Proceedings of the 10th International Colloquium on Paratuberculosis

#76
Towards improved reporting standards for test evaluation studies for paratuberculosis
Ian A Gardner
University <strong>of</strong> California, Davis, USA
A 2008 review <strong>of</strong> test evaluation studies for paratuberculosis concluded “<strong>the</strong>re is a pr<strong>of</strong>ound lack <strong>of</strong> reliable test
evaluations, and future assessments should be conducted more stringently to allow appropriate interpretation
and comparison across populations”. One approach to improve quality is to develop consensus-based reporting
standards. Development <strong>of</strong> standards for paratuberculosis has several potential benefits. First, standards
could help avoid tests <strong>of</strong> poor utility that don’t improve management decisions by livestock producers or reduce
potential public health risks. Second, provision <strong>of</strong> design and analysis guidelines for researchers, grant proposal
reviewers and test developers interested in licensure <strong>of</strong> <strong>the</strong>ir products would help improve consistency <strong>of</strong> <strong>the</strong>
review and assessment process. Finally, standards could help guide choices <strong>of</strong> sample types to be included in
repositories or sample banks developed for use in test validation studies.
In human medicine, <strong>the</strong> STARD (Standards for Reporting <strong>of</strong> Diagnostic Accuracy) initiative was started to
improve <strong>the</strong> accuracy, completeness and transparency <strong>of</strong> studies reporting on diagnostic accuracy. More than
200 biomedical journals (including 2 veterinary journals, Acta Veterinaria Scandinavica and BMC Veterinary
Research) endorse <strong>the</strong> STARD statement (available at www.stard-statement.org/) and most recommend use <strong>of</strong>
<strong>the</strong> STARD checklist <strong>of</strong> 25 items in <strong>the</strong>ir instructions to authors. The STARD checklist was primarily developed
for evaluation <strong>of</strong> tests in individual human patients with clinical disease and hence, may not be directly
extrapolated to testing scenarios in animal health, which <strong>of</strong>ten focus on subclinical infection in individuals, herd
tests, and pooled tests. Also, unlike human medicine we <strong>of</strong>ten do not have <strong>the</strong> financial or technical resources
to truly define <strong>the</strong> infection status <strong>of</strong> study units and hence, latent class modeling approaches may be needed
for statistical analysis.
A consensus meeting to discuss reporting standards will occur prior to <strong>the</strong> ICP meeting and this presentation
will update progress on <strong>the</strong> initiative.
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