Consensus-based reporting standards for diagnostic test accuracy studies for paratuberculosis in ruminants

Ian A. Gardner, Søren S. Nielsen, Richard J. Whittington, Michael T. Collins, Douwe Bakker, Beth Harris, Srinand Sreevatsan, Jason E. Lombard, Raymond Sweeney, David R. Smith, Jerrie Gavalchin, Shigetoshi Eda

Research output: Contribution to journalArticlepeer-review

74 Scopus citations


The Standards for Reporting of Diagnostic Accuracy (STARD) statement ( was developed to encourage complete and transparent reporting of key elements of test accuracy studies in human medicine. The statement was motivated by widespread evidence of bias in test accuracy studies and the finding that incomplete or absent reporting of items in the STARD checklist was associated with overly optimistic estimates of test performance characteristics. Although STARD principles apply broadly, specific guidelines do not exist to account for unique considerations in livestock studies such as herd tests, potential use of experimental challenge studies, a more diverse group of testing purposes and sampling designs, and the widespread lack of an ante-mortem reference standard with high sensitivity and specificity. The objective of the present study was to develop a modified version of STARD relevant to paratuberculosis (Johne's disease) in ruminants. Examples and elaborations for each of the 25 items were developed by a panel of experts using a consensus-based approach to explain the items and underlying concepts. The new guidelines, termed STRADAS-paraTB (Standards for Reporting of Animal Diagnostic Accuracy Studies for paratuberculosis), should facilitate improved quality of reporting of the design, conduct and results of paratuberculosis test accuracy studies which were identified as " poor" in a review published in 2008 in Veterinary Microbiology.

Original languageEnglish (US)
Pages (from-to)18-34
Number of pages17
JournalPreventive Veterinary Medicine
Issue number1-2
StatePublished - Aug 1 2011

Bibliographical note

Funding Information:
We thank Vivek Kapur and Tiffany Cunningham for technical assistance and the Johne's Disease Integrated Program (USDA-NIFA Award No. 2008-55620-18710 ) for funding the meetings of coauthors of the manuscript.


  • Paratuberculosis
  • Reporting standards
  • Sensitivity and specificity
  • Test accuracy


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