A new and improved confidence interval for the Mantel-Haenszel risk difference

Stat Med. 2014 Jul 30;33(17):2968-83. doi: 10.1002/sim.6122. Epub 2014 Mar 6.

Abstract

Writing the variance of the Mantel-Haenszel estimator under the null of homogeneity and inverting the corresponding test, we arrive at an improved confidence interval for the common risk difference in stratified 2 × 2 tables. This interval outperforms a variety of other intervals currently recommended in the literature and implemented in software. We also discuss a score-type confidence interval that allows to incorporate strata/study weights. Both of these intervals work very well under many scenarios common in stratified trials or in a meta-analysis, including situations with a mixture of both small and large strata sample sizes, unbalanced treatment allocation, or rare events. The new interval has the advantage that it is available in closed form with a simple formula. In addition, it applies to matched pairs data. We illustrate the methodology with various stratified clinical trials and a meta-analysis. R code to reproduce all analysis is provided in the Appendix.

Keywords: difference of proportion; matched pairs; meta-analysis; score interval; stratified 2 × 2 tables.

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Clinical Trials as Topic*
  • Confidence Intervals
  • Data Interpretation, Statistical*
  • Humans
  • Influenza Vaccines / standards
  • Influenza, Human / prevention & control
  • Meta-Analysis as Topic*
  • Multiple Myeloma / drug therapy
  • Multiple Myeloma / mortality
  • Risk*
  • Sample Size*

Substances

  • Antineoplastic Agents
  • Influenza Vaccines