A Workshop to Develop Reporting Guidelines for Interventions Studies in Food Safety and Production Animal Science: Modifying the CONSORT Statement

This workshop provided a forum for researchers to gain consensus on modifications to the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting livestock trials with health, production or food safety outcomes. The workshop resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and a 22-item checklist.

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Objective

The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting livestock trials with health, production or food safety outcomes.

Conclusions

A two-day consensus meeting was held on November 18-19, 2008 in Chicago, Ill, United States of America, to achieve the objective. Prior to the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Prior to the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items may need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT  (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety (LFS) and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional sub-item was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.

Deliverable

Investigators have published the REFLECT statement : Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety. The publication was accepted by 5 journals (Preventive Veterinary Medicine, Journal of Veterinary Internal Medicine, Journal of Food Protection, Zoonoses and Public Health and Journal of Swine Health and Production) and the accompanying Explanation and Elaboration document was published in 2 journals (Journal of Food Protection, Zoonoses and Public Health).

Investigators retained copyright of the REFLECT statement and they REFLECT statement is available on line at www.reflect-statement.org. Translations of the checklist on the website include Spanish and French.