Circulation, Vol 61, 508-515, Copyright © 1980 by American Heart Association
KL Lee, JF McNeer, CF Starmer, PJ Harris and RA Rosati
A simulated randomized clinical trial in coronary artery disease was
conducted to illustrate the need for clinical judgment and modern
statistical methods in assessing therapeutic claims in studies of complex
diseases. Clinicians should be aware of problems that occur when a patient
sample is subdivided and treatment effects are assessed within multiple
prognostic categories. In this example, 1073 consecutive, medically treated
coronary artery disease patients from the Duke University data bank were
randomized into two groups. The groups were reasonably comparable and, as
expected, there was no overall difference in survival. In a subgroup of 397
patients characterized by three-vessel disease and an abnormal left
ventricular contraction, however, survival of group 1 patients was
significantly different from that of group 2 patients. Multivariable
adjustment procedures revealed that the difference resulted from the
combined effect of small imbalances in the distribution of several
prognostic factors. Another subgroup was identified in which a significant
survival difference was not explained by multivariable methods. These are
not unlikely examples in trials of a complex disease. Clinicians must
exercise careful judgment in attributing such results to an efficacious
therapy, as they may be due to chance or to inadequate baseline
comparability of the groups.
ARTICLES
Clinical judgment and statistics. Lessons from a simulated randomized trial in coronary artery disease
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