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The sequential analysis of repeated binary responses: a score test for the case of three time points
Author(s) -
Sooriyarachchi Marina Roshini,
Whitehead John,
Whitehead Anne,
Bolland Kim
Publication year - 2005
Publication title -
statistics in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.996
H-Index - 183
eISSN - 1097-0258
pISSN - 0277-6715
DOI - 10.1002/sim.2339
Subject(s) - time point , interim , interim analysis , binary data , computer science , statistics , test (biology) , clinical trial , binary number , medicine , mathematics , arithmetic , paleontology , philosophy , archaeology , pathology , biology , history , aesthetics
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. Copyright © 2005 John Wiley & Sons, Ltd.