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OCR for page 128
Appendix B
Examples of Practice Guidelines
Practice guidelines and criteria for reviewing medical care come in a
great variety of forms. Although some variations may be merely stylistic,
others are linked closely lo the intended uses and users of the guidelines.
Some developers of guidelines present their products in multiple forms.
To illustrate something of the range of ways in which guidelines are
presented, three relatively simple guidelines for breast cancer screening are
displayed below in their enticed. In addition, one patient management
algorithm is included. The last example is a photostat of the actual algo-
rithm; the other examples have been prepared in layouts and typefaces that
closely but not exactly reproduce the originals.
128
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APPENDIX B
EXAMPLE 1
REPORT OF THE U.S. PREVENTIVE SERVICES TASK FORCE
Screening for Breast Cancer
129
The first guideline comes from the 1989 report of the U.S. Preventive
Services Task Force, a 419-page document intended mainly for primary
care providers. The methodology of the 20-member task force was, in
many respects, modeled on that of a similar Canadian group first convened
in 1976, in which a systematic process and explicit criteria were used tO
review evidence and develop recommendations. The task force's objective
was "to develop comprehensive recommendations addressing preventive
services for all age groups" for 60 target conditions.
The report of the group describes its origins, methodology, and par-
ticipants and includes a set of age-specific charts listing services to be
considered during periodic health examinations for patients in seven differ-
ent age groups. Recommendations for patient education and counseling are
also included. After this introductory material, three sections of the report
present recommendations related to screening services, counseling, and
immunizations/chemoprophylaxis. Within the section on screening services,
sets of guidelines related to 47 specific clinical problems are organized as
separate chapters. Each chapter follows the approximate format presented
in the example below.
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130
CLINICAL PRACTICE GUIDELINES
SCREENING FOR BREAST CANCER
Recommenciation: All women over age 40 should receive
an annual clinical breast examination. Mammography every
one to two years is recommended for all women beginning
at age 50 and concluding at approximately age 75 unless
pathology has been detected. It may be prudent to begin
mammography at an earlier age for women at high risk for
breast cancer (see C/inica/ /ntervention). Although the
teaching of breast self-examination is not specifically
recommended at this time, there is insufficient evidence to
recommend any change in current breast self-examination
practices.
Burden of Suffering
In the United States in 1989, an estimated 142,000 new cases of breast
cancer will occur in women, and 43,000 women will die of this disease.:
Breast cancer accounts for 28% of all newly diagnosed cancers in women
and 18% of female cancer deaths. The age-adjusted mortality rate from
breast cancer has been almost unchanged over the past 10 years. Breast
cancer is the leading contributor to premature cancer mortality in women.2
Because women of the "baby boom" generation are now reaching age 40,
the number of breast cancer cases and deaths will increase substantially
over the next 40 years unless age-spec~ic incidence and mortality rates
decline.
Important risk factors for breast cancer include sex, geographic
location, and age. Breast cancer is much more common in women than
men, and the highest rates of breast cancer exist in North America and
northern Europe. In American women, the annual Incidence of breast
cancer increases rapidly with age, from approximately 20 per 100,000 at
OCR for page 131
APPENDIX B
131
age 30 to 180 per 100,000 at age 50.3 The risk for women with a family
history of premenopausally diagnosed breast cancer in a first~egree
relative is about two to three times that of the average woman of the same
age in the general populations 5 Women with previous breast cancer are
at increased risk, as are women with a history of benign breast
diseased 4 6 Other factors with some clinical or statistical association with
breast cancer include first pregnancy after age 30, menarche before age
12, menopause after age 50, obesity, high socioeconomic status, and a
history of ovarian or endometrial cancer. '4'7
Efficacy of Screening Tests
The three screening tests usually considered for breast cancer are
clinical examination of the breast, x-ray mammography, and breast self-
examination (BSE). The sensitivity and specificity of clinical examination
of the breast varies with the skill and experience of the examiner and with
the characteristics of the individual breast being examined. Over the five
years of the Breast Cancer Detection Demonstration Project (BBCDDP), the
estimated sensitivity of clinical examination alone was 45°/O. Data from
studies using manufactured breast models show that mean sensitivity
among registered nurses was 65% compared with 55°/O for untrained
women.8 9 Detection by physicians was 87% for lumps 1.0 cm in diameter,
a size comparable to that used in the studies involving nurses and
women.
Estimates of the sensitivity of mammography depend on a number of
factors, including the size of the lesion, the age of the patient, and the
extent of follow-up to determine the proportion of "negative" masses that
are later found to be malignant (i.e., false negatives). The average
sensitivity of the combined clinical examination and mammography in the
five years of the BCDDP was 75°~. The estimated sensitivity for
mammography alone was 71%.8 A recent report from a multicenter trial
estimated the sensitivity of an initial mammographic examination to be
about 75°/O.~ In a study of 499 women, mammography had an overall
sensitivity Of 78%, but it was reduced to 70°/O when only lesions under 1.0
cm in diameter were considered. Sensitivity for all breast cancers in
women over 50 was 87%, while sensitivity in women under 51 was 56%.
In the 10-year follow-up of a Dutch study, the sensitivity of mammography
was 80% for women aged 50 and above and 60% for those under 50.~3
The specificity of mammography is about 94-990/o.~i'i3 Even with this
excellent specificity, however, false positives can occur frequently if the test
is performed routinely in populations with a low prevalence of breast
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132
CLINICAL PRACTICE GUIDEL~INES
cancer. Thus, most abnormal results of mammograms performed on
young women without known risk factors for breast cancer are likely to be
false positives. BCODP data show that only 10% of women with positive
(mammography and clinical examination) screening results were found to
have cancer,:4 and a recent multicenter trial reported a positive predictive
value of only 7% for initial mammographic examinations. There is no
study that shows that the sensitivity or specificity of mammography is
increased when "baseline" mammograms are available for comparison.
Studies of mammography have shown large variations in observer
(radiologist interpreter) performance.~~~7 In a study using 100
xeroradiographic mammograms, including 10 of women with proven
cancers, the number of lesions identified as "suspicious for cancer" by 9
radiologists ranged from 10 to 45.~5 In a large breast cancer screening
study in Canada, agreement was poor between radiologists at five
screening centers and a single reference radiologist.26
Because exposure to ionizing radiation can be carcinogenic,
widespread testing by mammography has the potential of producing some
cases of radiation-induced cancer. However, radiation exposure from
mammography has decreased dramatically with the development of
dedicated mammography equipment and low~ose techniques. ~' ~9
Radiation exposure varies with breast size as well as with the specific
equipment and technique used.~7~~9 Thus, it is important for operators to
use low~ose equipment and proper technique to limit unnecessary
exposure to ionizing radiation during mammography.
Self-examination of the breast appears to be a less sensitive form of
screening than clinical examination, and its specificity remains uncertain.
Using reasonable assumptions applied to data from the BCDDP, the
estimated overall sensitivity of BSE alone was found to be 26% in women
also screened by mammography and physical examination.8 Estimated
BSE sensitivity in the BCDDP varied by age group; it was most sensitive for
women 35-39 years of age (41%) and least sensdwe for women aged 60-
74 (21%~.8 Among participants in a breast cancer registry, BSE was
reported to detect 34°/O of cancers.
In a study of women's ability to detect breast lumps, untrained
volunteers were able to detect 25% of lumps ranging in size from 0.25 to
3.0 cm in diameter.8 2: The study showed that the sensitivity of BSE can
be improved by training. A 30-minute training session increased the mean
lump detection rate to 50O/o.2~ Although training sessions have increased
detection rates, they also increase false-positive rates. False-positive BSE
may result in unnecessary physician visits, heightened anxiety levels in
women, and increased radiographic and surgical procedures No study
yet reported has directly compared the sensitivity or specificity of self
OCR for page 133
APPENDIX B
133
examination with that of clinical examination and mammography, in part
due to the methodologic difficulties with properly designing such a study.
Effectiveness of Early Detection
The results of several large studies have convincingly demonstrated the
effectiveness of clinical examination and mammographic screening for
breast cancer in women aged 50 and older. The Health Insurance Plan of
Greater New York (HIP) in 1963 began a randomized prospective study of
clinical examination and mammography in 62,000 women.22 The tollow-
up of this group now exceeds 18 years. In women who were over age 50
at the time of entry into the study, mortality from breast cancer in the
screened group was more than 50% lower than in the unscreened group
at five years. This effect has gradually decreased to about 21% after 18
years.
In the Swedish 'two county study,U a randomized controlled trial was
begun in 1977 using single-view mammograms to screen about 78,000
women every 20 to 36 months.23 After six years of follow-up, the group of
women who were over age 50 at the time of entry showed a significant
decrease in breast cancer mortality. A recently reported randomized
controlled trial in Malmo, Sweden, found that in 8.8 years of follow-up
women aged 55 and older who receded periodic mammographic
screening had a significant reduction in mortality from breast cancer. 4 In
the Netherlands, a screening program of single-view mammography every
two years for women over age 35 was introduced in 1975.25 After seven
years, this case-control study showed that mammography significantly
reduced the risk of mortality from breast cancer in women 50 and over.
A case-control study in Italy also reported a strong inverse relationship
between mortality from breast cancer and mammographic screening in
women aged 50 and older.26
More than 280,000 women in the United States were screened with a
combination of clinical examination and mammography during the Breast
Cancer Detection Demonstration Project.27 This demonstration project was
not designed as a research study, however, and lacked a control group.
Effectiveness was inferred by comparing the outcome among BCDDP
participants with that observed in national cancer surveillance programs.
These comparisons showed that BCDDP participants had higher survival
rates than those of breast cancer cases in national sample groups.27 The
finding of increased five-year survival was confirmed in a recent analysis of
the BCDDP data, which also demonstrated that cumulative mortality from
breast cancer was 80% of that expected of BCDDP participants without
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134
CONICAL PRACTICE GUIDELINES
diagnosed breast cancer at the start of the study 28 Due to the absence
of internal controls in the original design of this study, however, it is unclear
to what extent these References were due to selection bias, lead-time bias,
and other sources of bias.29
Although most authorities agree on the benefits of screening women
aged 50 and over for breast cancer, there has been some uncertainty
about the effectiveness of mammographic screening in women between
the ages of 40 and 49 29-32 Mammography for women under 50 has not
been shown to be effective in reducing breast cancer mortality in the
Swedish Two count/' trial23 or the Dutch study,25 although the follow-up
period may not have been of sufficient duration to detect an effect on
mortality. The Malrno, Sweden, trial also reported no benefit for women
under age 55, but the mean follow-up period was less than 9 years;
moreover, 24% of women in the control group are thought to have received
mammography outside of the screening program and as many as 26% of
women in the intervention program did not attend screening. 4
Follow-up data from the HIP study suggest that women aged 4049
who receive periodic mammography and clinical examination may
experience a reduction of about 25% in breast cancer mortality, but the
investigators and others have not found this difference to be statistically
significant.22 32 Interpretations of statistical significance when analyzing
these data are influenced by a number of factors, some of which include
the definition of the 4049 age group (i.e., age at entry into study vs. age
at diagnosis), the length of follow-up, and the denominator chosen to
calculate mortal ty (women entering the study vs. cases of breast cancer).
The difference in mortality is statistically significant when cases of breast
cancer are used as the denominator and age at entry defines the age
group.33 Statistical significance may, however, be less a consideration than
clinical significance. Although nearly 28,000 women aged 40~9 entered
the HIP trial, after over 18 years there were only 16 fewer breast cancer
deaths among screened women (61 deaths) than in the control group (77
deaths), a difference of about 12 in 10,000 women screened.33, 4
There are few data regarding the optimal frequency of mammography
or the age at which to discontinue screening in the asymptomatic elderly.
Although an annual interval is widely recommended, a recent analysis of
data from the Swedish 'two county' study found little evidence that an
annual interval conferred greater benefit than screening every two years.35
Although there are no reliable data on the optimal age to conclude
mammographic screening, there are uncertainties regarding the
effectiveness of screening beyond age 75 in asymptomatic women with
consistently normal results on previous examinations. The incidence of
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APPENDIX B
135
new disease in this population may be relatively low and thus the
effectiveness of screening may be limited, but reliable data are lacking.
Although no large study has quantitated the effectiveness of breast
cancer screening for women in high-risk groups, it is apparent that these
women have a greater probability of developing the disease.30 If screening
can reduce the risk of mortality from breast cancer, there may be a greater
effect from screening those in high risk groups, but studies confirming this
effect are lacking. Further, established risk factors are present in less than
one-quarter of women with breast cancer, so that a screening program
restricted to high-risk groups is likely to miss the majority of cases.
Retrospective studies of the effectiveness of BSE have produced mixed
results, and BSE has not been studied in a prospective controlled trial with
mortality as an outcome.8 A recent meta-analysis of pooled data from 12
studies found that women who practiced BSE before their illness were less
likely to have a tumor of 2.0 cm or more in diameter or to have evidence
of extension to lymph nodes.36 The studies from which these data were
obtained, however, suffer from important design limitations and provide
little information on clinical outcome (e.g., breast cancer mortality).
Recommendations of Others
The American Cancer Society37 and the National Cancer Institute38
recommend monthly BSE and regular clinical examination of the breast for
all women; baseline mammography between ages 35 and 40, followed by
annual or biennial mammograms from ages 4049; and annual
mammograms beginning at age 50. These recommendations have been
supported by other groups such as the American Medical Association,39
the American College of Obstetricians and Gynecologists,40 and the
American College of Radiology.4~ A joint statement on screening for breast
cancer involving many of these organizations is currently being developed
under the organization of the American College of Radiology. 2
In contrast, the Canadian Task Force, 43 American College of
Physicians,44 and other authorities45 46 support annual clinical breast
examinations for all women starting at age 40 but do not recommend
beginning yearly mammography until age 50.
The World Health Organization states that there is insufficient evidence
that BSE is effective in reducing mortal ty from breast cancer.47 Thus, it
does not recommend BSE screening programs as public health policy,
although it finds equally insufficient evidence to change such programs
where they already exist.
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136
Discussion
CLINICAL PRACTICE GUIDELINES
At this time, there is little doubt that breast cancer screening by clinical
examination and mammography has the potential of reducing mortality
from breast cancer for women aged 50 and above. Most studies have not
shown a clear benefit from mammography in women aged 4049. Studies
that will provide important information on this topic are in progress.48 In
the meantime, ~ is unclear whether the effects on breast cancer mortality
achieved by screening women aged 40~9 are of sufficient magnitude to
justify the costs and potential adverse effects from false-positive results
that may occur as a result of widespread screening.34 Until more definitive
data become available, it is reasonable to concentrate the large effort and
expense associated with mammography on women in the age group for
which benefit has been most clearly demonstrated: those aged 50 and
above. Annual clinical breast examination is a prudent recommendation
for women aged 40~9.
Conclusions about the cost-effectiveness of mammography have not
been universally accepted. Charges vary greatly in the United States, but
in 1984 they averaged about $80-$100 per procedure.30 For screening
mammography to be widely used, it is likely that this charge would have
to be reduced to $50 or less.49 Even if only $50 were charged per
mammogram, surveying all of the women in the United States over 40
years of age would cost more than $2 billion a year.50 Others have drawn
attention to the additional costs of biopsies performed on the basis of false-
posit~e mammography results.30 There are also concerns about the
availability of the large numbers of trained radiologists needed to interpret
additional screening examinations.5095i
Wide variation is found in the quality and consistency of
mammography, as well as in the accuracy of interpretation, radiation
exposure, and cost.~5~~930 Radiation exposure during routine
mammography is frequently much higher than the optimal doses or the
minimal achievable doses usually quote0.~7~~9 All of the above caveats
about mammography argue for caution in the recommendation of
mammographic screening, as well as for the selection of mammographers
who maintain only the highest standards of quality.
The accuracy of BSE as currently practiced appears to be considerably
inferior to that of the combination of clinical breast examination and
mammography. False-positive BSE, especially among younger women in
whom breast cancer is uncommon, can lead to needless anxiety and
expense. With the present state of knowledge, ~ is difficult to make a
recommendation about the inclusion or exclusion of teaching BSE during
the periodic health examination. The WHO policy, neither recommending
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APPENDIX B
137
new BSE teaching programs nor changing existing ones, appears to be a
prudent interim approach pending new data.47
Clinical Intervention
Annual clinical breast examination is recommended for all women
aged 40 and above. Mammography every one to two years is
recommended for all women beginning at age 50 and concluding at
approximately age 75 unless pathology is detected. Obtaining
"baseline" mammograms before age 50 is not recommended. For the
special category of women at high risk because of a family history of
premenopausally diagnosed breast cancer in first~egree relatives, it
may be prudent to begin regular clinical breast examination and
mammography at an earlier age (e.g., age 35~. Clinicians should refer
patients to mammographers who use low~ose equipment and adhere
to high standards of quality control. Although teaching BSE is not
specifically recommended at this time, there is insufficient evidence
to recommend any change in current BSE practices.
Note: See Appenclix A for the U.S. Preventive Services Task Force
Table of Ratings for this topic. See also the relevant Task Force
background paper: O'Malley MS, Fletcher SW. U.S. Preventive Services
Task Force: screening for breast cancer with breast self-examination: a
critical review. JAMA 1987; 257:2196-203.
REFERENCES
1. American Cancer Society. Cancer statistics, 1989. CA 1989; 39:3-20.
2. Leads from MMWR. Premature mortality due to breast cancer--United
States, 1984. JAMA 1987; 3229-31.
3. McLellan GL Screening and early diagnosis of breast cancer. ~ Fam
Pract 19~: 26:561~.
4. Kelsey JL, Hildreth NG, Thompson WD. Epidemiological aspects of
breast cancer. Radial Clin North Am 1983; 21:3-12.
5. Kelsey UL. A review of the epidemiology of human breast cancer.
Epidemiol Rev 1979; 1 :74-109.
6. Dupont WD, Page DL. Risk factors for breast cancer in women with
proliferative breast disease. N Engl J heed 1985; 312:146-51.
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138
CLINICAL PRACTICE GUIDELINES
7. Seidman H. Stellman SD, Mushinski MH. A different perspective on
breast cancer risk factors: some implications of nonattributable risk. CA
1982; 32:301-13.
8. O'Malley MS, Fletcher SW. Screening for breast cancer with breast self
examination. JAMA 1987; 257:2197-293.
9. Haughey BP, Marshall JR, Mettlin C, et al. Nurses' ability to detect
nodules in silicone breast models. Oncol Nurs Forum 1984; 1:37~2.
10. Fletcher SW, O'Malley MS, Bunce ha. Physicians' abilities to detect
lumps in silicone breast models. SIGMA 1985; 253:2224-8.
11. Baines CJ, McFarlane DV, Miller AB. Sensitivity and specificity of first
screen mammography in 15 NBSS centres. Can Assoc Radial ~1 1988;
39:273~.
12. Eideiken S. Mammography and palpable cancer of the breast. Cancer
1988; 61:263-5.
13. Peeters PH, Verbeck AL, Hendricks JH, et al. The predictive value of
positive test results in screening for breast cancer by mammography
in the Nijmegen programme. Br ~ Cancer 1987; 56:667-71.
14. Wright CJ. Breast cancer screening: a different look at the evidence.
Surgery 1986; 100:594-8.
15. Boyd NF, Wofson C, Moskowitz M, et al. Observer variation in the
interpretation of xeromammograms. JNCI 1982; 68:357 63.
16. Baines Cal, McFarlane DV, Wall C. Audk procedures in the national
breast screening study: mammography interpretation. ~ Can Assoc
Radial 1986; 37:256 60.
17. Gadkin BM, Feig SA, Muir HD. The technical quality of mammography
in centers participating in a regional breast cancer awareness program.
Radiographics 1988; 8:13345.
18. Kimme-Smith C, Bassett LW, Gold RH. Evaluation of radiation dose,
focal spot, and automatic exposure of newer film-screen
mammography units. AdR 1987; 149:913-7.
19. Prado KE, Rakowski ~IT, Barragan F. et al. Breast radiation dose in
film/screen mammography. Health Physics 1988; 55:81-3.
20. Gould-Martin K, Paganini-Hill A, Cassagrande C, et al. Behavioral and
biological determinants of surgical stage of breast cancer. P rev liked
1982;11:441-53.
21. Hall DC, Adams OK, Stein GH, et al. Improved detection of human
breast lesions following experimental training. Cancer 1980; 46:408-1 1.
22 Shapiro S. Venet W. Strax P. et al., eds. Periodic screening for breast
cancer. Baltimore, Md.: Johns Hopkins Press, 1988.
23. Tabar L, Fagerberg CJG, Gad A, et al. Reduction in mortality from
breast cancer after mass screening with mammography: randomised
OCR for page 139
APPENDIX B
139
trial from the Breast Cancer Screening Working Group of the Swedish
National Board of Health and Welfare. Lancet 1985; 1:829-32.
24. Andersson 1, Aspegren K, danzon L, et al. Mammographic screening
and mortal ty from breast cancer: the Malmo Mammographic Screening
Trial. Br to 1 1988; 297:943~.
25. Verbeek ALIBI, Hendricks UHCL, Hollan PR, et al. Reduction of breast
cancer mortality through mass screening with modern mammography:
first results of the Nijmegen Project, 1975-1981. Lancet 1 984; 1:12224.
26. Palli D, Del Turco MR, Buiatti E, et al. A case-control study of the
efficacy of a non-randomized breast cancer screening program in
Florence (Italy). Into Cancer 1g86; 38:5014.
27. Seidman H. Gelb SK, Silverberg E, et al. Survival experience in the
breast cancer detection demonstration project. CA 1987: 37:258-90.
28. Morrison AS, Brisson ], Khalid N. Breast cancer incidence and
mortality in the Breast Cancer Detection Demonstration Project. UNCI
1988; 80:1540-7.
29. Bailar JC. FJIammography before age 50 years? An editorial. JAMA
1988; 259:1548-9.
30. Eddy DM, Hasselblad V, McGivney W. et al. The value of
mammography screening in women under age 50 years. JAbAA 1988;
259:1512-9.
31. Dodd GS, Taplin S. Is screening mammography routinely indicated for
women between 40 and 50 years of age? J Fam Pract 1988; 27:313-20
32. Day NE, Baines CJ, Chamberlain J. et al. UICC project on screening
for cancer: report of the workshop on screening for breast cancer. Int
~ Cancer 1986; 38:303-8.
33. Chu KC, Smart CR, Tarone RE. Analysis of breast cancer mortality and
stage distribution by age for the Health Insurance Plan clinical trial.
JNC11988;80:1125-32.
34. Eddy DM. Breast cancer screening (letter). JNCI 1989; 81 :234-5.
35. Tabar L, Faberberg G. Day NE, et al. What is the optimum interval
between mammographic screening examinations? An analysis based
on the latest results of the Swedish two-county breast cancer screening
trial. Int ~ Cancer 1987; 55:547-51.
36. Hill D, Wh~te V, ~lolley D, et al. Self examination of the breast: is it
beneficial? Meta-analysis of studies investigating breast self
examination and extent of disease in patients with breast cancer. Br
hAed J 2988; 297:271-5.
37. American Cancer Society. Summary of current guidelines for the
cancer-related checkup: recommendations. New York: American
Cancer Society, 1988.
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CLINICAL PRACTICE GUIDELINES
38. National Cancer Institute. Working guidelines for early detection:
rationale and supporting evidence to decrease mortality. Bethesda,
Md.: National Cancer Institute, 1987.
39. American Medical Association Mammography screening in
asymptomatic women 40 years and older (Resolution 93, 1~7~. Report
of the Council on Scientific Affairs, Report F (Abet. Chicago, 111.:
American M ed ical Association, 1 9~.
40. American College of Obstetricians and Gynecologists. Standards for
obstetric-gynecologic services, 6th ed. Washington, D.C.: American
College of Obstetricians and Gynecologists, 1985.
41. American College of Radiology. Policy statement: guidelines for
mammography. Reston, Va.: American College of Radiology, 1982.
42. Dodd GD, American College of Radiology. Personal communication,
February 1389.
43. Canadian Task Force on the Periodic Health Examination. The periodic
health examination: 2. 1985 update. Can Med Assoc~l 1986; 134:724-9.
44. American College of Physicians. The use of diagnostic tests for
screening and evaluating breast lesions. Ann Intern Med 1985;
103:147-51 .
45. Baines CJ. Breast-cancer screening: current evidence on
mammography and implications for practice. Can Fam Physician 1987;
33:91 5-22.
46. Frame PS. A critical review of adult health maintenance. Part 3.
Prevention of cancer. J Fam Pract 1986; 22:511-20.
47. World Health Organization. Self-examination in the early detection of
breast cancer. Bull WHO 1984; 62:861-9.
48. Miller AB. Screening for breast cancer. Breast Cancer Res Treat 1983;
3:1 43-56.
49. Sickles EA, Weber WN, Calvin HB, et al. Mammographic screening:
how to operate successfully at low cost. Radiology 1986; t60:95-7.
50. Dodd GS. The history and present status of radiographic screening for
breast carcinoma. Cancer [Suppl 7] 1987; 1 :671~.
51. Bassett LW, Diamond J], Gold RH, et al. Survey of mammography
practices. AJR 1 987; 1 49:1 1 49.
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APPENDIX B
141
EXAMPLE 2
AMERICAN COLLEGE OF PHYSICIANS
Screening for Breast Cancer
The guideline on screening for breast cancer, approved April 1989, is
a product of the Clinical Efficacy Assessment Project (CEAP), an internally
funded practice evaluation activity of the American College of Physicians.
Lois project has evaluated laboratory tests, other technologies, and med-
ical procedures and practices and made recommendations in the form of
statements or guidelines. A procedures manual for the project, published
in 1986, describes 10 elements involved in the CEAP's guidelines develop-
ment process: identification of technologies as candidates for evaluation,
criteria for selecting technologies to be evaluated, selection of consultants,
evaluation process, definition of terms, development of statement, review
of statement, ratification process, dissemination of statement, and recon-
sideration of previously approved statements. The primary audience is the
College's 68,000 members, who are specialists in internal medicine.
The ACP publishes guidelines in freestanding form as shown below
and also has published some sets of related guidelines in manual fonn.
Eventually, the College will publish a comprehensive volume of guidelines,
background papers, and other relevant materials. As the guideline shown
below illustrates, the freestanding guidelines do not describe the CEAP
process, nor do they cite the extensive scientific background papers that are
a key element in the evaluation process. For the breast cancer screening
guideline, the background paper was prepared by David M. Eddy and
published (as are many such papers) in 1989 in the Annals of Internal
Medicine.
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142
Independence Mall West, Sixth Street at Race, Philadelphia, PA 191061572, Tel 21~351-2400
CLINICAL PRACTICE GUIDELINES
American College of Physicians
Disease:
SCREENING FOR BREAST CANCER
Clinical
Efficacy
Assessment
Project
The majority of breast cancers are infiltrating ductal carcinomas; the remainder are of various pathologic
types. though prognosis varies slightly with pathologic type, the principles of screening and management
do not differ.
Risk factors for breast cancer include socioeconomic factors, personal or family history, mar tal status,
multiparity, age at first pregnancy, age at menarche and menopause, history of benign breast conditions,
and diet.
Screening test(s):
Two main tests are used for breast cancer screening: breast physical examination and mammography.
A breast physical examination performed by a trained practitioner entails visual inspection and manual
palpation of the breast.
Two types of mammography are used for breast cancer screening: plain-film and xeromammography.
Xerornammography is effective in 'identifying microcalc'dications associated with early breast cancers; plain-
film mammography is more effective at detecting poorly defined lesions.
Recommendations:
1.
Screening with breast physical examination is recommended annually for asymptomatic women age
40 and older.
2. Screening with breast physical examination and mammography is recommended annually for
asymptomatic women age 50 and older.
3. Screening with breast physical examination and mammography is recommended annually for women
at any age who have a personal history of breast cancer.
4. Screening with breast physical examination and mammography is recommended annually for women
age 40 or older who have a family history of breast cancer or who are otherwise at increased risk.
Rationale:
There is substantial direct evidence that breast cancer screening with breast physical examination and
mammography reduces mortalRy from breast cancer in women over the age of 50. The evidence of
effectiveness of mammography for women under age 50 is conflicting; however, the natural history of
breast cancer in women under age 50 is such that annual screening with mammography in women who are
at increased risk is strongly recommended. All women should be counselled regarding the benefits, risks
and costs so they might choose the screening strategy that suits their personal history and preferences.
The risks associated with breast cancer screening are primarily due to false-positive results which can lead
to further diagnostic tests, including breast biopsy. though radiation might increase the risk of a new
cancer, the carcinogenic effect of the radiation from mammography is extremely small.
Board of Regents
Approved 4/10/89
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APPENDIX B
143
EXAMPLE 3
GROUP HEALTH COOPERATIVE OF PU GET SOUND, INC.
Screening for Breast Cancer
The third guideline is taken from the Preventive Care Manual of the
Group Health Cooperative of Puget Sound (GHCPS), a manual intended
"to help physicians and nurses. . .provide comprehensive preventive health
care to [GHCPS] enrollees." The introduction to the manual describes
how the Group Health Medical Staff Committee on Prevention evaluates
screening tests and preventive interventions before they are recommended
by the committee for general use in GHCPS. The manual was first compiled
in 1987 as a draft document and is being revised on an ongoing basis.
The major part of the manual consists of summaries of the commit-
tee's recommendations. The breast cancer screening statement presented
below is one such summary. The manual is organized into separate sec-
tions on adult screening tests and interventions, pediatric screening tests
and interventions, and immunizations. It also includes other information
such as a bibliography and removable summary char es that allow quick ref-
erence for such information as well-adult screening schedules and general
immunization guidelines.
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144
CLINICAL PRACTICE GUIDELINES
GHC PREVENTIVE CARE MANUAL
Adult Screen
BREAST CANCER July, 1990 -update
Committee on Prevention
Reviewed- 1983, 1988
PURPOSE: Early detection of breast cancer reduces mortality in women over 50 and reduces the morbidity of
treatment.
WHO:
WHEN:
All women ages 40 and above, depending on risk factors, with increasing frequency and using
additional procedures as one gets older.
PROCEDURE: BREAST SELF EXAM (BSE): Patients are taught to exarnme their own breasts monthly. The
procedure should be reviewed with the patient at the time of professional breast exams.
PROFESSIONAL BR} AST EXAM (PE): A thorough exam by M.D. or other trained practitioner.
Goal is to detect any abnormalities that warrant further investigation.
MAMMOGRAPHY: An X-Ray study of the breast capable of detecting up to 80 - 85% of cancers.
BSE - Monthly - All women should be instructed in BSE, usually at the time of PE (see below)
and encouraged to perform the examination monthly.
PE - Annually - During the course of a clinic visit, and as part of a comprehensive evaluation at
the Breast Cancer Screening Program Center (BCSPC).
Mammography. Women age less than 40 may be referred for mammography if deemed clinically
advisable by their physician. Invitations to women age 40 or more to attend the BCSPC for a
comprehensive breast evaluation, including mammography will be scheduled according to the
following risk protocol.
RISK PROTOCOL
Mammography
Interval Women Age 40~9 Women Age 50 & Over
One Year Previous abnormal biopsy (atypia) OR As for women 44~9
two or more 1st degree relatives with
breast cancer (mother, daughter, sister).
Two Years One 1st degree relative with breast cancer. One 1st degree relative with breast
cancer OR at Icast So minor risk
factors.
Three Years At least one minor risk factor. All other women.
,N'ot Recommended too risk factors.
MINOR RISK FACI()RS
- Aunt, and/or grandmother with breast cancer
- Nlenarche age 10 or younger and/or menopause age 55 or older
- !x'o births OR first birth age 30 or older
- Previous negative breast biopsy
:
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APPENDIX B
145
Subject: Adult Screen
BREAST CANCER July, 1990 - Update
Committee on Prevention
Reviewed- 1983, 1988
FOLLOW IMP: Women with abnormalities detected through the GHC breast cancer screening program will be
followed through the program. The primary care physician will be kept informed. Other patients
with abnormal findings on BSE or PE should be managed by their primary MI) including referral
for surgical evaluation when indicated.
C()MMEISTS: Under the provisions of the GHC risk protocol, 83 percent of all women and 100 percent of all
women above age 49, will have mammography at some interval. The percent of women in each
screening interval group and their estimated relative risks of developing breast cancer are shown in
the table below. The risk algorithm and cancer outcomes from the program are being scientifically
evaluated.
At present it remains the physicians' prerogative to order a screening mammogram outside the
Breast Cancer Screening Program. Women with a history of breast cancer should get annual
mammography through their primary care physician.
Mammography Interval Percent of Estimated
Women Relative Risk
One Year 3% 114
Two Years 17~o 1.9-3.5
Three Years 63% 1.2-1.9
Not Recommended 17% 1.0
References:
1. Carter AP, Thompson RS, Elourdeau RV: A clinically effective Breast Cancer Screening
Program can be cost-effective too. Prev Med. 1987;16:29-34.
2. Taplin SH, Anderman C: Risk-based breast cancer screening in an HMO: The first year's
experience. Group Health Institute Proceedings, June 1987.
3. Thompson RS, Taplin SH, Carter AP, Schnitzer A, Anderman C, Anderson E, White E,
Wagner EH: A risk-based breast cancer screening program. HMO Practice 1988;2:17 7-191.
4. Taplin SH, Anderman C, Grothaus L: Breast cancer risk and participation in mammographic
screening. Am J Pub Health, 1989;79:1494~1498.
5. Thompson RS, Taplin S. Carter AP' Schnitzer F: Cost effectiveness in program delivery.
Cancer, Dec.15,1989;Supplement:2682-2689.
6. Taplin S. Thompson RS, Schnitzer F. Anderman CA, Immanuel V: Revisions in the Ilisk-
Based Breast Cancer Screening Program at Group Health Cooperative, (Cancer, in press for
August, 1990).
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146
CWlVICAL PRACTICE GUIDELINES
EXAMPLE 4
HARVARD COMMUNllY HEALTH PI^N
Dysuria Algorithm
The Harvard Community Health Plan (HCHP) is a multisite, group-
model HMO. Over the past several years, HCHP has developed an extensive
series of computer-accessible algorithms for ambulatory care management.
Each algorithm is developed by a task force of clinicians based on a
thorough review of the scientific literature. The task forces operate under
the guidance of a research faculty and staff who are experienced in algorithm
development
Each algorithm is followed by explanatory notes regarding options,
patients at special nsk, and recommended medications and dosages. Some
algorithms are several pages long. The HCHP dysuria algorithm is repro-
duced below.
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APPENDIX B
Dyslexia froqucncy
\ urgency I 1TI J
= ,
-
Obtain UA I
MEL 3
Pos
,
/ Fcvcr or
flanic pain
~. ~
~ Gino 5
< Pregnant
~8
No
/Documcated U11\
\ past 3 months
No
~ ~ 10
/ BUTS \ __ _
\ past year ~~
.
>~No ~.2
~'
/ He urinary tract \
structural \
abnormality or
\ other medical
illness
lo. . ~
){No 14
1
1. Singlc dcsc Rx (I))
2. Instruct patient to call if
not imprwcd p 2 days (E)
) >
1. Obtain UC
2. Multiple dose Rx
3. FhUCpRx
HCHP clinical guidelines ase designed to assist clinicians by providing an
analytical framewodc for the evaluation and tseatmcat of the more chignon
problems of HC~ patients. They "c not intended either to zeplecc
clinicians clinical judgemcat or to establish ~ phenol for all parents with
particular condition. It is understood that sosnc parents will not fit the
clinical conditions oontanplated by a guiddinc and that a guiddinc will
Ply establish Tic only appropriate approach to ~ problem.
147
2
Elaborate He
Ncg ~
-
Evaluatc for vag ~nc
atrophic), C~iCitiS,
. . .
so .plngltlS as
indicated
4
Ycs ~ | Pydo protocol
6
Ycs ' 1. ObtunUC
2. Multiplcdosc Rx(B)
3. EhUCpRx
9
r
1. Obtain 13C
2. If BCM implicated
consider change
3. Multiple dose Rx (B)
1. Obtain UC
~ Multiple dose Rx (13)
3. Ccmsidespsophyla~us
13
1 1 If recurs , . .
Irutlatc
pn~phylaxis (C)
11
Edith Braun, MD
Carolc Black, ~
Barbara Covey, MD
Joe Dorscy, MD
Lasty Gottlicb, MD
Talia Herman, ho)
Beth Ingram, PA
Carl Isihara, MD
Man Kim, MD
Tarn Lawralcc, ~
Canni Margolis, MD
Marvin Pack=, MD
Barbara Stewast, MD
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148
CLINICAL PRACTICE GU DELINES
ACUTE DYSURIA IN THE ADULT FEMALE
A. A primary goal of this algorithm is to separate women with acute uncompli-
cated UTI that can be treated with single dose antibiotic therapy from women
with complicated UTI that will require further evaluation or longer duration of
therapy. Therefore, women who have symptoms longer than 2 or 3 days,
women who have fever or flank pain, pregnant women and women with fre-
quent recurrences or other underlying medical problems need to be eliminated
from this algorithm. Initial steps in their management are suggested at branch
points of this algorithm, but other algorithms will be necessary to more fully
address the management of these groups of patients.
Stamm, W., Causes of the Acute Urethral Syndrome in Women, NEJM 1980; 303;
409-415.
B. Choices for multiple dose Rx include 7-10 day course of:
Trimethoprim sulfa DS BID (contraindicated in pregnancy, known G6PD
deficiency or allergic Hx).
Amoxici~lin 250 mg pa lid (1st choice in pregnancy).
Nitrofurantoin 50 mg QID (alternative for patient with multiple allergies
or pregnant patient with Hx Pen allergy).
C. Prophylaxis is usually continued for 6 months.
Options for prophylaxis include:
1. Trimethoprim sulfa 1/2 regular strength tab, QHS.
2. Nitrofurantoin 50 mg QHS (in pregnant patient or patient with Hx TJX
allergy or known G6PD deficiency).
Ronald, A. and Harding, G., Urinary Infection Prophylaxis in Women, Annals Int.
Med. 1981; 94(2) 268-269.
D. Options for single dose Rx include:
1. Trimethoprim sulfa DS 2 tabs x 1.
2. Amoxicill~n 3 gm pa x 1.
Kamaroff, A., Acute Dysuria ir1 Women, NEJM 1984; 310; 368-375.
Patients who have failed single dose Rx should be considered to have upper
tract infection and treated per pyelo protocol.
SOURCE: Harvard Community Health Plan, used with permission (abbrevia-
tions and other details as in original).
Representative terms from entire chapter:
cancer screening
