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Related Experiment Videos

Events per person year--a dubious concept

J Windeler1, S Lange

  • 1Institut für Medizinische Biometrie, Ruprecht-Karls-Universität Heidelberg, Germany.

BMJ (Clinical Research Ed.)
|February 18, 1995
PubMed
Summary

The widely used "fracture rate" for osteoporosis research lacks a sound statistical basis. This measure, counting fractures over patient observation time, should be abandoned for more valid clinical outcomes.

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Area of Science:

  • Osteoporosis research
  • Biostatistics
  • Clinical trial methodology

Background:

  • A "fracture rate" measure was introduced in 1982 for osteoporosis research.
  • This measure, relating fractures to cumulative observation time, is prevalent in scientific literature.

Purpose of the Study:

  • To critically evaluate the statistical validity and clinical interpretability of the "fracture rate" measure.
  • To advocate for the abandonment of this measure in favor of more robust outcome criteria.

Main Methods:

  • Conceptual analysis of the "fracture rate" measure.
  • Examination of underlying statistical assumptions and their violation.
  • Assessment of clinical interpretability and impact on outcome research.

Main Results:

  • The "fracture rate" measure lacks a sound statistical foundation.
  • Counting events (fractures) instead of patients violates basic statistical assumptions.
  • This invalidates common statistical tests and estimators, and its clinical interpretation is dubious.

Conclusions:

  • The "fracture rate" measure is statistically unsound and clinically questionable.
  • Its continued use hinders the identification of valid and meaningful clinical outcome criteria.
  • Researchers should abandon the "fracture rate" in osteoporosis studies.

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