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OCR for page 173
Effectiveness Research and Changing
Physician Practice Patterns
Harold C. Sox
Our goal has been to learn the circumstances in which technologies are
effective. Once that goal has been accomplished, however, we must meet a
second goal: that of altering physicians' behavior so that they implement
research findings appropriately and consistently.
My purpose is to discuss two assertions. First, it is difficult to be sure
that changes in doctors' practice habits are due to published recommendations.
Second, some of the resources of the Effectiveness Initiative should be
earmarked for studying the factors that influence physicians to adopt new
ways of practicing medicine and for testing interventions designed to promote
change.
EFFECTS OF RESEARCH ON MEDICAL PRACTICE
The relationship between a specified research result and changes in medical
practice is very complex. Diffusion, which is a term for the adoption of
new medical technology, also applies to altered ways of using technology,
such as might result from an effectiveness study. The determinants of
diffusion include the following (1, pp. 178-181~:
· Prevailing medical theory: A change in medical practice is more
likely to be adopted if it builds on existing theory and medical logic.
· Ease of learning a new practice style: How much effort is involved in
changing habits that have been ingrained and polished through years of
practice?
· The importance of the clinical problem: Is the problem one that is
likely to lead to death or disability for one's patients? If so, the physician
is more likely to make the effort.
· Advocacy by a professional leader: There is evidence that opinion
173
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EFFECTIVENESS AND OUTCOMES IN [IEALTH CARE
leaders in the medical community can influence their colleagues to adopt
new practices.
· Characteristics of the adopting physician: Have physicians' training
prepared them to grasp new concepts quickly and see the implications for
their patients? Do they have the ability to change from one style to another?
· The practice setting: Does the physician belong to a group practice in
which there is a lot of peer pressure to change? Are there financial pressures
to change, either to do more procedures in fee-for-service practice or to do
fewer in a prepaid practice? Are the new technologies available in the
practice setting?
.
The physician's control over decision making: Do physicians have
direct control over the decisions to acquire new technology or to make it
easier or more difficult to obtain access to the technology?
· The results of formally evaluating the technology: This component is
the one with which the Effectiveness Initiative is most concerned. The
evidence that formal evaluation affects medical practice will be discussed
later.
· The effectiveness of the channels of communication of evaluation findings:
If physicians are not aware of the results of a formal evaluation of a tech-
nology, its influence will be much diminished or delayed in taking effect.
Both the professional and the popular media are important in disseminating
information about technology, and the influence of the popular media on
patients' expectations of their physicians is a topic that is particularly neglected.
CLINICAL TRIALS
The recognized standard of evidence for clinical effectiveness is the clinical
trial with randomized controls. Do clinical trials influence medical practice?
Fineberg examined several studies that attempted to trace the influence of a
clinical trial (1, pp. 185-195~. To evaluate these studies, Fineberg first
established standards of evidence that change in practice style was attribut-
able to research results. First, what is the baseline pattern of using the
technology? Is there a trend among practicing physicians that is due to
factors unrelated to the research results? Second, is there evidence, perhaps
obtained through surveys, that physicians are aware of the research results?
Third, do the research results imply that a change in practice style should
occur? Fourth, is there a temporal relationship between the assessment
appearing in the medical literature and the subsequent changes in medical
practice?
Fineberg applied these research standards to 28 studies, of which only
ten were suitable for analysis. The others failed because the study results
did not have clear implications for practice, because there were no data on
practice style both before and after the assessment was published, or because
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APPLICATION TO CLINICAL PRACTICE
175
there were no quantitative data on the frequency of using the technology
that was being studied.
Fineberg9s study showed that only two of these ten studies contained
strong evidence that the published technology assessment affected practice
style. These two studies were among four in which there was evidence of a
marked change in practice style. In two of these studies, the randomized
trial preceded the change in practice, which is fairly strong evidence that
the randomized trial had something to do with the change in practice; in the
other two studies, the randomized trial did not precede the change in practice.
In five studies, there were small changes that were consistent with trends in
practice style, and in one there was no shift in practice style at all.
Fineberg's study shows that one of the more powerful forms of medical
knowledge, the results of a randomized clinical trial, had little measurable
effect on practice style.
CONSENSUS DEVELOPMENT CONFERENCES
The second example shows that a program aimed at effecting change, the
National Institutes of Health (NIH) Consensus Development Conferences,
had little measurable effect on practice (2~. The goal of these conferences
is professional and consumer consensus about the best way to use a technology.
The RAND Corporation studied the effect of four of these conferences on
clinical practice in hospitals. Table 1 shows the four conditions studied and
a selection of the recommendations of the NIH Consensus Development
Conference on these topics.
The RAND investigators used the recommendations of these conferences
as the standard of care against which to compare what they observed in
patient records in a randomly selected sample of hospitals. They measured
TABLE 1 RAND Study of NIH Consensus Conferences
Condition Selected Recommendations
Breast cancer Standard is total mastectomy with axillary dissection in
Stage 1 or 2
Breast cancer An estrogen receptor assay should be performed on each
primary tumor
Cesarean section A trial of labor in low-risk women with a previous
C-section
Unstable angina Unstable angina patients should have a coronary angiogram
on their first hospital admission for the condition
SOURCE: Adapted from Kosecoff et al. (2~.
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EFFECTIVENESS ED OUTCOMES IN HEALTH CARE
compliance with these recommendations in three time periods: for one year
starting two years before the conference; for one year starting one year
before the conference; and for one year staring nine months after the conference.
Table 2 shows the percent of cases in which there was compliance with
the recommendations of the consensus conference. There was no trend
toward increased compliance with the recommendation to perform total
mastectomy with axillary dissection in Stage I and Stage II breast cancer.
The RAND investigators studied compliance with a recommendation to test
for estrogen receptors in breast cancer. There was a strong trend among
practicing physicians toward increased compliance during all three periods
of observation. In addition, there was a significant increase in compliance
following the consensus conference, as compared with the entire period
prior to the conference. The consensus conference appeared to have made a
difference.
A trend could be observed throughout the three periods toward compliance
with a recommendation that low-risk pregnant women with a previous Ce-
sarean section be allowed a trial of labor. However, the consensus confer-
ence had no measurable effect on this decision. There was no trend toward
increased use of angiography in patients with unstable angina and no evidence
that the consensus conference had any effect.
The RAND investigators made three additional observations. First, com-
pliance was less than 50 percent during the year following the conference
for 6 of the 11 criteria. Therefore, compliance with these criteria was low.
Second, there was an overall trend toward increased compliance throughout
the three time periods. Thus, physicians were generally aware of the chang-
ing standards of practice, regardless of how much attention they paid to the
consensus conference recommendations. Finally, when the RAND investi
TABLE 2 RAND Study of Compliance with Recommendations of NIH
Consensus Conferences
Compliance (Percent)
Case Period 1 Period 2 Period 3
Mastectomy and axillary dissection 74 79 84
Estrogen receptors 54 78 86a b
Trial of labor 6 11 29a
Angiography 14 29 24
ap < 0.05 over entire period only.
bp < 0.05 for before-after.
SOURCE: Kosecoff et al. (2~.
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APPLICATION TO CLINICAL PRACTICE
177
gators examined compliance for each indication and each condition (not just
the sample illustrated in Table 1), the rate of change in compliance actually
slowed when time period 2, before the conference, was compared to time
period 3, after the conference. All in all, the NIH consensus conferences
had a limited immediate effect on practice style.
Doctors do change. They no longer do gastric freezing or Halstead
radical mastectomies. They discharge patients with uncomplicated myocardial
infarction in one week rather than three weeks, which was the practice 20
years ago. Each of these changes is consistent with the findings in a series
of empirical studies. Medical practice is moving ahead, albeit slowly, in a
direction that is consistent with research results. How do we reconcile this
change with our difficulty in establishing a cause-and-effect relationship
between specific studies or consensus recommendations and change in practice
style? The resolution of this paradox will require better understanding of
the factors that influence adoption of new practice styles.
WHAT SHOULD BE DONE
The present circumstances provide an opportunity that may not come our
way again soon. There has never been greater motivation to understand
how to change medical practice, and there is adequate support to begin the
task. We need much more research on the determinants of change in physicians'
practice style, and now is the time to begin.
Second, we should look to the professional societies to identify effective
clinical policies. Their recommendations should be based on research results,
with clear delineation of the logic leading from the research findings to the
recommendations. If the professional societies are to play this central role,
they should spend some time working together on a common approach to
developing guidelines. At present, no two organizations use the same methods.
When two organizations come to different conclusions about the same technology,
fruitful discussion about how to interpret the data may be impeded by disagreement
about the methods that were used in coming to a conclusion. A common
methodology should promote respect for each other's efforts and lead to
useful dialogue.
We need to intensify efforts to motivate change. Organizations that pay
for health care will be doing their part to motivate physicians, but we need
more vigorous programs to teach physicians how to deal responsibly with
fiscal pressures. The most efficient way to accomplish this task may be to
aim these programs al pnys~c~ans wno are recognized by their peers as the
opinion leaders in their professional community.
We need to keep our patients informed of research results that will affect
them. Well-informed patients can exert considerable influence at the time
of a close-call decision, either encouraging or frustrating attempts to practice
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
a lean style of medicine. There have been well-documented successes in
using the popular media to influence people to reduce their cardiovascular
risk. The same approach might help people to acquire a more realistic
understanding of the benefits and risks of patient care technologies.
Leaders in government, industry, and medicine must look upon the Effec-
tiveness Initiative as a long-term investment. Finding the truth about what
works in the practice of medicine will be an ongoing task, in which constantly
improving research methods are aimed at evolving technologies. The chal-
lenges are as daunting as those involved in basic biomedical research. It
will take a decade or more for the Effectiveness Initiative to achieve research
results that physicians can use to change the way that they practice medicine.
These research findings will not have their intended impact unless there is
an intensive effort to understand the factors that influence physicians to
change.
REFERENCES
1. Fineberg, H.V. Effects of Clinical Evaluation on the Diffusion of Medical
Technology. Pp. 176-210 in Assessing Medical Technology, Mosteller, F. ed. Wash-
ington D.C.: National Academy Press, 1985.
2. Kosecoff, J., Kanouse, D.E., Rogers, W.H., et al. Effects of the National
Institutes of Health Consensus Development Conferences on Physician Practice.
Journal of the American Medical Association 258:2708-13, 1987.
Representative terms from entire chapter:
medical practice
