Abstract
There is a clear need for new methods of treatment of acute disc herniation in dogs, most obviously to address the permanent loss of function that can arise because of the associated spinal cord injury. Clinical trials form the optimal method to introduce new therapies into everyday clinical practice because they are a reliable source of unbiased evidence of effectiveness. Although many designs are available, parallel cohort trials are most widely applicable to acute disc herniation in dogs. In this review another key trial design decision—that between pragmatic and explanatory approaches—is highlighted and used as a theme to illustrate the close relationship between trial objective and design. Acute disc herniation, and acute spinal cord injury, is common in dogs and there is a multitude of candidate interventions that could be trialed. Most current obstacles to large-scale clinical trials in dogs can be overcome by collaboration and cooperation amongst interested veterinarians.
Highlights
Introduction of new medical interventions into everyday practice requires assessment of safety, effectiveness and, preferably, comparison with currently available therapies
There is a strong rationale for clinical trials on spinal cord injury treatments in dogs and many have been carried out and are readly accessible via PubMed searches using the keywords “dog” “spinal cord injury” “trial.” It is readily apparent that few fulfill all the appropriate requirements for an effective clinical trial and many have design problems, such as lack of a control group, that limit their value
We describe here an explanatory trial focused on glyburide and a pragmatic trial focused on durotomy these specific approaches do not need to be linked in this way to these interventions
Summary
Introduction of new medical interventions into everyday practice requires assessment of safety, effectiveness and, preferably, comparison with currently available therapies. Kinetics and kinematics provide even more finely graded outcomes and kinematic analysis can be especially valuable because it can imply conduction across a lesion in the thoracolumbar area through detection of coordination of phase patterns of thoracic and pelvic limb stepping [42] These outcomes have been used to assess outcome in canine spinal cord injury trials because they are able to detect subtle changes in function [43, 44] that might realistically be expected to occur following an intervention in severely and chronically affected individuals. Crossover trials will rarely be appropriate for analyzing effects of interventions for spinal cord injury (especially acute injury, because time will be assumed to have a strong effect) and factorial trials require identification of interventions that might interact with each other (otherwise they have no advantage over parallel group trials) and there are few such combinations that have been identified in laboratory science
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