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

摘要

STUDY QUESTION Do authors of randomised clinical trials convey the fact that they have used a surrogate outcome and do they discuss the surrogate's validity? SUMMARYANSWER About one in five published randomised clinical trials uses a surrogate as a primary outcome, and only about one third of these trials report adequately on the use of a surrogate and its validity. WHAT IS KNOWN AND WHATTHIS PAPER ADDS Uncritical use of surrogate outcomes can be misleading and may have resulted in implementation of harmful interventions. Better reporting on surrogate outcomes is needed to avoid misleading conclusions and uncritical acceptance of new treatments.