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PART III
The IOM Clinica
Workshops
Condition
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The lOM Condition Workshops:
Introduction
Kenneth I. Shine
The individuals who participated in the IOM clinical condition work-
shops on breast cancer, hip fracture, and acute myocardial infarction believe
that the Health Care Financing Administration (HCFA) has taken a very
positive step in seeking to make its vast administrative data bases available
for effectiveness research. They recognize, however, that HCFA has taken
only a first step in what will be a very long journey. Many participants-
and all of them on this panel- come from academic medicine and from a
tradition of rigorous science and analysis. Not surprisingly, they caution
prudence in the use of such data because of a realistic awareness of pitfalls
to be avoided and obstacles to be surmounted.
The following three papers reflect this prudent caution. In breast cancer,
for example, treatment often involves in-hospital surgery and subsequent
radiation therapy or chemotherapy administered in an outpatient setting.
However, existing Medicare data are primarily hospital-based, and HCFA
does not yet have good ambulatory data. Evaluating mammography for its
effectiveness in breast cancer screening and diagnostic uses, to take another
example, will require long-term follow-up data, not simply data on acute
care encounters between the patient and a provider. On the other hand,
Medicare data can help immeasurably in focusing attention on the similari-
ties and differences between Medicare-age women and younger women.
Valerie D. Jackson has a special research interest in breast imaging. She
brings that expertise to bear on diagnosing and treating breast cancer in the
elderly.
Hip fracture was approached as a relatively straightforward clinical problem.
A single bone is involved, diagnosis is clear and consistent across different
practitioners, and surgery is the recommended intervention, followed by
rehabilitation. Yet as the committee delved into the issues, we realized how
51
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52
EFFECTIVENESS A]VD OUTCOMES IN HEALTH CARE
complicated it was to assess the effectiveness of prevention, of different
surgical and medical interventions, and of rehabilitation programs. Preven-
tion, for instance, requires that effective efforts begin long before an individual
reaches the age of Medicare eligibility. Research along these lines, therefore,
must link Medicare data bases to Medicaid and private insurance data bases
for a younger population, linkages that span federal and state as well as
public and private boundaries. In addition, different sites of care are required
for treating hip fracture, and unexplained geographic differences exist in
rates of fracture. David G. Murray, an orthopedic surgeon, examines these
and other effectiveness issues related to treating hip fracture.
One of the major issues confronted in the clinical workshops was how to
make the best use of administrative data bases for effectiveness and outcomes
research. Barbara J. McNeil, a radiologist and investigator with experience
in using large data bases, addresses the opportunities and the limits of using
claims data in acute myocardial infarction and other conditions.
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9
Breast Cancer
Valerie P. Jackson
Breast cancer, the second leading cause of cancer death in American
women, is a major health problem for women in the Medicare age group
because its incidence increases with advancing age. Currently, the Ameri-
can Cancer Society estimates that 1 in 10 American women will be affected
by this devastating and highly emotional disease during her lifetime. Sev-
eral studies have shown that screening mammography can detect breast
cancer at a more favorable stage, resulting in improved prognosis for screened
women found to have breast cancer (1-10~.
THE PROBLEM OF POOR COMPLIANCE
The American Cancer Society and the American College of Radiology
have recently been joined by most of the medical groups in this country in
recommending the following guidelines for screening mammography:
.
Baseline mammogram by age 40
· Mammogram every one to two years between ages 40 and 49
.
Yearly mammograms after age 50
The overall mortality statistics for breast cancer in the United States have
changed little in several decades, however, largely because of poor compli-
ance with screening mammography guidelines. Thus, screening mammography
has proven efficacy, but its effectiveness is diminished because it is underutilized.
Although we can detect tumors as small as 3 to 5 millimeters with mammography
(Figure 1), we continue to see too many large, clinically obvious carcino-
mas that carry a poor prognosis (Figure 2~. Noncompliance is a problem for
all groups of women, but it is particularly prevalent in our elderly and
indigent populations.
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
FIGURE 1 Oblique left mammogram of an asymptomatic 60-year-old woman. There
is a 4 millimeter slightly irregular mass in the upper portion of the breast (arrow),
which was found to be a small invasive ductal carcinoma at surgery. She has had no
evidence of spread to the axillary lymph nodes or elsewhere in her body in one year
of follow-up, and her prognosis is excellent.
As shown in Table 1, there are a number of potential reasons for poor
compliance. Cost is a major factor, particularly for elderly women on fixed
incomes. Many mammographers are working to decrease the cost of screening
mammography to approximately $50. If Medicare paid for screening (as
opposed to just diagnostic) mammograms, cost might no longer be a deter-
rent and compliance would improve.
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IOM CLINICAL CONDITION WORKSHOPS
55
FIGURE 2 Oblique left mammogram of a 60-year-old woman with bloody nipple
discharge and a large, hard, palpable mass behind the nipple. The mammogram
demonstrates a 6 centimeter mass, found to be invasive ductal carcinoma with posi
tive axillary lymph nodes at surgery. She died 6 months after mastectomy.
Vigorous compression is necessary in order to minimize radiation dose
and maximize image quality. Many women worry about pain from this
compression, and pain has been cited as a possible deterrent to mammography.
However, compression is adequately tolerated by the majority of women
(11) and is unlikely to be a significant factor in compliance.
Many women have difficulty finding the time to get a mammogram.
There are probably many psychological reasons for this, but we need to
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
TABLE 1 Noncompliance with Screening Mammography Guidelines
Potential Factor
Potential Solution
1. Cost of mammograms
2. Pain from compression
3. Time
4. Radiation exposure
5. Interpretation errors
6. Fear of finding cancer
Medicare payment for screening
Lower cost of mammograms
Education about advantages of compression
Compassionate technologist
improved access to screening mammography facilities
Less time necessary for examination
State-of-the-art equipment, appropriately used,
monitored, and maintained
Patient arid physician education
Consistently high-quality mammograms
Greater mammographer experience and education
Improved diagnostic criteria
Adjunctive use of ultrasound in selected cases
Patient education
make mammography facilities more accessible for patients and minimize
the time necessary for the examination.
Exposure to radiation was a serious consideration in previous years (12~;
however, mammography equipment and film systems have improved mark-
edly, and the radiation dose from properly performed mammography is so
small that radiation exposure is no longer a problem (131. It has been
estimated that, for women over age 50, the risk of having yearly mammograms
is one-tenth the risk of early death caused by failure to diagnose breast
cancer by screening mammography (14~.
Both women and their physicians are worried about interpretation errors
(that is, false negative and false positive studies). Unfortunately, there is
overlap in the appearances of benign and malignant processes, necessitating
biopsy or mammographic follow-up for differentiation. In spite of the extensive
experience with mammography in this country, there are some cancers that
are missed, either by negligence or because they are not mammographically
visible, even with a good quality film. Although education and careful
attention to technique and quality control will minimize these unfortunate
occurrences, it is unlikely that we can completely eliminate false negative
mammograms in the foreseeable future.
Breast cancer is a very emotional disease, and many women are afraid of
having breast cancer discovered. This fear may paralyze a woman to the
point where she will not undergo screening or diagnostic evaluations. Increased
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IOM CLINICAL CONDITION WORKSlIOPS
57
patient education regarding the benefits of early detection and treatment
should be targeted at specific geographic or socioeconomic groups, or both.
CONTROVERSIES
SCREENING
A number of controversies surround breast cancer screening. First, who
should be screened and at what intervals? The American Cancer Society
guidelines represent our "best guess" at appropriate intervals for women
over age 35. However, these are likely to be modified as our knowledge of
the biology of breast cancer increases. Currently, the majority of controversy
surrounds screening for women age 40 to 49 (15,16~. Although the efficacy
of screening mammography for women over age 50 is well established, we
do not know at what age screening should stop. Obviously, this will depend
on the patient's physiological status and whether she would benefit by having
a small, potentially curable, cancer detected, in light of her other disease
processes.
Is it effective to screen all women over the age of 35 or only those at
high risk? Unfortunately, most women with breast cancer do not have
identifiable risk factors, other than the fact that they are women who are
getting older. Thus, targeting specific "high-risk" groups for screening is
of limited value.
Why is screening mammography underutilized, and how can compliance
be improved? These are major issues in determining the effectiveness of
breast cancer screening in this country. Current investigations are studying
the reasons women do not go for mammograms and the reasons their physicians
do not order them. In the future, we must define and test interventions that
will improve compliance and improve our overall breast cancer mortality
statistics.
TREATMENT
A number of controversies surround treatment of breast cancer as well.
Debates rage over appropriate surgical approaches to various types of breast
cancer. In the past, the standard surgical treatment was a mastectomy (generally,
a modified radical mastectomy), which obviously left the woman without a
breast. In recent years, many surgeons have offered some women a less
mutilating approach: segmental resection with an axillary node dissection,
usually followed by radiation therapy. Large randomized controlled trials
have shown that these two treatments result in equal prognoses for most
women (17,18~. Unfortunately, many women, particularly elderly women,
may not be given any choice of surgical therapy (191.
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EFFECTIVENESS AND OUTCOMES IN HEALTlI CARE
Chemotherapy and hormonal therapy are relatively new interventions for
women with breast cancer and have improved the prognosis for selected
patients. Until recently, chemotherapy was generally reserved for women
with positive axillary lymph nodes at the time of surgery or for very young
women with a generally poor prognosis. However, recent studies (20-24)
have led the National Cancer Institute (NCI) to recommend that all breast
cancer patients, even those with node-negative tumors, have chemotherapy
or hormonal therapy, depending upon their age and a number of other tumor
factors. This has provoked considerable controversy among oncologists
and may be a deterrent to compliance with screening mammography. In the
past, we were able to tell women that if they had early cancer detected by
screening, they probably would not require chemotherapy, with its unpleasant
side effects. If the NCI recommendations are followed, women may feel
there is no advantage to early detection. We need to find new tests to
identify subgroups of women with node-negative breast cancer who are
most likely to benefit from chemotherapy.
THE ROLE OF EFFECTIVENESS STUDIES IN BREAST CANCER
There are many long-term considerations for women with breast cancer.
For example, what are the appropriate methods and intervals for follow-up
of women with cancer? What are the psychological needs of these patients,
particularly of elderly women? What are their reconstructive surgery op-
tions? Most important, what therapies improve quality of life as well as
mortality statistics? Surprisingly, these areas have received relatively little
attention in the past. Effectiveness studies may provide answers to these
questions.
Initial breast cancer effectiveness studies should involve mammography.
For optimal studies, we need much more data than are currently available
from the Medicare data bases. Because Medicare currently reimburses only
for diagnostic mammograms (meaning that the patient has some sort of a
problem, such as a palpable lump), we do not have data on screening
mammograms done on asymptomatic women. If Medicare pays for screen-
ing mammography, it will be a golden opportunity to study utilization and
effectiveness of breast cancer screening; however, we must accurately de-
termine and record the reason for the mammography (that is, screening vs.
diagnostic examination). We need to track the interpretations and outcomes
for all women who have mammograms. Some mammograms are going to
be interpreted as "negative" for cancer; others are going to be called "posi-
tive." Of those women with negative mammograms, we must find out how
many subsequently go on to have a breast cancer that was missed on th
mammogram (false negative mammogram). Tracking this information may
require years. Of women who have a positive mammogram (where a lesion
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IOM CLINICAL CONDITION WORKSlIOPS
59
is called suspicious), we must find out how many women actually have
cancer (true positive rate), how many have a benign lesion (false positive
rate), and how many women do not undergo further evaluation. Occasion-
ally a mammogram is interpreted as abnormal, but the patient and her phy-
sician are never notified or they choose not to do anything about it.
It is also crucial that we identify the temporal relationship between
mammography and biopsy. For example, if a woman has a mammogram in
January 1989 and has a biopsy positive for cancer in December 1989, the
study and the surgery may have very little relationship. We must know if
the mammogram prompted the biopsy and the length of time between the
mammogram and the surgery. Ideally, we should record inpatient and out-
patient diagnosis, treatment, and follow-up data on all of these women. It is
also very important that we have standardized terminology and recording of
data on tumor stage, cell type, and hormone receptor status. All of these
factors must be analyzed in order to obtain accurate data about the effec-
tiveness of breast cancer screening in the United States.
REFERENCES
1. Shapiro, S. Evidence on Screening for Breast Cancer from a Randomized
Trial. Cancer 39:2772-2782, 1977.
2. Shapiro, S., Venet, W., Strax, P., et al. Ten- to Fourteen-Year Effect of
Screening on Breast Cancer Mortality. Journal of the National Cancer Institute
69:349-355, 1982.
3. Shapiro, S., Venet, W., Strax, P., et al. Selection, Follow-up, and Analysis in
the Health Insurance Plan Study: A Randomized Trial with Breast Cancer Screen-
ing. NCI Monograph 67:65-74, 1985.
4. Baker, L.H. Breast Cancer Detection Demonstration Project: Five-Year Sum-
mary Report. Cancer 32:194-225, 1982.
5. Seidman, H., Gelb, S.K., Silverberg, E., et al. Survival Experience in the
Breast Cancer Detection Demonstration Project. Cancer 37:258-290, 1987.
6. Tabar, L., Fagerberg, C.J., Gad, A., et al. Reduction in Mortality from Breast
Cancer After Mass Screening with Mammography: Randomised Trial from the Breast
Cancer Screening Working Group of the Swedish National Board of Health and
Welfare. Lancet 1 :829-832, 1985.
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Nijmegen Project, 1975-1981. Lancet 1 :1222-1224, 1984.
8. Collette, H.J.A., Day, N.E., and Rombach, J.J. Evaluation of Screening for
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Control Study. Lancet 1:1224-1226, 1984.
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Efficacy of a Non-Randomized Breast Cancer Screening Program in Florence (Italy).
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EFFECTIVENESS AND OUTCOMES IN HEALTH CARE
Mortality from Breast Cancer: The Malmo Mammographic Screening Trial. British
Medical Journal 297:943-948, 1988.
11. Jackson, V.P., Lex, A.M., and Smith, D.J. Patient Discomfort During Screen-
Film Mammography. Radiology 168:421-423, 1988.
12. Bailar, J.C. Mammography: A Contrary View. Annals of Internal Medicine
84:77-84, 1976.
13. Feig, S.A. Radiation Risk from Mammography. Is it Clinically Significant?
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Risk Decision. Investigative Radiology 24:17- 19, 1989.
15. Eddy, D.M., Hasselblad, V., McGivney, W., et al. The Value of Mammography
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16. Moskowitz, M. Breast Cancer Screening: All's Well That Ends Well, or
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Without Radiation in the Treatment of Breast Cancer. New England Journal of
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18. Veronesi, U., Saccozzi, R., del Vecchio, M., et al. Comparing Radical
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1981.
19. Greenfield, S., Bianco, D.M., Elashoff, R.M., et al. Patterns of Care Related
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After One Course of Perioperative Adjuvant Chemotherapy for Node-Negative Breast
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