-square goodness-of-fit test. Method document, engine version 1.0.0, reviewed 2026-10-01. https://statwisely.com/methods/proportions-goodness-of-fit/
Cite the original references for the formulas your design uses as well.
References
- 1.Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. Hillsdale, NJ: Lawrence Erlbaum Associates; 1988.
- 2.Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000.
- 3.Eldridge SM, Ashby D, Kerry S. Sample size for cluster randomized trials: effect of coefficient of variation of cluster size and analysis method. International Journal of Epidemiology. 2006;35(5):1292–1300. doi:10.1093/ije/dyl129
- 4.Hayes RJ, Moulton LH. Cluster Randomised Trials. 2nd ed. Boca Raton: CRC Press; 2017.
- 5.Adams G, Gulliford MC, Ukoumunne OC, Eldridge S, Chinn S, Campbell MJ. Patterns of intra-cluster correlation from primary care research to inform study design and analysis. Journal of Clinical Epidemiology. 2004;57(8):785–794. doi:10.1016/j.jclinepi.2003.12.013