Author Interviews, FDA, JAMA, Medical Imaging / 04.12.2018

MedicalResearch.com Interview with: Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993 Aldo Badano, Ph.D. Deputy Director, Division of Imaging, Diagnostics, and Software Reliability Office of Science and Engineering Laboratories Center for Devices and Radiological Health Silver Spring, MD 20993  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Expensive and lengthy clinical trials can delay regulatory evaluation of innovative technologies, affecting patient access to high-quality medical products. Although computational modeling is increasingly being used in product development, it is rarely at the center of regulatory applications. Within this context, the VICTRE project attempted to replicate a previously conducted imaging clinical trial using only computational models. The VICTRE trial involved no human subjects and no clinicians. All trial steps were conducted in silico. The fundamental question the article addresses is whether in silico imaging trials are at a mature development stage to play a significant role in the regulatory evaluation of new medical imaging systems. The VICTRE trial consisted of in silico imaging of 2986 virtual patients comparing digital mammography (DM) and digital breast tomosynthesis (DBT) systems. The improved lesion detection performance favoring DBT for all breast sizes and lesion types was consistent with results from a comparative trial using human patients and radiologists. 
Author Interviews, Breast Cancer, Mammograms / 03.12.2018

MedicalResearch.com Interview with: Stamatia Destounis MD, FACR, FSBI, FAIUM Elizabeth Wende Breast Care Clinical Professor University of Rochester Imaging Sciences Rochester, NY 14620  MedicalResearch.com: What is the background for this study? What are the main findings? Response:  The current breast cancer screening recommendations in the United States are unclear regarding when to stop screening. Several societies with published recommendations conflict in regard to when to discontinue screeningmammography. There is little evidence studying the benefit of annual mammography in the population of women 75 and older. Due to this, we felt that it was a very important and timely topic to investigate, with the goal of providing further guidance on why screening mammography may be beneficial in this older population.
Author Interviews, Breast Cancer, JAMA, Mammograms / 27.04.2016

MedicalResearch.com Interview with: [caption id="attachment_23815" align="alignleft" width="250"]Elizabeth A. Rafferty, MD Department of Radiology, Massachusetts General Hospital, Boston Now with L&M Radiology, West Acton, Massachusetts Dr. Elizabeth Rafferty[/caption] Elizabeth A. Rafferty, MD Department of Radiology, Massachusetts General Hospital, Boston Now with L&M Radiology, West Acton, Massachusetts MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Rafferty: Breast tomosynthesis has been approved for mammographic screening in the United States for just over 5 years, and many single center studies have demonstrated its improved performance for screening outcomes over digital mammography alone. Our previously published multi-center analysis, (JAMA 2014;311(24), the largest study on this topic to date, demonstrated significantly improved cancer detection and reduced recall rates for women undergoing tomosynthesis compared with digital mammography alone.  In the current issue of JAMA we evaluate the differential screening performance after implementation of breast tomosynthesis as a function of breast density. While tomosynthesis continues to be increasingly available, questions remained about which women should be imaged with this technique. In particular, does this technology offer additional benefit for all women, or only for women with dense breasts. The size of the database compiled by the centers participating in this study allowed us to evaluate this important question. The most critical finding of our study was that the use of tomosynthesis for breast cancer screening significantly improved invasive cancer detection rates while simultaneously significantly reducing recall rates both for women with dense and non-dense breast tissue. Having said that, the magnitude of the benefit was largest for women with heterogeneously dense breast tissue; for this population, tomosynthesis increased the detection of invasive cancers by 50% while simultaneously reducing the recall rate by 14%.
Author Interviews, Breast Cancer, Education, NYU/NYMC, Radiology / 06.11.2015

[caption id="attachment_19146" align="alignleft" width="200"]Jiyon Lee, M.D. Assistant Professor of Radiology, NYU School of Medicine NYU Cancer Institute, Breast Imaging Center New York, New York 10016 Dr. Lee[/caption] MedicalResearch.com Interview with: Jiyon Lee, M.D. Assistant Professor of Radiology, NYU School of Medicine NYU Cancer Institute, Breast Imaging Center New York, New York 10016 Medical Research: What is the background for this study? What are the main findings? Dr. Lee:   Even before the USPSTF changed their breast screening guidelines in 2009, I conducted community outreach to help educate others on my area of expertise, breast imaging and breast screening. I presented lay friendly, illustrated, and practical explanations in a structured talk, about the big picture and the salient details, in a way that I would want if I were not a breast radiologist. As is customary for such community outreach, we solicited feedback from attendees. It was gratifying to hear the positive responses. That they wished for such education for others served as a clarion call that is understandable. Education should be objective and noncoercive.  “Knowledge is power,” but only if complete and accurate. Breast cancer is still a common disease, we are all at least at average risk, and screening is still standard of care.  Much of the debate surrounding screening mammography centers on the age of onset of screening and the optimal screening interval. The USPSTF states that shared-decision making between women and their providers may occur, especially for women in 40-49 year group.  But the TF does not stipulate when or how or by whom this talk will ensue, and notice that their guidelines refer to film mammography, and “biennial” mammography. Since the time of this manuscript, the American Cancer Society issued new guidelines on 10/20/2015 that among its bullet points emphasized annual mammography for women 45-54 years and deemphasized clinical breast exam, while supporting option to start annually at age 40 with shared decision making to weigh what are referred to as “risks” and benefits. Although the fine print does reaffirm that annually starting at age 40 is the screening model that saves the most lives, the ACS is encouraging deliberate value judgment regarding “risks” and “harms.” Their fine print is also intimating that women 55 and over have nondense tissue and that their cancers are indolent. The ensued publicity and mixed messaging have caused another cycle of confusion regarding breast cancer screening. As the experts in this field of image-based screening, radiologists have opportunity to clarify and contextualize the issues and details of the screening discussion, and can do so with objectivity, respect for all sides of the debate, and compassion. All responsible ways to continually educate both women and all providers will enable both sides to engage in the discussion fairly. Because as we discourage paternalistic medicine and promote shared decision making, it’s not fair play if all responsible sides do not get fair say. Do realize that not all women see providers regularly, and depending on the medical subspeciality, not all providers are mentioning screening til women reach a certain age and may not relay importance of the physical exam components that complement imaging. This article specifically highlights how such direct and interactive public education can effect potential benefit in two ways.
  • First, directly reduce one of the core criticisms about screening: the “anxiety” that women may experience, which is heavily weighed as a “harm” of screening.  Most women do not experience high anxiety, and are glad to have a test that may help them. And education can help demystify much of the process and protocol, and explain up to what may be that patient’s next test results if she engages in screening at all. No one can tell that.
  • Two, education can directly increase one of the necessary components of shared decision making that is presumed in implementing breast screening: informing women. The pre- and post-lecture questionnaire, along with fact-based quiz questions, provided insight and enabled learning opportunity for the audience that are not usual for community outreach.  Education that keeps on going—and is shareable!-- after the lecture is done.
Author Interviews, Breast Cancer, General Medicine / 31.05.2015

MedicalResearch.com Interview with: Bruno M. Heleno MD The Research Unit for General Practice and Section of General Practice Department of Public Health University of Copenhagen Medical Research: What is the background for this study? What are the main findings? Dr. Heleno: False positive mammography causes psychological distress. Several observational studies have shown this, and their results have been summarized in systematic reviews. However, it was unclear whether women requiring invasive tests (needle or surgical biopsy) were more distressed than women only requiring non-invasive procedures (clinical examination or imaging). Contrary to previous research, we found that these two groups of women were equally distressed during the 36 months of follow-up in our cohort. The best estimate for the difference for 12 related measures of distress was always close to zero.
Author Interviews, Breast Cancer, Geriatrics / 07.01.2015

MedicalResearch.com Interview with: Pamela Vacek, PhD Research Assistant Professor Department of Pathology Medical Biostatistics Unit, College of Medicine University of Vermont,  Burlingon, Vermont Medical Research: What is the background for this study? What are the main findings? Dr. Vacek: Clinical trials to evaluate the effectiveness of screening mammography have focused primarily on women under age 70 and, consequently, its benefit for older women is uncertain. However, many believe that the benefit of screening mammography diminishes as women age and acquire other health problems, because they are less likely to live long enough for any detected breast cancer to have a clinical impact. To gain insight into this, we followed approximately 20,000 women aged 70 and older for an average of 10 years to examine their mammography use, cancer detection and survival. We found that screening mammography use declined steadily (9% per year) after age 70, but this was not accompanied by decline in the incidence of invasive breast cancer. Hence, as the women aged breast cancer was more likely to be detected clinically than by screening. The clinically detected tumors were significantly larger and of more advance stage and were associated with poorer overall survival, for all but the oldest and most infirm women. We also found that the use of breast conserving surgery as the only treatment for early stage cancer increased markedly with age and was associated with shorter survival compared to women receiving radiation or mastectomy.
Author Interviews, Breast Cancer, General Medicine / 29.05.2014

Alai Tan, MD, PhD Assistant Professor Institute for Translational Science Dept. of Preventive Medicine & Community Health University of Texas Medical BranchMedicalResearch.com Interview with: Alai Tan, MD, PhD Assistant Professor Institute for Translational Science Dept. of Preventive Medicine & Community Health University of Texas Medical Branch MedicalResearch: What are the main findings of the study? Dr. Tan: We found that substantial proportions of women with limited life expectancy receive screening mammography. The screening rates were higher among women who saw more than one generalist physician and who had more visits to generalist physicians. The screening rates were higher among U.S. hospital referral regions with more primary care physicians, mammography facilities and radiologists.
Author Interviews, Radiology / 03.08.2013

Ana P Lourenco MD Assistant Professor of Diagnostic Imaging Alpert Medical School of Brown UniversityMedicalResearch.com Interview with: Ana P Lourenco MD Assistant Professor of Diagnostic Imaging Alpert Medical School of Brown University MedicalResearch.com What are the main findings of the study? Dr. Lourenco: Our study found a significantly higher recall rate for screening mammography at a tertiary referral hospital compared with a community private practice.  We compared recall rates for 5 fellowship trained radiologists reading at both sites, and all five radiologists had higher recall rates at the hospital site.  When we analyzed patient factors in an effort to explain why this might be, we found that the average age of patients in the hospital was younger (which is known to be associated with higher recall rate) and that more patients at the hospital had a personal history of prior breast biopsy or surgery (also known to be associated with higher recall rate).