The study reviewed here found that using both a clinical exam -- a manual exam of the breasts by a medical professional -- and a mammogram is better at detecting breast cancer than a mammogram alone. Still, clinical exams produced more false positives. A false positive is an abnormality that looks like a cancer, but turns out to be normal.
Done in Canada, the study involved more than 290,000 women and compared the effectiveness of breast cancer screening that included clinical exams AND regular mammograms to screening with only regular mammograms. The clinical exams were done by well-trained nurses who were experienced in proper breast exam technique.
Still, the more effective screening had more false positives:
This means that for every additional breast cancer detected by using a clinical exam in screening, 55 women had a false positive.
Monthly breast self-exam (BSE) and regular clinical breast exam were considered important parts of an overall breast cancer screening plan for all women for many years. A suspicious area found by BSE or a clinical exam allowed many breast cancers to be diagnosed and successfully treated. BSE, along with regular exams by a doctor and an annual mammogram starting at age 40, can help make sure that breast cancer is diagnosed early, when it's most treatable.
Still, screening tests aren't perfect. BSE, clinical exams, and mammograms can each result in false positives. Besides the fear of a breast cancer diagnosis, a false positive usually means more tests (including biopsies) and follow-up doctor visits. The process can be very stressful and upsetting.
Some doctors started questioning the usefulness of BSE and clinical exams in screening plans after some research showed that regular BSE and clinical exams didn't reduce the number of women who die from breast cancer.
From a public health perspective, this research suggests that regular BSE (and money spent to promote regular BSE) doesn't really change the overall effect breast cancer has on a population of women. So regularly recommending it (and spending money to promote it) may not make sense. These concerns caused the American Cancer Society (ACS) to change its BSE guidelines several years ago. The ACS now views BSE as an optional -- not a recommended -- screening technique. Regular clinical examination of the breast is still recommended by the ACS.
Healthcare decisions, including BSE and clinical examinations, are individual choices based on the information available and each person's unique situation. A woman can choose to make doing monthly BSE and having regular breast clinical exams part of her personal breast health monitoring and screening plan. In many cases, official recommendations and guidelines can affect whether or not insurance companies cover a screening technique or procedure. But at least for BSE this isn't true, as BSE costs only your time and commitment.Talk to your doctor about the pros and cons of regular BSE and clinical exams and whether these should be part of your personal breast cancer screening plan. Together you can make choices that makes the most sense for you. No matter what you and your doctor decide about BSE and breast clinical exams, it's very important to remember that if you're over 40 regular screening mammograms must be done.
Medical centers providing both mammography and clinical exams were more likely to detect breast cancer than centers offering mammography alone, but also far more likely to produce false positives, a Canadian study found.
In nine regional centers, all of which offer both types of screening, the sensitivity of an initial screen was 94.9% (95% CI 90.1 to 97.4), while in 59 affiliated centers offering both types, the sensitivity was 94.6% (95% CI 91.7 to 96.5).
By way of contrast, in 34 centers providing mammography alone, the sensitivity was 88.6% (95% CI 83.4 to 92.3), according to Anna M. Chiarelli, PhD, of Cancer Care Ontario in Toronto, and colleagues.
However, in the regional centers the false positive rate was 12.5% (95% CI 12 to 12.9) and in affiliated centers with both modalities it was 12.4% (95% CI 12.1 to 12.7).
That compared with a false positive rate of only 7.4% (95% CI 7.1 to 7.7) in the centers offering only mammography, the researchers reported in the Sept. 16 issue of the Journal of the National Cancer Institute.
For each additional cancer detected by clinical breast examination, there were an additional 55 false positive screens. So women should be advised of the risks and benefits of having a clinical exam in addition to mammography, the investigators said.
Controversy has persisted regarding the value of clinical breast examination, with randomized trials finding similar mortality reductions whether or not a mammogram is accompanied by a clinical exam.
Moreover, the examiner's experience and technique can affect the accuracy of clinical examination, and inappropriate referrals can increase cost, risk, and anxiety for patients.
Nonetheless, breast cancer experts contacted by MedPage Today and ABC News continue to disagree on the utility of clinical breast examination.
The Canadian researchers analyzed data from the Ontario Breast Screening Program to evaluate the accuracy of referrals for further assessment from the regional centers that began screening in 1990 and affiliated centers that began screening in 1995.
The screenings for the study were conducted between January 2002 and December 2003.
Clinical breast examinations were performed by 167 highly trained nurses, and standard craniocaudal and mediolateral oblique view mammograms were made using high-quality machines.
Among the 290,230 women who were screened, 232,515 had both clinical examinations and mammography, while 57,715 had mammography alone.
At centers offering both types of screening, the cancer detection rate for mammography alone was 5.9 per 1,000 and the false positive rate was 6.5%, while the detection rate with both types of screening was 6.3 per 1,000 and the false positive rate was 8.7.
"Therefore, with [clinical breast examination] an additional 0.4 cancers are detected per 1,000 women screened with an increase of 2.2 percentage points in the false positive rate," they wrote.
This meant that for 10,000 women screened, an additional four cancers would be detected, and among the 9,937 women without cancers there would be an additional 219 false positive screens.
An editorial accompanying the study stated that these numbers represent "a steep price for the potential gains" of adding clinical examination to mammography.
For women to make informed decisions about their healthcare, they must understand the risks as well as the benefits of screening tests, wrote editorialists Mary B. Barton, MD, of the Agency for Healthcare Research and Quality in Rockville, Md., and Joann G. Elmore, MD, of the University of Washington School of Medicine in Seattle.
The way this information is presented can influence patients' decisions, they noted.
Positive framing, for example, emphasizes beneficial outcomes (four more cancers would be detected) while negative framing emphasizes the risks (for every cancer detected by examination there will be 55 false positives).
"Low-tech primary care interventions that can decrease the burden of cancer in women are extremely appealing. At the same time, ineffective practices, or those with even marginal net benefit, would be a disservice to our patients," they wrote.
The study had limitations, according to the investigators. One was workup bias, with women being referred for a positive clinical examination being less likely to receive intensive follow-up than those referred because of an abnormal mammogram.
The findings also may have limited generalizability, because the nurses in the Ontario project were highly skilled and trained.
As the editorialists pointed out, clinical breast examination "must be done well if it is to be done at all."
When contacted by MedPage Today and ABC News, Daniel B. Kopans, MD, director of the Breast Imaging Division at Massachusetts General Hospital in Boston, argued that only mammography has been proven to save lives, and that randomized trials are needed to determine if breast examination does too.
"The only breast cancer screening test that has been shown to significantly decrease the death rate from breast cancer in randomized, controlled trials ... is mammography," Kopans said.
"Those of us who developed the field of breast imaging recognized the importance of standardizing the technique, monitoring outcomes, and adjusting our approaches as we learned more and more about breast evaluation. I strongly urge this approach be applied to [clinical breast examination]."
Freya Schnabel, MD, director of breast surgery at New York University, was more supportive of clinical exams.
"I cannot imagine that anyone could advocate abandoning clinical breast exams, even in a screened population," she said. "It's clear that the pickup rate is low when patients are well screened, but superficial and central lesions are frequently missed on mammography, and young women with dense breasts represent a specific population where there is a substantial false negative rate for mammography, making clinical exam particularly important."
She added, "As to the false positives on exam, many are resolved with simple, quick, relatively painless needle biopsies (MedPage Today) -- not such a big price to pay."
The study was funded by the Canadian Breast Cancer Foundation-Ontario Region, and editorialist Elmore received funding from the National Cancer Institute. The investigators did not report any conflicts of interest.
This article was developed in collaboration with ABC News.
Primary source: Journal of the National Cancer Institute Source reference: Chiarelli A, et al "The contribution of clinical breast examination to the accuracy of breast screening" J Natl Cancer Inst 2009; 101: 1236-43.Additional source: Journal of the National Cancer InstituteSource reference: Barton M, Elmore J "Pointing the way to informed medical decision making: test characteristics of clinical breast examination" J Natl Cancer Inst 2009; 101: 1223-25.
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