Saving Women's Lives Strategies for Improving Breast Cancer Detection and Diagnosis (2005) / Chapter Skim
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From page 341... ...
See also Analytical validity; menarche, 127 Sensitivity of technologies; Specificity menopause, 127 of biological technologies, 156, 160, 161 mutations, 128 biopsies, 161, 290, 299 radiation sensitivity, 48 CAD technology and, 202, 281 risk of breast cancer, 8, 20, 30, 31, 124, clinical trials of, 202-204 125, 126, 127, 130, 137, 143-144, defined, 326 199 digital mammography, 21, 93 sensitivity of mammography, 85, 87, molecular profiling, 170 281 MRI, 32, 45, 92, 96-98, 294 standard of care, 7, 40, 281 of radiation technologists, 111-112 utilization of mammography, 20, 64 341
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From page 342... ...
See also Angiogenesis, 159, 165, 172, 173, 287, 326 Annas, George, 215 Biomarkers and biomarker assays; Anti-angiogenesis drugs, 172 Molecular imaging; Molecular profiling; specific technologies Antibodies, 167, 175, 177 Antigens, 177, 326 clinical applications, 155, 156-157, 181 Antihypertensive and Lipid Lowering 182, 274 costs of, 166, 297 Treatment to Prevent Heart Attack Trial (ALLHAT) , 205, 206-207, 208- FDA approval, 161, 181 209, 210, 253 Bioluminate, Inc., 306 Bioluminescent probes, 175, 176, 178 APC gene, 137 Apoptosis, 165, 173, 175, 177 Biomarkers and biomarker assays.
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From page 343... ...
, 22, 157, 160-161 81, 190, 192 molecular, 164, 170, 335 Breast-conserving surgery, 1, 54, 55, 67 and risk stratification, 147 Breast density screening for candidates, 164, 169 age and, 45, 86 validation, 162-163 and biopsy method, 53 Biomira, Inc., 222 ethnic variation, 45, 128 Biopsy influential factors, 45, 86 accuracy and reliability, 161, 290, 299, mapping, 286 306 and risk of cancer, 127, 128 core needle, 52-53, 302, 304, 306, 329 and sensitivity of screening technologies, defined, 303, 327 2, 44-45, 48, 86, 96, 99-100, 105, density of breast tissue and, 53 281, 282, 294, 297, 298 fine needle aspiration, 126, 299, 301, Breast imagers. See also Radiologists 304-305, 331 capacity-building strategies, 104 image-guided, 292, 303, 305 demand for, 103-106 international comparisons, 68, 69, 70-71 shortages, 21, 101, 103, 106-107 LIN detection, 52 Breast self-examination, 223, 327 mammography sensitivity and, 21, 43, Breast size, 53, 55, 96, 100 48, 69 BreastScanIRTM, 222 microcalcifications and, 53, 54 Bristol-Myers Squibb, 206 positive, 126 Brookhaven National Laboratory, 283 prior, as risk factor, 8 Brown University, 110 rates, 48, 70-71 Burke, Wylie, 130 risk factors for, 48 SmartProbe, 303, 305-306 specimen handling, 166 C stereotactic, 52-53, 305, 339 supplemental technologies, 170, 305 CA 15-3 protein, 160, 161, 327 surgical, 53, 69, 71, 302, 303-304, 306 CA 125 biomarker, 327 California Breast Cancer Research Program, ultrasound-guided, 54, 285 unnecessary or "excess," 5, 48, 66, 68, 69 190, 192 vacuum-assisted, 53-54 Callback rates, 69, 75, 94, 271 BioScanIR® Technologies, Inc., 222 Canada, 5, 64, 72, 88, 90, 143, 144 Blood tests, 21, 142, 155-156, 182, 204 Cancer.
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From page 344... ...
See also protected health information, 214-215 Tamoxifen quality of, 11-12, 198-199, 202 Chemoprophylaxis, 328 radiologists' contributions to, 107, 109 Chemotherapy randomized, 42, 164, 201, 202, 206, defined, 328 328, 338 high-dose, 30 recruitment of subjects, 12-13, 207-211, mastectomy and, 1 212-213, 260, 277 Choline, 298 reporting adverse events, 239 Chromosomes, 166, 328 reviews by expert groups, 41-44 Cigarette smoking, 140, 301 of screening and diagnostic accuracy, Circadian rhythm, 287 202-204 Cisplatin, 167 of screening modality, 201-202, 236 Clement, Tony, 257 statistical analysis, 314-321 Clinical breast examination, 78, 99, 286, 328 surrogate endpoints, 100, 339 Clinical Imaging Drugs and Enhancers Clinical utility, defined, 328 Program, 180 Clinical validity, 162-163, 328 Clinical Laboratory Improvement Cloning, positional, 337 Amendments, 225, 256 Cohort studies, 124, 125, 328-329 Clinical outcomes Colorado Mammography Project, 264-266 defined, 328 Community-based programs, 79 predictors of, 161, 165 Comprehensive Cancer Centers, 243-244 Clinical Research Affiliates Funding Trials, Computed tomography, 176, 177, 178, 213 291, 292, 329, 332, 339 Clinical Research Enhancement Act, 205 Computer-aided detection (CAD) Clinical Trial Cooperative Groups, 180 accuracy, 202, 281, 317-318 Clinical trials.
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From page 345... ...
See DNA COMT gene, 136 Department of Defense, 278 Confounding factors, 324, 329 funding for breast cancer research, 10, Consolidated Appropriations Act for FY 22, 81, 191, 192 2004, 83 Medical Research Program, 22, 190 Contrast agents, 96-97, 177, 283, 329, 332 radiology training program, 110 Controlled observational studies, 329 Department of Health and Human Services, Cost-benefit analysis, 329 13, 277 Cost-effectiveness of technologies, 100, 170, Detection, early, 1, 2, 67, 69, 75, 282, 330 197, 232, 236, 265, 330 Detoxification enzymes, 134 Costs, 166 Diagnostic mammography of biological technologies, 166, 297 adjunct technologies, 298 of clinical trials, 206 defined, 37, 281, 330 of compliance with MQSA, 101-102 financial losses from, 103 of digital mammography, 93 interpretation of mammograms, 85, 112 of false positives, 4-5, 46, 75 technologies, 24-27, 96 of genetic testing, 131 Diagnostic testing, 330 of malpractice insurance, 98, 294 Dietary factors, 124, 301 quality assurance, 101-102 Diffraction enhanced imaging, 280, 283 of screening mammography, 75 Diffuse optical tomography, 173, 291-292 Cowden syndrome, 133 Digital Imaging and Communications in Critical Assessment of Microarray Data Medicine, 242 Analysis, 171 Digital Mammographic Imaging Screening Cross-sectional comparison, 330 Trial (DMIST) , 93, 203, 205, 208, Cultural factors, 78 229, 236, 253, 258, 282 Cummings, Steven, 142 Digital mammography.
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From page 346... ...
See Race/ethnicity treatment guidelines, 55 Etiology of breast cancer, 132, 331 treatment methods, 54-55 EUROCARE data set, 66 screening technology, 96-97 European Code Against Cancer, 5, 74 Ductal lavage, 164, 222, 295, 297, 331 European Commission, 42 Ducts European Institute of Oncology, 42 defined, 330 European Society for Medical Oncology, 42 necrotic debris, 53 Evaluation of detection technologies. See Duke University, 110 also Clinical trials; Technology assessment by health care payers, 227-234 E Evidence Practice Centers, 194 Eyre, Harmon, 114-115 ECRI, 195 Effectiveness of mammography screening controversy over, 3-4, 22, 41-44 F defined, 249-250, 331 measure of, 40-41 False negative results of national programs, 42 defined, 331 technology assessment, 249, 251 density of breasts and, 45 Efficacy of screening risk of, 2 age and, 42 False positive results CAD technology, 94, 95 and biopsy, 43 defined, 249-250, 331 CAD and, 94, 95 MRI, 98 costs of, 4-5, 46, 75 technology assessment, 249, 251 defined, 331 ultrasound, 100 density of breasts and, 45 Elastography, 26-27, 284-285, 286, 331 electrical-property-based technologies, Electrical impedance imaging, 26-27, 222, 290 255, 261, 288, 289-290, 331 intervals between screening and, 69, 72 Electrical potential measurements, 26-27, malpractice concerns and, 4, 89 288, 289, 331 and mammogram utilization, 47-48
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From page 347... ...
See also Genetic Food and Drug Administration. See also risk factors FDA review and approval Fat, dietary, 124 Center for Devices and Radiological FDA Modernization Act, 224, 225 Health, 221 FDA review and approval Center for Drug Evaluation and accelerated, 14, 226-227, 231, 239 Research, 181 advertising claims and, 221, 225, 256 CMS coordination with, 240 analyte-specific reagents, 225 Device Advice group, 227 approved technologies, 21, 24-27, 92, reporting adverse events, 239 94, 96, 98, 161, 173, 222-223, 279, standard setting for facilities, 82, 83 281, 282, 284, 286, 287, 289, 295, Fox, Nelene, 260 297 France, 66, 242 classification of devices, 219-221 Friends...you can count on, 193 clinical studies, 206, 211, 224, 231, 243, Frost & Sullivan, 258 252 Full-field digital mammography devices not requiring, 165-166, 218, accuracy, 21, 93, 202 224-226, 256 CAD use with, 94 guidance documents, 227 clinical trials, 93, 202, 203, 282 home-brew in vitro diagnostics, 225, costs, 93, 258 256-257 defined, 332 humanitarian device exemptions, 226 description, 24-25, 280, 282 improvements to, 226-227 FDA-approved systems, 21, 221, 222, inexperience with molecular 279, 282 technologies, 181 insurance coverage, 228-229, 232, 258 industry interactions with, 211, 224, 239 revenues, 259 intended use and, 221, 222-223 risk of breast cancer and use of, 92 investigational device exemption, 224 specificity, 93 mock 510(k)
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From page 348... ...
See also Mutations 103-104 and clinical research participation, 208 autosomal traits, 326 biomarkers, 129, 131, 147, 157, 158- clinical utility evaluations by payers, 159, 332 227-234 conditional, 231 BRCA genes, 126, 129-131, 140, 141, 144, 146-147, 327 CPT codes and, 232, 233, 258 breast density, 128 delays in decisions, 259 reimbursement policies, 103-104, 231, counseling, 148 environmental factors and, 129-130 232, 233-234, 239, 258 modeling, 8-9, 140-141, 144, 146-147, and technology adoption, 95, 188, 227 228, 230, 257-259 149, 157, 167 polymorphisms, 131-137, 167, 158 for treatment, 80 preventive interventions, 130 and utilization of mammography, 76, 78-79, 149 rare genetic syndromes, 133 Genetic testing, 131, 141, 148, 158, 208, Health Insurance Portability and 225, 256-258, 261, 296, 299-301 Accountability Act Privacy Rule and bioscience industry, 217-218 Genome defined, 332 and clinical research, 12, 13, 21, 163 screening, 132 164, 171, 211, 213-217 complexity of, 217 transcriptome, 340 Genomics of breast cancer, 164. See also and grant and contract review, 217 Molecular profiling; Proteomics of monitoring effects of, 12, 13, 218 obtaining protected health information, breast cancer barriers to clinical use, 170-172 214-217, 242 cancer clues, 166-167 personal health information identifiers, 214 expression profiles, 164, 165-166, 170 signaling circuitry, 159, 167-169 Program Announcements and Requests Genotype, 332, 336 for Applications, 217 purpose, 213
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From page 349... ...
, 241, HSP70 gene, 132, 136 242 Hyperplasia Interpretation. See Mammogram atypical, 52, 126, 326 interpretation defined, 332 Invasive breast cancer, 19 lobular, 52 age and, 51, 124 biomarkers, 159, 298-299 DCIS and, 52, 54, 126 I defined, 333 ductal carcinoma, 54-55, 333 IBM, 242 incidence, 51 iCAD, Inc., 21, 94, 222 international comparisons, 71 Illinois, 82 lobular carcinoma, 333 ImageChecker M1000®, 21, 94, 222, 281 malpractice litigation, 105 Imaging agents, 332-333 mammogram appearance, 52 Immune response to cancer, 131, 136 men, 139 Immunocytochemistry, 333 prognosis, 159 Immunohistochemical assay, 161, 167, 333 sensitivity of screening technologies, 97, Immunology, 333 99, 299 Immunomodulatory pathways, 136 survival rates, 71 In situ, defined, 333.
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From page 350... ...
See also Mammography Quality Malignant tumors, 334 Standards Act; other individual Malpractice litigation statutes and access to services, 4, 102-103, 104 access-promoting, 80 106 breast cancer-related, 79-82 and biopsy rates, 48 Lesions CAD and, 95-96 anaplastic, 52 insurance costs, 5, 102-103, 104, 113 comedo, 53 international comparisons, 67-68, 69 defined, 333 interpretation-related claims, 91, 105 margin visibility, 282 physician extenders and, 112-113 precancerous lesions, 286-287, 337 public expectations and, 105 Leukemia, 204, 327 reporting of radiologist performance Lewin Group, 259 and, 91-92 Li-Fraumeni syndrome, 133 settlement of frivolous cases, 89 Liotta, Lance, 182 tort reform, 104, 106 LKB1 gene, 133 and workforce shortages, 91-92, 104L-myc gene, 134 106 Lobular carcinoma in situ, 52, 126, 333, 334 MAMM, 212 Lobular intraepithelial neoplasia (LIN) , 52 Mammogram Loma Linda University, 111 defined, 281 Long Island Breast Cancer Research Project, image archives, 234, 240-242 208 Mammogram interpretation.
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From page 351... ...
See also Centers mammography; Screening for Medicare and Medicaid Services mammography; specific technologies CPT codes, 232, 233 defined, 334 defined, 335 facilities, 21 delays in coverage decisions, 259 personnel, see Breast imagers; reimbursement policies, 103, 229 Radiologists requirements for coverage, 228-229 technologies, 280-283 spending relative to health outcomes, Mammography Accreditation Program, 74 230 Mammography and Beyond report, 2, 109 withdrawal of coverage, 231 improvements since issuance of, 21 Medicare Catastrophic Coverage Act of research recommendations, 10-11, 190- 1988, 79, 81 191 Medicare Coverage Advisory Committee, technologies reviewed in, 24-27 194 Mammography Interpretive Skills Medicare Prescription Drug and Assessment, 74 Modernization Act, 80 Mammography Quality Standards Act Men, breast cancer, 139 (MQSA) , 47, 64 Menarche, 8, 127, 335 1998 Reauthorization, 80, 83 Menopause, 45, 86, 127, 142, 335 2003 Reauthorization, 80 Menstrual cycle, 45 costs of compliance, 101-102 Messenger RNA (mRNA)
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From page 352... ...
See also DNA, microarrays; Monoclonal antibodies, 225 Protein, microarrays Morbidity, 335 comparative genomic hybridization, Mortality rates, 19, 20 166-167 DCIS and, 50 costs, 166 defined, 336 defined, 335 early detection and, 67 regulatory challenges, 181 as endpoint, 164, 199, 201 sample handling, 170 international comparisons, 67, 69, 71, statistical analysis of data, 170-171 72 Microcalcifications, 32, 44 quality of services and, 69, 72, 76 and biopsy, 53, 54 race/ethnicity and, 76, 77 DCIS and, 52, 53, 54, 55, 99, 285 screening and, 1, 40-41, 43, 49, 66 defined, 285, 335 treatment and, 1, 66 and mammogram interpretation, 85, 94, Mouse Models of Human Cancer 283, 290 Consortium, 180 Microwave imaging, 26-27, 288, 290 Mucin-1 glycoprotein (MUC1) , 174 Midwestern State University, 111 Mucins, 160 Mikulski, Barbara, 82 Multidisciplinary Clinical Research MMP2, 174 Workforce Training Program, 238Molecular imaging 239 affinity probes, 173-175 Multidrug resistance, 173, 174, 175 animal studies, 9, 172-173, 175, 176, Multifocal breast cancer, 96 180, 181
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From page 353... ...
INDEX 353 Mutations National Center for Healthcare Technology, age factors, 128 196 on BRCA genes, 8, 49, 128, 129-131, National Digital Mammography Archive, 139, 144, 225, 256-258, 261, 296, 234, 240-242 299, 327 National Health Service Breast Screening cellular control disruptions, 168 Programme (UK) , 5, 72-73 defined, 336 National Heart, Lung, and Blood Institute, DNA repair mechanisms, 49, 128, 129, 206 166 National Institute of Biomedical Imaging in estrogen pathways, 135-136 and Bioengineering, 108, 196 germ-line, 126, 128, 158, 332 National Institutes of Health, 11, 107, 225, in immunomodulatory pathways, 136 230, 276, 278 in iron metabolism, 136 center programs, 243, 244 in metabolic pathways, 132, 134-135 Clinical Research Associates, 239 microsatellite, 335 Consensus Development Program, 194, mitigating influences, 130 196 penetrance, 129-130, 133-134, 144, 336 funding for breast cancer research, 22, radiation-induced, 130 23, 80-81, 190 random, 128 Office on Women's Health, 98 and screening technology, 96 Roadmap for Medical Research, 195, somatic, 128, 158, 167, 339 237, 238-239 in tumor suppressor genes, 340 National Library of Medicine, 171, 241 My Best Friend Breast Self-exam Pad, 223 National Surgical Adjuvant Breast and Myriad Genetics, Inc., 257 Bowel Project Study of Tamoxifen and Raloxifen, 140, 301 Native American Breast and Cervical N Cancer Treatment Technical Amendment Act, 80 NAT1/NAT2 genes, 134 Native Americans, 45, 80, 81 National Alliance of Breast Cancer Near-infrared fluorochromes, 178 Organizations, 212 Negative predictive value, 39, 97 National Breast and Cervical Cancer Early Neoangiogenesis, 287 Detection Program, 78, 80 Neoplasm, defined, 336 National Breast Cancer Coalition, 210, 212 Netherlands, 5-6, 65, 66, 74, 165, 271 213 Network for Cooperative Development of National Cancer Institute, 10, 13, 22, 42, Imaging Technology, 93, 98, 99, 93, 182, 208, 234, 236 196, 203, 235-237 Breast Cancer Research Progress Group, New York City, 101 10, 190 Nipple aspiration, 126, 302, 336 Cancer Imaging Program, 98, 179-180 Node-negative breast cancer, 159 Center for Bioinfomatics, 235 Nordic Cochrane Center, 41 Early Detection Research Network, 162- Norepinephrine, 136 163 North Carolina Breast Cancer Screening funding for research, 189-190, 191, 192, Program, 79 205, 235 Novel Imaging Technologies Program, 180 leadership role, 270, 275 Nurse practitioners, 110 National Center for Biotechnology Information, 171 National Center for Health Care O Technology, 196 National Center for Health Services Oak Ridge National Laboratory, 240 Research, 196 Obesity, 45, 86, 124, 130, 301
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From page 354... ...
intermediate, 333 applications, 173, 228, 295, 298 OvaCheck, 225 defined, 337 Ovarian cancer, 129, 156, 160, 169-170, description, 26-27, 295, 298 204, 225, 300, 302, 327 FDA approval, 228, 279 molecular imaging techniques, 173, 174, 175-177, 333 P multimodal, 177 reimbursement policy, 228, 258 Paget's disease of the nipple, 111, 336 PR gene, 135 Pakastanis, 133 Practice guidelines, 73, 109, 137-138 Pancreatic cancer, 160, 327 Precancerous lesions, 158, 160, 286-287, Pap smear, 78, 336 337 Papanicolaou, George N., 336 Prevalence Paramagnetic atom, 175, 177 defined, 39, 337 Parity, 45 positive predictive value and, 39, 40, 98 Patents screens, 67 as barriers to technology adoption, 256 Prevention of breast cancer, 2, 19 257 clinical trials, 140 composition of matter, 257, 329 defined, 337 methods of use, 257, 335 primary, 200 Patient-provider relationship, 147-148 secondary, 79, 199-200 Paulsen, Keith, 290 Pritzker, Kenneth, 161-162
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From page 355... ...
testing, 79, practice guidelines, 73, 109 160, 224-225, 228, 337 practice variation and, 86 Protected health information, 214-215 QUADAS checklist, 202 Protein recommendations, 4, 6-7, 270-273 microarrays, 164, 167-169, 170 and screening outcomes, 72-79 phosphorylation, 167, 168 self-assessment programs, 6, 73, 74, 265 post-translational processing, 168 site visits, 64-65, 83 probes, 177, 178 technology innovations and, 6-7, 92 recombinant, 175 100, 115, 264-266, 271 Protein kinase, 133 Proteomics of breast cancer. See also Protein; Serum, proteomic profiling R defined, 337 Proto-oncogenes, 132, 133-134, 337-338 R2 Technology, Inc., 21, 94, 95, 222, 281 Race/ethnicity PSA biomarker, 327 Psychological issues, 47 and access to screening, 76 PTEN gene, 133 and breast density, 45, 128 and incidence of breast cancer, 76, 77 Public expectations, 3, 29-32, 41, 105 Public interest in breast cancer, 29, 82 mortality rates and, 76, 77 risk assessment by, 140 Radiation exposure, hypersensitivity to, 48 Q 49, 126, 130, 142-143 Radiation technologists, 111-112 Qualia Computing, Inc., 222 Radioimmunoassay, 222 Quality Assessment of Diagnostic Accuracy Radiolabeled probes, 173, 174, 175 Studies (QUADAS)
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From page 356... ...
See also Clinical and decision making, 145-148, 149-150 trials; Technology assessment defined, 338 accelerating, 11, 226-227, 234 density of breasts and, 127, 128 animal studies, 172-173 double mastectomy and, 19 basic medical, 22, 188, 189-190, 195, epidemiological studies, 123, 125, 131, 274-275 137, 211, 273 biomarkers, 9, 157, 161-164, 169, 204- and frequency of screening, 141-142 205 Gail model, 8, 139-140, 141, 143, 273 challenges, 11, 14, 161-164, 170-172, individualized prediction, 7-8, 137-141 182-183 LIN and, 52 collaborative networks, 9-10, 11, 15, management, 4, 8, 10, 137-148 162-163, 179, 180, 182, 211, 218, media portrayal of, 3, 29, 30-31 230, 234-244, 274, 276 in men, 139 cost-effectiveness analysis, 197, 236 odds ratio, 336 counseling for developers, 237-240 perception, 3, 29, 143-145, 149, 276 FDA review and approval process, 188, physical exercise and, 130 218-227 reduction measures, 144 funding and funders, 22, 189-191, 192- relative, 123, 124, 128, 143, 338 193, 209-210, 234 and screening technology, 92, 96, 97-98, health care payers and, 227-234 294 HIPAA's impact on, 215-218 stratification, 48, 131-132, 137-139, medical device classification, 219-221 141-143, 146-147, 149, 199, 236, molecular imaging, 9, 172-173, 178-180 273
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From page 357... ...
See also Breast Screening for breast cancer imagers; Radiologists; Workforce defined, 338 issues goals, 20, 38, 40, 85 and interpretation of mammograms, 91 integration of approaches, 23-24, 29, 74 moonlighters, 109 key strategies for saving lives, 28-29 physician extenders, 7, 110-114, 272 standard of care, 109, 273, 281 273 standards of evidence, 38-41 recruitment, 80 Screening mammography. See also shortages, 6-7, 80, 91, 101-106, 109 Mammography interpretation; 110 Quality of screening services; and technology adoption, 108-109 Sensitivity of technologies; Specificity Second Look®, 21, 94, 222 adherence to guidelines, 143, 273, 276 Second opinions, 74, 103 adjunctive technologies, 6-7, 99, 155, Secondary cancer, 338 156, 157, 160-161, 219, 279, 284, Self-examination.
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From page 358... ...
, 173, 174, 175- early diagnosis and, 66-67, 69 177, 333 as endpoint, 199, 201 Small Animal Imaging Resource Program, incidence of cancer and, 199, 201 180 international comparisons, 66-67, 71 Smith, Robert A., 115 invasive breast cancer, 71 Social factors, access to screening, 76, 78 mastectomy and, 55 Social injustice, 76, 78 measuring, 199, 200 Social Security Act men, 138 Amendments of 1965, 79 overestimation, 333 Native American Breast and Cervical race/ethnicity and, 76 Cancer Treatment Technical Susan G Komen Foundation, 190, 192, 213 Amendment Act, 80 Susan Love MD Breast Cancer Foundation, Society of Breast Imaging, 90, 101 193, 212 Socioeconomic status, and access to "Suspicious" findings, 48, 98 screening, 5, 76 Sweden, 5-6, 65, 67, 72, 74, 90, 271 Soft copy, 94, 338 Systemic therapy, 339 Sonography.
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From page 359... ...
See also individual treatment and organizational change, 261-266, 276 modalities patents and, 256-257 clinical trials, 210 patients' willingness to pay and, 259 combinatorial, 168 perceptions of benefits and, 254 DCIS, 54-55 practitioners and, 108-109 decision aids, 146, 161 process, 251-254, 278 gene therapy, 172, 175 time lapse between R&D and, 23 high-dose chemotherapy with bone typology of adopters, 254 marrow transplantation, 210, 260 void-filling technologies, 260-261 image-guided, 172 volume-outcome hypothesis, 264 individualized case management, 9, 182 Technology assessment. See also Clinical international comparisons, 67 trials legislation related to, 80 assessors, 193, 194-195 molecular targeting, 9, 168-169, 172, centers, 194, 243-244, 276 175, 182 in clinical settings, 251-252 monitoring response to, 161, 169, 172, defined, 191, 193 175, 177, 182, 228, 236, 279 by health care delivery organizations, predicting response to, 167 250, 252-253 staging and follow-up, 96 by health care payers, 227-234 unnecessary, 1, 21-22, 54-56 history of federal involvement in, 196 Trex Medical Corp., 223 integration and coordination of, 11, Truquant® BRTM RIA, 222 195-196, 250, 252-253, 276, 278 Tumor suppressor genes, 137, 166, 299 scope of, 253-254 300, 336, 340
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From page 360... ...
Postal Service, 80 clinical applications, 54, 98-99, 173, Utilization of mammography 284, 285-286, 303 age and, 20, 64 clinical trials, 236 false positive results and, 47-48 combined with screening increasing, 269 mammography, 99 insurance coverage and, 76, 78-79, 149 contrast agents, 332 rates, 20, 76, 147-148 cost-effectiveness, 100 risk perception and, 143, 273, 276 defined, 339, 340 density of breast tissue and, 45, 99-100 description, 24-25, 284, 285-286 V FDA approval, 98, 222, 284 image storage, 242 Validity. See Clinical validity molecular imaging, 173, 176 Van Nuys Prognostic Index, 53 novel techniques, 26-27, 54, 173, 286 Vasoactive intestinal peptide receptors, 174 quality for screening, 96, 98-100 VDR gene, 137 United HealthCare, 195 Venipuncture, defined, 340 United Kingdom Veterans' Benefits Act of 1997, 80 data archives, 242 Veterans Health Administration, 80 intervals for screening, 5 Visual Analog Scale and Brief Pain organization of screening services, 5 Inventory, 46 perceptions of benefits of mammography, 145 quality assurance program, 65, 66, 74, W 92, 271 radiographers, 111, 112 Weber State University, 110 Weissleder, Ralph, 178 risk perception by women in, 143 malpractice environment, 69, 89, 111 WellPoint Health Networks, 195, 228, 229, 230, 232
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From page 361... ...
See also Breast imagers; X-rays Radiologists defined, 340 access to screening services, 4, 7, 21, monoenergetic, 335 100, 101-102, 103-106, 115 synchrotron-based machine, 260, 283 capacity building strategies, 7, 109-114 malpractice litigation, 91-92, 104-106, 112-113 Y physician extenders, 7, 110-114, 272- Y-Me National Breast Cancer Organization, 273 212 recommendations, 7 research and development, 106-109 technology adoption, 108-109 Z World Health Organization, 42. See also International Agency for Research on Zerhouni, Elias, 195, 237 Cancer Zheng, Bin, 94 principles of effective screening, 38
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