SAVING WOMEN’S LIVES
Strategies for Improving Breast Cancer Detection and Diagnosis
Janet E. Joy, Edward E. Penhoet, and Diana B. Petitti, Editors
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS
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NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.
Support for this project was provided by the Apex Foundation, the Breast Cancer Research Foundation, the Carl J. Herzog Foundation, Mr. Corbin Gwaltney, Mr. John Castle, the Josiah Macy Jr. Foundation, the Kansas Health Foundation, and the National Cancer Institute. This study was supported, in part, by Contract No. N01-OD-4-2139, TO #110 between the National Academy of Sciences and the National Cancer Institute. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
Library of Congress Cataloging-in-Publication Data
Saving women’s lives : strategies for improving breast cancer detection and diagnosis / Committee on New Approaches to Early Detection and Diagnosis of Breast Cancer, National Cancer Policy Board, Board on Science, Technology, and Economic Policy, Policy and Global Affairs Division ; Janet E. Joy, Edward E. Penhoet, and Diana B. Petitti, editors.
p. ; cm.
Includes bibliographical references and index.
ISBN 0-309-09213-2 (hardcover)
1. Breast—Cancer—Diagnosis. 2. Breast—Cancer—Government policy—United States. 3. Breast—Cancer—Prevention. 4. Medical screening.
[DNLM: 1. Breast Neoplasms—diagnosis. 2. Mammography. 3. Mass Screening. 4. Research. WP 870 S267 2004] I. Joy, Janet E. (Janet Elizabeth), 1953- II. Penhoet, Edward E. III. Petitti, Diana B. IV. National Cancer Policy Board (U.S.). Committee on New Approaches to Early Detection and Diagnosis of Breast Cancer. V. National Research Council (U.S.). Policy and Global Affairs. VI. National Research Council (U.S.). Board on Science, Technology, and Economic Policy.
RC280.B8S28 2004
616.99′449075—dc22
2004022343
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THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.
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The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.
COMMITTEE ON NEW APPROACHES TO EARLY DETECTION AND DIAGNOSIS OF BREAST CANCER
EDWARD E. PENHOET (Chair), Director,
Science and Higher Education Programs, Gordon and Betty Moore Foundation, San Francisco, CA
DIANA B. PETITTI (Vice Chair), Senior Scientific Advisor,
Health Policy and Medicine, Kaiser Permanente Southern California, Pasadena, CA
MARTIN D. ABELOFF, Director,
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD
COLIN B. BEGG, Chairman,
Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center
M. KATHLEEN BEHRENS, General Partner,
RS & Co. Venture Partners IV, L.P. RS Investments, San Francisco, CA
RICHARD BOHMER, Assistant Professor,
Harvard Business School
CHRISTINE BRUNSWICK, Vice President,
National Breast Cancer Coalition, Washington, DC
SANJIV S. GAMBHIR, Director,
Molecular Imaging Program at Stanford, Stanford University, Stanford, CA
ROBERT A. GREENES, Professor,
Radiology and Health Sciences & Technology, Harvard Medical School, Brigham and Women’s Hospital, Boston, MA
JEFFREY R. MARKS, Associate Professor,
Department of Surgery, Duke University Medical Center, Durham, NC
BARBARA J. MCNEIL, Ridley Watts Professor and Head,
Department of Health Care Policy, Harvard Medical School;
Professor of Radiology,
Brigham and Women’s Hospital, Boston, MA;
Head of Department of Health Care Policy,
Harvard Medical School, Boston, MA
DAVID C. MOWERY, Professor,
Walter A. Haas School of Business, University of California, Berkeley, CA
ETTA D. PISANO, Chief of Breast Imaging,
Department of Radiology, University of North Carolina Hospitals, Chapel Hill, NC
GLENN D. STEELE, President and CEO,
Geisinger Health System, Danville, PA
KIRBY G. VOSBURGH, Associate Director,
Center for Integration of Medicine and Innovative Technologies (CIMIT), Cambridge, MA
WILLIAM C. WOOD, Chief of Surgery,
Emory University Hospital, Atlanta, GA
Consultants
LAURA J. ESSERMAN, Director,
Carol Franc Buck Breast Care Center, University of California, San Francisco, CA
LANCE A. LIOTTA, Chief,
Laboratory of Pathology, National Cancer Institute, Bethesda, MD
LARRY NORTON, Deputy Physician-in-Chief and Director of Breast Cancer Programs,
Memorial Sloan-Kettering Cancer Center, New York, NY
Study Staff
JANET E. JOY, Study Director
ROGER C. HERDMAN, Director,
National Cancer Policy Board
JAMES J. DANIERO, Research Associate
ELIZABETH J. BROWN, Research Assistant
MARY ANN F. PRYOR, Project Assistant
ANIKE L. JOHNSON, Administrative Assistant
Reviewers
This report has been reviewed indraft form byindividuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s (NRC’s) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
Mina J. Bissell, Life Science Division, Lawrence Berkeley National Laboratory, Berkeley, CA
Steven R. Cummings, Research Institute at the California Pacific Medical Center, University of California, San Francisco, CA
Alan M. Garber, Center for Health Policy and Center for Primary Care and Outcomes Research, Stanford University, Stanford, CA
Lawrence H. Miike, Former Commissioner of Hawaii Department of Health, Honolulu, HI
Barbara S. Monsees, Mallinckrodt Institute of Radiology, St. Louis, MO
Charles B. Wilson, Health Technology Center, San Francisco, CA
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions
or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Paul D. Cleary, Ph.D., Professor of Health Care Policy, Harvard Medical School and Maureen Henderson, O.B.E., M.D., Emeritus Professor of Epidemiology and Medicine, University of Washington. Appointed by the NRC and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.
Acknowledgments
Progress in the fight against breast cancer has benefited enormously from the efforts of thousands of volunteers who have worked to raise awareness, money, and provide support to women with breast cancer. This report has likewise benefited enormously from the generous efforts of volunteers. In addition to committee members who volunteered their time and tremendous efforts, dozens of other experts volunteered their time either through formal presentations or through informal contacts with the study staff. Those who made formal presentations to the committee are listed in the workshop agendas in Appendix B. The following people provided technical comment on draft sections of the report: Nananda Col, David Feigal, Charles Finder, Joseph Hackett, Barbara Monsees, David Pwinica-Worms, Barbara Rimer, Mary Ropka, Alan Rosenberg, Mitchell Schnall, Karen Sepucha, Robert A. Smith, and Sean Tunis. Their expert counsel was much appreciated and invaluable. Kim Adcock, Leonard Berlin, and David Page, Laszlo Tabar, and Earl Steinberg provided critical reference material or shared their unpublished work. Pam Butler and Priscilla Butler were a treasure trove of information and shared many analyses related to workforce issues done by the American College of Radiology.
In addition to outside experts, Sharyl Nass, Maria Hewitt, and Jill Eden, study directors at the National Cancer Policy Board, were always generous and insightful in their advice about the many different issues related to the study. Elizabeth McCarthy and Jennifer VanRoeyen, both interns at the Institute of Medicine (IOM) for several months during the early stages of the study, did wonderful jobs of researching and developing
background material for the study. Elizabeth Brown had been on the IOM staff for only a few months and proved outstanding in her ability at filling in the many information holes that remained in the late stages of the report. James Daniero, the research associate throughout the study, was entrusted with an extraordinary amount of responsibility for the research, development, and production of this report. He has been dedicated and resourceful in solving countless challenges that arose during the course of the study—from coping with record-setting blizzards in the midst of committee meetings to preparing essential background materials while supervising the multitude of production and administrative tasks associated with the study. As much as he has provided exemplary staff support, he has been a pleasure and privilege for all to work with.
Roger Herdman, director of the National Cancer Policy Board, was always available for consultation and always provided wise and thoughtful perspectives on all matters of health policy and technology. His support at every stage of this project is enormously appreciated.
Alison Mack and Margie Patlak, consulting writers for various sections of the report, were wonderful colleagues who provided input to the study above and beyond their writing contributions. Jennifer Otten, Janice Mehler, and Bill McLeod of the IOM each provided wonderful assistance at different stages of the study, and all consistently went above and beyond the call of duty to help shepherd the study through the Academy process. Special thanks to Janet Joy for her tireless efforts in preparing this report on behalf of the committee and for her many contributions to obtaining and synthesizing the evidence that is the basis for the recommendations.
The committee also gratefully acknowledges Margaret E. Mahoney and Carol Richards who were instrumental in enlisting support for this report and whose vision led to its genesis.
Acronyms
AAMC
Association of American Medical Colleges
ACE
Angiotensin-Converting Enzyme
ACR
American College of Radiology
ACRIN
American College of Radiology Imaging Network
ACS
American Cancer Society
AHRQ
Agency for Healthcare Research and Quality
AIDS
Acquired Immunodeficiency Syndrome
ALLHAT
Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial
AMA
American Medical Association
ASRT
American Society of Radiologic Technicians
BCCPTA
Breast and Cervical Cancer Prevention and Treatment Act
BCS
Breast-conserving surgery
BI-RADS®
Breast Imaging Reporting and Data Systems
CABG
Coronary Artery Bypass Surgery
CAD
Computer-Assisted Detection
CDC
Centers for Disease Control and Prevention
CLIA
Clinical Laboratory Improvement Amendment
CMS
Centers for Medicare and Medicaid Services
CPT
Current Procedural Terminology
CT
Computed Tomography
DCIS
Ductal carcinoma in situ
DICOM
Digital Imaging and Communications in Medicine
DMIST
Digital Mammography Imaging Screening Trial
DoD
Department of Defense
EDRN
Early Detection Research Network
EIS
Electrical Impedance Scanning
FDA
Food and Drug Administration
GAO
Government Accounting Office
HDC/BMT
High-dose chemotherapy/Bone marrow transplant
HHS
Health and Human Services
HIPAA
Health Insurance Portability and Accountability Act
ICBIO
Interagency Council on Biomedical Imaging in Oncology
IDE
Investigational Device Exemption
IOM
Institute of Medicine
IRB
Institutional Review Board
LOH
Loss of Heterozygosity
MQSA
Mammography Quality Standards Act
MRI
Magnetic Resonance Imaging
NCI
National Cancer Institute
NCICB
National Cancer Institute Center for Bioinformatics
NDMA
National Digital Mammography Archives
NHSBSP
National Health Service Breast Screening Programme
NIBIB
National Institute of Biomedical Imaging and Bioengineering
NIH
National Institutes of Health
NINR
National Institute of Nursing Research
NSABP
National Surgical Adjuvant Breast and Bowel Project
PCR
Polymerase Chain Reaction
PDQ
Physician Data Query
PET
Positron Emission Tomography
PHI
Protected Health Information
PMA
Premarket Approval
PPV
Positive Predictive Value
PSA
Prostate Serum Antigen
QUADAS
Quality Assessment of Diagnostic Accuracy
RDOG
Radiology Diagnostic Oncology Group
ROC
Receiver Operating Characteristic
RT
Radiologic Technician
SEER
Surveillance, Epidemiology, and End Results
SPECT
Single-emission Photon Emission Computed Tomography
STAR
Study of Tamoxifen and Raloxifene
STARD
Standards for Reporting of Diagnostic Accuracy
USPSTF
U.S. Preventive Services Task Force
VNPI
Van Nuys Prognostic Index
WHO
World Health Organization
List of Boxes, Figures, and Tables
BOXES
1-1 |
Millions of Women Do Not Receive Annual Mammograms, |
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1-2 |
Statement of Task, |
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1-3 |
Misleading Marketing of MRI for Breast Cancer Screening, |
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2-1a |
Screening Terminology, |
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2-1b |
Hypothetical Screening Results, |
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2-2 |
After the Storm: Expert Reviews of Mammography Screening Trials, |
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2-3 |
Classification of DCIS, |
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2-4 |
Treatment for DCIS, |
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3-1 |
Quality Assurance for Breast Screening in the United Kingdom, |
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3-2 |
PERFORMS: A Self-Assessment Program to Improve Performance, |
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3-3 |
Breast Cancer Legislation, |
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3-4 |
Bodies Approved to Certify and Accredit the Quality of Mammography Facilities, |
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3-5 |
ACR BI-RADS®: Breast Imaging Reporting and Data System, |
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3-6 |
Mammograms and Malpractice, |
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3-7 |
The IOM on Tort Reform, |
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3-8 |
Who Does What in Mammography, |
4-1 |
Relative Versus Absolute Risk, |
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4-2 |
Epidemiological Methods for Discovering Genetic Links to Disease, |
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4-3 |
Male Breast Cancer Occurs, but Too Rarely to Screen with Mammography, |
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4-4 |
A Blood Test to Forego Mammography?, |
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5-1 |
CA 15-3, |
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5-2 |
Early Detection Research Network, |
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5-3 |
How Genetic Mutations Can Disrupt Control of Cellular Functions, |
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5-4 |
National Cancer Institute Support for Molecular Imaging Research, |
|
||
6-1 |
Brief History of Medical Technology Assessment in the U.S. Federal Government, |
|||
6-2 |
Common Failures in Clinical Trial Designs Submitted for Review, |
|||
6-3 |
Measuring Breast Cancer Survival: Kaplan-Meier Curves, |
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6-4 |
Treatments for Hypertension Tested in the ALLHAT Comparative Trial, |
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6-5 |
Herceptin®, |
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6-6 |
Personal Health Information Identifiers Under HIPAA, |
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6-7 |
Blue Cross Blue Shield Association Technology Evaluation Committee Requirements for National Coverage, |
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6-8 |
Medicare Requirements for Coverage: Steps to Obtaining Medicare Coverage, |
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6-9 |
Reengineering the Clinical Research Enterprise, |
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6-10 |
NIH Criteria for Establishing Center Programs, |
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7-1 |
Efficacy and Effectiveness, |
|||
7-2 |
Typology of Technology Adopters, |
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7-3 |
T-Scan: FDA Approval, but No Market, |
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7-4 |
Myriad Problems in International Gene Patenting, |
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7-5 |
Drug-Eluting Stents, |
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7-6 |
Minimally Invasive Cardiac Surgery: A Case Study in Technology Deployment, |
FIGURES
1-1 |
Personal stories in women’s magazines overrepresent the incidence of breast cancer in younger women and underrepresent it among older women, |
2-1 |
Trends in mammography dose and image quality, |
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2-2 |
Female breast cancer incidence (invasive and DCIS) by age-adjusted rates from 1973 to 2001, |
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3-1 |
Frequency of abnormal mammograms in North America compared to other countries, |
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3-2 |
Breast cancer incidence and mortality in white and black women, |
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3-3 |
Poverty is a greater barrier to mammography than race or ethnicity, |
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3-4 |
Mammographic sensitivity increases with a woman’s age, |
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3-5 |
Examples of MRI and x-ray images of two different cases of DCIS, |
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3-6 |
Fewer mammography facilities each year, |
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3-7 |
The ranks of academic radiologists are thin compared to other specialties, |
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4-1 |
Breast cancer screening based on stratified risk assessments, |
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4-2 |
Mammography use declines when breast cancer risk is greatest, |
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6-1 |
Pathway of medical technology development, |
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6-2 |
Distribution of public and charitable funding of breast cancer, |
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6-3 |
Percentage of NCI budget allocated to selected cancer types, |
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6-4 |
Architecture of the National Digital Mammography Archive, |
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C-1 |
Receiver operating characteristic graph of a varying decision threshold compared with a “useless test,” |
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C-2 |
Example of ROC curve analysis for computer-assisted detection, |
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C-3 |
Comparison of two diagnostic modalities without ROC curves, |
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C-4 |
Comparison of two diagnostic modalities utilizing ROC curves, |
TABLES
3-1 |
Breast Screening Programs in Different Countries, |
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3-2 |
Comparison of Screening Mammography Outcomes in the United States and Britain, |
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3-3 |
Factors That Affect the Quality of Screening Mammography, |
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3-4 |
Relationship Between Volume of Mammograms Read and Accuracy of Interpretation Is Inconsistent, |
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3-5 |
Mammography Volume Standards, |
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4-1 |
Age-Specific Probabilities of Developing Breast Cancer, |
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4-2 |
Risk Factors for Breast Cancer, |
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4-3 |
Genes Other Than BRCA1 and BRCA2 Involved in Breast Cancer Susceptibility, |
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4-4 |
Percent of Women Who Rated Certain Outcomes “Likely” Was Not Significantly Different for Diagnoses, Despite Significantly Different Prognoses, |
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4-5 |
Most Women in the United States Overestimate the Benefits of Mammography, |
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5-1 |
Biomarkers of Events in the Development of Breast Cancer: Their Potential Uses and Limitations, |
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5-2 |
Guiding Principles Used in Biomarker Validation, |
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5-3 |
Molecular Imaging in Breast Cancer Targets and Agents, |
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5-4 |
Characteristics of Various Molecular Imaging Modalities in Animal Studies, |
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6-1 |
Major Funders of Breast Cancer Research, |
|||
6-2 |
Federal and Private Technology Assessors, |
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6-3 |
Participation of Breast Cancer Organizations in Clinical Trial Accrual, |
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6-4 |
Options for Obtaining Protected Health Information for Research Under HIPAA Privacy Rule, |
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6-5 |
Device Classification and Application Requirements for FDA Review, |
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6-6 |
FDA Device Approvals for Breast Cancer Detection from 1995-2004, |
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7-1 |
The Three Phases of Technology Adoption, |
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7-2 |
Quality Measures Used in Colorado Mammography Project, |
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A-1 |
A Mutation-Positive Result May Have Both Benefits and Problems, |
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A-2 |
A Mutation-Negative Result Also Has Benefits and Problems, |