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Eligibility Criteria of Randomized Controlled Trials
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To the Editor: The study of the eligibility criteria of randomized controlled trials (RCTs) in high-impact general medical journals by Dr Van Spall and colleagues1 addresses a crucial issue for everyday clinical practice. Patients are often located in an area of "therapeutic uncertainty," since they would theoretically not have been eligible for any of the treatments tested in the clinical trials. Evidence comes from studies in the fields of cardiology, oncology, and psychiatry.2-4
It would be useful to know if the authors observed any independent association between the total number of exclusion criteria and positive results of an RCT. Such a correlation would cast more doubt on the transferability of RCT results to the target clinical population. In addition, in the multivariate analysis of the total number of exclusion criteria, the authors took into account the percentage of strongly, poorly, and potentially justified criteria; it would be more informative to . . . [Full Text of this Article]
Giorgio Costantino, MD;
Elisa Ceriani, MD
celisa78@virgilio.it
Anna Maria Rusconi, MD;
Nicola Montano, MD, PhD
Division of Internal Medicine II Department of Clinical Sciences L. Sacco Hospital University of Milan Milan, Italy
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RELATED LETTER
Eligibility Criteria of Randomized Controlled TrialsReply
Robert A. Fowler and Harriette G. C. Van Spall
JAMA. 2007;298(1):39-40.
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