Clinical Breast Examination: Is it still the Best Way?

OBJECTIVES: Practical Recommendations for Optimizing Performance and Reporting

Clinical breast examination (CBE) seeks to detect breast abnormalities or evaluate patient reports of symptoms to find palpable breast cancers at an earlier stage of progression. Treatment options for earlier-stage cancers are generally more numerous, include less toxic alternatives, and are usually more effective than treatments for later-stage cancers. For average-risk women aged 40 and younger, earlier detection of palpable tumors identified by CBE can lead to earlier therapy. After age 40, when mammography is recommended, CBE is regarded as an adjunct to mammography. Recent debate, however, has questioned the contributions of CBE to the detection of breast cancer in asymptomatic women. Clinicians remain widely divided about the level of evidence supporting CBE and their confidence in the examination. Yet, CBE is practiced extensively and continues to be recommended by many leading health organizations. This article hopefully can provide a brief review of evidence for CBE’s role in the earlier detection of breast cancer, highlight current practice issues, and suggest some recommendations that might show evidence of the nature and extent of CBE’s contribution to the earlier detection of breast cancer.

Has Clinical Breast Examination Made Any Contributions to the Earlier Detection of Breast Cancer? :

No clinical trial has compared CBE alone with a no-screening condition, and strong evidence demonstrating that mammography alone reduces breast cancer mortality makes it highly unlikely that a trial of CBE alone will ever be conducted. As discussed in the some of the current literature CBE detects some cancers not found by mammography, although its contribution to the early detection of breast cancers among asymptomatic women is very small. In addition, CBE may be important for women who do not receive regular mammograms, either because mammography is not recommended (women aged 40 and younger) or because some women do not receive screening mammography consistent with recommended guidelines. There is evidence that above and beyond early cancer detection, CBE may present an opportunity for health care providers to educate women about breast cancer, its symptoms, risk factors, and advances in its early detection, as well as normal breast composition and variability. It also lets clinicians discuss the benefits and limits of breast self-examination (BSE) and demonstrate BSE for women who elect to do it.

Who Recommends CBE and who does not? :

Organizations that provide clinical guidelines and practice policies for the early detection of breast cancer vary in their recommendations for CBE. Variation is by age at initiation, breast cancer risk status, frequency of CBE performance, and the strength of language used to recommend CBE. Some organizations continue to recommend CBE, while others make no recommendation regarding CBE for breast cancer screening among asymptomatic women. For example, the revised 2003 guidelines of the American Cancer Society recommend CBE as part of a periodic health examination, preferably at least every 3 years for women in their 20s and 30s and annually among asymptomatic women aged 40 years or older. The Susan G. Komen Breast Cancer Foundation also recommends CBE at least every 3 years among women aged 20 to 39 and annually beginning at age 40. Annual CBE beginning at age 40 also is recommended by the American College of Obstetricians and Gynecologists and the American College of Radiology. The American Medical Association recommends CBE every 1 to 2 years for women aged 40 to 49 years and annually beginning at 50 years of age. Several international groups also recommend CBE. The Canadian Task Force on Preventive Health Care recommends CBE every 1 to 2 years among women aged 50 to 69. The Scottish Intercollegiate Guidelines Network and the Royal New Zealand College of General Practitioners recommend CBE among specific age and breast cancer risk groups. Some of these organizations also emphasize the role of CBE in patient education and assisting women to become familiar with their own breasts. Other US and international organizations make no specific recommendation either for or against CBE. The US Preventive Services Task Force, for example, following a review of published literature on breast cancer screening, concluded that the evidence is insufficient to recommend for or against routine CBE alone to screen for breast cancer. The American College of Preventive Medicine, The American College of Physicians, and American Association of Family Practitioners do not address CBE in their breast cancer screening statements.

Are There Barriers to High-quality Performance of CBE? :

Although CBE generally continues to be recommended by many groups as a component of comprehensive breast cancer screening and is performed by large numbers of clinicians, the way in which it is performed varies considerably. In the NBCCEDP, reporting is standardized, but the method of performing CBE is not. The technique has also not been standardized in most screening trials. While the sensitivity and specificity of CBE were generally comparable across the NBCCEDP and screening trials, these levels of performance are lower than what could be achieved with standardization of technique and training to that standard. Studies that used well-described, standardized methods for performing CBE provide some evidence of higher levels of sensitivity in clinical examination. Training studies using objective, structured clinical examination have observed improvements in performance of CBE techniques and in patient interaction skills. Studies using silicone breast models show that both training in CBE technique and experience in detecting breast lumps can increase sensitivity for detecting lumps in the models, although specificity in many studies declines at higher levels of sensitivity. Studies of medical students and residents reveal low performance scores on objective examinations of CBE components, as well as low sensitivity and specificity using silicone breast models. Medical students’ perceptions of their own need for additional training and the small number of CBE they have actually performed illustrate the limits of current medical school training in the performance of CBE. Similarly, physicians report lack of confidence in their CBE skills and indicate high levels of interest in improving them.

Developing Recommendations for CBE Performance and Reporting

CBE presents an interesting challenge for clinical practice and public health. It is widely practiced, yet concern remains about its effectiveness in reducing breast cancer mortality. CBE is practiced with little standardization despite reasonable evidence that performance can be improved by training and experience. Furthermore, the lack of standardized performance and reporting has limited the availability of data to address questions about CBE’s role in breast cancer detection. Providing standards that are based on existing literature and expert opinion should lay the foundation for enhancing test sensitivity and specificity to the extent possible and provide a valuable tool to assist providers in improving test performance and communicating about test findings within and across specialties. Furthermore, enhancing the standardization of CBE performance, combined with more uniform interpretation and reporting will provide a basis for gathering much-needed data about the nature of CBE’s contribution to earlier detection of breast cancer. Such data are essential to resolving inconsistent practice guidelines across organizations and the resulting confusion for women and their health care providers.

Based on the research literature and expert guidance, a committee was formed of national and international experts well versed in CBE and its performance and reporting. This committee was charged with developing recommendations for physicians and health organizations that would enhance CBE performance and reporting. Members of the committee conferred in working groups and as a full committee through a series of conference calls and a face-to-face meeting held in Atlanta on October 10 and 11, 2002. The committee also worked in concert with a related American Cancer Society advisory group, the Breast Physical Examination Working Group (one of five working groups within the Breast Cancer Early Detection Guideline Review). Early drafts of the committee’s report were disseminated to a broad range of professional and public health organizations for review and comment. After comments were compiled and assessed, modifications were made to the report and recommendations regarding the implementation and improvement of clinical breast examination were made. The recommendation issued from this report follow:

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Recommendations on the Implementation and Interpretation of CBE

The examination

Adopt standards for CBE that include a stepwise progression of elements consisting of clinical history, visual inspection, and palpation.

Encourage widespread dissemination of standards for CBE.

Interpretation and reporting

Reporting should consist of a summary of relevant portions of a patient’s history and a description of whether the CBE is interpreted as normal/negative or abnormal. If abnormal, include a description of the visual and palpable finding, including changes in the appearance of skin or nipples, the presence of nipple discharge, the presence of breast masses or palpable asymmetries, and the presence of palpable lymph nodes.

Develop a consistent, standardized lexicon and format for documenting the interpretation and reporting of specific CBE findings.

Follow up

Adopt a standardized approach to follow up that provides continuous care to the patient until an appropriate resolution of findings is reached. This approach should make use of all appropriate follow-up options, ensure appropriate timing of subsequent actions, involve communication and coordination with other providers, and include proper documentation and tracking.

Overcoming barriers to the implementation of CBE

Examiner training

Develop and promote training systems to improve and maintain the proficiency of those who perform CBE, and encourage the integration of such systems into basic and continuing education programs for health care professionals.

Public education

Promote and encourage public education about CBE so that women know what to expect in the performance of CBE and follow-up care, understand the benefits, limitations, and potential harms associated with CBE, and become familiar with their own breast characteristics as well as health practices that might increase the likelihood of identifying breast abnormalities.

Research and quality improvement

Support and encourage research in key aspects of CBE, particularly questions related to characteristics of abnormalities found by CBE, the timing of the examination, training of examiners (clinicians), reporting systems, and CBE’s contributions to early detection of breast cancer, and the reduction of morbidity and mortality from this disease.

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CONCLUSIONS:

CBE can contribute to the ability of health care professionals and women to detect some breast cancers and should lead to appropriate follow-up care. These recommendations are only a first step in an incremental process of change and that many organizations and groups should be involved in. These recommendations provide a strong foundation for informing clinical practice, professional training, public education, and research efforts. Best practice is slow in being defined and many years may pass before a seemingly standard procedure becomes defined as “Best Practice”. CBE is widely practiced to good affect. We must be diligent is cooperating with the local and international organizations working to make CBE not only a valuable tool for clinician and patient but a standardized practice used in a universal manner.