The reflect statement: Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and elaboration

J. M. Sargeant, A. M. O'Connor, Ian Gardner, J. S. Dickson, M. E. Torrence, I. R. Dohoo, S. L. Lefebvre, P. S. Morley, A. Ramirez, K. Snedeker

Research output: Contribution to journalArticle

47 Citations (Scopus)

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 that 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 deliberate challenge models in some trials and the 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.

Original languageEnglish (US)
Pages (from-to)105-136
Number of pages32
JournalZoonoses and Public Health
Volume57
Issue number2
DOIs
StatePublished - Mar 1 2010

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Food Safety
Livestock
randomized clinical trials
food safety
Randomized Controlled Trials
livestock
Guidelines
medicine
Medicine
Population
group housing
food pathogens
Checklist
Publications
decision making
Decision Making

Keywords

  • Challenge studies and standards
  • Livestock
  • Randomized trials

ASJC Scopus subject areas

  • Epidemiology
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

The reflect statement : Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and elaboration. / Sargeant, J. M.; O'Connor, A. M.; Gardner, Ian; Dickson, J. S.; Torrence, M. E.; Dohoo, I. R.; Lefebvre, S. L.; Morley, P. S.; Ramirez, A.; Snedeker, K.

In: Zoonoses and Public Health, Vol. 57, No. 2, 01.03.2010, p. 105-136.

Research output: Contribution to journalArticle

Sargeant, JM, O'Connor, AM, Gardner, I, Dickson, JS, Torrence, ME, Dohoo, IR, Lefebvre, SL, Morley, PS, Ramirez, A & Snedeker, K 2010, 'The reflect statement: Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and elaboration', Zoonoses and Public Health, vol. 57, no. 2, pp. 105-136. https://doi.org/10.1111/j.1863-2378.2009.01312.x
Sargeant, J. M. ; O'Connor, A. M. ; Gardner, Ian ; Dickson, J. S. ; Torrence, M. E. ; Dohoo, I. R. ; Lefebvre, S. L. ; Morley, P. S. ; Ramirez, A. ; Snedeker, K. / The reflect statement : Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and elaboration. In: Zoonoses and Public Health. 2010 ; Vol. 57, No. 2. pp. 105-136.
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