Patient Self-Testing:
Tap Into Stong Consumer Trend To "Grow"
Your POL Business
(Part 1 of a 2-part series)
by Dr. Sheila Dunn
Reprinted with Permission from Washington G-2 Reports,
Physician Office Testing, February 1999
Americans are increasingly
performing diagnostic tests in the privacy of their own homes. In the
last 15 years, we've seen an explosion of home diagnostic kits being
marketed in pharmacies, grocery story chains, television spots, newspaper
ads, and even on billboards.
These kits have enabled consumers to test for pregnancy,
blood pressure, blood glucose, cholesterol, cancer, and HIV. And there's
a lot more in the pipeline: heart attack monitors, ulcer and gastritis
tests, and sexually transmitted disease tests, among others.
Predictions are that patient self-testing will continue
to skyrocket because of rising consumer expectations, technological
innovations, and managed care coverage limitations. Significantly, a
large aging population--the "baby-boomers"--is more involved
than any previous generation in managing their own health. Already,
they've made it a multi-billion dollar market, and they're willing to
pay for much of it out-of-pocket.
In this surge of consumer activism in healthcare, the
physician office laboratory is uniquely positioned to run a Patient
Self-Testing Program that can expand quality testing services and follow-up
and ultimately improve patient outcomes. In this two-part article, we'll
examine how to develop and administer such a patient-friendly program
that will markedly distinguish you from your competition.
Current Universe Of Home Tests
Consumers can buy tests
ranging from clinical laboratory tests to physiological tests for a
variety of purposes, from skin cancer detection to monitoring anti-coagulant
therapy (Figure 1).
Several tests, such as those which detect antibody to
HIV, consist of a specimen collection unit only; tests on the specimen
are performed in a referral laboratory. Other home tests require physician
intervention to act on the results. Still other tests allow patients
to self-manage their conditions based on results from tests performed
by the patient, such as glucose testing for diabetes.
Thus, the various types of home-based testing offer consumers
a range of participation and independence from the physician from high
to moderate to low, as illustrated below:
- High -- Patient Self-Management.
Patient performs the test and can adjust therapy independent of the
physician.
- Moderate -- Patient Self-Testing.
Patient performs the test and relays results to the physician who
must follow up on results by adjusting therapy, scheduling an appointment,
etc.
- Moderate -- Patient Specimen
Collection. Patient collects urine, saliva, blood, etc., and mails
the specimen to a testing facility. Consultation is available via
telephone. The laboratory does not share the results with the patient's
physician.
- Moderate -- Patient Self-Referral
(also known as direct access testing and authorized within limits
by certain states). Patient has tests performed in a pharmacy or retail
laboratory without a physician's order. Results are not shared with
the physician.
- Low -- Home Health Testing.
Patient has the testing performed at home by home health personnel.
Results become part of the patient's chart and are acted on immediately.
All laboratory tests approved for home use are waived
under federal regulations governing CLIA (Clinical Laboratory Improvement
Amendments). More CLIA-waived tests may someday be approved for home
use. Among these: erythrocyte sedimentation rate; hemoglobin instrument;
microhematocrit test; Helicobacter pylori kit; Streptococcus pyogenes
(Group A Strep) kit; gastric occult blood card test; glycosylated hemoglobin
(A1c) instrument; mononucleosis test kit; nicotine urine test; and vaginal
pH test.
Situations Suited To Home Testing
For patients with certain conditions, home testing is particularly applicable.
For example:
- Patients who must take warfarin (Coumadin) or heparin
therapy and need to have appropriate drug levels established; are
high risk; newly anti-coagulated patients whose drug levels are not
yet stable; and those who are taking warfarin for a limited period
of time, such as a few weeks of prophylaxis following hospital discharge
for orthopedic surgery.
- Patients who are starting or stopping a drug which
interferes with anti-coagulation therapy.
- Patients who self-manage diabetes.
- Patients who have a high-risk condition that requires
frequent monitoring.
- Patients with poor venous access. Point-of-care testing
that uses whole blood fingerstick samples is more comfortable for
these patients.
- Patients who do not have easy access to laboratory
services but require frequent testing. Many seniors relocate to warmer
climates in the winter months or travel extensively throughout the
year and find home testing convenient for their mobile lifestyle.
- Patients who meet one or more of the above conditions,
are capable of performing a test themselves, and can afford to purchase
the test kit.
Test kits and instruments designed for home use are relatively
simple to master and provide reliable results when used correctly. An
ideal patient who is motivated to test, is reliable, and can master
the testing process will provide his or her physician with dependable
data. But most patients are not ideal. That's why a Patient Self-Testing
Program you develop and administer must include initial training of
both patients and the program's personnel, as well as periodic competence
evaluation (more about this next month).
Most patient self-testing instruments today contain built-in
data storage, but most designs rely on external programs to receive
and manipulate the data. Some tests are performed without use of an
instrument, such as diagnostic test kits, and in these instances the
consumer must be relied on to communicate the results. More development
is needed in automatic data transmission, especially for testing requiring
close professional supervision.
Future Of Patient Self-Testing
Anticipating growth in the home testing market, manufacturers are devoting
major resources to development of non-invasive tests. Efforts to find
less invasive glucose tests accelerated with reports that glucose levels
in interstitial fluid (just below the skin) are proportional to blood
glucose concentrations. Some devices in development tap "minimally
invasive" processes to extract small amounts of this fluid for
analysis instead of blood.
The fact that patients dislike needles is well known,
yet the extent to which it compromises care and undermines public health
has not been determined. It is well known that diabetics don't monitor
their blood glucose level or take their insulin as often as they should
because of this dislike and discomfort. Now it appears that a virtually
needle-less future may be plausible.
In the next decade, expect to see non-invasive tests
such as wristwatch-style devices that monitor blood glucose levels and
sound an alarm when intervention is needed. Imagine a patch that draws
out interstitial fluid slowly, or a laser beam that creates a tiny port
from which fluid is extracted. Other research focuses on electromagnetic
radiation to measure blood glucose in such areas as the eye, which is
a painless process.
Couple this with a non-invasive drug delivery system,
such as a skin patch or a painless microneedle which blasts drugs in
powder form through the skin at high speed. Or go one step farther and
imagine an implantable microchip that performs diagnostic tests, delivers
immediate results both to the patient and to a physician at a remote
terminal, and provides time-release medication. The physician (or patient,
in some circumstances) would program a dosage adjustment based on the
test result.
Expect to see, in the near future, technology that integrates
training capabilities within analyzers designed for home use, even small
hand-held devices. The further miniaturization of electronics and optics
at both the detector stage and the data processing stage will enable
even a greater degree of portability than presently available.
Despite obstacles, the future of home testing is bright.
In the next decade, expect point-of-care testing networks to extend
from the home to the most sophisticated acute care settings. Put your
POL at the forefront of this movement. Catch the wave! Next month: Designing
and running a POL Patient Self-Testing Program.
>> Go to Part 2: Patient Self-Testing: Putting Together A Program Tuned
To Patient Staff Needs
