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The validity of a newly developed diagnostic method is usually proven by comparing with a well-grounded reference method. When measurements from a new method are continuous but in different units from a reference standard and having a linear relationship, validity can be usually assessed by Pearson correlation coefficient, but it does not provide clinical guidance for judging validity. We defined a limits-of-agreement derived from regression models for assessing validity of new method, and developed a sample size formula. The sample size formula to achieve a certain probability that the limits-of-agreement is within a pre-defined, clinically acceptable range [−δ, δ] was derived and the result is presented as a nomogram. When a ratio of upper bound of a limits-of-agreement to δ is expected to be 0.95, a sample size of approximately 300 achieves a 90% probability that the limits-of-agreement lies within ± δ. The simulation showed that the suggested sample size formula had the targeted coverages. The sample size determination based on a limits-of-agreement is practical for showing validity of new methods, measuring the same attribute but in different units, and the presented nomogram is useful.

Nomogram for sample size calculation in assessing validity of a new method based on a regression line