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From page 213... ... Index Accidental deaths, 18 Acetazolamide, 188n.9 Activities of daily living, 61 Adoption of technology, vii-viii, 149, 151, 169, 171-173, see also Diffusion of technology, Translation of technology Agency for Health Care Policy and Research, 14, 47, 183-184 Agriculture, 147 AIDS, vii drugs, 1,2,21,30, 155 and intermediate endpoints, 177 Alanine aminotransferase testing, 83 Alcoholism, 5 Allopurinol, 188n.9 Alpha-blockage drugs, 38 Alpha receptors, 154 Amantadine, 188n.9 American Association of Neurological Surgeons, 192n.48 American Society of Anesthesiologists, 62 American Urological Association, 42 Analgesics, 193n.65 Anaphylactoid reactions, 20 Angina pectoris, 9, 183, 193n.63 beta-blockers treatment, =6, 154 coronary artery bypass grafting, 6-7 data base analysis, 63-64 213 PTCA catheter equipment, 7-8 Angioplasty, 56 coronary, 7-8, 9 laser, 165-166, 170 Animal testing, 4, 153-154, 158, 172, l91n.32 Antibiotics, 54, 140 Antidepressants, 3, 188n.9 Anti-infective drugs, 157, 186, 193n.65, 193-194n.66 Anti-inflammatory drugs, 70, 188n.9 Antineoplastic drugs, 186 Anxiety, 5 APACHE II system, 60 Apgar score, 93 Aplastic anemia, 158-159 Arrow, Kenneth, 43 Arterial grafts, l91n.36 Arteriography, 6 Artificial heart, 165 Artificial Heart Assessment Panel, 17 Aspirin, 140, 145, 188n.9 Association for the Advancement of Medical Instrumentation, 168 Asthma, 5 Astra, 188n.10 Atherosclerotic disease, 3 Auranofin, 29, 157 Australia, 47 AZT, 30 Read the entire page →
From page 214... ... 214 Bacon, Francis, 1, 148 Bayesian statistical methods, 12, 101-116 hierarchical Bayes methods, 112 see also Meta-analysis Benign prostatic hyperplasia (BPH) 12, 33-38, 39-40, 41, 42, 81, 184 Benoxaprofen, 74 Bernard, Claude, 148 Beta-blockers, 9, 188nn.9, 10 angina pectoris treatment, 4-6, 193n.63 discovery of, 153, 154 practolol, 68 Beta receptors, 154 Biases, 129, 131, 133 case control studies and, 125, 126 coding, 56 Confidence Profile Method and, 102-103, 107-110, 113-114, 115 contact, 57 contamination, 102-103, 124, 130 cross-over, 102-103, 124, 125, 127, 129 databases and, 125, 126 dilution, 124, 130 intensity, 124 internal and external validity, 121, 124-126 meta-analysis and, 95 publication, 89 randomized controlled clinical trial and, 130, 157, 168, 189n.17 reporting and coding, 56-57 Bioengineering research, 162-163, l91n.31 Biological revolution, 1, 175 Biologicals, 149, 187-188n.4, 188n.5 Biomedical research, vii, 1, 9-10, 12, 149, 175, 178, 192n.46 Biomedical science, 43, 44, 45 Biotechnology industry, 151, 152 Black, James, 4 Blinding, 157, 189n.17 Blindness, 5 Blood cholesterol, 11, 18 Blood pressure, beta-blockers and, 154 Boehringer Ingelheim, 4n.3 Boston, 44 BPH, see Benign prostatic hyperplasia '`BPH Shared Medical Decision Making Procedure," 37-38, 40, 45-46 Breast cancer, 20 screening, 121-122, 127, 130-131 British Medical Journal, 18 Bronchodilators, 4 Bypass surgery, 54 CLOG, see Coronary artery bypass grafting Canada, 62 Cancer, 69 INDEX chemotherapy, 11, 17, 21 data bases, 62 drugs, 2, 21, 189n.19 mortality, 11, 18 surrogate endpoints and, 21 Captopril, 29, 157 Cardiac denervation, 6 Cardiac mortality, 11, 18 Cardiovascular disease data base, 7 Cardiovascular disease, surrogate endpoints end, 21 Cardiovascular drugs, 157, 186, 193n.65 Cardiovascular function, 24n.1 Cardiovascular implants, 165 Carotid endarterectomy, 54, 55 Case-control studies, 121, 122-123, 130, 161, 190n.28 bias in, 125, 126 Case Western Reserve University, 164 Central nervous system, 149 Cerebral ischemia, 3 Certificate of Need, 151, 169 Cesarean delivery, 92, 93 Charlson comorbidity index, 59 Chemical analysis, automated, 164 Chloramphenicol, 158-159 Cholecystectomy, 53-54, 175 Chymopapain, 20 Cimetidine, 177-178 Cleveland Clinic, 6 Clinical decision making, 10, 12-13, 43, 54 see also Decision making, shared Clinical endpoints, see Endpoints, Medical technologies Clinical evaluation, see Clinical procedures, Drugs, Medical devices, Observational studies, Surgical procedures Clinical procedures decision analysis and, 78-79, 85-86 development of, 149, 151, 170-173, 182-183, 192n.47 evaluation of, 3, 9, 13-14, 118, 128, 135-136, 173-174, 183-186, 187-188n.4 geographic variations, 3 post-marketing surveillance, 17-18, 144, 170175 research f~ndings and, 149, 175, 186 see also Medical technologies Clinical series, 121, 128 Clinical trials, 70, 83, 84, 184 data collection, 23-24 decision analysis and, 78-79, 82-83, 85-86 health status measures, 29, 32 Investigational New Drug, 155 medical devices, 166-168, l91n.38 new medical procedures, 173-174 Read the entire page →
From page 215... ... , ~7, 9, 89, 173, 193n.63 Coronary artery disease, 8, 63, 173 Coronary artery surgery, 89, 174 geographic variations, 182 Coronary Artery Surgery Study, 6-7, 174 Coronary death, 188n.9 Coronary thrombi, 16 Costs healthcare,41 45, 86, 127, 160, 169, 184, l90n.26 innovation, 118 new chemical enities, 176,192n.54, research, 161-162 Coumadin, 143 Courage to Fail (Fox and Swazey) , 171 Crossover bias, see Biases Cyclosporine, 140 Data bases, 12, 47-50, 51-54, 121, 123 automated, 3-4, 161, 185 bias in, 125, 126 Manitoba, 55, 56, 57, 59 60, 62 Medicaid, 12, 52, 161 medical device evaluations, 170 Medicare, 47~8, 53, 55, 56, 57, 62, 64 meta-analysis, 92 outcome measures, 6~61 Oxford Perinatal Trials, 93 Prescription-Event Monitoring, 73 primary, 63-64 quality of, 89 215 record linkage, 61-63 risk adjustment, 58-60 strengths of, 49-54 weaknesses of, 55-58 see also Medical technologies Decision analysis, 12-13, 36, 45, 78-87, 185 Decision making, shared, 39, 40-41, 44, 45-46 Denmark, 42 Descartes, Rene, 148 Devices, see Medical devices Device Experience Network, 170 Diabetes insipidus, 188n.9 Diabetes mellitus, 55 Diagnosis-related groups (DRG) Read the entire page →
From page 216... ... , 11, 156 Esophagitis, 74 Europe bioengineering research, 162 health insurance systems, 47 new drug development, 176, 187 European Cooperative Surgery Study, 6-7, 174 European Economic Community, 193n.60 Evaluation, see Clinical procedures, Drugs, Medical devices, Observational studies, Surgical procedures Event monitoring, 72 Experimental research designs, 13-14, 129 External validity, 121, 124-126 Extracranial-intracranial (EC/IC) bypass surgery, 3, 173, 192n.48 [amily Practitioner Committee (United Kingdom) Read the entire page →
From page 217... ... , 61, 63, 151, 169, 191-192n.44 217 Health insurance coverage, 57 data base research, 12, 47, 51, 52, 55, 57, 58-59, 60-62, 63-64, 175 Health maintenance organizations (HMOs) , 161 Health outcomes, 117 Health status measurement, 10, 23-32 Heart attack, 119 beta-blockers and, 154 Heart disease, practolol treatment, 68 Heart surgery, 73 Heart transplants, 192n.50 Heparin, 140 Hepatitis, non-A non-B, 83, 84 Hepatitis B vaccination, 84-85, 86 Heuristics, 12, 126-128, 133 Hierarchical Bayes method, 112 see also Bayesian statistical methods Hip fractures, 63 Hip replacement, 55 geographic variations, 182 Hospitals data bases, 48, 55, 56-57, 58, 62 and medical devices, 169 mortality, 60, 63 readmission, 57, 61 Human testing, 154-155, 176, 186, 187-188n.4, 189n.14, 192n.53 Hyper-cholesterolemia, 156 Hyperkalemia, 76 Hypertension, 3, 5 Hysterectomy, 19, 52, 57, 175 Imaging techniques, 149 Immunoassays, 78 Immunosuppression, 143 Imperial Chemical Industries (ICI) Read the entire page →
From page 218... ... , 83~4, 180 Maine, prostatectomy survey, 33, 35, 41, 42 Mammary arteries, 7 Mammography, 130 Manitoba data system, 51-52, 55, 56, 57, 59-60, 62 prostatectomy survey, 42, 50, 53, 63 Massachusetts Institute of Technology, 164 Mastectomy, 20 Measuring Health (McDowell and Newell) , 27 Medicaid, data base, 12, 52, 161 Medical audit, 2~21 Medical decision making, see Clinical decision making Medical Device Amendments, see Food, Drug, and Cosmetic Act Medical device industry, 29, 151, 178, 184 Medical devices, 191nn.36, 37 clinical evaluation of, 23, 135-136, 18~181, 183-186, 187-188n.4, 191n.32 decision analysis and, 78 development of, 9, 149, 151, 164-169, 18~182, 191n.35, 191-192n.44, 192n.45, 193n.61 invention of, 162-164 post-marketing surveillance, 144, 169-170 see also Medical technologies Medical profession and drug efficacy, 139 FDA and, 139 and post-marketing studies, 141-142, 144-145 and regulation, 135-138 see also Hospitals, Physicians Medical societies, 192n.47 Medical technologies biases and, 124-126, 127-128 clinical evaluation of, 1-4, 9-10, 13-14, 5~51, 117-120, 128-134, 135-136, 15~151, 183-186 data base research, 60 decision analysis and, 78 development of, 149-151, 187-188n.4 economic evaluation of, 2n.1 endpoints in, 16 post-marketing surveillance, 17-18 quality of information and, 121-124 technology families, 112, 113 see also Clinical procedures, Data bases, Drugs, Medical devices, Surgical procedures Medicare, 191-192n.44 Mortality Predictor System, 60 Read the entire page →
From page 219... ... , 72-73 Office of Technology Assessment (OTA) , 162 Ophthalmologic disorders, 21 Oraflex, 74 Organization for Economic Cooperation and Development, 192nn.46, 52 Orphan drugs, 189-19On.23 Orthopedic surgery, 55 Osmosin, 74 Outcomes, 11, 13-14, 183, 185 all-cause, 11, 16, 18, 19, 21 conditionJdisease-specif~c, 11, 16, 18, 19, 20 data base analysis, 50, 51, 58, 60 61, 63, 175 errors in measurement of, 102, 124, 125, 127 research, 33, 38, 43, 45-46 surrogate endpoints and, 16, 20 Oxford Data Base of Perinatal Trials, 93 Oxicams, 155 Parkinson s disease, 171 Patent protection, 13, 163, 178, 186, 188n.12, 193nn.58, 59, 60 Patient events, 12 Patient Outcomes Research Team (PORT) Read the entire page →
From page 220... ... , l90n.25 Probenecid, 188n.9 Procedures, see Clinical procedures Product License Application, 159 Pronethalol, 4, 154 Propranolol, 4-5, 154 Prospect theory, 86-87 Prospective Payment System, 56, 160, 169 Prospective trials, 38, 105 Prostatectomy, 19, 50, 54, 62, 63, 175 effectiveness, 34-38, 41 mortality, 42-43, 53 Prostatic cancer, 143 Prostatic hyperplasia, benign (BPH) , see Benign prostatic hyperplasia Prostatotomy, 38 Psychopharmacological drugs, 157, 186, 188n.9, 193n.65, 193-194n.66 Psychotherapy, 89-90, 91, 170 PTCA, see Percutaneous transluminal coronary angioplasty Public health, 92 Public Health Service Act (1944) Read the entire page →
From page 221... ... , 33 Sulfinpyrazone, 188n.9 Surgical procedures, 192n.51 angina pectoris, 6-7 data base analysis of, 55, 56, 61 development of, 3, 9, 170, 172-173 eff~cacy studies, 62 evaluation of, 41, 45, 54, 118, 174 geographic variations in rates, 35-38 mortality, 39, 60, 85-86 see also Clinical procedures, Medical technologies Surrogate endpoints, see Endpoints Sweden, 192n.46 Swine flu vaccine, 19 Switzerland, 192n.46 Read the entire page →
From page 222... ... , 5, 11-12,68,71-74,77 Yellow Card System, 70, 73-74, 16~161, l90n.27 INDEX United States biomedical research, 162, 192n.46 Congress, 14, 140, 176-177 drug pricing in, l90n.25 drug research investment, 175-177 health insurance systems, 47-48, 57, 62 medical device regulation, 164 new drug introductions, 187, 192n.54 patent law, 178 post-marketing surveillance in, 17, 139, 142, 160 see also Food and Drug Administration Urethra, 42 Urologists, 17-18, 33-34, 42 Utilities, see Patient preferences Vaccination hepatitis B 84-85, 86 influenza, 52, 53 swine flu, 19 Vaginal cancer, 19 Validity, see External validity, Internal validity Variations, see Geographic vanations Vascular surgery, 55 Veterans Administration, 6-7, 8, 174 Videodisc technology, 37, 38 Vineberg procedure, 7n.4, 173 Viral diseases, 140 Wales, 71-72 WallStreet Journal, 16, 17 Watchful waiting, 35, 36-38, 39, 41, 54, 81, 82 Watt, James, 148 West Germany, biomedical research, 162, 192n.46 White, E Read the entire page →

From page 213...

... Index Accidental deaths, 18 Acetazolamide, 188n.9 Activities of daily living, 61 Adoption of technology, vii-viii, 149, 151, 169, 171-173, see also Diffusion of technology, Translation of technology Agency for Health Care Policy and Research, 14, 47, 183-184 Agriculture, 147 AIDS, vii drugs, 1,2,21,30, 155 and intermediate endpoints, 177 Alanine aminotransferase testing, 83 Alcoholism, 5 Allopurinol, 188n.9 Alpha-blockage drugs, 38 Alpha receptors, 154 Amantadine, 188n.9 American Association of Neurological Surgeons, 192n.48 American Society of Anesthesiologists, 62 American Urological Association, 42 Analgesics, 193n.65 Anaphylactoid reactions, 20 Angina pectoris, 9, 183, 193n.63 beta-blockers treatment, =6, 154 coronary artery bypass grafting, 6-7 data base analysis, 63-64 213 PTCA catheter equipment, 7-8 Angioplasty, 56 coronary, 7-8, 9 laser, 165-166, 170 Animal testing, 4, 153-154, 158, 172, l91n.32 Antibiotics, 54, 140 Antidepressants, 3, 188n.9 Anti-infective drugs, 157, 186, 193n.65, 193-194n.66 Anti-inflammatory drugs, 70, 188n.9 Antineoplastic drugs, 186 Anxiety, 5 APACHE II system, 60 Apgar score, 93 Aplastic anemia, 158-159 Arrow, Kenneth, 43 Arterial grafts, l91n.36 Arteriography, 6 Artificial heart, 165 Artificial Heart Assessment Panel, 17 Aspirin, 140, 145, 188n.9 Association for the Advancement of Medical Instrumentation, 168 Asthma, 5 Astra, 188n.10 Atherosclerotic disease, 3 Auranofin, 29, 157 Australia, 47 AZT, 30

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From page 214...

... 214 Bacon, Francis, 1, 148 Bayesian statistical methods, 12, 101-116 hierarchical Bayes methods, 112 see also Meta-analysis Benign prostatic hyperplasia (BPH) 12, 33-38, 39-40, 41, 42, 81, 184 Benoxaprofen, 74 Bernard, Claude, 148 Beta-blockers, 9, 188nn.9, 10 angina pectoris treatment, 4-6, 193n.63 discovery of, 153, 154 practolol, 68 Beta receptors, 154 Biases, 129, 131, 133 case control studies and, 125, 126 coding, 56 Confidence Profile Method and, 102-103, 107-110, 113-114, 115 contact, 57 contamination, 102-103, 124, 130 cross-over, 102-103, 124, 125, 127, 129 databases and, 125, 126 dilution, 124, 130 intensity, 124 internal and external validity, 121, 124-126 meta-analysis and, 95 publication, 89 randomized controlled clinical trial and, 130, 157, 168, 189n.17 reporting and coding, 56-57 Bioengineering research, 162-163, l91n.31 Biological revolution, 1, 175 Biologicals, 149, 187-188n.4, 188n.5 Biomedical research, vii, 1, 9-10, 12, 149, 175, 178, 192n.46 Biomedical science, 43, 44, 45 Biotechnology industry, 151, 152 Black, James, 4 Blinding, 157, 189n.17 Blindness, 5 Blood cholesterol, 11, 18 Blood pressure, beta-blockers and, 154 Boehringer Ingelheim, 4n.3 Boston, 44 BPH, see Benign prostatic hyperplasia '`BPH Shared Medical Decision Making Procedure," 37-38, 40, 45-46 Breast cancer, 20 screening, 121-122, 127, 130-131 British Medical Journal, 18 Bronchodilators, 4 Bypass surgery, 54 CLOG, see Coronary artery bypass grafting Canada, 62 Cancer, 69 INDEX chemotherapy, 11, 17, 21 data bases, 62 drugs, 2, 21, 189n.19 mortality, 11, 18 surrogate endpoints and, 21 Captopril, 29, 157 Cardiac denervation, 6 Cardiac mortality, 11, 18 Cardiovascular disease data base, 7 Cardiovascular disease, surrogate endpoints end, 21 Cardiovascular drugs, 157, 186, 193n.65 Cardiovascular function, 24n.1 Cardiovascular implants, 165 Carotid endarterectomy, 54, 55 Case-control studies, 121, 122-123, 130, 161, 190n.28 bias in, 125, 126 Case Western Reserve University, 164 Central nervous system, 149 Cerebral ischemia, 3 Certificate of Need, 151, 169 Cesarean delivery, 92, 93 Charlson comorbidity index, 59 Chemical analysis, automated, 164 Chloramphenicol, 158-159 Cholecystectomy, 53-54, 175 Chymopapain, 20 Cimetidine, 177-178 Cleveland Clinic, 6 Clinical decision making, 10, 12-13, 43, 54 see also Decision making, shared Clinical endpoints, see Endpoints, Medical technologies Clinical evaluation, see Clinical procedures, Drugs, Medical devices, Observational studies, Surgical procedures Clinical procedures decision analysis and, 78-79, 85-86 development of, 149, 151, 170-173, 182-183, 192n.47 evaluation of, 3, 9, 13-14, 118, 128, 135-136, 173-174, 183-186, 187-188n.4 geographic variations, 3 post-marketing surveillance, 17-18, 144, 170175 research f~ndings and, 149, 175, 186 see also Medical technologies Clinical series, 121, 128 Clinical trials, 70, 83, 84, 184 data collection, 23-24 decision analysis and, 78-79, 82-83, 85-86 health status measures, 29, 32 Investigational New Drug, 155 medical devices, 166-168, l91n.38 new medical procedures, 173-174

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From page 215...

... , ~7, 9, 89, 173, 193n.63 Coronary artery disease, 8, 63, 173 Coronary artery surgery, 89, 174 geographic variations, 182 Coronary Artery Surgery Study, 6-7, 174 Coronary death, 188n.9 Coronary thrombi, 16 Costs healthcare,41 45, 86, 127, 160, 169, 184, l90n.26 innovation, 118 new chemical enities, 176,192n.54, research, 161-162 Coumadin, 143 Courage to Fail (Fox and Swazey) , 171 Crossover bias, see Biases Cyclosporine, 140 Data bases, 12, 47-50, 51-54, 121, 123 automated, 3-4, 161, 185 bias in, 125, 126 Manitoba, 55, 56, 57, 59 60, 62 Medicaid, 12, 52, 161 medical device evaluations, 170 Medicare, 47~8, 53, 55, 56, 57, 62, 64 meta-analysis, 92 outcome measures, 6~61 Oxford Perinatal Trials, 93 Prescription-Event Monitoring, 73 primary, 63-64 quality of, 89 215 record linkage, 61-63 risk adjustment, 58-60 strengths of, 49-54 weaknesses of, 55-58 see also Medical technologies Decision analysis, 12-13, 36, 45, 78-87, 185 Decision making, shared, 39, 40-41, 44, 45-46 Denmark, 42 Descartes, Rene, 148 Devices, see Medical devices Device Experience Network, 170 Diabetes insipidus, 188n.9 Diabetes mellitus, 55 Diagnosis-related groups (DRG)

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From page 216...

... , 11, 156 Esophagitis, 74 Europe bioengineering research, 162 health insurance systems, 47 new drug development, 176, 187 European Cooperative Surgery Study, 6-7, 174 European Economic Community, 193n.60 Evaluation, see Clinical procedures, Drugs, Medical devices, Observational studies, Surgical procedures Event monitoring, 72 Experimental research designs, 13-14, 129 External validity, 121, 124-126 Extracranial-intracranial (EC/IC) bypass surgery, 3, 173, 192n.48 [amily Practitioner Committee (United Kingdom)

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From page 217...

... , 61, 63, 151, 169, 191-192n.44 217 Health insurance coverage, 57 data base research, 12, 47, 51, 52, 55, 57, 58-59, 60-62, 63-64, 175 Health maintenance organizations (HMOs) , 161 Health outcomes, 117 Health status measurement, 10, 23-32 Heart attack, 119 beta-blockers and, 154 Heart disease, practolol treatment, 68 Heart surgery, 73 Heart transplants, 192n.50 Heparin, 140 Hepatitis, non-A non-B, 83, 84 Hepatitis B vaccination, 84-85, 86 Heuristics, 12, 126-128, 133 Hierarchical Bayes method, 112 see also Bayesian statistical methods Hip fractures, 63 Hip replacement, 55 geographic variations, 182 Hospitals data bases, 48, 55, 56-57, 58, 62 and medical devices, 169 mortality, 60, 63 readmission, 57, 61 Human testing, 154-155, 176, 186, 187-188n.4, 189n.14, 192n.53 Hyper-cholesterolemia, 156 Hyperkalemia, 76 Hypertension, 3, 5 Hysterectomy, 19, 52, 57, 175 Imaging techniques, 149 Immunoassays, 78 Immunosuppression, 143 Imperial Chemical Industries (ICI)

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From page 218...

... , 83~4, 180 Maine, prostatectomy survey, 33, 35, 41, 42 Mammary arteries, 7 Mammography, 130 Manitoba data system, 51-52, 55, 56, 57, 59-60, 62 prostatectomy survey, 42, 50, 53, 63 Massachusetts Institute of Technology, 164 Mastectomy, 20 Measuring Health (McDowell and Newell) , 27 Medicaid, data base, 12, 52, 161 Medical audit, 2~21 Medical decision making, see Clinical decision making Medical Device Amendments, see Food, Drug, and Cosmetic Act Medical device industry, 29, 151, 178, 184 Medical devices, 191nn.36, 37 clinical evaluation of, 23, 135-136, 18~181, 183-186, 187-188n.4, 191n.32 decision analysis and, 78 development of, 9, 149, 151, 164-169, 18~182, 191n.35, 191-192n.44, 192n.45, 193n.61 invention of, 162-164 post-marketing surveillance, 144, 169-170 see also Medical technologies Medical profession and drug efficacy, 139 FDA and, 139 and post-marketing studies, 141-142, 144-145 and regulation, 135-138 see also Hospitals, Physicians Medical societies, 192n.47 Medical technologies biases and, 124-126, 127-128 clinical evaluation of, 1-4, 9-10, 13-14, 5~51, 117-120, 128-134, 135-136, 15~151, 183-186 data base research, 60 decision analysis and, 78 development of, 149-151, 187-188n.4 economic evaluation of, 2n.1 endpoints in, 16 post-marketing surveillance, 17-18 quality of information and, 121-124 technology families, 112, 113 see also Clinical procedures, Data bases, Drugs, Medical devices, Surgical procedures Medicare, 191-192n.44 Mortality Predictor System, 60

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From page 219...

... , 72-73 Office of Technology Assessment (OTA) , 162 Ophthalmologic disorders, 21 Oraflex, 74 Organization for Economic Cooperation and Development, 192nn.46, 52 Orphan drugs, 189-19On.23 Orthopedic surgery, 55 Osmosin, 74 Outcomes, 11, 13-14, 183, 185 all-cause, 11, 16, 18, 19, 21 conditionJdisease-specif~c, 11, 16, 18, 19, 20 data base analysis, 50, 51, 58, 60 61, 63, 175 errors in measurement of, 102, 124, 125, 127 research, 33, 38, 43, 45-46 surrogate endpoints and, 16, 20 Oxford Data Base of Perinatal Trials, 93 Oxicams, 155 Parkinson s disease, 171 Patent protection, 13, 163, 178, 186, 188n.12, 193nn.58, 59, 60 Patient events, 12 Patient Outcomes Research Team (PORT)

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From page 220...

... , l90n.25 Probenecid, 188n.9 Procedures, see Clinical procedures Product License Application, 159 Pronethalol, 4, 154 Propranolol, 4-5, 154 Prospect theory, 86-87 Prospective Payment System, 56, 160, 169 Prospective trials, 38, 105 Prostatectomy, 19, 50, 54, 62, 63, 175 effectiveness, 34-38, 41 mortality, 42-43, 53 Prostatic cancer, 143 Prostatic hyperplasia, benign (BPH) , see Benign prostatic hyperplasia Prostatotomy, 38 Psychopharmacological drugs, 157, 186, 188n.9, 193n.65, 193-194n.66 Psychotherapy, 89-90, 91, 170 PTCA, see Percutaneous transluminal coronary angioplasty Public health, 92 Public Health Service Act (1944)

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From page 221...

... , 33 Sulfinpyrazone, 188n.9 Surgical procedures, 192n.51 angina pectoris, 6-7 data base analysis of, 55, 56, 61 development of, 3, 9, 170, 172-173 eff~cacy studies, 62 evaluation of, 41, 45, 54, 118, 174 geographic variations in rates, 35-38 mortality, 39, 60, 85-86 see also Clinical procedures, Medical technologies Surrogate endpoints, see Endpoints Sweden, 192n.46 Swine flu vaccine, 19 Switzerland, 192n.46

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From page 222...

... , 5, 11-12,68,71-74,77 Yellow Card System, 70, 73-74, 16~161, l90n.27 INDEX United States biomedical research, 162, 192n.46 Congress, 14, 140, 176-177 drug pricing in, l90n.25 drug research investment, 175-177 health insurance systems, 47-48, 57, 62 medical device regulation, 164 new drug introductions, 187, 192n.54 patent law, 178 post-marketing surveillance in, 17, 139, 142, 160 see also Food and Drug Administration Urethra, 42 Urologists, 17-18, 33-34, 42 Utilities, see Patient preferences Vaccination hepatitis B 84-85, 86 influenza, 52, 53 swine flu, 19 Vaginal cancer, 19 Validity, see External validity, Internal validity Variations, see Geographic vanations Vascular surgery, 55 Veterans Administration, 6-7, 8, 174 Videodisc technology, 37, 38 Vineberg procedure, 7n.4, 173 Viral diseases, 140 Wales, 71-72 WallStreet Journal, 16, 17 Watchful waiting, 35, 36-38, 39, 41, 54, 81, 82 Watt, James, 148 West Germany, biomedical research, 162, 192n.46 White, E

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Index Pages 213-222

Index
Pages 213-222