Cited by 97Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAnimal testing and alternatives

The REFLECT Statement: Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and Elaboration

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Sargeant, J.M., O’connor, A.M., Gardner, I.A., Dickson, J.S., Torrence, M.E., Dohoo, Consensus Meeting Participants I.R., Lefebvre, S.L., Morley, P.S. +2 more·2010·Journal of Food Protection

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.

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  1. O'Connor, A. M., N. G. Wellman, M. Rice, and L. Funk. Evaluating the quality of reporting randomized clinical trials for antibiotic treatment of bovine respiratory disease: 1970-2005. J. Am. Vet. Med. Assoc., in press.

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Authors
Sargeant, J. M., O’connor, A. M., Gardner, I. A., Dickson, J. S., Torrence, M. E., Dohoo, C. M. P. I. R., Lefebvre, S. L., Morley, P. S., Ramirez, A., & Snedeker, K.
Affiliations
  • Ontario Veterinary College (CA)
  • University of California, Davis (US)
  • Iowa State University (US)
  • Agricultural Research Service (US)
  • University of Prince Edward Island (CA)
  • American Veterinary Medical Association (US)
  • Colorado State University (US)
Corresponding author
Sargeant, J.M.
Venue
Journal of Food Protection
Publisher
Elsevier BV
Published
2010-03
Volume
73
Issue
3
Pages
579-603
ISSN
0362-028X (ISSN-L)
OpenAlex
W2890610674
Cited by
97
References
123
Citations by year
2026: 2 · 2025: 4 · 2024: 3 · 2023: 4 · 2022: 7 · 2021: 13 · 2020: 5 · 2019: 14 · 2018: 3 · 2017: 5 · 2016: 4 · 2015: 6 · 2014: 5 · 2013: 1 · 2012: 9
FWCI
6.31
Type
journal article
Language
en
Open access
Locations
  • Journal of Food Protection (publishedVersion, public-domain)
  • PubMed (publishedVersion)
Funders
  • U.S. Department of Agriculture
  • Public Health Agency of Canada
  • Public Health Agency
  • Food Safety and Inspection Service
  • Canadian Institutes of Health Research
  • Institute of Population and Public Health
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
Keywords
reporting guidelines, randomized controlled trials, livestock, food safety, CONSORT statement, group housing, group allocation, reporting checklist
MeSH terms
Animals, Animal Welfare, Animals, Domestic, Consumer Product Safety, Humans, Periodicals as Topic, Publishing, Writing, Randomized Controlled Trials as Topic, Guidelines as Topic, Editorial Policies

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