The sequential analysis of repeated binary responses: a score test for the case of three time points

Stat Med. 2006 Jul 15;25(13):2196-214. doi: 10.1002/sim.2339.

Abstract

In this paper a robust method is developed for the analysis of data consisting of repeated binary observations taken at up to three fixed time points on each subject. The primary objective is to compare outcomes at the last time point, using earlier observations to predict this for subjects with incomplete records. A score test is derived. The method is developed for application to sequential clinical trials, as at interim analyses there will be many incomplete records occurring in non-informative patterns. Motivation for the methodology comes from experience with clinical trials in stroke and head injury, and data from one such trial is used to illustrate the approach. Extensions to more than three time points and to allow for stratification are discussed.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic / methods*
  • Craniocerebral Trauma / drug therapy
  • Data Interpretation, Statistical*
  • Excitatory Amino Acid Antagonists / therapeutic use
  • Glasgow Outcome Scale
  • Humans
  • Models, Biological*
  • Models, Statistical*
  • Piperidines / therapeutic use

Substances

  • Excitatory Amino Acid Antagonists
  • Piperidines
  • eliprodil