Marijke Vroomen Durning, RN

Editors make every effort to ensure this information is updated and accurate. This information is not intended as legal advice.

Breast density notification laws have been put into effect in 30 states. Breast density notification laws vary but are intended to inform women who have undergone mammography about the risks posed by breast density.

The intent of such a law was to give women the necessary information to decide on further action if they had dense breast tissue. Dense breast tissue makes it harder to identify cancer on a mammogram and may also be associated with an increased risk of breast cancer, according to the American College of Radiology (ACR). Women with dense breasts are encouraged to discuss with their physicians their possible increased risk of breast cancer and the difficulty that mammography may have in detecting tumors. Critics of such a law or of how such a law is implemented believe that women may receive the information in less than ideal circumstances, which can lead to increased anxiety, as well as additional medical procedures.

“The manner in which the information is shared is important,” Richard Frank, MD, PhD, chief medical officer for Siemens Healthcare North America and founding member of the Quantitative Imaging Biomarkers Alliance of the Radiological Society of North America, told 

. “There might be value in not just sending a letter through the mail, but giving it to her. She then has an opportunity to actually talk about it.” In most cases, the letters are mailed, so the content of the letter is paramount. The letter’s text varies considerably across the states. Frank believes that women would be better served with a single informed letter issued from the federal level.

An example of ineffective language used in some states is one that raises more questions than it answers, according to Frank. Such letters say, “

 you have dense breasts, and then what the options are. So the woman is going to look at that letter and say, ‘why did I receive this letter?’” It doesn’t tell her if she does or doesn’t have dense breasts, nor does it inform her of her particular situation, Frank explained. A letter that says “if” you have dense breasts, is a good example of one that might only raise concerns and not be helpful, he said.

For a more effective letter, Frank liked the one by physicians in Michigan: “It says, ‘your mammogram shows that your breast tissue is dense.' There is the opening line, a clear statement,” he stated.

“You’re receiving this letter because your breast tissue is dense. Dense breast tissue is very common and is not abnormal. However, dense breast tissue can make it harder to find cancer through a mammogram” is a common explanation in some state’s notification letters. Frank pointed out that these lines explain why it might be a good idea for this woman to undergo other imaging techniques. “And then the letter goes on to say something else: also dense breast tissue may increase your risk for breast cancer.”

The letter continues: “‘This information about the results of your mammogram is given to you to raise your awareness. Use this information to talk to your physician.’ So now they are giving specific instructions for what you should do with this,” Frank said. “There is no question in the mind of the woman. ‘What is my status, what is there relevance and what should I do about it?’”

 for physicians who would like to learn more about the breast density laws. In addition, they have some 

The first state to pass breast density notification legislation was Connecticut in 2009. Many states have followed since then. Check out our interactive map to see which states have passed breast density notification legislation (and their recommended text), what states are in process and what states haven’t approached the controversial topic yet.

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UPDATED. Many states have laws on breast density notification after mammography screening – but not all notification is the same.

Breast Density Notification Laws by State - Interactive Map

 concluded that combining mammography with automated breast ultrasound (ABUS) improved readers’ detection of breast cancer in women with dense breast tissue, compared with mammography alone.

According to the authors, this study also found that use of ABUS allowed for standardization and reduced operator dependence required with the use of hand-held ultrasound. In addition, imaging with ABUS was quicker (1.5 minutes) compared with the handheld examination (20 minutes). The time difference could make it easier to integrate ABUS into the screening environment, they wrote.

 interviewed corresponding author Maryellen L. Giger, PhD, A.N. Pritzker Professor of Radiology, the Committee on Medical Physics, and the College at the University of Chicago, to learn more about the study and its significance.

What drew your interest to ABUS in this particular technique?

I have a 30-year history of working in breast cancer imaging, having investigated various multimodalities, including mammography, ultrasound, and MRI. My long-term history is in developing computer-AED diagnosis and automatic computer vision methods to extract information from breast images to help in the detection, diagnosis, and assessment of therapeutic response of breast cancer.

In addition, as an imaging physicist, I have an insight into new modalities, and a history of conducting reader studies, which are statistically rigorous methods of comparing or assessing the role of new technology in terms of their benefit to radiologists.

How would the ABUS system fit in with the goal of personalized medicine?

Think of this scenario: A woman comes in for her screening mammogram. She has the mammogram and it’s noted that she has dense breasts, and nothing was found on the mammogram; that is, it’s a mammography negative read. In that case, she would go to another imaging modality, such as ABUS for improving detection of lesions in the dense breast.  This is how the reader study was structured: Mammography alone versus mammography plus ABUS.[[{"type":"media","view_mode":"media_crop","fid":"49669","attributes":{"alt":"Maryellen L. Giger, PhD","class":"media-image media-image-right","id":"media_crop_6178111963688","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"6019","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 255px; width: 170px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Maryellen L. Giger, PhD","typeof":"foaf:Image"}}]]

Currently women with dense breast tissue may go on to have a hand-held ultrasound screening following mammography. Do you see ABUS as a replacement for this?

To me, and this is my opinion and I’m not a radiologist, if a woman comes in and has a mammogram and there’s no cancer seen, no lesion seen, instead of going to hand-held ultrasound, she would go for ABUS, because ABUS is going to cover the entire volume of the breast. You don’t have to worry about missing a region of the breast as you might with the hand-held device.

It can be difficult to get some women screened for breast cancer in the first place because of the back and forth controversy about its utility and the risk of false positives. Some studies say women should be screened often, other studies say not as often. How can we educate women about knowing that this system may be available to them, that this is something they may want to discuss with their physician?

There are laws now in some states that when a woman goes for screening, she has to be told if she has dense breasts. There are various websites and public initiatives that let people know about the importance of mammography, plus the importance of subsequent screening of dense breasts. So I think women are becoming more aware of the issue.

The physicians could explain how the dense portions in a dense breast interact similarly with the X-rays used to produce a mammogram, and thus the dense portion could potentially hide a cancer.  The cancer is camouflaged by the dense parts of the breast.  Also, since a mammogram is a 2D image from a 3D volume (that is, the breast), density parts elsewhere in the breast could also “hide” the cancer.

So by going through regular PR routes, and us talking about it-sometimes we’re asked to give talks to women’s clubs, for example-that’s another route. Women are very interested in this kind of introduction to new screening protocols.

What would you like radiologists to take away from the study?

Some people may argue that this study was a reader study and not real life. The reason we did a reader study is that if we did this in real life, we would have thousands and thousands of women having to participate in a clinical study for multiple years – potentially tens of thousands of women because the probability for cancer in the general public is low. But in a reader study, we can evaluate the new imaging system efficiently, and include multiple radiologists as readers. In a clinical study, you might have one reader per image, and here we had 17 readers per case. 

We worked very hard on developing a reader study that would mimic the clinical scenario. And keep in mind that in our reader study, we had both mammographically-negative and mammographically-positive cases.

In the study, it mentions the need for extensive training to use ABUS effectively. In a separate email interview, co-author Marc Inciardi, MD, explained the training provided:

The readers, who are radiologists, came for a full day of training at the reader study site, after receiving online training. They then had two days to read all the cases in the reader study. By the end of the reader study, it appeared that each radiologist was quite comfortable with reading the 3D ABUS images.

Reader training is a combination of orientation to the unique workstation displaying 3D data sets including “knobology,” direction on evaluation of the 3D datasets in a step-wise logical progression, and finally an approach to breast cancer screening using ABUS, with the goal of improving sensitivity without negatively affecting specificity (call-back rate). Recorded acquisition of the 3D volume ABUS datasets helps the radiologist appreciate the unique nature of the large format transducer and contrast the size difference between hand held transducer and the ABUS transducer. Understanding redundant information provided in overlapping 3D datasets improves sensitivity and specificity. Quality issues that may compromise sensitivity and specificity are addressed with discussion of potential pitfalls of positioning and compression help the reader gain a better foundation in interpretation of ABUS images.

 Module 1: A one-hour peer-to-peer webinar with an initial orientation to ABUS.

Module 2: A three-hour web-based session of self-paced tutorials of ABUS cases.

 Modules 3 and 4: The “nuts and bolts” of ABUS interpretation, consisting of live peer-to-peer interactive instruction with hands-on ABUS interpretation and assessment of image quality.

Modules 3 and 4 may be delivered in-person by a qualified Peer-Educator, or remotely through a virtual classroom that utilizes bilateral remote desktop sharing between the Peer-Educator and ABUS-Learner with live video/voice conferencing. After training is complete, each ABUS-Learner completes a final Self-Assessment of 10 cases at his/her own pace to gauge individual performance. The cases consist of cancer cases, benign findings, and normal cases. Individual results are provided to the ABUS-Learner and benchmarked against the performance of his or her peers.

Improved detection of breast cancer with automated breast ultrasound, according to study.

Q&A: Automated Breast US Screening for Dense Tissue

In January, the American College of Radiology and the American College of Cardiology jointly issued imaging 

 for patients presenting to the ER with complaints of chest pain. The document, which was published in the 

Journal of the American College of Radiology

Journal of the American College of Cardiology

, reviews and rates 20 clinical scenarios related to chest pain that could require emergency imaging.

Patients with complaints of chest pain are the second largest group of ER patients, representing 5.4% of the nearly 130 million ER visits in 2010, according to authors of the guidelines. While diagnosis is often based on the patient’s clinical presentation and history, if the cause is not obvious, imaging may help identify or exclude potentially life-threatening conditions.

interviewed co-author Frank Rybicki, MD, PhD, professor and chair of radiology at the University of Ottawa, chief of medical imaging at the Ottawa Hospital in Canada, and chairperson for the ACR Metrics Committee, as well as vascular imaging specialty chair for the ACR Appropriateness Criteria, about the new guidelines.

Before this guideline document, there were some recommendations for the different clinical scenarios, but they were not comprehensive and they were not put together in one place. Imaging is very important in the emergency room and it’s costly. There was a large unmet need to gather guidelines for this purpose and then to put them into a simple format so that they could be used by emergency room physicians.

There are four entry points into the clinical scenarios, and from those four entry points, there are 20 clinical scenarios that cover a large number of patients who present to the emergency room with chest pain and require imaging. This document provides guidelines for appropriate imaging for these patients. All major imaging modalities that are applicable for emergency room patients were included.

These 20 clinical scenarios are easy to interpret. They cover a large fraction of the patients who will come to the emergency room with chest pain, and the document should help guide the clinician’s clinical judgment on the initial appropriate imaging study to order for these patients.

Who was involved in drawing up the guidelines?[[{"type":"media","view_mode":"media_crop","fid":"45424","attributes":{"alt":"Frank Rybicki, MD, PhD","class":"media-image media-image-right","id":"media_crop_9465094201788","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5205","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 252px; width: 180px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Frank Rybicki, MD, PhD","typeof":"foaf:Image"}}]]

The writing panel included stakeholders from cardiology, emergency medicine, and radiology. There was a separate group of reviewers who critically reviewed the document, and then there was a third independent group of raters. That rating panel also included the key stakeholders, and readers of the document can identify the individual raters who represented each society.

There are campaigns, such as the Choosing Wisely Campaign, which are designed to educate people-including the general public-about the appropriateness of certain tests and treatments. Would patients benefit from knowing these types of guidelines as well?

The guidelines are developed for emergency room physicians and the tables are designed to be readily accessible and easily read from the palm of the physician’s hand. The authors recognize that patients have increasing, and important, awareness of their medical conditions. We also recognize that patients may be able to ascertain which of the four entry points that they fall in. It may be harder for a patient to correctly place themselves into one of the20 clinical scenarios or indications. However, it is important for patients to understand that there are specific indications and that guidelines for each indication now exist to help guide appropriate imaging.

What has the response to the guidelines been?

Overall, a large majority of the readership of these guidelines have strongly welcomed them. The process for developing the document has been extensively used and validated, and the separation of the writing, review, and rating panels ensured that the rating was as impartial as possible. Because the members of the rating panel covered so many sub-specialties, there were several scenarios for which some modalities received a rating of M*. This refers to “May be appropriate,” with the caveat that this was reached because mathematical consensus among the rating panel was not reached.

This is not a surprising result – different specialists have different views, and it is sometimes the case that the peer-reviewed literature offers support, but not definitive support, for a specific imaging modality for a specific clinical scenario. What this does, in fact, is identify areas where the stakeholders should focus on either more data, or further analyses and reflection on the data that do exist. It is also important to emphasize that these guidelines drew from all available peer-review literature, and both the writing panel and the independent review panel brought these data to the raters, who had a face-to-face meeting to clarify and vet any discrepancies. However, definitive peer-review data for each clinical scenario is often lacking. In this situation, the rating panel used their expert opinion to guide the document. These individuals were chosen by the societies represented in the rating panel because they are experts in the field. This is not a weakness – in fact it is a strength. Just as patients want their doctor to use expert opinion based on the best data to make clinical decisions, the rating panel used their expertise applied to the clinical data to determine the recommendations as they appear in the document.

I’ve dedicated a large portion of my professional career to working on appropriateness criteria because I recognize that it is of critical importance, and that medicine needs to integrate these guidelines into clinical decision support. I will continue to do appropriateness criteria because it’s a key part of the Imaging 3.0 initiative at the ACR, and it’s a critical aspect of doing the best imaging possible for our patients.

In terms of this particular topic, I’ve expressed to our colleagues in all areas of medicine that I am happy to work with all groups to generate updates, perhaps develop more granular clinical scenarios, and to work on additional “living” documents as more information becomes available.

Why it’s important for radiologists to focus on appropriateness of ER cardiac imaging.

Q&A: New ER Cardiac Imaging Guidelines

The U.S. Preventive Services Task Force (USPSTF) has issued its final 

 for breast cancer screening, which include confirmation that screening mammography every two years among women aged 40 to 74 is effective in reducing deaths due to breast cancer, with the greatest benefit seen among women aged 50 to 74.

While the findings are similar to those from 2009, the new guidelines include new considerations regarding additional screening for women with dense breast tissue with normal screening mammograms, as well as the use of digital breast tomosynthesis (3D mammography) in screening.

 interviewed Task Force Chairperson Kirsten Bibbins-Domingo, PhD, MD, MAS, about the newest guidelines and their implications for patients and physicians.

As part of the normal process, the Task Force routinely updates recommendations so that they are as current as possible, aiming to update topics approximately every five years. Since the Task Force last made a breast cancer screening recommendation in 2009, it was time for the Task Force to review the evidence and issue a new recommendation.

How do they differ from the most recent guidelines?[[{"type":"media","view_mode":"media_crop","fid":"44800","attributes":{"alt":"Kirsten Bibbins-Domingo, PhD, MD, MAS","class":"media-image media-image-right","id":"media_crop_5500506061719","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5046","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 209px; width: 170px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Kirsten Bibbins-Domingo, PhD, MD, MAS","typeof":"foaf:Image"}}]]

For the first time, the Task Force looked at the effectiveness of digital breast tomosynthesis as a way to screen for breast cancer. While 3D mammography is an emerging technology, there is very little evidence available that examines the ultimate effectiveness of this newer screening method and therefore, the Task Force was unable to make a recommendation for or against its use. This is also the first time that the Task Force looked at the effectiveness of additional screening for women who have known dense breasts but an otherwise negative mammogram. The evidence on how additional screening with an ultrasound, MRI, or 3D mammography may or may not help women with dense breasts is unclear. Therefore, the Task Force cannot make a recommendation for or against additional screening. These are all important areas for future research.

Are the guidelines the same for all density of breast tissue?

The Task Force commissioned a separate evidence review that examined the effectiveness of additional breast cancer screening in women who have or are found to have dense breasts. Unfortunately, the evidence on how additional screening with an ultrasound, MRI, or 3D mammography may or may not help women with dense breasts is unclear, and the Task Force issued an “I statement. “The Task Force hopes that, in the future, there will be more evidence available so that they can make a more definitive recommendation on this important issue that we know impacts many women.

Whenever new proposals, such as screening for breast cancer every two years, are released, some women whose cancers were detected by annual screening are concerned because they believe that their annual screening saved their life. What would you say to them?

We understand that upon learning of a cancer diagnosis, there is a strong desire to treat or remove the cancer, regardless of potential harms of treatment. However, sometimes this course of action can cause more harm than good, because the cancer would never have posed a threat to a woman’s health. Currently, it is not possible to know for any individual woman whether or not her cancer will progress. As a result, almost all women diagnosed with breast cancer are treated. The discovery of an overdiagnosed cancer, therefore, can result in overtreatment, including invasive procedures, chemotherapy, and radiation, that can have significant harms. It’s important for all women to have all the available evidence so they can have a conversation with their doctors about the potential benefits and harms of screening and make the decision that is best for them.

Is there a concern that these guidelines may add to the confusion that already exists regarding the optimal frequency of breast cancer screening?

The Task Force’s findings affirm a convergence among groups who have recently issued evidence-based guidelines. The Task Force, the American Cancer Society, and many others have affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age. Support of a personal, informed choice for women in their early 40s is shared by the Task Force, the American Cancer Society, the American College of Physicians, the American Academy of Family Physicians, and the Canadian Task Force on Preventive Health Care. The Task Force and others fully support the shift toward shared decision making that is emerging, and we are glad to see that it is part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests. The Task Force is hopeful that our recommendations on breast cancer screening will be perceived as an important part of a growing consensus among experts in evidence-based medicine.

The Task Force addresses the insurance issue regarding screening. Is there a concern that women may be refused screening based on these new guidelines?

The Task Force does not make recommendations for or against insurance coverage and its final recommendations do not impact insurance coverage for breast cancer screening. Through a unique provision of federal law, legislators guaranteed that women in their 40s, as well as older women, who have private insurance will not have a co-pay for their screening mammogram. Coverage of mammography for Medicare beneficiaries was established by another statute and is not bound by Task Force recommendations. As clinicians, we hope that our nation will continue to strive to help all individuals get access to those preventive services that can enable people to live healthier, longer lives.

What is the take-away message from the guidelines?

We believe all women deserve to understand what the science says about both the potential benefits and harms of breast cancer screening-so they are empowered to make the best choice for themselves, together with their doctor. We hope our work can help advance progress in that direction for the benefit of all women. The science shows that screening is most beneficial for women ages 50 to 74. For women in their 40s, our findings support a range of individual choices-from beginning regular mammograms sometime during this decade, to waiting until age 50 to begin screening.â

Diagnostic Imaging talks with the USPSTF about its newly released final recommendations for breast cancer screening.

Marijke Vroomen Durning, RN

Articles

Breast Density Notification Laws by State - Interactive Map

Q&A: Automated Breast US Screening for Dense Tissue

Q&A: New ER Cardiac Imaging Guidelines

Q&A: USPSTF Final Breast Cancer Screening Recommendations