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Review
. 2010 Aug 18:341:c3653.
doi: 10.1136/bmj.c3653.

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

Jeppe Lerche la Cour  1 , Jesper Brok, Peter C Gøtzsche
Affiliations
Review

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

Jeppe Lerche la Cour et al. BMJ. .

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.

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Conflict of interest statement

Competing interest: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any company for the submitted work; no financial relationships with any companies that might have an interest in the submitted work in the previous 3 years; no other relationships or activities that could appear to have influenced the submitted work.

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Selection of trials
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