Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 66, Issue 23, Pages 2648-2662Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2015.10.023
Keywords
intention-to-treat analysis; logistic models; proportional hazards models; randomized controlled trials as topic; risk assessment; statistics
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This paper tackles several statistical controversies that are commonly faced when reporting a major clinical trial. Topics covered include: multiplicity of data, interpreting secondary endpoints and composite endpoints, the value of covariate adjustment, the traumas of subgroup analysis, assessing individual benefits and risks, alternatives to analysis by intention to treat, interpreting surprise findings (good and bad), and the overall quality of clinical trial reports. All is put in the context of topical cardiology trial examples and is geared to help trialists steer a wise course in their statistical reporting, thereby giving readers a balanced account of trial findings. (C) 2015 by the American College of Cardiology Foundation.
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