Index

A

AAC Consulting Group, Inc., 223

Access to breast imaging

cultural factors, 78

financial factors, 2, 4-5, 21, 69, 76, 78, 100, 103-106

legislation promoting, 80

patents and, 257

as quality assurance component, 4, 75-79

race/ethnicity and, 76

of risk assessments, 8

social factors, 76, 78

socioeconomic status and, 5, 76

and survival rates, 66-67

uninsured women, 5, 76, 78-79

waiting times, 7, 101

workforce issues, 4, 7, 21, 100, 101-102, 103-106, 115

Accuracy.

See also Analytical validity;

Sensitivity of technologies;

Specificity

of biological technologies, 156, 160, 161

biopsies, 161, 290, 299

CAD technology and, 202, 281

clinical trials of, 202-204

defined, 326

digital mammography, 21, 93

molecular profiling, 170

MRI, 32, 45, 92, 96-98, 294

of radiation technologists, 111-112

screen-film mammography, 21, 92

of specialists vs. generalists, 86, 89, 94-95, 101, 281

standards for reporting, 202

Adjuvant therapy, 1, 55, 299, 326

AdvaMed, 196

Advanced Mammography Systems, Inc., 223

Advanced Medical Laboratories, Inc., 222

Advocacy groups, 12-13, 79, 82, 210-211, 277

African Americans, 45, 76, 77, 78, 128, 133, 208

Age factors

at birth of first child, 8, 127

DCIS, 51, 52

density of breast tissue, 45, 86

efficacy of mammography, 42

incidence of breast cancer, 43, 50, 51, 142

menarche, 127

menopause, 127

mutations, 128

radiation sensitivity, 48

risk of breast cancer, 8, 20, 30, 31, 124, 125, 126, 127, 130, 137, 143-144, 199

sensitivity of mammography, 85, 87, 281

standard of care, 7, 40, 281

utilization of mammography, 20, 64



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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Index A AAC Consulting Group, Inc., 223 Access to breast imaging cultural factors, 78 financial factors, 2, 4-5, 21, 69, 76, 78, 100, 103-106 legislation promoting, 80 patents and, 257 as quality assurance component, 4, 75-79 race/ethnicity and, 76 of risk assessments, 8 social factors, 76, 78 socioeconomic status and, 5, 76 and survival rates, 66-67 uninsured women, 5, 76, 78-79 waiting times, 7, 101 workforce issues, 4, 7, 21, 100, 101-102, 103-106, 115 Accuracy. See also Analytical validity; Sensitivity of technologies; Specificity of biological technologies, 156, 160, 161 biopsies, 161, 290, 299 CAD technology and, 202, 281 clinical trials of, 202-204 defined, 326 digital mammography, 21, 93 molecular profiling, 170 MRI, 32, 45, 92, 96-98, 294 of radiation technologists, 111-112 screen-film mammography, 21, 92 of specialists vs. generalists, 86, 89, 94-95, 101, 281 standards for reporting, 202 Adjuvant therapy, 1, 55, 299, 326 AdvaMed, 196 Advanced Mammography Systems, Inc., 223 Advanced Medical Laboratories, Inc., 222 Advocacy groups, 12-13, 79, 82, 210-211, 277 African Americans, 45, 76, 77, 78, 128, 133, 208 Age factors at birth of first child, 8, 127 DCIS, 51, 52 density of breast tissue, 45, 86 efficacy of mammography, 42 incidence of breast cancer, 43, 50, 51, 142 menarche, 127 menopause, 127 mutations, 128 radiation sensitivity, 48 risk of breast cancer, 8, 20, 30, 31, 124, 125, 126, 127, 130, 137, 143-144, 199 sensitivity of mammography, 85, 87, 281 standard of care, 7, 40, 281 utilization of mammography, 20, 64

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Agency for Healthcare Research and Quality, 11, 194, 195, 196, 199, 234, 276, 278 Alcohol intake, 127, 301 Allan, Janet D., 43 Alleles, 326 American Cancer Society, 13, 42, 114, 139, 190, 192, 211, 232, 297 American College of Radiology (ACR), 44, 74, 89, 91, 103, 233 Imaging Network (ACRIN), 93, 98, 99, 196, 203, 235-237 Mammography Accreditation Program, 82, 83 and radiological associate, 110-111 Task Force on Human Resources, 107 American Heart Association, 206, 232 American Italian Cancer Foundation, 42 American Medical Association, 196, 233 American Society of Clinical Oncology, 42, 96, 233 American Society of Radiological Technologists (ASRT), 110, 111 AmeriScan™, 32 Analytical validity, 326 Anatomical technologies electrical-property-based, 288-290 mammography and its improvements, 280-283 MRI-based, 293-294 optical-property-based, 292-293 physical-property-based, 284-287 Androgens, 135, 136 Angiogenesis, 159, 165, 172, 173, 287, 326 Annas, George, 215 Anti-angiogenesis drugs, 172 Antibodies, 167, 175, 177 Antigens, 177, 326 Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), 205, 206-207, 208-209, 210, 253 APC gene, 137 Apoptosis, 165, 173, 175, 177 AR gene, 136 Arkansas Department of Health, 82 Artificial intelligence systems, 169 Ashkenazi Jewish women, 129, 130, 131 Asian Americans, 45, 128, 133 Association of American Medical Colleges, 12, 218 AstraZeneca, 206 Ataxia telangiectasia, 133 ATM gene, 133 Atypical hyperplasia, 52, 126, 326 Augmented breasts, 96, 294 Austin, Melissa, 130 Australia, 5, 65 Avon Foundation, 99, 190, 192 Axillary node dissection, 67 B Balanced Budget Refinement Act of 1999, 233 Basement membrane, 50, 52 Benign lesions, 52, 97, 98, 170, 294 Berlin, Leonard, 89 Berwick, Donald, 249, 261 Beta-galactosidase, 177 BI-RADS®, 44, 83, 84, 91 Bias, 99 in clinical trials, 326-327 confounding, 324, 329 defined, 323-324 follow-up losses, 203, 324 interpretation, 315 lead-time, 201, 333 length, 201, 333 sampling, 129, 201, 333 systematic or measurement errors, 163, 324 Bioinfomatics, 235, 239, 327 Biologically based technologies. See also Biomarkers and biomarker assays; Molecular imaging; Molecular profiling; specific technologies clinical applications, 155, 156-157, 181-182, 274 costs of, 166, 297 FDA approval, 161, 181 Bioluminate, Inc., 306 Bioluminescent probes, 175, 176, 178 Biomarkers and biomarker assays. See also Genetic markers; individual biomarkers accuracy, 156, 160, 161 clinical applications, 157, 158-159, 160-161 as decision aid, 160-161, 169 defined, 157, 327

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis discovery and development, 9, 157, 161-164, 169, 204-205 for DNA stability, 335 handling of tissue samples, 163 ideal, 157, 160, 161-162 limitations, 157, 158-159, 160 as mammography complement, 155, 157, 160-161 molecular, 164, 170, 335 and risk stratification, 147 screening for candidates, 164, 169 validation, 162-163 Biomira, Inc., 222 Biopsy accuracy and reliability, 161, 290, 299, 306 core needle, 52-53, 302, 304, 306, 329 defined, 303, 327 density of breast tissue and, 53 fine needle aspiration, 126, 299, 301, 304-305, 331 image-guided, 292, 303, 305 international comparisons, 68, 69, 70-71 LIN detection, 52 mammography sensitivity and, 21, 43, 48, 69 microcalcifications and, 53, 54 positive, 126 prior, as risk factor, 8 rates, 48, 70-71 risk factors for, 48 SmartProbe, 303, 305-306 specimen handling, 166 stereotactic, 52-53, 305, 339 supplemental technologies, 170, 305 surgical, 53, 69, 71, 302, 303-304, 306 ultrasound-guided, 54, 285 unnecessary or “excess,” 5, 48, 66, 68, 69 vacuum-assisted, 53-54 BioScanIR® Technologies, Inc., 222 Blood tests, 21, 142, 155-156, 182, 204 Blue Cross Blue Shield Association Technology Evaluation Center, 194, 228-229, 232, 258 Body mass index, 124, 127 Bone density screening, 79, 260 Bone marrow transplantation, 30 BRCA genes, 8, 49, 128, 129-131, 132, 139, 140, 144, 256-258, 261, 296, 327 Breast and Cervical Cancer Mortality Prevention Act, 81 Breast and Cervical Cancer Prevention and Treatment Act (BCCPTA), 79, 80 Breast Cancer Action, 212 Breast Cancer Detection Demonstration Project, 8, 140 Breast Cancer Research Foundation, 193, 210 Breast Cancer Research Program (DoD), 22, 81, 190, 192 Breast-conserving surgery, 1, 54, 55, 67 Breast density age and, 45, 86 and biopsy method, 53 ethnic variation, 45, 128 influential factors, 45, 86 mapping, 286 and risk of cancer, 127, 128 and sensitivity of screening technologies, 2, 44-45, 48, 86, 96, 99-100, 105, 281, 282, 294, 297, 298 Breast imagers. See also Radiologists capacity-building strategies, 104 demand for, 103-106 shortages, 21, 101, 103, 106-107 Breast self-examination, 223, 327 Breast size, 53, 55, 96, 100 BreastScanIR™, 222 Bristol-Myers Squibb, 206 Brookhaven National Laboratory, 283 Brown University, 110 Burke, Wylie, 130 C CA 15-3 protein, 160, 161, 327 CA 125 biomarker, 327 California Breast Cancer Research Program, 190, 192 Callback rates, 69, 75, 94, 271 Canada, 5, 64, 72, 88, 90, 143, 144 Cancer. See also other histological sites defined, 327 registry data, 163-164 types, 327 Cancer Biomedical Informatics Grid, 235 Cancer Therapy Evaluation Program, 180 Carcinogens, 128, 131, 134, 301, 327 Carcinoma defined, 327 in situ, 327; see also Ductal carcinoma in situ promoters, 128, 131

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Case-control studies, 124, 125, 132, 204-205, 327-328 Case reports, 328 Catecholamine transmitters, 136 Cathepsin B, 175 Cathepsin D, 174, 175, 178 Catheter, 328 cDNA, 164, 170, 328 CEA biomarker, 327 Cell culture, 328 Cell cycle regulation, 165, 173 Cell proliferation activities, 174 Cell surface receptors, 173, 175, 177, 225 Center for Molecular Imaging Research, 178 Centers for Disease Control and Prevention, 42, 78 Centers for Medicare and Medicaid Services (CMS), 11, 29, 95, 110, 188, 194, 196, 208, 228, 230, 240, 252, 256, 276 Chaperone protein, 136 Chemoprevention, 300-301, 328. See also Tamoxifen Chemoprophylaxis, 328 Chemotherapy defined, 328 high-dose, 30 mastectomy and, 1 Choline, 298 Chromosomes, 166, 328 Cigarette smoking, 140, 301 Circadian rhythm, 287 Cisplatin, 167 Clement, Tony, 257 Clinical breast examination, 78, 99, 286, 328 Clinical Imaging Drugs and Enhancers Program, 180 Clinical Laboratory Improvement Amendments, 225, 256 Clinical outcomes defined, 328 predictors of, 161, 165 Clinical Research Affiliates Funding Trials, 213 Clinical Research Enhancement Act, 205 Clinical Trial Cooperative Groups, 180 Clinical trials. See also Methodological issues; Research and development; Technology assessment ACRIN, 93, 98, 99, 196, 203, 235-237 advantage of participating, 208-209 ALLHAT model, 205, 206-207, 208-209, 210, 253 bias in, 326-327 of biomarkers, 163-164, 204-205 blind study, 99, 206, 324, 327 comparative, 205-207, 230, 236, 253 costs, 11, 206 defined, 328 design of, 23-24, 107, 164, 198-199 FDA-required, 206, 221, 224, 231, 243 with elderly participants, 228 follow-up studies, 203, 215, 324 funding, 205, 206, 243 HIPAA and, 12, 21, 162-164, 171, 211, 213-217 large-scale, multicenter, 23, 96, 98, 99-100, 202, 205-218, 235-237, 243-244, 274-275 multiple reader multiple case ROC, 319-321 prevention, 140 protected health information, 214-215 quality of, 11-12, 198-199, 202 radiologists’ contributions to, 107, 109 randomized, 42, 164, 201, 202, 206, 328, 338 recruitment of subjects, 12-13, 207-211, 212-213, 260, 277 reporting adverse events, 239 reviews by expert groups, 41-44 of screening and diagnostic accuracy, 202-204 of screening modality, 201-202, 236 statistical analysis, 314-321 surrogate endpoints, 100, 339 Clinical utility, defined, 328 Clinical validity, 162-163, 328 Cloning, positional, 337 Cohort studies, 124, 125, 328-329 Colorado Mammography Project, 264-266 Community-based programs, 79 Comprehensive Cancer Centers, 243-244 Computed tomography, 176, 177, 178, 291, 292, 329, 332, 339 Computer-aided detection (CAD) accuracy, 202, 281, 317-318 benefits, 94-96, 271, 281 defined, 329 description, 280, 281

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis FDA-approved systems, 21, 94, 222, 279, 281 image archive and, 240-241 and interpretation of mammograms, 6-7, 93-96, 271-272 reimbursement policy, 95, 258 risk of breast cancer and use of, 92 sensitivity, 94, 95 workflow impact, 95, 96 COMT gene, 136 Confounding factors, 324, 329 Consolidated Appropriations Act for FY 2004, 83 Contrast agents, 96-97, 177, 283, 329, 332 Controlled observational studies, 329 Cost-benefit analysis, 329 Cost-effectiveness of technologies, 100, 170, 197, 232, 236, 265, 330 Costs, 166 of biological technologies, 166, 297 of clinical trials, 206 of compliance with MQSA, 101-102 of digital mammography, 93 of false positives, 4-5, 46, 75 of genetic testing, 131 of malpractice insurance, 98, 294 quality assurance, 101-102 of screening mammography, 75 Cowden syndrome, 133 Critical Assessment of Microarray Data Analysis, 171 Cross-sectional comparison, 330 Cultural factors, 78 Cummings, Steven, 142 Cy5.5-cathepsin D sensitive peptide protected graft copolymer, 174 Cy5.5 poly L-lysine monooxypolyethylene glycol, 174 CYP17 gene, 135 CYP19 gene, 135 CYP1A1 gene, 134 CYP1B1 gene, 135 CYP2D6 gene, 135 Cysts, 52, 98, 285, 299, 304, 305 Cytogenetics, 330 Cytokines, 136 Cytological screening, 126, 330 Cytology, 330 D D-Luciferin, 178 Databases and data repositories, 66, 163-164, 171, 180, 215, 234, 235, 240-242, 276 Decision aids, 160-161, 169, 197 Density. See Breast density Deoxyribonucleic acid. See DNA Department of Defense, 278 funding for breast cancer research, 10, 22, 81, 191, 192 Medical Research Program, 22, 190 radiology training program, 110 Department of Health and Human Services, 13, 277 Detection, early, 1, 2, 67, 69, 75, 282, 330 Detoxification enzymes, 134 Diagnostic mammography adjunct technologies, 298 defined, 37, 281, 330 financial losses from, 103 interpretation of mammograms, 85, 112 technologies, 24-27, 96 Diagnostic testing, 330 Dietary factors, 124, 301 Diffraction enhanced imaging, 280, 283 Diffuse optical tomography, 173, 291-292 Digital Imaging and Communications in Medicine, 242 Digital Mammographic Imaging Screening Trial (DMIST), 93, 203, 205, 208, 229, 236, 253, 258, 282 Digital mammography. See Full-field digital mammography Digital tomosynthesis mammography, 282-283 DNA defined, 330 exons, 331 hybridization techniques, 164, 166-167 imaging, 175 methylation, 166, 335 microarrays, 164, 165-167, 170, 171, 299 microsatellites, 335 oligonucleotides, 164, 165, 170, 335, 336 radiation damage, 49 repair defects, 49, 128, 129, 166, 301 stability, 335

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Dopamine, 136 Dose-response relationship, 49, 330 Dosimetry, 330 Drug-eluting stents, 259 DucPrep™ Breast, 222 Ductal carcinoma in situ (DCIS) age and, 51, 52 classification, 52, 53 defined, 330-331, 333 diagnosis, 50-54, 305 effectiveness of treatment, 50 incidence, 49-50, 51, 52, 55-56 and invasive breast cancer, 50, 54, 126 microcalcifications, 52, 53, 54, 55, 99, 285 multicentric, 97, 294 nonprogressive, 55-56 overtreatment concerns, 1, 21-22, 54-56 prognosis, 144-145 recurrence rates, 55 risk assessment, 140 treatment guidelines, 55 treatment methods, 54-55 screening technology, 96-97 Ductal lavage, 164, 222, 295, 297, 331 Ducts defined, 330 necrotic debris, 53 Duke University, 110 E ECRI, 195 Effectiveness of mammography screening controversy over, 3-4, 22, 41-44 defined, 249-250, 331 measure of, 40-41 of national programs, 42 technology assessment, 249, 251 Efficacy of screening age and, 42 CAD technology, 94, 95 defined, 249-250, 331 MRI, 98 technology assessment, 249, 251 ultrasound, 100 Elastography, 26-27, 284-285, 286, 331 Electrical impedance imaging, 26-27, 222, 255, 261, 288, 289-290, 331 Electrical potential measurements, 26-27, 288, 289, 331 Electronic palpation, 284, 286, 331 Elscint, Inc., 223 Epidemiological studies, 49 data sources, 242 defined, 331 molecular, 335 recruitment for, 208, 211, 277 of risk factors for breast cancer, 123, 125, 131, 137, 211 Epigenetic changes, 158, 165, 331 Epinephrine, 136 Epithelial cells, 50, 52, 331 ER genes, 135, 174 erbB2 gene, 167 erbB2 protein, 167 erbB2 receptor, 161 Esserman, Laura, 63 Estonia, 66 Estrogen, 76, 124, 125, 132, 134, 135-136, 142, 158, 161, 174 Ethnicity. See Race/ethnicity Etiology of breast cancer, 132, 331 EUROCARE data set, 66 European Code Against Cancer, 5, 74 European Commission, 42 European Institute of Oncology, 42 European Society for Medical Oncology, 42 Evaluation of detection technologies. See also Clinical trials; Technology assessment by health care payers, 227-234 Evidence Practice Centers, 194 Eyre, Harmon, 114-115 F False negative results defined, 331 density of breasts and, 45 risk of, 2 False positive results and biopsy, 43 CAD and, 94, 95 costs of, 4-5, 46, 75 defined, 331 density of breasts and, 45 electrical-property-based technologies, 290 intervals between screening and, 69, 72 malpractice concerns and, 4, 89 and mammogram utilization, 47-48

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis MRI, 98 psychological effects, 47 risk of, 2, 38-39, 45 second opinions and, 74 specialists vs. generalists, 89 Family history of breast cancer, 8, 124, 126, 127, 128, 129, 131, 139, 141, 143, 144, 148, 300, 331. See also Genetic risk factors Fat, dietary, 124 FDA Modernization Act, 224, 225 FDA review and approval accelerated, 14, 226-227, 231, 239 advertising claims and, 221, 225, 256 analyte-specific reagents, 225 approved technologies, 21, 24-27, 92, 94, 96, 98, 161, 173, 222-223, 279, 281, 282, 284, 286, 287, 289, 295, 297 classification of devices, 219-221 clinical studies, 206, 211, 224, 231, 243, 252 devices not requiring, 165-166, 218, 224-226, 256 guidance documents, 227 home-brew in vitro diagnostics, 225, 256-257 humanitarian device exemptions, 226 improvements to, 226-227 inexperience with molecular technologies, 181 industry interactions with, 211, 224, 239 intended use and, 221, 222-223 investigational device exemption, 224 mock 510(k) application, 224 “off-label” use, 225 potential safety risk and, 219-221 premarket approval application, 221, 224 process, 218-227, 255-256, 320-321 role of, 218 time for, 227 Federal Employees Benefits Program, 260 Feigal, David, 221, 227 Fibrocystic breast disease, 52, 204 Financial factors, 46, 80. See also Costs; Health insurance coverage; Malpractice issues access to screening, 2, 21, 69, 76, 78, 100, 103-106 diagnostic mammography losses, 103 in facility closures, 4, 103-106 Fischer Imaging Corp., 222 Florida, 101 Fluorochrome, 175 Fluorodeoxyglucose, 173, 174, 298 Fluoroestradion, 174 Fluoroscopy, 126 Fluorothymidine, 174 Food and Drug Administration. See also FDA review and approval Center for Devices and Radiological Health, 221 Center for Drug Evaluation and Research, 181 CMS coordination with, 240 Device Advice group, 227 reporting adverse events, 239 standard setting for facilities, 82, 83 Fox, Nelene, 260 France, 66, 242 Friends…you can count on, 193 Frost & Sullivan, 258 Full-field digital mammography accuracy, 21, 93, 202 CAD use with, 94 clinical trials, 93, 202, 203, 282 costs, 93, 258 defined, 332 description, 24-25, 280, 282 FDA-approved systems, 21, 221, 222, 279, 282 insurance coverage, 228-229, 232, 258 revenues, 259 risk of breast cancer and use of, 92 specificity, 93 and workflow, 93 Functional imaging, 173 Funding basic medical research, 22, 189-191, 192-193, 209-210 clinical trials, 205, 206, 243 technology development, 234 G Gail, Mitchell, 140 Gamma camera/single-emission photon emission computed tomography, 173 Gastrointestinal tract cancers, 160, 228, 327 Gel electrophoresis, 332 GenBank, 225

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Gene. See also specific genes amplification, 166, 167, 168, 326 copying alterations, 168 defined, 332 positional cloning, 337 profiling, 296, 299 in susceptibility to breast cancer, 126, 129-137, 327 therapy, 172, 175 tumor suppressor, 137, 166, 299-300, 336, 340 Gene expression altered, 158 data repository, 171 molecular imaging of, 173, 175, 178 multidrug resistance, 173 profiling, 164, 165-166, 170, 296 Gene product interactions, 132 General Accounting Office, 80, 83 General Electric Medical Systems, 222, 282 Genetic linkage analysis, 129, 334 Genetic markers, 129, 131, 147, 157, 158-159, 332 Genetic risk factors. See also Mutations autosomal traits, 326 biomarkers, 129, 131, 147, 157, 158-159, 332 BRCA genes, 126, 129-131, 140, 141, 144, 146-147, 327 breast density, 128 counseling, 148 environmental factors and, 129-130 modeling, 8-9, 140-141, 144, 146-147, 149, 157, 167 polymorphisms, 131-137, 167, 158 preventive interventions, 130 rare genetic syndromes, 133 Genetic testing, 131, 141, 148, 158, 208, 225, 256-258, 261, 296, 299-301 Genome defined, 332 screening, 132 transcriptome, 340 Genomics of breast cancer, 164. See also Molecular profiling; Proteomics of breast cancer barriers to clinical use, 170-172 cancer clues, 166-167 expression profiles, 164, 165-166, 170 signaling circuitry, 159, 167-169 Genotype, 332, 336 Germany, 242 Global Summit on Mammographic Screening, 41, 42-43 Glucose transporter-1 (Glut 1), 174 Gotzsche, Peter, 41-43 Gradishar, William J., 96 GSTM1 gene, 134 GSTP1 gene, 134 GSTT1 gene, 134 H Hall-effect imaging, 26-27 Harvard Medical School, 236 Hayes, Inc., 195 Health Care Financing Administration, 196 Health care payers. See also Medicare evaluation of new technologies, 227-234 Health Industry Manufacturers Association, 196 Health insurance coverage and access to screening, 5, 76, 78-79, 103-104 and clinical research participation, 208 clinical utility evaluations by payers, 227-234 conditional, 231 CPT codes and, 232, 233, 258 delays in decisions, 259 reimbursement policies, 103-104, 231, 232, 233-234, 239, 258 and technology adoption, 95, 188, 227-228, 230, 257-259 for treatment, 80 and utilization of mammography, 76, 78-79, 149 Health Insurance Portability and Accountability Act Privacy Rule and bioscience industry, 217-218 and clinical research, 12, 13, 21, 163-164, 171, 211, 213-217 complexity of, 217 and grant and contract review, 217 monitoring effects of, 12, 13, 218 obtaining protected health information, 214-217, 242 personal health information identifiers, 214 Program Announcements and Requests for Applications, 217 purpose, 213

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis and telemammography, 217 and tissue and data repositories, 215, 242 Health maintenance organizations, 332 Herceptin, 167, 210 Heterogeneous characteristics, 159, 161, 332 Heterozygosity defined, 332 loss of, 158, 167, 334 Hexokinase 1, 174 HFE/HH gene, 136 HGF/SF60, 174 High-dose chemotherapy with bone marrow transplantation, 210, 260 Hispanics, 76 Histology, 126, 161, 332 History of breast cancer, 126 Hodgkin’s disease, 126 Hollebeek, Robert, 242 Holologic, Inc., 222, 223, 283 Hormone receptor positive cancer, 125 Hormone replacement therapy, 45, 86, 125, 127, 281 HRAS1 gene, 133 HSP70 gene, 132, 136 Hyperplasia atypical, 52, 126, 326 defined, 332 lobular, 52 I IBM, 242 iCAD, Inc., 21, 94, 222 Illinois, 82 ImageChecker M1000®, 21, 94, 222, 281 Imaging agents, 332-333 Immune response to cancer, 131, 136 Immunocytochemistry, 333 Immunohistochemical assay, 161, 167, 333 Immunology, 333 Immunomodulatory pathways, 136 In situ, defined, 333. See also Ductal carcinoma in situ; Lobular carcinoma in situ In Vivo Cellular and Molecular Imaging Centers, 180 Incidence of breast cancer DCIS, 49-50, 51, 52, 55-56 defined, 333 as endpoint, 199 rates, 1, 31, 43, 50, 51, 76, 77, 142 screens, 67 and survival, 199, 200 Indian Health Care Improvement Act, 1992 Amendments, 81 Indian Health Service, 80 Infiltrating ductal carcinoma, 165, 333 Inflammatory breast cancer, 333 InfoWorld, 240-241 Infrared Sciences Corp., 222 Infrared thermography, 222, 285, 286-287 Institute of Medicine, 80, 106, 193, 230 Instrumentarium Corp., 223 Insurance. See Health insurance coverage; Medicaid; Medicare Intelligent Systems Software, 21, 94 Interagency Council on Biomedical Imaging in Oncology, 234, 237-240 Intergenerational harm, 46 International Agency for Research on Cancer, 41, 42 International Breast MRC Consortium, 98 International Union Against Cancer, 42 Internet2 (Next Generation Internet), 241, 242 Interpretation. See Mammogram interpretation Invasive breast cancer, 19 age and, 51, 124 biomarkers, 159, 298-299 DCIS and, 52, 54, 126 defined, 333 ductal carcinoma, 54-55, 333 incidence, 51 international comparisons, 71 lobular carcinoma, 333 malpractice litigation, 105 mammogram appearance, 52 men, 139 prognosis, 159 sensitivity of screening technologies, 97, 99, 299 survival rates, 71 treatment, 260 Inventive Products, Inc., 223 131/125Iodine, 174 Iodobenzamide, 174 Iowa, 82 Iron metabolism, 136 Italy, 66

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis J Japan, 242 Johns Hopkins University, 166 K Kaiser Permanente, 194 Kaplan-Meier method, 199, 200 Kopans, Daniel, 283 Korea, 45 L Laser-Assisted In Situ Keratomileusis (LASIK) surgery, 226 Legislation. See also Mammography Quality Standards Act; other individual statutes access-promoting, 80 breast cancer-related, 79-82 Lesions anaplastic, 52 comedo, 53 defined, 333 margin visibility, 282 precancerous lesions, 286-287, 337 Leukemia, 204, 327 Lewin Group, 259 Li-Fraumeni syndrome, 133 Liotta, Lance, 182 LKB1 gene, 133 L-myc gene, 134 Lobular carcinoma in situ, 52, 126, 333, 334 Lobular intraepithelial neoplasia (LIN), 52 Loma Linda University, 111 Long Island Breast Cancer Research Project, 208 Lorad Digital Breast Imager, 222 Lumpectomy. See Breast-conserving surgery Lung cancer, 1, 160, 327 Lymphoma, defined, 327 M Magnetic resonance imaging accuracy, 32, 45, 92, 96-98, 202, 294 clinical applications, 96-98, 177, 294, 303 clinical trials, 236, 293-294, 325 contrast-enhanced, 96-97, 293, 294, 332 costs, 98, 294 deceptive marketing of, 30, 31-32, 98, 279 defined, 334 description, 24-25, 293-294 elastographic, 286 FDA approval, 96, 98, 279 functional, 177 image storage, 242 molecular imaging, 174, 175, 176, 177-178 utilization, 258 Magnetic resonance spectroscopy, 26-27, 175, 295, 298-299, 334 Magnetomammography, 26-27 Malignant transformation, 334 Malignant tumors, 334 Malpractice litigation and access to services, 4, 102-103, 104-106 and biopsy rates, 48 CAD and, 95-96 insurance costs, 5, 102-103, 104, 113 international comparisons, 67-68, 69 interpretation-related claims, 91, 105 physician extenders and, 112-113 public expectations and, 105 reporting of radiologist performance and, 91-92 settlement of frivolous cases, 89 tort reform, 104, 106 and workforce shortages, 91-92, 104-106 MAMM, 212 Mammogram defined, 281 image archives, 234, 240-242 Mammogram interpretation. See also Sensitivity of technologies BI-RADS® scale, 44, 83, 84, 91, 242 bias, 315 CAD technology and, 6-7, 93-96, 271-272 case variation and, 85-87 communicating results to patients, 80, 83 context and organizational factors, 67, 86, 89 decision thresholds, 314-319 diagnostic vs. screening, 85, 112

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis double readings, 64-65, 67, 75, 86, 94, 95, 111, 112, 113, 271 first screens vs. subsequent screens, 85, 87 improving, 80, 90-92, 114 legislation, 80 microcalcifications and, 85, 94, 283 by nonphysicians, 111-114, 115, 271-273 options for improving, 90-92 outsourcing to overseas radiologists, 109-110 professional development, 73 quality of, 6-7, 66, 67, 69, 73, 74, 80, 86-89, 103-106 radiologist volume, 91 reporting of performance results, 80, 91-92 ROC analysis, 314-321 self-assessment programs, 74, 271 by specialists vs. generalists, 86, 89, 94-95, 101, 281 standardization of, 45, 69, 83, 91, 98 training, 73, 86, 89, 92, 271, 283 variability among radiologists, 83, 84, 86 volume of procedures and, 69, 87-89, 90, 265 workforce issues, 103-104, 112-113, 271-272 Mammography. See also Diagnostic mammography; Screening mammography; specific technologies defined, 334 facilities, 21 personnel, see Breast imagers; Radiologists technologies, 280-283 Mammography Accreditation Program, 74 Mammography and Beyond report, 2, 109 improvements since issuance of, 21 research recommendations, 10-11, 190-191 technologies reviewed in, 24-27 Mammography Interpretive Skills Assessment, 74 Mammography Quality Standards Act (MQSA), 47, 64 1998 Reauthorization, 80, 83 2003 Reauthorization, 80 costs of compliance, 101-102 criticisms of, 74 data collection requirements, 5 personnel requirements, 113, 272 positive results of, 74, 83, 271 purpose, 61, 79 requirements, 81, 82-83, 113 volume standards, 6, 90, 265 MammoReader®, 21, 94, 222 Marathons, 210-211 Mass media on benefits of mammography, 2-4, 29, 31-32, 41 and “breakthrough” technologies, 4, 30, 31-32 risk portrayal, 3, 29, 30-31, 49, 143 Mass spectroscopy, 334 Massachusetts General Hospital, 178, 283 Mastectomy for DCIS, 55 modified radical, 1, 67 prophylactic bilateral, 19, 130, 144, 273, 301, 337 Maynard, C. Douglas, 107-108 MBF Sales LLC, 223 McGill Pain Questionnaire, 46 MDR1 Pgp, 174 Medicaid, 76, 80, 233, 334. See also Centers for Medicare and Medicaid Services Medical physicist, 113 Medicare, 64, 78, 79, 81. See also Centers for Medicare and Medicaid Services CPT codes, 232, 233 defined, 335 delays in coverage decisions, 259 reimbursement policies, 103, 229 requirements for coverage, 228-229 spending relative to health outcomes, 230 withdrawal of coverage, 231 Medicare Catastrophic Coverage Act of 1988, 79, 81 Medicare Coverage Advisory Committee, 194 Medicare Prescription Drug and Modernization Act, 80 Men, breast cancer, 139 Menarche, 8, 127, 335 Menopause, 45, 86, 127, 142, 335 Menstrual cycle, 45 Messenger RNA (mRNA), 335, 340

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Met tyrosine kinase, 174 Meta-analyses, 132, 199, 335 Metaplasia, 335 Metastatic cancer, 52, 160, 161, 298, 299, 335 Methodological issues bias, 99, 129, 163, 201-202, 323-324, 329, 333 control groups, 323 cross-country comparisons, 69 descriptions of diagnostic or therapeutic techniques, 325 endpoints, 199-201, 323 extrapolation of results, 204-205 generalizability, 320 Gotzsche-Olsen study, 41-43 and meta-analyses, 132, 199, 335 patient population characteristics, 322-323 reference standard, 203 in risk assessments, 123, 124, 131, 199 sample size, 131, 203, 320 statistical analysis and reporting of results, 202, 203, 205, 320, 325, 339 variability in cancer detection tests, 319-321 5-Methylcytosine, 335 Mettlin, Curtis J., 115 Microarrays. See also DNA, microarrays; Protein, microarrays comparative genomic hybridization, 166-167 costs, 166 defined, 335 regulatory challenges, 181 sample handling, 170 statistical analysis of data, 170-171 Microcalcifications, 32, 44 and biopsy, 53, 54 DCIS and, 52, 53, 54, 55, 99, 285 defined, 285, 335 and mammogram interpretation, 85, 94, 283, 290 Microwave imaging, 26-27, 288, 290 Midwestern State University, 111 Mikulski, Barbara, 82 MMP2, 174 Molecular imaging affinity probes, 173-175 animal studies, 9, 172-173, 175, 176, 180, 181 clinical applications, 172, 179, 181-182 clinical research, 236, 237 defined, 172 FDA approval, 177 functional imaging technologies and, 173 MRI, 177-178 multimodal, 176, 177, 178 NCI initiatives, 179-180 noninvasive, 175 optical, 178 radiological, 175-177 research and development, 9, 172-173, 178-180 targets and agents, 174 Molecular Imaging Central, 179 Molecular Imaging Database, 180 Molecular markers, 164, 170, 335. See also Genetic markers Molecular profiling analysis and interpretation of data, 170-171 applications, 164, 165, 168-169, 170 barriers to clinical use, 9, 170-172 clinical trials, 164 high-throughput techniques, 164 limitations, 166, 170, 171-172, 302 regulatory challenges, 181 Monoclonal antibodies, 225 Morbidity, 335 Mortality rates, 19, 20 DCIS and, 50 defined, 336 early detection and, 67 as endpoint, 164, 199, 201 international comparisons, 67, 69, 71, 72 quality of services and, 69, 72, 76 race/ethnicity and, 76, 77 screening and, 1, 40-41, 43, 49, 66 treatment and, 1, 66 Mouse Models of Human Cancer Consortium, 180 Mucin-1 glycoprotein (MUC1), 174 Mucins, 160 Multidisciplinary Clinical Research Workforce Training Program, 238-239 Multidrug resistance, 173, 174, 175 Multifocal breast cancer, 96

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Mutations age factors, 128 on BRCA genes, 8, 49, 128, 129-131, 139, 144, 225, 256-258, 261, 296, 299, 327 cellular control disruptions, 168 defined, 336 DNA repair mechanisms, 49, 128, 129, 166 in estrogen pathways, 135-136 germ-line, 126, 128, 158, 332 in immunomodulatory pathways, 136 in iron metabolism, 136 in metabolic pathways, 132, 134-135 microsatellite, 335 mitigating influences, 130 penetrance, 129-130, 133-134, 144, 336 radiation-induced, 130 random, 128 and screening technology, 96 somatic, 128, 158, 167, 339 in tumor suppressor genes, 340 My Best Friend Breast Self-exam Pad, 223 Myriad Genetics, Inc., 257 N NAT1/NAT2 genes, 134 National Alliance of Breast Cancer Organizations, 212 National Breast and Cervical Cancer Early Detection Program, 78, 80 National Breast Cancer Coalition, 210, 212-213 National Cancer Institute, 10, 13, 22, 42, 93, 182, 208, 234, 236 Breast Cancer Research Progress Group, 10, 190 Cancer Imaging Program, 98, 179-180 Center for Bioinfomatics, 235 Early Detection Research Network, 162-163 funding for research, 189-190, 191, 192, 205, 235 leadership role, 270, 275 National Center for Biotechnology Information, 171 National Center for Health Care Technology, 196 National Center for Health Services Research, 196 National Center for Healthcare Technology, 196 National Digital Mammography Archive, 234, 240-242 National Health Service Breast Screening Programme (UK), 5, 72-73 National Heart, Lung, and Blood Institute, 206 National Institute of Biomedical Imaging and Bioengineering, 108, 196 National Institutes of Health, 11, 107, 225, 230, 276, 278 center programs, 243, 244 Clinical Research Associates, 239 Consensus Development Program, 194, 196 funding for breast cancer research, 22, 23, 80-81, 190 Office on Women’s Health, 98 Roadmap for Medical Research, 195, 237, 238-239 National Library of Medicine, 171, 241 National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifen, 140, 301 Native American Breast and Cervical Cancer Treatment Technical Amendment Act, 80 Native Americans, 45, 80, 81 Near-infrared fluorochromes, 178 Negative predictive value, 39, 97 Neoangiogenesis, 287 Neoplasm, defined, 336 Netherlands, 5-6, 65, 66, 74, 165, 271 Network for Cooperative Development of Imaging Technology, 93, 98, 99, 196, 203, 235-237 New York City, 101 Nipple aspiration, 126, 302, 336 Node-negative breast cancer, 159 Nordic Cochrane Center, 41 Norepinephrine, 136 North Carolina Breast Cancer Screening Program, 79 Novel Imaging Technologies Program, 180 Nurse practitioners, 110 O Oak Ridge National Laboratory, 240 Obesity, 45, 86, 124, 130, 301

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Observational studies, defined, 336 Occult cancer, 96, 97, 160, 336 Olsen, Ole, 41-43 Omnibus Budget Reconciliation Act of 1990, 79, 81 OmniCorder, 222 Office of Health Technology Assessment, 196 Office of Human Research Protections, 239 Office of Medical Applications of Research, 194, 196 Office of Personnel Management, 260 Office of Technology Assessment, 196 Oncogenes, 132, 175, 337 Oncotype DX, 165, 225 Optical imaging animal studies, 176 applications, 173, 174, 178, 291-292 defined, 336 description, 26-27, 291-292 multimodal, 178 of near-infrared absorption by hemoglobin, 173, 174, 291-292 probes, 173, 174, 175, 176, 178, 291-292 Oral contraceptives, 140 Osteoporosis, 260 Outcomes. See also Clinical outcomes; Screening outcomes intermediate, 333 OvaCheck, 225 Ovarian cancer, 129, 156, 160, 169-170, 204, 225, 300, 302, 327 P Paget’s disease of the nipple, 111, 336 Pakastanis, 133 Pancreatic cancer, 160, 327 Pap smear, 78, 336 Papanicolaou, George N., 336 Paramagnetic atom, 175, 177 Parity, 45 Patents as barriers to technology adoption, 256-257 composition of matter, 257, 329 methods of use, 257, 335 Patient-provider relationship, 147-148 Paulsen, Keith, 290 Penetrance, 129-130, 133-134, 144, 336 PERFORMS (PERsonal perFORmance in Mammographic Screening), 73, 74, 88 Personnel. See Breast imagers; Radiologists; Screening personnel Petricoin, Emmanuel, 171 Peutz-Jeghers syndrome, 133 Pfizer, 206 Phelps, Michael, 177 Phenotype, 336, 337 Phillips Medical Systems, Inc., 223 Phosphorylation, 167, 168 Photonics, 337 Physician assistants, 110 Physicians Data Query, 42 Physicians Insurers Association of America, 105 Polycyclic aromatic hydrocarbons, 134, 135 Polymerase chain reaction, 164, 337 Polymorphisms, 131-137, 337 Positive predictive value of biomarkers, 162-163, 205 for biopsy, 67 calculation, 39-40 defined, 39, 337 MRI, 98 prevalence of disease and, 39, 40, 98 Positron emission tomography (PET) applications, 173, 228, 295, 298 defined, 337 description, 26-27, 295, 298 FDA approval, 228, 279 molecular imaging techniques, 173, 174, 175-177, 333 multimodal, 177 reimbursement policy, 228, 258 PR gene, 135 Practice guidelines, 73, 109, 137-138 Precancerous lesions, 158, 160, 286-287, 337 Prevalence defined, 39, 337 positive predictive value and, 39, 40, 98 screens, 67 Prevention of breast cancer, 2, 19 clinical trials, 140 defined, 337 primary, 200 secondary, 79, 199-200 Pritzker, Kenneth, 161-162

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Probability. See also Risk of breast cancer lifetime, 129, 300, 334 p value, 338 ProDuct Catheter, 222 ProDuct Health, Inc., 222 Progesterone, 76, 124, 125, 135, 161 Prognosis biomarkers, 159 DCIS, 144-145 defined, 337 molecular imaging, 173 molecular profiling, 165, 166, 299 perceptions of, 144-145 Progression of disease, 337 Proprietary rights, 337 Prostate cancer, 22, 190, 225, 327, 337 Prostate-specific antigen (PSA) testing, 79, 160, 224-225, 228, 337 Protected health information, 214-215 Protein microarrays, 164, 167-169, 170 phosphorylation, 167, 168 post-translational processing, 168 probes, 177, 178 recombinant, 175 Protein kinase, 133 Proteomics of breast cancer. See also Protein; Serum, proteomic profiling defined, 337 Proto-oncogenes, 132, 133-134, 337-338 PSA biomarker, 327 Psychological issues, 47 PTEN gene, 133 Public expectations, 3, 29-32, 41, 105 Public interest in breast cancer, 29, 82 Q Qualia Computing, Inc., 222 Quality Assessment of Diagnostic Accuracy Studies (QUADAS), 202 Quality of screening services. See also Mammogram interpretation; Sensitivity of technologies; Specificity access to services and, 4, 5, 75-79 accreditation and certification of facilities, 82-83 best practices, 74-75, 253 breast density and, 85, 86 case variation and, 85-87 compliance costs, 101-102 and deployment of new technologies, 264-266 enforcement, 64-65, 83 financial issues, 4-5, 74, 75 history of breast cancer and, 86 integrated health services and, 5, 6, 74, 87 international models, 5-6, 64-73, 74-75, 86, 90, 114, 270-271 legislation, 5, 74, 79-83, 115; see also Mammography Quality Standards Act organizational factors, 5-6, 67, 75, 86, 89, 114, 115, 264-266 performance measures, 75, 85-87 physician extenders and, 7, 112, 271 practice guidelines, 73, 109 practice variation and, 86 QUADAS checklist, 202 recommendations, 4, 6-7, 270-273 and screening outcomes, 72-79 self-assessment programs, 6, 73, 74, 265 site visits, 64-65, 83 technology innovations and, 6-7, 92-100, 115, 264-266, 271 R R2 Technology, Inc., 21, 94, 95, 222, 281 Race/ethnicity and access to screening, 76 and breast density, 45, 128 and incidence of breast cancer, 76, 77 mortality rates and, 76, 77 risk assessment by, 140 Radiation exposure, hypersensitivity to, 48-49, 126, 130, 142-143 Radiation technologists, 111-112 Radioimmunoassay, 222 Radiolabeled probes, 173, 174, 175 Radiologic technologists, 5, 113, 272 Radiological associate, 110-111 Radiological imaging, 175-177 Radiological Society of North America, 107 Radiologists. See also Breast imagers academic, 107, 108 clinical research by, 106-109 foreign, 109-110 interpretation of mammograms, 86, 89, 91, 103, 281 malpractice concerns, 104-106

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis moonlighters, 109 practice variation, 86 reimbursement policies, 103 retired, 109 and technology adoption, 108-109 training, 92, 107, 110, 242, 265, 272 workforce shortages, 4, 100, 101-102, 103-106 Radiology Diagnostic Oncology Group, 236 Radiology practitioner assistant, 110 Radiotherapy, 1, 54, 55 Recall rates. See Callback rates Recommendations leadership role in implementing, 270, 275 quality improvements in screening mammography, 4, 6-7, 270-273 research and development, 4, 10-11, 12-13, 14, 15, 276-277 risk modeling and communication, 4, 8, 10, 273-276 summary of, 16-17 technology adoption process, 4, 14-15, 278 Recurrence of breast cancer, 55, 225 Red-shifted fluorescent proteins, 178 Reliability and reproducibility, 94, 290, 338 Raloxifen, 140, 301 Reproductive factors, 8, 127 Research and development. See also Clinical trials; Technology assessment accelerating, 11, 226-227, 234 animal studies, 172-173 basic medical, 22, 188, 189-190, 195, 274-275 biomarkers, 9, 157, 161-164, 169, 204-205 challenges, 11, 14, 161-164, 170-172, 182-183 collaborative networks, 9-10, 11, 15, 162-163, 179, 180, 182, 211, 218, 230, 234-244, 274, 276 cost-effectiveness analysis, 197, 236 counseling for developers, 237-240 FDA review and approval process, 188, 218-227 funding and funders, 22, 189-191, 192-193, 209-210, 234 health care payers and, 227-234 HIPAA’s impact on, 215-218 medical device classification, 219-221 molecular imaging, 9, 172-173, 178-180 molecular profiling, 170-172 pathway from adoption to clinical practice, 188, 189 population measures of cancer status, 199-201 priorities, 10-11, 190-191 public support for, 209-210 quality of clinical trials and, 198-199 radiologists in, 106-109 reorganization plan, 237, 238-239 screening and diagnostic accuracy improvements, 202-204 support for discovery, 189-197 translational, 238, 249, 275, 340 workforce training, 238-239, 275 Risk of breast cancer. See also Genetic risk factors; Probability; other specific risk factors absolute (lifetime), 43, 123-124, 143, 326 age and, 8, 20, 30, 31, 124, 125, 126, 127, 130, 137, 143-144 assessment, 8, 22, 123, 132, 137, 139-141, 149, 157, 167, 236 and biopsies, 48 communication of, 10, 147-148, 149, 275-276 counseling, 148 DCIS, 140 and decision making, 145-148, 149-150 defined, 338 density of breasts and, 127, 128 double mastectomy and, 19 epidemiological studies, 123, 125, 131, 137, 211, 273 and frequency of screening, 141-142 Gail model, 8, 139-140, 141, 143, 273 individualized prediction, 7-8, 137-141 LIN and, 52 management, 4, 8, 10, 137-148 media portrayal of, 3, 29, 30-31 in men, 139 odds ratio, 336 perception, 3, 29, 143-145, 149, 276 physical exercise and, 130 reduction measures, 144 relative, 123, 124, 128, 143, 338 and screening technology, 92, 96, 97-98, 294 stratification, 48, 131-132, 137-139, 141-143, 146-147, 149, 199, 236, 273

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis study designs, 123, 124, 131, 199 uncertainty, 145-147 RNA. See also Messenger RNA polymerase, 340 transcription, 340 ROC analysis curves mapping decision thresholds, 315-319 decision thresholds on individual readers, 314-315 multiple-reader, multiple-case, 319-321 Rosenberg, Alan, 228, 230, 232 Rosenberg, R.N., 188 S Sarcoma, defined, 327 Schwartz, Lisa, 31-32 Scintimammography defined, 338 description, 26-27, 295, 297-298 EIS compared, 290 FDA approval, 223 tracers, 173 Screen-film (conventional x-ray) mammography accuracy, 21, 92 defined, 338 description, 24-25, 280, 281 FDA approved systems, 223, 279 Screening for breast cancer defined, 338 goals, 20, 38, 40, 85 integration of approaches, 23-24, 29, 74 key strategies for saving lives, 28-29 standard of care, 109, 273, 281 standards of evidence, 38-41 Screening mammography. See also Mammography interpretation; Quality of screening services; Sensitivity of technologies; Specificity adherence to guidelines, 143, 273, 276 adjunctive technologies, 6-7, 99, 155, 156, 157, 160-161, 219, 279, 284, 285, 287, 289-290, 292 benefits, 20, 37, 141, 145 contralateral, 98, 236 controversy over value of, 2, 3-4, 22, 41-44, 63 DCIS dilemma, 49-56 defined, 37 expert reviews of trials, 42-43 facility closures, 103-106 FDA-approved technologies, 21, 94, 96, 98, 279 frequency, 5, 51-52, 67, 69, 72, 141-142 funding for, 80 harms from, 43, 46-49, 141 international comparisons, 63-72 legislation, 79-84 as mammography complement, 155, 157, 160-161 media portrayal of benefits, 2, 29, 31-32, 41 menstrual cycle and, 45 pain and anxiety, 2, 43, 45, 46-47 perceptions of effectiveness, 143, 145, 146 radiation risk, 48-49 referrals, 64-65, 75 standard of care, 7, 40, 281 technologies, 24-27, 280-283 utilization rates, 20, 76, 147-148 views per breast, 64-65, 67 WHO guidelines, 38 Screening outcomes. See also Mortality rates; Survival abnormal, 67, 68, 70 international comparisons, 69-72 quality assurance and, 72-79 terminology, 39 volume of procedures and, 87-89 Screening personnel. See also Breast imagers; Radiologists; Workforce issues and interpretation of mammograms, 91 moonlighters, 109 physician extenders, 7, 110-114, 272-273 recruitment, 80 shortages, 6-7, 80, 91, 101-106, 109-110 and technology adoption, 108-109 Second Look®, 21, 94, 222 Second opinions, 74, 103 Secondary cancer, 338 Self-examination. See Breast self-examination Senographe 2000D, 222, 282, 283 Sensitivity of technologies, 314-315 age factors, 85, 87, 281 CAD, 94, 95 calculation, 38, 39

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis defined, 38, 39, 203, 281, 338 density of breast tissue and, 2, 44-45, 48, 49, 86, 96, 99-100, 105, 281, 282, 294, 297, 298 electrical-property-based technologies, 289, 290 false negatives, 2 false positives, 2, 21, 38-39, 43, 47-48, 87, 89, 94 international comparisons, 70 molecular profiling methods, 169, 170 MRI, 32, 45, 96-97 organizational efficiency and, 265 of radiation technologists, 111 screen-film vs. other technologies, 92, 94, 96-98, 156, 281 SensoScan FFDM, 222 Serum estradiol, 142 proteomic profiling, 159, 164, 169-170, 171, 225, 261, 296, 301-302 Siemens Medical Systems, 223 Sigma-2 receptors, 174 Signal transduction, 173, 338 Single nucleotide polymorphism, 158, 167 Single-photon emission computer tomography (SPECT), 173, 174, 175-177, 333 Small Animal Imaging Resource Program, 180 Smith, Robert A., 115 Social factors, access to screening, 76, 78 Social injustice, 76, 78 Social Security Act Amendments of 1965, 79 Native American Breast and Cervical Cancer Treatment Technical Amendment Act, 80 Society of Breast Imaging, 90, 101 Socioeconomic status, and access to screening, 5, 76 Soft copy, 94, 338 Sonography. See Ultrasound Spain, 66 Specificity calculation, 39 defined, 38, 39, 203, 281, 339 electrical-property-based technologies, 289, 290 international comparisons, 70 lesion margin visibility, 282 molecular profiling methods, 169, 170 of radiation technologists, 111 screen-film mammography, 156, 281 Specimen banks, 339 Spectroscopy. See also Magnetic resonance spectroscopy defined, 339 electrical impedance, 290 Squamous cell carcinoma, 339 Staging of breast cancer, 66-67, 96, 99 Stamp Out Breast Cancer Act, 80-81 Standard of care, 7, 40, 161, 281 Standards for Reporting Diagnostic Accuracy, 202 State laws regulating mammography, 79 States as Certifiers program, 80 Statistical analysis, 314-321 Sullivan, Daniel, 98 Supervised analysis, 165 Surrogate endpoints, 100, 339 Surveillance, defined, 339 Surveillance Epidemiology and End Results (SEER, U.S.) data set, 66 Survival benefit, 333 defined, 199, 339 early diagnosis and, 66-67, 69 as endpoint, 199, 201 incidence of cancer and, 199, 201 international comparisons, 66-67, 71 invasive breast cancer, 71 mastectomy and, 55 measuring, 199, 200 men, 138 overestimation, 333 race/ethnicity and, 76 Susan G. Komen Foundation, 190, 192, 213 Susan Love MD Breast Cancer Foundation, 193, 212 “Suspicious” findings, 48, 98 Sweden, 5-6, 65, 67, 72, 74, 90, 271 Systemic therapy, 339 T T-Scan 2000, 219, 222, 255, 256, 289 Tamoxifen, 54, 55, 130, 301 Technetium-99m, 174, 297 Technologies anatomical, 280-294 biological, 295-302

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis biopsy, 302-306 “breakthrough,” 4, 26, 30, 31-32, 191, 279 FDA-approved, 21, 24-27, 92, 94, 96, 98, 161, 173, 222-223, 279, 281, 282, 284, 286, 287, 289, 295, 297 high-throughput, 164, 169, 332 inappropriate, 109 “promising,” 279 reviewed in Mammography and Beyond report, 24-27 Technology adoption in clinical practice, 3, 100 complexity and, 254-255 consumer demand and, 259-260 cost-effectiveness considerations, 14, 197 deployment, 14, 249-250, 252, 253, 261-266 drivers of, 100, 254-261 FDA approval and, 13, 14, 198, 255-257 information management and, 262, 263 insurance coverage and, 13, 14, 95, 188, 227-228, 229, 257-259 integration into practice, 3, 14, 250, 232, 253, 261-266 minimally invasive cardiac surgery, 263, 264 monitoring, 249, 250, 252, 253, 265 and organizational change, 261-266, 276 patents and, 256-257 patients’ willingness to pay and, 259 perceptions of benefits and, 254 practitioners and, 108-109 process, 251-254, 278 time lapse between R&D and, 23 typology of adopters, 254 void-filling technologies, 260-261 volume-outcome hypothesis, 264 Technology assessment. See also Clinical trials assessors, 193, 194-195 centers, 194, 243-244, 276 in clinical settings, 251-252 defined, 191, 193 by health care delivery organizations, 250, 252-253 by health care payers, 227-234 history of federal involvement in, 196 integration and coordination of, 11, 195-196, 250, 252-253, 276, 278 scope of, 253-254 Telemammography, 109-110, 217, 240, 282, 339 Telomerase expression, 173 Texas Department of Health, 82 TGFBR16a, 134 Thermoacoustic computed tomography, 26-27 Thermography, 26-27, 255, 285, 286-287, 339 Thermorhythmometry, 285, 287 Thermotherapy, 339 Tissue array, 340 Tissue samples, handling, 163 TNF-alpha gene, 132, 136 Tomography. See also Computed tomography defined, 340 fluorescence-mediated, 178 Tomosynthesis. See also Digital tomosynthesis mammography defined, 340 Tp53 gene, 133 TranScan Medical, Inc., 222 Transcription. See also RNA mutations, 134, 135, 137 Transcriptome, 340 Transforming growth factor, 134 Treatment. See also individual treatment modalities clinical trials, 210 combinatorial, 168 DCIS, 54-55 decision aids, 146, 161 gene therapy, 172, 175 high-dose chemotherapy with bone marrow transplantation, 210, 260 image-guided, 172 individualized case management, 9, 182 international comparisons, 67 legislation related to, 80 molecular targeting, 9, 168-169, 172, 175, 182 monitoring response to, 161, 169, 172, 175, 177, 182, 228, 236, 279 predicting response to, 167 staging and follow-up, 96 unnecessary, 1, 21-22, 54-56 Trex Medical Corp., 223 Truquant® BR™ RIA, 222 Tumor suppressor genes, 137, 166, 299-300, 336, 340

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Tumorigenesis changes common in, 165 defined, 340 ionic imbalances, 288, 289 metabolism, 173 vascular activity, 173, 287, 291, 292 Tumors cell surface receptors, 173, 175, 177 defined, 340 electrical conducting properties, 290 high-grade, 54-55 immune response to, 136 marker, 340 occult, 96, 97, 160, 336 palpable, 98-99, 305, 336 staging, 66-67 Tunis, Sean, 228, 230, 232 U UGT1A1 gene, 136 Ultramark 9 HDI Ultrasound System, 222 Ultrasound clinical applications, 54, 98-99, 173, 284, 285-286, 303 clinical trials, 236 combined with screening mammography, 99 contrast agents, 332 cost-effectiveness, 100 defined, 339, 340 density of breast tissue and, 45, 99-100 description, 24-25, 284, 285-286 FDA approval, 98, 222, 284 image storage, 242 molecular imaging, 173, 176 novel techniques, 26-27, 54, 173, 286 quality for screening, 96, 98-100 United HealthCare, 195 United Kingdom data archives, 242 intervals for screening, 5 organization of screening services, 5 perceptions of benefits of mammography, 145 quality assurance program, 65, 66, 74, 92, 271 radiographers, 111, 112 risk perception by women in, 143 malpractice environment, 69, 89, 111 National Health Service Breast Screening Programme, 5, 72-73 screening outcomes, 70-71 volume standards, 90 workforce issues, 111, 112 United States Preventive Services Task Force, 43, 194, 232 University of California at Los Angeles, 177 University of California at San Francisco, 306 University of Chicago, 240 University of Kentucky, 110 University of Medicine and Dentistry, 111 University of North Carolina, 111, 240, 283 University of Pennsylvania, 240 University of Texas Health Science Center, 42 University of Toronto, 240 University of Virginia, 292 Unsupervised analysis, 165, 169 Urokinase plasminogen activator, 159 U.S. Air Force, 109 U.S. Army, 109 U.S. Navy, 109 U.S. Postal Service, 80 Utilization of mammography age and, 20, 64 false positive results and, 47-48 increasing, 269 insurance coverage and, 76, 78-79, 149 rates, 20, 76, 147-148 risk perception and, 143, 273, 276 V Validity. See Clinical validity Van Nuys Prognostic Index, 53 Vasoactive intestinal peptide receptors, 174 VDR gene, 137 Venipuncture, defined, 340 Veterans’ Benefits Act of 1997, 80 Veterans Health Administration, 80 Visual Analog Scale and Brief Pain Inventory, 46 W Weber State University, 110 Weissleder, Ralph, 178 WellPoint Health Networks, 195, 228, 229, 230, 232

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Saving Women’s Lives: Strategies for Improving Breast Cancer Detection and Diagnosis Whites, 76, 128, 133, 208 Windy Hill Technology, Inc. Aspirator, 222 Workforce issues. See also Breast imagers; Radiologists access to screening services, 4, 7, 21, 100, 101-102, 103-106, 115 capacity building strategies, 7, 109-114 malpractice litigation, 91-92, 104-106, 112-113 physician extenders, 7, 110-114, 272-273 recommendations, 7 research and development, 106-109 technology adoption, 108-109 World Health Organization, 42. See also International Agency for Research on Cancer principles of effective screening, 38 X X-rays defined, 340 monoenergetic, 335 synchrotron-based machine, 260, 283 Y Y-Me National Breast Cancer Organization, 212 Z Zerhouni, Elias, 195, 237 Zheng, Bin, 94

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