Outcomes Measurements in Upper-Limb Prosthetics: Why So Elusive?
By Judith Otto The O&P EDGE assembled a panel of upper-extremity
specialists to share their expertise and express their opinions on
a variety of subjects relating to upper-limb prosthetics. Their
responses are featured in a series of articles in print and
online.
Our panel of experts:
Randall Alley, BSc, CP, FAAOP, is the head of
Clinical Research and Business Development for the Hanger
Prosthetics & Orthotics Upper Extremity Prosthetic Program. He
is chair of the Upper-Limb Prosthetics Society of the American
Academy of Orthotists and Prosthetists (AAOP) and an international
lecturer and consultant.
Diane Atkins, OTR, A clinical assistant
professor in Physical Medicine and Rehabilitation at the Baylor
College of Medicine in Houston, Atkins is an occupational therapist
who has specialized in amputee rehabilitation for more than 25
years-with special focus on rehabilitation of the upper-limb
amputee.
John Billock, CPO/L, FAAOP, a past president of
the Academy, is the clinical/executive director of the Orthotics
& Prosthetics Rehabilitation Engineering Centre, Warren,
Ohio.
Carl Brenner, CPO, is the director of
Prosthetic Research at the Michigan Institute for Electronic Limb
Development, Livonia, Michigan.
John M. Miguelez, CP, FAAOP, president of
Advanced Arm Dynamics, serves as a clinical consultant worldwide on
issues regarding upper-extremity prosthetics and operates a Center
of Excellence in Dallas, Texas.
Robert H. Meier III, MD, is the founder of
Amputee Services of America, a comprehensive "center of excellence"
that addresses issues related to limb amputation. Meier's
experience in rehabilitating persons with amputation encompasses
some 2,700 amputees, 45 percent of whom are upper-limb
amputees.
Question: Why, in your opinion, have accurate and
acceptable outcomes measurements in upper-limb prosthetics been so
elusive?
Alley: There are innumerable reasons for the
lack of adequate outcomes in upper-extremity prosthetics. The
problem lies in two distinct areas: the sheer scope and variety of
variables surrounding and unique to each case, and the instruments
used to gather the data.
Acceptable outcomes are elusive because many of the variables
involved that are critical in determining patient acceptance of an
upper-extremity prosthesis have little to do with the prosthetic
device, and more to do with psychological and psychosocial
adaptation to traumatic upper-limb loss, which is more common than
congenital amelia or elective amputation.
So while the focus has been on comparing one type of prosthetic
control to another, we need to look more closely at determining,
for example, when presented with two patients with identical limb
loss and matching prosthetic devices, why one was successful and
the other was not. This is the crux of the issue.*
*Note: See Alley's in-depth discussion of the outcome
measurements problem in OrthoKinetic Review, "Optimum Outcomes,"
April 2002.
Atkins: Outcomes measures for upper-extremity
amputees are very difficult to define in clear objective terms. The
score is prone to be very subjective-based upon (a) the experience
of the evaluator-usually an occupational therapist, and (b) the
knowledge of the evaluator of what is appropriate to ask the
amputee to do with a prosthesis.
So many questions must first be answered: Is it more appropriate
for the unilateral amputee to do an activity without the prosthesis
and accomplish the activity with the good side? If the prosthesis
is used to assist in dressing, for example, is the prosthesis
helpful or a hindrance in terms of time and effort? Does the
amputee need adaptations tor clothing to achieve independence? How
do we account for extraneous body movements that may be used to
accomplish an activity? What is an appropriate time factor to
allow?
How can all these considerations be factored into a simple
outcome measure?
Since the level of the amputation and the dominance or
non-dominance of the limb involved will impact the scoring, should
there be a different expected outcome measurement and score
dependent upon (a) the level of limb loss, (b) whether the dominant
or non-dominant limb was lost, and (c) whether the amputee is
unilateral or bilateral?
Having a consistent evaluator at the initial stage of
evaluation, mid-point and end of the evaluation should be kept in
mind, as well.
These are just a few of the factors that play a large part in
this equation. A good outcome measurement tool is definitely
needed, but the ease with which it is designed and executed is the
challenge.
Billock: Developing acceptable outcomes
measurements is difficult in all areas of prosthetics. I think,
however, that there is just not sufficient effort being made to
pursue this particular problem. Speaking for myself as an
independent facility owner, I find the requirements of managing a
business in general day-to-day practice and serving patients
challenging enough; there's not much spare time to get together
with other prosthetists and try to evolve such a system, although
one is certainly needed.
The complexities and shortcomings of today's reimbursement
system are another such key issue-also not getting the attention it
should.
Since there are smaller numbers of upper-limb patients, this is
an area of prosthetics that receives less attention. Likewise,
there is not as much focus on upper-limb prosthetics for that
reason. In schools with prosthetic programs, there is less time is
spent on teaching upper-limb prosthetics because of the lesser
likelihood that students may someday have to fit an upper-limb
patient.
Brenner: I think for the greater part, the
failure to develop appropriate outcome measures is because the
population we are dealing with is so small in terms of potential
patients, and there are fewer upper-limb practitioners. We're also
dealing with a low-utilization issue, as opposed to lower limbs
where there is extremely high utilization. Major programs such as
Medicare need to equate function with components.
However, upper-limb procedures are not driven in that way by
third parties, simply because utilization isn't very high.
Miguelez: I think they've been elusive for a
number of reasons.
1) There are probably three tiers of prosthetic experience in
the United States-which apply to prosthetists, therapists, and
doctors, as well: Those who see a lot of upper-limb amputees are in
one tier; those who see perhaps two to five a year in another; and
those who rarely see an upper limb amputee in the third tier.
Coming up with appropriate outcomes studies is difficult because
not only are the practitioners' experience levels so diverse, but
the outcomes are practitioner-related; you have a much greater
potential for maximizing rehab potential if you go to a prosthetist
who has more experience.
That group of experienced practitioners is very small and can be
competitive, so sharing that information among themselves is
something we haven't seen.
2) There are several outcomes measurement systems, but they are
somewhat antiquated. They are based on a body-powered approach as
the primary approach, then try to shoehorn in other prosthetic
options. An appropriate outcome measurement needs to really look at
all the options.
3) Such studies need to look not only at the time of
therapy-within the first few days of fitting-but also a year after
prosthetic intervention, when the patient has had time to fully
adjust to his prosthesis. I can get someone functional within a few
days, but if the patient is still using the prosthesis a year
later, it means we have truly solved his issue, and the prosthesis
has been integrated into his lifestyle. This is much more
challenging than the question of whether he can open and close the
terminal device or flex the elbow, or pick up X or Y.
4) There are several outcome measurement tools available, but we
don't have one that covers everything. The question is, do we
develop our own? That could solve our company's internal
challenges; but then when you share your findings with other
people, they're not using your system, so your data doesn't mean a
lot.
If you use an existing system, you'll find that none of them
have a really comprehensive approach that we can all agree
upon.
I'd love to see such a system that offers the ability to
influence patient decisions based on reproducible tests that could
perhaps demonstrate that the experience of the rehab team does have
a direct impact on the patient's ability to maximize rehab
potential.
We've all discussed this-but coming up with a measurement tool
specific to upper limb patient needs is a real challenge due to the
personalities involved. When I was in charge of the NovaCare upper
extremity program, there was a lot of discussion about this. I
wouldn't say that this is a contentious situation, but if a company
puts costly resources into the development of such a tool, it's
difficult for them to share it freely-or it has been so far.
Meier: Outcomes measurements in upper-extremity
prosthetics have been difficult to develop simply because no one
has been willing to take the time, effort, and expense to do so.
Compiling scientifically valid data takes time most people are not
willing to spend.
The responsibility for coming up with a reliable measurement
tool probably belongs in a center of excellence with an academic
base. At one time, the old NovaCare organization was attempting to
develop a system, but they were basing it on patient satisfaction,
which is not the most proper criterion if data is to be valid and
reliable. Patients may be satisfied with poor workmanship or
function because they don't know the difference. Judith Otto is a freelance writer based in Holly Springs, Mississippi. 
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