Open Access The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration

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Abstract:

Concerns about the completeness and accuracy of reporting of randomized clinical trials (RCTs) and the impact of poor reporting on decision-making have been documented in the medical field over the past several decades. Experience from RCTs in human medicine would suggest that failure to report critical trial features can be associated with biased estimated effect measures, and there is evidence to suggest similar biases occur in RCTs conducted in livestock populations. In response to these concerns, standardized guidelines for reporting RCTs were developed and implemented in human medicine. The Consolidated Standards of Reporting Trials (CONSORT) statement was first published in 1996 with a revised edition published in 2001. The CONSORT statement consists of a 22-item checklist for reporting a RCT and a flow diagram to follow the number of participants at each stage of a trial. An explanation and elaboration document not only defines and discusses the importance of each of the items, but also provides examples of how this information could be supplied in a publication. Differences between human and livestock populations necessitate modifications to the CONSORT statement to maximize its usefulness for RCTs involving livestock. These have been addressed in an extension of the CONSORT statement titled the REFLECT statement: Methods and processes of creating reporting guidelines for randomized control trials for livestock and food safety. The modifications made for livestock trials specifically addressed the common use of group housing and group allocation to intervention in livestock studies, the use of a deliberate challenge model in some trials, and common use of non-clinical outcomes, such as contamination with a foodborne pathogen. In addition, the REFLECT statement for RCTs in livestock populations proposed specific terms or further clarified terms as they pertained to livestock studies.

Document Type: Review Article

Affiliations: 1: Centre for Public Health and Zoonoses and Department of Population Medicine, Ontario Veterinary College, University of Guelph, Guelph, Ontario, Canada N1G 2W1. sargeanj@uoguelph.ca 2: Veterinary Diagnostic and Production Animal Medicine, Iowa State University, Veterinary Medicine Research Institute Building 4, Ames, Iowa 50011, USA 3: Department of Medicine and Epidemiology, School of Veterinary Medicine, University of California, Davis, California 95616, USA 4: Department of Animal Science, Iowa State University, 215F Meat Laboratory, Ames, Iowa 50011, USA 5: U.S. Department of Agriculture, Agricultural Research Service, GWCC-4-2194, 5601 Sunnyside Avenue, Beltsville, Maryland 20870, USA 6: Department of Health Management, Atlantic Veterinary College, University of Prince Edward Island, Charlottetown, Prince Edward Island, Canada C1A 4P3 7: American Veterinary Medical Association, 1931 North Meacham Road, Suite 100, Schaumburg, Illinois 60173, USA 8: Department of Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University, Fort Collins, Colorado 80523-1678, USA 9: Centre for Public Health and Zoonoses and Department of Population Medicine, Ontario Veterinary College, University of Guelph, Guelph, Ontario, Canada N1G 2W1

Publication date: March 1, 2010

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    First published in 1937, the Journal of Food Protection®, is a refereed monthly publication. Each issue contains scientific research and authoritative review articles reporting on a variety of topics in food science pertaining to food safety and quality. The Journal is internationally recognized as the leading publication in the field of food microbiology with a readership exceeding 11,000 scientists from 70 countries. The Journal of Food Protection® is indexed in Index Medicus, Current Contents, BIOSIS, PubMed, Medline, and many others.

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