Sample Size for Assessing Agreement between Two Methods of Measurement by Bland−Altman Method

Lu Meng-Jie (), Zhong Wei-Hua (), Liu Yu-Xiu (), Miao Hua-Zhang (), Li Yong-Chang () and Ji Mu-Huo ()
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Lu Meng-Jie: Department of Medical Statistics, Jinling Hospital, Southern Medical University, 305 East Zhongshan Road, Nanjing 210002, China
Zhong Wei-Hua: Department of Medical Statistics, Jinling Hospital, Southern Medical University, 305 East Zhongshan Road, Nanjing 210002, China
Liu Yu-Xiu: Department of Medical Statistics, Jinling Hospital, Southern Medical University, 305 East Zhongshan Road, Nanjing 210002, China
Miao Hua-Zhang: Department of Medical Statistics, Jinling Hospital, Southern Medical University, 305 East Zhongshan Road, Nanjing 210002, China
Li Yong-Chang: Department of Medical Statistics, Jinling Hospital, Southern Medical University, 305 East Zhongshan Road, Nanjing 210002, China
Ji Mu-Huo: Department of Anesthesiology, Jinling Hospital, Nanjing University, Nanjing 210002, China

The International Journal of Biostatistics, 2016, vol. 12, issue 2, 8

Abstract: The Bland–Altman method has been widely used for assessing agreement between two methods of measurement. However, it remains unsolved about sample size estimation. We propose a new method of sample size estimation for Bland–Altman agreement assessment. According to the Bland–Altman method, the conclusion on agreement is made based on the width of the confidence interval for LOAs (limits of agreement) in comparison to predefined clinical agreement limit. Under the theory of statistical inference, the formulae of sample size estimation are derived, which depended on the pre-determined level of α, β, the mean and the standard deviation of differences between two measurements, and the predefined limits. With this new method, the sample sizes are calculated under different parameter settings which occur frequently in method comparison studies, and Monte-Carlo simulation is used to obtain the corresponding powers. The results of Monte-Carlo simulation showed that the achieved powers could coincide with the pre-determined level of powers, thus validating the correctness of the method. The method of sample size estimation can be applied in the Bland–Altman method to assess agreement between two methods of measurement.

Keywords: Bland-Altman method; limits of agreement; method comparison study; Monte-Carlo simulation; sample size estimation (search for similar items in EconPapers)
Date: 2016
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DOI: 10.1515/ijb-2015-0039

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