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.

Articles

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.

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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.

Q&A: USPSTF Final Breast Cancer Screening Recommendations

As the availability of diagnostic tests and treatment options grows, the medical community is left with a double-edged sword. Patient complaints are more thoroughly investigated, providing earlier diagnosis, but physicians are finding more false positives and incidental findings that may not have caused problems if left undetected, and financial resources are stretched.

To combat this, the Choosing Wisely campaign challenges medical specialties to list steps that members could take to use health care resources more effectively. The program has grown to include more than 70 medical societies.

 looked at all neurology-related Choosing Wisely items. After categorizing the items according to neurological specialty, disease and symptoms, and tests and treatments, the researchers, led by Brian Callaghan, MD, a neurologist at the University of Michigan in Ann Arbor, found that of 370 items provided by 65 medical societies, 20% (74 items) were relevant to neurologists. Several were duplicates, which the researchers recommended be prioritized. Callaghan shared his thoughts with 

We started looking at testing based on Choosing Wisely, and MRI was by far the thing that we spend the most money on. In fact, we spend more money on MRI than on procedures like electromyography (EMG) and electroencephalography (EEG). In this country, we spend more on neurology-ordered imaging than we do on neurology visits to the doctor.

Then, when you start looking at common conditions, the most common neurologic condition is probably headache. If we're trying to be more efficient, we should see where we're spending our money and what we’re spending it on. Headache neuroimaging was a natural fit. 

And what you did find?[[{"type":"media","view_mode":"media_crop","fid":"44636","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_951045364246","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"5011","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: 160px; width: 160px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Brian Callaghan, MD","typeof":"foaf:Image"}}]]

We found that we spend about a billion dollars on headache neuroimaging. And this isn't influenced by different red flags that might prompt neuroimaging. Even when we focused on the patient population least likely to need neuroimaging, such as patients with migraines, they still had an incredibly high chance of undergoing imaging.

What do you say to the patients who go to the neurologist and insist on having imaging done? And physicians who are confronted with these requests? 

I think it really is a two-way street. Patients want the imaging and physicians want it, but for different reasons. Patients are worried about having a brain tumor. From a doctor's standpoint, they're scared of missing the very rare causes of headache, partly because that's how we're trained to not miss anything and partly because of some medical legal aspects. Both parties have their reasons. That's why almost 50% of patients with migraines will end up with neuroimaging after a handful of years. 

What I think people don't understand is that with [MRIs for migraines], you're much more likely to find a false positive than a true positive. Those false positives can lead to more tests and potentially even interventions that can harm. We're involved in a project right now that's going to try to show just how much harm is possible for patients getting MRIs.

It is a consensus that patients with common migraines shouldn't get neuroimaging, but I think there are two problems. One is the guidelines are not clear. It is also really hard to change behavior. Even if we all agree when to get neuroimaging, changing what's currently going on is something that is hard to do.

What was the goal behind the study and what message would you like people to take away from this? 

I think one of the goals would be to educate patients that they should engage in a conversation with their physician about the need for these tests. We should be questioning why we're getting certain tests, and definitely in the context of headache and MRI.

Specific to headache and MRI, it's true that the yield of finding something on MRI is very low in someone with migraines, on the order of 1%. If you take healthy research volunteers, there's a very comparable yield. It's not clear that the yield in patients with migraines is any higher than people just off the street.

The Choosing Wisely guidelines are mostly the guidelines that people can all agree upon, developed by specialty societies, so they're by the very people that have the most invested in doing the tests. These are the things that most physicians agree on.

Choosing Wisely forces neurology to confront its issue with overutilization in imaging. 

Q&A: Neuroimaging: More False Positives than True Positives?

As various forms of radiology imaging became more accessible within the community, its use soared. According to data obtained from Medicare, imaging spending per beneficiary was $350.54 in 2004. This cost peaked at $405.41 by 2006, a 7.8% annual increase from baseline, and then began decreasing significantly to $298.63 in 2012, a 4.4% annual decrease from peak.

, Andrew B. Rosenkrantz, MD, Danny R. Hughes, PhD, and Richard Duszak, MD, sought to determine state-level trends in Medicare spending on medical imaging. They found that while nearly all states saw spending decrease since the peak, two states bucked the trend and spent more. Maryland had a 12.5% average annual increase since 2005 and Oregon had a 4.8% average annual increase since 2008.

 spoke with Andrew Rosenkrantz, MD, a radiologist at NYU Langone Medical Center in New York City, about the study and its implications.

Why was it important for you to do this study? 

It has been well documented that national Medicare spending for medical imaging has decreased since about 2006. However, this trend has not been explored on a state-by-state basis. Geographic variation in utilization and spending is an important policy concern, and insights into such variation can help better understand the potential impact of relevant policy on access and outcomes.

Did you have any preconceived ideas of what you might find and if so, were there any surprises?

It was surprising that only two states had actual spending increases during the time that all remaining states had spending decreases. In particular, Maryland and Oregon, both have federal waivers in place that support unique health plans in those states, perhaps shielding them from the impact of broader national trends. In addition, the abrupt nature in the decline in spending was notable in the sense that it began within the same two-year window in nearly every state.

What message would you like our readers to gain from this study? 

The decrease in Medicare spending on medical imaging began abruptly in nearly every state in either 2005 or 2006, and was sustained during the following years. Nonetheless, there was substantial state-to-state variation in imaging spending, with such variation changing over time. Future relevant policy should consider the impact on access and outcomes that may result from such variation and substantial reductions in imaging spending.

Are there future topics for research that you suggest on this topic, and if so, what should they look at? 

Future studies would be helpful to try and identify the exact causes of the observed imaging trends. In addition, studies could explore the variation at even smaller geographic units, such as cities and ZIP codes. Also, it would be useful to evaluate the impact of the observed changes in imaging spending, such as potential restricted access for patients in need of such exams.

A recent study in AJR noted that spending on imaging has actually decreased in most of the U.S.

Q&A: Investigating State Level Trends in Imaging Costs

As scrutiny increases on the effectiveness of breast cancer screening guidelines, pressure also mounts on radiologist performance in both screening and diagnostic mammography.

Researchers have found that minimum interpretive volume requirements, as well as minimal requirements for diagnostic interpretation for radiologists, could reduce the number of false-positive work-ups for breast cancer. But while experience does play a major role in image interpretation, other variables outside of the radiologist's control may also have an effect.

Breast density, prior history of mammography, and the presence of symptoms such as a lump are associated with higher interpretive performance by radiologists, according to a study published in the 

. The study looked at patient and radiologist characteristics for two types of diagnostic mammograms that took place between 1998 and 2008: added evaluation of a recent screening mammogram and evaluation of a breast-related problem. Approximately 20% of the radiologists were affiliated with an academic institution.

Seven regions in the U.S. were represented in this study. Two-hundred-forty-four radiologists who interpreted 274,401 diagnostic mammograms performed for additional evaluation responded to the survey. A total of 104,115 examinations were performed for additional evaluation of a recent mammogram, 4663 with cancer. Another 170,286 examinations were performed for evaluation of a breast problem, 7007 with cancer.

The researchers evaluated patient and radiologist characteristics associated with false-positive rate and sensitivity for each diagnostic mammogram type:

“Multiple patient characteristics were associated with measures of interpretive performance, and radiologist academic affiliation was associated with higher sensitivity for both indications for diagnostic mammograms,” the authors wrote.

The researchers found that several patient characteristics were associated with the false-positive rate, such as older age and breasts that were not heterogeneously dense. Radiologist characteristics included:

 10–19 years of mammography interpretation

 Greater percentage of time spent in breast imaging

 Greater screening and diagnostic interpretive volume

The results also showed that if indication for the diagnostic mammogram was a breast lump, compared with nipple discharge or pain, the interpretations were more likely to be false-positives and have higher sensitivity.

Radiologist characteristics associated with higher false-positive rates included:

 Having never been named in a malpractice suit

“These results indicate the potential for improved radiologist training, using evaluation of their own performance relative to best practices, and for improved clinical outcomes with health care system changes to maximize access to diagnostic mammography interpretation in academic settings,” the researchers concluded.

 spoke with Sara Jackson, MD, MPH, who led this study. Jackson is a clinical assistant professor in the Department of Medicine, and director of the Adult Medicine Clinic at Harborview Medical Center, in Seattle, Washington.[[{"type":"media","view_mode":"media_crop","fid":"40768","attributes":{"alt":"","class":"media-image media-image-right","id":"media_crop_1364592183399","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"4226","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: 201px; width: 200px; float: right;","title":"Sara Jackson, MD, MPH","typeof":"foaf:Image"}}]]

Variability in performance for diagnostic mammography had previously been identified, and we were looking to see if we could elucidate opportunities to improve performance based upon patient or radiologist characteristics.

It was surprising that many patient characteristics are associated with sensitivity and false positive rate, but this wasn’t the case for radiologist characteristics. We expected factors such as radiologists' experience and volume of interpretation to be associated with better interpretive performance. But, while radiologists with academic affiliations were more likely to have greater interpretive sensitivity, little else was identified. This may indicate that the variability is primarily due to inherent patient or breast tissue characteristics.

With the changes in technology, do you think that the differences between the academic-based radiologists and those who aren't in academia will change?

This is speculative and not based upon our study, but I suspect that any technologic changes that alter performance would affect academics and non-academics similarly. Teleradiology, however, could potentially improve access to diagnostic interpretation by academic radiologists, as capacity allows.

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

Although academic radiologists have higher cancer detection rates, overall, the interpretive accuracy of diagnostic mammograms is high for all.

Also, the patient characteristics, including factors inherent to breast tissue, are associated with most of the variability in diagnostic mammography interpretation, and these are difficult to modify.

What's next for you? What would you like to look at?

It would be interesting to study continuing education opportunities for radiologists who interpret diagnostic mammograms that are designed by academic radiologists, and incorporate the radiologists’ own performance data relative to benchmarks for academic practice. Additionally, study of health system opportunities that maximize access to academic interpretation of diagnostic mammography would be of interest.

A look at what radiologist and patient factors play a role in false-positive mammography.

Q&A: Radiologist, Patient Factors and Mammography Accuracy

Mobile technology is expanding in health care and radiologists tend to be early adopters. The advancing technology allows them to remotely access patient images and reports when needed. To that end, radiologists must keep up with the latest news that will affect the devices they use and how they use them.

Last month, David Hirschorn, MD, director of radiology informatics at Staten Island University Hospital in New York, participated in a panel discussion at ACR 2015 called Reshaping Radiology Through Mobile: Apps, Technologies, and FDA Regulations. The conference was held in Washington, DC.

 spoke with Dr. Hirschorn about the future in mobile apps and devices for radiologists.

Why are you interested in mobile apps and its future in radiology? 

I’ve studied radiology displays for probably over 10 years, trying to understand what radiologists really need in order to read a CT scan, MRI or X-ray. When mobile apps entered the arena, questions arose about the image quality available on mobile devices. People wondered if you can read an X-ray or CT scan, or anything off of a mobile device.

Mobile displays are different than what you have on a desktop display. For example, what is the effect of the ambient light? Even if the device is functioning perfectly normally, if you’re at the beach or on the ski slope, where it’s just too bright around you, you need to be able to see that screen.

How popular do you see these mobile apps? How accepting are the radiologists of them?

These apps are very popular. Radiologists definitely want remote access to their images. They’d love to be able to sign-off on their reports remotely. They definitely need access to radiology information on their phone. There’s barely a radiologist left who doesn’t own a smartphone and would love to use this stuff.

But it’s not so simple. Getting these apps isn’t like buying a game, when you buy it, you have it. These apps generally only work in conjunction with a server within a computer system that was purchased by the radiologist’s institution. The apps don’t do anything by themselves. They’re not going to do much for you unless your hospital has a server for them to connect to and can give you your patients’ images.

But it’s different when it comes to references, and radiologists use a lot of references. They can have their educational material, guidelines and things like that. If they want to test their own skills or whether you want them to learn something, there are plenty of apps for that. When it even comes to scheduling and other things, they can get the apps for that.

How does the FDA fit into the development of mobile apps for radiology?

In 2011, the FDA put out a draft guidance to mobile medical applications, which was finalized in 2013. This included the definition of terms as to what is a mobile medical application, what is in scope, and what is out of scope. For example, smartphone and tablet manufacturers are not medical device manufacturers. So they’re not going to be held accountable if you, or I, or anyone, take them and use them for a medical purpose.

The companies that write the software are the ones that are going to be held responsible for making sure that the hardware and software function properly, and whatever quality control they need to do to make sure that this is an appropriate function.

The federal government recognizes that the old rules wouldn’t apply to the new arena of mobile devices. They’re getting other government agencies involved and they’re reaching out to the industry and professional community. They’re getting stakeholders involved, everyone from patient advocate groups to professional societies, like the American College of Radiology, and the companies that manufacture medical applications, to insurance companies. They want input from everyone into what they’re calling the Health IT Safety Center.

So, with the input from all stakeholders, instead of just the government doing whatever they think best, they know that they don’t know. They are making a pretty applaudable effort to reach out to all stakeholders involved, not just the traditional ones. They’re trying to make sure that they’re doing what’s best for the American patient.

For example, the FDA said that high-risk designation is for something that’s being used to diagnose a patient or to decide how much radiation therapy to give a patient; in other words, something that’s going to directly affect the diagnosis or treatment of a patient. High risk is what the FDA will continue to regulate.

But other government departments can regulate medium and lower risk issues. Medium risks can be a little more amorphous, something like a computer program that tells a doctor best practice guidelines. Reference books, on the other hand, are low risk. You read them to gather your own information.

The bulk of the responsibility, for the medium risk issues, is going to go over to 

There is still a lot to come in both the development and regulation of mobile devices and applications, but Dr. Hirschorn believes that the FDA is taking the right approach as it comes up with better ideas on how to regulate medical software overall, not just mobile apps.

WASHINGTON, DC-Where mobile apps fit into the future of radiology was discussed at ACR 2015.

Q&A: Radiologists at the Forefront of Mobile App Use

The debate about the optimal screening guidelines for women at average risk of developing breast cancer continues, with some physicians supporting annual screening, starting at age 40, as advocated by the American Cancer Society and other organizations. While other physicians follow the U.S. Preventive Services Task Force 

, which call for screening every two years, starting at age 50.

Arguments against annual screening focus on the risks related to concerns about overdiagnosis and management of certain types of breast cancer, which not only result in unnecessary treatments for patients, but also in extra financial costs overall.

, researchers found that the overdiagnosis of breast cancer was variable, ranging from about 22% to 31% in the U.S. This led to a national cost of $4 billion each year, which the researchers said was much higher than previously documented.

 interviewed study coauthor Kenneth D. Mandl, MD, MPH, to learn more about the study and its findings. Mandl is a professor at Harvard Medical School and the Boston Children's Hospital Chair in Biomedical Informatics and Population Health.[[{"type":"media","view_mode":"media_crop","fid":"34886","attributes":{"alt":"Kenneth D. Mandl, MD, MPH","class":"media-image media-image-right","id":"media_crop_6502839203769","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"3714","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: 185px; width: 200px; border-width: 0px; border-style: solid; margin: 1px; float: right;","title":"Kenneth D. Mandl, MD, MPH","typeof":"foaf:Image"}}]]

What do you see as an ideal breast cancer screening process that wouldn’t be as expensive as what we have now?

Part of the solution may be to lower the frequency of screening, to biennial instead of annual, for example. The U.S. Preventive Services Task Force recommended abandoning screening in women age 40 to 49, but the 

 recommended abandoning mammography altogether.

The evidence to date may not support universal breast cancer screening of asymptomatic women. An intermediate approach is to adopt a personalized risk-based approach, rather than a population-based strategy. In other words, we should only screen women with high risk of breast cancer, for whom the benefit of screening outweighs the risk. These would include women who have a family history of breast cancer.

Is family history of breast cancer the only criteria for a personalized risk-based approach? What else would constitute high risk?

No, other risk factors should be taken into account. Risk factors that have been found to be associated with breast cancer include age, genetic risk factors (eg, BRCA1 and BRCA2), exposure to radiation therapy to the breast/chest, long-term use of hormone replacement therapy, and denser breasts.

What is your opinion of the Swiss Medical Board recommendation of abandoning mammography altogether? If we are only screening high-risk women, what modality do you propose be used?

The Swiss Medical Board recommends that population-based screening of asymptomatic women should be replaced by a more individualized approach. This is supported by existing evidence, and will substantially reduce the harms of false-positive mammograms and breast cancer overdiagnoses.

We should still use mammography but in a selected group.

This study looked at women aged from 40 to 59. Do you believe that there would be similar findings for women over 60 years?

False-positive mammograms and overdiagnosis rates are likely to be lower for women who are older than 60 years. Nonetheless, the risks remain and should be carefully considered.

How do you see the medical community containing the costs that are associated with breast screening and the outcomes?

Currently, it’s the fear of litigation and the lack of understanding of the harm screening could cause, as well as the biology of cancers, which are driving the overuse of screening technology.

In a recent effort to rein in breast cancer overdiagnosis and overtreatment, a working group from the National Cancer Institute suggested renaming ductal carcinoma in situ (DCIS) to exclude the word carcinoma. This, we hope, will help doctors and patients better understand the nature of DCIS, and to avoid what may be unneeded and potentially harmful treatments.

What is the status of the suggestion to remove carcinoma from DCIS?

If lack of understanding of the harm is part of why breast cancer screening is so costly, what kind of harms exist that clinicians may not be aware of?

Many clinicians are unaware of the high rates of false-positive mammograms and breast cancer overdiagnoses, and that many lesions detected through mammography screening will not actually become clinically evident in the patient’s lifetime. Unfortunately, the widely used 5-year survival rate of cancer is misleading many clinicians into believing that mammography screening of asymptomatic women actually saves lives, as most clinicians are not aware of the concept of lead-time and length biases.

What would you say to someone who would counter that the costs associated with breast screening would be worth it because of the lives screening does save?

In our study, we only looked at refutable downsides of mammography-false positives and overdiagnoses. Other studies are increasingly concluding that the benefits may be very questionable. It is worth noting that with the initiation of population-based breast cancer screening in the U.S., breast cancer mortality rate has not substantially decreased.

Is it possible to quantify the lives saved from breast cancer screening versus the amount of money spent on these programs and on overdiagnosis?

You might look at the landmark study published in the 

.The number of lives that were potentially saved through early breast cancer screening is very small, and is confounded by improved cancer treatment. The study showed that mammography has increased the detection of indolent lesions, and not the detection of late stage cancers.

Coauthor of study discusses  the costs of overdiagnosis and overtreatment of breast cancer.

Q&A: Why is Breast Cancer Screening So Costly?

Low-dose chest CT, a useful and effective screening tool for patients at high risk for developing lung cancer, has recently been approved for coverage by 

. Until recently, only private payers have been covering the procedure, excluding a significant number of people who could benefit from such screening. Now, because of the increased demand from patients who will be eligible through Medicare coverage, more health systems will be introducing lung cancer screening programs.

 spoke with Ella Kazerooni, MD, MS, associate chair for clinical affairs and division director of cardiothoracic radiology at the University of Michigan Health System, about the implementation of their lung screening program.

How did the University of Michigan Health System program starte and what was involved in getting it off the ground?


Like a lot of places, we had a small fledgling program, but we’ve been planning for this latest development for the past 18 months, hoping for a good outcome [from CMS]. I chair the ACR Lung Cancer Screening Committee and there were many efforts involved in putting together CT Accreditation Programs, developing Lung-RADS, and building the registry, all things that I’ve been working on ahead of the effort.

As the process moved along, I’ve been making sure that our practice is ready for coverage. We did things like build a better order in our electronic medical record, so we could meet all of the documentation details that are required for coverage reimbursement. These are things like smoking cessation requirements, good decision making, making sure that people are the right number of pack-years, and more.

We have a group that includes our IT folks, both from EPIC and from radiology. We need all the data elements that are going to be required for the registry. We need to extract the data from electronic medical systems and to be able to export them to the ACR’s Lung Cancer Screening Registry with as little human interaction as necessary.

Did you find anything that needed more work than you thought it might?

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One thing a lot of people might not have been doing yet in their practices is looking at smoking histories. We started looking at the smoking histories in our EMR a little over a year ago. It turns out that while meaningful use requirements include documenting smoking as “yes” or “no,” we don’t do so well on documenting pack-years. As a health system, we met the “yes” or “no” documentation across all of our clinics, but if you’re going to have that data to support appropriateness of screening, you need pack-years in your EMR.

We started running reports of when people entered “yes” for smoking and if pack-years were documented. We found documentation of pack-years was in the low 40%. So, we had to do some educational efforts. We worked with our entire ambulatory care system here at the university to educate the clinic leaders, both physicians and management leaders, as well as the medical assistants about why pack-year documentation was important, how to do it, and where to do it in the EMR. Now, we track quarterly the pack-year documentation in order to get that information back to the clinics to see how well they’re doing.

When do you see this program being fully available?


I think right now we’re on the precipice from that switch. All the things line up. The recommendation from USPSTF in December 2013 has meant that third party payers are required to cover the screening with no copay under the Affordable Car Act terms. The CMS decision brings us the next large wave of people, because they were not covered under the Affordable Care Act-USPSTF required coverage. So, that CMS has now come forward is huge.

Health systems must prepare to increase their low-dose CT lung cancer screening capabilities to accommodate a new, larger pool of Medicare patients.