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Clinical Research Design and

Patient-Oriented Outcomes

Dorothy Cimino Brown

Introduction

It has been over a decade since theWall Street
Journalran the expose style article “This Joint ́
Problem Makes Dogs, Owners, Weak In the
Knees...An $80 Pet’s $6,000 Bill”. The story
was felt by many to blow the whistle on
the ‘epidemic’ of canine stifle surgeries in the
United States by citing statistics such as: “The
number of dog knees undergoing cruciate-
ligament repair each year in America is esti-
mated to now exceed 1.2 million.”, “Such treat-
ments have helped fuel a doubling of the num-
ber of veterinary surgeons in the U.S”, and
“...Americans spent $1.32 billion to fix dog
knees in 2003”. Much of the article focused
on the statistics around the owner’s perspec-
tive on the cost of cruciate surgery, but none
on how the surgery had benefited their dog’s
health and well-being – because those statis-
tics did not exist. It is only relatively recently
that the owner’s assessment is routinely con-
sidered as an outcome measure in clinical
research. Veterinary medicine is following the
lead of human clinical research, where there is
a shift towards patient-oriented investigations.
Veterinarians are now partnering with own-
ers to identify the health-related priorities for

companion animals in their pursuit to improve

patient outcomes. Using well-developed owner

assessments in well-designed clinical research

studies allows the generation of data to appro-

priately and convincingly support treatment

options that are presented to owners for the ben-

efit of their pets. These assessments are becom-

ing increasingly available, but are of little scien-

tific value if not appropriately incorporated into

well-designed studies. This chapter focuses on

the evolution of validated owner assessments

in dogs with orthopaedic disease, and clini-

cal research design considerations in dogs with

cruciate ligament rupture in particular.

Owner assessments in orthopaedic

disease

When un-validated owner assessments utilize

mathematical manipulation (e.g., summation or

averaging) of responses to a set of questions

asked of the owner to generate a ‘score’, it is

impossible to know whether the results (either

positive or negative) are due to the interven-

tion or rather to inconsistencies and inaccu-

racies associated with the outcome score. The

methodology for development and validation

Advances in the Canine Cranial Cruciate Ligament, Second Edition. Edited by Peter Muir. © 2018 ACVS Foundation.
This Work is a co-publication between the American College of Veterinary Surgeons Foundation and Wiley-Blackwell.

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