Free research tool

Bland–Altman sample size calculator

Enter the expected mean and SD of the differences between device and reference, and the largest difference you'd accept. The calculator returns the number of paired measurements needed for the confidence intervals of both limits of agreement to fall inside that range at your chosen power, using the method of Lu et al. (2016), with a power curve you can export.

Updated . Free, no sign-up. Calculations run in your browser and your data is never uploaded.

1. Assumptions

Pre-filled with the free prostate-specific antigen example in Lu et al. (2016), section 5. Use a pilot study or published validation of a similar device for the mean and SD of differences.

2. Required sample size

Paired measurements
79
Achieved power 80.2%
Expected limits of agreement
−0.001046 to 0.00338
μ ± z × σ (95%)
Non-centrality τ₁, τ₂
2.85, 13.55
Lu et al. eqs. 3–4
Sample size for other error rates
α80% power90% power
0.0579105
0.01118148
501001500.00.20.40.60.81.0Number of paired measurements (n)Powern = 79

3. Methods paragraph

The sample size was calculated with the method of Lu et al. (2016) for Bland–Altman agreement studies. Assuming a mean difference of 0.001167 and a standard deviation of differences of 0.001129, with a maximum allowed difference of ±0.004, 95% limits of agreement, a two-sided α of 0.05 and 80% power, 79 paired measurements are required (achieved power 80.2%). Calculated with the ChatPPG Bland-Altman Sample Size Calculator (version 1.0; https://chatppg.com/tools/bland-altman-sample-size-calculator).

Cite this analysis

Cite the methods papers for the statistics you report, and the tool if it helped. ChatPPG. Bland-Altman Sample Size Calculator (version 1.0). 2026. https://chatppg.com/tools/bland-altman-sample-size-calculator. Accessed 2026-10-18.

Preview BibTeX
@software{chatppg_bland_altman_sample_size_calculator_2026,
  author = {{ChatPPG}},
  title = {{Bland-Altman Sample Size Calculator}},
  year = {2026},
  version = {1.0},
  publisher = {ChatPPG},
  url = {https://chatppg.com/tools/bland-altman-sample-size-calculator},
  urldate = {2026-10-18}
}

@article{lu2016,
  author = {Lu, Meng-Jie and Zhong, Wei-Hua and Liu, Yu-Xiu and Miao, Hua-Zhang and Li, Yong-Chang and Ji, Mu-Huo},
  title = {{Sample size for assessing agreement between two methods of measurement by Bland-Altman method}},
  journal = {The International Journal of Biostatistics},
  year = {2016},
  volume = {12},
  number = {2},
  pages = {20150039},
  doi = {10.1515/ijb-2015-0039}
}

@article{bland1986,
  author = {Bland, J. Martin and Altman, Douglas G.},
  title = {{Statistical methods for assessing agreement between two methods of clinical measurement}},
  journal = {The Lancet},
  year = {1986},
  volume = {327},
  number = {8476},
  pages = {307--310},
  doi = {10.1016/S0140-6736(86)90837-8}
}

@article{bland1999,
  author = {Bland, J. Martin and Altman, Douglas G.},
  title = {{Measuring agreement in method comparison studies}},
  journal = {Statistical Methods in Medical Research},
  year = {1999},
  volume = {8},
  number = {2},
  pages = {135--160},
  doi = {10.1177/096228029900800204}
}

@article{lenth1989,
  author = {Lenth, Russell V.},
  title = {{Algorithm AS 243: cumulative distribution function of the non-central t distribution}},
  journal = {Applied Statistics},
  year = {1989},
  volume = {38},
  number = {1},
  pages = {185--189},
  doi = {10.2307/2347693}
}

The method

Lu et al. (2016) treat agreement as two one-sided tests: the upper confidence limit of the upper limit of agreement must fall below the maximum allowed difference δ, and the lower confidence limit of the lower limit must fall above −δ. With expected mean difference μ, SD σ and z = 1.96 for 95% limits:

SE = σ × √(1/n + z²/(2(n − 1))) (eqs. 1–2)

τ₁ = (δ − μ − zσ)/SE and τ₂ = (δ + μ − zσ)/SE

β₁ and β₂ are the probabilities that a non-central t variable with n − 1 degrees of freedom and non-centrality τ₁ or τ₂ falls below t₁₋α/₂,ₙ₋₁ (eqs. 3–4), and power = 1 − (β₁ + β₂) (eq. 5). The calculator finds the smallest n whose power reaches your target. The non-central t distribution is computed with Lenth's (1989) algorithm AS 243.

Choosing the inputs

The mean and SD of the differences should come from a pilot study or a published validation of a similar device. The wearable accuracy tables list published bias and limits of agreement for heart rate, HRV, SpO2 and sleep, and the SD can be recovered from published limits as (upper − lower)/(2 × 1.96). The maximum allowed difference is a clinical or practical judgement and must be set before the study. The required n rises steeply as δ approaches |μ| + 1.96σ, and no sample size works once δ is below that.

How it compares with the paper

The calculator reproduces R's SimplyAgree::blandPowerCurve, which implements the same equations, to seven decimal places of power. For the paper's worked example (μ = 0.001167, σ = 0.001129, δ = 0.004, α = 0.05, 80% power) it returns 79 pairs with 80.2% power. The paper reports 83, and its Table 1 values run 1–3 higher than the smallest n that meets equation 5, because the paper starts from an iterative approximation (its equation 6) and steps upward. Either way the power at the paper's n is above the target, so 83 is a slightly conservative choice.

Frequently asked questions

How many participants does a Bland–Altman study need?

It depends on how large the expected differences are relative to the acceptable limit. With Lu et al.'s method, if the SD of differences is 1 unit, the mean difference is 0 and the acceptable limit is ±2.5 units, about 108 to 110 pairs give 80% power at α = 0.05. If the limit is ±3 units, about 31 to 33 suffice.

What is the maximum allowed difference?

It's the largest difference between device and reference that would not matter clinically or practically, fixed before data collection. For example, a heart rate study might pre-specify ±5 bpm. Agreement is shown when the confidence intervals of both limits of agreement fall inside ±δ.

Does this account for repeated measurements per participant?

No. Lu et al. (2016) assume independent pairs. With several pairs per participant the effective sample size is smaller, so plan more participants or use a method designed for repeated measures.

Why does a non-zero mean difference increase the sample size?

Bias pushes one limit of agreement towards its acceptable boundary, so that limit's confidence interval must be narrower to stay inside, which needs more data.

Is my data uploaded anywhere?

No. The calculations run in your browser with JavaScript. Pasted or uploaded files are read locally and never sent to ChatPPG or anyone else, so you can use it with unpublished study data.

References

  1. Lu MJ, Zhong WH, Liu YX, et al.. Sample size for assessing agreement between two methods of measurement by Bland-Altman method. The International Journal of Biostatistics. 2016;12(2):20150039. doi:10.1515/ijb-2015-0039
  2. Bland JM, Altman DG. Statistical methods for assessing agreement between two methods of clinical measurement. The Lancet. 1986;327(8476):307-310. doi:10.1016/S0140-6736(86)90837-8
  3. Bland JM, Altman DG. Measuring agreement in method comparison studies. Statistical Methods in Medical Research. 1999;8(2):135-160. doi:10.1177/096228029900800204
  4. Lenth RV. Algorithm AS 243: cumulative distribution function of the non-central t distribution. Applied Statistics. 1989;38(1):185-189. doi:10.2307/2347693

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