The REFLECT Statement: Reporting guidelines for randomized controlled trials in livestock and food safety: Explanation and Elaboration
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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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This manuscript is reported following the Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety (REFLECT) statement.
“This manuscript is reported following the Reporting Guidelines for Randomized Controlled Trials for Livestock and Food Safety (REFLECT) statement”
From A randomized controlled trial investigating the effect of transport duration and age at transport on surplus dairy calves: Part II. Impact on hematological variables. (2023) · cites this paper as Sargeant et al., 2010
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Wisener, L. V., Sargeant, J. M., O'Connor, A. M. C., Faires, M. C., & Glass-Kaastra, S. K. (2014) · Zoonoses and Public Health · doi:10.1111/zph.12112 · Cited by 69 · see citing works
Sargeant, J. M., O'Connor, A. M. C., Dohoo, I. R., Erb, H. N., Cevallos, M., Egger, M., Ersbøll, A. K., Martin, S. W., Nielsen, L. R., Pearl, D. L., et al. (2016) · Journal of Veterinary Internal Medicine · doi:10.1111/jvim.14574 · Cited by 60 · see citing works
A mixed treatment comparison meta-analysis of antibiotic treatments for bovine respiratory disease
O'Connor, A. M. C., Coetzee, J. F., da Silva, N., & Wang, C. (2012) · Preventive Veterinary Medicine · doi:10.1016/j.prevetmed.2012.11.025 · Cited by 58 · see citing works
Kabera, F., Dufour, S., Keefe, G. P., Cameron, M., & Roy, J. (2020) · Journal of Dairy Science · doi:10.3168/jds.2019-17438 · Cited by 59 · see citing works
ADSA Foundation Scholar Award: New frontiers in calf and heifer nutrition—From conception to puberty
van Niekerk, J. K., Fischer-Tlustos, A. J., Wilms, J. N., Hare, K. S., Welboren, A. C., Lopez, A. J., Yohe, T. T., Cangiano, L. R., Leal, L. N., & Steele, M. A. (2021) · Journal of Dairy Science · doi:10.3168/jds.2020-20004 · Cited by 55 · see citing works
Roy, J., & Keefe, G. P. (2012) · Veterinary Clinics of North America Food Animal Practice · doi:10.1016/j.cvfa.2011.12.004 · Cited by 44 · see citing works
Research synthesis in veterinary science: Narrative reviews, systematic reviews and meta-analysis
O'Connor, A. M. C., & Sargeant, J. M. (2015) · The Veterinary Journal · doi:10.1016/j.tvjl.2015.08.025 · Cited by 39 · see citing works
Brace, S., Taylor, D., & O'Connor, A. M. C. (2010) · Vaccine · doi:10.1016/j.vaccine.2010.05.041 · Cited by 38 · see citing works
van der Leij, W. J. R., Selman, L. D. A. M., Vernooij, J. C. M., & Vinke, C. M. (2019) · PLoS ONE · doi:10.1371/journal.pone.0223492 · Cited by 37 · see citing works
Apley, M. D. (2015) · Veterinary Clinics of North America Food Animal Practice · doi:10.1016/j.cvfa.2014.11.009 · Cited by 36 · see citing works
Lin, C., Cui, J., Peng, Z., Qian, K., Wu, R., Cheng, Y., & Yin, W. (2022) · European journal of medical research · doi:10.1186/s40001-022-00839-0 · Cited by 34 · see citing works
Smadi, H., Sargeant, J. M., Shannon, H. S., & Raina, P. S. (2012) · Journal of Epidemiology and Global Health · doi:10.1016/j.jegh.2012.12.001 · Cited by 33 · see citing works
Winder, C. B., Churchill, K. J., Sargeant, J. M., LeBlanc, S. J., O'Connor, A. M. C., & Renaud, D. L. (2019) · Journal of Dairy Science · doi:10.3168/jds.2018-15797 · Cited by 32 · see citing works
Randomized Controlled Trials and Challenge Trials: Design and Criterion for Validity
Sargeant, J. M., Kelton, D. F., & O'Connor, A. M. C. (2014) · Zoonoses and Public Health · doi:10.1111/zph.12126 · Cited by 31 · see citing works
Evaluating the effectiveness of colostrum as a therapy for diarrhea in preweaned calves
Carter, H. S. M., Steele, M. A., Costa, J. H. C., & Renaud, D. L. (2022) · Journal of Dairy Science · doi:10.3168/jds.2022-22187 · Cited by 33 · see citing works
Baruch, J., Cernicchiaro, N., Cull, C. A., Lechtenberg, K. F., Nickell, J. S., & Renter, D. G. (2019) · Journal of Animal Science · doi:10.1093/jas/skz107 · Cited by 29 · see citing works
Sutter, F., Borchardt, S., Schuenemann, G. M., Rauch, E., Erhard, M., & Heuwieser, W. (2019) · Journal of Dairy Science · doi:10.3168/jds.2019-16524 · Cited by 30 · see citing works
Young, I., Wilhelm, B. J., Cahill, S. M., Nakagawa, R., Desmarchelier, P. M., & Rajić, A. (2016) · Journal of Food Protection · doi:10.4315/0362-028x.jfp-16-203 · Cited by 28 · see citing works
Sponsorship bias and quality of randomised controlled trials in veterinary medicine
Wareham, K., Hyde, R., Grindlay, D. J. C., Brennan, M. L., & Dean, R. S. (2017) · BMC Veterinary Research · doi:10.1186/s12917-017-1146-9 · Cited by 28 · see citing works
The efficacy of antibiotics to control colibacillosis in broiler poultry: a systematic review
Sargeant, J. M., Bergevin, M. D., Churchill, K. J., Dawkins, K., Deb, B., Dunn, J. N., Logue, C. M., Novy, A., O'Connor, A. M. C., Reist, M., et al. (2019) · Animal Health Research Reviews · doi:10.1017/s1466252319000264 · Cited by 27 · see citing works
Reporting guidelines for primary research: Saying what you did
O'Connor, A. M. C. (2010) · Preventive Veterinary Medicine · doi:10.1016/j.prevetmed.2010.09.010 · Cited by 25 · see citing works
Downs, S. H., Parry, J. E., Upton, P. A., Broughan, J. M., Goodchild, A. V., Nuñéz-García, J., Greiner, M., Abernethy, D. A., Cameron, A. R., Cook, A. J. C., et al. (2017) · Preventive Veterinary Medicine · doi:10.1016/j.prevetmed.2017.11.004 · Cited by 26 · see citing works
An introduction to systematic reviews in animal health, animal welfare, and food safety
O'Connor, A. M. C., & Sargeant, J. M. (2014) · Animal Health Research Reviews · doi:10.1017/s146625231400005x · Cited by 26 · see citing works
Lipolysis inhibition as a treatment of clinical ketosis in dairy cows: A randomized clinical trial
Chirivi, M., Cortés-Beltrán, D., Munsterman, A. S., O'Connor, A., & Contreras, G. A. (2023) · Journal of Dairy Science · doi:10.3168/jds.2023-23409 · Cited by 25 · see citing works
Sargeant, J. M., O'Connor, A. M. C., Dohoo, I. R., Erb, H. N., Cevallos, M., Egger, M., Ersbøll, A. K., Martin, S. W., Nielsen, L. R., Pearl, D. L., et al. (2016) · Journal of Food Protection · doi:10.4315/0362-028x.jfp-16-016 · Cited by 25 · see citing works
A systematic review of the efficacy of antibiotics for the prevention of swine respiratory disease
Sargeant, J. M., Bergevin, M. D., Churchill, K. J., Dawkins, K., Deb, B., Dunn, J. N., Hu, D., Moody, C. M., O'Connor, A. M. C., O’Sullivan, T. L., et al. (2019) · Animal Health Research Reviews · doi:10.1017/s1466252319000185 · Cited by 25 · see citing works
Moura, C., Totton, S. C., Sargeant, J. M., O’Sullivan, T. L., Linhares, D. C. L., & O'Connor, A. M. C. (2019) · Journal of Swine Health and Production · doi:10.54846/jshap/1125 · Cited by 21 · see citing works
McMullen, C. K., Sargeant, J. M., Kelton, D. F., Churchill, K. J., Cousins, K. S., & Winder, C. B. (2021) · Journal of Dairy Science · doi:10.3168/jds.2020-19873 · Cited by 22 · see citing works
Clinical Trials in Veterinary Medicine: A New Era Brings New Challenges
Oyama, M. A., Ellenberg, S. S., & Shaw, P. A. (2017) · Journal of Veterinary Internal Medicine · doi:10.1111/jvim.14744 · Cited by 23 · see citing works
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Goetz, H. M., Creutzinger, K. C., Kelton, D. F., Costa, J. H. C., Winder, C. B., Gomez, D. E., & Renaud, D. L. (2023) · Journal of Dairy Science · doi:10.3168/jds.2022-22367 · Cited by 20 · see citing works
Hu, D., Wang, C., & O'Connor, A. M. C. (2020) · PLoS ONE · doi:10.1371/journal.pone.0222690 · Cited by 20 · see citing works
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Epidemiology and the Evidence-Based Medicine Approach
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Reporting of methodological features in observational studies of pre-harvest food safety
Sargeant, J. M., O'Connor, A. M. C., Renter, D. G., Kelton, D. F., Snedeker, K. G., Wisener, L. V., Leonard, E. K., Guthrie, A., & Faires, M. C. (2010) · Preventive Veterinary Medicine · doi:10.1016/j.prevetmed.2010.10.009 · Cited by 18 · see citing works
Blinding terminology used in reports of randomized controlled trials involving dogs and cats
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Wareham, K., Hyde, R., Grindlay, D. J. C., Brennan, M. L., & Dean, R. S. (2017) · BMC Veterinary Research · doi:10.1186/s12917-017-1207-0 · Cited by 16 · see citing works
Safety and serologic response to a Haemonchus contortus vaccine in alpacas
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Costa, A., MARCHI, M. D., Sagrafoli, D., Lanzi, H., Amatiste, S., Boselli, C., & Giacinti, G. (2021) · Veterinary Sciences · doi:10.3390/vetsci8120298 · Cited by 9 · see citing works
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Ayrle, H., Nathues, H., Bieber, A., Durrer, M., Quander-Stoll, N., Mevissen, M., & Walkenhorst, M. (2019) · Veterinary Record · doi:10.1136/vr.105131 · Cited by 8 · see citing works
Evaluating Treatment Options for Common Bovine Diseases Using Published Data and Clinical Experience
O'Connor, A. M. C., & Fajt, V. R. (2015) · Veterinary Clinics of North America Food Animal Practice · doi:10.1016/j.cvfa.2014.11.001 · Cited by 7 · see citing works
Information retrieval for systematic reviews in food and feed topics: A narrative review
Wood, H., O'Connor, A. M. C., Sargeant, J. M., & Glanville, J. (2018) · Research Synthesis Methods · doi:10.1002/jrsm.1289 · Cited by 7 · see citing works
Reporting quality of abstracts of veterinary randomized controlled trials
Maranville, R., Popken, A. K., Reynders, R. M., Brandão, J., & Girolamo, N. D. (2021) · Journal of the American Veterinary Medical Association · doi:10.2460/javma.258.3.303 · Cited by 6 · see citing works
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Stopping rules in veterinary randomized controlled trials
Habing, G. G., & Kaneene, J. B. (2011) · Journal of the American Veterinary Medical Association · doi:10.2460/javma.239.9.1197 · Cited by 6 · see citing works
Payne, S. M., Nicholas‐Davies, P., & Home, R. A. (2019) · Frontiers in Sustainable Food Systems · doi:10.3389/fsufs.2019.00062 · Cited by 7 · see citing works
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ARRIVE and CONSORT guidelines: do they have a place in Veterinary Anaesthesia and Analgesia?
Axiak-Flammer, S., & Trim, C. (2016) · Veterinary Anaesthesia and Analgesia · doi:10.1111/vaa.12329 · Cited by 6 · see citing works
Hu, D., Wang, C., & O'Connor, A. M. C. (2019) · bioRxiv (Cold Spring Harbor Laboratory) · doi:10.1101/760942 · Cited by 6 · see citing works
McMullen, C. K., Sargeant, J. M., Kelton, D. F., O'Connor, A. M. C., Reedman, C. N., Hu, D., Glanville, J., Wood, H., & Winder, C. B. (2021) · Frontiers in Animal Science · doi:10.3389/fanim.2021.726401 · Cited by 5 · see citing works
Snedeker, K. G., Canning, P. E., Totton, S. C., & Sargeant, J. M. (2011) · Preventive Veterinary Medicine · doi:10.1016/j.prevetmed.2011.11.004 · Cited by 5 · see citing works
Dixon, A. L., Hanthorn, C. J., Pendell, D. L., Cernicchiaro, N., & Renter, D. G. (2022) · Translational Animal Science · doi:10.1093/tas/txac077 · Cited by 5 · see citing works
Sargeant, J. M., O'Connor, A. M. C., O’Sullivan, T. L., & Ramirez, A. (2023) · Journal of Swine Health and Production · doi:10.54846/jshap/1300 · Cited by 5 · see citing works
Snedec, T., Bittner-Schwerda, L., Rachidi, F., Theinert, K. B., Pietsch, F., Spilke, J., Baumgartner, W., Möbius, G., Starke, A., & Schären, M. (2022) · Journal of Dairy Science · doi:10.3168/jds.2021-20673 · Cited by 4 · see citing works
Camp, M. V., Renaud, D. L., Duffield, T. F., Gómez, D. E., Mcfarlane, W. J., Marshall, J. A., & Winder, C. B. (2021) · Veterinary Sciences · doi:10.3390/vetsci9060288 · Cited by 4 · see citing works
Efficacy of pain management for cattle castration: A systematic review and meta-analysis
Nogues, E., Stojkov, J., Stojkova, B. J., von Keyserlingk, M. A. G., & Weary, D. M. (2025) · Animal Welfare · doi:10.1017/awf.2025.10016 · Cited by 4 · see citing works
Epidemiology and the Evidence-Based Medicine Approach
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Lovatt, F., Powell, J. J., Bastos, C. A. P., & McCrone, I. S. (2025) · Veterinary Record · doi:10.1002/vetr.70169 · Cited by 2 · see citing works
Yáñez, U., Álvarez, J., Lorenzo, G., Cainzos, J. M., Dubuc, J., González, J. J. B., Herradón, P. J. G., Peña, A. I., & Arias, L. Á. Q. (2024) · Research in Veterinary Science · doi:10.1016/j.rvsc.2024.105368 · Cited by 2 · see citing works
Assessment of documentation provided on the use of rubber slats in the flooring of pig holdings
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Aligning valid research outcomes with stakeholder values—what do they need for decision-making?
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Reporting Quality of Controlled-trial Abstracts from Chicken Research
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Economic analysis of randomized controlled trial data: a framework and feedlot cattle case study
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Agrivoltaic Systems: Systematic Review and Meta-Analysis Relating Energy, Soil, and Crop Parameters
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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
- hybrid
- doi.org
- Licence
- 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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