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BMJ. 2010 Aug 18;341:c3653. doi: 10.1136/bmj.c3653.

Inconsistent reporting of surrogate outcomes in randomised clinical trials: cohort study.

Author information

  • 1Copenhagen Trial Unit, Rigshospitalet, Copenhagen University Hospital, DK-2100 Copenhagen, Denmark. Jeppelerche@hotmail.com

Abstract

OBJECTIVE:

To assess if authors of randomised clinical trials convey the fact that they have used surrogate outcomes and discussed their validity.

DESIGN:

Cohort study.

SETTING:

Six major general medical journals.

PARTICIPANTS:

Randomised clinical trials published in 2005 and 2006 that used a surrogate as a primary outcome.

RESULTS:

Of 626 published randomised clinical trials, 109 (17%) used a surrogate as a primary outcome. Of these trials, 62 (57%, 95% confidence interval 47% to 67%) clearly reported that the primary outcome was a surrogate. Only 38 (35%, 26% to 45%) also discussed the validity of the surrogate.

CONCLUSION:

Only about one third of authors of randomised clinical trials that used a surrogate as a primary outcome reported adequately on the surrogate. Better reporting is needed.

PMID:
20719823
PMCID:
PMC2923691
[PubMed - indexed for MEDLINE]
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