Establishing Guidelines for Reporting Clinical Trials

An Extension of the CONSORT Statement for Trials Involving Livestock with Production, Health, and Food Safety Outcomes

Abstract

Recently, several reviews of clinical trials in preharvest
food safety and production animal medicine
have identified issues with lack of reporting of key
methodological quality features and items necessary
for interpretation and replication of trial findings. In
human medicine, similar issues with the reporting of
clinical trials were identified 10-15 years ago. This led
to the publication of the CONsolidated Standards Of
Reporting Trials (CONSORT) statement, which consists
of a checklist of 22 items that should be reported when
publishing a clinical trial, a flow diagram to describe
participant movement at all stages of a trial, and an
explanation and elaboration document. The CONSORT
statement is endorsed by hundreds of medical journals
and has resulted in improvements in trial reporting.
Livestock clinical trials incorporate issues not covered
by CONSORT, including the distinction between animal
owners and study subjects, the frequent allocation of
treatments to groups, the conduct in both research and
commercial settings, and the common use of deliberate
disease challenge models.