Sample size for individually matched case-control studies.

The standard formulas used to calculate sample size for an individually matched case-control study assume a constant probability of exposure throughout the pool of possible controls. We propose new formulas that allow for heterogeneity in the probability of exposure among controls in different matched sets. Since matching factors are suspected of being confounders, they are expected to divide the total population into subgroups with different proportions exposed. Thus, the assumption of homogeneity of exposure among controls, made by the currently used formulas, is inconsistent with the assumptions used to design a matched study. The proposed formulas avoid this inconsistency. We present an example to illustrate how heterogeneity can affect the required sample size.