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Continuing Education

The Need for Performance and Standardization of the Best Clinical Breast Exam
Nancy Bishop Day
ABSTRACT Breast cancer is the most frequently diagnosed cancer in women. Mammography is not perfect; on average, it will detect about 80% to 90% of breast cancers in women without symptoms. Clinical breast exam (CBE) is widely used in this country, although controversy about this technique exists, and studies largely do not support CBE.The American Cancer Society (ACS), in collaboration with the Centers for Disease Control and Prevention (CDC), developed a committee in 2002 to provide standards and recommendations for physicians and health organizations to enhance CBE performance and reporting.They also recommended the vertical strip method for CBE and development of a system of reporting utilizing the Breast Imaging Reporting and Data System and its lexicon developed by the American College of Radiology. CBE sensitivity has been shown to improve with training, use of silicone models, and live breast models to provide feedback.The MammaCare technique has been shown to increase sensitivity in performing CBE; however, many practitioners are still using the older concentric circle, or radial spokes method.This article presents the best-evidence-based method of CBE and also presents a good argument for standardization of CBE methodology. Keywords: Breast cancer physical exam, breast cancer prevention, screening breast exam

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reast cancer is the most frequently diagnosed cancer in women. Breast cancer ranks second among cancer deaths in women (after lung cancer).1 An estimated 178,480 new cases of invasive breast cancer were expected to occur among women in the United States in 2007. In addition to invasive breast cancer, 62,030 new cases of in situ breast cancer were expected to occur among women in 2007. Of these, approximately 85% were ductal carcinoma in situ (DCIS).An estimated 40,910 breast cancer deaths (40,460 women, 450 men) were expected to occur in 2007. All major US medical organizations recommend screening mammography for women 40 years and older. Screening mammograms reduce breast cancer mortality by about 20% to 35% in women 50 to 69 years old and slightly less in women 40 to 49 years old.2 Several organizations that provide clinical guidelines and practice policies for the early detection of breast cancer vary in their recommendations for clinical breast examination (CBE). Some continue to recommend CBE, while others make no recommendation (Table 1).3-9 CBE can be used either for screening (to detect breast cancer in asymptomatic women), or diagnosis (to evaluate breast complaints, primarily to rule out breast cancer). In primary care, screening CBEs are more commonly performed. Most research has been directed to screening, rather than diagnostic CBE.10 LITERATURE REVIEW Evidence from the randomized Canadian National Breast Screening Study (NBSS), in which women from 50 through 59 years were offered either a standardized CBE alone, or a CBE and mammography annually for 5 years, demonstrates that the 7-year breast cancer-specific mortality rate in both groups were similar.This suggests that mammography may not offer mortality rate advantages over a careful screening CBE, at least for women in their 50s.10,11 The Health Insurance Plan (HIP) study was done during mammography's infancy (in the 1960s) and found that most cancers were detected by CBE. Mortality reduction after 10 years demonstrated a 29% decrease that was similar to a 30% decrease in the Swedish 2-County trial, which used mammography alone.The similarity in the percentage of reduced
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mortality rates found in these 2 approaches, along with the NBSS approach previously described, shows favor for the effectiveness of carefully conducted CBE.10 The sensitivity and specificity of CBE has been estimated based on data from large screening studies, a nationwide community-based program, and a managed care organization. Barton and Harris10 examined data from the Health Insurance Plan of New York Study (1963-1966), the United Kingdom Trial (1979-1988), the Breast Cancer Detection Demonstration Project (19731981), the West London Study (1973-1977), the National Breast Screening Study (NBSS) 1 (1980-1988), and NBSS 2 (1980-1988). NBSS 2 was the only randomized controlled screening trial in which the control group used CBE as the sole screening modality in women 50 to 59 years old. Pooling the data resulted in estimates of 54.1% for sensitivity and 94% for specificity, similar to values in the National Breast and Cervical Cancer Early Detection Program (BCCEDP) study.12,13 The sensitivity of screening CBE in clinical trials is 54%, but 3 studies in community-based programs have reported much lower sensitivity, ranging from 28% to 36%.When only asymptomatic women were considered, sensitivity to screening CBE was 36%. In the Canadian trial, examiners used a standard protocol with an average duration of 5 to 10 minutes, which likely contributed to the achievement of 69% sensitivity.A study in an ambulatory setting found that the average duration of CBE for both breasts was less than 2 minutes.14 In comparing the sensitivity of CBE and mammography in a trial that used both methods, mammography outperformed CBE. However, the sensitivity of the combined method was greater than that of mammography alone, because CBE detected cancers that had been missed by mammography.The proportion of cancers detected by CBE alone ranged from 3.4% in the Edinburgh trial to 45% in the HIP study. Proportions of breast cancers found by CBE but missed by mammography in other studies ranged from 5.2% to 29%.10,15-17 (About 15% of women with a palpable cancer have a mammogram that does not detect abnormal findings.18) Cancer detection rates were increased with CBE by 5% to 8% over those of mammography alone.15 The precision and accuracy of CBE is difficult to research because the examination is not well described in the majority of studies. A standardized CBE would likely improve the precision.11 CBE duration correlated
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Table 1. Organizations With Clinical Guidelines and Practice Policies for CBE
Organization
American Cancer Society American College of Obstetrics & Gynecology American College of Radiology American Medical Association Association of Womens Health, Obstetric & Neonatal Nurses Susan G. Komen Breast Cancer Foundation US Preventive Services Task Force* CBE at least every 3 years ages 2039 CBE CBE yearly CBE every 12 years for women ages 4049

Clinical Guidelines
CBE at least every 3 years in 20s and 30s

Practice Policies
CBE and mammogram yearly at age 40+3 CBE yearly beginning at age 404 CBE yearly beginning at age 405 CBE yearly at beginning at age 506 Screening mammogram with or without CBE every 12 years beginning at age 40+7 CBE yearly beginning at age 40+8 Mammography with or without CBE every 12 years for age 40+9

*US PSTF concluded that the evidence is insufficient to recommend for or against routine CBE alone to screen for breast cancer. No screening trial has examined the benefits of CBE alone without mammography compared to no screening.9 American College of Preventive Medicine, American College of Physicians, and American Association of Family Practitioners do not address CBE in their breast screening statements.5

significantly with lump detection accuracy involving silicone breast models.The highest recorded sensitivity in human studies was 69%, achieved in the NBSS, in which examiners took between 5 and 10 minutes to complete the examination on both breasts.10 The most widely published and studied CBE technique is the MammaCare Method developed by Pennypacker et al.10,12 This is a specific method of palpation that is taught using silicone models to identify a lump as small as 2 mm.The suggested time required to examine both breasts of an average patient ranges from 6 to 8 minutes.10,12 Only one study has compared different search patterns, including vertical strips, radial spokes that converge on the nipple and concentric circles, in relationship to completeness of search.The vertical strips pattern significantly increased search proficiency compared with the radial spokes pattern (67.9% vs 44.7%) or the concentric circles pattern (64.4% vs 38.9%).12 STANDARDIZATION OF CBE CBE is performed extensively across the United States. The National Breast and Cervical Early Detection Program (NBCCEDP) is mandated under law to provide both mammography and CBE screening. Now in its 15th year, the NBCCEDP has provided screening services to uninsured women in all 50 states, the District of Columbia, 6 US territories, and 15 American Indian/Alaska
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Native organizations. In NBCCEDP, reporting is standardized but the method of performing the CBE is not.5 Screening CBE involves the search for cancer; therefore, there may be legal as well as medical reasons for performing it properly. Failure to diagnose breast cancer is a leading reason for malpractice claims, and primary care clinicians account for one half of the indemnity payments made.10 Normal breasts are often lumpy; the clinician's job is to distinguish normal from abnormal lumps. Common distortions of breast architecture include cysts, which are thought to arise from obstructed collecting ducts, and fibroadenomas, which are caused by an overgrowth of periductal stromal connective tissue within the lobules of the breast. Other benign processes such as mammary duct ectasia and intraductal papilloma within the ductal system may cause a mass, or nipple discharge. Most of these benign lesions carry no increased risk of breast cancer; however, one pathological lesion, atypical hyperplasia, does increase risk by 3 to 5 times. Each of these benign processes may cause symptoms or signs that mimic malignancy.10,19 The American Cancer Society, in collaboration with the Centers for Disease Control and Prevention (CDC), developed a committee in October 2002 to provide standards and recommendations for physicians and health organizations to enhance CBE performance and reporting.
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Figure 1. Position of patient and direction of palpation for clinical breast examination.

Used with permission from Barton MB, et al. JAMA 1999; 282:12701280. Copyright 1999,American Medical Association.All rights reserved. They recommended the vertical strip technique, using the pads of the 3 middle fingers with 3 different levels of pressure.5 The recommendations incorporate practices from the MammaCare method because its components have been validated in independent investigations of CBE technique.10 THE CLINICAL BREAST EXAM After taking a history and assessing for risk factors, the patient should be prepared for the CBE. In a study done by Foxall et al,20 women were more satisfied with their breast exams when they were comfortable, and the provider was responsive, relaxed, and gave clear information.The ideal time frame for an exam is from day 5 to 10 after onset of menses.The exam should be performed on all females after the development of breasts.
Inspection

with the hands pushing tightly on the hips to contract the pectoral muscles.This will aid in identification of asymmetry in breast shape or contour, and skin changes such as erythema, retraction, and dimpling, as well as nipple changes.5
Checking for lymphadenopathy

The patient should be sitting for palpation of the supra clavicular and axillary regions to detect adenopathy (a standard part of the exam, but untested).10 Breast cancer was found in only 1 woman (0.07% of 1401cases) with isolated axillary lymphadenopathy and normal CBE results.21 There are 4 sets of axillary nodes: the apex of the axilla, central nodes, pectoral nodes, and subscapular nodes. Referral is indicated for any newly identified nodes or those that are firm, large, tender, or fixed.22
Patient position

The importance of inspection is unproved. It is suggested that in asymptomatic women, clinicians should concentrate on the CBE.10,21 If the patient is symptomatic, or an abnormality is discovered during palpation, careful inspection should be added. Most practitioners will include inspection while they perform CBE.10 The patient should be sitting
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The Cahan position should be used to flatten the lateral part of the breast. Have the patient roll onto her contralateral hip, rotate her shoulders back into a supine position, and place her ipsilateral hand on her forehead. This can be modified to spread breast tissue more evenly over the chest wall (Figure 1).10,22
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Figure 2. Palpation technique.

Used with permission from Barton MB, et al. JAMA 1999; 282:12701280. Copyright 1999,American Medical Association.All rights reserved.
Perimeter

Breast tissue extends laterally toward the axilla and superiorly toward the clavicle. Cover the pentagon area bordered by the clavicle superiorly, the mid sternum medially, the midaxillary line laterally, and the bra line inferiorly.
Pattern of search

Begin in the axilla in a straight line down the mid axillary line to the bra line.The fingers then move medially, and palpation continues up the chest in a straight line to the clavicle.The entire breast is covered in this manner, going up and down between the clavicle and the bra line to examine all breast tissue; rows should be overlapping (Figure 1).5,10,22
Palpation

ferent pressureslight, medium, and deepare made (Figures 2 and 3). Palpation of the nipple is performed in the same manner as the rest of the breast.5,10,22 If the patient has had a mastectomy, the chest wall, skin, and incision should be included.5 Women with breast implants are examined in the same manner. Remember to be especially vigilant in palpating the upper outer quadrants of both breasts (breast cancer occurs more frequently in this area [41%, followed by 34% behind the nipple]).Although some texts call for squeezing of the nipple to express discharge of women with otherwise normal CBE, only women with bloody or clear spontaneous, unilateral discharge need to have a work-up.5,10,22
CBE sensitivity

Palpate with the 3 middle fingers, which are held together, with the metacarpal-phalangeal joint slightly flexed.The pads, not the tips, are the examining surface. Each area is palpated by making small circles as if following the edge of a dime.At each spot, 3 circles using 3 dif346 The Journal for Nurse Practitioners - JNP

Increased in older women (younger women have denser breasts)12,23 Slightly decreased in women with larger breasts.10 Decreased sensitivity in women with increased background nodularity, or ill-defined fibrocystic changes. (It is harder to detect abnormalities).10
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Figure 3. Levels of pressure for palpation of breast tissue, shown in a cross-sectional view of the right breast.

Used with permission from Barton MB, et al. JAMA 1999; 282:12701280. Copyright 1999,American Medical Association.All rights reserved. Decreased in obese women (BMI > 25) by 48% for lowest weight quartile, and 23% for highest.12 Increased in Asian women versus white women.12 Sensitivity is lower in premenopausal women (70%), intermediate in perimenopausal women (87%), and greatest in postmenopausal women (93%).12 INTERPRETATION AND REPORTING As with the performance of CBE, no standardized system or terminology exists for describing nodularity, thickening, mass, etc. Interpretation involves identification of visual and palpable characteristics of the breast and lymph nodes.The results of CBE can be interpreted in 2 ways: Normal/Negative (no abnormalities on visual inspection and palpation) or Abnormal (asymmetrical findings on either visual inspection or palpation that warrant further evaluation and possible
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referral). Reporting should include a description of all findings in specific and precise language. Electronic reporting should be encouraged, to the extent possible.5 EDUCATIONAL NEEDS Studies have shown that medical students and physicians have not received adequate training in CBE, yet many recognize the need for further training.5,24,25 One study showed significant improvement using standardized patients (people trained for role playing, and as models for CBE).26,27 Another study evaluated a formalized course of instruction.28 Three randomized trials used silicone breast models, which were shown to significantly improve sensitivity.5,10 Fletcher et al12 reported that the mean number of lumps detected in silicone breast models varied by physician specialty.
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The Oregon Health & Science University School of Medicine (OHSU) received grants through the CDC to train medical students, residents, and practicing clinicians. In 2003, they opened the only MammaCare training center west of the Mississippi River.29 Dr. Elizabeth Steiner, associate director of the Breast Health Education Program and Assistant Professor of Family Medicine in the OHSU School of Medicine, states: Feedback from live models is important because some providers worry they will hurt women and won't apply enough pressure to detect abnormalities in deeper tissue.30 Dr. Steiner is helping several academic health centers across the nation to replicate the OHSU program. FURTHER RESEARCH NEEDS There are many aspects of CBE that need further research, such as the following: Sensitivity and specificity in clinical practice settings and among women of different ages: pre, peri, and post menopausal. The method of initial detection of abnormalities: CBE, mammography, ultrasound, MRI, or BSE. Discovery made by patient, partner, or provider. Characteristics of masses identified such as: size, shape, consistency, mobility, and external texture. Timing of the exam. Training in CBE and what components are needed, optimal frequency, characteristics of effective trainers, and measurement of training effectiveness. Reporting systems research to include: acceptance of standardization and the feasibility of expanding medical records or registry databases. Evaluation of cost effectiveness.5 (In a study by Shen and Parmigiani,31 screening mammography performed every 2 exams and CBE done at every exam had the lowest marginal cost per year of qualityadjusted life saved.) Improvement of current screening and diagnostic modalities, and development of new technology.The palpation imaging (PI) device, which scans an abnormality, consists of a notebook-computer-sized device attached to a broad-based transducer. It records a scan or video in real-time display and can be used in electronic records as a word document for referral information, and comparison each year for possible changes, as well as legal documentation.32
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CONCLUSION Studies do not provide great evidence to support CBE. However, mammography misses 10% to 20% of breast cancers in asymptomatic women. Further research is needed to provide information for improved detection of breast cancer. In the meantime, practitioners must adopt the currently recommended technique and help standardize CBE. As professionals, we must be accountable to our patients and provide care using the best evidence-based practice available.We must continue to set high standards and be able to evaluate and assess what we are doing, to measure our performance. By standardizing CBE and its reporting, we will be aiding researchers in finding the answers.We will also be improving documentation and decreasing our liability. I have seen some awful CBEs in my years of practice; in fact, some could be misconstrued and misinterpreted by patients as being borderline molestation. I am a preceptor for graduate students who are also not receiving any instruction in their programs on CBE. Although many of my peers (myself included) are older practitioners, we must change. It may not be easy, but it is necessary. As the old saying goes:If something is worth doing, then it is worth doing well.
References 1. American Cancer Society. Cancer facts and figures 2007. Atlanta: American Cancer Society, 2007. 2. Elmore JG, Armstrong K, Lehman C. Screening for breast cancer. JAMA. 2005;293:1245-1256. 3. American Cancer Society. American Cancer Society Guidelines. Available at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id= 3745&nbr=2971. Accessed July 16, 2007. 4. American College of Obstetricians and Gynecologists. Breast cancer screening guidelines. Available at: http://www.guideline.gov/summary/ summary.aspx?ss=15&doc_id=3990&nbr=3129. Accessed July 16, 2007. 5. Saslow D, Hannan J, Osuch J. Clinical breast examination: practical recommendations for optimizing performance and reporting. CA Cancer J Clinic. 2004;54:327-344. 6. American Medical Association. H-55.985 screening and education programs for breast and cervical cancer risk reduction. 1995. Available at: http://www.ama-assn.org/apps/pf_new/pf_online?f_n=browse& doc+policyfiles/HnE/H-55.9. Accessed August 2, 2007. 7. Association of Women's Health, Obstetric and Neonatal Nurses. Breast Health Surveillance. Clinical Position Statement. 2000. Available at: http:www.awhonn.org. Accessed July 26, 2007. 8. Susan G Komen for the Cure. National breast and cervical cancer early detection program. 2007. Available at: http://cms.komen.org/stellent/ websites/printpage.asp/ref=http://cms.komen.org/komen/Pu. Accessed July 18, 2007. 9. US Preventive Task Force. Screening for breast cancer: recommendations and rationale. National Guideline Clearinghouse. 2002. Available at: http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=3419& nbr=2645. Last accessed July 29, 2007. 10. Barton MB, Harris R. Does this patient have breast cancer? JAMA. 1999;282:1270-1280. 11. Journal of the National Cancer Institute. Canadian National Breast Screening Study-2: Thirteen-year results of a randomized trial in women aged 50-59 years. JNCI. 2000;92(18):1490-1499. 12. McDonald S, Saslow D. Performance and reporting of clinical breast examination: a review of the literature. CA Cancer J Clin. 2004;54:345-361.

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13. Harrison-Woolrych M, Purdie D. Breast and pelvic examination in women taking hormone replacement therapy. Br J Obstetr Gynaecol. 2001;108:12011203. 14. Fenton J, Barton, M. Screening clinical breast examination: how often does it miss lethal breast cancer? J Natl Cancer Inst Monogr. 2005;35:67-71. 15. Bencej C, Decker K, Chiarelli A. Contribution of CBE to mammography screening in the early detection of breast cancer. J Med Screen. 2003;10(1):16. 16. Miller AB, To T, Bains CJ. Annual screening with mammography and breast examination did not reduce cancer mortality in women 40 to 49 years of age [Commentary]. Am Coll Physicians. 2003;138(2):38-40. 17. Gotzsche PC. Regular self-examination or clinical examination for early detection of breast cancer [Review]. Cochrane Collaboration. 2007;2:1-15. 18. Haas JS, Kaplan CP. Evaluation and outcomes of women with a breast lump and a normal mammogram result. Department of Medicine, Brigham and Women's Hospital, Harvard Medical School. 2005;692-696. 19. Ozanne EM, Klemp JR. Breast cancer risk assessment and prevention: a framework for shared decision-making consultations. Breast J. 2006;12(2):103-113. 20. Foxall MJ, Barron CR. Women's satisfaction with breast and gynecological cancer screening. Women Health. 2003;38(1):21-36. 21. Goodson WH, Grissom NA. Streamlining clinical breast examination. J Natl Cancer Inst. 2005;97(19):1476-1477. 22. Barr HJ, Dolan MS. Breast cancer module II: health history and clinical breast examination. CDC Breast Cancer Modules 2007. Available at: http://www.medscape.com/viewprogram/6340_pnt. Accessed July 10, 2007. 23. Hobson K. Density danger (early diagnosis of breast cancer). US News World Rep. 2007;142(5):80-81. 24. Wallace A, MacKenzie T. Women's primary care providers and breast cancer screening: who's following the guidelines? Am J Obstetr Gynecol. 2006;194(3):744-748. 25. Iannotti RJ, Finney LJ. Effect of clinical breast examination training on practitioner's perceived competence. Cancer Detect Prev. 2002;26(2):146148. 26. Coleman EA, Stewart CB. An evaluation of standardized patients in improving clinical breast examinations for military women. Cancer Nurs Int J Cancer Care. 2004;27(6):474-482. 27. Costanaz ME, Luckmann R, Quirk ME. The effectiveness of using standardized patients to improve community physician skills in mammography counseling and clinical breast exam. Preventive Medicine. 1999;29:241-248. 28. Madan AK, Colbert PM, Beech B. Effect of a short structured session on medical student breast cancer screening knowledge. Breast J. 2003;9(4):295297. 29. OHSU Cancer Institute. OHSU clinical breast exam program first in nation to teach medical students, residents and practicing clinicians most optimal breast exam technique. February 27, 2003. Available at: http://www.ohsu.edu/ new/2003/022703exam.html. Accessed July 10, 2007. 30. OHSU Cancer Institute. OHSU unique in broadbased teaching of new breast exam recommendations. November 10, 2004. Available at: http://www. eurekalert.org/pub_releases/2004-11/ohs-oui 1 10904.php. Accessed July 12, 2007. 31. Shen Y, Parmigiani G. A model-based comparison of breast cancer screening strategies: mammograms and clinical breast examinations. Cancer Epidemiol Biomarkers Prev. 2005;14(2):529-532. 32. Kaufaman CS, Jacobson L. Digital documentation of the physical examination: moving the clinical breast exam to the electronic medical record. Am J Surg. 2006;192(4):444-449.

Nancy Bishop Day, MSN,WHNP-BC, is employed at East Tennessee Regional Department of Health (Knoxville,TN) Claiborne, and Grainger Country Health Departments. She can be reached at nancy_day_03@yahoo.com. In conjunction with national eithical standards, the author reports no relationships with business or industry that represent a conflict of interest.
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