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7
The Clinical Perspective
Paul F. Griner
The IOM's core committee, which generated the report on the Effective-
ness Initiative, suggested a number of objectives that would be achieved by
effectiveness research. First, the knowledge gained would help clinicians in
their day-to-day management of patients. Second, it would improve the
peer review process. Third, it would aid policymakers in the allocation of
Medicare resources. I believe this knowledge will also affect patient participation
in decision making and the organization and delivery of health care.
The extent to which the knowledge gained from this initiative will be
applied in the real world will be determined by a number of very complex
factors. Some will affect the provider, some the patient, and some the
item within which they both operate. My purpose in this chapter is to
suggest some of the issues that I believe require attention if the knowledge
gained from the Effectiveness Initiative is to be used to its fullest advantage.
ISSUES IN THE USEFULNESS OF EFFECTIVENESS RESEARCH
There are five issues in particular that I would like to focus on. First, the
knowledge must have attributes that are important to the provider; second,
it must be readily accessible; third, it must facilitate patient involvement;
fourth, financial incentives must be in line with the directions suggested by
the new knowledge; and finally, as I see it, the problem of unbalanced
regulation within the health care industry must be corrected.
MEETING PHYSICIANS' NEEDS
The first requirement bears on the credibility and usefulness of the information
to the provider. The need is obvious for accuracy, relevance, and measures
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39
of outcome that go well beyond morbidity and mortality, measures that are
meaningful and that do not suffer the constraints of data collected princi-
pally for purposes of payment.
Not enough has been said, however, about the need for knowledge that is
not limited by age and about which practicing physicians feel a sense of
ownership. We must have clinical data that span the age distribution of the
diseases of interest. Otherwise, we limit our understanding of the natural
history of the illness, we miss opportunities to intervene early, and we fail
to recognize age-dependent differences in treatment options. All of these
deficiencies reduce the usefulness of the knowledge to the practicing physician.
This point was made previously by the committee, but it bears repeating.
Another reason for the generation of disease-specific data bases that span
time and are not age-limited is that these data will require years to amass
and to evaluate. We presume, at least we hope, that by that time universal
access to health care will have been achieved. Whether such access is
financed centrally or is in large part pluralistic, as it is today, insurance
benefits cannot be determined equitably if clinical knowledge is limited by
age considerations.
The need for ownership of the knowledge by practicing physicians is my
second point on this first issue. In my opinion, it is a critical element.
Knowledge that is generated and evaluated solely by payers or by health
services researchers, or both, will be suspect. Medical organizations need
to be involved, they need to be empowered, and they need to be ready to
promote the knowledge among their members.
I note that the committee report reflects on how little is known about
what influences the behavior of health care providers. I suggest that there
is a fair amount of anecdotal information to support the premise that, if
competent providers are given relevant and accurate data, data that they
have had a hand in developing, their behavior will be influenced accordingly.
Still on the subject of physician ownership and empowerment, we need
to recognize that the primary care physician must be the principal recipient
of knowledge acquired through the Effectiveness Initiative, whether as a
general internist, a family physician, or a general pediatrician. These are
the groups that currently feel most disenfranchised as the result of intrusive
regulation and draconian reimbursement policies. We need to consider the
practice of the generalist: how it is organized, how generalists are reim-
bursed, and what elements must be addressed if their practices are to em-
brace the knowledge gained from the Effectiveness Initiative.
ACCESSIBILITY OF RESULTS
The second theme is the need for ready access to data that will aid in
clinical decision making. Everyone recognizes the difficulty that physicians
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have in keeping up with the extraordinarily rapid advances in medical knowledge
and the technology to apply that knowledge. It seems clear that the same
can be expected with regard to the findings of the Effectiveness Initiative
unless the knowledge can be provided in real time and in a usable fashion.
It is one thing to impart a few salient points in a peer-reviewed journal; it
is quite another to provide a comprehensive data base from which to extract
information bearing on the many variables that need to be considered for
diagnostic or management decisions regarding an individual patient. We
are all aware of prepackaged information currently available for use in a
personal computer. Such information is likely to be most effective for
relatively straightforward tasks, such as choosing the most cost-effective
antibiotic for a particular infection. The more difficult task is the use of
information about the host of patient variables that need to be considered in
evaluating treatment for options such as balloon angioplasty, bypass surgery,
or medical management for the 67-year-old diabetic who has angina, emphysema,
and hypertension.
For the everyday considerations, primary care physicians will benefit
immeasurably from the availability of a comprehensive data base that can
be accessed quickly. We have a few prototypes of this kind in this country,
such as Duke University's cardiovascular data base. Referring again to
physician ownership of new data, a very important step will be to secure the
input of practicing physicians into decisions bearing on the nature of the
data to be collected, how they are analyzed, and how they might be made
most usable.
AIDING PATIENT INVOLVEMENT
The third point has to do with patient participation in decision making. I
am going to be brief here because Albert Mulley goes into this subject later
in this volume (1~.
Most patients continue to defer to their physicians in selecting the proper
treatment option. There would undoubtedly be more patient participation in
decision making if we had better knowledge concerning the outcomes of
various treatment options. This knowledge would need to be packaged in
such a way that the patient could fully understand the issues, explore the
benefits and risks of each option, and choose among them according to his
or her unique values, values that the physician must not assume.
It is quite exciting to see people such as John Wennberg, Albert Mulley,
Michael Barry, and others beginning to take advantage of the technology
that currently exists by preparing an educational program on treatment options
for patients with benign prostatic hypertrophy. Some of my colleagues in
urology in Rochester are now in the process of evaluating the efficacy of
this approach. The findings will be of great interest to all of us.
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RELATION TO PAYMENT MECHANISMS
41
Now to the fourth point, one of particular concern to me. It has to do
with the potential conflict between the findings of effectiveness research
and how providers are paid for their services. Under Medicare, hospitals
and physicians are paid by the number of units of service they render.
Because the price per unit of service is controlled, whether through annual
increments below the rate of inflation or whatever, the system responds by
attempting to increase the number of units provided to ensure financial
stability. Among the results are unnecessary hospitalizations, most of which
are not picked up through utilization review; unhealthy competition; unnecessary
duplication of technology and other health resources; and, perhaps most
important, a slowing down of change in the way services should be organized
and delivered to take advantage of out-of-hospital alternatives to care and to
enhance continuity of care.
Twenty-five years ago, the medical chief resident at Yale-New Haven
Hospital, Eli Schimmel, wrote an article published in the Annals of Internal
Medicine under the title, "The Hazards of Hospitalization." I have always
carried that article with me, physically and in my mind. It is just as relevant
today as it was then. No patient should be in the hospital unless it is
required. Hospitalization poses a risk.
I have the unusual challenge, as well as opportunity, of wearing two hats
at the same time the hat of a professional who understands what we should
be doing in patient care and the hat of a hospital administrator who has a
fiduciary responsibility to ensure the financial vitality of our hospital. These
present a conflict of interest. For example, for every open-heart surgery
case above a given volume, the hospital averages a profit of $20,000. But it
also costs the hospital $45,000 for the treatment of infants weighing less
than 2 pounds in the neonatal intensive care unit.
We had 43 such babies last year. Forty of them left the hospital alive.
That $45,000 average cost is reimbursed at a much lower figure and has to
be underwritten one way or another. The surplus from the individual open-
heart surgery cases helps to do that.
Our volume-driven system obviously has adjusted well, because much of
the hospital care that is not necessary can still be shown to be appropriate-
or at least not inappropriate. The work of Robert Brook and his colleagues
has shown us that. The strength of the Effectiveness Initiative is that, for
the diseases that are to be studied, it should be possible to find out what is
both appropriate and necessary; that will be particularly helpful, given our
interest in increasing patient involvement in decision making.
Such findings will almost certainly indicate that fewer rather than more
procedures and hospitalizations are in order, at least for patients who are
currently receiving care. Unless the reimbursement system is changed from
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one that is driven by volume to one that provides incentives for more discriminating
and coordinated use of health resources, the findings from effectiveness research
are going to be accepted grudgingly and implemented slowly. We will
continue to see patients hospitalized unnecessarily for cardiac catheterization
and many other procedures, or discharged early after their hip fracture without
adequate provision for rehabilitation services.
Application of the fruits of the Effectiveness Initiative demands reform
of the current price-based reimbursement system, reforms that avoid the
incentives to do too much. We need to be sure, however, to avoid a response
that is too far in the other direction, one that is occasionally seen with
global budgeting systems, where too little care can become the risk.
UNBALANCED REGULATION
My fifth point has to do with regulation. We have, in my opinion, a
problem of unbalanced regulation in the health services industry. We have
extremely tight regulation of hospitals and of physicians for the hospital
component of their practices. We have loose regulation in the out-of-hospital
marketplace. The proliferation of freestanding diagnostic and treatment
centers is an excellent example of unnecessary duplication of facilities,
where opportunities for unneeded services are greatly increased. Future
health policy should pay attention to the issue of balanced regulation if we
are going to achieve the objectives of the effectiveness initiative.
IMPACT OF THE EFFECTIVENESS INITIATIVE
Let me close with a word or two about where I think the Effectiveness
Initiative will have its greatest impact. For two of the three diseases at the
top of HCFA's priority list, there is a disturbing underuse of services. Four
of five women at the ages where screening is known to be effective for
early detection of breast cancer do not undergo such screening. The majority
of poor or near-poor persons have low rates of utilization of diagnostic and
therapeutic procedures for their underlying coronary artery disease. I believe
the findings of the Effectiveness Initiative will result in an even more strik-
ing picture of missed opportunities among these populations.
The initiative should help change for the better the general approach to
medical practice. After all, the Effectiveness Initiative can address only a
limited number of illnesses, perhaps 20, perhaps 50. While better knowledge
regarding treatment of these conditions will obviously improve quality and
limit health care inflation, it will still account for only a very small fraction
of total health care.
Built into the Effectiveness Initiative are approaches that eventually should
change the very fabric of medical practice. Some of them I have already
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43
referred to. They include a much stronger role for patients in decisions
relating to their health care and greater physician support, perhaps even
enthusiasm, for a systematic study of outcomes of care once the value of
such heretofore unavailable information is recognized.
The Effectiveness Initiative will also facilitate the incorporation of functional
assessment and quality-of-life measures into the day-to-day practice of medicine,
measures that are so greatly lacking now. I believe that, in the long run,
these results of the Effectiveness Initiative are going to be among its greatest
contributions, contributions that go far beyond the knowledge gained through
specific attention to given illnesses.
I conclude by simply repeating the caution that I began with: the ultimate
impact of the products of this initiative will be determined by the extent to
which they address important requirements of the provider, are readily accessible,
promote patient involvement, are accompanied by a reimbursement system
that provides incentives, not constraints, for their application, and are facilitated
by more balanced regulation.
REFERENCE
1. Mulley, A.G. Applying Effectiveness and Outcomes Research to Clinical
Practice. Pp. 179-189 in Electiveness and Outcomes in Health Care. Heithoff, K.A.
and Lohr, K.N. eds. Washington, D.C.: National Academy Press, 1990.
Representative terms from entire chapter:
knowledge gained