Abstract
Objective
To examine the extent to which the Consolidated Standards of Reporting Trials (CONSORT)
reporting guidelines improved clinical trials reporting and subject attrition, which
may undermine the credibility of published randomized clinical trials (RCTs).
Study Design and Setting
Published RCTs reported in two major medical journals before and after the CONSORT
guidelines were systematically reviewed; one used the CONSORT statement (JAMA) and
one did not (NEJM).
Results
The quality of RCT reporting improved for both journals, but JAMA showed more significant
and consistent improvements in all aspects of RCT reporting. Subject attrition was
better accounted for after the publication of CONSORT, although the attrition rates
for various reasons actually increased. Attrition due to unknown reasons, as a percentage
of total attrition, declined dramatically, from 68.7% pre-CONSORT to 13.0% post-CONSORT.
Conclusions
Attrition of study subjects remains a serious problem in RCTs. Bias from selective
attrition can undermine the presumptive scientific advantage of RCTs. The CONSORT
guidelines improved RCT reporting when they were implemented but did not substantially
improve reported attrition rates.
Keywords
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Article info
Publication history
Published online: October 04, 2006
Accepted:
June 26,
2006
Identification
Copyright
© 2007 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
