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Related Experiment Videos

Adjusting for baseline: change or percentage change?

L Kaiser1

  • 1Biometrics Department, Sterling-Winthrop Research Institute, Rensselaer, New York 12144.

Statistics in Medicine
|October 1, 1989
PubMed
Summary

Choosing between change from baseline and percentage change from baseline is crucial for clinical trial analysis. This study guides the selection using baseline plots to avoid incorrect treatment response interpretations.

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Medical Data Analysis

Background:

  • Clinical trials frequently collect baseline and response data for patient assessments.
  • Change from baseline and percentage change from baseline are common analysis variables for treatment comparisons.

Purpose of the Study:

  • To provide guidance on selecting the appropriate analysis variable (change vs. percentage change from baseline).
  • To illustrate the impact of choosing the incorrect adjusted response variable in clinical trial data analysis.

Main Methods:

  • Utilizing plots of change from baseline and percentage change from baseline against baseline values.
  • Presenting illustrative examples to demonstrate the problem and its consequences.

Main Results:

  • Visualizations reveal differences in how change from baseline and percentage change from baseline represent treatment response.
  • The choice of analysis variable can significantly impact the interpretation of treatment efficacy.

Conclusions:

  • Graphical analysis is essential for selecting the correct response variable in clinical trials.
  • Misapplication of adjusted response variables can lead to erroneous conclusions regarding treatment effectiveness.

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