Scientific Publications by FDA Staff

J Swine Health Prod 2016 Nov-Dec;24(6):315-5

Methods and processes of developing the strengthening the reporting of observational studies in epidemiology--Veterinary (STROBE-Vet) statement.

Sargeant JM, O'Connor AM, Dohoo IR, Erb HN, Cevallos M, Egger M, Ersboll AK, Martin SW, Nielsen LR, Pearl DL, Pfeiffer DU, Sanchez J, Torrence ME, Vigre H, Waldner C, Ward MP

BACKGROUND: Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. OBJECTIVE: To develop an extension of the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) statement that addresses unique reporting requirements for observational studies in veterinary medicine related to health, production, welfare, and food safety. DESIGN: Consensus meeting of experts. SETTING: Mississauga, Canada. PARTICIPANTS: Seventeen experts from North America, Europe, and Australia. METHODS: Experts, completed a pre-meeting survey about whether items in the STROBE statement should be added to or modified to address unique issues related to observational studies in animal species with health, production, welfare, or food safety outcomes. During the meeting, each STROBE item was discussed to determine whether or not re-wording was recommended and whether additions were warranted. Anonymous voting was used to determine consensus. RESULTS: Six items required no modifications or additions. Modifications or additions were made to the STROBE items 1 (title and abstract), 3 (objectives), 5 (setting), 6 (participants), 7 (variables), 8 (data sources-measurement), 9 (bias), 10 (study size), 12 (statistical methods), 13 (participants), 14 (descriptive data), 15 (outcome data), 16 (main results), 17 (other analyses), 19 (limitations), and 22 (funding). CONCLUSION: The methods and processes used were similar to those used for other extensions of the STROBE statement. The use of this STROBE statement extension should improve reporting of observational studies in veterinary research by recognizing unique features of observational studies involving food-producing and companion animals, products of animal origin, aquaculture, and wildlife.