• Open Access

The REFLECT Statement: Methods and Processes of Creating Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety

Authors

  • A.M. O'Connor,

    1. Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA
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  • J.M. Sargeant,

    1. Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA
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  • I.A. Gardner,

    1. Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA
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  • J.S. Dickson,

    1. Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA
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  • M.E. Torrence,

    1. Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA
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  • consensus meeting participants: C.E. Dewey, I.R. Dohoo, R.B. Evans, J.T. Gray, M. Greiner, G. Keefe, S.L. Lefebvre, P.S. Morley, A. Ramirez, W. Sischo, D.R. Smith, K. Snedeker, J. Sofos, M.P. Ward, R. Wills

    1. Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA
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  • Remaining addresses included in Appendix.

  • Note from the editor: The REFLECT statement is also published in Journal of Food Protection, Zoonoses and Public Health, and Journal of Swine Health and Production. The Editorial board of this journal believes that the contents of this report will be an important forward step in standardizing the design and implementation of randomized clinical trials in animal health and food safety research arena. Authors can use any one of these references when citing REFLECT. Furthermore, the REFLECT Statement should be read in conjunction with the REFLECT Explanation and Elaboration Document, which are available at the REFLECT statement website, http://www.reflect-statement.org.

Corresponding author: A. O'Connor, Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA 50011; e-mail: oconnor@iastate.edu.

Abstract

The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18–19, 2008 in Chicago, IL, to achieve the objective. Before 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. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would 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 and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem 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.

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