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PEDIATRICS Vol. 108 No. 6 December 2001, pp. 1383-1384

Caution About Trial Methodology and Statistics

To the Editor—

Bilgin and coworkers1 recently reported a significant decrease in mortality in septic neutropenic neonates treated with granulocyte-macrophage colony-stimulating factor (GM-CSF). We wish to call in question the methodology and handling of statistics in their study. The trial was neither placebo-controlled nor double-blinded, and in addition the reader gets the impression that the randomization was not concealed. Indeed: "Patients were assigned alternatively to the rhGM-CSF or control groups according to their order of admission." Because only a P value of <.05 and no confidence intervals (CIs) were reported, we reanalyzed the raw data.2 The power of the performed {chi}2 test with {alpha} = .05 . . . [Full Text of this Article]




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