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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

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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

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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

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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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140 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).