Universitet Methods and processes of developing the strengthening the reporting of observational studies in epidemiology-veterinary ( STROBE-Vet )

Reporting of observational studies in veterinary research presents challenges that often are not addressed in published reporting guidelines. Our objective was 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. We conducted a consensus meeting with 17 experts in Mississauga, Canada. Experts completed a premeeting survey about whether items in the STROBE statement should be modified or added 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 rewording was recommended, and whether additions were warranted. Anonymous voting was used to determine consensus. 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 and 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). 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. Observational studies are a common methodological approach in veterinary research and have been used to estimate the frequency of a disease or condition, test hypotheses, generate new hypotheses, or generate data suitable as input for systematic reviews and meta-analyses, risk assessments, and other data-dependent models, such as mathematical and simulated disease models. Thus, observational studies may be used to estimate the prevalence or incidence of a condition, to investigate the distribution of conditions in time and space, to explore risk factors and compare management options, to create explanatory models, or to evaluate diagnostic test accuracy. Comprehensive and transparent reporting of an observational study’s design, execution, and results is essential for the interpretation of the * Author for correspondence. Tel: þ1 519 824 4120, Ext 54045; Fax: 519-763-8621; E-mail: sargeanj@uoguelph.ca. † In order to encourage dissemination of the STROBE-Vet Statement, this article is published in the following journals: Journal of Food Protection, Journal of Swine Health and Production, Journal of Veterinary Internal Medicine, Preventive Veterinary Medicine, Zoonoses and Public Health. The Explanation and Elaboration STROBE-Vet document for each checklist item is available in companion publications in Journal of Veterinary Internal Medicine and Zoonoses and Public Health. The original STROBE statement is published in Journal of Clinical Epidemiology Web site (http://www.jclinepi.com), Annals of Internal Medicine, BMJ, Bulletin of the World Health Organization, Epidemiology, The Lancet, PLoS Medicine, and Preventive Medicine. The authors jointly own the copyright of this article. 2211 Journal of Food Protection, Vol. 79, No. 12, 2016, Pages 2211–2219 doi:10.4315/0362-028X.JFP-16-016 Published 2016 by the International Association for Food Protection This is an open access article under the CC BY license (https://creativecommons.org/licenses/by/4.0/) research in terms of evaluating its applicability for the reader and its potential for bias and for the data to be used as input for other studies, such as meta-analyses and risk assessments. The peer-review process also benefits from guidelines describing appropriate reporting. In human health care, inadequacies in reporting of key information in observational studies have been documented (6, 15, 21). Although there is less documented empirical evidence of deficiencies in reporting observational studies in veterinary medicine, absence of evidence is not evidence of absence. Indeed, some evidence of inadequate reporting exists in the literature on preharvest food safety (19). The STROBE statement (www.strobe-statement.org) was developed to provide guidance for the reporting of observational studies related to human health. It consists of a 22-item checklist that is accompanied by a document describing the development of the STROBE statement (24) and an elaboration document that provides explanations of each item, as well as examples of complete reporting of each item (23). The STROBE guidelines focus on cohort, casecontrol, and cross-sectional studies of aspects of human medicine and public health, although many of the principles also apply to other observational study designs, such as hybrid designs or ecological studies. The STROBE statement has been modified for use in specific content areas within epidemiology, including genetic-association studies (STREGA) (8), molecular epidemiology (STROBEME) (5), and molecular epidemiology for infectious diseases (STROME-ID) (4). There are some nuances of conducting and reporting studies in animal populations that are unique from other areas of epidemiology (17). Thus, the CONsolidated Standards Of Reporting Trials (CONSORT) statement for reporting randomized controlled trials in human medicine (9) was previously modified for use in veterinary medicine. The result was the creation and publication of the reporting guidelines for randomized controlled trials for livestock and food safety (REFLECT) statement (14, 18). Similarly, while the STROBE statement and the accompanying elaboration document provide an excellent resource for conducting, reporting, and reading observational studies, modifications to address specific issues in veterinary medicine will increase its applicability in this field (17). Here, we describe the methods and processes used to develop an extension of the STROBE statement that forms the basis for the standardized reporting guidelines for observational studies in veterinary medicine (STROBEVet). As a separate companion paper, the STROBE-Vet explanation and elaboration document (11, 12) provides the methodological background for the items contained in the STROBE-Vet statement, as well as illustrative examples of appropriate reporting. We strongly recommend that the STROBE-Vet checklist be used in conjunction with the explanation and elaboration document for all observational studies related to animal health, production, welfare, or food safety outcomes. MATERIALS AND METHODS The process for extending reporting-guideline statements (e.g., STROBE and CONSORT) to meet the specific needs of individual disciplines has been documented (1, 10). We used these reports to design the approach used for developing the statement reported herein. Steering committee. A steering committee was responsible for the development of the revised veterinary extension of the STROBE statement. This group, composed of four members (coauthors J.M.S., A.M.O.C., H.N.E., and I.R.D.), first met to discuss the idea in December 2012. The committee agreed to explore the need for modifying the original STROBE statement and to use the approach reported previously as a guideline for the modification (10). The committee secured funding for the project, identified potential participants, invited the potential participants to attend a consensus meeting, organized the meeting, and was responsible for subsequent steps involved in preparation and publication of the papers as detailed below. Funding. Funding was required to cover the costs of the consensus meeting (e.g., travel, accommodations, and meeting rooms). The decision was made by the steering committee not to seek funding from pharmaceutical or biological companies commonly associated with veterinary research. Efforts to obtain funding were limited to not-for-profit nongovernment organizations, academic institutions, and a publishing company. Funding was received from the Canadian Association for Veterinary Epidemiology and Preventive Medicine (CAVEPM), the Centre for Veterinary Epidemiology (CVER) at the University of Prince Edward Island, the Centre for Public Health and Zoonoses (CPHAZ) at the University of Guelph, Iowa State University, Cornell University, and the publishing company VER Inc, Prince Edward Island, Canada. Sufficient funds were obtained to pay for all local expenses for the participants at the consensus meeting. Funds to cover travel costs for participants were not obtained; therefore, in general, participants fully funded their own travel and the sources of these funds were not identified. Identification of participants. The committee’s aim was to bring together a group of experts familiar with the design, conduct, and statistical analysis of observational studies concerning animal health, production, welfare, and food safety. Another aim was to include researchers with experience in a wide variety of areas, including food-animal production, companion-animal medicine, veterinary public health, and food safety. Representation from multiple countries was sought, with an effort to include several participants with relevant editorial experience. The steering committee decided to limit the size of the meeting to approximately 20 participants, including the four committee members. The size limitation was based on funding and the need for a group size that facilitated interaction and active discussion. The steering committee identified experts for invitation based on areas of expertise (many with multiple areas) and geographic locations. Invitations to attend the meeting were sent via e-mail by J.M.S. to the first 20 individuals on the list. The email invitation requested tha