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Can Evidence-Based Medicine Benefit Orthotics?
By Miki Fairley To be truly effective in a practical way, orthotic
research needs to involve both technological research and clinical
research, according to Christopher Morris, senior orthotist,
Department of Orthotics, Nuffield Orthopaedic Centre and the
University of Oxford, United Kingdom.
Orthoses are designed to overcome specific biomechanical
problems with the aim of achieving clinical treatment goals, Morris
explained concisely during a presentation at the 2004 Annual
Meeting and Scientific Symposium of the American Academy of
Orthotists & Prosthetists.
 Technological research, which is undertaken by
orthotists and bioengineers, involves finding plausible solutions
to biomechanical problems, Morris elaborated. "However, solving
biomechanical problems does not necessarily ensure that the
clinical treatment goals are achieved; neither does it tell us
whether the orthosis will be more effective than other
interventions in achieving the same goals," he explained, adding,
"To answer these questions, we need clinical research."
Enter evidence-based medicine (EBM). "A culture of
evidence-based healthcare has been adopted internationally," Morris
pointed out, calling attention to several consensus conferences
convened by the International Society for Prosthetics &
Orthotics (ISPO) to review the evidence for specific clinical
applications of orthoses.
Why is evidence-based medicine becoming a global buzzword not
only in orthotics and prosthetics, but also in healthcare
generally? Both consumers and payers are demanding more evidence
that treatments produce the desired outcomes - and that this can be
proved.
So, just what is evidence-based medicine? According to the
University of Illinois, evidence-based medicine has been defined as
"...an approach to practicing medicine in which the clinician is
aware of the evidence in support of clinical practice, and the
strength of that evidence."
A clear, concise definition is offered by the University of
Minnesota Evidence-Based Health Care Project (EBHC), "an approach
in which clinicians and healthcare professionals utilize the
current best evidence in making decisions about the care of
patients." The university adds, "It involves continuously and
systematically searching, appraising, and incorporating
contemporaneous research findings into clinical practice." The
university then makes a vital point. "The overall goal is improving
patient care through lifelong learning."
The Centre for Evidence-Based Medicine (CEBM), University of
Toronto, Canada, defines evidence-based medicine as "...the
integration of best research evidence with clinical expertise and
patient values." The CEBM then goes on to define best research
evidence. "By 'best research evidence,' we mean clinically
relevant research, often from the basic sciences of medicine, but
especially from patient-centered clinical research into the
accuracy and precision of diagnostic tests (including the clinical
examination), the power of prognostic markers, and the efficacy and
safety of therapeutic, rehabilitative, and preventive regimens."
The center pointed out that new evidence from clinical research can
invalidate previously accepted diagnostic tests and treatments,
replacing them with new ones that are more powerful, accurate, and
efficacious.
CEBM defines clinical expertise as "the ability to use
our clinical skills and past experience to rapidly identify each
patient's unique health state and diagnosis, their individual risks
and benefits of potential interventions, and their personal value
and expectations." To CEBM, patient values are "the unique
preferences, concerns, and expectations each patient brings to a
clinical encounter and which must be integrated into clinical
decisions if they are to serve the patient."
When these three elements - best research evidence,
clinical expertise, and patient values - are integrated,
they form a diagnostic and therapeutic alliance, which optimizes
clinical outcomes and quality of life, according to CEBM.
Poor Research-Clinical Error
 So, what is the quality of research in O&P?
Pretty poor, according to Morris. Most published orthotic research
describes studies with small numbers of subjects, short follow-up
periods, and inadequate controls for comparison, he asserted. "In
fact, there remains a dearth of unbiased clinical research
regarding the effectiveness of orthoses across the spectrum of
their application," he said.
This poor methodological basis, according to Morris, leads to
these errors of interpretation of findings: 1) "Believing there are
benefits from orthoses when in fact there are not," or 2)
"Rejecting using orthoses which may actually confer benefits."
Another complication arises when there's a choice between two
orthoses, and one is more expensive. Morris raised the question of
how the cost of the more expensive orthosis can be justified on the
basis of health benefits without appropriate research. If clinical
research is going to be conducted and results disseminated, then
studies must be designed appropriately and reported transparently,
he stressed.
Perthes Disease Kids: An Example
To graphically illustrate the need for orthotic research to
evolve, Morris cited the example of children with Perthes disease.
"In this degenerative condition of the hip, conventional wisdom for
many years suggested that the limb should be unloaded and the hip
abducted and internally rotated," he noted. "Despite the array of
interesting and innovative devices designed to overcome the
biomechanical problem, none demonstrated any measurable clinical
treatment effect and, for the most part, have all been abandoned."
Morris also pointed out the adverse psychosocial effect on the
young patients who were encumbered with the ineffective
equipment.
Why Isn't Research Better?
Several factors are responsible for the poor design of clinical
trials in orthotics, according to Morris. He listed the limited
resource capacity of orthotists to undertake research and that
there are specific challenges to evaluating the effectiveness of
orthoses in general. Also, some clinicians themselves become
obstacles to research. "There are clinicians who perceive clinical
research and evidence-based practice as either worthless or a
threat to their clinical art and autonomy, rather than as the
natural progression of a science."
Clinicians also can disregard the results of properly designed
and conducted research studies. Morris cited the instance of a
large randomized controlled trial evaluating different orthoses and
footwear for treatment of asymptomatic flat feet in children. The
result? "This study clearly showed that orthoses do not alter the
natural history of flat feet," said Morris. "Despite this, there
undoubtedly remain centers that routinely provide insoles and
[shoes] with the intention of creating arches in the child's foot."
He added, "So even when we have the evidence, there are
implementation challenges of changing clinical practices."
Benefiting Manufacturers
Actually, sound research studies can benefit not only patients
and practitioners, but also orthotic device manufacturers, Morris
pointed out. "In orthotics we are being offered new components and
materials but are unsure for which patients they work best, and
also whether the increased cost is justified." He cited the new
generation of "intelligent" knee joints as an example in which
unbiased clinical research should be employed on a large scale to
evaluate what the advantages are for specific patient groups.
"Commercially, once this information is identified and
disseminated, not only will more patients benefit, but the
companies will sell more products," he noted.
The alternative is that individual clinicians try new orthoses
with one or two patients, usually in an unsystematic way, and often
not funded or reported as a clinical experiment, Morris said.
"Sadly, despite the enthusiasm and innovation involved in this
activity, there is little contribution to the scientific basis of
orthotics," he commented.
Research Vital to Patient Welfare
Morris again stressed the importance to patients and healthcare
purchases of how well orthoses achieve treatment goals, a
distinction from simply overcoming a biomechanical problem. "As
history has shown us, if we do not undertake this task, we will not
be sure whether we are harming our patients or improving their
health." Clinicians thus have a responsibility to be aware of
research findings and appraise their scientific merit, Morris
pointed out, urging, "When opportunities present themselves, we
should positively encourage or actively participate in clinical
research."
Table Of Contents - May 2005
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