Journal
JOURNAL OF CLINICAL EPIDEMIOLOGY
Volume 55, Issue 8, Pages 783-786Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/S0895-4356(02)00440-7
Keywords
meta-analysis; clinical trials; random allocation
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Randomized clinical trial (RCT) publications with inappropriate random-sequence generation, lack of allocation concealment, or imperfect blinding yield inflated estimates of effect compared to those in which adequate methods are described. RCTs that do not state methods used yield similar effect estimates, suggesting that inadequate methods were used. We compared RCT publications with investigator reports of actual practice for 40 rheumatology RCTs published in 1997/1998. In RCTs in which these methods were not described in the trial reports and would thus have been characterized as inadequate, investigators reported using methods of random-sequence generation and allocation concealment that would be considered adequate in 77.4 and 78.1% of RCTs, respectively. This suggests that, in contrast to previous reports, inadequate random-sequence generation and allocation concealment, per se, may not be a major problem in RCTs. Characterizing RCTs as good or poor quality based on the published report is likely to be inappropriate. (C) 2002 Elsevier Science Inc. All rights reserved.
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