Comparison of treatment effect sizes associated with surrogate and final patient relevant outcomes in randomised controlled trials: meta-epidemiological study.

ABSTRACT:

Objective

To quantify and compare the treatment effect and risk of bias of trials reporting biomarkers or intermediate outcomes (surrogate outcomes) versus trials using final patient relevant primary outcomes.

Design

Meta-epidemiological study.

Data sources

All randomised clinical trials published in 2005 and 2006 in six high impact medical journals: Annals of Internal Medicine, BMJ, Journal of the American Medical Association, Lancet, New England Journal of Medicine, and PLoS Medicine.

Study selection

Two independent reviewers selected trials.

Data extraction

Trial characteristics, risk of bias, and outcomes were recorded according to a predefined form. Two reviewers independently checked data extraction. The ratio of odds ratios was used to quantify th

SUBMITTER: Ciani O 

PROVIDER: S-EPMC3558411 | biostudies-literature | 2013 Jan

REPOSITORIES: biostudies-literature