Saving Women's Lives Strategies for Improving Breast Cancer Detection and Diagnosis: A Breast Cancer Research Foundation and Institute of Medicine Symposium (2005) / Chapter Skim
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Simultaneous Group Discussions with Invited Speakers
Simultaneous Group Discussions with Invited Speakers
Pages 68-117
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From page 68... ...
Focusing only on improving the steps, not on how women get from one step to another, will not result in improved breast cancer screening.
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From page 69... ...
FIGURE 3.1 The screening process. The whole process leads to at least two outcomes that can be examined - the long-term outcome of mortality and some short-term outcomes, like reductions in late stage disease.
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From page 70... ...
-- 52 percent of late stage breast cancers. · Absence of detection -- 40 percent of late-stage breast cancers.
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From page 71... ...
estimate 0/E 55-69 .79 n/a Cohort 1990 Italy analysis Mortality ratio 50-69 .75 (.54-1.04) NOTE: Effect = breast cancer with organized screening/control population; Confidence Interval = 95 percent confidence interval.
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From page 72... ...
We looked at a method of improving clinical image quality and reported that interval cancers were more likely to occur in mammograms of poor quality (Taplin et al., 2002) , and we are currently studying computer assisted detection.
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From page 73... ...
So organized care 16 or 14 Women 12 (Regional 10 10,000 Cancer per 8 6 Breast Stage) of 4 50+, health-plan p=0.10 Rate Distant 50+, community p=0.003 2 40-49, health-plan p=0.54 40-49, community p=0.02 0 1983-1984 1985-19861987-1988 1989-1990 1991-19921993-1994 1995-1996 1997-1998 Year FIGURE 3.2 Group health rates of women found with late stage disease are lower as a result of early detection.
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From page 74... ...
Those are important questions for us and for our society. REBECCA SMITH-BINDMAN, M.D., Associate Professor, Radiology, Epidemiology, and Biostatistics, Obstetrics, Gynecology, and Reproductive Medicine, University of California, San Francisco: There has been an enormous amount published over the last few decades about who is getting screening mammography.
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From page 75... ...
among different racial and ethnic groups, but differences persist in breast cancer mortality and tumor stage at diagnosis. Clearly, if mammography were working, we would expect breast cancer mortality rates to decline coincident with improvements in screening mammography rates.
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From page 76... ...
They display the adjusted odds of advanced stage cancer by race and ethnicity using white women (set at one) as the reference.
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From page 77... ...
We asked whether women who were similarly screened would have similar types of cancer, or are minority women who are similarly screened still at increased risk for advanced cancers. The latter would suggest a biological explanation, the former discrepancies in mammography use.
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From page 78... ...
Similar results were found for advanced stage, lymph node involvement, and symptoms. Tumor grade did not change much from the most recent to the most distant mammography groups, and Afri can Americans persistently had higher grade tumors as noted earlier by Dr.
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From page 79... ...
This is a single organized screening program which differs in many ways from the United States, but basically provides mammograms very similar to those in the United States, by radiologists whose training is very similar, and with very similar technology. In the United States, I included data from two sources, 978,591 women from the Breast Cancer Surveillance Consortium and 613,388 women from the CDC's National Breast and Cervical Cancer Early Detection Program.
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From page 80... ...
Balanced with the recall rate is the resulting cancer detection rate, how many cancers are you finding by calling back women. You might be willing to accept a very high recall rate if you are finding a lot of cancers, including invasive cancer and ductal carcinoma in situ (DCIS)
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From page 81... ...
The rates of cancer detection are very similar in the two countries. In 50- to 54-year-old women, approximately 6 cancers per 1,000 were detected by screening mammography.
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From page 82... ...
On the other hand, a recall rate of two percent is not acceptable unless you find a certain number of cancers. So they have targets, and because they have set them and because they have a coordinated effort to reach very specific recall and cancer detection rates, they are better able to reach their targets.
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From page 83... ...
, found that there was wide variation in image quality and radiation dose among mammography facilities. In 1987, the American College of Radiology (ACR)
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From page 84... ...
All interpreting physicians, radiologic technologists, and medical physicists that provide mammography services must meet specific initial and continuing training, education, and experience requirements. Specifically, the interpreting physician must have a valid state license, be either board certified in diagnostic radiology or have at least three months of formal training in mammography, have 60 category one continuing medical education (CME)
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From page 85... ...
These cover the equipment's basic requirements, including evaluation of the automatic exposure control, dose (which generates a lot of patient interest and concern, although problems are few) , phantom image quality, and radiation output, among others.
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From page 86... ...
Historically, doses were fairly high, but they have declined significantly with only a slight increase recently because breast imagers have determined that more exposed (darker) films improve image quality.
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From page 87... ...
8 9 Phantom Dose 6 8 Mean 4 7 2 6 0 5 1970 1975 1980 1985 1990 1995 2000 2005 Year FIGURE 3.5 Image quality has improved and radiation dose decreased. JAMES BORGSTEDE, M.D., FACR, Chairman, Board of Chancellors, American College of Radiology, Clinical Professor of Radiology, University of Colorado Health Science Center: I am a practicing radiologist in Colorado Springs who personally interprets more than 3,600 mammograms and performs more than 100 image guided breast biopsies each year.
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From page 88... ...
And will professional liability insurance carriers be willing to insure
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From page 89... ...
Dr. Smith-Bindman's Figure 3.10 compared recall rates for first mammograms in the U.K.
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From page 90... ...
The all inclusive payment for screening mammography in my practice, including physician work, practice expense, and professional liability insurance, is $83.58. My costs include $14.78 for compliance with MQSA and either $124.54 for hospital or $86.60 for office costs, all according to an ACR survey of 37 radiology practices in the spring of 2001.
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From page 91... ...
We should use physician extenders, not for prescreening, but for hanging mammograms, contacting patients, and logistics work, and we certainly do that in our practice. Computer assisted detection is the way to go for that second pair of eyes, and we need to continue to work to improve its quality.
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From page 92... ...
How do we motivate practitioners who are not in similar model systems to practice integrated health care? What are the financial incentives and disin
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From page 93... ...
DR. SMITH-BINDMAN: Are you saying that, given the higher breast cancer mortality rates in the U.K., those data are inconsistent with our results suggesting mammography is done very well there?
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From page 94... ...
We will be moving now to the wrap-up session in the other room, and there will be more time to interact over there. Second Group Discussion Developing and Delivering New DetectionTechnologies Richard Bohmer, M.B.Ch.B., M.P.H., Assistant Professor, Harvard Business School and Member, Committee on Saving Women's Lives: Strategies for Improving Breast Cancer Detection and Diagnosis MODERATOR AND RAPPORTEUR: We are going to be focusing on the development and delivery of innovative and new detection technologies.
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From page 95... ...
These data are likely to be both quantitative and qualitative, the latter being a class of data we are a little bit less used to using in medical practice. So there will be data not only about how well the technology performs in the absolute, which is the kind of data that goes to the FDA, but also about how the technology performs in comparison to other technologies or how technologies perform when used in concert with other technologies.
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From page 96... ...
Similar comments have come from related reports, one of which was the IOM report, Large-Scale Biomedical Science: Exploring Strategies for Future Research that was released June 19, 2003 (Institute of Medicine, 2003)
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From page 97... ...
The trial is being carried out by the American College of Radiology Imaging Network (ACRIN) , which is the cooperative group that we fund at NCI to review clinical trials in digital mammography.
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From page 98... ...
There is no database or registry that could give you information on all the radiologists that interpret chest X-rays, or all the conventional radiologists who do some conventional procedure. But mammography is the exception because all radiologists who interpret mammograms have to be certified as meeting quality standards by the FDA.
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From page 99... ...
So the task is very much like the child's game, Where's Waldo. I use this as an example to illustrate that I think we need to understand the interpretive process and its implications for development of computer assisted detection (CAD)
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From page 100... ...
DR. NORTON: Over the years in drug development, we learned how to structure clinical trials, phases 1, 2, and 3, so that their results could change practice, even though we might ask many other kinds of scientific questions, targeting, relative efficacy, about a drug.
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From page 101... ...
In imaging trials, it very much depends on the skill and the abilities of the imager. Very large trials like our DMIST trial, will attempt to get at that by providing data that will allow us to compare the ROC curves of the two different technologies.
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From page 102... ...
DR. ESSERMAN: Only about a third of breast cancer screening is done by breast imagers, so knowing that the trialists are mostly breast imagers, you can immediately say that they are very different.
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From page 103... ...
Early evaluations need to have adequate statistics and be designed in such a way that allows a decision on whether or not to scale up, but the bar for starting large-scale clinical trials should be very high. Since large-scale clinical trials will require that the technology be fixed over a long period of time, the changes in our understanding of the development and treatment of breast cancer, which are likely to continue at a rapid pace over that period, may not be accommodated.
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From page 104... ...
That was an example of how progress can be made through scientist-engineerresearch clinician partnerships. Unfortunately, some of the positive factors which have made virtual colonoscopy such a strong contender for clinical use are not present in mammography.
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From page 105... ...
There is a formal Overview BCBSA TEC BCBS Plans Framing Key Questions Health Plan Analyzing Evidence MAP Process Review TEC Evaluating Against by Expert Published the Criteria Panel Assessments FIGURE 3.6 Technology assessment at Blue Cross and Blue Shield.
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From page 106... ...
3) The technology must improve the net health outcome.
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From page 107... ...
In the screening setting, we do see some randomized controlled trials and that is great, but in the diagnostic imaging literature in general, that is not the reality. Indirect evidence is the reality that links a chain of evidence: the performance of the diagnostic test; its effect on patient management; and what it does to health outcomes.
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From page 108... ...
For anyone who is interested in learning more about specific technology assessments and the kind of things we do, we have a website which you can visit at http://www.bcbs.com/tec. ERIC BAUGH, M.D., Senior Vice President, Medical Affairs, Care First Blue Cross and Blue Shield: I will discuss how we go from the technology assessment that Dr.
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From page 109... ...
Policy · Goal: Company-wide consistency Written or automated program or protocols providing controls to appropriately pay claims for services Influenced by: · Medical Policy · Appropriateness of Medical Care Utilization/ Case · Benefits Management Influenced by: · Medical Policy Benefit · Competitive Analysis · Legislation · Medical sign-off Contractual services provided to implement Medical Policy · Regulatory requirements · Legal sign-off · Sales/Marketing · Marketing/Sales sign-off · Cost of Care · Executive sign-off Quality Medical Care · Right Care · Right Time · Right Provider Medical Policy · Right Setting A prudent plan or course of action or guiding principle reflecting · Right Cost community standards for diagnosis, treatment and care to: 1. Promote health or wellness, prevent illness 2.
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From page 110... ...
that tracks new and emerging health technologies and gives us impact utilization and cost data. I refer to new technologies for breast cancer detection evaluated to date that provide no clinical benefit when compared to mammography or biopsy, or small benefit for a limited subset of the population when added to mammography as adjunctive.
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From page 111... ...
This is burdensome to the clinician, member, and plan, and plans need to consider the time and cost of this as with other coverage restrictions. A retrospective review after payment is a third approach to implement medical policy of this type.
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From page 112... ...
In Maryland, health plans are mandated to cover patient care costs of clinical trials involving serious or lifethreatening conditions. In effect, this mandate requires contingency coverage.
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From page 113... ...
Now we can look carefully at CAD in the context of other alternatives. To begin our assessment, we supplemented the Blue Cross and Blue Shield evidence assessment.
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From page 114... ...
DR. BAUGH: We would have paid for clinical trials had that been an option, but at the time, it was mandated in the courts that we pay without benefit of a clinical trial.
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From page 115... ...
DR. NORTON: The argument for reimbursement of the patient care costs in clinical trials is that it is cheaper in the long run for everybody, and better for patients.
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From page 116... ...
116 SAVING WOMEN'S LIVES SYMPOSIUM DR. PETITTI: I am thinking of the CT colonography trial.
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From page 117... ...
There is still a complete disconnect between clinical trials and molecular approaches to cancer biology. We must somehow deal with that.
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