title: The REFLECT statement: methods and processes of creating reporting guidelines for randomized controlled trials for livestock and food safety.
abstract: The conduct of randomized controlled trials in livestock with production, health, and food-safety outcomes presents unique challenges that might not be adequately reported in trial reports. The objective of this project was to modify the CONSORT (Consolidated Standards of Reporting Trials) statement to reflect the unique aspects of reporting these livestock trials. A 2-day consensus meeting was held on November 18-19, 2008 in Chicago, IL, to achieve the objective. Before the meeting, a Web-based survey was conducted to identify issues for discussion. The 24 attendees were biostatisticians, epidemiologists, food-safety researchers, livestock production specialists, journal editors, assistant editors, and associate editors. Before the meeting, the attendees completed a Web-based survey indicating which CONSORT statement items would need to be modified to address unique issues for livestock trials. The consensus meeting resulted in the production of the REFLECT (Reporting Guidelines for Randomized Control Trials) statement for livestock and food safety and 22-item checklist. Fourteen items were modified from the CONSORT checklist, and an additional subitem was proposed to address challenge trials. The REFLECT statement proposes new terminology, more consistent with common usage in livestock production, to describe study subjects. Evidence was not always available to support modification to or inclusion of an item. The use of the REFLECT statement, which addresses issues unique to livestock trials, should improve the quality of reporting and design for trials reporting production, health, and food-safety outcomes.
authors.affiliation: Vet Diagnostic & Production Animal Medicine, Veterinary Medicine Research Institute Building 4, Iowa State University, Ames, IA 50011, USA. oconnor@iastate.edu
authors.forename: A M
authors.initials: AM
authors.lastname: O'Connor
authors.forename: J M
authors.initials: JM
authors.lastname: Sargeant
authors.forename: I A
authors.initials: IA
authors.lastname: Gardner
authors.forename: J S
authors.initials: JS
authors.lastname: Dickson
authors.forename: M E
authors.initials: ME
authors.lastname: Torrence
authors.forename: C E
authors.initials: CE
authors.lastname: Dewey
authors.forename: I R
authors.initials: IR
authors.lastname: Dohoo
authors.forename: R B
authors.initials: RB
authors.lastname: Evans
authors.forename: J T
authors.initials: JT
authors.lastname: Gray
authors.forename: M
authors.initials: M
authors.lastname: Greiner
authors.forename: G
authors.initials: G
authors.lastname: Keefe
authors.forename: S L
authors.initials: SL
authors.lastname: Lefebvre
authors.forename: P S
authors.initials: PS
authors.lastname: Morley
authors.forename: A
authors.initials: A
authors.lastname: Ramirez
authors.forename: W
authors.initials: W
authors.lastname: Sischo
authors.forename: D R
authors.initials: DR
authors.lastname: Smith
authors.forename: K
authors.initials: K
authors.lastname: Snedeker
authors.forename: J
authors.initials: J
authors.lastname: Sofos
authors.forename: M P
authors.initials: MP
authors.lastname: Ward
authors.forename: R
authors.initials: R
authors.lastname: Wills
mesh_terms: D000827:Animal Welfare; D000818:Animals; D000829:Animals, Domestic; D003257:Consumer Product Safety; D035081:Editorial Policies; D017408:Guidelines as Topic; D006801:Humans; D010506:Periodicals as Topic / Q000592:standards; D011643:Publishing / Q000592:standards; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D014956:Writing / Q000592:standards