Quality of reporting of noninferiority and equivalence randomized trials

JAMA : the Journal of the American Medical Association
Anne Le HenanffPhilippe Ravaud

Abstract

Noninferiority and equivalence trials aim to show that the experimental treatment is not clinically worse than (noninferior) or clinically similar to (equivalent) a control active treatment. These study objectives imply particular planning and analysis. To assess the methodologic quality of reports of randomized controlled trials of noninferiority and equivalence. We searched MEDLINE and the Cochrane Central Register of Controlled Trials for reports of randomized controlled trials of noninferiority and equivalence hypotheses published between January 1, 2003, and December 31, 2004. Data extracted by use of a standardized form involved assessment of choice of noninferiority or equivalence margins, sample size calculation, sets of patients analyzed, method of statistical testing and reporting results, and conclusions. A total of 162 reports were included in the analysis (116 reports of noninferiority and 46 of equivalence). The margin defining noninferiority or equivalence was described in most reports (156 [96.3%]), with justification of the margin in only 33 (20.4%). Almost one quarter of the reports (35 [21.6%]) did not describe a sample size calculation, and an additional 11 (6.8%) did not take into account a prespecified non...Continue Reading

Associated Clinical Trials

Aug 26, 2008·Dott. Giuseppe Citerio

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