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In Reply: In response to Dr Costantino and colleagues, we did examine associations between the total number of exclusion criteria and outcome of RCTs. We found substantial variability in the reporting of an RCT as "positive" or "negative." Occasionally, the study hypothesis and a priori-designated primary outcome were not clearly stated. Among 258 RCTs with a clearly identified and reported hypothesis and primary outcome, 185 (71.7%) had a positive outcome and 73 (28. 3%) had a negative primary outcome. This asymmetry in rate of publication of positive and negative trials has been shown by others.^1-3 However, we found no difference between the number of exclusion criteria of "positive" vs "negative" RCTs (mean [SD], 9.6 [6.3] vs 9.7 [6.0], respectively; P = .97).

We examined independent associations among the total number of exclusions (Table 4 in our article) and specific trial characteristics. We chose to subsequently examine the percentage of poorly justified . . . [Full Text of this Article]

Robert A. Fowler, MD, MS
rob.fowler@sunnybrook.ca
Department of Medicine
University of Toronto and Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada

Harriette G. C. Van Spall, MD
Department of Medicine
Division of Cardiology
University of Toronto
Ontario, Canada

RELATED LETTER

Eligibility Criteria of Randomized Controlled Trials
Giorgio Costantino, Elisa Ceriani, Anna Maria Rusconi, and Nicola Montano
JAMA. 2007;298(1):39.
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