Audrey Ruple leads effort to standardize reporting guidelines in clinical trials with dogs and cats

Getting researchers on the same page is essential to science.

A group led by Virginia Tech’s Audrey Ruple seeks to do just that in regard to reporting guidelines for randomized controlled clinical trials involving dogs and cats, with two papers establishing the guidelines and the rationale behind those guidelines appearing in the journal Frontiers in Veterinary Medicine.

Ruple, the Dorothy A. and Richard G. Metcalf Professor of Veterinary Medical Informatics and associate professor of quantitative epidemiology at the Virginia-Maryland College of Veterinary Medicine, was joined by Annette O’Connor, chair of the Michigan State University College of Veterinary Medicine’s Department of Large Animal Clinical Sciences and professor of epidemiology; Laura E. Selmic, the Teckie and Don Shackelford Chair in Canine Medicine at the Ohio State University; and Jan Sargeant, emeritus professor at the University of Guelph in Ontario, Canada, on the steering committee for a panel of 56 experts from academia and the public and private sectors in developing the PetSORT guidelines.

Ruple said she and her collaborators went through a year of published results from randomized controlled clinical trials conducted in dogs and cats and found, in general, “they weren't reported well, meaning that in the majority of cases they weren't reported completely and key methodological features were often missing, which makes it difficult to interpret trial results.”

That led to the effort to standardize the reporting guidelines for those clinical trials. “The point of it is to ensure that we are doing a good job of reporting, especially because when we think about meta-analyses, which is where we combine result of multiple randomized controlled trials, if the initial trials are not reported well, we can’t synthesize their results,” Ruple said. “And so then it becomes a research wastage issue.”

Guidelines from research in human populations were modified for dogs and cats to create the PetSORT checklist, which can be viewed online.

“For instance, human randomized controlled trials don’t account for how euthanasia is dealt with in the analyses,” Ruple said. “In pet populations, we do need to do that. Euthanasia does exist in human populations, but not at the level that it does in dog and cat population. So that’s the kind of guideline that has been created to reflect the population in which these studies are being conducted.”

Now that the guidelines are being published, applying them will require journal editors and private and public labs across North America to begin utilizing them in order for them to affect the quality of reporting.

“Our next step is to approach journal editors and start getting influential to say we will no longer publish randomized controlled trials in the absence of this checklist being completed, so eventually it will become part of their submission process,” Ruple said. “We’ve got this whole battery of checklists now for research conducted using large animals and companion animals, and we plan to send them out to all the academic research teams across the U.S., Canada, Australia, and the U.K., and will include deans of research so they will be more aware of their existence and hopefully they will then pass that on to their faculty

“Plus, with having a group of 56 experts as our consensus panel, we hope that they will also serve as advocates for the inclusion of the PetSORT guidelines in their spheres of influence as well.”

The benefits of the new reporting process will reach veterinary clinics and pet owners, collaborators said.

“Of course, improved reporting of trial results also directly impacts the well-being of pets and even benefits clinicians’ well-being by reducing uncertainty in clinical decision-making,” O’Connor said.

“Most of the clinical recommendations that we make in medicine, what your average general practitioner veterinarian is recommending you do for the health of your pet, are based upon randomized controlled trials that are done in dog or cat populations at research institutions or within industry,” Ruple said. “The reason we know how certain treatments work is because of randomized controlled trials. So it really will affect the everyday in a really invisible way for most pet owners, but in a way that can have major impact in terms of long-term health and longevity for the various species.”