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Sample size requirements for case-control study designs

Published by National Institutes of Health | U.S. Department of Health & Human Services | Metadata Last Checked: September 06, 2025 | Last Modified: 2025-09-06
Background Published formulas for case-control designs provide sample sizes required to determine that a given disease-exposure odds ratio is significantly different from one, adjusting for a potential confounder and possible interaction. Results The formulas are extended from one control per case to F controls per case and adjusted for a potential multi-category confounder in unmatched or matched designs. Interactive FORTRAN programs are described which compute the formulas. The effect of potential disease-exposure-confounder interaction may be explored. Conclusions Software is now available for computing adjusted sample sizes for case-control designs.

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