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

INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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 INSTITUTE OF MEDICINE AND NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. Washington, DC 20001 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 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America. Cover designed by Beth Schlenoff.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. 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. www.national-academies.org

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 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

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis The National Academies is pleased to acknowledge that a gift in support of this project was made in honor of Sallie Nicholls, Beth Weibling, Jane Carlson Williams, Bonnie Main, and Amy McGraw, and in memory of Joan Morgan and Mabel Frost McCaw.

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Contents     EXECUTIVE SUMMARY   1 1   INTRODUCTION   19      A Safety Net,   20      Beyond Mammography,   21      Investing in Research,   22      Scope of This Study,   24      Public Expectations Are High,   29      Study Process,   32      Organization of This Report,   33      References,   34 2   BENEFITS AND LIMITATIONS OF MAMMOGRAPHY   37      Screening Versus Diagnosis,   37      Standards of Evidence,   38      Mammography Under Fire,   41      Breast Density Affects Mammographic Sensitivity,   44      The Harms of Mammography,   46      The DCIS Dilemma,   49      References,   56

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 3   IMPROVING BREAST CANCER SCREENING SERVICES   63      Screening Outcomes Vary by Country,   63      Quality Assurance Improves Outcomes,   72      Improving Mammography,   79      Other Technology Options,   92      Breast Imagers Needed,   100      Summary,   114      References,   116 4   UNDERSTANDING BREAST CANCER RISK   123      Breast Density,   128      Genetic Risk Factors,   128      Managing Risk,   137      Summary,   148      References,   150 5   BIOLOGICALLY BASED TECHNOLOGIES   155      Clues to Breast Cancer: Individual Biomarkers,   157      Profiles of Breast Cancer: Genomics and Proteomics,   164      Pictures of Breast Cancer: Molecular Imaging,   172      Novel In Vitro Diagnostic Tests Pose Unique Regulatory Challenges,   181      Summary,   181      References,   183 6   THE NECESSARY ENVIRONMENT FOR RESEARCH AND DEVELOPMENT   188      Support for Discovery Research Is Adequate,   189      Methodological Issues,   198      Large-Scale, Higher Quality Clinical Trials Are Needed,   205      FDA Assesses Safety and Efficacy,   218      Health Care Payers Assess Clinical Value,   227      Research and Development Should Be Integrated,   234      References,   244 7   TRANSLATING NEW TECHNOLOGIES INTO IMPROVED PATIENT OUTCOMES   249      Process of Technology Adoption,   251      The Many Drivers of Technology Adoption,   254      Technology and Organizational Change,   261      Summary,   267      References,   267

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 8   RECOMMENDATIONS   269     A.   Improve Current Application of Screening Mammography,   270     B.   Integrate Biology, Technology, and Risk Models to Develop New Screening Strategies for Breast Cancer,   273     C.   Improve the Environment for Research and Development of New Technologies for Breast Cancer Detection,   276     D.   Improve the Implementation and Use of New Technologies,   278      References,   278     APPENDIXES     A   Breast Cancer Technology Overview   279 B   Workshop Agendas   310 C   ROC Analysis: Key Statistical Tool for Evaluating Detection Technologies   314 D   Common Weaknesses in Study Designs   322     GLOSSARY   326     INDEX   341

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis List of Boxes, Figures, and Tables BOXES 1-1   Millions of Women Do Not Receive Annual Mammograms,   20 1-2   Statement of Task,   28 1-3   Misleading Marketing of MRI for Breast Cancer Screening,   32 2-1a   Screening Terminology,   39 2-1b   Hypothetical Screening Results,   40 2-2   After the Storm: Expert Reviews of Mammography Screening Trials,   42 2-3   Classification of DCIS,   53 2-4   Treatment for DCIS,   55 3-1   Quality Assurance for Breast Screening in the United Kingdom,   72 3-2   PERFORMS: A Self-Assessment Program to Improve Performance,   73 3-3   Breast Cancer Legislation,   80 3-4   Bodies Approved to Certify and Accredit the Quality of Mammography Facilities,   82 3-5   ACR BI-RADS®: Breast Imaging Reporting and Data System,   84 3-6   Mammograms and Malpractice,   105 3-7   The IOM on Tort Reform,   106 3-8   Who Does What in Mammography,   113

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 4-1   Relative Versus Absolute Risk,   124 4-2   Epidemiological Methods for Discovering Genetic Links to Disease,   125 4-3   Male Breast Cancer Occurs, but Too Rarely to Screen with Mammography,   139 4-4   A Blood Test to Forego Mammography?,   142 5-1   CA 15-3,   160 5-2   Early Detection Research Network,   162 5-3   How Genetic Mutations Can Disrupt Control of Cellular Functions,   168 5-4   National Cancer Institute Support for Molecular Imaging Research,   180 6-1   Brief History of Medical Technology Assessment in the U.S. Federal Government,   196 6-2   Common Failures in Clinical Trial Designs Submitted for Review,   198 6-3   Measuring Breast Cancer Survival: Kaplan-Meier Curves,   200 6-4   Treatments for Hypertension Tested in the ALLHAT Comparative Trial,   206 6-5   Herceptin®,   210 6-6   Personal Health Information Identifiers Under HIPAA,   214 6-7   Blue Cross Blue Shield Association Technology Evaluation Committee Requirements for National Coverage,   229 6-8   Medicare Requirements for Coverage: Steps to Obtaining Medicare Coverage,   229 6-9   Reengineering the Clinical Research Enterprise,   238 6-10   NIH Criteria for Establishing Center Programs,   244 7-1   Efficacy and Effectiveness,   250 7-2   Typology of Technology Adopters,   254 7-3   T-Scan: FDA Approval, but No Market,   256 7-4   Myriad Problems in International Gene Patenting,   257 7-5   Drug-Eluting Stents,   259 7-6   Minimally Invasive Cardiac Surgery: A Case Study in Technology Deployment,   263 FIGURES 1-1   Personal stories in women’s magazines overrepresent the incidence of breast cancer in younger women and underrepresent it among older women,   31

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 2-1   Trends in mammography dose and image quality,   49 2-2   Female breast cancer incidence (invasive and DCIS) by age-adjusted rates from 1973 to 2001,   51 3-1   Frequency of abnormal mammograms in North America compared to other countries,   68 3-2   Breast cancer incidence and mortality in white and black women,   77 3-3   Poverty is a greater barrier to mammography than race or ethnicity,   78 3-4   Mammographic sensitivity increases with a woman’s age,   87 3-5   Examples of MRI and x-ray images of two different cases of DCIS,   97 3-6   Fewer mammography facilities each year,   102 3-7   The ranks of academic radiologists are thin compared to other specialties,   108 4-1   Breast cancer screening based on stratified risk assessments,   138 4-2   Mammography use declines when breast cancer risk is greatest,   144 6-1   Pathway of medical technology development,   189 6-2   Distribution of public and charitable funding of breast cancer,   190 6-3   Percentage of NCI budget allocated to selected cancer types,   191 6-4   Architecture of the National Digital Mammography Archive,   241 C-1   Receiver operating characteristic graph of a varying decision threshold compared with a “useless test,”   316 C-2   Example of ROC curve analysis for computer-assisted detection,   317 C-3   Comparison of two diagnostic modalities without ROC curves,   318 C-4   Comparison of two diagnostic modalities utilizing ROC curves,   319 TABLES 1-1   Imaging Technologies for Breast Cancer Reviewed in Mammography and Beyond,   24 2-1   BI-RADS® (fourth edition) Scale for Characterizing Breast Composition,   44 2-2   Age Differences in DCIS Detected by Screening Mammography,   52

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis 3-1   Breast Screening Programs in Different Countries,   64 3-2   Comparison of Screening Mammography Outcomes in the United States and Britain,   70 3-3   Factors That Affect the Quality of Screening Mammography,   86 3-4   Relationship Between Volume of Mammograms Read and Accuracy of Interpretation Is Inconsistent,   88 3-5   Mammography Volume Standards,   90 4-1   Age-Specific Probabilities of Developing Breast Cancer,   125 4-2   Risk Factors for Breast Cancer,   126 4-3   Genes Other Than BRCA1 and BRCA2 Involved in Breast Cancer Susceptibility,   133 4-4   Percent of Women Who Rated Certain Outcomes “Likely” Was Not Significantly Different for Diagnoses, Despite Significantly Different Prognoses,   145 4-5   Most Women in the United States Overestimate the Benefits of Mammography,   146 5-1   Biomarkers of Events in the Development of Breast Cancer: Their Potential Uses and Limitations,   158 5-2   Guiding Principles Used in Biomarker Validation,   163 5-3   Molecular Imaging in Breast Cancer Targets and Agents,   174 5-4   Characteristics of Various Molecular Imaging Modalities in Animal Studies,   176 6-1   Major Funders of Breast Cancer Research,   192 6-2   Federal and Private Technology Assessors,   194 6-3   Participation of Breast Cancer Organizations in Clinical Trial Accrual,   212 6-4   Options for Obtaining Protected Health Information for Research Under HIPAA Privacy Rule,   216 6-5   Device Classification and Application Requirements for FDA Review,   220 6-6   FDA Device Approvals for Breast Cancer Detection from 1995-2004,   222 7-1   The Three Phases of Technology Adoption,   251 7-2   Quality Measures Used in Colorado Mammography Project,   265 A-1   A Mutation-Positive Result May Have Both Benefits and Problems,   300 A-2   A Mutation-Negative Result Also Has Benefits and Problems,   301

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