The reporting characteristics of bovine respiratory disease clinical intervention trials published prior to and following publication of the REFLECT statement

Totton, S C and Cullen, J N and Sargeant, J M and O’Connor, A M

Preventative Veterinary Medicine (2018) 150: 117–125

DOI: 10.1016/j.prevetmed.2017.12.015

Abstract

The goal of the REFLECT Statement (Reporting guidElines For randomized controLled trials in livEstoCk and food safeTy) (published in 2010) was to provide the veterinary research community with reporting guidelines tailored for randomized controlled trials for livestock and food safety. Our objective was to determine the prevalence of REFLECT Statement reporting of items 1-19 in controlled trials published in journals between 1970 and 2017 examining the comparative efficacy of FDA-registered antimicrobials against naturally acquired BRD (bovine respiratory disease) in weaned beef calves in Canada or the USA, and to compare the prevalence of reporting before and after 2010, when REFLECT was published. We divided REFLECT Statement, items 3, 5, 10, and 11 into subitems, because each dealt with multiple elements requiring separate assessment. As a result, 28 different items or subitems were evaluated independently. We searched MEDLINE((R)) and CABI (CAB Abstracts((R)) and Global Health((R))) (Web of Science) in April 2017 and screened 2327 references. Two reviewers independently assessed the reporting of each item and subitem. Ninety-five references were eligible for the study. The reporting of the REFLECT items showed a point estimate for the prevalence ratio \textgreater1 (i.e. a higher proportion of studies published post-2010 reported this item compared to studies published pre-2010), apart from items 10.3, i.e., item 10, subitem 3 (who assigned study units to the interventions), 13 (the flow of study units through the study), 16 (number of study units in analysis), 18 (multiplicity), and 19 (adverse effects). Fifty-three (79%) of 67 studies published before 2010 and all 28 (100%) papers published after 2010 reported using a random allocation method in either the title, abstract, or methods (Prevalence ratio=1.25; 95% CI (1.09,1.43)). However, 8 studies published prior to 2010 and 7 studies published post-2010 reported the term "systematic randomization" or variations of this term (which is not true randomization) to describe the allocation procedure. Fifty-five percent (37/67) of studies published pre-2010 reported blinding status (blinded/not blinded) of outcome assessors, compared to 24/28 (86%) of studies published post-2010 (Prevalence ratio=1.5, 95% CI (1.19, 2.02)). The reporting of recommended items in journal articles in this body of work is generally improving; however, there is also evidence of confusion about what constitutes a random allocation procedure, and this suggests an educational need. As this study is observational, this precludes concluding that the publication of the REFLECT Statement was the cause of this trend.

Citation

Totton, S. C., Cullen, J. N., Sargeant, J. M., & O’Connor, A. M. (2018). The reporting characteristics of bovine respiratory disease clinical intervention trials published prior to and following publication of the REFLECT statement. Preventative Veterinary Medicine, 150, 117–125. https://doi.org/10.1016/j.prevetmed.2017.12.015 Cattle, Cows, Bovines, Bovine respiratory disease, Randomised Controlled Trials, REFLECT Controlled trial Standards

Keywords

• Cattle
• Cows
• Bovines
• Bovine respiratory disease
• Randomised Controlled Trials
• REFLECT Controlled trial Standards