Document Type
Article
Publication Version
Published Version
Publication Date
2010
Journal or Book Title
Journal of Food Protection
Volume
73
Issue
3
First Page
579
Last Page
603
DOI
10.4315/0362-028X-73.3.579
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.
Rights
Works produced by employees of the U.S. Government as part of their official duties are not copyrighted within the U.S. The content of this document is not copyrighted.
Language
en
File Format
application-pdf
Recommended Citation
Sargeant, Jan M.; O'Connor, Annette M.; Gardner, Ian A.; Dickson, James S.; Torrence, Mary E.; Dohoo, Ian R.; Lefebvre, Sandra L.; Morley, Paul S.; Ramirez, Alejandro; and Snedeker, Kate, "The REFLECT Statement: Reporting Guidelines for Randomized Controlled Trials in Livestock and Food Safety: Explanation and Elaboration" (2010). Veterinary Diagnostic and Production Animal Medicine Publications. 5.
https://lib.dr.iastate.edu/vdpam_pubs/5
Included in
Animal Sciences Commons, Large or Food Animal and Equine Medicine Commons, Veterinary Preventive Medicine, Epidemiology, and Public Health Commons
Comments
This article is from Journal of Food Protection 73 (2010): pp.579-603, doi: 10.4315/0362-028X-73.3.579.